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Mitchel is a reporter for MDedge based in the Philadelphia area. He started with the company in 1992, when it was International Medical News Group (IMNG), and has since covered a range of medical specialties. Mitchel trained as a virologist at Roswell Park Memorial Institute in Buffalo, and then worked briefly as a researcher at Boston Children's Hospital before pivoting to journalism as a AAAS Mass Media Fellow in 1980. His first reporting job was with Science Digest magazine, and from the mid-1980s to early-1990s he was a reporter with Medical World News. @mitchelzoler
PURE Healthy Diet Score validated
MUNICH – A formula for scoring diet quality that during its development phase significantly correlated with overall survival received validation when tested using three independent, large data sets that together included almost 80,000 people.
With these new findings the PURE Healthy Diet Score had now shown consistent, significant correlations with overall survival and the incidence of MI and stroke in a total of about 218,000 people from 50 countries who had been followed in any of four separate studies. This new validation is especially notable because the optimal diet identified by the scoring system diverged from current American diet recommendations in two important ways: Optimal food consumption included three daily servings of full-fat dairy and 1.5 servings daily of unprocessed red meat Andrew Mente, PhD, reported at the annual congress of the European Society of Cardiology. He explained this finding as possibly related to the global scope of the study, which included many people from low- or middle-income countries where average diets are usually low in important nutrients.
The PURE Healthy Diet Score should now be “considered for broad, global dietary recommendations,” Dr. Mente said in a video interview. Testing a diet profile in a large, randomized trial would be ideal, but also difficult to run. Until then, the only alternative for defining an evidence-based optimal diet is observational data, as in the current study. The PURE Healthy Diet Score “is ready for routine use,” said Dr. Mente, a clinical epidemiologist at McMaster University in Hamilton, Canada.
Dr. Mente and his associates developed the Pure Healthy Diet Score with data taken from 138,527 people enrolled in the Prospective Urban Rural Epidemiology (PURE) study. They published a pair of reports in 2017 with their initial findings that also included some of their first steps toward developing the score (Lancet. 2017 Nov 4; 380[10107]:2037-49; 380[10107]:2050-62). The PURE analysis identified seven food groups for which daily intake levels significantly linked with survival: fruits, vegetables, nuts, legumes, dairy, red meat, and fish. Based on this, they devised a scoring formula that gives a person a rating of 1-5 for each of these seven food types, from the lowest quintile of consumption, which scores 1, to the highest quintile, which scores 5. The result is a score than can range from 7 to 35. They then divided the PURE participants into quintiles based on their intakes of all seven food types and found the highest survival rate among people in the quintile with the highest intake level for all of the food groups.
The best-outcome quintile consumed on average about eight servings of fruits and vegetables daily, 2.5 servings of legumes and nuts, three servings of full-fat daily, 1.5 servings of unprocessed red meat, and 0.3 servings of fish (or about two servings of fish weekly). Energy consumption in the best-outcome quintile received 54% of calories as carbohydrates, 28% as fat, and 18% as protein. In contrast, the worst-outcomes quintile received 69% of calories from carbohydrates, 19% from fat, and 12% from protein.
In a model that adjusted for all measured confounders the people in PURE with the best-outcome diet had a statistically significant, 25% reduced all-cause mortality, compared with people in the quintile with the worst diet.
To validate the formula the researchers used data collected from three other trials run by their group at McMaster University:
- The ONTARGET and TRANSCEND studies (N Engl J Med. 2008 Apr 10;358[15]:1547-58), which together included diet and outcomes data for 31,546 patients with vascular disease. Diet analysis and scoring showed that enrolled people in the quintile with the highest score had a statistically significant 24% relative reduction in mortality, compared with the quintile with the worst score after adjusting for measured confounders.
- The INTERHEART study (Lancet. 2004 Sep 11;364[9438]:937-52), which had data for 27,098 people and showed that the primary outcome of incident MI was a statistically significant 22% lower after adjustment in the quintile with the best diet score, compared with the quintile with the worst score.
- The INTERSTROKE study (Lancet. 2016 Aug 20;388[10046]:761-75), with data for 20,834 people, showed that the rate of stroke was a statistically significant 25% lower after adjustment in the quintile with the highest diet score, compared with those with the lowest score.
Dr. Mente had no financial disclosures.
Dr. Mente and his associates have validated the PURE Healthy Diet Score. However, it remains unclear whether the score captures all of the many facets of diet, and it’s also uncertain whether the score is sensitive to changes in diet.
Another issue with the quintile analysis that the researchers used to derive the formula was that the spread between the median scores of the bottom, worst-outcome quartile and the top, best-outcome quartile was only 7 points on a scale that ranged from 7 to 35. The small magnitude of the difference in scores between the bottom and top quintiles might limit the discriminatory power of this scoring system.
Eva Prescott, MD, is a cardiologist at Bispebjerg Hospital in Copenhagen. She has been an advisor to AstraZeneca, NovoNordisk, and Sanofi. She made these comments as designated discussant for the report.
Dr. Mente and his associates have validated the PURE Healthy Diet Score. However, it remains unclear whether the score captures all of the many facets of diet, and it’s also uncertain whether the score is sensitive to changes in diet.
Another issue with the quintile analysis that the researchers used to derive the formula was that the spread between the median scores of the bottom, worst-outcome quartile and the top, best-outcome quartile was only 7 points on a scale that ranged from 7 to 35. The small magnitude of the difference in scores between the bottom and top quintiles might limit the discriminatory power of this scoring system.
Eva Prescott, MD, is a cardiologist at Bispebjerg Hospital in Copenhagen. She has been an advisor to AstraZeneca, NovoNordisk, and Sanofi. She made these comments as designated discussant for the report.
Dr. Mente and his associates have validated the PURE Healthy Diet Score. However, it remains unclear whether the score captures all of the many facets of diet, and it’s also uncertain whether the score is sensitive to changes in diet.
Another issue with the quintile analysis that the researchers used to derive the formula was that the spread between the median scores of the bottom, worst-outcome quartile and the top, best-outcome quartile was only 7 points on a scale that ranged from 7 to 35. The small magnitude of the difference in scores between the bottom and top quintiles might limit the discriminatory power of this scoring system.
Eva Prescott, MD, is a cardiologist at Bispebjerg Hospital in Copenhagen. She has been an advisor to AstraZeneca, NovoNordisk, and Sanofi. She made these comments as designated discussant for the report.
MUNICH – A formula for scoring diet quality that during its development phase significantly correlated with overall survival received validation when tested using three independent, large data sets that together included almost 80,000 people.
With these new findings the PURE Healthy Diet Score had now shown consistent, significant correlations with overall survival and the incidence of MI and stroke in a total of about 218,000 people from 50 countries who had been followed in any of four separate studies. This new validation is especially notable because the optimal diet identified by the scoring system diverged from current American diet recommendations in two important ways: Optimal food consumption included three daily servings of full-fat dairy and 1.5 servings daily of unprocessed red meat Andrew Mente, PhD, reported at the annual congress of the European Society of Cardiology. He explained this finding as possibly related to the global scope of the study, which included many people from low- or middle-income countries where average diets are usually low in important nutrients.
The PURE Healthy Diet Score should now be “considered for broad, global dietary recommendations,” Dr. Mente said in a video interview. Testing a diet profile in a large, randomized trial would be ideal, but also difficult to run. Until then, the only alternative for defining an evidence-based optimal diet is observational data, as in the current study. The PURE Healthy Diet Score “is ready for routine use,” said Dr. Mente, a clinical epidemiologist at McMaster University in Hamilton, Canada.
Dr. Mente and his associates developed the Pure Healthy Diet Score with data taken from 138,527 people enrolled in the Prospective Urban Rural Epidemiology (PURE) study. They published a pair of reports in 2017 with their initial findings that also included some of their first steps toward developing the score (Lancet. 2017 Nov 4; 380[10107]:2037-49; 380[10107]:2050-62). The PURE analysis identified seven food groups for which daily intake levels significantly linked with survival: fruits, vegetables, nuts, legumes, dairy, red meat, and fish. Based on this, they devised a scoring formula that gives a person a rating of 1-5 for each of these seven food types, from the lowest quintile of consumption, which scores 1, to the highest quintile, which scores 5. The result is a score than can range from 7 to 35. They then divided the PURE participants into quintiles based on their intakes of all seven food types and found the highest survival rate among people in the quintile with the highest intake level for all of the food groups.
The best-outcome quintile consumed on average about eight servings of fruits and vegetables daily, 2.5 servings of legumes and nuts, three servings of full-fat daily, 1.5 servings of unprocessed red meat, and 0.3 servings of fish (or about two servings of fish weekly). Energy consumption in the best-outcome quintile received 54% of calories as carbohydrates, 28% as fat, and 18% as protein. In contrast, the worst-outcomes quintile received 69% of calories from carbohydrates, 19% from fat, and 12% from protein.
In a model that adjusted for all measured confounders the people in PURE with the best-outcome diet had a statistically significant, 25% reduced all-cause mortality, compared with people in the quintile with the worst diet.
To validate the formula the researchers used data collected from three other trials run by their group at McMaster University:
- The ONTARGET and TRANSCEND studies (N Engl J Med. 2008 Apr 10;358[15]:1547-58), which together included diet and outcomes data for 31,546 patients with vascular disease. Diet analysis and scoring showed that enrolled people in the quintile with the highest score had a statistically significant 24% relative reduction in mortality, compared with the quintile with the worst score after adjusting for measured confounders.
- The INTERHEART study (Lancet. 2004 Sep 11;364[9438]:937-52), which had data for 27,098 people and showed that the primary outcome of incident MI was a statistically significant 22% lower after adjustment in the quintile with the best diet score, compared with the quintile with the worst score.
- The INTERSTROKE study (Lancet. 2016 Aug 20;388[10046]:761-75), with data for 20,834 people, showed that the rate of stroke was a statistically significant 25% lower after adjustment in the quintile with the highest diet score, compared with those with the lowest score.
Dr. Mente had no financial disclosures.
MUNICH – A formula for scoring diet quality that during its development phase significantly correlated with overall survival received validation when tested using three independent, large data sets that together included almost 80,000 people.
With these new findings the PURE Healthy Diet Score had now shown consistent, significant correlations with overall survival and the incidence of MI and stroke in a total of about 218,000 people from 50 countries who had been followed in any of four separate studies. This new validation is especially notable because the optimal diet identified by the scoring system diverged from current American diet recommendations in two important ways: Optimal food consumption included three daily servings of full-fat dairy and 1.5 servings daily of unprocessed red meat Andrew Mente, PhD, reported at the annual congress of the European Society of Cardiology. He explained this finding as possibly related to the global scope of the study, which included many people from low- or middle-income countries where average diets are usually low in important nutrients.
The PURE Healthy Diet Score should now be “considered for broad, global dietary recommendations,” Dr. Mente said in a video interview. Testing a diet profile in a large, randomized trial would be ideal, but also difficult to run. Until then, the only alternative for defining an evidence-based optimal diet is observational data, as in the current study. The PURE Healthy Diet Score “is ready for routine use,” said Dr. Mente, a clinical epidemiologist at McMaster University in Hamilton, Canada.
Dr. Mente and his associates developed the Pure Healthy Diet Score with data taken from 138,527 people enrolled in the Prospective Urban Rural Epidemiology (PURE) study. They published a pair of reports in 2017 with their initial findings that also included some of their first steps toward developing the score (Lancet. 2017 Nov 4; 380[10107]:2037-49; 380[10107]:2050-62). The PURE analysis identified seven food groups for which daily intake levels significantly linked with survival: fruits, vegetables, nuts, legumes, dairy, red meat, and fish. Based on this, they devised a scoring formula that gives a person a rating of 1-5 for each of these seven food types, from the lowest quintile of consumption, which scores 1, to the highest quintile, which scores 5. The result is a score than can range from 7 to 35. They then divided the PURE participants into quintiles based on their intakes of all seven food types and found the highest survival rate among people in the quintile with the highest intake level for all of the food groups.
The best-outcome quintile consumed on average about eight servings of fruits and vegetables daily, 2.5 servings of legumes and nuts, three servings of full-fat daily, 1.5 servings of unprocessed red meat, and 0.3 servings of fish (or about two servings of fish weekly). Energy consumption in the best-outcome quintile received 54% of calories as carbohydrates, 28% as fat, and 18% as protein. In contrast, the worst-outcomes quintile received 69% of calories from carbohydrates, 19% from fat, and 12% from protein.
In a model that adjusted for all measured confounders the people in PURE with the best-outcome diet had a statistically significant, 25% reduced all-cause mortality, compared with people in the quintile with the worst diet.
To validate the formula the researchers used data collected from three other trials run by their group at McMaster University:
- The ONTARGET and TRANSCEND studies (N Engl J Med. 2008 Apr 10;358[15]:1547-58), which together included diet and outcomes data for 31,546 patients with vascular disease. Diet analysis and scoring showed that enrolled people in the quintile with the highest score had a statistically significant 24% relative reduction in mortality, compared with the quintile with the worst score after adjusting for measured confounders.
- The INTERHEART study (Lancet. 2004 Sep 11;364[9438]:937-52), which had data for 27,098 people and showed that the primary outcome of incident MI was a statistically significant 22% lower after adjustment in the quintile with the best diet score, compared with the quintile with the worst score.
- The INTERSTROKE study (Lancet. 2016 Aug 20;388[10046]:761-75), with data for 20,834 people, showed that the rate of stroke was a statistically significant 25% lower after adjustment in the quintile with the highest diet score, compared with those with the lowest score.
Dr. Mente had no financial disclosures.
REPORTING FROM THE ESC CONGRESS 2018
Key clinical point:
Major finding: The highest-scoring quintiles had about 25% fewer deaths, MIs, and strokes, compared with the lowest-scoring quintiles.
Study details: The PURE Healthy Diet Score underwent validation using three independent data sets with a total of 79,478 people.
Disclosures: Dr. Mente had no financial disclosures.
GARFIELD-AF registry: DOACs cut mortality 19%
MUNICH – Treatment of real-world patients newly diagnosed with atrial fibrillation using a direct oral anticoagulant led to benefits that tracked the advantages previously seen in randomized, controlled trials of these drugs, based on findings from more than 26,000 patients enrolled in a global registry.
Atrial fibrillation patients enrolled in the GARFIELD-AF(Global Anticoagulant Registry in the Field) study who started treatment with a direct oral anticoagulant (DOAC) had a 19% relative risk reduction in all-cause mortality during 2 years of follow-up, compared with patients on an oral vitamin K antagonist (VKA) regimen (such as warfarin), a statistically significant difference after adjustment for 30 demographic, clinical, and registry variables, A. John Camm, MD, said at the annual congress of the European Society of Cardiology. The analysis also showed trends toward lower rates of stroke or systemic thrombosis as well as major bleeding events when patients received a DOAC, compared with those on VKA, but these differences were not statistically significant, reported Dr. Camm, a professor of clinical cardiology at St. George’s University of London.
The analyses run by Dr. Camm and his associates also confirmed the superiority of oral anticoagulation. There was an adjusted 17% relative risk reduction in all-cause mortality during 2-year follow-up in patients on any form of oral anticoagulation, compared with patients who did not receive anticoagulation, a statistically significant difference. The comparison of patients on any oral anticoagulant with those not on treatment also showed a significant lowering of stroke or systemic embolism, as well as a 36% relative increase in the risk for a major bleeding episode that was close to statistical significance.
These findings in a registry of patients undergoing routine care “suggest that the effectiveness of oral anticoagulants in randomized clinical trials can be translated to the broad cross section of patients treated in everyday practice,” Dr. Camm said. However, he highlighted two important qualifications to the findings.
First, the analysis focused on the type of anticoagulation patients received at the time they entered the GARFIELD-AF registry and did not account for possible changes in treatment after that. Second, the analysis did not adjust for additional potential confounding variables, which Dr. Camm was certain existed and affected the findings.
“I’m concerned that a confounder we have not been able to account for is the quality of medical care that patients received,” he noted. “The substantial reduction in mortality [using a DOAC, compared with a VKA] is not simply due to reductions in stroke or major bleeding. We must look at other explanations, such as differences in quality of care and access to care.”
The analyses have also not yet looked at outcomes based on the specific DOAC a patient received – apixaban, dabigatran, edoxaban, or rivaroxaban – something that Dr. Camm said is in the works.
GARFIELD-AF enrolled nearly 35,000 patients with newly diagnosed atrial fibrillation and at least one stroke risk factor in 35 countries from April 2013 to September 2016. The analysis winnowed this down to 26,742 patients who also had a CHA2DS2-VASc score of at least 2 (which identifies patients with a high thrombotic risk) and had complete enrollment and follow-up data.
GARFIELD-AF was funded in part by Bayer. Dr. Camm reported being an adviser to Bayer, Boehringer Ingelheim, Daiichi Sankyo, and Pfizer/Bristol-Myers Squibb.
MUNICH – Treatment of real-world patients newly diagnosed with atrial fibrillation using a direct oral anticoagulant led to benefits that tracked the advantages previously seen in randomized, controlled trials of these drugs, based on findings from more than 26,000 patients enrolled in a global registry.
Atrial fibrillation patients enrolled in the GARFIELD-AF(Global Anticoagulant Registry in the Field) study who started treatment with a direct oral anticoagulant (DOAC) had a 19% relative risk reduction in all-cause mortality during 2 years of follow-up, compared with patients on an oral vitamin K antagonist (VKA) regimen (such as warfarin), a statistically significant difference after adjustment for 30 demographic, clinical, and registry variables, A. John Camm, MD, said at the annual congress of the European Society of Cardiology. The analysis also showed trends toward lower rates of stroke or systemic thrombosis as well as major bleeding events when patients received a DOAC, compared with those on VKA, but these differences were not statistically significant, reported Dr. Camm, a professor of clinical cardiology at St. George’s University of London.
The analyses run by Dr. Camm and his associates also confirmed the superiority of oral anticoagulation. There was an adjusted 17% relative risk reduction in all-cause mortality during 2-year follow-up in patients on any form of oral anticoagulation, compared with patients who did not receive anticoagulation, a statistically significant difference. The comparison of patients on any oral anticoagulant with those not on treatment also showed a significant lowering of stroke or systemic embolism, as well as a 36% relative increase in the risk for a major bleeding episode that was close to statistical significance.
These findings in a registry of patients undergoing routine care “suggest that the effectiveness of oral anticoagulants in randomized clinical trials can be translated to the broad cross section of patients treated in everyday practice,” Dr. Camm said. However, he highlighted two important qualifications to the findings.
First, the analysis focused on the type of anticoagulation patients received at the time they entered the GARFIELD-AF registry and did not account for possible changes in treatment after that. Second, the analysis did not adjust for additional potential confounding variables, which Dr. Camm was certain existed and affected the findings.
“I’m concerned that a confounder we have not been able to account for is the quality of medical care that patients received,” he noted. “The substantial reduction in mortality [using a DOAC, compared with a VKA] is not simply due to reductions in stroke or major bleeding. We must look at other explanations, such as differences in quality of care and access to care.”
The analyses have also not yet looked at outcomes based on the specific DOAC a patient received – apixaban, dabigatran, edoxaban, or rivaroxaban – something that Dr. Camm said is in the works.
GARFIELD-AF enrolled nearly 35,000 patients with newly diagnosed atrial fibrillation and at least one stroke risk factor in 35 countries from April 2013 to September 2016. The analysis winnowed this down to 26,742 patients who also had a CHA2DS2-VASc score of at least 2 (which identifies patients with a high thrombotic risk) and had complete enrollment and follow-up data.
GARFIELD-AF was funded in part by Bayer. Dr. Camm reported being an adviser to Bayer, Boehringer Ingelheim, Daiichi Sankyo, and Pfizer/Bristol-Myers Squibb.
MUNICH – Treatment of real-world patients newly diagnosed with atrial fibrillation using a direct oral anticoagulant led to benefits that tracked the advantages previously seen in randomized, controlled trials of these drugs, based on findings from more than 26,000 patients enrolled in a global registry.
Atrial fibrillation patients enrolled in the GARFIELD-AF(Global Anticoagulant Registry in the Field) study who started treatment with a direct oral anticoagulant (DOAC) had a 19% relative risk reduction in all-cause mortality during 2 years of follow-up, compared with patients on an oral vitamin K antagonist (VKA) regimen (such as warfarin), a statistically significant difference after adjustment for 30 demographic, clinical, and registry variables, A. John Camm, MD, said at the annual congress of the European Society of Cardiology. The analysis also showed trends toward lower rates of stroke or systemic thrombosis as well as major bleeding events when patients received a DOAC, compared with those on VKA, but these differences were not statistically significant, reported Dr. Camm, a professor of clinical cardiology at St. George’s University of London.
The analyses run by Dr. Camm and his associates also confirmed the superiority of oral anticoagulation. There was an adjusted 17% relative risk reduction in all-cause mortality during 2-year follow-up in patients on any form of oral anticoagulation, compared with patients who did not receive anticoagulation, a statistically significant difference. The comparison of patients on any oral anticoagulant with those not on treatment also showed a significant lowering of stroke or systemic embolism, as well as a 36% relative increase in the risk for a major bleeding episode that was close to statistical significance.
These findings in a registry of patients undergoing routine care “suggest that the effectiveness of oral anticoagulants in randomized clinical trials can be translated to the broad cross section of patients treated in everyday practice,” Dr. Camm said. However, he highlighted two important qualifications to the findings.
First, the analysis focused on the type of anticoagulation patients received at the time they entered the GARFIELD-AF registry and did not account for possible changes in treatment after that. Second, the analysis did not adjust for additional potential confounding variables, which Dr. Camm was certain existed and affected the findings.
“I’m concerned that a confounder we have not been able to account for is the quality of medical care that patients received,” he noted. “The substantial reduction in mortality [using a DOAC, compared with a VKA] is not simply due to reductions in stroke or major bleeding. We must look at other explanations, such as differences in quality of care and access to care.”
The analyses have also not yet looked at outcomes based on the specific DOAC a patient received – apixaban, dabigatran, edoxaban, or rivaroxaban – something that Dr. Camm said is in the works.
GARFIELD-AF enrolled nearly 35,000 patients with newly diagnosed atrial fibrillation and at least one stroke risk factor in 35 countries from April 2013 to September 2016. The analysis winnowed this down to 26,742 patients who also had a CHA2DS2-VASc score of at least 2 (which identifies patients with a high thrombotic risk) and had complete enrollment and follow-up data.
GARFIELD-AF was funded in part by Bayer. Dr. Camm reported being an adviser to Bayer, Boehringer Ingelheim, Daiichi Sankyo, and Pfizer/Bristol-Myers Squibb.
REPORTING FROM THE ESC CONGRESS 2018
Key clinical point:
Major finding: Direct oral anticoagulant–treated patients had a 19% relative reduction in all-cause death, compared with patients on a vitamin K antagonist.
Study details: The GARFIELD-AF registry, which included 26,742 patients with newly diagnosed atrial fibrillation.
Disclosures: GARFIELD-AF was funded in part by Bayer. Dr. Camm has been an adviser to Bayer, Boehringer Ingelheim, Daiichi Sankyo, and Pfizer/Bristol-Myers Squibb.
Drug-coated balloons shown noninferior to DES in thin coronaries
MUNICH – for preventing the clinical consequences of restenosis during 12 months following coronary intervention, according to results from a prospective, randomized, multicenter trial.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Drug-coated balloons are already used to treat in-stent coronary restenosis. The findings of the current study establish the tested DCB as noninferior to a DES for treating coronary stenoses in narrow arteries less than 3 mm in diameter, Raban V. Jeger, MD, said at the annual congress of the European Society of Cardiology. The DCB approach avoids placing a metal stent in a narrow coronary and thus has no long-term risk for in-stent thrombosis, said Dr. Jeger, a professor of cardiology at Basel (Switzerland) University Hospital. Dr. Jeger acknowledged that the tested DCB is more expensive than the second-generation DES used as the comparator in most of the control patients, “but I think the benefit to patients is worth” the added cost, he said when discussing his report.
The BASKET-SMALL 2 (NCT01574534) study enrolled 758 patients at 14 centers in Switzerland, Germany, and Austria. The trial limited enrollment to patients who were scheduled to undergo percutaneous coronary intervention for stenosis in a coronary artery that was at least 2.0 mm and less than 3.0 mm in diameter and had first undergone successful predilatation without any flow-limiting dissections or residual stenosis, a step in the DCB procedure that adds to the procedure’s cost.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The study randomized patients to treatment with either a balloon coated with paclitaxel/iopromide (SeQuent Please) or a DES. The first quarter of patients randomized into the DES arm received a first-generation, paclitaxel-eluting DES (Taxus Element); the remaining patients in the comparator arm received a second-generation everolimus-eluting DES (Xience). The DCB tested is not approved for U.S. marketing.
The primary endpoint was the combined rate of cardiac death, nonfatal MI, or target vessel revascularization during 12 months of follow-up. In the intention-to-treat analysis, this occurred in 7.33% of the DCB patients and in 7.45% of the DES patients, a difference that was not statistically significant and that met the prespecified criterion for noninferiority of the DCB. Concurrently with Dr. Jeger’s report at the congress, the results also appeared in an article published in The Lancet (Lancet. 2018 Sep 8;392[10190]:849-56).
One limitation of the study was that the first 25% of patients enrolled into the DES arm received a first-generation DES, while the remaining 75% received a second-generation device. Analysis of the primary endpoint by DES type showed that events occurred more than twice as often in the patients who received a first-generation DES, and their inclusion may have affected the comparator group’s results.
Coronary arteries that need percutaneous intervention and are less than 3 mm in diameter constitute about a third of all target vessels, and they are especially common among women and in patients with diabetes, Dr. Jeger said. Despite this, women made up about a quarter of the study enrollment, and about a third had diabetes. He also noted that a key aspect of adopting the DCB approach into routine practice is that operators would need to have the “courage” to accept some amount of recoil and “minor” dissections after DCB treatment and not feel compelled to correct these with a stent.
Other features of the BASKET-SMALL 2 trial also have raised concerns about the immediate clinical implications of the results, said Roxana Mehran, MD, a professor of medicine at Icahn School of Medicine at Mount Sinai, New York, and the congress’s designated discussant for the report.
The study began in 2012, which means it took more than 5 years to enroll and suggests that the study may have a selection bias. Dr. Mehran also questioned whether it was really a small vessel study, with an enrollment criterion of less than 3 mm in diameter. A future study should be done in “truly” small vessels, those thinner than 2.5 mm, she said.
Dr. Mehran agreed it’s attractive to speculate that, by using a DCB and avoiding stent placement, fewer patients will eventually have very-late adverse events, but this must be proven with longer follow-up and in larger numbers of patients, she said.
Treating thin coronary arteries is a problem because they have a higher risk for in-stent restenosis, although usually we will put a stent in arteries that are at least 2.5 mm wide and sometimes in coronaries as narrow as 2.25 mm. That’s using the narrowest stent we have available. Sometimes in vessels this size, if the result from initial balloon angioplasty looks good on angiography, we accept that outcome and do not place a stent.
Steen Dalby Kristensen, MD , is a professor of cardiology at Aarhus University in Skejby, Denmark. He had no relevant disclosures. He made these comments in a video interview.
Treating thin coronary arteries is a problem because they have a higher risk for in-stent restenosis, although usually we will put a stent in arteries that are at least 2.5 mm wide and sometimes in coronaries as narrow as 2.25 mm. That’s using the narrowest stent we have available. Sometimes in vessels this size, if the result from initial balloon angioplasty looks good on angiography, we accept that outcome and do not place a stent.
Steen Dalby Kristensen, MD , is a professor of cardiology at Aarhus University in Skejby, Denmark. He had no relevant disclosures. He made these comments in a video interview.
Treating thin coronary arteries is a problem because they have a higher risk for in-stent restenosis, although usually we will put a stent in arteries that are at least 2.5 mm wide and sometimes in coronaries as narrow as 2.25 mm. That’s using the narrowest stent we have available. Sometimes in vessels this size, if the result from initial balloon angioplasty looks good on angiography, we accept that outcome and do not place a stent.
Steen Dalby Kristensen, MD , is a professor of cardiology at Aarhus University in Skejby, Denmark. He had no relevant disclosures. He made these comments in a video interview.
MUNICH – for preventing the clinical consequences of restenosis during 12 months following coronary intervention, according to results from a prospective, randomized, multicenter trial.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Drug-coated balloons are already used to treat in-stent coronary restenosis. The findings of the current study establish the tested DCB as noninferior to a DES for treating coronary stenoses in narrow arteries less than 3 mm in diameter, Raban V. Jeger, MD, said at the annual congress of the European Society of Cardiology. The DCB approach avoids placing a metal stent in a narrow coronary and thus has no long-term risk for in-stent thrombosis, said Dr. Jeger, a professor of cardiology at Basel (Switzerland) University Hospital. Dr. Jeger acknowledged that the tested DCB is more expensive than the second-generation DES used as the comparator in most of the control patients, “but I think the benefit to patients is worth” the added cost, he said when discussing his report.
The BASKET-SMALL 2 (NCT01574534) study enrolled 758 patients at 14 centers in Switzerland, Germany, and Austria. The trial limited enrollment to patients who were scheduled to undergo percutaneous coronary intervention for stenosis in a coronary artery that was at least 2.0 mm and less than 3.0 mm in diameter and had first undergone successful predilatation without any flow-limiting dissections or residual stenosis, a step in the DCB procedure that adds to the procedure’s cost.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The study randomized patients to treatment with either a balloon coated with paclitaxel/iopromide (SeQuent Please) or a DES. The first quarter of patients randomized into the DES arm received a first-generation, paclitaxel-eluting DES (Taxus Element); the remaining patients in the comparator arm received a second-generation everolimus-eluting DES (Xience). The DCB tested is not approved for U.S. marketing.
The primary endpoint was the combined rate of cardiac death, nonfatal MI, or target vessel revascularization during 12 months of follow-up. In the intention-to-treat analysis, this occurred in 7.33% of the DCB patients and in 7.45% of the DES patients, a difference that was not statistically significant and that met the prespecified criterion for noninferiority of the DCB. Concurrently with Dr. Jeger’s report at the congress, the results also appeared in an article published in The Lancet (Lancet. 2018 Sep 8;392[10190]:849-56).
One limitation of the study was that the first 25% of patients enrolled into the DES arm received a first-generation DES, while the remaining 75% received a second-generation device. Analysis of the primary endpoint by DES type showed that events occurred more than twice as often in the patients who received a first-generation DES, and their inclusion may have affected the comparator group’s results.
Coronary arteries that need percutaneous intervention and are less than 3 mm in diameter constitute about a third of all target vessels, and they are especially common among women and in patients with diabetes, Dr. Jeger said. Despite this, women made up about a quarter of the study enrollment, and about a third had diabetes. He also noted that a key aspect of adopting the DCB approach into routine practice is that operators would need to have the “courage” to accept some amount of recoil and “minor” dissections after DCB treatment and not feel compelled to correct these with a stent.
Other features of the BASKET-SMALL 2 trial also have raised concerns about the immediate clinical implications of the results, said Roxana Mehran, MD, a professor of medicine at Icahn School of Medicine at Mount Sinai, New York, and the congress’s designated discussant for the report.
The study began in 2012, which means it took more than 5 years to enroll and suggests that the study may have a selection bias. Dr. Mehran also questioned whether it was really a small vessel study, with an enrollment criterion of less than 3 mm in diameter. A future study should be done in “truly” small vessels, those thinner than 2.5 mm, she said.
Dr. Mehran agreed it’s attractive to speculate that, by using a DCB and avoiding stent placement, fewer patients will eventually have very-late adverse events, but this must be proven with longer follow-up and in larger numbers of patients, she said.
MUNICH – for preventing the clinical consequences of restenosis during 12 months following coronary intervention, according to results from a prospective, randomized, multicenter trial.
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Drug-coated balloons are already used to treat in-stent coronary restenosis. The findings of the current study establish the tested DCB as noninferior to a DES for treating coronary stenoses in narrow arteries less than 3 mm in diameter, Raban V. Jeger, MD, said at the annual congress of the European Society of Cardiology. The DCB approach avoids placing a metal stent in a narrow coronary and thus has no long-term risk for in-stent thrombosis, said Dr. Jeger, a professor of cardiology at Basel (Switzerland) University Hospital. Dr. Jeger acknowledged that the tested DCB is more expensive than the second-generation DES used as the comparator in most of the control patients, “but I think the benefit to patients is worth” the added cost, he said when discussing his report.
The BASKET-SMALL 2 (NCT01574534) study enrolled 758 patients at 14 centers in Switzerland, Germany, and Austria. The trial limited enrollment to patients who were scheduled to undergo percutaneous coronary intervention for stenosis in a coronary artery that was at least 2.0 mm and less than 3.0 mm in diameter and had first undergone successful predilatation without any flow-limiting dissections or residual stenosis, a step in the DCB procedure that adds to the procedure’s cost.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The study randomized patients to treatment with either a balloon coated with paclitaxel/iopromide (SeQuent Please) or a DES. The first quarter of patients randomized into the DES arm received a first-generation, paclitaxel-eluting DES (Taxus Element); the remaining patients in the comparator arm received a second-generation everolimus-eluting DES (Xience). The DCB tested is not approved for U.S. marketing.
The primary endpoint was the combined rate of cardiac death, nonfatal MI, or target vessel revascularization during 12 months of follow-up. In the intention-to-treat analysis, this occurred in 7.33% of the DCB patients and in 7.45% of the DES patients, a difference that was not statistically significant and that met the prespecified criterion for noninferiority of the DCB. Concurrently with Dr. Jeger’s report at the congress, the results also appeared in an article published in The Lancet (Lancet. 2018 Sep 8;392[10190]:849-56).
One limitation of the study was that the first 25% of patients enrolled into the DES arm received a first-generation DES, while the remaining 75% received a second-generation device. Analysis of the primary endpoint by DES type showed that events occurred more than twice as often in the patients who received a first-generation DES, and their inclusion may have affected the comparator group’s results.
Coronary arteries that need percutaneous intervention and are less than 3 mm in diameter constitute about a third of all target vessels, and they are especially common among women and in patients with diabetes, Dr. Jeger said. Despite this, women made up about a quarter of the study enrollment, and about a third had diabetes. He also noted that a key aspect of adopting the DCB approach into routine practice is that operators would need to have the “courage” to accept some amount of recoil and “minor” dissections after DCB treatment and not feel compelled to correct these with a stent.
Other features of the BASKET-SMALL 2 trial also have raised concerns about the immediate clinical implications of the results, said Roxana Mehran, MD, a professor of medicine at Icahn School of Medicine at Mount Sinai, New York, and the congress’s designated discussant for the report.
The study began in 2012, which means it took more than 5 years to enroll and suggests that the study may have a selection bias. Dr. Mehran also questioned whether it was really a small vessel study, with an enrollment criterion of less than 3 mm in diameter. A future study should be done in “truly” small vessels, those thinner than 2.5 mm, she said.
Dr. Mehran agreed it’s attractive to speculate that, by using a DCB and avoiding stent placement, fewer patients will eventually have very-late adverse events, but this must be proven with longer follow-up and in larger numbers of patients, she said.
REPORTING FROM THE ESC CONGRESS 2018
Key clinical point: Drug-coated balloon treatment worked as well as drug-eluting stents in thin coronaries.
Major finding: Twelve-month MACE occurred in 7.33% of balloon-treated patients and in 7.45% of stent-treated patients.
Study details: BASKET-SMALL 2, an international, multicenter randomized trial with 758 patients.
Disclosures: The investigator-initiated study received partial funding from B. Braun, the company that markets the drug-coated balloon (SeQuent Please) tested in the study. Dr. Jeger has received research funding from B. Braun. Dr. Mehran has been a consultant to Abbott, Bayer, BSC, and CSL Behring and has received research funding from Abbott, Astra Zeneca, Bayer, BCC, DSI, and Janssen.
Coronary CT FFR sharpens patient assessment in two studies
MUNICH – Noninvasive assessment of fractional flow reserve (FFR) within coronary arteries using data collected by CT angiography again has been shown to provide important additional diagnostic information that better guides patient management.
“The value of FFRCT is to reduce the number of patients who go to the cath lab. For patients with a stenosis of 60% that is not likely to have functional significance we can avoid catheterization and treat the patient medically. FFRCT is a valuable technology, but my concern is that currently it costs about $1,400 for this test,” commented Todd C. Villines, MD, a cardiologist at Georgetown University in Washington who was a discussant for the study. “Given the cost, we need to better define the patients on whom we use FFRCT and integrate it into clinical decision making,” Dr. Villines said in an interview.
Perhaps the best demonstration of the potential role for FFRCT came from a single-center study at Aarhus (Denmark) University with 3,674 patients with stable chest pain who underwent CCTA as their initial assessment for suspected coronary artery disease between May 2014 and December 2016. More than two-thirds of these patients had coronary stenoses of less than 30% and had no further assessment or treatment, and 11% had at least one coronary stenosis of at least 70% on CCTA and then had follow-up testing by either conventional angiography or myocardial perfusion imaging. The report at the congress focused on the 697 patients with an inconclusive result based on CCTA alone and at least one stenosis of 30%-69% who underwent FFRCT analysis, and focused specifically on 677 patients with a useful FFRCT result.
Of these patients, 410 (61% of this subgroup) had no coronary lesion that created a FFRCT of 0.8 or less. All received treatment with optimal medical therapy only, and after a median follow-up had a 3.9% incidence of the primary endpoint, the combined rate of all-cause death, nonfatal MI, hospitalization for unstable angina, or unplanned revascularization. This 3.9% rate was not significantly different from the 2.8% rate seen during follow-up of the patients with no coronary stenosis of 30% or greater.
The remaining 267 patients (39% of the subgroup) with a FFRCT that showed 80% or less flow reserve either received optimal medical therapy (112 patients, 42% of this group) or angiography by coronary catheterization (155 patients, 58% of this group).
The second report used data collected from 5,083 patients entered into a multinational registry, ADVANCE, with symptoms suggestive of coronary artery disease and results from CCTA that suggested coronary stenosis. The collaborating researchers then used the CCTA results to generate a FFR analysis for 4,893 (96%) of the patients, and the analysis was usable for 4,737 of them. The FFRCT results led to reclassification of the management strategy for 67% of the patients, the primary endpoint for this analysis, reported Timothy A. Fairbairn, MD, a cardiologist at the Liverpool (England) Heart and Chest Hospital.
One limitation of this study was the relatively brief, 90-day follow-up, but it is the first real-world, multicenter assessment of the utility and safety of FFRCT.
These findings highlight what a “disruptive technology” FFRCT represents, commented Dr. Villines. He also noted that the reclassifications triggered by the FFRCT analysis led to fewer patients undergoing invasive angiography, a good outcome from a cost-effectiveness perspective.
Concurrently with Dr. Fairbairn’s report the results from ADVANCE also appeared in an article published online (Euro Heart J. 2018 Aug 25. doi: 10.1093/eurheartj/ehy530).
A third FFRCT study reported at the session, the Computed Tomographic Evaluation of Atherosclerotic Determinants of Myocardial Ischemia (CREDENCE) study, enrolled 612 patients with suspected coronary artery disease who had been referred for and underwent invasive coronary angiography with FFR evaluation at 13 international centers, including several in the United States. All 612 patients also had assessment by CCTA and FFRCT, and also some type of functional myocardial perfusion assessment using positron emission tomography, single-photon emission CT, or coronary MR.
The Aarhus University study received no commercial funding. Dr. Nørgaard has received research funding from Edwards; Siemens; and HeartFlow, the company that markets FFR analysis for coronary CT angiography data. The ADVANCE registry was sponsored by HeartFlow. Dr. Fairbairn has been a speaker for Heartflow. Dr. Stuijfzand and Dr. Villines had no relevant disclosures.
MUNICH – Noninvasive assessment of fractional flow reserve (FFR) within coronary arteries using data collected by CT angiography again has been shown to provide important additional diagnostic information that better guides patient management.
“The value of FFRCT is to reduce the number of patients who go to the cath lab. For patients with a stenosis of 60% that is not likely to have functional significance we can avoid catheterization and treat the patient medically. FFRCT is a valuable technology, but my concern is that currently it costs about $1,400 for this test,” commented Todd C. Villines, MD, a cardiologist at Georgetown University in Washington who was a discussant for the study. “Given the cost, we need to better define the patients on whom we use FFRCT and integrate it into clinical decision making,” Dr. Villines said in an interview.
Perhaps the best demonstration of the potential role for FFRCT came from a single-center study at Aarhus (Denmark) University with 3,674 patients with stable chest pain who underwent CCTA as their initial assessment for suspected coronary artery disease between May 2014 and December 2016. More than two-thirds of these patients had coronary stenoses of less than 30% and had no further assessment or treatment, and 11% had at least one coronary stenosis of at least 70% on CCTA and then had follow-up testing by either conventional angiography or myocardial perfusion imaging. The report at the congress focused on the 697 patients with an inconclusive result based on CCTA alone and at least one stenosis of 30%-69% who underwent FFRCT analysis, and focused specifically on 677 patients with a useful FFRCT result.
Of these patients, 410 (61% of this subgroup) had no coronary lesion that created a FFRCT of 0.8 or less. All received treatment with optimal medical therapy only, and after a median follow-up had a 3.9% incidence of the primary endpoint, the combined rate of all-cause death, nonfatal MI, hospitalization for unstable angina, or unplanned revascularization. This 3.9% rate was not significantly different from the 2.8% rate seen during follow-up of the patients with no coronary stenosis of 30% or greater.
The remaining 267 patients (39% of the subgroup) with a FFRCT that showed 80% or less flow reserve either received optimal medical therapy (112 patients, 42% of this group) or angiography by coronary catheterization (155 patients, 58% of this group).
The second report used data collected from 5,083 patients entered into a multinational registry, ADVANCE, with symptoms suggestive of coronary artery disease and results from CCTA that suggested coronary stenosis. The collaborating researchers then used the CCTA results to generate a FFR analysis for 4,893 (96%) of the patients, and the analysis was usable for 4,737 of them. The FFRCT results led to reclassification of the management strategy for 67% of the patients, the primary endpoint for this analysis, reported Timothy A. Fairbairn, MD, a cardiologist at the Liverpool (England) Heart and Chest Hospital.
One limitation of this study was the relatively brief, 90-day follow-up, but it is the first real-world, multicenter assessment of the utility and safety of FFRCT.
These findings highlight what a “disruptive technology” FFRCT represents, commented Dr. Villines. He also noted that the reclassifications triggered by the FFRCT analysis led to fewer patients undergoing invasive angiography, a good outcome from a cost-effectiveness perspective.
Concurrently with Dr. Fairbairn’s report the results from ADVANCE also appeared in an article published online (Euro Heart J. 2018 Aug 25. doi: 10.1093/eurheartj/ehy530).
A third FFRCT study reported at the session, the Computed Tomographic Evaluation of Atherosclerotic Determinants of Myocardial Ischemia (CREDENCE) study, enrolled 612 patients with suspected coronary artery disease who had been referred for and underwent invasive coronary angiography with FFR evaluation at 13 international centers, including several in the United States. All 612 patients also had assessment by CCTA and FFRCT, and also some type of functional myocardial perfusion assessment using positron emission tomography, single-photon emission CT, or coronary MR.
The Aarhus University study received no commercial funding. Dr. Nørgaard has received research funding from Edwards; Siemens; and HeartFlow, the company that markets FFR analysis for coronary CT angiography data. The ADVANCE registry was sponsored by HeartFlow. Dr. Fairbairn has been a speaker for Heartflow. Dr. Stuijfzand and Dr. Villines had no relevant disclosures.
MUNICH – Noninvasive assessment of fractional flow reserve (FFR) within coronary arteries using data collected by CT angiography again has been shown to provide important additional diagnostic information that better guides patient management.
“The value of FFRCT is to reduce the number of patients who go to the cath lab. For patients with a stenosis of 60% that is not likely to have functional significance we can avoid catheterization and treat the patient medically. FFRCT is a valuable technology, but my concern is that currently it costs about $1,400 for this test,” commented Todd C. Villines, MD, a cardiologist at Georgetown University in Washington who was a discussant for the study. “Given the cost, we need to better define the patients on whom we use FFRCT and integrate it into clinical decision making,” Dr. Villines said in an interview.
Perhaps the best demonstration of the potential role for FFRCT came from a single-center study at Aarhus (Denmark) University with 3,674 patients with stable chest pain who underwent CCTA as their initial assessment for suspected coronary artery disease between May 2014 and December 2016. More than two-thirds of these patients had coronary stenoses of less than 30% and had no further assessment or treatment, and 11% had at least one coronary stenosis of at least 70% on CCTA and then had follow-up testing by either conventional angiography or myocardial perfusion imaging. The report at the congress focused on the 697 patients with an inconclusive result based on CCTA alone and at least one stenosis of 30%-69% who underwent FFRCT analysis, and focused specifically on 677 patients with a useful FFRCT result.
Of these patients, 410 (61% of this subgroup) had no coronary lesion that created a FFRCT of 0.8 or less. All received treatment with optimal medical therapy only, and after a median follow-up had a 3.9% incidence of the primary endpoint, the combined rate of all-cause death, nonfatal MI, hospitalization for unstable angina, or unplanned revascularization. This 3.9% rate was not significantly different from the 2.8% rate seen during follow-up of the patients with no coronary stenosis of 30% or greater.
The remaining 267 patients (39% of the subgroup) with a FFRCT that showed 80% or less flow reserve either received optimal medical therapy (112 patients, 42% of this group) or angiography by coronary catheterization (155 patients, 58% of this group).
The second report used data collected from 5,083 patients entered into a multinational registry, ADVANCE, with symptoms suggestive of coronary artery disease and results from CCTA that suggested coronary stenosis. The collaborating researchers then used the CCTA results to generate a FFR analysis for 4,893 (96%) of the patients, and the analysis was usable for 4,737 of them. The FFRCT results led to reclassification of the management strategy for 67% of the patients, the primary endpoint for this analysis, reported Timothy A. Fairbairn, MD, a cardiologist at the Liverpool (England) Heart and Chest Hospital.
One limitation of this study was the relatively brief, 90-day follow-up, but it is the first real-world, multicenter assessment of the utility and safety of FFRCT.
These findings highlight what a “disruptive technology” FFRCT represents, commented Dr. Villines. He also noted that the reclassifications triggered by the FFRCT analysis led to fewer patients undergoing invasive angiography, a good outcome from a cost-effectiveness perspective.
Concurrently with Dr. Fairbairn’s report the results from ADVANCE also appeared in an article published online (Euro Heart J. 2018 Aug 25. doi: 10.1093/eurheartj/ehy530).
A third FFRCT study reported at the session, the Computed Tomographic Evaluation of Atherosclerotic Determinants of Myocardial Ischemia (CREDENCE) study, enrolled 612 patients with suspected coronary artery disease who had been referred for and underwent invasive coronary angiography with FFR evaluation at 13 international centers, including several in the United States. All 612 patients also had assessment by CCTA and FFRCT, and also some type of functional myocardial perfusion assessment using positron emission tomography, single-photon emission CT, or coronary MR.
The Aarhus University study received no commercial funding. Dr. Nørgaard has received research funding from Edwards; Siemens; and HeartFlow, the company that markets FFR analysis for coronary CT angiography data. The ADVANCE registry was sponsored by HeartFlow. Dr. Fairbairn has been a speaker for Heartflow. Dr. Stuijfzand and Dr. Villines had no relevant disclosures.
REPORTING FROM THE ESC CONGRESS 2018
U.S. perspective: Euro hypertension guidelines look a lot like ours
MUNICH – The “overwhelming impression” that Paul K. Whelton, MD, has of the newly revised hypertension diagnosis and management guidelines of the European Society of Cardiology is their similarity to hypertension guidelines released by the American College of Cardiology and American Heart Association in November 2017.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
“We both recommend the same treatment target, of less than 130/80 mm Hg,” noted Dr. Whelton, professor at Tulane University in New Orleans, although the European guidelines (Euro J Cardiology. 2018 Sep 1; 39[33]:3021-104) put more qualifications on this target and specify treating to no lower than 130 mm Hg systolic pressure in patients who are at least 65 years old as well as in patients with chronic kidney disease at any age. In a video interview, Dr. Whelton also cited areas of disagreement, such as how patients with an untreated blood pressure of 130-139 mm Hg are classified (high normal in the European guidelines, stage 1 hypertension in the U.S. guidelines), and whether initial drug monotherapy is a reasonable treatment strategy (U.S. says yes, Europe says no).
Dr. Whelton noted that recent modeling studies have documented the potential public health benefits from following the diagnosis and management approaches set forth in the 2017 U.S. guidelines (J Am Coll Cardiol. 2018 May;71[19]:e127-e248). For example, an analysis based on data collected by the U.S. National Health and Nutrition Examination Survey during 2013-2016 showed that following the 2017 guidelines for diagnosing and treating hypertension would have resulted in prevention of more than twice the number of cardiovascular disease events nationally as compared with application of the prior, 2014 U.S. hypertension guideline (JAMA. 2014 Feb 5;311[5]:507-20): 610,000 events prevented, compared with 270,000 events prevented. The same study showed that the 2017 guidelines would have nearly doubled the number of all-cause deaths prevented, with 334,000 deaths prevented, compared with 177,000 prevented by applying the 2014 guidelines (JAMA Cardiology. 2018 July;3[7]:572-81).
Dr. Whelton had no commercial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
MUNICH – The “overwhelming impression” that Paul K. Whelton, MD, has of the newly revised hypertension diagnosis and management guidelines of the European Society of Cardiology is their similarity to hypertension guidelines released by the American College of Cardiology and American Heart Association in November 2017.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
“We both recommend the same treatment target, of less than 130/80 mm Hg,” noted Dr. Whelton, professor at Tulane University in New Orleans, although the European guidelines (Euro J Cardiology. 2018 Sep 1; 39[33]:3021-104) put more qualifications on this target and specify treating to no lower than 130 mm Hg systolic pressure in patients who are at least 65 years old as well as in patients with chronic kidney disease at any age. In a video interview, Dr. Whelton also cited areas of disagreement, such as how patients with an untreated blood pressure of 130-139 mm Hg are classified (high normal in the European guidelines, stage 1 hypertension in the U.S. guidelines), and whether initial drug monotherapy is a reasonable treatment strategy (U.S. says yes, Europe says no).
Dr. Whelton noted that recent modeling studies have documented the potential public health benefits from following the diagnosis and management approaches set forth in the 2017 U.S. guidelines (J Am Coll Cardiol. 2018 May;71[19]:e127-e248). For example, an analysis based on data collected by the U.S. National Health and Nutrition Examination Survey during 2013-2016 showed that following the 2017 guidelines for diagnosing and treating hypertension would have resulted in prevention of more than twice the number of cardiovascular disease events nationally as compared with application of the prior, 2014 U.S. hypertension guideline (JAMA. 2014 Feb 5;311[5]:507-20): 610,000 events prevented, compared with 270,000 events prevented. The same study showed that the 2017 guidelines would have nearly doubled the number of all-cause deaths prevented, with 334,000 deaths prevented, compared with 177,000 prevented by applying the 2014 guidelines (JAMA Cardiology. 2018 July;3[7]:572-81).
Dr. Whelton had no commercial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
MUNICH – The “overwhelming impression” that Paul K. Whelton, MD, has of the newly revised hypertension diagnosis and management guidelines of the European Society of Cardiology is their similarity to hypertension guidelines released by the American College of Cardiology and American Heart Association in November 2017.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
“We both recommend the same treatment target, of less than 130/80 mm Hg,” noted Dr. Whelton, professor at Tulane University in New Orleans, although the European guidelines (Euro J Cardiology. 2018 Sep 1; 39[33]:3021-104) put more qualifications on this target and specify treating to no lower than 130 mm Hg systolic pressure in patients who are at least 65 years old as well as in patients with chronic kidney disease at any age. In a video interview, Dr. Whelton also cited areas of disagreement, such as how patients with an untreated blood pressure of 130-139 mm Hg are classified (high normal in the European guidelines, stage 1 hypertension in the U.S. guidelines), and whether initial drug monotherapy is a reasonable treatment strategy (U.S. says yes, Europe says no).
Dr. Whelton noted that recent modeling studies have documented the potential public health benefits from following the diagnosis and management approaches set forth in the 2017 U.S. guidelines (J Am Coll Cardiol. 2018 May;71[19]:e127-e248). For example, an analysis based on data collected by the U.S. National Health and Nutrition Examination Survey during 2013-2016 showed that following the 2017 guidelines for diagnosing and treating hypertension would have resulted in prevention of more than twice the number of cardiovascular disease events nationally as compared with application of the prior, 2014 U.S. hypertension guideline (JAMA. 2014 Feb 5;311[5]:507-20): 610,000 events prevented, compared with 270,000 events prevented. The same study showed that the 2017 guidelines would have nearly doubled the number of all-cause deaths prevented, with 334,000 deaths prevented, compared with 177,000 prevented by applying the 2014 guidelines (JAMA Cardiology. 2018 July;3[7]:572-81).
Dr. Whelton had no commercial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
REPORTING FROM THE ESC CONGRESS 2018
New Euro hypertension guidelines target most adults to less than 130/80 mm Hg
MUNICH – The European Society of Cardiology joined other international cardiology groups in endorsing lower targets for blood pressure treatment and lower pressure thresholds for starting drug treatment in its revised hypertension diagnosis and management guidelines released in August during the Society’s annual congress here.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
“Provided that treatment is well tolerated, treated blood pressure should be targeted to 130/80 mm Hg or lower in most patients,” Giuseppe Mancia, MD, said as he and his colleagues presented the new guidelines at the annual congress of the European Society of Cardiology.
Although the new European guidelines further buttress this more aggressive approach to blood pressure management that first appeared almost a year ago in U.S. guidelines from the American College of Cardiology and the American Heart Association, an approach that remains controversial among U.S. primary care physicians, the European strategy (Eur Heart J. 2018 Sep 1;39[33]:3021-104) was generally more cautious than the broader endorsement of lower blood pressure goals advanced by the U.S. recommendations (J Am Coll Cardiol. 2018 May;71[19]:e127-e248).
In the European approach, “the first objective is to treat to less than 140/90 mm Hg. If this is well tolerated, then treat to less than 130/80 mm Hg in most patients,” said Dr. Mancia, cochair of the European writing panel. Further pressure reductions to less than 130/80 mm Hg are usually harder, the incremental benefit from further reduction is less than when pressures first fall below 140/90 mm Hg, and the evidence for incremental benefit of any size from further pressure reduction is less strong for certain key patient subgroups: people at least 80 years old, and patients with diabetes, chronic kidney disease, or coronary artery disease, said Dr. Mancia, an emeritus professor at the University of Milan.
“The consistency between two major guidelines is important, but there are differences that may look subtle but are not subtle,” he said in a video interview. “If a patient gets to less than 140 mm Hg, the doctor should not think that’s a failure; it’s a very important result.”
One striking example of how the two guidelines differ on treatment targets is for people at least 80 years old. The overall blood pressure threshold for starting drug treatment in patients this age in the European guidelines is 160/90 mm Hg, although it remains at 140/90 for people aged 65-79 years old “provided that treatment is well tolerated” and the patients are “fit.” The 2017 U.S. guidelines, by contrast, say that considering drug treatment for everyone with a pressure at or above 130/80 mm Hg is a class I recommendation regardless of age as long as the person is “noninstitutionalized, ambulatory, [and] community-dwelling.” Once an older patient of any age, 65 years or older, starts drug treatment to reduce blood pressure, the European guidelines allow for treating to a target systolic blood pressure of 130-139 mm Hg as long as the regimen is well tolerated, and the guidelines say that a diastolic pressure target of less than 80 mm Hg should be considered for all adults regardless of age.
The new European guidelines also define adults with an untreated pressure of 130-139/85-89 mm Hg as “high normal,” rather than the “stage 1 hypertension” designation given to people with pressures of 130-139/80-89 mm Hg in the U.S. guidelines. Robert M. Carey, MD, vice chair of the U.S. guidelines panel, minimized this as a “semantic” difference, and he highlighted that management of people with pressures in this range is roughly similar in the two sets of recommendations. “The name is different, but treatment is the same,” Dr. Carey said.
The European guidelines call for initial lifestyle interventions, followed by drug treatment “that may be considered” for patients who have “very-high” cardiovascular risk because of established cardiovascular disease, especially coronary artery disease, and detail the specific clinical conditions that fall into the very-high-risk category. The U.S. guidelines say that stage 1 hypertension patients should get lifestyle interventions, followed by drug treatment for the roughly 30% of patients in this category who score at least a 10% 10-year risk on the American College of Cardiology’s Atherosclerotic Cardiovascular Disease Risk Estimator Plus.The new European guidelines are a “validation” of the ACC/AHA 2017 guidelines, commented Dr. Carey, a professor of medicine at the University of Virginia in Charlottesville. “Overall, we’re delighted to have these two major groups” agree, he said in an interview. “There is a tremendous amount of concurrence.”
Other areas of agreement between the two guidelines include their emphasis on careful and repeated blood pressure measurement, including out-of-office measurement, before settling on a diagnosis of hypertension; systematic assessment of possible masked or white-coat hypertension in selected people; and frequent use of combined drug treatment including initiation of a dual-drug, single-pill regimen when starting drug treatment and aggressive follow-up by adding a third drug when needed. However, in another divergence the U.S. guidelines give a much stronger endorsement to starting treatment with monotherapy, a strategy the European guidelines scrapped.
Dr. Carey also noted that the European endorsement of three antihypertensives formulated into a single pill for patients who need more than two drugs would be difficult for American clinicians to follow as virtually no such formulations are approved for U.S. use.
Dr. Mancini has received honoraria from Boehringer Ingelheim, CVRx, Daiichi Sankyo, Ferrer, Medtronic, Menarini, Merck, Novartis, Recordati, and Servier. Dr. Williams has been a consultant to Novartis, Relypsa, and Vascular Dynamics, and he has spoken on behalf of Boehringer Ingelheim, Daiichi Sankyo, Novartis, and Servier. Dr. Carey and Dr. Whelton had no commercial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
MUNICH – The European Society of Cardiology joined other international cardiology groups in endorsing lower targets for blood pressure treatment and lower pressure thresholds for starting drug treatment in its revised hypertension diagnosis and management guidelines released in August during the Society’s annual congress here.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
“Provided that treatment is well tolerated, treated blood pressure should be targeted to 130/80 mm Hg or lower in most patients,” Giuseppe Mancia, MD, said as he and his colleagues presented the new guidelines at the annual congress of the European Society of Cardiology.
Although the new European guidelines further buttress this more aggressive approach to blood pressure management that first appeared almost a year ago in U.S. guidelines from the American College of Cardiology and the American Heart Association, an approach that remains controversial among U.S. primary care physicians, the European strategy (Eur Heart J. 2018 Sep 1;39[33]:3021-104) was generally more cautious than the broader endorsement of lower blood pressure goals advanced by the U.S. recommendations (J Am Coll Cardiol. 2018 May;71[19]:e127-e248).
In the European approach, “the first objective is to treat to less than 140/90 mm Hg. If this is well tolerated, then treat to less than 130/80 mm Hg in most patients,” said Dr. Mancia, cochair of the European writing panel. Further pressure reductions to less than 130/80 mm Hg are usually harder, the incremental benefit from further reduction is less than when pressures first fall below 140/90 mm Hg, and the evidence for incremental benefit of any size from further pressure reduction is less strong for certain key patient subgroups: people at least 80 years old, and patients with diabetes, chronic kidney disease, or coronary artery disease, said Dr. Mancia, an emeritus professor at the University of Milan.
“The consistency between two major guidelines is important, but there are differences that may look subtle but are not subtle,” he said in a video interview. “If a patient gets to less than 140 mm Hg, the doctor should not think that’s a failure; it’s a very important result.”
One striking example of how the two guidelines differ on treatment targets is for people at least 80 years old. The overall blood pressure threshold for starting drug treatment in patients this age in the European guidelines is 160/90 mm Hg, although it remains at 140/90 for people aged 65-79 years old “provided that treatment is well tolerated” and the patients are “fit.” The 2017 U.S. guidelines, by contrast, say that considering drug treatment for everyone with a pressure at or above 130/80 mm Hg is a class I recommendation regardless of age as long as the person is “noninstitutionalized, ambulatory, [and] community-dwelling.” Once an older patient of any age, 65 years or older, starts drug treatment to reduce blood pressure, the European guidelines allow for treating to a target systolic blood pressure of 130-139 mm Hg as long as the regimen is well tolerated, and the guidelines say that a diastolic pressure target of less than 80 mm Hg should be considered for all adults regardless of age.
The new European guidelines also define adults with an untreated pressure of 130-139/85-89 mm Hg as “high normal,” rather than the “stage 1 hypertension” designation given to people with pressures of 130-139/80-89 mm Hg in the U.S. guidelines. Robert M. Carey, MD, vice chair of the U.S. guidelines panel, minimized this as a “semantic” difference, and he highlighted that management of people with pressures in this range is roughly similar in the two sets of recommendations. “The name is different, but treatment is the same,” Dr. Carey said.
The European guidelines call for initial lifestyle interventions, followed by drug treatment “that may be considered” for patients who have “very-high” cardiovascular risk because of established cardiovascular disease, especially coronary artery disease, and detail the specific clinical conditions that fall into the very-high-risk category. The U.S. guidelines say that stage 1 hypertension patients should get lifestyle interventions, followed by drug treatment for the roughly 30% of patients in this category who score at least a 10% 10-year risk on the American College of Cardiology’s Atherosclerotic Cardiovascular Disease Risk Estimator Plus.The new European guidelines are a “validation” of the ACC/AHA 2017 guidelines, commented Dr. Carey, a professor of medicine at the University of Virginia in Charlottesville. “Overall, we’re delighted to have these two major groups” agree, he said in an interview. “There is a tremendous amount of concurrence.”
Other areas of agreement between the two guidelines include their emphasis on careful and repeated blood pressure measurement, including out-of-office measurement, before settling on a diagnosis of hypertension; systematic assessment of possible masked or white-coat hypertension in selected people; and frequent use of combined drug treatment including initiation of a dual-drug, single-pill regimen when starting drug treatment and aggressive follow-up by adding a third drug when needed. However, in another divergence the U.S. guidelines give a much stronger endorsement to starting treatment with monotherapy, a strategy the European guidelines scrapped.
Dr. Carey also noted that the European endorsement of three antihypertensives formulated into a single pill for patients who need more than two drugs would be difficult for American clinicians to follow as virtually no such formulations are approved for U.S. use.
Dr. Mancini has received honoraria from Boehringer Ingelheim, CVRx, Daiichi Sankyo, Ferrer, Medtronic, Menarini, Merck, Novartis, Recordati, and Servier. Dr. Williams has been a consultant to Novartis, Relypsa, and Vascular Dynamics, and he has spoken on behalf of Boehringer Ingelheim, Daiichi Sankyo, Novartis, and Servier. Dr. Carey and Dr. Whelton had no commercial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
MUNICH – The European Society of Cardiology joined other international cardiology groups in endorsing lower targets for blood pressure treatment and lower pressure thresholds for starting drug treatment in its revised hypertension diagnosis and management guidelines released in August during the Society’s annual congress here.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
“Provided that treatment is well tolerated, treated blood pressure should be targeted to 130/80 mm Hg or lower in most patients,” Giuseppe Mancia, MD, said as he and his colleagues presented the new guidelines at the annual congress of the European Society of Cardiology.
Although the new European guidelines further buttress this more aggressive approach to blood pressure management that first appeared almost a year ago in U.S. guidelines from the American College of Cardiology and the American Heart Association, an approach that remains controversial among U.S. primary care physicians, the European strategy (Eur Heart J. 2018 Sep 1;39[33]:3021-104) was generally more cautious than the broader endorsement of lower blood pressure goals advanced by the U.S. recommendations (J Am Coll Cardiol. 2018 May;71[19]:e127-e248).
In the European approach, “the first objective is to treat to less than 140/90 mm Hg. If this is well tolerated, then treat to less than 130/80 mm Hg in most patients,” said Dr. Mancia, cochair of the European writing panel. Further pressure reductions to less than 130/80 mm Hg are usually harder, the incremental benefit from further reduction is less than when pressures first fall below 140/90 mm Hg, and the evidence for incremental benefit of any size from further pressure reduction is less strong for certain key patient subgroups: people at least 80 years old, and patients with diabetes, chronic kidney disease, or coronary artery disease, said Dr. Mancia, an emeritus professor at the University of Milan.
“The consistency between two major guidelines is important, but there are differences that may look subtle but are not subtle,” he said in a video interview. “If a patient gets to less than 140 mm Hg, the doctor should not think that’s a failure; it’s a very important result.”
One striking example of how the two guidelines differ on treatment targets is for people at least 80 years old. The overall blood pressure threshold for starting drug treatment in patients this age in the European guidelines is 160/90 mm Hg, although it remains at 140/90 for people aged 65-79 years old “provided that treatment is well tolerated” and the patients are “fit.” The 2017 U.S. guidelines, by contrast, say that considering drug treatment for everyone with a pressure at or above 130/80 mm Hg is a class I recommendation regardless of age as long as the person is “noninstitutionalized, ambulatory, [and] community-dwelling.” Once an older patient of any age, 65 years or older, starts drug treatment to reduce blood pressure, the European guidelines allow for treating to a target systolic blood pressure of 130-139 mm Hg as long as the regimen is well tolerated, and the guidelines say that a diastolic pressure target of less than 80 mm Hg should be considered for all adults regardless of age.
The new European guidelines also define adults with an untreated pressure of 130-139/85-89 mm Hg as “high normal,” rather than the “stage 1 hypertension” designation given to people with pressures of 130-139/80-89 mm Hg in the U.S. guidelines. Robert M. Carey, MD, vice chair of the U.S. guidelines panel, minimized this as a “semantic” difference, and he highlighted that management of people with pressures in this range is roughly similar in the two sets of recommendations. “The name is different, but treatment is the same,” Dr. Carey said.
The European guidelines call for initial lifestyle interventions, followed by drug treatment “that may be considered” for patients who have “very-high” cardiovascular risk because of established cardiovascular disease, especially coronary artery disease, and detail the specific clinical conditions that fall into the very-high-risk category. The U.S. guidelines say that stage 1 hypertension patients should get lifestyle interventions, followed by drug treatment for the roughly 30% of patients in this category who score at least a 10% 10-year risk on the American College of Cardiology’s Atherosclerotic Cardiovascular Disease Risk Estimator Plus.The new European guidelines are a “validation” of the ACC/AHA 2017 guidelines, commented Dr. Carey, a professor of medicine at the University of Virginia in Charlottesville. “Overall, we’re delighted to have these two major groups” agree, he said in an interview. “There is a tremendous amount of concurrence.”
Other areas of agreement between the two guidelines include their emphasis on careful and repeated blood pressure measurement, including out-of-office measurement, before settling on a diagnosis of hypertension; systematic assessment of possible masked or white-coat hypertension in selected people; and frequent use of combined drug treatment including initiation of a dual-drug, single-pill regimen when starting drug treatment and aggressive follow-up by adding a third drug when needed. However, in another divergence the U.S. guidelines give a much stronger endorsement to starting treatment with monotherapy, a strategy the European guidelines scrapped.
Dr. Carey also noted that the European endorsement of three antihypertensives formulated into a single pill for patients who need more than two drugs would be difficult for American clinicians to follow as virtually no such formulations are approved for U.S. use.
Dr. Mancini has received honoraria from Boehringer Ingelheim, CVRx, Daiichi Sankyo, Ferrer, Medtronic, Menarini, Merck, Novartis, Recordati, and Servier. Dr. Williams has been a consultant to Novartis, Relypsa, and Vascular Dynamics, and he has spoken on behalf of Boehringer Ingelheim, Daiichi Sankyo, Novartis, and Servier. Dr. Carey and Dr. Whelton had no commercial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
REPORTING FROM THE ESC CONGRESS 2018
Pregnancy boosts cardiac disease mortality nearly 100-fold
MUNICH – Women with cardiac disease who became pregnant had a nearly 100-fold higher mortality rate, compared with pregnant women without cardiac disease, according to the outcomes of more than 5,700 pregnancies in an international registry of women with cardiac disease.
In addition to increased mortality, women with cardiac disease who become pregnant also had a greater than 100-fold higher rate of developing heart failure, compared with pregnant women without cardiac disease.
Despite these highly elevated relative risks, the absolute rate of serious complications from pregnancy for most women with heart disease was relatively modest. The worst prognosis by far was for the 1% of women in the registry who had pulmonary arterial hypertension at the time their pregnancy began. For these women, mortality during pregnancy was about 9%, and new-onset heart failure occurred in about one third. Another subgroup showing particularly poor outcomes were women classified with WHO IV maternal cardiovascular risk by the modified World Health Organization criteria, which corresponds to having an “extremely high risk of maternal mortality or severe morbidity,” according to guidelines published in the European Heart Journal (2011 Dec 1;32[24]:3147-97).These women, constituting 7% of the registry cohort, had a 2.5% mortality rate during pregnancy and a 33% incidence of heart failure.
Across all women with cardiac disease enrolled in the registry, the incidence of death during pregnancy was 0.6% and the incidence of heart failure was 11%. Women without cardiac disease have rates of 0.007% and less than 0.1%, respectively, Jolien Roos-Hesselink, MD, said at the annual congress of the European Society of Cardiology.
“The most important message of my talk is that all patients should be counseled, not just the women at high risk, for whom pregnancy is contraindicated, but also the women at low risk,” who can have a child with relative safety, she said. “Many women [with cardiac disease] can go through pregnancy at low risk.” Counseling is the key so that women know their risk before becoming pregnant, stressed Dr. Roos-Hesselink, a cardiologist at Erasmus Medical Center in Rotterdam, the Netherlands.
Based on the observed rates of mortality and other complications, pulmonary arterial hypertension and the other cardiac conditions that define a WHO IV maternal risk classification remain contraindications for pregnancy, she said. According to the 2011 guidelines from the European Society of Cardiology for managing cardiovascular disease during pregnancy, the full list of conditions that define a WHO IV classification are the following:
- Pulmonary arterial hypertension of any cause.
- Severe systemic ventricular dysfunction (a left ventricular ejection fraction of less than 30%) or New York Heart Association functional class III or IV.
- Previous peripartum cardiomyopathy with any residual impairment of left ventricular function.
- Severe mitral stenosis or severe symptomatic aortic stenosis.
- Marfan syndrome with the aorta dilated to more than 45 mm.
- Aortic dilatation greater than 50 mm in aortic disease associated with a bicuspid aortic valve.
- Native severe coarctation.
The registry data, collected during 2007-2018, showed a clear increase in the percentage of women with WHO class IV cardiovascular disease who became pregnant and entered the registry despite the contraindication designation for that classification, rising from about 1% of enrolled women in 2008 and 2009 to more than 10% of women in 2013, 2016, and 2017. “Individualization is necessary, but all these women are at very high risk and should be counseled against pregnancy,” Dr. Roos-Hesselink said.
The Registry of Pregnancy and Cardiac Disease (ROPAC) enrolled 5,739 pregnant women at any of 138 participating centers in 53 countries including the United States. Clinicians submitted WHO classification of cardiovascular risk for 5,711 of these women. The most common risk was congenital heart disease in 57% of enrolled women, followed by valvular heart disease in 29% and cardiomyopathy in 7%. Nearly 1,200 women in the registry – about 21% of the total – had a WHO I classification, which meant that they would be expected to have no detectable increase in mortality rate during pregnancy, compared with women without cardiac disease, and either no rise in morbidity or a mild effect.
Delivery was by cesarean section in 44% of the pregnancies, roughly twice the rate in women without diagnosed cardiac disease, even though published guidelines don’t advise cesarean delivery because of cardiac disease, Dr. Roos-Hesselink said. “Cesarean sections are used too often, in my opinion,” she commented, but added that many of these women require delivery at a tertiary, specialized center.
Overall fetal mortality was 1%, nearly threefold higher than in pregnancies in women without cardiac disease, and the overall incidence of fetal and neonatal complications was especially high, at 53%, in women with pulmonary arterial hypertension. The incidence of obstetrical complications was roughly similar across the range of cardiac disease type, ranging from 16% to 24%. Premature delivery occurred in 28% of women in the high-risk WHO IV class, compared with a 13% rate among women in the WHO I class. The mortality rate was 0.2% among the WHO class I women, and their heart failure incidence was 5%.
The ROPAC registry is sponsored by the European Society of Cardiology. Dr. Roos-Hesselink had no disclosures.
MUNICH – Women with cardiac disease who became pregnant had a nearly 100-fold higher mortality rate, compared with pregnant women without cardiac disease, according to the outcomes of more than 5,700 pregnancies in an international registry of women with cardiac disease.
In addition to increased mortality, women with cardiac disease who become pregnant also had a greater than 100-fold higher rate of developing heart failure, compared with pregnant women without cardiac disease.
Despite these highly elevated relative risks, the absolute rate of serious complications from pregnancy for most women with heart disease was relatively modest. The worst prognosis by far was for the 1% of women in the registry who had pulmonary arterial hypertension at the time their pregnancy began. For these women, mortality during pregnancy was about 9%, and new-onset heart failure occurred in about one third. Another subgroup showing particularly poor outcomes were women classified with WHO IV maternal cardiovascular risk by the modified World Health Organization criteria, which corresponds to having an “extremely high risk of maternal mortality or severe morbidity,” according to guidelines published in the European Heart Journal (2011 Dec 1;32[24]:3147-97).These women, constituting 7% of the registry cohort, had a 2.5% mortality rate during pregnancy and a 33% incidence of heart failure.
Across all women with cardiac disease enrolled in the registry, the incidence of death during pregnancy was 0.6% and the incidence of heart failure was 11%. Women without cardiac disease have rates of 0.007% and less than 0.1%, respectively, Jolien Roos-Hesselink, MD, said at the annual congress of the European Society of Cardiology.
“The most important message of my talk is that all patients should be counseled, not just the women at high risk, for whom pregnancy is contraindicated, but also the women at low risk,” who can have a child with relative safety, she said. “Many women [with cardiac disease] can go through pregnancy at low risk.” Counseling is the key so that women know their risk before becoming pregnant, stressed Dr. Roos-Hesselink, a cardiologist at Erasmus Medical Center in Rotterdam, the Netherlands.
Based on the observed rates of mortality and other complications, pulmonary arterial hypertension and the other cardiac conditions that define a WHO IV maternal risk classification remain contraindications for pregnancy, she said. According to the 2011 guidelines from the European Society of Cardiology for managing cardiovascular disease during pregnancy, the full list of conditions that define a WHO IV classification are the following:
- Pulmonary arterial hypertension of any cause.
- Severe systemic ventricular dysfunction (a left ventricular ejection fraction of less than 30%) or New York Heart Association functional class III or IV.
- Previous peripartum cardiomyopathy with any residual impairment of left ventricular function.
- Severe mitral stenosis or severe symptomatic aortic stenosis.
- Marfan syndrome with the aorta dilated to more than 45 mm.
- Aortic dilatation greater than 50 mm in aortic disease associated with a bicuspid aortic valve.
- Native severe coarctation.
The registry data, collected during 2007-2018, showed a clear increase in the percentage of women with WHO class IV cardiovascular disease who became pregnant and entered the registry despite the contraindication designation for that classification, rising from about 1% of enrolled women in 2008 and 2009 to more than 10% of women in 2013, 2016, and 2017. “Individualization is necessary, but all these women are at very high risk and should be counseled against pregnancy,” Dr. Roos-Hesselink said.
The Registry of Pregnancy and Cardiac Disease (ROPAC) enrolled 5,739 pregnant women at any of 138 participating centers in 53 countries including the United States. Clinicians submitted WHO classification of cardiovascular risk for 5,711 of these women. The most common risk was congenital heart disease in 57% of enrolled women, followed by valvular heart disease in 29% and cardiomyopathy in 7%. Nearly 1,200 women in the registry – about 21% of the total – had a WHO I classification, which meant that they would be expected to have no detectable increase in mortality rate during pregnancy, compared with women without cardiac disease, and either no rise in morbidity or a mild effect.
Delivery was by cesarean section in 44% of the pregnancies, roughly twice the rate in women without diagnosed cardiac disease, even though published guidelines don’t advise cesarean delivery because of cardiac disease, Dr. Roos-Hesselink said. “Cesarean sections are used too often, in my opinion,” she commented, but added that many of these women require delivery at a tertiary, specialized center.
Overall fetal mortality was 1%, nearly threefold higher than in pregnancies in women without cardiac disease, and the overall incidence of fetal and neonatal complications was especially high, at 53%, in women with pulmonary arterial hypertension. The incidence of obstetrical complications was roughly similar across the range of cardiac disease type, ranging from 16% to 24%. Premature delivery occurred in 28% of women in the high-risk WHO IV class, compared with a 13% rate among women in the WHO I class. The mortality rate was 0.2% among the WHO class I women, and their heart failure incidence was 5%.
The ROPAC registry is sponsored by the European Society of Cardiology. Dr. Roos-Hesselink had no disclosures.
MUNICH – Women with cardiac disease who became pregnant had a nearly 100-fold higher mortality rate, compared with pregnant women without cardiac disease, according to the outcomes of more than 5,700 pregnancies in an international registry of women with cardiac disease.
In addition to increased mortality, women with cardiac disease who become pregnant also had a greater than 100-fold higher rate of developing heart failure, compared with pregnant women without cardiac disease.
Despite these highly elevated relative risks, the absolute rate of serious complications from pregnancy for most women with heart disease was relatively modest. The worst prognosis by far was for the 1% of women in the registry who had pulmonary arterial hypertension at the time their pregnancy began. For these women, mortality during pregnancy was about 9%, and new-onset heart failure occurred in about one third. Another subgroup showing particularly poor outcomes were women classified with WHO IV maternal cardiovascular risk by the modified World Health Organization criteria, which corresponds to having an “extremely high risk of maternal mortality or severe morbidity,” according to guidelines published in the European Heart Journal (2011 Dec 1;32[24]:3147-97).These women, constituting 7% of the registry cohort, had a 2.5% mortality rate during pregnancy and a 33% incidence of heart failure.
Across all women with cardiac disease enrolled in the registry, the incidence of death during pregnancy was 0.6% and the incidence of heart failure was 11%. Women without cardiac disease have rates of 0.007% and less than 0.1%, respectively, Jolien Roos-Hesselink, MD, said at the annual congress of the European Society of Cardiology.
“The most important message of my talk is that all patients should be counseled, not just the women at high risk, for whom pregnancy is contraindicated, but also the women at low risk,” who can have a child with relative safety, she said. “Many women [with cardiac disease] can go through pregnancy at low risk.” Counseling is the key so that women know their risk before becoming pregnant, stressed Dr. Roos-Hesselink, a cardiologist at Erasmus Medical Center in Rotterdam, the Netherlands.
Based on the observed rates of mortality and other complications, pulmonary arterial hypertension and the other cardiac conditions that define a WHO IV maternal risk classification remain contraindications for pregnancy, she said. According to the 2011 guidelines from the European Society of Cardiology for managing cardiovascular disease during pregnancy, the full list of conditions that define a WHO IV classification are the following:
- Pulmonary arterial hypertension of any cause.
- Severe systemic ventricular dysfunction (a left ventricular ejection fraction of less than 30%) or New York Heart Association functional class III or IV.
- Previous peripartum cardiomyopathy with any residual impairment of left ventricular function.
- Severe mitral stenosis or severe symptomatic aortic stenosis.
- Marfan syndrome with the aorta dilated to more than 45 mm.
- Aortic dilatation greater than 50 mm in aortic disease associated with a bicuspid aortic valve.
- Native severe coarctation.
The registry data, collected during 2007-2018, showed a clear increase in the percentage of women with WHO class IV cardiovascular disease who became pregnant and entered the registry despite the contraindication designation for that classification, rising from about 1% of enrolled women in 2008 and 2009 to more than 10% of women in 2013, 2016, and 2017. “Individualization is necessary, but all these women are at very high risk and should be counseled against pregnancy,” Dr. Roos-Hesselink said.
The Registry of Pregnancy and Cardiac Disease (ROPAC) enrolled 5,739 pregnant women at any of 138 participating centers in 53 countries including the United States. Clinicians submitted WHO classification of cardiovascular risk for 5,711 of these women. The most common risk was congenital heart disease in 57% of enrolled women, followed by valvular heart disease in 29% and cardiomyopathy in 7%. Nearly 1,200 women in the registry – about 21% of the total – had a WHO I classification, which meant that they would be expected to have no detectable increase in mortality rate during pregnancy, compared with women without cardiac disease, and either no rise in morbidity or a mild effect.
Delivery was by cesarean section in 44% of the pregnancies, roughly twice the rate in women without diagnosed cardiac disease, even though published guidelines don’t advise cesarean delivery because of cardiac disease, Dr. Roos-Hesselink said. “Cesarean sections are used too often, in my opinion,” she commented, but added that many of these women require delivery at a tertiary, specialized center.
Overall fetal mortality was 1%, nearly threefold higher than in pregnancies in women without cardiac disease, and the overall incidence of fetal and neonatal complications was especially high, at 53%, in women with pulmonary arterial hypertension. The incidence of obstetrical complications was roughly similar across the range of cardiac disease type, ranging from 16% to 24%. Premature delivery occurred in 28% of women in the high-risk WHO IV class, compared with a 13% rate among women in the WHO I class. The mortality rate was 0.2% among the WHO class I women, and their heart failure incidence was 5%.
The ROPAC registry is sponsored by the European Society of Cardiology. Dr. Roos-Hesselink had no disclosures.
REPORTING FROM THE ESC CONGRESS 2018
Key clinical point: Women with cardiac disease who became pregnant had substantially increased mortality and morbidity.
Major finding: Pregnancy mortality was 0.6% in women with cardiac disease versus 0.007% in women without cardiac disorders.
Study details: The ROPAC registry, which enrolled 5,739 pregnant women at any of 138 centers in 53 countries during 2007-2018.
Disclosures: The ROPAC registry is sponsored by the European Society of Cardiology. Dr. Roos-Hesselink had no disclosures.
Coronary CT angiography radiation dose fell 78% from 2007-2017
MUNICH – The median radiation dosage received by patients worldwide undergoing coronary CT angiography fell by 78% from 2007 to 2017, according to a prospective study with more than 4,500 patients.
This substantial drop in radiation occurred with a steady rate of nondiagnostic CT scans, less than 2% in both 2007 and 2017.
“Given the high diagnostic accuracy and the low radiation dose, coronary CT angiography should be considered as a first-line diagnostic test,” Jörg Hausleiter, MD, said at the annual congress of the European Society of Cardiology.
The results also showed a huge disparity in the range of radiation doses used worldwide, with a 37-fold intersite variability in the median dose. This finding “underlines the need for further site-specific training and adaptation of contemporary cardiac scan protocols,” said Dr. Hausleiter, professor of medicine at the University of Munich Clinic. He suggested updated imaging guidelines on radiation levels, more educational sessions on how to perform coronary CT angiography, and actions by vendors to adjust their standard imaging protocols.
The Prospective Multicenter Registry on Radiation Dose Estimates of Cardiac CT Angiography in Daily Practice in 2017 (PROTECTION-VI) study included 4,502 patients from a total of 61 sites in 32 countries. At each participating site, investigators enrolled consecutive adults during a randomly selected month in 2017, with a median of 51 patients enrolled at each site undergoing diagnostic coronary CT angiography. Comparison data for 2007 came from a similar study run by Dr. Hausleiter and his associates at that time, with 1,965 patients undergoing coronary CT angiography (JAMA. 2009 Feb 4;301[5]:500-7). In 2007, the median dose-length product of radiation for each scan was 885 mGy x cm, which corresponds to a radiation dose of about 12.4 mSv. In 2017, the median dose-length product was 195 mGy x cm, corresponding to a dose of about 2.7 mSv. By both measures the median dose dropped by roughly 78%.
A multivariate analysis identified three changes in the way clinicians obtained most of the CT scans during the two studied time periods that seemed to explain the drop in radiation dose. First, more scan protocols in 2017 used low tube potential; second, more protocols in 2017 used prospectively ECG-triggered axial high-pitch scans; and third, 2017 had increased use of iterative image reconstruction, Dr. Hausleiter said. Patient variables that had modest but significant links with increased radiation doses were higher body weight, higher heart rate, and no sinus rhythm.
Concurrently with Dr. Hausleiter’s talk at the congress, the results appeared in an article online (Euro Heart J. 2018 Aug 25. doi: 10.1093/eurheartj/ehy546).
The results from the PROTECTION VI study show that the radiation doses used today for coronary CT angiography are very low. But the study is limited by looking only at the median doses used at 61 sites worldwide. I hope that the dose level seen in the study is what is now used at community hospitals across the United States, but for the time being we can’t be sure.
With today’s CT technology, as long as the dose-length product a patient receives is less than 200 mGy x cm, the facility is doing a good job of minimizing radiation exposure. As CT technology continues to improve, we can expect the median dose to fall even more in the future.
Todd C. Villines, MD , a cardiologist at Georgetown University in Washington and immediate past president of the Society of Cardiovascular CT, made these comments in an interview. He had no relevant disclosures.
The results from the PROTECTION VI study show that the radiation doses used today for coronary CT angiography are very low. But the study is limited by looking only at the median doses used at 61 sites worldwide. I hope that the dose level seen in the study is what is now used at community hospitals across the United States, but for the time being we can’t be sure.
With today’s CT technology, as long as the dose-length product a patient receives is less than 200 mGy x cm, the facility is doing a good job of minimizing radiation exposure. As CT technology continues to improve, we can expect the median dose to fall even more in the future.
Todd C. Villines, MD , a cardiologist at Georgetown University in Washington and immediate past president of the Society of Cardiovascular CT, made these comments in an interview. He had no relevant disclosures.
The results from the PROTECTION VI study show that the radiation doses used today for coronary CT angiography are very low. But the study is limited by looking only at the median doses used at 61 sites worldwide. I hope that the dose level seen in the study is what is now used at community hospitals across the United States, but for the time being we can’t be sure.
With today’s CT technology, as long as the dose-length product a patient receives is less than 200 mGy x cm, the facility is doing a good job of minimizing radiation exposure. As CT technology continues to improve, we can expect the median dose to fall even more in the future.
Todd C. Villines, MD , a cardiologist at Georgetown University in Washington and immediate past president of the Society of Cardiovascular CT, made these comments in an interview. He had no relevant disclosures.
MUNICH – The median radiation dosage received by patients worldwide undergoing coronary CT angiography fell by 78% from 2007 to 2017, according to a prospective study with more than 4,500 patients.
This substantial drop in radiation occurred with a steady rate of nondiagnostic CT scans, less than 2% in both 2007 and 2017.
“Given the high diagnostic accuracy and the low radiation dose, coronary CT angiography should be considered as a first-line diagnostic test,” Jörg Hausleiter, MD, said at the annual congress of the European Society of Cardiology.
The results also showed a huge disparity in the range of radiation doses used worldwide, with a 37-fold intersite variability in the median dose. This finding “underlines the need for further site-specific training and adaptation of contemporary cardiac scan protocols,” said Dr. Hausleiter, professor of medicine at the University of Munich Clinic. He suggested updated imaging guidelines on radiation levels, more educational sessions on how to perform coronary CT angiography, and actions by vendors to adjust their standard imaging protocols.
The Prospective Multicenter Registry on Radiation Dose Estimates of Cardiac CT Angiography in Daily Practice in 2017 (PROTECTION-VI) study included 4,502 patients from a total of 61 sites in 32 countries. At each participating site, investigators enrolled consecutive adults during a randomly selected month in 2017, with a median of 51 patients enrolled at each site undergoing diagnostic coronary CT angiography. Comparison data for 2007 came from a similar study run by Dr. Hausleiter and his associates at that time, with 1,965 patients undergoing coronary CT angiography (JAMA. 2009 Feb 4;301[5]:500-7). In 2007, the median dose-length product of radiation for each scan was 885 mGy x cm, which corresponds to a radiation dose of about 12.4 mSv. In 2017, the median dose-length product was 195 mGy x cm, corresponding to a dose of about 2.7 mSv. By both measures the median dose dropped by roughly 78%.
A multivariate analysis identified three changes in the way clinicians obtained most of the CT scans during the two studied time periods that seemed to explain the drop in radiation dose. First, more scan protocols in 2017 used low tube potential; second, more protocols in 2017 used prospectively ECG-triggered axial high-pitch scans; and third, 2017 had increased use of iterative image reconstruction, Dr. Hausleiter said. Patient variables that had modest but significant links with increased radiation doses were higher body weight, higher heart rate, and no sinus rhythm.
Concurrently with Dr. Hausleiter’s talk at the congress, the results appeared in an article online (Euro Heart J. 2018 Aug 25. doi: 10.1093/eurheartj/ehy546).
MUNICH – The median radiation dosage received by patients worldwide undergoing coronary CT angiography fell by 78% from 2007 to 2017, according to a prospective study with more than 4,500 patients.
This substantial drop in radiation occurred with a steady rate of nondiagnostic CT scans, less than 2% in both 2007 and 2017.
“Given the high diagnostic accuracy and the low radiation dose, coronary CT angiography should be considered as a first-line diagnostic test,” Jörg Hausleiter, MD, said at the annual congress of the European Society of Cardiology.
The results also showed a huge disparity in the range of radiation doses used worldwide, with a 37-fold intersite variability in the median dose. This finding “underlines the need for further site-specific training and adaptation of contemporary cardiac scan protocols,” said Dr. Hausleiter, professor of medicine at the University of Munich Clinic. He suggested updated imaging guidelines on radiation levels, more educational sessions on how to perform coronary CT angiography, and actions by vendors to adjust their standard imaging protocols.
The Prospective Multicenter Registry on Radiation Dose Estimates of Cardiac CT Angiography in Daily Practice in 2017 (PROTECTION-VI) study included 4,502 patients from a total of 61 sites in 32 countries. At each participating site, investigators enrolled consecutive adults during a randomly selected month in 2017, with a median of 51 patients enrolled at each site undergoing diagnostic coronary CT angiography. Comparison data for 2007 came from a similar study run by Dr. Hausleiter and his associates at that time, with 1,965 patients undergoing coronary CT angiography (JAMA. 2009 Feb 4;301[5]:500-7). In 2007, the median dose-length product of radiation for each scan was 885 mGy x cm, which corresponds to a radiation dose of about 12.4 mSv. In 2017, the median dose-length product was 195 mGy x cm, corresponding to a dose of about 2.7 mSv. By both measures the median dose dropped by roughly 78%.
A multivariate analysis identified three changes in the way clinicians obtained most of the CT scans during the two studied time periods that seemed to explain the drop in radiation dose. First, more scan protocols in 2017 used low tube potential; second, more protocols in 2017 used prospectively ECG-triggered axial high-pitch scans; and third, 2017 had increased use of iterative image reconstruction, Dr. Hausleiter said. Patient variables that had modest but significant links with increased radiation doses were higher body weight, higher heart rate, and no sinus rhythm.
Concurrently with Dr. Hausleiter’s talk at the congress, the results appeared in an article online (Euro Heart J. 2018 Aug 25. doi: 10.1093/eurheartj/ehy546).
REPORTING FROM THE ESC CONGRESS 2018
Key clinical point: The median radiation dose during coronary CT angiography fell from 2007 to 2017.
Major finding: The median dose-length product was 195 mGY x cm in 2017 and 885 mGy x cm in 2007.
Study details: PROTECTION VI, a prospective study run at 61 sites in 32 countries.
Disclosures: PROTECTION VI received no commercial funding. Dr. Hausleiter has received research funding from Abbott Vascular.
New MI definition aims to better distinguish infarction from injury
MUNICH – The worldwide cardiology community’s newly revised universal definition of an MI refines the way that cardiologists distinguish between myocardial infarction and myocardial injury, said Joseph S. Alpert, MD, one of the two chairs of the definition-writing panel.
“We had three previous definitions, but there is still a lot of confusion [about distinguishing] between injury and infarction. We definitely hope that this fourth definition will further help people distinguish the two and help people determine whether or not a patient has an MI,” said Dr. Alpert following a session at the annual congress of the European Society of Cardiology that introduced some of the key elements of the new revision.
Days before the ESC congress, a task force formed by the European Society of Cardiology, the American College of Cardiology, the American Heart Association, and the World Heart Federation released the Fourth Universal Definition of Myocardial Infarction (2018) (J Am Coll Cardiol. 2018 Aug 24. doi: 10.1016/j.jacc.2018.08.1038), which follows the series of three prior MI definitions that these groups have issued since the first iteration came out in 2007 (J Am Coll Cardiol. 2007;50[22]:2173-95).
The new revision includes 5 “new concepts,” 14 updated concepts, and 6 new sections since the third universal definition from 2012. The change that topped Dr. Alpert’s list of key messages was the need to determine whether a rise in cardiac troponin, a key biomarker of cardiac damage, resulted from infarction or injury.
These two alternative diagnoses mean “a very different outlook for patients. Treatment is different, and their prognosis is different. It’s important to make the distinction,” said Dr. Alpert, professor of medicine at the University of Arizona in Tucson.
The new changes to making an MI diagnosis will likely help drive a couple of important changes in the way U.S. patients with suspected myocardial injury or infarction get assessed, he said in an interview. The first change will be wide uptake of high sensitivity cardiac troponin (hscTn) assays over the next 5 years or so, as the ability to measure this key diagnostic biomarker progresses from its initial Food and Drug Administration approval for the U.S. market in 2017 to “close to 100% of U.S. hospitals using it,” he predicted. A big issue that is currently slowing even quicker adoption of hscTn is that many hospitals, including the one where Dr. Alpert practices, still have laboratory contracts in place that tether them to older troponin-testing technologies and make it economically unfeasible to change until their contracts expire. The contract in place where Dr. Alpert practices runs out in 2019, and soon after that happens he expects to gain the ability to order a hscTn test.
The new, fourth definition says that hscTn is “recommended for routine clinical use,” but routine U.S. use “won’t be immediate because many hospitals will put in hscTn only when their old contract runs out,” he said.
Another practice-changing impact from the fourth definition may be expanded U.S. availability and use of MR imaging, which the fourth definition identified as the most informative and versatile of the several imaging options used to confirm or rule out an MI.
Cardiac MR “provides both functional and tissue characterization. It’s the technique with the most potential,” able to noninvasively identify “both the nature and extent of myocardial damage,” explained Chiara Bucciarelli-Ducci, MD, a cardiologist and imaging specialist at the Bristol (England) Heart Institute. A single cardiac MR scan “gives many answers,” said Dr. Bucciarelli-Ducci, who also served on the fourth definition task force and spoke at the session about the document’s revised imaging recommendations.
“In the setting of acute MI, cardiac MR can also be used to assess the presence and extent of myocardium at risk (myocardial edema), myocardial salvage, microvascular obstruction, intramyocardial hemorrhage, and infarct size, all markers of myocardial injury that have prognostic value,” according to the fourth definition. “In patients with possible acute MI but unobstructed coronary arteries, cardiac MR can help to diagnose alternative conditions such as myocarditis, Takotsubo syndrome, embolic infarction, or MI with spontaneous recanalization.”
“What’s turning out is that, a large number of patients with chest pain have an infection and not an MI, and cardiac MR can distinguish inflammation and myocarditis from infarction. We’re now doing a lot more MRs,” Dr. Alpert said. Although MR capability is not as widely available today as other imaging methods, like echocardiography and CT, over the next 5 years that will likely change, he said. But Dr. Alpert cautioned that not every patient with a suspected MI needs MR assessment. It’s best focused for selected patients with an uncertain diagnosis based on the core indicators of disease: history, ECG, changes in hscTn levels over time, and a chest x-ray. “MR is for when there are questions,” he said. When patients present with classic MI signs and symptoms the diagnosis can depend just on the basics, perhaps supplemented with a more widely available imaging method like echocardiography to look for wall motion abnormalities, he said. “If echo shows good left ventricular function you probably don’t need MR.” he said.
CT coronary angiography (CTCA) is another useful diagnostic tool, and right now is more widely available than MR. CTCA “may be used to diagnose coronary artery disease in patients with an acute coronary syndrome event in the emergency department or chest pain unit, particularly in low- to intermediate-risk patients with normal hscTn at presentation,” said the fourth definition. But Dr. Alpert cited the radiation dose from CT as a limiting factor. “We have patients who get repeat CT scans, and we know that increases their cancer risk. There is no such thing as a totally safe dose of radiation.” Lack of radiation exposure is another feature that makes MR imaging attractive.
Dr. Alpert had no disclosures. Dr. Bucciarelli-Ducci has had a financial relationship with Circle Cardiovascular Imaging.
MUNICH – The worldwide cardiology community’s newly revised universal definition of an MI refines the way that cardiologists distinguish between myocardial infarction and myocardial injury, said Joseph S. Alpert, MD, one of the two chairs of the definition-writing panel.
“We had three previous definitions, but there is still a lot of confusion [about distinguishing] between injury and infarction. We definitely hope that this fourth definition will further help people distinguish the two and help people determine whether or not a patient has an MI,” said Dr. Alpert following a session at the annual congress of the European Society of Cardiology that introduced some of the key elements of the new revision.
Days before the ESC congress, a task force formed by the European Society of Cardiology, the American College of Cardiology, the American Heart Association, and the World Heart Federation released the Fourth Universal Definition of Myocardial Infarction (2018) (J Am Coll Cardiol. 2018 Aug 24. doi: 10.1016/j.jacc.2018.08.1038), which follows the series of three prior MI definitions that these groups have issued since the first iteration came out in 2007 (J Am Coll Cardiol. 2007;50[22]:2173-95).
The new revision includes 5 “new concepts,” 14 updated concepts, and 6 new sections since the third universal definition from 2012. The change that topped Dr. Alpert’s list of key messages was the need to determine whether a rise in cardiac troponin, a key biomarker of cardiac damage, resulted from infarction or injury.
These two alternative diagnoses mean “a very different outlook for patients. Treatment is different, and their prognosis is different. It’s important to make the distinction,” said Dr. Alpert, professor of medicine at the University of Arizona in Tucson.
The new changes to making an MI diagnosis will likely help drive a couple of important changes in the way U.S. patients with suspected myocardial injury or infarction get assessed, he said in an interview. The first change will be wide uptake of high sensitivity cardiac troponin (hscTn) assays over the next 5 years or so, as the ability to measure this key diagnostic biomarker progresses from its initial Food and Drug Administration approval for the U.S. market in 2017 to “close to 100% of U.S. hospitals using it,” he predicted. A big issue that is currently slowing even quicker adoption of hscTn is that many hospitals, including the one where Dr. Alpert practices, still have laboratory contracts in place that tether them to older troponin-testing technologies and make it economically unfeasible to change until their contracts expire. The contract in place where Dr. Alpert practices runs out in 2019, and soon after that happens he expects to gain the ability to order a hscTn test.
The new, fourth definition says that hscTn is “recommended for routine clinical use,” but routine U.S. use “won’t be immediate because many hospitals will put in hscTn only when their old contract runs out,” he said.
Another practice-changing impact from the fourth definition may be expanded U.S. availability and use of MR imaging, which the fourth definition identified as the most informative and versatile of the several imaging options used to confirm or rule out an MI.
Cardiac MR “provides both functional and tissue characterization. It’s the technique with the most potential,” able to noninvasively identify “both the nature and extent of myocardial damage,” explained Chiara Bucciarelli-Ducci, MD, a cardiologist and imaging specialist at the Bristol (England) Heart Institute. A single cardiac MR scan “gives many answers,” said Dr. Bucciarelli-Ducci, who also served on the fourth definition task force and spoke at the session about the document’s revised imaging recommendations.
“In the setting of acute MI, cardiac MR can also be used to assess the presence and extent of myocardium at risk (myocardial edema), myocardial salvage, microvascular obstruction, intramyocardial hemorrhage, and infarct size, all markers of myocardial injury that have prognostic value,” according to the fourth definition. “In patients with possible acute MI but unobstructed coronary arteries, cardiac MR can help to diagnose alternative conditions such as myocarditis, Takotsubo syndrome, embolic infarction, or MI with spontaneous recanalization.”
“What’s turning out is that, a large number of patients with chest pain have an infection and not an MI, and cardiac MR can distinguish inflammation and myocarditis from infarction. We’re now doing a lot more MRs,” Dr. Alpert said. Although MR capability is not as widely available today as other imaging methods, like echocardiography and CT, over the next 5 years that will likely change, he said. But Dr. Alpert cautioned that not every patient with a suspected MI needs MR assessment. It’s best focused for selected patients with an uncertain diagnosis based on the core indicators of disease: history, ECG, changes in hscTn levels over time, and a chest x-ray. “MR is for when there are questions,” he said. When patients present with classic MI signs and symptoms the diagnosis can depend just on the basics, perhaps supplemented with a more widely available imaging method like echocardiography to look for wall motion abnormalities, he said. “If echo shows good left ventricular function you probably don’t need MR.” he said.
CT coronary angiography (CTCA) is another useful diagnostic tool, and right now is more widely available than MR. CTCA “may be used to diagnose coronary artery disease in patients with an acute coronary syndrome event in the emergency department or chest pain unit, particularly in low- to intermediate-risk patients with normal hscTn at presentation,” said the fourth definition. But Dr. Alpert cited the radiation dose from CT as a limiting factor. “We have patients who get repeat CT scans, and we know that increases their cancer risk. There is no such thing as a totally safe dose of radiation.” Lack of radiation exposure is another feature that makes MR imaging attractive.
Dr. Alpert had no disclosures. Dr. Bucciarelli-Ducci has had a financial relationship with Circle Cardiovascular Imaging.
MUNICH – The worldwide cardiology community’s newly revised universal definition of an MI refines the way that cardiologists distinguish between myocardial infarction and myocardial injury, said Joseph S. Alpert, MD, one of the two chairs of the definition-writing panel.
“We had three previous definitions, but there is still a lot of confusion [about distinguishing] between injury and infarction. We definitely hope that this fourth definition will further help people distinguish the two and help people determine whether or not a patient has an MI,” said Dr. Alpert following a session at the annual congress of the European Society of Cardiology that introduced some of the key elements of the new revision.
Days before the ESC congress, a task force formed by the European Society of Cardiology, the American College of Cardiology, the American Heart Association, and the World Heart Federation released the Fourth Universal Definition of Myocardial Infarction (2018) (J Am Coll Cardiol. 2018 Aug 24. doi: 10.1016/j.jacc.2018.08.1038), which follows the series of three prior MI definitions that these groups have issued since the first iteration came out in 2007 (J Am Coll Cardiol. 2007;50[22]:2173-95).
The new revision includes 5 “new concepts,” 14 updated concepts, and 6 new sections since the third universal definition from 2012. The change that topped Dr. Alpert’s list of key messages was the need to determine whether a rise in cardiac troponin, a key biomarker of cardiac damage, resulted from infarction or injury.
These two alternative diagnoses mean “a very different outlook for patients. Treatment is different, and their prognosis is different. It’s important to make the distinction,” said Dr. Alpert, professor of medicine at the University of Arizona in Tucson.
The new changes to making an MI diagnosis will likely help drive a couple of important changes in the way U.S. patients with suspected myocardial injury or infarction get assessed, he said in an interview. The first change will be wide uptake of high sensitivity cardiac troponin (hscTn) assays over the next 5 years or so, as the ability to measure this key diagnostic biomarker progresses from its initial Food and Drug Administration approval for the U.S. market in 2017 to “close to 100% of U.S. hospitals using it,” he predicted. A big issue that is currently slowing even quicker adoption of hscTn is that many hospitals, including the one where Dr. Alpert practices, still have laboratory contracts in place that tether them to older troponin-testing technologies and make it economically unfeasible to change until their contracts expire. The contract in place where Dr. Alpert practices runs out in 2019, and soon after that happens he expects to gain the ability to order a hscTn test.
The new, fourth definition says that hscTn is “recommended for routine clinical use,” but routine U.S. use “won’t be immediate because many hospitals will put in hscTn only when their old contract runs out,” he said.
Another practice-changing impact from the fourth definition may be expanded U.S. availability and use of MR imaging, which the fourth definition identified as the most informative and versatile of the several imaging options used to confirm or rule out an MI.
Cardiac MR “provides both functional and tissue characterization. It’s the technique with the most potential,” able to noninvasively identify “both the nature and extent of myocardial damage,” explained Chiara Bucciarelli-Ducci, MD, a cardiologist and imaging specialist at the Bristol (England) Heart Institute. A single cardiac MR scan “gives many answers,” said Dr. Bucciarelli-Ducci, who also served on the fourth definition task force and spoke at the session about the document’s revised imaging recommendations.
“In the setting of acute MI, cardiac MR can also be used to assess the presence and extent of myocardium at risk (myocardial edema), myocardial salvage, microvascular obstruction, intramyocardial hemorrhage, and infarct size, all markers of myocardial injury that have prognostic value,” according to the fourth definition. “In patients with possible acute MI but unobstructed coronary arteries, cardiac MR can help to diagnose alternative conditions such as myocarditis, Takotsubo syndrome, embolic infarction, or MI with spontaneous recanalization.”
“What’s turning out is that, a large number of patients with chest pain have an infection and not an MI, and cardiac MR can distinguish inflammation and myocarditis from infarction. We’re now doing a lot more MRs,” Dr. Alpert said. Although MR capability is not as widely available today as other imaging methods, like echocardiography and CT, over the next 5 years that will likely change, he said. But Dr. Alpert cautioned that not every patient with a suspected MI needs MR assessment. It’s best focused for selected patients with an uncertain diagnosis based on the core indicators of disease: history, ECG, changes in hscTn levels over time, and a chest x-ray. “MR is for when there are questions,” he said. When patients present with classic MI signs and symptoms the diagnosis can depend just on the basics, perhaps supplemented with a more widely available imaging method like echocardiography to look for wall motion abnormalities, he said. “If echo shows good left ventricular function you probably don’t need MR.” he said.
CT coronary angiography (CTCA) is another useful diagnostic tool, and right now is more widely available than MR. CTCA “may be used to diagnose coronary artery disease in patients with an acute coronary syndrome event in the emergency department or chest pain unit, particularly in low- to intermediate-risk patients with normal hscTn at presentation,” said the fourth definition. But Dr. Alpert cited the radiation dose from CT as a limiting factor. “We have patients who get repeat CT scans, and we know that increases their cancer risk. There is no such thing as a totally safe dose of radiation.” Lack of radiation exposure is another feature that makes MR imaging attractive.
Dr. Alpert had no disclosures. Dr. Bucciarelli-Ducci has had a financial relationship with Circle Cardiovascular Imaging.
REPORTING FROM THE ESC CONGRESS 2018
FOURIER analysis: PCSK9 inhibition helps MetS patients the most
MUNICH – Patients with hypercholesterolemia, atherosclerotic cardiovascular disease, and metabolic syndrome received a bigger benefit from treatment with a PCSK9 inhibitor than did otherwise similar patients without metabolic syndrome in a post hoc analysis of data collected from a placebo-controlled trial of a PCSK9 inhibitor with more than 27,000 total participants.
The analysis showed that patients with metabolic syndrome (MetS) treated with the proprotein convertase subtilisin–kexin type 9 (PCSK9) inhibitor evolocumab in the FOURIER study had a statistically significant 17% relative risk reduction in the study’s primary efficacy endpoint compared with placebo, while those without MetS had an 11% relative risk reduction that did not reach statistical significance, Prakash Deedwania, MD, said at the annual congress of the European Society of Cardiology. “Given their higher baseline risk [for cardiovascular disease events], patients with metabolic syndrome had a larger absolute reduction in cardiovascular events,” said Dr. Deedwania, a professor of medicine at the University of California, San Francisco.
For the study’s secondary endpoint of the combined rate of cardiovascular disease death, nonfatal MI, and nonfatal stroke, patients with MetS treated with evolocumab had a statistically significant 24% relative risk reduction compared with placebo, while those without MetS had an insignificant 14% reduction. Dr. Deedwania and his associates calculated these relative risk reductions and those for the primary endpoint using adjustments for baseline differences between the MetS and non-MetS subgroups in age, race, sex, history of diabetes, history of MI, heart failure, smoking, renal function, LDL cholesterol levels, and use of a high-intensity dosage of a statin. Among the 27,342 patients enrolled in the trial 16,361 (60%) had MetS at entry into the study, which made this “the largest study ever reported for patients with metabolic syndrome,” he noted.
“Evolocumab was still effective in patients without metabolic syndrome, but it was of lesser magnitude, and that combined with the fewer patients in the non–metabolic syndrome subgroup meant the effect did not reach statistical significance,” Dr. Deedwania explained. “These data help identify the patients who benefit the most from treatment with an expensive drug,” a PCSK9 inhibitor. Based on list prices the annual cost for treatment with a PCSK9 inhibitor such as evolocumab (Repatha) or a second approved drug from this class, alirocumab (Praluent), is roughly $14,000 (JAMA Cardiol. 2017 Oct;2[10]:1066-8).
The analysis run by Dr. Deedwania used data collected in the FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk) trial, which had showed an overall relative risk reduction of 15% compared with placebo during a median follow-up of 2.2 years for the primary endpoint of cardiovascular death, nonfatal MI, nonfatal stroke, hospitalization for unstable angina, or coronary revascularization (N Engl J Med. 2017 May 4;376[18]:1713-22). The study ran at 1,242 sites in 49 countries. He and his associates identified enrolled patients with MetS using the definition of the 2001 Third Report from the National Cholesterol Education Program: People with at least three of five criteria – fasting blood glucose of at least 100 mg/dL; waist circumference greater than 102 cm in men and 88 cm in women; systolic blood pressure of at least 135 mm Hg, diastolic blood pressure of at least 85 mm Hg, or a history of hypertension diagnosis; a triglyceride level greater than 150 mg/dL; and an HDL cholesterol level of less than 40 mg/dL in men and less than 50 mg/dL in women (JAMA. 2001 May 16;285[19]:2486-97).
The new analysis also showed that treatment with evolocumab led to an incremental, average reduction in LDL cholesterol of 58% in patients with MetS and 61% in patients without MetS at the time of enrollment. The patients with MetS in FOURIER overall had a significantly higher number of primary endpoint events, 15.8%, than enrolled patients without MetS, 12.9%, regardless of whether or not they received evolocumab, a relative risk of 21% more events after adjustment. The analysis also showed that treatment with evolocumab was equally safe and well tolerated by patients regardless of whether or not they had MetS, and that patients with MetS had no increased incidence of diabetes or elevations in fasting blood glucose or hemoglobin A1c while on treatment compared with those without MetS.
Dr. Deedwania has been a consultant to Amgen, the company that markets evolocumab, and to Sanofi, the company that markets a different PCSK9 inhibitor, alirocumab.
[email protected]
On Twitter @mitchelzoler
Given the relatively high cost for the PCSK9 inhibitor drugs, clinicians need to know which patients are likely to get the biggest bang for the buck from these agents. This will be not just patients with the highest risks for cardiovascular disease events, but those with modifiable risk factors.
The finding of greater benefit from evolocumab in patients with metabolic syndrome seen in this new analysis of data from FOURIER is consistent with other reported analyses from this trial, which identified other markers of greater benefit such as peripheral artery disease, recent MIs, and multivessel coronary artery disease. The next step will be to try to put all these findings together and figure out which patients get the most benefit from treatment. If society can’t afford to treat all eligible patients with expensive PCSK9 inhibitors, we need to learn how to use these drugs in the most cost-effective way.
Stephen J. Nicholls, MD , is professor of cardiology at the University of Adelaide, Australia. He has received research funding from and has been a consultant to several drug companies including Amgen and Sanofi/Regeneron, the companies that market PCSK9 inhibitors. He made these comments in an interview.
Given the relatively high cost for the PCSK9 inhibitor drugs, clinicians need to know which patients are likely to get the biggest bang for the buck from these agents. This will be not just patients with the highest risks for cardiovascular disease events, but those with modifiable risk factors.
The finding of greater benefit from evolocumab in patients with metabolic syndrome seen in this new analysis of data from FOURIER is consistent with other reported analyses from this trial, which identified other markers of greater benefit such as peripheral artery disease, recent MIs, and multivessel coronary artery disease. The next step will be to try to put all these findings together and figure out which patients get the most benefit from treatment. If society can’t afford to treat all eligible patients with expensive PCSK9 inhibitors, we need to learn how to use these drugs in the most cost-effective way.
Stephen J. Nicholls, MD , is professor of cardiology at the University of Adelaide, Australia. He has received research funding from and has been a consultant to several drug companies including Amgen and Sanofi/Regeneron, the companies that market PCSK9 inhibitors. He made these comments in an interview.
Given the relatively high cost for the PCSK9 inhibitor drugs, clinicians need to know which patients are likely to get the biggest bang for the buck from these agents. This will be not just patients with the highest risks for cardiovascular disease events, but those with modifiable risk factors.
The finding of greater benefit from evolocumab in patients with metabolic syndrome seen in this new analysis of data from FOURIER is consistent with other reported analyses from this trial, which identified other markers of greater benefit such as peripheral artery disease, recent MIs, and multivessel coronary artery disease. The next step will be to try to put all these findings together and figure out which patients get the most benefit from treatment. If society can’t afford to treat all eligible patients with expensive PCSK9 inhibitors, we need to learn how to use these drugs in the most cost-effective way.
Stephen J. Nicholls, MD , is professor of cardiology at the University of Adelaide, Australia. He has received research funding from and has been a consultant to several drug companies including Amgen and Sanofi/Regeneron, the companies that market PCSK9 inhibitors. He made these comments in an interview.
MUNICH – Patients with hypercholesterolemia, atherosclerotic cardiovascular disease, and metabolic syndrome received a bigger benefit from treatment with a PCSK9 inhibitor than did otherwise similar patients without metabolic syndrome in a post hoc analysis of data collected from a placebo-controlled trial of a PCSK9 inhibitor with more than 27,000 total participants.
The analysis showed that patients with metabolic syndrome (MetS) treated with the proprotein convertase subtilisin–kexin type 9 (PCSK9) inhibitor evolocumab in the FOURIER study had a statistically significant 17% relative risk reduction in the study’s primary efficacy endpoint compared with placebo, while those without MetS had an 11% relative risk reduction that did not reach statistical significance, Prakash Deedwania, MD, said at the annual congress of the European Society of Cardiology. “Given their higher baseline risk [for cardiovascular disease events], patients with metabolic syndrome had a larger absolute reduction in cardiovascular events,” said Dr. Deedwania, a professor of medicine at the University of California, San Francisco.
For the study’s secondary endpoint of the combined rate of cardiovascular disease death, nonfatal MI, and nonfatal stroke, patients with MetS treated with evolocumab had a statistically significant 24% relative risk reduction compared with placebo, while those without MetS had an insignificant 14% reduction. Dr. Deedwania and his associates calculated these relative risk reductions and those for the primary endpoint using adjustments for baseline differences between the MetS and non-MetS subgroups in age, race, sex, history of diabetes, history of MI, heart failure, smoking, renal function, LDL cholesterol levels, and use of a high-intensity dosage of a statin. Among the 27,342 patients enrolled in the trial 16,361 (60%) had MetS at entry into the study, which made this “the largest study ever reported for patients with metabolic syndrome,” he noted.
“Evolocumab was still effective in patients without metabolic syndrome, but it was of lesser magnitude, and that combined with the fewer patients in the non–metabolic syndrome subgroup meant the effect did not reach statistical significance,” Dr. Deedwania explained. “These data help identify the patients who benefit the most from treatment with an expensive drug,” a PCSK9 inhibitor. Based on list prices the annual cost for treatment with a PCSK9 inhibitor such as evolocumab (Repatha) or a second approved drug from this class, alirocumab (Praluent), is roughly $14,000 (JAMA Cardiol. 2017 Oct;2[10]:1066-8).
The analysis run by Dr. Deedwania used data collected in the FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk) trial, which had showed an overall relative risk reduction of 15% compared with placebo during a median follow-up of 2.2 years for the primary endpoint of cardiovascular death, nonfatal MI, nonfatal stroke, hospitalization for unstable angina, or coronary revascularization (N Engl J Med. 2017 May 4;376[18]:1713-22). The study ran at 1,242 sites in 49 countries. He and his associates identified enrolled patients with MetS using the definition of the 2001 Third Report from the National Cholesterol Education Program: People with at least three of five criteria – fasting blood glucose of at least 100 mg/dL; waist circumference greater than 102 cm in men and 88 cm in women; systolic blood pressure of at least 135 mm Hg, diastolic blood pressure of at least 85 mm Hg, or a history of hypertension diagnosis; a triglyceride level greater than 150 mg/dL; and an HDL cholesterol level of less than 40 mg/dL in men and less than 50 mg/dL in women (JAMA. 2001 May 16;285[19]:2486-97).
The new analysis also showed that treatment with evolocumab led to an incremental, average reduction in LDL cholesterol of 58% in patients with MetS and 61% in patients without MetS at the time of enrollment. The patients with MetS in FOURIER overall had a significantly higher number of primary endpoint events, 15.8%, than enrolled patients without MetS, 12.9%, regardless of whether or not they received evolocumab, a relative risk of 21% more events after adjustment. The analysis also showed that treatment with evolocumab was equally safe and well tolerated by patients regardless of whether or not they had MetS, and that patients with MetS had no increased incidence of diabetes or elevations in fasting blood glucose or hemoglobin A1c while on treatment compared with those without MetS.
Dr. Deedwania has been a consultant to Amgen, the company that markets evolocumab, and to Sanofi, the company that markets a different PCSK9 inhibitor, alirocumab.
[email protected]
On Twitter @mitchelzoler
MUNICH – Patients with hypercholesterolemia, atherosclerotic cardiovascular disease, and metabolic syndrome received a bigger benefit from treatment with a PCSK9 inhibitor than did otherwise similar patients without metabolic syndrome in a post hoc analysis of data collected from a placebo-controlled trial of a PCSK9 inhibitor with more than 27,000 total participants.
The analysis showed that patients with metabolic syndrome (MetS) treated with the proprotein convertase subtilisin–kexin type 9 (PCSK9) inhibitor evolocumab in the FOURIER study had a statistically significant 17% relative risk reduction in the study’s primary efficacy endpoint compared with placebo, while those without MetS had an 11% relative risk reduction that did not reach statistical significance, Prakash Deedwania, MD, said at the annual congress of the European Society of Cardiology. “Given their higher baseline risk [for cardiovascular disease events], patients with metabolic syndrome had a larger absolute reduction in cardiovascular events,” said Dr. Deedwania, a professor of medicine at the University of California, San Francisco.
For the study’s secondary endpoint of the combined rate of cardiovascular disease death, nonfatal MI, and nonfatal stroke, patients with MetS treated with evolocumab had a statistically significant 24% relative risk reduction compared with placebo, while those without MetS had an insignificant 14% reduction. Dr. Deedwania and his associates calculated these relative risk reductions and those for the primary endpoint using adjustments for baseline differences between the MetS and non-MetS subgroups in age, race, sex, history of diabetes, history of MI, heart failure, smoking, renal function, LDL cholesterol levels, and use of a high-intensity dosage of a statin. Among the 27,342 patients enrolled in the trial 16,361 (60%) had MetS at entry into the study, which made this “the largest study ever reported for patients with metabolic syndrome,” he noted.
“Evolocumab was still effective in patients without metabolic syndrome, but it was of lesser magnitude, and that combined with the fewer patients in the non–metabolic syndrome subgroup meant the effect did not reach statistical significance,” Dr. Deedwania explained. “These data help identify the patients who benefit the most from treatment with an expensive drug,” a PCSK9 inhibitor. Based on list prices the annual cost for treatment with a PCSK9 inhibitor such as evolocumab (Repatha) or a second approved drug from this class, alirocumab (Praluent), is roughly $14,000 (JAMA Cardiol. 2017 Oct;2[10]:1066-8).
The analysis run by Dr. Deedwania used data collected in the FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk) trial, which had showed an overall relative risk reduction of 15% compared with placebo during a median follow-up of 2.2 years for the primary endpoint of cardiovascular death, nonfatal MI, nonfatal stroke, hospitalization for unstable angina, or coronary revascularization (N Engl J Med. 2017 May 4;376[18]:1713-22). The study ran at 1,242 sites in 49 countries. He and his associates identified enrolled patients with MetS using the definition of the 2001 Third Report from the National Cholesterol Education Program: People with at least three of five criteria – fasting blood glucose of at least 100 mg/dL; waist circumference greater than 102 cm in men and 88 cm in women; systolic blood pressure of at least 135 mm Hg, diastolic blood pressure of at least 85 mm Hg, or a history of hypertension diagnosis; a triglyceride level greater than 150 mg/dL; and an HDL cholesterol level of less than 40 mg/dL in men and less than 50 mg/dL in women (JAMA. 2001 May 16;285[19]:2486-97).
The new analysis also showed that treatment with evolocumab led to an incremental, average reduction in LDL cholesterol of 58% in patients with MetS and 61% in patients without MetS at the time of enrollment. The patients with MetS in FOURIER overall had a significantly higher number of primary endpoint events, 15.8%, than enrolled patients without MetS, 12.9%, regardless of whether or not they received evolocumab, a relative risk of 21% more events after adjustment. The analysis also showed that treatment with evolocumab was equally safe and well tolerated by patients regardless of whether or not they had MetS, and that patients with MetS had no increased incidence of diabetes or elevations in fasting blood glucose or hemoglobin A1c while on treatment compared with those without MetS.
Dr. Deedwania has been a consultant to Amgen, the company that markets evolocumab, and to Sanofi, the company that markets a different PCSK9 inhibitor, alirocumab.
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REPORTING FROM THE ESC CONGRESS 2018
Key clinical point: PCSK9 inhibition produced the biggest benefit in patients with metabolic syndrome.
Major finding: In patients with metabolic syndrome, treatment with evolocumab cut the primary endpoint by a relative 17% compared with placebo.
Study details: Post hoc analysis of data from FOURIER, a multicenter, randomized trial with 27,342 patients.
Disclosures: Dr. Deedwania has been a consultant to Amgen, the company that markets evolocumab, and to Sanofi, the company that markets a different PCSK9 inhibitor, alirocumab.