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PARIS – A strong tide has turned in favor of early percutaneous coronary intervention in patients with stable coronary artery disease, with the proviso that they must display objective evidence of hemodynamically significant stenosis as demonstrated by measurement of fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR).
Indeed, the consistent results of multiple studies presented at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions prompted the meeting organizers to issue a formal summary statement.
“PCI results in less angina, better quality of life, less urgent revascularizations, and less spontaneous MIs compared to medical treatment alone. The longer the observation period is, the more benefit is shown for PCI,” declared Michael Haude, MD, president of the European Association of Percutaneous Cardiovascular Interventions and a cardiologist at Heinrich Heine University in Düsseldorf, Germany.
“” on the basis of the latest studies featuring a contemporary approach, said Dr. Haude, noting that most prior studies of PCI versus medical therapy alone did not use latest-generation drug-eluting stent technology, featuring thin struts, improved antirestenosis drugs, and better drug-release technology and kinetics.
Among the persuasively positive studies presented at EuroPCR 2018 were the 5-year outcomes of FFR-guided PCI versus medical therapy alone in the FAME 2 trial, a secondary analysis of the controversial ORBITA trial, which placed early PCI for stable CAD in a more favorable light than initially reported, and an analysis from the comprehensive national Swedish Coronary Angiography and Angioplasty Registry (SCAAR).
These and several other studies presented at the conference conveyed a consistent message that early PCI in patients with stable CAD and physiologically significant coronary lesions results in improved clinical outcomes and symptomatic relief compared with medical management alone. Conversely, in patients without objective evidence of potentially reversible ischemia based on FFR or iFR, there is no reason to expect benefit from revascularization.
FAME 2
Panagiotis Xaplanteris, MD, PhD, of the Cardiovascular Center at Aalst, Belgium, presented the final 5-year follow-up of FAME 2 (the Fractional Flow Reserve versus Angiography for Multivessel Evaluation 2) trial, in which 888 patients with stable CAD and at least one hemodynamically significant coronary stenosis as defined by an FFR value of 0.80 or less in a major artery were randomized to FFR-guided PCI plus guideline-directed medical therapy or to medical therapy alone.
The long-term favorable impact of the early interventional strategy was striking: At 5 years, the rate of the primary composite endpoint of death, MI, or urgent revascularization was 13.9% in the early PCI group, roughly half of the 27% rate in the medically managed group. And this intention-to-treat analysis understates the true benefit of early PCI, since by the 5-year mark fully 51% of patients in the medically managed arm had crossed over to PCI.
The difference in the composite endpoint was driven largely by the early PCI group’s lesser need for urgent revascularization, defined as revascularization performed during any unplanned hospital admission for symptoms prompting revascularization. Most of these urgent revascularizations were prompted by in-hospital positive cardiac biomarkers, ECG changes, or unstable angina.
An important finding that was not apparent during shorter-term follow-up is that, by the 5-year mark, the early PCI strategy conferred a significant reduction in the risk of acute MI: 8.1% versus 12%. This difference was mainly due to the early PCI group’s lower rate of nonprocedurally related spontaneous MI: 6.5% compared with 10.2% in the control group, for a 38% relative risk reduction.
Discussant Philip Urban, MD, director of interventional cardiology at Hospital de la Tour in Geneva, said the take-home message from FAME 2 for him was simple: “If it ain’t broke, don’t fix it; but if it is, don’t procrastinate.”
Martin B. Leon, MD, observed that, up until now, when he has discussed with patients who have stable CAD the possibility of undergoing PCI, he has described the potential benefits as being reduced ischemia and improved symptoms with no significant impact on the hard endpoints of acute MI or death. FAME 2 has changed all that.
“What I really enjoyed about this presentation is that you dissected the improvement and demonstrated clearly that spontaneous MIs are in fact reduced with PCI in patients with stable CAD, which is a hard endpoint. And I would even argue that yours is a minimalistic analysis in the sense that many of the urgent revascularization patients likely would have ended up being nontransmural MIs as well. So I think this gives credence to the understanding that PCI not only affects ischemia but also affects the hard endpoint of spontaneous MI. And you need a large study like this with a 5-year endpoint to clarify those issues,” noted Dr. Leon, professor of medicine at Columbia University in New York.
ORBITA revisited
ORBITA was the first-ever randomized blinded trial of real versus sham PCI in patients with stable CAD. When Rasha Al-Lamee, MD, presented the primary results at the TCT 2017 conference in Denver, reporting that PCI failed to show a significant improvement in exercise time compared with placebo PCI, reaction was swift and furious. Interventionalists criticized the study’s choice of treadmill exercise time as an inappropriately squishy primary endpoint. Noninterventionalists saw ORBITA as confirming their view that many interventional cardiologists are catheter cowboys.
However, with additional time for further data analysis, Dr. Al-Lamee reported at EuroPCR 2018 that, in fact, the degree of ischemia seen on baseline iFR and FFR entirely predicted the extent of objective improvement in ischemia on dobutamine stress echocardiography in response to PCI. The 25% of participants whose iFR and FFR were greater than the generally accepted thresholds for intervention did not derive any significant placebo-subtracted benefit from PCI. In contrast, the lower the baseline FFR and iFR values – meaning the greater the impairment of blood flow across a stenotic lesion – the greater the reduction in ischemia in response to true PCI.
Of note, at the end of the 6-week blinded study period, 85% of patients in the control group opted for PCI.
“This is the trial everyone is talking about. Even on Twitter, it’s really dominating,” observed discussant Davide Capodanno, MD, PhD, of the University of Catania, Italy. “And this new freedom from angina endpoint, this is a win for PCI.”
Asked what she would do differently if she could do ORBITA over again, Dr. Al-Lamee didn’t hesitate: “If I were to do it again, I absolutely agree that exercise time would not be the primary endpoint I would choose.”
SCAAR
Elmir Omerovic, MD, PhD, presented an update from the long-running observational prospective Swedish national registry. The analysis included 3,460 patients who underwent PCI for stable angina with FFR and/or iFR guidance and 21,221 others whose PCI was performed based solely on coronary angiography.
At the beginning of the 10-year study period, FFR/iFR was utilized in 5%-6% of PCIs for stable CAD; today that rate has climbed to 40%, according to the cardiologist.
He reported no financial conflicts of interest regarding his study.
Simultaneously with Dr. Xaplanteris’ presentation of the final 5-year outcomes of FAME 2, the results were published online (N Engl J Med. 2018 May 22. doi: 10.1056/NEJMoa1803538). He reported having no financial conflicts of interest.
Similarly, Dr. Al-Lamee’s updated analysis of ORBITA was simultaneously published (Circulation. 2018 May 22. doi: 10.11161/CIRCULATIONAHA.118.033801). She, too, reported having no financial conflicts regarding this investigator-initiated study.
Dr. Haude expressed confidence that these studies will result in significant changes in the next iteration of the European Society of Cardiology guidelines on chronic coronary syndrome, likely to be issued in 2019 or 2020.
PARIS – A strong tide has turned in favor of early percutaneous coronary intervention in patients with stable coronary artery disease, with the proviso that they must display objective evidence of hemodynamically significant stenosis as demonstrated by measurement of fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR).
Indeed, the consistent results of multiple studies presented at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions prompted the meeting organizers to issue a formal summary statement.
“PCI results in less angina, better quality of life, less urgent revascularizations, and less spontaneous MIs compared to medical treatment alone. The longer the observation period is, the more benefit is shown for PCI,” declared Michael Haude, MD, president of the European Association of Percutaneous Cardiovascular Interventions and a cardiologist at Heinrich Heine University in Düsseldorf, Germany.
“” on the basis of the latest studies featuring a contemporary approach, said Dr. Haude, noting that most prior studies of PCI versus medical therapy alone did not use latest-generation drug-eluting stent technology, featuring thin struts, improved antirestenosis drugs, and better drug-release technology and kinetics.
Among the persuasively positive studies presented at EuroPCR 2018 were the 5-year outcomes of FFR-guided PCI versus medical therapy alone in the FAME 2 trial, a secondary analysis of the controversial ORBITA trial, which placed early PCI for stable CAD in a more favorable light than initially reported, and an analysis from the comprehensive national Swedish Coronary Angiography and Angioplasty Registry (SCAAR).
These and several other studies presented at the conference conveyed a consistent message that early PCI in patients with stable CAD and physiologically significant coronary lesions results in improved clinical outcomes and symptomatic relief compared with medical management alone. Conversely, in patients without objective evidence of potentially reversible ischemia based on FFR or iFR, there is no reason to expect benefit from revascularization.
FAME 2
Panagiotis Xaplanteris, MD, PhD, of the Cardiovascular Center at Aalst, Belgium, presented the final 5-year follow-up of FAME 2 (the Fractional Flow Reserve versus Angiography for Multivessel Evaluation 2) trial, in which 888 patients with stable CAD and at least one hemodynamically significant coronary stenosis as defined by an FFR value of 0.80 or less in a major artery were randomized to FFR-guided PCI plus guideline-directed medical therapy or to medical therapy alone.
The long-term favorable impact of the early interventional strategy was striking: At 5 years, the rate of the primary composite endpoint of death, MI, or urgent revascularization was 13.9% in the early PCI group, roughly half of the 27% rate in the medically managed group. And this intention-to-treat analysis understates the true benefit of early PCI, since by the 5-year mark fully 51% of patients in the medically managed arm had crossed over to PCI.
The difference in the composite endpoint was driven largely by the early PCI group’s lesser need for urgent revascularization, defined as revascularization performed during any unplanned hospital admission for symptoms prompting revascularization. Most of these urgent revascularizations were prompted by in-hospital positive cardiac biomarkers, ECG changes, or unstable angina.
An important finding that was not apparent during shorter-term follow-up is that, by the 5-year mark, the early PCI strategy conferred a significant reduction in the risk of acute MI: 8.1% versus 12%. This difference was mainly due to the early PCI group’s lower rate of nonprocedurally related spontaneous MI: 6.5% compared with 10.2% in the control group, for a 38% relative risk reduction.
Discussant Philip Urban, MD, director of interventional cardiology at Hospital de la Tour in Geneva, said the take-home message from FAME 2 for him was simple: “If it ain’t broke, don’t fix it; but if it is, don’t procrastinate.”
Martin B. Leon, MD, observed that, up until now, when he has discussed with patients who have stable CAD the possibility of undergoing PCI, he has described the potential benefits as being reduced ischemia and improved symptoms with no significant impact on the hard endpoints of acute MI or death. FAME 2 has changed all that.
“What I really enjoyed about this presentation is that you dissected the improvement and demonstrated clearly that spontaneous MIs are in fact reduced with PCI in patients with stable CAD, which is a hard endpoint. And I would even argue that yours is a minimalistic analysis in the sense that many of the urgent revascularization patients likely would have ended up being nontransmural MIs as well. So I think this gives credence to the understanding that PCI not only affects ischemia but also affects the hard endpoint of spontaneous MI. And you need a large study like this with a 5-year endpoint to clarify those issues,” noted Dr. Leon, professor of medicine at Columbia University in New York.
ORBITA revisited
ORBITA was the first-ever randomized blinded trial of real versus sham PCI in patients with stable CAD. When Rasha Al-Lamee, MD, presented the primary results at the TCT 2017 conference in Denver, reporting that PCI failed to show a significant improvement in exercise time compared with placebo PCI, reaction was swift and furious. Interventionalists criticized the study’s choice of treadmill exercise time as an inappropriately squishy primary endpoint. Noninterventionalists saw ORBITA as confirming their view that many interventional cardiologists are catheter cowboys.
However, with additional time for further data analysis, Dr. Al-Lamee reported at EuroPCR 2018 that, in fact, the degree of ischemia seen on baseline iFR and FFR entirely predicted the extent of objective improvement in ischemia on dobutamine stress echocardiography in response to PCI. The 25% of participants whose iFR and FFR were greater than the generally accepted thresholds for intervention did not derive any significant placebo-subtracted benefit from PCI. In contrast, the lower the baseline FFR and iFR values – meaning the greater the impairment of blood flow across a stenotic lesion – the greater the reduction in ischemia in response to true PCI.
Of note, at the end of the 6-week blinded study period, 85% of patients in the control group opted for PCI.
“This is the trial everyone is talking about. Even on Twitter, it’s really dominating,” observed discussant Davide Capodanno, MD, PhD, of the University of Catania, Italy. “And this new freedom from angina endpoint, this is a win for PCI.”
Asked what she would do differently if she could do ORBITA over again, Dr. Al-Lamee didn’t hesitate: “If I were to do it again, I absolutely agree that exercise time would not be the primary endpoint I would choose.”
SCAAR
Elmir Omerovic, MD, PhD, presented an update from the long-running observational prospective Swedish national registry. The analysis included 3,460 patients who underwent PCI for stable angina with FFR and/or iFR guidance and 21,221 others whose PCI was performed based solely on coronary angiography.
At the beginning of the 10-year study period, FFR/iFR was utilized in 5%-6% of PCIs for stable CAD; today that rate has climbed to 40%, according to the cardiologist.
He reported no financial conflicts of interest regarding his study.
Simultaneously with Dr. Xaplanteris’ presentation of the final 5-year outcomes of FAME 2, the results were published online (N Engl J Med. 2018 May 22. doi: 10.1056/NEJMoa1803538). He reported having no financial conflicts of interest.
Similarly, Dr. Al-Lamee’s updated analysis of ORBITA was simultaneously published (Circulation. 2018 May 22. doi: 10.11161/CIRCULATIONAHA.118.033801). She, too, reported having no financial conflicts regarding this investigator-initiated study.
Dr. Haude expressed confidence that these studies will result in significant changes in the next iteration of the European Society of Cardiology guidelines on chronic coronary syndrome, likely to be issued in 2019 or 2020.
PARIS – A strong tide has turned in favor of early percutaneous coronary intervention in patients with stable coronary artery disease, with the proviso that they must display objective evidence of hemodynamically significant stenosis as demonstrated by measurement of fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR).
Indeed, the consistent results of multiple studies presented at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions prompted the meeting organizers to issue a formal summary statement.
“PCI results in less angina, better quality of life, less urgent revascularizations, and less spontaneous MIs compared to medical treatment alone. The longer the observation period is, the more benefit is shown for PCI,” declared Michael Haude, MD, president of the European Association of Percutaneous Cardiovascular Interventions and a cardiologist at Heinrich Heine University in Düsseldorf, Germany.
“” on the basis of the latest studies featuring a contemporary approach, said Dr. Haude, noting that most prior studies of PCI versus medical therapy alone did not use latest-generation drug-eluting stent technology, featuring thin struts, improved antirestenosis drugs, and better drug-release technology and kinetics.
Among the persuasively positive studies presented at EuroPCR 2018 were the 5-year outcomes of FFR-guided PCI versus medical therapy alone in the FAME 2 trial, a secondary analysis of the controversial ORBITA trial, which placed early PCI for stable CAD in a more favorable light than initially reported, and an analysis from the comprehensive national Swedish Coronary Angiography and Angioplasty Registry (SCAAR).
These and several other studies presented at the conference conveyed a consistent message that early PCI in patients with stable CAD and physiologically significant coronary lesions results in improved clinical outcomes and symptomatic relief compared with medical management alone. Conversely, in patients without objective evidence of potentially reversible ischemia based on FFR or iFR, there is no reason to expect benefit from revascularization.
FAME 2
Panagiotis Xaplanteris, MD, PhD, of the Cardiovascular Center at Aalst, Belgium, presented the final 5-year follow-up of FAME 2 (the Fractional Flow Reserve versus Angiography for Multivessel Evaluation 2) trial, in which 888 patients with stable CAD and at least one hemodynamically significant coronary stenosis as defined by an FFR value of 0.80 or less in a major artery were randomized to FFR-guided PCI plus guideline-directed medical therapy or to medical therapy alone.
The long-term favorable impact of the early interventional strategy was striking: At 5 years, the rate of the primary composite endpoint of death, MI, or urgent revascularization was 13.9% in the early PCI group, roughly half of the 27% rate in the medically managed group. And this intention-to-treat analysis understates the true benefit of early PCI, since by the 5-year mark fully 51% of patients in the medically managed arm had crossed over to PCI.
The difference in the composite endpoint was driven largely by the early PCI group’s lesser need for urgent revascularization, defined as revascularization performed during any unplanned hospital admission for symptoms prompting revascularization. Most of these urgent revascularizations were prompted by in-hospital positive cardiac biomarkers, ECG changes, or unstable angina.
An important finding that was not apparent during shorter-term follow-up is that, by the 5-year mark, the early PCI strategy conferred a significant reduction in the risk of acute MI: 8.1% versus 12%. This difference was mainly due to the early PCI group’s lower rate of nonprocedurally related spontaneous MI: 6.5% compared with 10.2% in the control group, for a 38% relative risk reduction.
Discussant Philip Urban, MD, director of interventional cardiology at Hospital de la Tour in Geneva, said the take-home message from FAME 2 for him was simple: “If it ain’t broke, don’t fix it; but if it is, don’t procrastinate.”
Martin B. Leon, MD, observed that, up until now, when he has discussed with patients who have stable CAD the possibility of undergoing PCI, he has described the potential benefits as being reduced ischemia and improved symptoms with no significant impact on the hard endpoints of acute MI or death. FAME 2 has changed all that.
“What I really enjoyed about this presentation is that you dissected the improvement and demonstrated clearly that spontaneous MIs are in fact reduced with PCI in patients with stable CAD, which is a hard endpoint. And I would even argue that yours is a minimalistic analysis in the sense that many of the urgent revascularization patients likely would have ended up being nontransmural MIs as well. So I think this gives credence to the understanding that PCI not only affects ischemia but also affects the hard endpoint of spontaneous MI. And you need a large study like this with a 5-year endpoint to clarify those issues,” noted Dr. Leon, professor of medicine at Columbia University in New York.
ORBITA revisited
ORBITA was the first-ever randomized blinded trial of real versus sham PCI in patients with stable CAD. When Rasha Al-Lamee, MD, presented the primary results at the TCT 2017 conference in Denver, reporting that PCI failed to show a significant improvement in exercise time compared with placebo PCI, reaction was swift and furious. Interventionalists criticized the study’s choice of treadmill exercise time as an inappropriately squishy primary endpoint. Noninterventionalists saw ORBITA as confirming their view that many interventional cardiologists are catheter cowboys.
However, with additional time for further data analysis, Dr. Al-Lamee reported at EuroPCR 2018 that, in fact, the degree of ischemia seen on baseline iFR and FFR entirely predicted the extent of objective improvement in ischemia on dobutamine stress echocardiography in response to PCI. The 25% of participants whose iFR and FFR were greater than the generally accepted thresholds for intervention did not derive any significant placebo-subtracted benefit from PCI. In contrast, the lower the baseline FFR and iFR values – meaning the greater the impairment of blood flow across a stenotic lesion – the greater the reduction in ischemia in response to true PCI.
Of note, at the end of the 6-week blinded study period, 85% of patients in the control group opted for PCI.
“This is the trial everyone is talking about. Even on Twitter, it’s really dominating,” observed discussant Davide Capodanno, MD, PhD, of the University of Catania, Italy. “And this new freedom from angina endpoint, this is a win for PCI.”
Asked what she would do differently if she could do ORBITA over again, Dr. Al-Lamee didn’t hesitate: “If I were to do it again, I absolutely agree that exercise time would not be the primary endpoint I would choose.”
SCAAR
Elmir Omerovic, MD, PhD, presented an update from the long-running observational prospective Swedish national registry. The analysis included 3,460 patients who underwent PCI for stable angina with FFR and/or iFR guidance and 21,221 others whose PCI was performed based solely on coronary angiography.
At the beginning of the 10-year study period, FFR/iFR was utilized in 5%-6% of PCIs for stable CAD; today that rate has climbed to 40%, according to the cardiologist.
He reported no financial conflicts of interest regarding his study.
Simultaneously with Dr. Xaplanteris’ presentation of the final 5-year outcomes of FAME 2, the results were published online (N Engl J Med. 2018 May 22. doi: 10.1056/NEJMoa1803538). He reported having no financial conflicts of interest.
Similarly, Dr. Al-Lamee’s updated analysis of ORBITA was simultaneously published (Circulation. 2018 May 22. doi: 10.11161/CIRCULATIONAHA.118.033801). She, too, reported having no financial conflicts regarding this investigator-initiated study.
Dr. Haude expressed confidence that these studies will result in significant changes in the next iteration of the European Society of Cardiology guidelines on chronic coronary syndrome, likely to be issued in 2019 or 2020.
REPORTING FROM EUROPCR 2018