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Early furosemide treatment associated with decrease in hospital mortality for acute heart failure
Citation: Matsue Y et al. Time-to-furosemide treatment and mortality in patients hospitalized with acute heart failure. J Am Coll Cardiol. 2017 Jun 27;69(25):3042-51.
Early furosemide treatment associated with decrease in hospital mortality for acute heart failure
Citation: Matsue Y et al. Time-to-furosemide treatment and mortality in patients hospitalized with acute heart failure. J Am Coll Cardiol. 2017 Jun 27;69(25):3042-51.
Early furosemide treatment associated with decrease in hospital mortality for acute heart failure
Citation: Matsue Y et al. Time-to-furosemide treatment and mortality in patients hospitalized with acute heart failure. J Am Coll Cardiol. 2017 Jun 27;69(25):3042-51.
ACC guidance addresses newer HFrEF options
It might be prudent to , according to a new expert consensus document from the American College of Cardiology on managing heart failure with reduced ejection fraction.
“While rising natriuretic peptide concentrations are correlated with adverse outcomes, this relationship can be confounded with the use of sacubitril/valsartan. Due to neprilysin inhibition, concentrations of BNP rise in patients treated with sacubitril/valsartan and tend not to return to baseline despite chronic therapy. In contrast, NT-proBNP concentrations typically decrease, as NT-proBNP is not a substrate for neprilysin,” explained authors led by heart failure pathway writing committee chairman Clyde W. Yancy, MD, chief of cardiology at Northwestern University in Chicago (J Am Coll Cardiol. 2017 Dec 22. doi: 10.1016/j.jacc.2017.11.025).
Treatment of heart failure with reduced ejection fraction (HFrEF) “can feel overwhelming, and many opportunities to improve patient outcomes are being missed; hopefully, this Expert Consensus Decision Pathway may streamline care to realize best possible patient outcomes,” the authors wrote.
The 10 issues and their detailed answers address therapeutic options, adherence, treatment barriers, drug costs, special populations, and palliative care. The document is full of tables and figures of treatment algorithms, drug doses, and other matters.
There’s a good deal of advice about using two newer HFrEF options: sacubitril/valsartan and ivabradine (Corlanor). Sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitor (ANRI), is a switch agent for patients who tolerate but remain symptomatic on ACE inhibitors (ACEIs) or angiotensin II receptor blockers (ARB). Moving over to sacubitril/valsartan has been shown to decrease the risk of hospitalization and death.
Switching from an ACEI requires a 36-hour washout period to avoid angdioedema; no washout is needed for ARB switches. Sacubitril/valsartan doses can be increased every 2-4 weeks to allow time for adjustment to vasodilatory effects. In one study, gradual titration over about 6 weeks maximized attainment of target dosages. As with ACEIs and ARBs, titration might require lowering loop diuretic doses, with careful attention paid to potassium concentrations.
“The committee is aware that clinicians may occasionally consider initiating ANRI in patients who have not previously been treated with an ACEI or ARB. To be explicitly clear, no predicate data supports this approach,” but it “might be considered” if patients are well informed of the risks, including angioedema and hypotension, the committee wrote.
Ivabradine is for patients whose resting heart rate is at or above 70 bpm despite maximal beta-blocker treatment. “It is important to emphasize that ivabradine is indicated only for patients in sinus rhythm, not in those with atrial fibrillation, patients who are 100% atrially paced, or unstable patients. From a safety standpoint, patients treated with ivabradine had more bradycardia and developed more atrial fibrillation as well as transient blurring of vision,” according to the consensus document.
Turning to wireless implantable pulmonary artery pressure monitoring, another newer approach, the group noted that, compared with standard care, it reduced hospitalization and led to more frequent adjustment of diuretic doses, suggesting a benefit “in well-selected patients with recurrent congestion. … The impact on mortality is unknown.”
“For a number of reasons,” hydralazine/isosorbide dinitrate “is often neglected in eligible patients. However, given the benefits of this combination (43% relative reduction in mortality and 33% relative reduction in HF hospitalization), African-American patients should receive these drugs once target or maximally tolerated doses of beta-blocker and ACEI/ ARB/ARNI are achieved. This is especially important for those patients with [New York Heart Association] class III to IV symptoms,” the committee members said.
Regarding treatment adherence, the group noted that “monetary incentives or other rewards for adherence to medications may be cost saving for highly efficacious and inexpensive drugs such as beta-blockers.”
The work was supported by the ACC with no industry funding. Dr. Yancy had no disclosures.
SOURCE: Yancy C et. al. J Am Coll Cardiol. 2017 Dec 22. doi: 10.1016/j.jacc.2017.11.025
It might be prudent to , according to a new expert consensus document from the American College of Cardiology on managing heart failure with reduced ejection fraction.
“While rising natriuretic peptide concentrations are correlated with adverse outcomes, this relationship can be confounded with the use of sacubitril/valsartan. Due to neprilysin inhibition, concentrations of BNP rise in patients treated with sacubitril/valsartan and tend not to return to baseline despite chronic therapy. In contrast, NT-proBNP concentrations typically decrease, as NT-proBNP is not a substrate for neprilysin,” explained authors led by heart failure pathway writing committee chairman Clyde W. Yancy, MD, chief of cardiology at Northwestern University in Chicago (J Am Coll Cardiol. 2017 Dec 22. doi: 10.1016/j.jacc.2017.11.025).
Treatment of heart failure with reduced ejection fraction (HFrEF) “can feel overwhelming, and many opportunities to improve patient outcomes are being missed; hopefully, this Expert Consensus Decision Pathway may streamline care to realize best possible patient outcomes,” the authors wrote.
The 10 issues and their detailed answers address therapeutic options, adherence, treatment barriers, drug costs, special populations, and palliative care. The document is full of tables and figures of treatment algorithms, drug doses, and other matters.
There’s a good deal of advice about using two newer HFrEF options: sacubitril/valsartan and ivabradine (Corlanor). Sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitor (ANRI), is a switch agent for patients who tolerate but remain symptomatic on ACE inhibitors (ACEIs) or angiotensin II receptor blockers (ARB). Moving over to sacubitril/valsartan has been shown to decrease the risk of hospitalization and death.
Switching from an ACEI requires a 36-hour washout period to avoid angdioedema; no washout is needed for ARB switches. Sacubitril/valsartan doses can be increased every 2-4 weeks to allow time for adjustment to vasodilatory effects. In one study, gradual titration over about 6 weeks maximized attainment of target dosages. As with ACEIs and ARBs, titration might require lowering loop diuretic doses, with careful attention paid to potassium concentrations.
“The committee is aware that clinicians may occasionally consider initiating ANRI in patients who have not previously been treated with an ACEI or ARB. To be explicitly clear, no predicate data supports this approach,” but it “might be considered” if patients are well informed of the risks, including angioedema and hypotension, the committee wrote.
Ivabradine is for patients whose resting heart rate is at or above 70 bpm despite maximal beta-blocker treatment. “It is important to emphasize that ivabradine is indicated only for patients in sinus rhythm, not in those with atrial fibrillation, patients who are 100% atrially paced, or unstable patients. From a safety standpoint, patients treated with ivabradine had more bradycardia and developed more atrial fibrillation as well as transient blurring of vision,” according to the consensus document.
Turning to wireless implantable pulmonary artery pressure monitoring, another newer approach, the group noted that, compared with standard care, it reduced hospitalization and led to more frequent adjustment of diuretic doses, suggesting a benefit “in well-selected patients with recurrent congestion. … The impact on mortality is unknown.”
“For a number of reasons,” hydralazine/isosorbide dinitrate “is often neglected in eligible patients. However, given the benefits of this combination (43% relative reduction in mortality and 33% relative reduction in HF hospitalization), African-American patients should receive these drugs once target or maximally tolerated doses of beta-blocker and ACEI/ ARB/ARNI are achieved. This is especially important for those patients with [New York Heart Association] class III to IV symptoms,” the committee members said.
Regarding treatment adherence, the group noted that “monetary incentives or other rewards for adherence to medications may be cost saving for highly efficacious and inexpensive drugs such as beta-blockers.”
The work was supported by the ACC with no industry funding. Dr. Yancy had no disclosures.
SOURCE: Yancy C et. al. J Am Coll Cardiol. 2017 Dec 22. doi: 10.1016/j.jacc.2017.11.025
It might be prudent to , according to a new expert consensus document from the American College of Cardiology on managing heart failure with reduced ejection fraction.
“While rising natriuretic peptide concentrations are correlated with adverse outcomes, this relationship can be confounded with the use of sacubitril/valsartan. Due to neprilysin inhibition, concentrations of BNP rise in patients treated with sacubitril/valsartan and tend not to return to baseline despite chronic therapy. In contrast, NT-proBNP concentrations typically decrease, as NT-proBNP is not a substrate for neprilysin,” explained authors led by heart failure pathway writing committee chairman Clyde W. Yancy, MD, chief of cardiology at Northwestern University in Chicago (J Am Coll Cardiol. 2017 Dec 22. doi: 10.1016/j.jacc.2017.11.025).
Treatment of heart failure with reduced ejection fraction (HFrEF) “can feel overwhelming, and many opportunities to improve patient outcomes are being missed; hopefully, this Expert Consensus Decision Pathway may streamline care to realize best possible patient outcomes,” the authors wrote.
The 10 issues and their detailed answers address therapeutic options, adherence, treatment barriers, drug costs, special populations, and palliative care. The document is full of tables and figures of treatment algorithms, drug doses, and other matters.
There’s a good deal of advice about using two newer HFrEF options: sacubitril/valsartan and ivabradine (Corlanor). Sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitor (ANRI), is a switch agent for patients who tolerate but remain symptomatic on ACE inhibitors (ACEIs) or angiotensin II receptor blockers (ARB). Moving over to sacubitril/valsartan has been shown to decrease the risk of hospitalization and death.
Switching from an ACEI requires a 36-hour washout period to avoid angdioedema; no washout is needed for ARB switches. Sacubitril/valsartan doses can be increased every 2-4 weeks to allow time for adjustment to vasodilatory effects. In one study, gradual titration over about 6 weeks maximized attainment of target dosages. As with ACEIs and ARBs, titration might require lowering loop diuretic doses, with careful attention paid to potassium concentrations.
“The committee is aware that clinicians may occasionally consider initiating ANRI in patients who have not previously been treated with an ACEI or ARB. To be explicitly clear, no predicate data supports this approach,” but it “might be considered” if patients are well informed of the risks, including angioedema and hypotension, the committee wrote.
Ivabradine is for patients whose resting heart rate is at or above 70 bpm despite maximal beta-blocker treatment. “It is important to emphasize that ivabradine is indicated only for patients in sinus rhythm, not in those with atrial fibrillation, patients who are 100% atrially paced, or unstable patients. From a safety standpoint, patients treated with ivabradine had more bradycardia and developed more atrial fibrillation as well as transient blurring of vision,” according to the consensus document.
Turning to wireless implantable pulmonary artery pressure monitoring, another newer approach, the group noted that, compared with standard care, it reduced hospitalization and led to more frequent adjustment of diuretic doses, suggesting a benefit “in well-selected patients with recurrent congestion. … The impact on mortality is unknown.”
“For a number of reasons,” hydralazine/isosorbide dinitrate “is often neglected in eligible patients. However, given the benefits of this combination (43% relative reduction in mortality and 33% relative reduction in HF hospitalization), African-American patients should receive these drugs once target or maximally tolerated doses of beta-blocker and ACEI/ ARB/ARNI are achieved. This is especially important for those patients with [New York Heart Association] class III to IV symptoms,” the committee members said.
Regarding treatment adherence, the group noted that “monetary incentives or other rewards for adherence to medications may be cost saving for highly efficacious and inexpensive drugs such as beta-blockers.”
The work was supported by the ACC with no industry funding. Dr. Yancy had no disclosures.
SOURCE: Yancy C et. al. J Am Coll Cardiol. 2017 Dec 22. doi: 10.1016/j.jacc.2017.11.025
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
FDA approves angiotensin II for shock patients
Angiotensin II has been approved for use in intravenous infusions to increase blood pressure in adults with septic or other distributive shock, the Food and Drug Administration announced.
Shock-related drops in blood pressure can restrict blood flow to vital organs and can result in organ failure and death. “There is a need for treatment options for critically ill hypotensive patients who do not adequately respond to available therapies,” Norman Stockbridge, MD, PhD, director of the division of cardiovascular and renal products in the FDA’s Center for Drug Evaluation and Research, said in a written statement.
The effectiveness of angiotensin II for treating critically low blood pressure was confirmed in a clinical trial of 321 patients who were in shock. A significant number of patients responded to angiotensin II treatment, compared with those given placebo. In combination with conventional treatments, angiotensin II increased blood pressure safely and effectively, according to the FDA statement.
Angiotensin II can cause serious blood clots, and prophylactic treatment for such issues is recommended.
The application for angiontensin II was received under Priority Review. The goal of Priority Review is for the FDA to take action on the application within 6 months if the agency determines that an approved drug would improve the safety and effectiveness of treating a serious medical condition.
Angiotensin II injections will be marketed as Giapreza by La Jolla Pharmaceutical Company.
Angiotensin II has been approved for use in intravenous infusions to increase blood pressure in adults with septic or other distributive shock, the Food and Drug Administration announced.
Shock-related drops in blood pressure can restrict blood flow to vital organs and can result in organ failure and death. “There is a need for treatment options for critically ill hypotensive patients who do not adequately respond to available therapies,” Norman Stockbridge, MD, PhD, director of the division of cardiovascular and renal products in the FDA’s Center for Drug Evaluation and Research, said in a written statement.
The effectiveness of angiotensin II for treating critically low blood pressure was confirmed in a clinical trial of 321 patients who were in shock. A significant number of patients responded to angiotensin II treatment, compared with those given placebo. In combination with conventional treatments, angiotensin II increased blood pressure safely and effectively, according to the FDA statement.
Angiotensin II can cause serious blood clots, and prophylactic treatment for such issues is recommended.
The application for angiontensin II was received under Priority Review. The goal of Priority Review is for the FDA to take action on the application within 6 months if the agency determines that an approved drug would improve the safety and effectiveness of treating a serious medical condition.
Angiotensin II injections will be marketed as Giapreza by La Jolla Pharmaceutical Company.
Angiotensin II has been approved for use in intravenous infusions to increase blood pressure in adults with septic or other distributive shock, the Food and Drug Administration announced.
Shock-related drops in blood pressure can restrict blood flow to vital organs and can result in organ failure and death. “There is a need for treatment options for critically ill hypotensive patients who do not adequately respond to available therapies,” Norman Stockbridge, MD, PhD, director of the division of cardiovascular and renal products in the FDA’s Center for Drug Evaluation and Research, said in a written statement.
The effectiveness of angiotensin II for treating critically low blood pressure was confirmed in a clinical trial of 321 patients who were in shock. A significant number of patients responded to angiotensin II treatment, compared with those given placebo. In combination with conventional treatments, angiotensin II increased blood pressure safely and effectively, according to the FDA statement.
Angiotensin II can cause serious blood clots, and prophylactic treatment for such issues is recommended.
The application for angiontensin II was received under Priority Review. The goal of Priority Review is for the FDA to take action on the application within 6 months if the agency determines that an approved drug would improve the safety and effectiveness of treating a serious medical condition.
Angiotensin II injections will be marketed as Giapreza by La Jolla Pharmaceutical Company.
Improvements made in safe opioid prescribing practices but crisis far from over
Clinical question: How have national and county-level opioid prescribing practices changed from the years 2006 to 2015?
Background: The opioid epidemic is currently at the forefront of public health crises, with more than 15,000 deaths caused by prescription opioid overdoses in 2015 alone and an estimated 2 million people with an opioid use disorder associated with prescription opioids. The opioid epidemic also has a significant financial burden with the cost of opioid overdose, abuse, and dependence totaling $78.5 billion/year in the United States. As the utilization of opioids to treat noncancer pain quadrupled during 1999-2010, so did the prevalence of opioid misuse disorder and overdose deaths from prescription opioids. This study reviewed prescribing practices at the national and county level during 2006-2015 in hopes of understanding how this affected the opioid crisis.
Setting: The data were summarized from a sample of pharmacies throughout the United States.
Synopsis: Data were obtained via the QuintilesIMS Data Warehouse, which estimated the number of opioid prescriptions, based upon a sample of 59,000 U.S. pharmacies (88% of total prescriptions). The amount of prescriptions peaked in 2010 then decreased yearly through 2015, yet remained about three times as high as prescription rates from 1999. Opioid prescribing practices had significant variation throughout the country, with higher prescription rates associated with smaller cities, larger white population, higher rates of Medicaid and unemployment, and higher prevalence of arthritis and diabetes. Variation in prescribing practices at the county level represents lack of consensus and evidence-based guidelines.
The authors suggest that providers carefully weigh the risks and benefits of opioids and review the Guideline for Prescribing Opioids for Chronic Pain from the Centers for Disease Control and Prevention. At the state and local levels, mandated pain clinic regulations and Physician Drug Monitoring Programs also are needed for continued improvement in opioid-related deaths. Weaknesses of study included lack of clinical outcomes and use of QuintilesIMS to estimate prescriptions that has not been validated.
Bottom line: Although rates of opioid prescriptions have improved since 2010, substantial changes and regulations for prescribing practices are needed at the state and local levels.
Citation: Guy GP Jr. et al. Vital Signs: Changes in opioid prescribing in the United States, 2006-2015. MMWR Morb Mortal Wkly Rep. 2017;66:697704.
Dr. Farber is a medical instructor, Duke University Health System.
Clinical question: How have national and county-level opioid prescribing practices changed from the years 2006 to 2015?
Background: The opioid epidemic is currently at the forefront of public health crises, with more than 15,000 deaths caused by prescription opioid overdoses in 2015 alone and an estimated 2 million people with an opioid use disorder associated with prescription opioids. The opioid epidemic also has a significant financial burden with the cost of opioid overdose, abuse, and dependence totaling $78.5 billion/year in the United States. As the utilization of opioids to treat noncancer pain quadrupled during 1999-2010, so did the prevalence of opioid misuse disorder and overdose deaths from prescription opioids. This study reviewed prescribing practices at the national and county level during 2006-2015 in hopes of understanding how this affected the opioid crisis.
Setting: The data were summarized from a sample of pharmacies throughout the United States.
Synopsis: Data were obtained via the QuintilesIMS Data Warehouse, which estimated the number of opioid prescriptions, based upon a sample of 59,000 U.S. pharmacies (88% of total prescriptions). The amount of prescriptions peaked in 2010 then decreased yearly through 2015, yet remained about three times as high as prescription rates from 1999. Opioid prescribing practices had significant variation throughout the country, with higher prescription rates associated with smaller cities, larger white population, higher rates of Medicaid and unemployment, and higher prevalence of arthritis and diabetes. Variation in prescribing practices at the county level represents lack of consensus and evidence-based guidelines.
The authors suggest that providers carefully weigh the risks and benefits of opioids and review the Guideline for Prescribing Opioids for Chronic Pain from the Centers for Disease Control and Prevention. At the state and local levels, mandated pain clinic regulations and Physician Drug Monitoring Programs also are needed for continued improvement in opioid-related deaths. Weaknesses of study included lack of clinical outcomes and use of QuintilesIMS to estimate prescriptions that has not been validated.
Bottom line: Although rates of opioid prescriptions have improved since 2010, substantial changes and regulations for prescribing practices are needed at the state and local levels.
Citation: Guy GP Jr. et al. Vital Signs: Changes in opioid prescribing in the United States, 2006-2015. MMWR Morb Mortal Wkly Rep. 2017;66:697704.
Dr. Farber is a medical instructor, Duke University Health System.
Clinical question: How have national and county-level opioid prescribing practices changed from the years 2006 to 2015?
Background: The opioid epidemic is currently at the forefront of public health crises, with more than 15,000 deaths caused by prescription opioid overdoses in 2015 alone and an estimated 2 million people with an opioid use disorder associated with prescription opioids. The opioid epidemic also has a significant financial burden with the cost of opioid overdose, abuse, and dependence totaling $78.5 billion/year in the United States. As the utilization of opioids to treat noncancer pain quadrupled during 1999-2010, so did the prevalence of opioid misuse disorder and overdose deaths from prescription opioids. This study reviewed prescribing practices at the national and county level during 2006-2015 in hopes of understanding how this affected the opioid crisis.
Setting: The data were summarized from a sample of pharmacies throughout the United States.
Synopsis: Data were obtained via the QuintilesIMS Data Warehouse, which estimated the number of opioid prescriptions, based upon a sample of 59,000 U.S. pharmacies (88% of total prescriptions). The amount of prescriptions peaked in 2010 then decreased yearly through 2015, yet remained about three times as high as prescription rates from 1999. Opioid prescribing practices had significant variation throughout the country, with higher prescription rates associated with smaller cities, larger white population, higher rates of Medicaid and unemployment, and higher prevalence of arthritis and diabetes. Variation in prescribing practices at the county level represents lack of consensus and evidence-based guidelines.
The authors suggest that providers carefully weigh the risks and benefits of opioids and review the Guideline for Prescribing Opioids for Chronic Pain from the Centers for Disease Control and Prevention. At the state and local levels, mandated pain clinic regulations and Physician Drug Monitoring Programs also are needed for continued improvement in opioid-related deaths. Weaknesses of study included lack of clinical outcomes and use of QuintilesIMS to estimate prescriptions that has not been validated.
Bottom line: Although rates of opioid prescriptions have improved since 2010, substantial changes and regulations for prescribing practices are needed at the state and local levels.
Citation: Guy GP Jr. et al. Vital Signs: Changes in opioid prescribing in the United States, 2006-2015. MMWR Morb Mortal Wkly Rep. 2017;66:697704.
Dr. Farber is a medical instructor, Duke University Health System.
Addition of azithromycin to maintenance therapy is beneficial in adults with uncontrolled asthma
Clinical question: Does azithromycin decrease the frequency of asthma exacerbations in adults with persistent asthma symptoms despite use of inhaled corticosteroid (ICS) and a long-acting beta-agonist (LABA)?
Background: Asthma is a chronic inflammatory airway disease that is highly prevalent worldwide within a subset of people with asthma who have symptoms that are poorly controlled despite ICS and LABA maintenance therapy. Currently, add-on therapy options include monoclonal antibodies, which are cost prohibitive. The need for additional therapeutic options exists. At the same time, macrolide antibiotics are known to have anti-inflammatory, antiviral, and antibacterial effects and have proven to have beneficial effects on asthma symptoms.
Setting: Multiple sites throughout Australia.
Synopsis: The AMAZES trial enrolled 420 adult patients with symptomatic asthma despite current use of ICS and LABA. Patients were randomly assigned to receive azithromycin 500 mg or placebo three times a week for 48 weeks. Patients who had hearing impairment, prolonged QTc interval, or emphysema were excluded.
Azithromycin reduced the frequency of asthma exacerbations, compared with placebo (1.07 vs. 1.86 exacerbations/patient-year; incidence rate ratio 0.59; 95% confidence interval, 0.47-0.74; P less than .0001). It also significantly improved asthma-related quality of life according to the Asthma Quality of Life Questionnaire (adjusted mean difference, 0.36; 95% CI, 0.21-0.52; P = .001). Diarrhea occurred more commonly in the azithromycin group but did not result in a higher withdrawal rate.
A significant limitation of this study was generalizability, as the median patient age was 60 years and race was not reported. More research is needed to determine the effect of long-term azithromycin use on microbial resistance.
Bottom line: Adding azithromycin to maintenance ICS and LABA therapy in patients with symptomatic asthma decreased the frequency of asthma exacerbations and improved quality of life.
Citation: Gibson PG et al. Effect of azithromycin on asthma exacerbations and quality of life in adults with persistent uncontrolled asthma (AMAZES): A randomised, double-blind, placebo-controlled trial. Lancet. 2017 Aug 12;390(10095):659-68.
Dr. Farber is a medical instructor, Duke University Health System.
Clinical question: Does azithromycin decrease the frequency of asthma exacerbations in adults with persistent asthma symptoms despite use of inhaled corticosteroid (ICS) and a long-acting beta-agonist (LABA)?
Background: Asthma is a chronic inflammatory airway disease that is highly prevalent worldwide within a subset of people with asthma who have symptoms that are poorly controlled despite ICS and LABA maintenance therapy. Currently, add-on therapy options include monoclonal antibodies, which are cost prohibitive. The need for additional therapeutic options exists. At the same time, macrolide antibiotics are known to have anti-inflammatory, antiviral, and antibacterial effects and have proven to have beneficial effects on asthma symptoms.
Setting: Multiple sites throughout Australia.
Synopsis: The AMAZES trial enrolled 420 adult patients with symptomatic asthma despite current use of ICS and LABA. Patients were randomly assigned to receive azithromycin 500 mg or placebo three times a week for 48 weeks. Patients who had hearing impairment, prolonged QTc interval, or emphysema were excluded.
Azithromycin reduced the frequency of asthma exacerbations, compared with placebo (1.07 vs. 1.86 exacerbations/patient-year; incidence rate ratio 0.59; 95% confidence interval, 0.47-0.74; P less than .0001). It also significantly improved asthma-related quality of life according to the Asthma Quality of Life Questionnaire (adjusted mean difference, 0.36; 95% CI, 0.21-0.52; P = .001). Diarrhea occurred more commonly in the azithromycin group but did not result in a higher withdrawal rate.
A significant limitation of this study was generalizability, as the median patient age was 60 years and race was not reported. More research is needed to determine the effect of long-term azithromycin use on microbial resistance.
Bottom line: Adding azithromycin to maintenance ICS and LABA therapy in patients with symptomatic asthma decreased the frequency of asthma exacerbations and improved quality of life.
Citation: Gibson PG et al. Effect of azithromycin on asthma exacerbations and quality of life in adults with persistent uncontrolled asthma (AMAZES): A randomised, double-blind, placebo-controlled trial. Lancet. 2017 Aug 12;390(10095):659-68.
Dr. Farber is a medical instructor, Duke University Health System.
Clinical question: Does azithromycin decrease the frequency of asthma exacerbations in adults with persistent asthma symptoms despite use of inhaled corticosteroid (ICS) and a long-acting beta-agonist (LABA)?
Background: Asthma is a chronic inflammatory airway disease that is highly prevalent worldwide within a subset of people with asthma who have symptoms that are poorly controlled despite ICS and LABA maintenance therapy. Currently, add-on therapy options include monoclonal antibodies, which are cost prohibitive. The need for additional therapeutic options exists. At the same time, macrolide antibiotics are known to have anti-inflammatory, antiviral, and antibacterial effects and have proven to have beneficial effects on asthma symptoms.
Setting: Multiple sites throughout Australia.
Synopsis: The AMAZES trial enrolled 420 adult patients with symptomatic asthma despite current use of ICS and LABA. Patients were randomly assigned to receive azithromycin 500 mg or placebo three times a week for 48 weeks. Patients who had hearing impairment, prolonged QTc interval, or emphysema were excluded.
Azithromycin reduced the frequency of asthma exacerbations, compared with placebo (1.07 vs. 1.86 exacerbations/patient-year; incidence rate ratio 0.59; 95% confidence interval, 0.47-0.74; P less than .0001). It also significantly improved asthma-related quality of life according to the Asthma Quality of Life Questionnaire (adjusted mean difference, 0.36; 95% CI, 0.21-0.52; P = .001). Diarrhea occurred more commonly in the azithromycin group but did not result in a higher withdrawal rate.
A significant limitation of this study was generalizability, as the median patient age was 60 years and race was not reported. More research is needed to determine the effect of long-term azithromycin use on microbial resistance.
Bottom line: Adding azithromycin to maintenance ICS and LABA therapy in patients with symptomatic asthma decreased the frequency of asthma exacerbations and improved quality of life.
Citation: Gibson PG et al. Effect of azithromycin on asthma exacerbations and quality of life in adults with persistent uncontrolled asthma (AMAZES): A randomised, double-blind, placebo-controlled trial. Lancet. 2017 Aug 12;390(10095):659-68.
Dr. Farber is a medical instructor, Duke University Health System.
Isolation precautions are associated with higher costs, longer LOS
Clinical question: What are the effects of isolation precautions on hospital outcomes and cost of care?
Background: Previous studies have found that isolation precautions negatively affect various aspects of patient care, including frequency of contact with clinicians, adverse events in the hospital, measures of patient well-being, and patient experience scores. It is not known how isolation precautions affect other hospital-based metrics, such as 30-day readmissions, length of stay (LOS), in-hospital mortality, and cost of care.
Study design: Multisite, retrospective, propensity score–matched cohort study.
Setting: Three academic tertiary care hospitals in Toronto.
Synopsis: The authors used administrative databases and propensity-score modeling to match isolated patients and nonisolated controls. Researchers included 17,649 control patients, 737 patients isolated for methicillin-resistant Staphylococcus aureus (contact isolation), and 1,502 patients isolated for respiratory illnesses (contact and droplet isolation) in the study. Patients isolated for MRSA had a higher 30-day readmission rate than did controls (19% vs. 14.7%), a longer average length of stay (11.9 days vs. 9.1 days), and higher direct costs ($11,009 vs. $7,670). Patients isolated for respiratory illnesses had a longer average length of stay (8.5 days vs. 7.6 days) and higher direct costs ($7,194 vs. $6,294). No differences in adverse events rates or in-hospital mortality were observed between control patients and patients in either isolation group.
Some of the differences observed may be from illness severity rather than from the effects of isolation, especially in the MRSA group. There was no difference observed in rates of adverse outcomes, such as falls or medication errors, or in rates of formal patient complaints to the hospital. It is possible that propensity score modeling corrected for unidentified biases in prior studies that found differences in these types of outcomes.
Bottom line: Isolation precautions are associated with higher costs and longer LOS in hospitalized general medicine patients.
Citation: Tran K et al. The effect of hospital isolation precautions on patient outcomes and cost of care: A multisite, retrospective, propensity score-matched cohort study. J Gen Intern Med. 2017;32(3):262-8.
Dr. Wachter is an assistant professor of medicine at Duke University.
Clinical question: What are the effects of isolation precautions on hospital outcomes and cost of care?
Background: Previous studies have found that isolation precautions negatively affect various aspects of patient care, including frequency of contact with clinicians, adverse events in the hospital, measures of patient well-being, and patient experience scores. It is not known how isolation precautions affect other hospital-based metrics, such as 30-day readmissions, length of stay (LOS), in-hospital mortality, and cost of care.
Study design: Multisite, retrospective, propensity score–matched cohort study.
Setting: Three academic tertiary care hospitals in Toronto.
Synopsis: The authors used administrative databases and propensity-score modeling to match isolated patients and nonisolated controls. Researchers included 17,649 control patients, 737 patients isolated for methicillin-resistant Staphylococcus aureus (contact isolation), and 1,502 patients isolated for respiratory illnesses (contact and droplet isolation) in the study. Patients isolated for MRSA had a higher 30-day readmission rate than did controls (19% vs. 14.7%), a longer average length of stay (11.9 days vs. 9.1 days), and higher direct costs ($11,009 vs. $7,670). Patients isolated for respiratory illnesses had a longer average length of stay (8.5 days vs. 7.6 days) and higher direct costs ($7,194 vs. $6,294). No differences in adverse events rates or in-hospital mortality were observed between control patients and patients in either isolation group.
Some of the differences observed may be from illness severity rather than from the effects of isolation, especially in the MRSA group. There was no difference observed in rates of adverse outcomes, such as falls or medication errors, or in rates of formal patient complaints to the hospital. It is possible that propensity score modeling corrected for unidentified biases in prior studies that found differences in these types of outcomes.
Bottom line: Isolation precautions are associated with higher costs and longer LOS in hospitalized general medicine patients.
Citation: Tran K et al. The effect of hospital isolation precautions on patient outcomes and cost of care: A multisite, retrospective, propensity score-matched cohort study. J Gen Intern Med. 2017;32(3):262-8.
Dr. Wachter is an assistant professor of medicine at Duke University.
Clinical question: What are the effects of isolation precautions on hospital outcomes and cost of care?
Background: Previous studies have found that isolation precautions negatively affect various aspects of patient care, including frequency of contact with clinicians, adverse events in the hospital, measures of patient well-being, and patient experience scores. It is not known how isolation precautions affect other hospital-based metrics, such as 30-day readmissions, length of stay (LOS), in-hospital mortality, and cost of care.
Study design: Multisite, retrospective, propensity score–matched cohort study.
Setting: Three academic tertiary care hospitals in Toronto.
Synopsis: The authors used administrative databases and propensity-score modeling to match isolated patients and nonisolated controls. Researchers included 17,649 control patients, 737 patients isolated for methicillin-resistant Staphylococcus aureus (contact isolation), and 1,502 patients isolated for respiratory illnesses (contact and droplet isolation) in the study. Patients isolated for MRSA had a higher 30-day readmission rate than did controls (19% vs. 14.7%), a longer average length of stay (11.9 days vs. 9.1 days), and higher direct costs ($11,009 vs. $7,670). Patients isolated for respiratory illnesses had a longer average length of stay (8.5 days vs. 7.6 days) and higher direct costs ($7,194 vs. $6,294). No differences in adverse events rates or in-hospital mortality were observed between control patients and patients in either isolation group.
Some of the differences observed may be from illness severity rather than from the effects of isolation, especially in the MRSA group. There was no difference observed in rates of adverse outcomes, such as falls or medication errors, or in rates of formal patient complaints to the hospital. It is possible that propensity score modeling corrected for unidentified biases in prior studies that found differences in these types of outcomes.
Bottom line: Isolation precautions are associated with higher costs and longer LOS in hospitalized general medicine patients.
Citation: Tran K et al. The effect of hospital isolation precautions on patient outcomes and cost of care: A multisite, retrospective, propensity score-matched cohort study. J Gen Intern Med. 2017;32(3):262-8.
Dr. Wachter is an assistant professor of medicine at Duke University.
Urgent endoscopy is associated with lower mortality in high-risk patients with acute nonvariceal GI bleeding
Clinical question: Is urgent endoscopy (less than 6 hours after ED presentation) better than elective endoscopy (6-48 hours after presentation) to decrease mortality and rebleeding in high-risk patients with acute nonvariceal upper GI bleeding (ANVGIB)?
Background: High-risk ANVGIB patients (Glasgow-Blatchford score greater than 7) are recommended to undergo early endoscopy, within 24 hours of presentation. The impact of urgent endoscopy (less than 6 hours) on patient outcomes is not clear.
Study design: Retrospective observation study.
Setting: Single tertiary referral center in South Korea.
Synopsis: Investigators retrospectively reviewed 961 high-risk ANVGIB patients, 571 patients underwent urgent endoscopy and 390 patients had elective endoscopy (6-48 hours), to compare clinical features and outcomes. The urgent group was slightly older, had a higher Rockall score, lower blood pressure, and higher incidence of shock on admission.
Urgent endoscopy was associated with significantly lower 28-day mortality (1.6% vs 3.8%). Urgent endoscopy also was associated with higher packed red blood cell transfusion volume (2.6 U vs. 2.3 U) and greater need for endoscopic intervention (69.5% vs. 53.5%) and embolization (2.8% vs. 0.5%). There was no significant difference in rebleeding rates, need for ICU admission, vasopressor use, and length of hospital stay between the urgent and elective endoscopy groups. The authors conclude that urgent endoscopy was associated with lower mortality rate but not rebleeding in high-risk patients with ANVGIB.
Despite differences between these two groups, based on this retrospective data, it is reasonable to suggest that urgent endoscopy may be beneficial for reducing mortality in high-risk patients with ANVGIB.
Bottom line: Urgent endoscopy may be beneficial in reducing mortality in high-risk patients with acute nonvariceal gastrointestinal bleeding.
Citation: Cho SH et al. Outcomes and role of urgent endoscopy in high-risk patients with acute nonvariceal gastrointestinal bleeding. Clin Gastroenterol Hepatol. 2017 Jun 19. pii: S1542-3565(17)30736-X.
Dr. Patel is a hospitalist and an assistant professor of medicine, Duke University Health System.
Clinical question: Is urgent endoscopy (less than 6 hours after ED presentation) better than elective endoscopy (6-48 hours after presentation) to decrease mortality and rebleeding in high-risk patients with acute nonvariceal upper GI bleeding (ANVGIB)?
Background: High-risk ANVGIB patients (Glasgow-Blatchford score greater than 7) are recommended to undergo early endoscopy, within 24 hours of presentation. The impact of urgent endoscopy (less than 6 hours) on patient outcomes is not clear.
Study design: Retrospective observation study.
Setting: Single tertiary referral center in South Korea.
Synopsis: Investigators retrospectively reviewed 961 high-risk ANVGIB patients, 571 patients underwent urgent endoscopy and 390 patients had elective endoscopy (6-48 hours), to compare clinical features and outcomes. The urgent group was slightly older, had a higher Rockall score, lower blood pressure, and higher incidence of shock on admission.
Urgent endoscopy was associated with significantly lower 28-day mortality (1.6% vs 3.8%). Urgent endoscopy also was associated with higher packed red blood cell transfusion volume (2.6 U vs. 2.3 U) and greater need for endoscopic intervention (69.5% vs. 53.5%) and embolization (2.8% vs. 0.5%). There was no significant difference in rebleeding rates, need for ICU admission, vasopressor use, and length of hospital stay between the urgent and elective endoscopy groups. The authors conclude that urgent endoscopy was associated with lower mortality rate but not rebleeding in high-risk patients with ANVGIB.
Despite differences between these two groups, based on this retrospective data, it is reasonable to suggest that urgent endoscopy may be beneficial for reducing mortality in high-risk patients with ANVGIB.
Bottom line: Urgent endoscopy may be beneficial in reducing mortality in high-risk patients with acute nonvariceal gastrointestinal bleeding.
Citation: Cho SH et al. Outcomes and role of urgent endoscopy in high-risk patients with acute nonvariceal gastrointestinal bleeding. Clin Gastroenterol Hepatol. 2017 Jun 19. pii: S1542-3565(17)30736-X.
Dr. Patel is a hospitalist and an assistant professor of medicine, Duke University Health System.
Clinical question: Is urgent endoscopy (less than 6 hours after ED presentation) better than elective endoscopy (6-48 hours after presentation) to decrease mortality and rebleeding in high-risk patients with acute nonvariceal upper GI bleeding (ANVGIB)?
Background: High-risk ANVGIB patients (Glasgow-Blatchford score greater than 7) are recommended to undergo early endoscopy, within 24 hours of presentation. The impact of urgent endoscopy (less than 6 hours) on patient outcomes is not clear.
Study design: Retrospective observation study.
Setting: Single tertiary referral center in South Korea.
Synopsis: Investigators retrospectively reviewed 961 high-risk ANVGIB patients, 571 patients underwent urgent endoscopy and 390 patients had elective endoscopy (6-48 hours), to compare clinical features and outcomes. The urgent group was slightly older, had a higher Rockall score, lower blood pressure, and higher incidence of shock on admission.
Urgent endoscopy was associated with significantly lower 28-day mortality (1.6% vs 3.8%). Urgent endoscopy also was associated with higher packed red blood cell transfusion volume (2.6 U vs. 2.3 U) and greater need for endoscopic intervention (69.5% vs. 53.5%) and embolization (2.8% vs. 0.5%). There was no significant difference in rebleeding rates, need for ICU admission, vasopressor use, and length of hospital stay between the urgent and elective endoscopy groups. The authors conclude that urgent endoscopy was associated with lower mortality rate but not rebleeding in high-risk patients with ANVGIB.
Despite differences between these two groups, based on this retrospective data, it is reasonable to suggest that urgent endoscopy may be beneficial for reducing mortality in high-risk patients with ANVGIB.
Bottom line: Urgent endoscopy may be beneficial in reducing mortality in high-risk patients with acute nonvariceal gastrointestinal bleeding.
Citation: Cho SH et al. Outcomes and role of urgent endoscopy in high-risk patients with acute nonvariceal gastrointestinal bleeding. Clin Gastroenterol Hepatol. 2017 Jun 19. pii: S1542-3565(17)30736-X.
Dr. Patel is a hospitalist and an assistant professor of medicine, Duke University Health System.
Journal of Hospital Medicine – Dec. 2017
BACKGROUND: Identifying hospitals that are both early and consistent adopters of high-value care can help shed light on the culture and practices at those institutions that are necessary to promote high-value care nationwide. The use of troponin testing to diagnose acute myocardial infarction (AMI), and not testing for myoglobin or creatine kinase-MB (CK-MB), is a high-value recommendation of the Choosing Wisely® campaign.
OBJECTIVE: To examine the variation in cardiac biomarker testing and the effect of the Choosing Wisely® troponin-only testing recommendation for the diagnosis of AMI.
DESIGN: A retrospective, observational study using administrative ordering data from Vizient’s Clinical Database/Resource Manager.
PATIENTS: Hospitalized patients with a principal discharge diagnosis of AMI.
INTERVENTION: The Choosing Wisely® recommendation to order troponin-only testing to diagnose AMI was released during the first quarter of 2015.
RESULTS: In 19 hospitals, troponin-only testing was consistently ordered to diagnose AMI before the Choosing Wisely® recommendation and throughout the study period. In 34 hospitals, both troponin testing and myoglobin/CK-MB testing were ordered to diagnose AMI even after the Choosing Wisely® recommendation. In 26 hospitals with low rates of troponin-only testing before the Choosing Wisely® recommendation, the release of the recommendation was associated with a statistically significant increase in the rate of troponin-only testing to diagnose AMI.
CONCLUSION: In institutions with low rates of troponin-only testing prior to the Choosing Wisely® recommendation, the recommendation was associated with a significant increase in the rate of troponin-only testing.
Read the entire article in the Dec. 2017 issue of the Journal of Hospital Medicine.
Also in JHM this month
Hospital perceptions of Medicare’s Sepsis Quality Reporting Initiative
AUTHORS: Ian J. Barbash, MD, MS; Kimberly J. Rak, PhD; Courtney C. Kuza, MPH; and Jeremy M. Kahn, MD, MS
Health literacy and hospital length of stay: An inpatient cohort study
AUTHORS: Ethan G. Jaffee, MD; Vineet M. Arora, MD, MAPP; Madeleine I. Matthiesen, MD; David O. Meltzer, MD, PhD, MHM; and Valerie G. Press, MD, FAAP, FACP, MPH
How exemplary teaching physicians interact with hospitalized patients
AUTHORS: Sanjay Saint, MD, MPH, FHM; Molly Harrod, PhD; Karen E. Fowler, MPH; and Nathan Houchens, MD, FACP, FHM
A randomized cohort controlled trial to compare intern sign-out training interventions
AUTHORS: Soo-Hoon Lee, PhD; Christopher Terndrup, MD; Phillip H. Phan, PhD; Sandra E. Zaeh, MD; Kwame Atsina, MD; Nicole Minkove, MD; Alexander Billioux, MD; DPhil, Souvik Chatterjee, MD; Idoreyin Montague, MD; Bennett Clark, MD; Andrew Hughes, MD; and Sanjay V. Desai, MD
BACKGROUND: Identifying hospitals that are both early and consistent adopters of high-value care can help shed light on the culture and practices at those institutions that are necessary to promote high-value care nationwide. The use of troponin testing to diagnose acute myocardial infarction (AMI), and not testing for myoglobin or creatine kinase-MB (CK-MB), is a high-value recommendation of the Choosing Wisely® campaign.
OBJECTIVE: To examine the variation in cardiac biomarker testing and the effect of the Choosing Wisely® troponin-only testing recommendation for the diagnosis of AMI.
DESIGN: A retrospective, observational study using administrative ordering data from Vizient’s Clinical Database/Resource Manager.
PATIENTS: Hospitalized patients with a principal discharge diagnosis of AMI.
INTERVENTION: The Choosing Wisely® recommendation to order troponin-only testing to diagnose AMI was released during the first quarter of 2015.
RESULTS: In 19 hospitals, troponin-only testing was consistently ordered to diagnose AMI before the Choosing Wisely® recommendation and throughout the study period. In 34 hospitals, both troponin testing and myoglobin/CK-MB testing were ordered to diagnose AMI even after the Choosing Wisely® recommendation. In 26 hospitals with low rates of troponin-only testing before the Choosing Wisely® recommendation, the release of the recommendation was associated with a statistically significant increase in the rate of troponin-only testing to diagnose AMI.
CONCLUSION: In institutions with low rates of troponin-only testing prior to the Choosing Wisely® recommendation, the recommendation was associated with a significant increase in the rate of troponin-only testing.
Read the entire article in the Dec. 2017 issue of the Journal of Hospital Medicine.
Also in JHM this month
Hospital perceptions of Medicare’s Sepsis Quality Reporting Initiative
AUTHORS: Ian J. Barbash, MD, MS; Kimberly J. Rak, PhD; Courtney C. Kuza, MPH; and Jeremy M. Kahn, MD, MS
Health literacy and hospital length of stay: An inpatient cohort study
AUTHORS: Ethan G. Jaffee, MD; Vineet M. Arora, MD, MAPP; Madeleine I. Matthiesen, MD; David O. Meltzer, MD, PhD, MHM; and Valerie G. Press, MD, FAAP, FACP, MPH
How exemplary teaching physicians interact with hospitalized patients
AUTHORS: Sanjay Saint, MD, MPH, FHM; Molly Harrod, PhD; Karen E. Fowler, MPH; and Nathan Houchens, MD, FACP, FHM
A randomized cohort controlled trial to compare intern sign-out training interventions
AUTHORS: Soo-Hoon Lee, PhD; Christopher Terndrup, MD; Phillip H. Phan, PhD; Sandra E. Zaeh, MD; Kwame Atsina, MD; Nicole Minkove, MD; Alexander Billioux, MD; DPhil, Souvik Chatterjee, MD; Idoreyin Montague, MD; Bennett Clark, MD; Andrew Hughes, MD; and Sanjay V. Desai, MD
BACKGROUND: Identifying hospitals that are both early and consistent adopters of high-value care can help shed light on the culture and practices at those institutions that are necessary to promote high-value care nationwide. The use of troponin testing to diagnose acute myocardial infarction (AMI), and not testing for myoglobin or creatine kinase-MB (CK-MB), is a high-value recommendation of the Choosing Wisely® campaign.
OBJECTIVE: To examine the variation in cardiac biomarker testing and the effect of the Choosing Wisely® troponin-only testing recommendation for the diagnosis of AMI.
DESIGN: A retrospective, observational study using administrative ordering data from Vizient’s Clinical Database/Resource Manager.
PATIENTS: Hospitalized patients with a principal discharge diagnosis of AMI.
INTERVENTION: The Choosing Wisely® recommendation to order troponin-only testing to diagnose AMI was released during the first quarter of 2015.
RESULTS: In 19 hospitals, troponin-only testing was consistently ordered to diagnose AMI before the Choosing Wisely® recommendation and throughout the study period. In 34 hospitals, both troponin testing and myoglobin/CK-MB testing were ordered to diagnose AMI even after the Choosing Wisely® recommendation. In 26 hospitals with low rates of troponin-only testing before the Choosing Wisely® recommendation, the release of the recommendation was associated with a statistically significant increase in the rate of troponin-only testing to diagnose AMI.
CONCLUSION: In institutions with low rates of troponin-only testing prior to the Choosing Wisely® recommendation, the recommendation was associated with a significant increase in the rate of troponin-only testing.
Read the entire article in the Dec. 2017 issue of the Journal of Hospital Medicine.
Also in JHM this month
Hospital perceptions of Medicare’s Sepsis Quality Reporting Initiative
AUTHORS: Ian J. Barbash, MD, MS; Kimberly J. Rak, PhD; Courtney C. Kuza, MPH; and Jeremy M. Kahn, MD, MS
Health literacy and hospital length of stay: An inpatient cohort study
AUTHORS: Ethan G. Jaffee, MD; Vineet M. Arora, MD, MAPP; Madeleine I. Matthiesen, MD; David O. Meltzer, MD, PhD, MHM; and Valerie G. Press, MD, FAAP, FACP, MPH
How exemplary teaching physicians interact with hospitalized patients
AUTHORS: Sanjay Saint, MD, MPH, FHM; Molly Harrod, PhD; Karen E. Fowler, MPH; and Nathan Houchens, MD, FACP, FHM
A randomized cohort controlled trial to compare intern sign-out training interventions
AUTHORS: Soo-Hoon Lee, PhD; Christopher Terndrup, MD; Phillip H. Phan, PhD; Sandra E. Zaeh, MD; Kwame Atsina, MD; Nicole Minkove, MD; Alexander Billioux, MD; DPhil, Souvik Chatterjee, MD; Idoreyin Montague, MD; Bennett Clark, MD; Andrew Hughes, MD; and Sanjay V. Desai, MD
Use of the dual-antiplatelet therapy score to guide treatment duration after percutaneous coronary intervention
Clinical question: Can the dual-antiplatelet therapy scoring system be used to determine which patients undergoing percutaneous coronary intervention (PCI) would benefit from prolonged (24 months) DAPT?
Background: Prolonged DAPT therapy has been estimated to prevent 8 myocardial infarctions per 1,000 persons treated for 1 year but at the cost of 6 major bleeding events with no clear mortality benefit. Given these trade-offs, the DAPT score could be used to identify patients who would benefit or would be harmed from prolonged DAPT. The safety and efficacy of DAPT duration as guided by the DAPT score has not been assessed outside the derivation cohort. This study applied the DAPT score to the PRODIGY trial patients to evaluate safety and outcomes of DAPT for 24 months versus a less than 6-month regimen.
Setting: PCI patients in PRODIGY trial.
Synopsis: In the original derivation cohort, a low DAPT score of less than 2 identified patients whose bleeding risks outweigh ischemic benefits and a high score above 2 identifies patients for whom ischemic benefits outweigh bleeding risks. When the DAPT score was applied to the 1,970 patients enrolled in PRODIGY, 55% had a low score and 45% had a high score. The primary efficacy outcomes of death, MI, and stroke were evaluated as well as primary safety outcomes of bleeding according to the Bleeding Academic Research Consortium definition. The reduction in the primary efficacy outcomes with 24-month vs. 6-month DAPT was greater in patients with a high DAPT score but only in the older paclitaxel-eluting stents. Since these stents have mostly fallen out of favor, there are some limitations to the applicability of the study findings. The study also provides support for 6 months of DAPT for patients with a DAPT score of less than 2.
Bottom line: For patients who underwent PCI with a DAPT score of less than 2, the risk for bleeding appears to be higher than are the ischemic benefits, while patients who had a high DAPT score of greater than 2 with a first-generation stent, the ischemic benefits of prolonged DAPT seemed to outweigh the bleeding risks.
Citation: Piccolo R et al. Use of the dual-antiplatelet therapy score to guide treatment duration after percutaneous coronary intervention. Ann Intern Med. 2017 Jul 4;167(1):17-25
Dr. Setji is a hospitalist and medical director, Duke University Hospital.
Clinical question: Can the dual-antiplatelet therapy scoring system be used to determine which patients undergoing percutaneous coronary intervention (PCI) would benefit from prolonged (24 months) DAPT?
Background: Prolonged DAPT therapy has been estimated to prevent 8 myocardial infarctions per 1,000 persons treated for 1 year but at the cost of 6 major bleeding events with no clear mortality benefit. Given these trade-offs, the DAPT score could be used to identify patients who would benefit or would be harmed from prolonged DAPT. The safety and efficacy of DAPT duration as guided by the DAPT score has not been assessed outside the derivation cohort. This study applied the DAPT score to the PRODIGY trial patients to evaluate safety and outcomes of DAPT for 24 months versus a less than 6-month regimen.
Setting: PCI patients in PRODIGY trial.
Synopsis: In the original derivation cohort, a low DAPT score of less than 2 identified patients whose bleeding risks outweigh ischemic benefits and a high score above 2 identifies patients for whom ischemic benefits outweigh bleeding risks. When the DAPT score was applied to the 1,970 patients enrolled in PRODIGY, 55% had a low score and 45% had a high score. The primary efficacy outcomes of death, MI, and stroke were evaluated as well as primary safety outcomes of bleeding according to the Bleeding Academic Research Consortium definition. The reduction in the primary efficacy outcomes with 24-month vs. 6-month DAPT was greater in patients with a high DAPT score but only in the older paclitaxel-eluting stents. Since these stents have mostly fallen out of favor, there are some limitations to the applicability of the study findings. The study also provides support for 6 months of DAPT for patients with a DAPT score of less than 2.
Bottom line: For patients who underwent PCI with a DAPT score of less than 2, the risk for bleeding appears to be higher than are the ischemic benefits, while patients who had a high DAPT score of greater than 2 with a first-generation stent, the ischemic benefits of prolonged DAPT seemed to outweigh the bleeding risks.
Citation: Piccolo R et al. Use of the dual-antiplatelet therapy score to guide treatment duration after percutaneous coronary intervention. Ann Intern Med. 2017 Jul 4;167(1):17-25
Dr. Setji is a hospitalist and medical director, Duke University Hospital.
Clinical question: Can the dual-antiplatelet therapy scoring system be used to determine which patients undergoing percutaneous coronary intervention (PCI) would benefit from prolonged (24 months) DAPT?
Background: Prolonged DAPT therapy has been estimated to prevent 8 myocardial infarctions per 1,000 persons treated for 1 year but at the cost of 6 major bleeding events with no clear mortality benefit. Given these trade-offs, the DAPT score could be used to identify patients who would benefit or would be harmed from prolonged DAPT. The safety and efficacy of DAPT duration as guided by the DAPT score has not been assessed outside the derivation cohort. This study applied the DAPT score to the PRODIGY trial patients to evaluate safety and outcomes of DAPT for 24 months versus a less than 6-month regimen.
Setting: PCI patients in PRODIGY trial.
Synopsis: In the original derivation cohort, a low DAPT score of less than 2 identified patients whose bleeding risks outweigh ischemic benefits and a high score above 2 identifies patients for whom ischemic benefits outweigh bleeding risks. When the DAPT score was applied to the 1,970 patients enrolled in PRODIGY, 55% had a low score and 45% had a high score. The primary efficacy outcomes of death, MI, and stroke were evaluated as well as primary safety outcomes of bleeding according to the Bleeding Academic Research Consortium definition. The reduction in the primary efficacy outcomes with 24-month vs. 6-month DAPT was greater in patients with a high DAPT score but only in the older paclitaxel-eluting stents. Since these stents have mostly fallen out of favor, there are some limitations to the applicability of the study findings. The study also provides support for 6 months of DAPT for patients with a DAPT score of less than 2.
Bottom line: For patients who underwent PCI with a DAPT score of less than 2, the risk for bleeding appears to be higher than are the ischemic benefits, while patients who had a high DAPT score of greater than 2 with a first-generation stent, the ischemic benefits of prolonged DAPT seemed to outweigh the bleeding risks.
Citation: Piccolo R et al. Use of the dual-antiplatelet therapy score to guide treatment duration after percutaneous coronary intervention. Ann Intern Med. 2017 Jul 4;167(1):17-25
Dr. Setji is a hospitalist and medical director, Duke University Hospital.
Outcomes of alcohol septal ablation in younger patients with obstructive hypertrophic cardiomyopathy
Clinical question: Is alcohol septal ablation (ASA) safe in younger patients with obstructive hypertrophic cardiomyopathy (HCM)?
Background: ASA is a class III recommendation for younger patients when myectomy is a viable option. This recommendation was based on the lack of evidence for younger patients whereas myectomy already was proven to be safe and effective.
Setting: 7 tertiary centers from 4 European countries during 1996-2015.
Synopsis: With 1,200 patients, this was the largest ASA cohort to date. The cohort was divided into three groups: young (less than 50 years), middle age (51-65 years), and old (greater than 65 years). During the periprocedural period, young patients had better outcomes than did older patients in regards to complete heart block, cardiac tamponade, and mortality. After 5.4 years of follow-up, young patients had favorable outcomes for long-term survival after ASA and comparable rates of adverse antiarrhythmic events; 95% of these young patients were functioning in NYHA class I or II at follow-up. These young patients also had half the risk of permanent pacemaker implantation, compared with older patients. In an analysis of very young patients (younger than 35 years), ASA appeared to be safe and effective as well. Additionally, young patients who were treated with more than 2.5 mL alcohol had higher all-cause mortality, compared with patients who were treated with less than 2.5 mL.
Bottom line: For patients aged 50 years or less with HCM, ASA and surgical myectomy are both safe and effective for relief of symptoms.
Citation: Liebregts M et al. Outcomes of alcohol septal ablation in younger patients with obstructive hypertrophic cardiomyopathy. JACC: Cardiovascular Interventions. Jun 2017:1134-43.
Dr. Setji is a hospitalist and medical director, Duke University Hospital.
Clinical question: Is alcohol septal ablation (ASA) safe in younger patients with obstructive hypertrophic cardiomyopathy (HCM)?
Background: ASA is a class III recommendation for younger patients when myectomy is a viable option. This recommendation was based on the lack of evidence for younger patients whereas myectomy already was proven to be safe and effective.
Setting: 7 tertiary centers from 4 European countries during 1996-2015.
Synopsis: With 1,200 patients, this was the largest ASA cohort to date. The cohort was divided into three groups: young (less than 50 years), middle age (51-65 years), and old (greater than 65 years). During the periprocedural period, young patients had better outcomes than did older patients in regards to complete heart block, cardiac tamponade, and mortality. After 5.4 years of follow-up, young patients had favorable outcomes for long-term survival after ASA and comparable rates of adverse antiarrhythmic events; 95% of these young patients were functioning in NYHA class I or II at follow-up. These young patients also had half the risk of permanent pacemaker implantation, compared with older patients. In an analysis of very young patients (younger than 35 years), ASA appeared to be safe and effective as well. Additionally, young patients who were treated with more than 2.5 mL alcohol had higher all-cause mortality, compared with patients who were treated with less than 2.5 mL.
Bottom line: For patients aged 50 years or less with HCM, ASA and surgical myectomy are both safe and effective for relief of symptoms.
Citation: Liebregts M et al. Outcomes of alcohol septal ablation in younger patients with obstructive hypertrophic cardiomyopathy. JACC: Cardiovascular Interventions. Jun 2017:1134-43.
Dr. Setji is a hospitalist and medical director, Duke University Hospital.
Clinical question: Is alcohol septal ablation (ASA) safe in younger patients with obstructive hypertrophic cardiomyopathy (HCM)?
Background: ASA is a class III recommendation for younger patients when myectomy is a viable option. This recommendation was based on the lack of evidence for younger patients whereas myectomy already was proven to be safe and effective.
Setting: 7 tertiary centers from 4 European countries during 1996-2015.
Synopsis: With 1,200 patients, this was the largest ASA cohort to date. The cohort was divided into three groups: young (less than 50 years), middle age (51-65 years), and old (greater than 65 years). During the periprocedural period, young patients had better outcomes than did older patients in regards to complete heart block, cardiac tamponade, and mortality. After 5.4 years of follow-up, young patients had favorable outcomes for long-term survival after ASA and comparable rates of adverse antiarrhythmic events; 95% of these young patients were functioning in NYHA class I or II at follow-up. These young patients also had half the risk of permanent pacemaker implantation, compared with older patients. In an analysis of very young patients (younger than 35 years), ASA appeared to be safe and effective as well. Additionally, young patients who were treated with more than 2.5 mL alcohol had higher all-cause mortality, compared with patients who were treated with less than 2.5 mL.
Bottom line: For patients aged 50 years or less with HCM, ASA and surgical myectomy are both safe and effective for relief of symptoms.
Citation: Liebregts M et al. Outcomes of alcohol septal ablation in younger patients with obstructive hypertrophic cardiomyopathy. JACC: Cardiovascular Interventions. Jun 2017:1134-43.
Dr. Setji is a hospitalist and medical director, Duke University Hospital.