Cardio Trial Files: Cardiac Rehab Program for CHD, Pulmonary Vein Isolation +/- Left Atrial Appendage Ligation in AFib, and Empagliflozin vs. Placebo Post-MI
Early hybrid cardiac rehabilitation in congenital heart disease (QUALIREHAB)
Amedro P et al. European Heart Journal (April 2024)
Bottom Line: The QUALIREHAB study was a multicentre, randomized, controlled trial that evaluated a 12-week hybrid cardiac rehabilitation program for adolescent and young adult CHD patients with impaired cardiopulmonary fitness. The intervention group received the rehabilitation program while the comparator group received standard of care. The primary outcome was the change in health-related quality of life (HRQoL) from baseline to 12-month follow-up. The intervention group showed a statistically significant improvement in HRQoL [mean difference 3.8; 95% confidence interval (CI) 0.2; 7.3; P = .038], body mass index, physical activity, and disease knowledge compared to the control group. The intervention was also found to be safe and well-tolerated. These results suggest that the QUALIREHAB program may be beneficial for improving HRQoL in the adult population with CHD and non-congenital cardiac disease.
Pulmonary Vein Isolation With or Without Left Atrial Appendage Ligation in Atrial Fibrillation (aMAZE)
Lakkireddy DR et al. JAMA (April 2024)
Bottom Line: This multicenter, prospective, open-label, randomized clinical trial evaluated the safety and effectiveness of percutaneous left atrial appendage ligation adjunctive to planned pulmonary vein isolation for non-paroxysmal atrial fibrillation. A total of 610 patients were enrolled and randomized in a 2:1 ratio to undergo left atrial appendage ligation and pulmonary vein isolation or pulmonary vein isolation alone. The primary effectiveness outcome was freedom from documented atrial arrhythmias lasting more than 30 seconds at 12 months after undergoing pulmonary vein isolation. The primary safety outcome was a composite of predefined serious adverse events compared with a prespecified 10% performance goal 30 days after the procedure. The study found that left atrial appendage ligation adjunctive to pulmonary vein isolation did not meet prespecified efficacy criteria for freedom from atrial arrhythmias at 12 months, but did meet prespecified safety criteria and demonstrated high rates of closure at 12 months.
Empagliflozin after Acute Myocardial Infarction
Butler J et al. NEJM (April 2024)
Bottom Line: This double-blind, randomized, placebo-controlled trial evaluated the safety and efficacy of empagliflozin in patients at risk for heart failure after acute myocardial infarction. A total of 6522 patients were randomized in a 1:1 ratio to receive either empagliflozin 10 mg daily or placebo. The primary outcome was a composite of hospitalization for heart failure or death from any cause. Median follow-up duration was 17.9 months. The results showed no significant difference between the two groups (hazard ratio, 0.90; 95% confidence interval [CI], 0.76 to 1.06; P=0.21, placebo as referent). Adverse events were consistent with the known safety profile of empagliflozin. In conclusion, empagliflozin did not significantly lower the risk of first hospitalization for heart failure or death from any cause compared to placebo in this patient population.
Cardio Trial Files Issue #CRD-2024-12
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