Daily Cardiology Research Analysis

BACKGROUND: Novel biodegradable patent foramen ovale (PFO) closure devices offer a promising therapeutic option. The efficacy and safety of the novel biodegradable devices compared with nitinol devices have not yet been investigated in a randomized clinical trial. METHODS: This multicenter, randomized, noninferiority trial examined whether the novel biodegradable PFO closure device achieves comparable closure success rates as traditional nitinol devices while demonstrating disappearance of the protruding parts of the device on echocardiography. A total of 190 patients with PFO were enrolled and randomly assigned to receive either the biodegradable device (n=96) or the nitinol device (n=94). The primary efficacy end point was PFO closure success rate at 6 months postprocedure as demonstrated by contrast echocardiography. We continued to evaluate device-related complications, device disappearance on echocardiography, and closure success rates over a 24-month follow-up period. RESULTS: Successful PFO closure was achieved in 87 patients (90.63%) in the biodegradable device group and 86 patients (91.49%) in the nitinol device control group. The lower limit of the 95% CI of absolute difference was -8.98%, greater than the predefined noninferiority margin of -10%, confirming that the biodegradable device was not inferior to the nitinol device in terms of closure success. One patient in the trial group required surgical device removal because of intraprocedural deformation. No deaths, embolism, thrombus on the device, or erosion were observed in either group throughout the entire study period. Transthoracic echocardiography revealed that the hyperechoic area corresponding to the biodegradable device began decreasing within the first year after implantation and disappeared on echocardiography by 24 months after implantation. CONCLUSIONS: The novel biodegradable PFO closure device, which disappears on echocardiography within 24 months after implantation, demonstrates noninferiority to the traditional nitinol device in both efficacy and safety.

AIMS: The effectiveness of exercise-based cardiac rehabilitation (ExCR) for coronary heart disease (CHD) has been debated during the past decade. The objectives of the Cardiac Rehabilitation Meta-Analysis of Trials in people with CHD using individual participant data (IPD) (CaReMATCH) study were to: (1) provide contemporary estimates on the effectiveness of ExCR for CHD; and (2) examine potential differential effects of ExCR across subgroups. METHODS: Individual participant data from randomized controlled trials comparing ExCR to no ExCR controls were pooled. To reflect contemporary ExCR practice, trials had to be published since 2010. The outcomes of all-cause and cardiovascular (CVD)-related mortality and hospitalization, and health-related quality of life (HRQoL) were analysed. RESULTS: From 30 eligible trials (10,677 participants), IPD were obtained from 8 trials (4,975 participants, 93.5% post-myocardial infarction). Compared to controls, participation in ExCR resulted in a lower risk for all cause (hazard ratio [HR] 0.68, 95% confidence interval [CI]: 0.53, 0.87) and CVD-related hospitalization (HR 0.62, 95% CI: 0.47, 0.83), and higher HRQoL up to 12 months follow-up (mean difference in utility index: 0.032, 95% CI: 0.003, 0.061). No differences were found in all-cause and CVD mortality (HR 0.99, 95% CI: 0.74, 1.32; HR 0.80, 95% CI: 0.32, 2.04, respectively). Subgroup analyses showed stronger improvements of HRQoL with ExCR in people with lower HRQoL and lower education level, and larger reductions in hospitalization risk in those with a lower left ventricular ejection fraction, lower baseline exercise capacity, beta-blockers use, and with a previous history of cardiovascular disease. No other subgroup effects were observed. CONCLUSION: Our IPD meta-analysis, reflecting trials published since 2010, highlighted that contemporary ExCR is effective in reducing risk of hospitalization and improving HRQoL in those with CHD. Importantly, we reveal treatment benefits to be robust and consistent across most participant subgroups. Together, these data support the class I recommendation of international clinical guidelines that ExCR should be offered to all people with CHD.

IMPORTANCE: The head-to-head comparative effectiveness and safety of individual glucagon-like peptide-1 receptor agonists (GLP-1RAs) are not well understood. OBJECTIVE: To compare risks of kidney, cardiovascular, and death outcomes among patients with type 2 diabetes initiating GLP-1RAs in the Department of Veterans Affairs (VA) health system. DESIGN, SETTING, AND PARTICIPANTS: This comparative effectiveness study used an active-comparator, new-user target trial-emulation design with national data linked among the VA, Medicare, and US Renal Data System. Participants were GLP-1RA-naive veterans with type 2 diabetes and without end-stage kidney disease treated with metformin who started liraglutide, semaglutide, or dulaglutide between January 1, 2018, and December 31, 2021. Data were analyzed from September 2024 to June 2025. EXPOSURE: Liraglutide, semaglutide, or dulaglutide. MAIN OUTCOMES AND MEASURES: Kidney failure (sustained estimated glomerular filtration rate <15 mL/min/1.73 m2 or initiation of kidney replacement therapy), composite cardiovascular and kidney metabolic (CKM) events (kidney failure or major adverse cardiovascular events [MACE]; myocardial infarction, heart failure, or stroke/transient ischemic attack), MACE, all-cause death, and adverse gastrointestinal events (gastroparesis, intestinal obstruction, gallstones, acute cholecystitis, acute pancreatitis) were evaluated separately through March 31, 2023. RESULTS: Of 21 790 included veterans (mean [SD] age, 63.5 [10.8] years, 19 823 [91.0%] male), 5425 (24.9%), 10 838 (49.7%), and 5527 (24.9%) initiated liraglutide, semaglutide, and dulaglutide, respectively. In weighted Cox regression models, compared with initiation of semaglutide, liraglutide initiation had similar hazards for kidney failure (hazard ratio [HR], 0.93; 95% CI, 0.60-1.44), the CKM composite outcome (HR, 0.96; 95% CI, 0.84-1.10), and MACE (HR, 0.95; 95% CI, 0.83-1.09). Results were similar with liraglutide vs dulaglutide and dulaglutide vs semaglutide comparisons. Liraglutide had significantly lower hazard of all-cause death compared with semaglutide under intent-to-treat analyses (HR, 0.83; 95% CI, 0.69-0.99), which lost significance in per-protocol models. Compared with dulaglutide, liraglutide was associated with a lower risk of all-cause mortality in both the intent-to-treat (HR, 0.69; 95% CI, 0.58-0.83) and per-protocol (HR, 0.50; 95% CI, 0.31-0.82) analyses, but compared with semaglutide, dulaglutide had higher hazard of mortality only in the per-protocol model (HR, 1.72; 95% CI, 1.20-2.47). The only observed difference for the gastrointestinal adverse events was a decreased risk for gallstones and acute cholecystitis with dulaglutide vs semaglutide (gallstones: HR, 0.72; 95% CI, 0.54-0.95; acute cholecystitis: HR, 0.62; 95% CI, 0.39-0.99). CONCLUSIONS AND RELEVANCE: In this comparative effectiveness study in veterans with diabetes, liraglutide, semaglutide, and dulaglutide initiators had similar risks for kidney and cardiovascular outcomes. Head-to-head randomized trials are needed to confirm these findings.