Daily Cardiology Research Analysis

BACKGROUND AND AIMS: The optimal approach to coronary revascularization in patients undergoing transcatheter aortic valve implantation (TAVI) remains debated. Fractional flow reserve (FFR) may improve the identification of ischaemia-producing lesions compared to angiographic assessment alone, but data in the TAVI population are lacking. METHODS: In this multicentric, open-label, randomized, superiority trial with blind adjudication of adverse events, patients with aortic stenosis and intermediate coronary lesions undergoing TAVI were randomized 1:1 to FFR-guided or angiography-guided percutaneous coronary intervention (PCI). The trial was registered at ClinicalTrials.gov (NCT03360591). All randomized patients were included in the primary analysis according to the intention-to-treat principle. The primary endpoint was a major adverse cardiac and cerebrovascular event (MACCE) at 12 months of follow-up, defined as a composite of all-cause death, myocardial infarction, ischaemia-driven target vessel revascularization, disabling stroke, or major bleeding. RESULTS: A total of 320 patients were enrolled across 15 Italian centres. The median age of the patients was 86 years [interquartile range (IQR) 83-90], and the median STS score was 3% (IQR 2-5). The median SYNTAX score was 7 (IQR 5-11). FFR-guided PCI was associated with a significantly lower rate of MACCE at 12 months compared with angiography-guided PCI (8.5% vs 16.0%; hazard ratio .52; 95% confidence interval .27-.99; P = .047). The difference in the primary endpoint was primarily driven by a reduction in all-cause mortality (hazard ratio .31; 95% confidence interval .10-.96). Other components of the composite were numerically lower but not statistically significant. CONCLUSIONS: In patients undergoing TAVI with intermediate coronary lesions, FFR-guided PCI was associated with a reduced risk of MACCE at 12 months. These findings support a physiology-based revascularization strategy in this frail, elderly population.

BACKGROUND AND AIMS: The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention in patients with acute coronary syndrome remains uncertain. This analysis examined the temporal patterns of ischaemic and bleeding risks of early aspirin withdrawal compared with DAPT. METHODS: NEO-MINDSET randomized 3410 acute coronary syndrome patients undergoing successful percutaneous coronary intervention with drug-eluting stents within 4 days of hospital admission to either potent P2Y12 inhibitor monotherapy (prasugrel or ticagrelor) or standard DAPT (aspirin plus a potent P2Y12 inhibitor) for 12 months. This prespecified landmark analysis examined early (0-30 days) and late (31-365 days) follow-up events. Co-primary outcomes were (i) the composite of all cause death, myocardial infarction, stroke, or urgent target-vessel revascularization (ischaemic outcome) and (ii) Bleeding Academic Research Consortium type 2, 3, or 5 bleeding. RESULTS: At 30 days, the composite ischaemic outcome occurred in 3.3% of patients receiving monotherapy vs 1.8% with DAPT (risk difference 1.5%, 95% confidence interval .4%-2.6%; P = .006). Bleeding occurred in .6% vs 1.5% (risk difference -.8%, 95% confidence interval -1.5%-.1%; P = .018). In the landmark analysis between Days 31 and 365, ischaemic outcome rates were similar between study groups (3.8% each; P = .977), while bleeding remained less frequent with monotherapy (1.3% vs 3.5%; risk difference -2.2%, 95% confidence interval -3.2%-1.1%; P > .001). CONCLUSIONS: This prespecified 30-day landmark analysis suggests an excess of ischaemic risk with monotherapy vs DAPT in the first 30 days but not thereafter, whereas an aspirin-free strategy was consistently associated with fewer bleeding events within and after 30 days.

BACKGROUND AND AIMS: Although use of the subcutaneous implantable cardioverter defibrillator (S-ICD) is increasing, evidence from industry-independent and unselected populations remains limited. METHODS: HONEST is a ongoing nationwide academic observational study enrolling 98.2% of patients implanted with an S-ICD across France (2012-2019). Five-year clinical endpoints were centrally adjudicated. RESULTS: Overall, 4924 patients were enrolled (mean age 49.9 ± 15 years, 76.7% male, 63.0% for primary prevention). Implants used general anaesthesia (78.9%), and defibrillation testing (82.6%). Perioperative complications (within 30 days) occurred in 4.4%. At 5 years, cumulative incidence rates were 13.8% for inappropriate shocks, 10.8% for early battery depletion, 2.4% for infections, 1.5% for lead dysfunction, and 1.4% for chronic discomfort. Reoperation was required in 16.9%, need for cardiac pacing in 3.1%, and definite S-ICD extraction in 8.4%. Inappropriate shocks were independently associated with male sex (hazard ratio [HR] 1.29, 95% confidence interval [CI] 1.14-1.46, P < .001), obesity (HR 1.35, 95% CI 1.02-1.79, P = .032), arrhythmogenic right ventricular cardiomyopathy (HR 1.70, 95% CI 1.03-2.81, P = .036), and the presence of a pacemaker (HR 2.20, 95% CI 1.16-4.17, P = .016). SMART Pass filtering significantly reduced inappropriate shocks (HR 0.67, 95% CI 0.50-0.89, P = .007). Among patients with inappropriate shocks, ∼1% developed induced ventricular fibrillation (one fatality), and 10% underwent device extraction. Ineffective shocks or undetected arrhythmias occurred in only 0.2%. Among 547 deaths (11.1%), 53.9% were cardiovascular, including 26 sudden deaths, and 8 were S-ICD/procedure-related, with none related to S-ICD extraction. CONCLUSIONS: This nationwide study refines the long-term event profile of S-ICD therapy and may inform clinical practice and device selection.