Serial assessment of strut coverage of biodegradable polymer drug-eluting stent at 1, 2, and 3 months after stent implantation by optical frequency domain imaging: the DISCOVERY 1TO3 study (Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent With Biodegradable Polymer at 1, 2, and 3 Months

BACKGROUND: To assess the vessel-healing pattern of Ultimaster drug-eluting stent using optical frequency domain imaging. Our hypothesis is that biodegradable polymer-based drug-eluting technology allows complete very early strut coverage.METHODS AND RESULTS: The DISCOVERY 1TO3 study (Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent With Biodegradable Polymer at 1, 2, and 3 Months) is a prospective, single-arm, multicenter study. A total of 60 patients with multivessel disease requiring staged procedure at 1 month were treated with Ultimaster. Optical frequency domain imaging was acquired at baseline, 1, 2, and 3 months. The primary end point is optical frequency domain imaging-assessed strut coverage at 3 months. Mean age of patients was 67.2±9.9 years, and 73.3% were male, and 36.7% presented with acute coronary syndrome. A total of 132 lesions were treated, with average 1.4 lesions per patient treated at baseline and 1.1 lesions treated at 1 month. Strut coverage at 3 months of single implanted stents (n=71, primary end point) was 95.2±5.2% and of combined single and overlapped stents was 95.4±4.9%. Strut coverage of combined single and overlapped stents at 1 (n=49) and 2 months (n=38) was 85.1±12.7% and 87.9±10.8%, respectively...

Short-versus long-term Dual Antiplatelet therapy after drug-eluting stent implantation in women versus men: A sex-specific patient-level pooled-analysis of six randomized trials

Background: Whether the efficacy and safety of dual antiplatelet therapy (DAPT) are uniform between sexes is unclear. We sought to compare clinical outcomes between short-(6 months) versus long-term (1 year) DAPT after drug-eluting stent (DES) placement inwomen and men. Methods and Results: We pooled individual patient data from 6 randomizedtrials of DAPT (EXCELLENT, OPTIMIZE, PRODIGY, RESET, SECURITY, ITALIC PLUS).The primary outcome was 1-year risk of major adverse cardiac events (MACE). The mainsecondary outcome was 1-year risk of any bleeding. Out of the 11,473 randomized patients included in the pooled dataset, 3,454 (30%) were females. At 1-year follow-up, women hadhigher risk of MACE (3.6% vs. 2.8%; P 5 0.01) but similar risk of bleeding (1.9% vs. 1.6%;P 5 0.16) as compared with men. Compared with long-term DAPT, short-term DAPT wasassociated with similar rates of MACE in both women (HR 0.88; 95% CI 0.62–1.25) and men(HR 1.25; 95% CI 0.95–1.6; P interaction 5 0.08)]. At 1-year follow-up, short-term DAPT wasassociated with lower rates of bleeding as compared with long-term DAPT in both women(HR 0.84; 95% CI 0.51–1.37) and men (HR 0.58; 95% CI 0.40–0.84; P–interaction 5 0.25). The presence of MVD was associated with higher MACE rates in the short-term DAPT group inwomen (HR: 1.16; CI 0.60–2.23) and men (HR: 2.29; CI 1.22–4.29; P interaction 5 0.25). Conclusions: Short-term DAPT is associated with similar rates of MACE but lower risk ofbleeding when as compared with prolonged DAPT. There was no significant difference between sexes in the population studied...

Efficacy and safety of dual antiplatelet therapy after complex PCI

BACKGROUND: Optimal upfront dual antiplatelet therapy (DAPT) duration after complex percutaneous coronary intervention (PCI) with drug-eluting stents (DES) remains unclear. OBJECTIVES: This study investigated the efficacy and safety of long-term (≥12 months) versus short-term (3 or 6 months) DAPT with aspirin and clopidogrel according to PCI complexity. METHODS: The authors pooled patient-level data from 6 randomized controlled trials investigating DAPT durations after PCI. Complex PCI was defined as having at least 1 of the following features: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or chronic total occlusion. The primary efficacy endpoint was major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction, or stent thrombosis. The primary safety endpoint was major bleeding. Intention-to-treat was the primary analytic approach. RESULTS: Of 9,577 patients included in the pooled dataset for whom procedural variables were available, 1,680 (17.5%) underwent complex PCI. Overall, 85% of patients received new-generation DES. At a median follow-up time of 392 days (interquartile range: 366 to 710 days), patients who underwent complex PCI had a higher risk of MACE (adjusted hazard ratio [HR]: 1.98; 95% confidence interval [CI]: 1.50 to 2.60; p < 0.0001)...