Stone GW, et al. - Experts assessed polymeric everolimus-eluting bioresorbable vascular scaffolds (BVS) with optimized implantation technique vs cobalt-chromium everolimus-eluting stents in terms of target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 30 days in patients with stable coronary artery disease or acute coronary syndromes. Non-inferior 30-day and 1-year rates of target lesion failure and angina were the results with polymeric BVS implanted with optimized technique vs metallic DES in an expanded patient population.

Methods

• Experts recruited patients with stable coronary artery disease or acute coronary syndromes aged 18 years or older from 147 hospitals in 5 countries (US, Germany, Australia, Singapore, and Canada) in the active-controlled, blinded, multicenter, randomized ABSORB IV trial.
• They randomly assigned (1:1) the enrolled patients to receive polymeric everolimus-eluting BVS (Absorb; Abbott Vascular, Santa Clara, CA, USA) with optimized implantation technique or cobalt-chromium everolimus-eluting stents (EES; Xience; Abbott Vascular, Santa Clara, CA, US).
• They stratified randomization by diabetic status, whether patients would have been eligible for enrolment in the previous ABSORB III trial, and site.
• Researchers masked the patients and clinical assessors to randomization.
• Target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 30 days, tested for non-inferiority with a 2.9% margin for the risk difference was the primary endpoint.
• Intention to treat analysis was performed.

Results

• As per data, 18,722 patients were screened for eligibility between August 15, 2014 and March 31, 2017, 2,604 of whom were enrolled.
• They assigned 1,296 patients to BVS, and 1,308 patients to EES; at 30 days and 1 year, follow-up data were available for 1,288 and 1,254 patients with BVS and for 1,303 and 1,272 patients with EES, respectively.
• In 622 (24%) of 2,602 patients, biomarker-positive acute coronary syndromes were present, and, by angiographic core laboratory analysis, 78 (3%) of 2,893 of lesions were in very small vessels.
• In 64 (5.0%) patients assigned to BVS, target lesion failure occurred at 30 days and 48 (3.7%) patients assigned to EES (difference 1.3%, upper 97.5% confidence limit 2.89; one-sided p_{non-inferiority}=0.0244).
• They noted occurrence of target lesion failure at 1 year in 98 (7.8%) patients assigned to BVS and 82 (6.4%) patients assigned to EES (difference 1.4%, upper 97.5% confidence limit 3.4; one-sided p_{non-inferiority}=0.0006).
• Results demonstrated that in 270 (20.3%) patients assigned to BVS and 274 (20.5%) patients assigned to EES (difference -0.3%, 95% CI -3.4% to 2.9%; one-sided p_{non-inferiority}=0.0008; two-sided p_superiority=0.8603) angina, adjudicated by a central events committee, occurred at 1 year.
• Findings suggested that device thrombosis within 1 year occurred in nine (0.7%) patients assigned to BVS and four (0.3%) patients assigned to EES (p=0.1586).