Bioresorbable everolimus-eluting vascular scaffold for patients presenting with non STelevation-acute coronary syndrome: A three-years follow-up1.

AIM: To investigate three-year outcomes of patients presenting with nonSTelevation acute coronary syndrome (NSTE-ACS) treated with bioresorbable everolimus-eluting vascular scaffolds (BRS). METHODS AND RESULTS: The study included a total of 488 consecutive patients, enrolled between May 2012 and December 2013 (median age 65 [56-74], 392 men. 269 patients presented with either NSTEMI or unstable angina at the time of enrolling, 219 patients with stable or silent angina. The primary device-oriented endpoint (Target Lesion Failure, TLF) was defined as a combination of cardiovascular death, target vessel myocardial infarction or clinically driven target lesion revascularization.Among the cardiac risk factors, NSTE-ACS patients were more frequently smokers (P = 0.028), had less frequently dyslipidemia (P = 0.003) and a history of prior PCI (P < 0.01).The median follow-up was 1070[763-1197] days. The three-years incidence of TLF was slightly higher but did not differ significantly between groups (NSTE-ACS: 16.3% vs. 15.9%, p = 0.163). Accordingly, there was no difference in any of the other endpoints. CONCLUSION: Treatment of NSTE-ACS with BRS appears to be safe and effective. In this group, risk factors for events during follow up did not differ as compared to the general population.

Characteristics, Predictors, and Mechanisms of Thrombosis in Coronary Bioresorbable Scaffolds: Differences Between Early and Late Events.

OBJECTIVES: The study sought to investigate the incidence, characteristics, predictors, and possible mechanisms of early and 3-year coronary scaffold thrombosis (ScT). BACKGROUND: An increased incidence of both early and late ScT has been shown in randomized trials. METHODS: Consecutive patients were enrolled in a single-center registry. Quantitative coronary angiography was performed. Incidence and predictors of ScT were assessed with Kaplan-Meier and Cox regression analyses. RESULTS: A total of 657 patients (63 ± 12 years of age, 79% men, 21% diabetic, 64% acute coronary syndrome) who received 925 coronary bioresorbable scaffolds (BRS) (Abbott Vascular, Santa Clara, California) between May 2012 and January 2015 were enrolled. Clinical and procedural characteristics and outcome data at 1,076 (interquartile range: 762 to 1,206) days (3-year follow-up rate 93%) were collected. Twenty-eight ScTs were recorded: 14 early (Kaplan-Meier estimate: 2.2%), 5 late (Kaplan-Meier estimate: 0.9%), and 9 very late (Kaplan-Meier estimate: 1.7%). The incidence of ScT followed a U-shaped curve with highest incidence at the extremes of the distributions of reference vessel diameter (RVD) and the ratio of BRS nominal diameter to RVD. At quantitative coronary angiography, RVD (hazard ratio [HR]: 0.14; 95% confidence interval [CI]: 0.04 to 0.49) and BRS oversizing (ratio of BRS nominal diameter to RVD >1.15; HR: 107.40; 95% CI: 9.20 to 1,261.30) emerged as potent predictors of early ScT. RVD (HR: 9.55; 95% CI: 3.90 to 23.42) and BRS undersizing (ratio of BRS nominal diameter to RVD <0.85; HR: 0.0004; 95% CI: 0.0000 to 0.0400) predicted late or very late ScT (all p < 0.0001). The incidence of both early and late or very late ScT were lower (∼80% reduction) when an optimal implantation technique was used. The most important factor appeared to be vessel and BRS sizing. CONCLUSIONS: Different mechanisms underlie early and late ScT: although incomplete BRS deployment was a predictor of the former, the latter was associated with large vessel size and BRS undersizing. However, both phenomena are significantly less frequent with an optimized implantation technique. (Mainz Intracoronary Database. The Coronary Slow-flow and Microvascular Diseases Registry [MICAT]; NCT02180178).