Early and Late Outcomes With the Absorb Bioresorbable Vascular Scaffold: Final Report From the ABSORB Clinical Trial Program.

BACKGROUND

The risk-benefit ratio of the Absorb bioresorbable vascular scaffold (BVS) may vary before and after 3 years, the time point of complete bioresorption of the poly-L-lactic acid scaffold.

OBJECTIVES

The aim of this study was to determine the time-varying outcomes of the Absorb BVS compared with cobalt-chromium everolimus-eluting stents (EES) from a large individual-patient-data pooled analysis of randomized trials.

METHODS

The individual patient data from 5 trials that randomized 5,988 patients undergoing percutaneous coronary intervention to the Absorb BVS vs EES with 5-year follow-up were pooled. The primary effectiveness and safety endpoints were target lesion failure (TLF) (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) and device thrombosis (DT).

RESULTS

Between 0 and 5 years, TLF occurred in 15.9% BVS patients vs 13.1% EES patients (HR: 1.25; 95% CI: 1.08-1.43; P = 0.002), and DT occurred in 2.2% vs 1.0%, respectively (HR: 2.38; 95% CI: 1.49-3.79; P = 0.0002). Between 0 and 3 years, TLF occurred in 12.4% BVS patients vs 9.3% EES patients (HR: 1.35; 95% CI: 1.15-1.59; P = 0.0002), and DT occurred in 2.0% vs 0.6%, respectively (HR: 3.58; 95% CI: 2.01-6.36; P < 0.0001). Between 3 and 5 years, TLF occurred in 4.5% BVS patients vs 4.7% EES patients (HR: 0.99; 95% CI: 0.76-1.27; P = 0.91), and DT occurred in 0.2% vs 0.4%, respectively (HR: 0.49; 95% CI: 0.18-1.38; P = 0.17). By spline analysis, the TLF hazard by 5 years was lower with BVS than EES.

CONCLUSIONS

Compared with EES treatment, BVS increased TLF and DT rates through 5-year follow-up. However, the period of excess risk for the first-generation Absorb BVS ended at 3 years, when poly-L-lactic acid bioresorption is complete. Thereafter event rates were comparable or lower with BVS. (ABSORB II Randomized Controlled Trial, NCT01425281; A Clinical Evaluation of Absorb™ Bioresorbable Vascular Scaffold [Absorb™ BVS] System in Chinese Population - ABSORB CHINA Randomized Controlled Trial [ABSORB CHINA], NCT01923740; AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 [Absorb™ BVS] in Japanese Population [ABSORB JAPAN], NCT01844284; ABSORB III Randomized Controlled Trial [ABSORB III], NCT01751906; Absorb IV Randomized Controlled Trial, NCT02173379).