Five-year clinical outcomes of STEMI patients treated with a pre-specified bioresorbable vascular scaffold implantation technique: Final results of the BVS STEMI STRATEGY-IT.

Abstract

Background: Data on Absorb bioresorbable vascular scaffold (BVS) use in patients presenting with ST-segment elevation myocardial infarction (STEMI) are limited. Furthermore, Absorb studies including STEMI patients lacked a prespecified implantation technique to optimize BVS deployment. This study examines the 5-year outcomes of BVS in STEMI patients using an optimized implantation strategy and the impact of prolonged dual antiplatelet therapy (DAPT).

Methods: The BVS STEMI STRATEGY-IT study is a prospective, non-randomized, single-arm multicenter trial (NCT02601781). It involved 505 STEMI patients undergoing primary percutaneous coronary intervention with a predefined BVS implantation protocol. Key endpoints were a 5-year device-oriented composite endpoint (DOCE) of cardiac death, target-vessel myocardial infarction (TV-MI), and ischemia-driven target lesion revascularization (ID-TLR). The study also compared outcomes based on DAPT duration (36 months vs. shorter).

Results: 502 (99.4 %) patients completed the 5-year follow-up. DOCE rate was 2.4 %. ID-TLR, TV-MI, and cardiac death rates were 1.6 %, 0.8 %, and 0.6 %, respectively. No DOCE occurred between three and five years. Scaffold thrombosis (ScT) was 1 %, all occurring within 24 months. Longer-term DAPT significantly reduced DOCE (1.3 % vs. 4.3 %; HR: 0.29; 95 % CI: 0.1-0.9; p = 0.03) driven by a lower rate of TV-MI (0 % vs. 2.2 %; p = 0.018) compared to shorter-term DAPT, as well as ScT (0 % vs 2.7 %, p = 0.007).

Conclusions: This study shows favorable 5-year outcomes for BVS in selected STEMI patients with an optimized implantation strategy. Prolonged DAPT further improved outcomes, emphasizing its role in reducing adverse events during scaffold resorption. Further research is needed to assess newer-generation bioresorbable devices.