Impact of Outcome Measure and Duration of Follow-Up on the Reliability of Clinical Trials Assessing the Efficacy and Safety of Coronary Artery Stents

Abstract

Background: Advances in coronary stent design have reduced rates of coronary restenosis and the need for further revascularisation. However, compared with second-generation (2nd-Gen) drug-eluting stents (DES), first-generation(1st-Gen) DES and bioresorbable coronary scaffolds (BVS) have an increased risk of stent thrombosis (ST), which may not have been adequately assessed in individual studies. A meta-analysis was undertaken to evaluate the best choice of endpoint and follow-up duration, to detect any increased risk of stent or scaffold thrombosis.