Moving Toward Eradication of Stent Thrombosis

Improved clinical outcomes have supported the use of drug-eluting stents (DES) in preference to bare-metal stents. However, the possibility of late occlusive stent thrombosis (ST), a long-term iatrogenic complication, has somewhat tempered enthusiasm. Evidence has recently accumulated to show that all DES are not equal for the risk of ST. The long-term follow-up results of the SORT OUT IV (Scandinavian Organization for Randomized Trials with Clinical Outcome) trial add to the body of knowledge demonstrating safety with everolimus-eluting stent (EES [Xience V or Promus; Abbott Vascular, Abbott Park, Illinois]) that is improved compared with that of sirolimus-eluting stent (SES [Cypher Select+; Cordis, Fremont, California]) (1). The Danish Organization of Randomized Trials with Clinical Outcome, an independent clinical research collaboration of 5 university hospitals, conducted an impressive program to evaluate different stents, polymers, and drugs. The present registry-based randomized trial was able to recruit 30% of the consecutive patients (n = 2,774) undergoing PCI in Denmark over 2 years. Cardiovascular events were blindly adjudicated. The primary endpoints of cardiac death, myocardial infarction (MI), definite ST, and clinically driven target vessel revascularization were not different between the 2 stents at 9-month follow-up (4.9% vs. 5.2%, respectively; p for noninferiority = 0.02). However, in the present 5-year follow-up report, a significant 20% reduction of the primary endpoints was observed with EES (14.0% vs. 17.4%, respectively; p = 0.02), driven mostly by a large reduction of very late definite ST (0.2% vs. 1.4%, respectively), the Kaplan-Meier curves diverging beyond 1 year, when patients were left taking only aspirin therapy.