Two-Year TWENTE Data Published

May 15, 2012—Two-year follow-up data from the randomized TWENTE study were published by Kenneth Tandjung, MD, et al online ahead of print in the Journal of the American College of Cardiology.

The aim of the TWENTE study was to assess the safety and efficacy of the Endeavor Resolute zotarolimus-eluting stent (ZES; Medtronic, Inc., Minneapolis, MN) versus the Xience V everolimus-eluting stent (EES; Abbott Vascular, Santa Clara, CA) after strict discontinuation of dual-antiplatelet therapy (DAPT) after 12 months. Only limited long-term follow-up data are available from head-to-head comparisons of second-generation drug-eluting stents, the investigators noted.

The investigators concluded that after 2 years of follow-up and stringent discontinuation of DAPT beyond 12 months, Resolute ZES and Xience V EES showed similar results in terms of safety and efficacy for treating patients with a majority of complex lesions and off-label indications for drug-eluting stents.

As noted in the in the Journal of the American College of Cardiology, TWENTE is an investigator-initiated study performed in a population with many complex patients and lesions and only limited exclusion criteria. Patients were randomly assigned 1:1 to ZES (n = 697) or EES (n = 694).

With 2-year follow-up information available on all patients, the investigators reported that the rate of DAPT continuation beyond 12 months was very low (5.4%). The primary endpoint, target-vessel failure (TVF), was a composite of cardiac death, target vessel–related myocardial infarction, and target vessel revascularization, which did not differ between the ZES and EES (10.8% vs 11.6; P = .65), despite fewer target lesion revascularizations with the EES (2.6% vs 4.9%; P = .03). The patient-oriented composite endpoint was similar (16.4% vs 17.1%; P = .75). Two-year definite or probable stent thrombosis rates were 1.2% and 1.4% (P = .63), respectively. Very late definite or probable stent thrombosis occurred in only two patients in each study arm (0.3% vs 0.3%; P = 1), reported the investigators in the Journal of the American College of Cardiology.