Safety of second-generation drug-eluting stents three years after randomised use in the TWENTE trial

• Published in: EuroIntervention Vol. 10; no. 11; pp. 1276 - 1279
• Main Authors: Löwik, Marije M, Lam, Ming Kai, Sen, Hanim, Tandjung, Kenneth, van Houwelingen, K Gert, de Man, Frits H A F, Stoel, Martin G, Louwerenburg, J Hans W, Linssen, Gerard C M, Doggen, Carine J M, von Birgelen, Clemens
• Format: Journal Article
• Language: English
• Published: France 01.03.2015
• Subjects: Acute Coronary Syndrome - drug therapy; Acute Coronary Syndrome - surgery; Aged; Angina, Stable - drug therapy; Angina, Stable - surgery; Antineoplastic Agents - therapeutic use; Cardiovascular Diseases - mortality; Coronary Stenosis - drug therapy; Coronary Stenosis - surgery; Drug-Eluting Stents; Everolimus - therapeutic use; Female; Humans; Longitudinal Studies; Male; Middle Aged; Myocardial Infarction - epidemiology; Myocardial Revascularization - utilization; Percutaneous Coronary Intervention - instrumentation; Reoperation; Sirolimus - analogs & derivatives; Sirolimus - therapeutic use; Thrombosis - epidemiology; Treatment Outcome
• ISSN: 1774-024X; 1969-6213
• DOI: 10.4244/EIJY14M08_11

To assess three-year clinical outcome following randomised use of the second-generation Resolute zotarolimus-eluting stent (ZES) and the XIENCE V everolimus-eluting stent (EES). For Resolute ZES and randomised use, outcome data ≥3 years are relatively scarce. The TWENTE trial examined 1,391 patients with stable angina or non-ST-elevation acute coronary syndromes, of whom 21.6% were diabetics, 70.1% had complex B2 or C lesions and 77.4% had "off-label" indications for DES use. Three-year follow-up data were obtained in 1,381 patients (99.3%; 10 withdrawals). Adverse clinical events were independently adjudicated. The primary endpoint target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction and clinically indicated target vessel revascularisation, was 12.1% for Resolute ZES and 13.4% for XIENCE V EES (p=0.50). Cardiac death rates were 1.9% vs. 3.5% (p=0.06); the other individual components of TVF also showed no significant between-group differences. The rates of definite-or-probable stent thrombosis (1.4% vs. 1.6%, p=0.82) and very late stent thrombosis (0.6% vs. 0.4%, p=1.0) did not differ between the groups. Three-year follow-up data of patients included in the randomised TWENTE trial demonstrated similar and sustained safety and efficacy of Resolute ZES and XIENCE V EES.