Comparison of eligible non-enrolled patients and the randomised TWENTE trial population treated with Resolute and XIENCE V drug-eluting stents

• Published in: EuroIntervention Vol. 8; no. 6; pp. 664 - 671
• Main Authors: SEN, Hanim, TANDJUNG, Kenneth, NIENHUIS, Mark B, VERHORST, Patrick M. J, VAN DER PALEN, Job, VON BIRGELEN, Clemens, BASALUS, Mounir W. Z, LÖWIK, Marije M, VAN HOUWELINGEN, Gert K, STOEL, Martin G, LOUWERENBURG, Hans W, DE MAN, Frits H. A. F, LINSSEN, Gerard C. M, NIJHUIS, Rogier
• Format: Journal Article
• Language: English
• Published: Toulouse Société Europa Edition 01-10-2012
• Subjects: Aged; Biological and medical sciences; Cardiology. Vascular system; Cardiovascular Agents - administration & dosage; Chi-Square Distribution; Coronary Artery Disease - mortality; Coronary Artery Disease - therapy; Coronary heart disease; Diseases of the cardiovascular system; Drug-Eluting Stents; Eligibility Determination; Everolimus; Female; Heart; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Medical sciences; Middle Aged; Multivariate Analysis; Myocardial Infarction - etiology; Netherlands; Odds Ratio; Patient Selection; Percutaneous Coronary Intervention - adverse effects; Percutaneous Coronary Intervention - instrumentation; Percutaneous Coronary Intervention - mortality; Prospective Studies; Prosthesis Design; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Risk Factors; Sirolimus - administration & dosage; Sirolimus - analogs & derivatives; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Time Factors; Treatment Outcome; Netherlands; Human; coronary artery disease; Atherectomy; drug-eluting stent; Angioplasty; Coronary artery; Instrumentation therapy; Cardiovascular disease; Patient; randomised controlled trial; Coronary heart disease; Percutaneous route; percutaneous coronary intervention; Population; Drug eluting stent; Comparative study; TWENTE trial
• ISSN: 1774-024X; 1969-6213
• DOI: 10.4244/EIJV8I6A104

The TWENTE trial recently enrolled more than 80% of all eligible patients, who were randomised to zotarolimus-eluting Resolute or everolimus-eluting XIENCE V stents. In the present study, we investigated whether eligible, non-enrolled patients differed from the randomised TWENTE trial population in baseline characteristics and one-year outcome.
Characteristics of 1,709 eligible patients were analysed. Independent external adjudication of clinical events was likewise performed for non-enrolled (n=318) and randomised patients (n=1,391). Non-enrolled and randomised patients did not differ in gender distribution, diabetes mellitus, and clinical presentation, but differed significantly in age and cardiovascular history. Nevertheless, clinical outcome after one year did not differ in the primary composite endpoint target-vessel failure (TVF; 9.8% vs. 8.1%; p=0.34), and its components cardiac death (1.6% vs. 1.2%; p=0.61), target vessel-related myocardial infarction (4.7% vs. 4.6%; p=0.92), and target-vessel revascularisation (3.8% vs. 3.0%; p=0.48). Previous bypass surgery predicted TVF in non-enrolled patients (p=0.001); removal of these patients resulted in identical TVF rates for non-enrolled and randomised patients (7.3% vs. 7.3%; p=0.99).
Despite some differences in baseline characteristics, non-enrolled and randomised patients did not differ in one-year outcome, which was favourable for both populations and may be related to the drug-eluting stents used.