Comparison of eligible non-enrolled patients and the randomised TWENTE trial population treated with Resolute and Xience V drug-eluting stents
Hanim Sen, Kenneth Tandjung, Mounir W Z Basalus, Marije M Löwik, Gert K van Houwelingen, Martin G Stoel, Hans W Louwerenburg, Frits H A F de Man, Gerard C M Linssen, Rogier Nijhuis, Mark B Nienhuis, Patrick M J Verhorst, Job van der Palen, Clemens von Birgelen, Hanim Sen, Kenneth Tandjung, Mounir W Z Basalus, Marije M Löwik, Gert K van Houwelingen, Martin G Stoel, Hans W Louwerenburg, Frits H A F de Man, Gerard C M Linssen, Rogier Nijhuis, Mark B Nienhuis, Patrick M J Verhorst, Job van der Palen, Clemens von Birgelen
Abstract
Aims: 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.
Methods and results: 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).
Conclusions: 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.
Trial registration: ClinicalTrials.gov NCT01066650.
Source: PubMed