ArticlesZotarolimus-eluting durable-polymer-coated stent versus a biolimus-eluting biodegradable-polymer-coated stent in unselected patients undergoing percutaneous coronary intervention (SORT OUT VI): a randomised non-inferiority trial
Introduction
The introduction of drug-eluting stents (DES) consisting of a metal platform and a polymer surface with controlled release of antiproliferative agents has reduced the incidence of restenosis and the need for target-vessel revascularisation compared with bare-metal stents (BMS).1, 2, 3 First-generation DES with durable polymers, however, were associated with increased risk of stent thrombosis, especially very late after discontinuation of dual antiplatelet therapy.4, 5 Remnants of polymer material after drug release is completed are potential triggers for chronic inflammatory responses that can lead to impaired endothelialisation of the stent strut and positive vessel remodelling, and increase the risk of stent thrombosis.6, 7 These findings drove the development of DES with biocompatible durable polymers to lower the risk of inflammation, or of biodegradable polymers that are eventually absorbed and render stent surfaces similar to those of BMS. Durable-polymer-coated DES have been thoroughly investigated in clinical trials.8, 9, 10, 11, 12, 13, 14 Few studies, however, have compared those coated with durable polymers and biodegradable polymers, and most that have been compared have released only everolimus or sirolimus.15, 16, 17, 18, 19, 20, 21 Meta-analyses suggest that new-generation DES coated with biocompatible durable polymers and biodegradable polymers have similar safety and efficacy.22, 23, 24, 25 The Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) VI trial was a non-inferiority trial done to investigate the safety and efficacy of each type of stent eluting, respectively, zotarolimus and biolimus.
Section snippets
Study design and patients
SORT OUT VI was an open-label, randomised, multicentre, non-inferiority trial done at three university hospitals across western Denmark. All patients who presented with stable coronary artery disease or acute coronary syndromes, including myocardial infarction with or without ST-segment elevation, and at least one coronary lesion with more than 50% stenosis in a vessel with a diameter of 2·25–4·00 mm between March, 2011, and August, 2012, were screened for eligibility. No restrictions were
Results
We screened 7103 patients and randomly assigned 2999 patients with 3674 lesions to receive either the durable-polymer zotarolimus-eluting stent (1502 patients with 1883 lesions) or the biodegradable-polymer biolimus-eluting stent (1497 patients with 1791 lesions; figure 1). Baseline demographic and clinical characteristics in the two study groups were well balanced except for previous PCI, number of lesions per patient, and lesion length (table 1). High proportions of patients in the two stent
Discussion
This head-to-head comparison showed non-inferiority of the durable-polymer zotarolimus-eluting stent compared with the biodegradable-polymer biolimus-eluting stent in unselected patients. Excellent outcomes were seen for both stent types in relation to definite stent thrombosis, which is important in view of the complexity of disease, including a high rate of acute coronary syndromes, in our trial population.
Our event rates for the primary endpoint in patients who received the durable-polymer
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