A polymer-free dual drug-eluting stent in patients with coronary artery disease: a randomized trial vs. polymer-based drug-eluting stents.

Abstract

Long-term polymer residue in the coronary milieu is a consequence of current drug-eluting stent (DES) therapy and has been implicated in late adverse events. We developed a novel polymer-free rapamycin- and probucol-eluting stent (Dual-DES) and compared its efficacy against commercially available permanent polymer-based sirolimus-eluting (SES; Cypher) and zotarolimus-eluting (ZES; Endeavor) stents. Between March 2006 and July 2007, a total of 1007 patients undergoing coronary stenting of de novo lesions, in native vessels, were randomized to treatment with SES (n = 335), Dual-DES (n = 333), or ZES (n = 339). The primary endpoint was binary angiographic restenosis at 6-8 month follow-up angiography. Secondary endpoints were angiographic in-stent late loss; and target lesion revascularization (TLR), death/myocardial infarction and stent thrombosis at 12 months. Follow-up angiographic data were available for 828 (82.2%) patients. There was a significant difference in both binary restenosis and TLR across treatment groups (P = 0.003 and P < 0.001, respectively). Binary restenosis in the Dual-DES group (11.0%) was significantly lower than that in the ZES group (19.3%; P = 0.002) but comparable with that in the SES group (12.0%; P = 0.68). Similarly, TLR with Dual-DES (6.8%) was significantly lower than ZES (13.6%; P = 0.001) but not different to that of SES (7.2%; P = 0.83). These differences were mirrored in the extent of late loss across the groups. No differences were observed between stent groups in terms of death/myocardial infarction or stent thrombosis. A novel polymer-free Dual-DES is associated with high anti-restenotic efficacy without recourse to carrier polymer. Potential long-term clinical advantage of this platform remains subject to investigation. Study registered at ClinicalTrials.gov. Identifier number: NCT00332397.