A Comparison of Drug-eluting Stents for Percutaneous Coronary Intervention – Background, Rationale and Design of the COMPARE Trial

Pieter C Smits
European Cardiology, 2009;5(2):69-70
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Abstract

Drug-eluting stents (DES) can reduce the risk of restenosis associated with percutaneous intervention procedures. However, the first-generation sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) are associated with a higher rate of stent thrombosis compared with bare-metal stents (BMS). Recently, an everolimus-eluting stent (EES) has been developed and data from randomised, controlled trials have demonstrated the safety and efficacy of the EES in the treatment of coronary artery disease. The randomised, all-comer, real-world COMPARE trial has compared the clinical outcomes achieved with two DES (EES and PES) in a real-world setting. It was a physician-initiated, single-centre, open-label, randomised, all-comer, real-world study. The study was designed to allow an evaluation of stent efficacy and safety in a real-world setting with a diverse and complex population. Accordingly, the results are intended to provide more patient-orientated rather than device-orientated data. Preliminary results from the COMPARE trial suggest that the EES is safe and efficacious in the diverse patient population of the study.
Keywords
Percutaneous coronary intervention (PCI), drug-eluting stents (DES), paclitaxel, everolimus, SPIRIT, COMPARE
Disclosure The author has no conflicts of interest to declare.
Received: December 04, 2009 | Accepted December 18, 2009 | Citation European Cardiology, 2009;5(2):69-70
Correspondence: Pieter C Smits, Department of Cardiology, Maasstad Ziekenhuis, Groene Hilledijk 315, 3075 EA Rotterdam, The Netherlands. E: SmitsP@maasstadziekenhuis.nl

The high rate of restenosis associated with percutaneous coronary intervention (PCI) procedures1,2 can be reduced with the implantation of metallic stents into the stenotic vessels.3,4 Initially, bare-metal stents (BMS) were introduced, which were found to substantially reduce the rate of restenosis (~20–30%). However, BMS were associated with a high rate of in-stent restenosis. The knowledge that neointimal formation can result in restenosis after stent implantation led to the development of drug-eluting stents (DES), which are now commonly used for PCI procedures.5–7 DES are metallic stents coated with antiproliferative agents. The drug in question is intended to reduce inflammation or inhibit cell proliferation. In randomised controlled trials, a significant reduction in restenosis, late lumen loss and target lesion revascularisation (TLR) has been noted with DES compared with BMS.8–11 The first-generation DES include the sirolimus-eluting Cypher™ stent (Cordis Corp, Miami, Florida) and the polymer-based paclitaxel-eluting Taxus® Express™ stent (Boston Scientific, Natick, Massachusetts). Data from large randomised clinical trials have demonstrated the efficacy and safety of paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES).10–12 However, a higher rate of predominantly late stent thrombosis (ST) has been reported with these DES compared with BMS,12 and this has been linked to the possibility of delayed and incomplete endothelialisation with the DES.13,14 Second- and third-generation DES have subsequently been developed with the aim of further improving the safety and efficacy profiles of the DES.

The polymer-based everolimus-eluting Xience V™ stent (Abbott Vascular, Santa Clara, CA, US) is one example of a second-generation DES. Pre-clinical data from a 14-day rabbit iliac model have shown a faster re-endothelialisation rate with everolimus-eluting stents (EES) versus sirolimus-, zatarolimus- or paclitaxel-eluting stents.15 In terms of clinical results, the SPIRIT series of randomised clinical trials have shown the EES to be safe and efficacious for the treatment of coronary artery disease (CAD).16–18 An analysis of the pooled two-year results from SPIRIT II and SPIRIT III showed that patients treated with EES experienced low rates of additional cardiac death, myocardial infarction (MI) and ST between one- and two-year follow-up.19

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