The everolimus-eluting stent is better than the second generation paclitaxel-eluting stent in unselected patients undergoing percutaneous coronary intervention (PCI)*in terms of safety and efficacy, concludes the COMPARE study, published Online First (www.thelancet.com) and in an upcoming edition of the Lancet. On the basis these findings, the authors suggest that paclitaxel-eluting stents should no longer be used in everyday clinical practice. The Article is written by Dr Pieter Cornelis Smits, Dr. Elvin Kedhi, and Dr. Eugene McFadden, Department of Cardiology, Maasstad Ziekenhuis, Rotterdam, the Netherlands, and colleagues.
Compared with the currently available first-generation drug-eluting stents, second-generation drug-eluting stents have been designed with the goal of improving safety, efficacy, and device performance. Everolimus, a semisynthetic sirolimus analogue, is released from a thin coating of biocompatible fluoropolymer on an open cell, thin strut, cobalt-chromium frame. A significant reduction in serious adverse cardiac events was noted in patients with the everolimus-eluting stent compared with those who had the first-generation paclitaxel-eluting stent. This first-generation stent has been superseded in Europe by the new-generation paclitaxel-eluting stent since September, 2005. Whether such differences persist with a new-generation paclitaxel-eluting stent that consists of the same polymer but has a different stent platform is not known.
The COMPARE study randomly assigned 1800 consecutive patients (aged 18 years) undergoing PCI at one centre to treatment with everolimus-eluting and second-generation paclitaxel-eluting stents. The primary endpoint was a composite of safety and efficacy (all-cause mortality, heart attack, and target vessel revascularisation**) within 12 months.
Follow-up was completed in 1797 patients. The primary endpoint occurred in 56 (6%) patients in the everolimus-eluting stent group versus 82 (9%) in the paclitaxel-eluting stent group (relative risk of primary endpoint occurring was 31% lower for the everolimus group). The difference was attributable to a lower rate of stent thrombosis (6 [<1%] vs 23 [3%]), heart attack (25 [3%] vs 48 [5%]), and target vessel revascularisation (21 [ 2%] vs 54 [6%]). Cardiac death, non-fatal myocardial infarction, or target-lesion revascularisation occurred in 44 [5%] patients in the everolimus-stent group versus 74 [8%] patients in the paclitaxel-stent group.
The authors say: "The use of second-generation everolimus-eluting stents, compared with paclitaxel-eluting stents, was associated with a significant reduction in the risk of major adverse cardiac events at 1 year. This difference was a result of reduction in the rate of myocardial infarction, a safety component of the primary endpoint, and reduction in repeat revascularisation of the target vessel."
They conclude: "The everolimus-eluting stent is better than the second generation paclitaxel-eluting stent in unselected patients in terms of safety and efficacy. On the basis of our results, we suggest that paclitaxel-eluting stents should no longer be used in everyday clinical practice."
Dr Pieter Cornelis Smits, Department of Cardiology, Maasstad Ziekenhuis, Rotterdam, the Netherlands. T) +31-10-2913322 E) smitsp@maasstadziekenhuis.nl
For full Article, see: http://press.thelancet.com/compare.pdf
Notes to editors: *Percutaneous coronary intervention (PCI), commonly known as coronary angioplasty, is a therapeutic procedure used to treat the narrowed arteries of the heart in patients with coronary heart disease. The term balloon angioplasty is commonly used to describe PCI, which describes the inflation of a balloon within the coronary artery to crush the 'plaque' causing the narrowing into the walls of the artery. Stents can then be inserted to prevent the artery re-narrowing.
** target vessel revascularisation: restoring blood flow in a vessel after PCI
An accompanying Comment is not available at this time, but will be available when the Article in published in a future weekly issue of the Lancet.
Journal
The Lancet