The conclusions of the COMPARE study are published Online First and in an upcoming edition of The Lancet. Based on the findings, the authors suggest that paclitaxel-eluting stents should no longer be used in everyday clinical practice. The everolimus-eluting stent is superior to the second generation paclitaxel-eluting stent in unselected patients undergoing percutaneous coronary intervention (PCI) in terms of safety and efficacy. Percutaneous coronary intervention (PCI) is commonly known as coronary angioplasty. It 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. The article is the work of Dr Pieter Cornelis Smits, Dr. Elvin Kedhi, and Dr. Eugene McFadden, Department of Cardiology, Maasstad Ziekenhuis, Rotterdam, the Netherlands, and colleagues.

Second-generation drug-eluting stents have been designed with the purpose of improving safety, efficacy, and device performance compared with the currently available first-generation drug-eluting stents. Everolimus is a semisynthetic sirolimus analogue. It is released from a thin coating of biocompatible fluoropolymer on an open cell, thin strut, cobalt-chromium frame. With the use of the everolimus-eluting stent, a significant reduction in serious adverse cardiac events was noted in patients compared with those who had the first-generation paclitaxel-eluting stent. In Europe, this first-generation stent is considered outdated and replaced by new-generation paclitaxel-eluting stent since September, 2005. It is unclear whether such differences persist with a new-generation paclitaxel-eluting stent that consists of the same polymer but has a different stent platform.

A total of 1,800 consecutive patients participated in the COMPARE study. They were aged from 18 to 85 years. They were randomly assigned to undergo 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 which restores blood flow in a vessel after PCI, within 12 months.

In 1,797 patients, follow-up was completed. The primary endpoint occurred in 56 (6 percent) patients in the everolimus-eluting stent group compared to 82 (9 percent) in the paclitaxel-eluting stent group. The relative risk of primary endpoint occurring was 31 percent lower for the everolimus group. The difference was attributable to a lower rate of:

• stent thrombosis: occurred in 6 patients (less than 1 percent) compared to 23 patients (3 percent)
• heart attack: occurred in 25 patients (3 percent) compared to 48 patients (5 percent)
• target vessel revascularisation: occurred in 21 patients ( 2 percent) compared to 54 patients (6 percent)

Cardiac death, non-fatal myocardial infarction, or target-lesion revascularisation occurred in 44 patients (5 percent) in the everolimus-stent group versus 74 patients (8 percent) in the paclitaxel-stent group.

The authors explain: “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 write in conclusion: “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.”

“Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial”
Elvin Kedhi, Kaiyum Sheik Joesoef, Eugene McFadden, Jochem Wassing, Carlos van Mieghem, Dick Goedhart, Pieter Cornelis Smits
DOI: 10.1016/S0140-6736(09)62127-9
The Lancet

Written by Stephanie Brunner (B.A.)