(Radiology Review) Sirolimus- or paclitaxel-eluting stents were superior to conventional balloon angioplasty for preventing restenosis in patients with in-stent restenosis, according to a recent study by German researchers.
"Drug-eluting stents have drastically reduced restenosis risk compared with bare metal stents and conventional balloon angioplasty," Dr. Adnan Kastrati and colleagues wrote. However, they sought to determine whether drug-eluting stents were superior for treating patients with in-stent restenosis. Their research was published in the January edition of the Journal of American Medical Association.
At the German Heart Center in Munich, investigators analyzed the results of a randomized controlled trial of 300 patients with angiographically significant in-stent restenosis (50% or greater diameter reduction) during a five-month period.
Patients were randomly divided into one of three groups and were treated with either conventional balloon angioplasty, sirolimus-eluting stent, or paclitaxel-eluting stent.
At follow-up angiography, 45% of patients treated with balloon angioplasty had developed restenosis. Restenosis developed in 14% of the patients treated with sirolimus stents and in 22% of the patients treated with paclitaxel stent.
"When compared with balloon angioplasty, receiving a sirolimus stent had a relative risk of angiographic restenosis of 0.32; a paclitaxel stent had an relative risk of 0.49," the researchers reported.
"Target vessel revascularization was defined as any repeat percutaneous coronary intervention or aortocoronary bypass surgery involving the target vessel due to lumen renarrowing associated with symptoms or objective signs of ischemia," they wrote. The rate of target vessel revascularization was 8% for patients with a sirolimus stent, 19% for a paclitaxel stent, and 33% for balloon angioplasty. Therefore, the authors also determined that sirolimus-eluting stents might be superior to paclitaxel-eluting stents in this high-risk subset of patients.
"For patients with in-stent restenosis, a strategy based on sirolimus- or paclitaxel-eluting stents is superior to conventional balloon angioplasty for the prevention of recurrent restenosis," they concluded. No difference in mortality or incidence of myocardial infarction was found when they compared the three groups during the 12 months following intervention.
"Sirolimus-Eluting Stent or Paclitaxel-Eluting Stent vs Balloon Angioplasty for Prevention of Recurrences in Patients with Coronary In-Stent Restenosis -- A Randomized Controlled Trial"
Kastrati, Adnan et al
Deutsches Herzzentrum
Lazarettstrasse 36
80636 Munich, Germany
JAMA 2005 (January); 293:165-171.
By Radiology Review
January 31, 2005
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