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Sept. 15, 2005 — Compared to bare metal stents, placement of stents that release the medication paclitaxel reduces the risk of the artery re-narrowing nine months following angioplasty for patients with complex coronary artery lesions, according to an article in the September 14 issue of the Journal of the American Medical Association.
Drug-eluting stents have revolutionized the treatment of atherosclerotic coronary artery disease, according to background information in the article. These stents (which release medications, such as sirolimus and paclitaxel) have been shown to safely reduce clinical and angiographic restenosis (narrowing again of the artery after treatment) compared with bare metal stents. Enrollment in the trials for these stents, however, was restricted to relatively simple stenoses (vessel diameter of 2.5 to 3.75 mm with lesion length 30 mm or less). More than 55 percent of lesions currently treated with these bioactive devices may fall outside this range. The efficacy of drug-eluting stents has not been established for small vessels (in which the utility of stents as a class is still uncertain), large vessels (in which outcomes with bare metal stents are favorable), or in long lesions requiring multiple stents.
Gregg W. Stone, M.D., of Columbia University Medical Center and Cardiovascular Research Foundation, New York, and colleagues conducted a study (the TAXUS V trial) to investigate the safety and efficacy of a paclitaxel-eluting stent in a patient population with more complex coronary lesions than previously studied. The trial, conducted from February 2003 to March 2004 at 66 academic and community-based institutions, included 1,156 patients who underwent stent implantation in a single coronary artery stenosis (vessel diameter, 2.25-4.0 mm; lesion length, 10-46 mm), including 664 patients (57.4 percent) with complex or previously unstudied lesions (requiring 2.25-mm, 4.0-mm, and/or multiple stents) and had 9-month clinical and angiographic follow-up. Patients were randomly assigned to receive one or more bare metal stents (n = 579) or identical-appearing paclitaxel-eluting stents (n = 577).
The average reference vessel diameter was 2.69 mm, the reference lesion length was 17.2 mm. An average of 1.38 stents (total average length, 28.4 mm) were implanted per lesion. Stents of 2.25 mm and 4.0 mm in diameter were used in 18 percent and 17 percent of lesions, respectively; multiple stents were used in 33 percent of lesions.
"Compared with bare metal stents, implantation of paclitaxel-eluting stents reduced the 9-month rate of target lesion revascularization from 15.7 percent to 8.6 percent and target vessel revascularization from 17.3 percent to 12.1 percent. Among patients receiving the paclitaxel-eluting stent compared with a bare metal stent, the rate of in-stent restenosis was reduced with from 31.9 percent to 13.7 percent and analysis segment angiographic restenosis was reduced from 33.9 percent to 18.9 percent," the authors write.
"By multivariate analysis, randomization to the paclitaxel-eluting stent was an independent predictor of freedom from 9-month target lesion revascularization [2.2 times more likely], target vessel revascularization [1.7 times more likely], and restenosis [2.9 times more likely]. These benefits were achieved with comparable safety in both groups, with similar rates of cardiac death, myocardial infarction, and stent thrombosis at 1 and 9 months."
"In conclusion, the TAXUS V trial investigated the use of paclitaxel-eluting stents in a patient population with more complex lesions than had been previously studied. Angiographic restenosis and target vessel revascularization were significantly reduced in the entire cohort, as well as in t