Comparison of a Polymer-Based Paclitaxel-Eluting Stent With a Bare Metal Stent in Patients With Complex Coronary Artery Disease

Abstract

Drug-eluting stents have revolutionized the treatment of atherosclerotic coronary artery disease. The demonstration that both sirolimus-eluting and paclitaxel-eluting stents safely reduce clinical and angiographic restenosis compared with bare metal stents^1-4 has resulted in an estimated 160 000 of these devices currently being implanted per month worldwide (unpublished data, Boston Scientific Corp, Natick, Mass), signifying drug-eluting stents as by far the most widely used permanent bioprosthesis. Enrollment in the pivotal randomized trials,^1-4 however, was restricted to relatively simple stenoses (vessel diameter of 2.5-3.75 mm with lesion length ≤30 mm). More than 55% of lesions currently treated with these bioactive devices may fall outside this range.⁵ 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),⁶ large vessels (in which outcomes with bare metal stents are favorable),^7-11 or in long lesions requiring multiple stents (a complex subset with increased periprocedural complications and reduced efficacy).^7-12 Therefore, we performed a prospective, multicenter, randomized trial to investigate the safety and efficacy of a paclitaxel-eluting stent in a patient population with more complex lesions than previously studied.