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• W2080342308 abstract "PERCUTANEOUS CORONARY INTERVENTIONS (PCIS) HAVE become the dominant form of revascularization. This evolution has been based on the results of a large number of pivotal randomized trials. Since the pioneering work of Gruntzig, 2 major developments have revolutionized clinical cardiology practice. The first was the introduction of bare metal stents by Sigwart and Puel in 1986 and results following use of stents to treat impending or acute vessel closure after balloon angioplasty were subsequently reported in 1987. Stent implantation improved both acute and long-term results following angioplasty, but perhaps more important from the patient’s perspective, dramatically reduced the need for emergency coronary artery bypass graft (CABG) surgery. The second development was the advent of drug-eluting stents in an effort to prevent a need for repeat revascularization due to restenosis. Multiple studies comparing PCI with CABG surgery have shown that the superiority of CABG surgery predominately rests with its advantage in lower rates of repeat revascularization. Drug-eluting stents have the potential to redress this imbalance but only if effective in complex lesions. To date, enthusiasm for use of drug-eluting stents is based on key trials involving use of the sirolimus-eluting stent and the polymer-based, paclitaxel-eluting stent. Both stents demonstrated a dramatic reduction in the need for revascularization when compared with the bare metal stent in relative simple coronary artery lesions (shorter than 18 mm and located in vessels 2.5 mm in diameter). Safety and efficacy were demonstrated with a more than 2-fold reduction in the need for repeat revascularization with the drugeluting stent compared with the bare metal stent. Longer lesions ( 30 mm in length) were evaluated in subsequent trials and again safety and efficacy were confirmed. In this issue of JAMA, Stone and colleagues report the results of a randomized trial evaluating the paclitaxeleluting TAXUS stent (Boston Scientific Corp, Natick, Mass) in more complex lesions. This study, TAXUS V, follows the sequence of other paclitaxel-eluting stent trials that have included progressively more complex lesions than the first human paclitaxel-eluting stent trial. This trial enrolled patients with lesions as long as 46 mm and lesions located in smaller vessels with a minimal diameter of 2.25 mm and also allowed use of multiple stents (on the same lesion) with minimal overlap between 2 stents. The study by Stone et al moves the field of drug-eluting stents closer to clinical practice but there is still a relatively long way to go. For instance, the investigators did not allow enrollment of patients with total occlusions, bifurcational, ostial, severely calcified, or thrombus-containing lesions. In addition, no multiple index lesions were included; this means that for the purpose of the end-point analysis only 1 lesion treated with the paclitaxel-eluting stent was evaluated. If drug-eluting stents were reserved only for lesions of this level of complexity, as many as 160 000 stents per month around the world might not have been implanted. This large study randomized 1172 patients at 66 US centers and has a well-balanced and appropriate representation of patients with clinically relevant characteristics in both groups: 30% of the patients had medically treated diabetes mellitus and 30% had unstable angina. Moreover, there were high rates of clinical follow-up, nearly 98%, and angiographic follow-up, exceeding 85%. At least 200 patients had lesions located in vessels smaller than 2.25 mm in diameter (high risk for adverse events), and at least 200 had lesions located in vessels with a diameter of 4.0 mm (low risk for adverse events). These 2 subgroups of patients with lesion characteristics at the opposite ends of the spectrum may make the overall results more difficult to interpret correctly, but on the other hand may stimulate interest in the specific evaluation of these 2 subgroups. A third, rather unique subgroup, from the perspective of randomized trials, is that 379 patients had multiple stents placed in the same lesion. The primary end point evaluated is important and pertinent for any study of drug-eluting stents: ischemia-driven target vessel revascularization. In the entire study population, target vessel revascularization and target lesion revascularization at 9 months occurred in 17.3% and 15.7% of" @default.
• W2080342308 created "2016-06-24" @default.
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• W2080342308 date "2005-09-14" @default.
• W2080342308 modified "2023-09-25" @default.
• W2080342308 title "Paclitaxel-Eluting Stents in Complex Lesions" @default.
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• W2080342308 doi "https://doi.org/10.1001/jama.294.10.1268" @default.
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