Clinical Efficacy of Polymer-Based Paclitaxel-Eluting Stents in the Treatment of Complex, Long Coronary Artery Lesions From a Multicenter, Randomized Trial

Abstract

on behalf of the TAXUS VI InvestigatorsBackground-Intracoronary polymer-based stent delivery of paclitaxel has been shown to be effective in reducing restenosis in simple coronary lesions, but the evidence base for contemporary use in longer, more complex coronary stenoses is lacking. Methods and Results-TAXUS VI is a prospective, multicenter, double-blind, randomized trial assessing clinical and angiographic outcomes of the TAXUS Moderate Release paclitaxel-eluting stent in the treatment of long, complex coronary artery lesions. Four hundred forty-eight patients at 44 sites were randomized (1:1) between a drug-eluting TAXUS Express 2 and an uncoated Express 2 control stent. Per protocol, the 9-month follow-up included an angiographic reevaluation in all patients. The primary end point was the rate of target-vessel revascularization 9 months after the study procedure; secondary end points included the rate of target-lesion revascularization and binary restenosis at follow-up. Mean lesion length in the study was 20.6 mm, with a mean stent-covered length of 33.4 mm. Of all lesions, 55.6% were classified as complex lesions (type C of the AHA/ACC classification). At 9 months, target-vessel revascularization was 9.1% in the TAXUS group and 19.4% in the control group (Pϭ0.0027; relative reduction, 53%). Target-lesion revascularization was reduced from 18.9% to 6.8%, respectively (Pϭ0.0001). The incidence of major adverse cardiac events was similar in the 2 groups, 16.4% and 22.5% in TAXUS and control, respectively (Pϭ0.12), including comparable rates for acute myocardial infarction. Binary restenosis in the stented area was reduced from 32.9% in the control group to 9.1% in the TAXUS patients (PϽ0.0001). Conclusions-The

Treatment of diffuse coronary artery disease with long lengths (≥30 mm) of intracoronary stents

“…However, these rates continued to be significantly lower in those who were treated with DES. Finally, the restenosis rates observed in our study were similar to the restenosis rates observed in other studies with systematic angiographic follow-up (6,8,9,13).…”

“…Surprisingly, neither group showed any association between stent length and restenosis. This is an unexpected finding since several previous studies have shown a correlation between stent length and/or placement of multiple stents with restenosis, particularly with BMS [1][2][3][4][5][6][7][8][9][10][11][12]. Many of these studies evaluated early generation BMS, comparisons were made to short, focal coronary lesions, and the definition of "long lesions" was conservative compared to our study.…”

“…In the Taxus-VI study, patients with long, complex coronary lesions were randomized to treatment with either a paclitaxel eluting stent or a BMS [9]. In the Taxus-VI cohort, the mean lesion length was 20.6 mm and the mean stent length was 33.4 mm.…”

Inhibition of neointimal hyperplasia in rats treated with atorvastatin after carotid artery injury may be mainly associated with down-regulation of survivin and Fas expression

“…Previous studies demonstrated that the rate of restenosis is 7.6-18.9% in patients implanted with paclitaxel-eluting stents (Dawkins et al, 2005;Lansky et al, 2005;Mehilli et al, 2006) and 6.9-14.2% in patients treated with sirolimuseluting stents Kastrati et al, 2005;Mehilli et al, 2006). These results indicated that we need to study more the effects of drug eluting, and it is necessary to seek a new method to prevent restenosis.…”

Performance figures of invasive cardiology in Germany 2006 and 2007 focussing on coronary artery disease

“…Taking the positive long-term results of PCI with adjuvant drug-eluting stent (DES) implantation as compared to subgroups with no stents or bare metal stent implantations into account [11,15,21,22,26], the current use of DES is considered rather restrictive [27,28]. Despite the low percentage of PCI patients receiving DES in Germany (24.0% in 2005 and 29.4% in 2006) the percentage further decreased in 2007 (27.5%).…”