Final results of a randomized trial comparing the MULTI-LINK stent with the Palmaz-Schatz stent for narrowings in native coronary arteries

Abstract

The MULTI-LINK (ML) stent is a novel second generation coronary stent. The ACS MultiLink Stent Clinical Equivalence in De Novo Lesions Trial (ASCENT) randomized 1,040 patients with single, de novo native vessel lesions to treatment with the ML stent or the benchmark Palmaz-Schatz (PS) stent, to demonstrate that the ML stent was not inferior to (i.e., equivalent or better than) the PS stent in terms of target vessel failure by 9 months. Successful stent delivery was achieved in 98.8% versus 96.9% of patients, with a slightly lower postprocedural diameter stenosis (8% vs 10%, p = 0.04), and no difference in 30-day major adverse cardiac events (5.0% vs 6.5%) for the ML stent versus the PS stent. The primary end point of target vessel failure at 9 months was seen in 15.1% of ML-treated patients versus 16.7% of PS-treated patients, with the ML proving to be equal or superior to the PS stent (p <0.001 by test for equivalency). In a prespecified subset, angiographic restudy showed a nonsignificant trend for reduced ML restenosis (16.0% vs 22.1%). Thus, the ML stent showed excellent deliverability and acute results, with 9-month clinical and 6-month angiographic outcomes that were equivalent or better than the PS stent.

Relationship of Late Loss in Lumen Diameter to Coronary Restenosis in Sirolimus-Eluting Stents

“…25 BAR rates and TLR rates ranging between 15% and 25% for stents and between 20% and 40% for other angioplasty devices [5][6][7][8] allowed detection of modest differences in restenosis rates in clinical trials of fewer than 1000 subjects. 26,27 The evaluation of restenosis in the DES era is more complex.…”

“…1,31 Bare metal stent trials and registries have demonstrated mean late losses varying from 0.6 to 1.2 mm. 5,6,26,27,[32][33][34][35] The RAVEL trial of the sirolimus-eluting Bx Velocity stent was the first randomized trial to report a stent with an average late loss well below the expected historical range, as well as its own control arm (in-stent late loss Ϫ0.01 mm active versus 0.80 mm control), which corresponded to a BAR rate of 0% for the active arm versus 26% in the control arm. 36 As the positive mean of any normal distribution is reduced enough so that its spread becomes significantly bounded by zero, it becomes right-skewed.…”

“…4 The moderately high rates of BAR and TLR seen in conventional trials (15% to 40%) have provided enough power for adequate discrimination between competing percutaneous therapies enrolling Ϸ1000 subjects. [5][6][7][8][9] In contrast, several recent drug-eluting stent (DES) trials have demonstrated a breakthrough in the reduction of late restenosis compared with bare metal stents, with a consistent incidence of BAR and TLR below 10%. 10,11 Even with the achieved low rates, which may underestimate the rate in actual practice or in high-risk groups, [12][13][14][15][16][17] cost-effectiveness analysis provides economic and quality-of-life incentives to distinguish therapies with restenosis rates below 10%.…”

Quantitative Assessment of Angiographic Restenosis After Sirolimus-Eluting Stent Implantation in Native Coronary Arteries

“…19 Angiographic studies in patients treated with BMS have reported binary restenosis rates within the stent and within the treated arterial segment that included its nonstented margins. 6,7 Although previous BMS stent studies did not examine the specific lumen changes at the proximal or distal nonstent margins, intravascular ultrasound studies have shown that balloon injury proximal and distal to the stent may result in lumen renarrowing resulting from arterial remodeling at the edges of the stent. 9 Studies evaluating angiographic outcomes in patients undergoing radiation brachytherapy or using radioactive stents have also shown that proliferation at the stent edges may be associated with higher-than-expected restenosis rates at the stent margins ("candy wrapper effect") because of an untoward effect of low-dose radiation at the stent margins.…”

Clinical and Angiographic Results After MULTI-LINK Stent Implantation and Their Relation to Aggregation of Risk Factors. Two-Year Follow-up.

“…The results of trials using the ACS MULTI-LINK (ML) stent (Guidant, Santa Clara, CA, USA), one of the recently developed stents, were similar to or slightly better than those of trials using the PS stent. 5,6 However, the follow-up periods in those trials were less than 9 months, so little is known about long-term (>12 months) outcome after ML stent implantation. The purpose of this study, therefore, was to evaluate the relatively long-term clinical outcome (2 years) of patients with coronary artery disease treated with the ML Circulation Journal Vol.66, October 2002 stent and to determine independent factors correlated with target lesion revascularization and cardiac events.…”