Non–Polymer-Based Paclitaxel-Coated Coronary Stents for the Treatment of Patients With De Novo Coronary Lesions

Abstract

; for the DELIVER Clinical Trial InvestigatorsBackground-Paclitaxel, a microtubule-stabilizing compound with potent antitumor activity, has been shown to inhibit smooth muscle cell proliferation and migration. The DELIVER trial was a prospective, randomized, blinded, multicenter clinical evaluation of the non-polymer-based paclitaxel-coated ACHIEVE stent compared with the stainless steel Multi-Link (ML) PENTA stent. Methods and Results-A total of 1043 patients with focal de novo coronary lesions, Ͻ25 mm in length, in 2.5-to 4.0-mm vessels were randomized (ACHIEVE nϭ524; ML PENTA nϭ519). Angiographic follow-up was performed in a subset of 442 patients (ACHIEVE nϭ228; ML PENTA nϭ214). Prespecified end points were a 40% reduction in target-vessel failure at 9 months (primary clinical end point) and a 50% reduction in binary restenosis at 8 months (major secondary end point). Baseline clinical characteristics were comparable between the groups. Patients in ACHIEVE had more type C lesions and a larger reference diameter. At follow-up, stent late loss was 0.81 versus 0.98 mm (Pϭ0.003), stent binary restenosis was 14.9% versus 20.6% (Pϭ0.076), and target-vessel failure was 11.9% versus 14.5% (Pϭ0.12) for ACHIEVE and ML PENTA, respectively. Conclusions-The ACHIEVE paclitaxel-coated stent decreased neointimal proliferation compared with the bare-metal PENTA stent; however, this reduction was insufficient to meet the prespecified primary end point of target-vessel failure and the secondary end point of binary restenosis.

The cell cycle: A critical therapeutic target to prevent vascular proliferative disease

“…As showed in the DELIVER I study (Cook Incorporated, USA; Guidant Corporation), highdose paclitaxel delivery through nonpolymer-based stents resulted in a significant inhibition of neointima proliferation; however, this reduction did not translate into a sufficient decrease of targeted vessel failure and ISR (Table 1) (133). The TAXUS program (Boston Scientific, USA) employs a polymer coating that provides biphasic drug release, with an initial burst of paclitaxel release in the first two days, followed by low-level release lasting for the next 10 days.…”

Effect of a novel drug-eluted balloon coated with Genistein before stent implantation in porcine coronary arteries

“…In coronary arteries, however, excessive formation of neointima has been successfully inhibited by the implantation of drug-eluting stents, providing a platform for sustained drug release, which is believed to be a precondition of successful restenosis inhibition (27). Their implementation in clinical practice has however disclosed unexpected long-term results due to the delay in healing accompanied by the risk of late stent thrombosis (28,29).…”

Clinical and Angiographic Outcomes After Multi-Link PENTA Stent Implantation in Japanese Patients With Coronary Artery Disease

“…1,2) The DELIVER trial using the ML PENTA stent reported good clinical and angiographic results; target vessel failure (death, Q-wave or non-Qwave myocardial infarction, target lesion revascularization) was 14.5% at 9 months and stent binary restenosis was 20.6% at 8 months. 1) In the present study, although 46 (54%) patients had diabetes mellitus and the ACC/AHA lesion characteristics of the stented lesion were all B2 or C, the rate of target lesion revascularization was 18.6% and the rate of cardiac events was 24.4% at 9 months. We previously reported on the angiographic restenosis rates of the Palmaz-Schatz (PS) stent (Cordis Corporation, Miami, Florida) and ACS ML stent (Guidant Corporation, Santa Clara, California).…”

“…1,2) The present study was designed to evaluate the clinical (9-month) and angiographic (6-month) results of the ML PENTA stent in complex coronary lesions (modified American College of Cardiology/American Heart Association (ACC/AHA) lesion type B2 or C) 3,4) and to determine independent factors correlated with target lesion revascularization.…”