No abstract

A new vascular hemostasis device can significantly reduce the puncture site hemostasis time and the time to ambulation without significantly increasing the risk of peripheral vascular complications. The role of this technology in reducing complications, length of hospital stay and cost remains to be determined.

; 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.