The clinical evaluation of the Endeavor zotarolimus-eluting coronary stent in Japanese patients with de novo native coronary artery lesions: primary results and 3-year follow-up of the Endeavor Japan study.

Background: Angiographic and clinical outcomes associated with coronary stents eluting the new molecular entity zotarolimus have been well characterized in a variety of geographies and patient subsets. The Endeavor Japan study is the first prospective clinical trial to evaluate the safety and efficacy of the Endeavor zotarolimus-eluting stent (ZES) in the treatment of Japanese patients with single de novo lesions in native coronary arteries.

Methods And Materials: This nonrandomized, prospective, multicenter, single-arm trial of 99 subjects with inclusion criteria (elective percutaneous revascularization of single native de novo coronary artery lesions with length ≥14 and ≤27 mm with reference vessel diameters between 2.

First-in-human study of the Endeavor ABT-578-eluting phosphorylcholine-encapsulated stent system in de novo native coronary artery lesions: Endeavor I Trial.

Aims: The Endeavor I study was the first clinical study evaluating the safety and feasibility of the Endeavor stent system in the treatment of symptomatic coronary artery disease. The Endeavor Stent System comprises a new cytostatic, antiproliferative and immunosuppressive agent in the same class of drugs as sirolimus, (ABT-578), a phosphorylcholine polymer-based coating, and an established cobalt-alloy stent with thin struts, (Driver stent).

Methods And Results: One hundred consecutive patients with symptomatic ischemic heart disease due to de novo, obstructive lesions of native coronary arteries were treated with the Endeavor stent system at eight centers in Australia and New Zealand according to contemporary practice.

Comparison of rotational atherectomy with conventional balloon angioplasty in the prevention of restenosis of small coronary arteries: results of the Dilatation vs Ablation Revascularization Trial Targeting Restenosis (DART).

Background: The optimum treatment of obstructive coronary disease in small (<3.0 mm diameter) arteries remains unknown. Rotational atherectomy is an approved treatment that might reduce the vascular injury during percutaneous coronary intervention compared with angioplasty.

Cutting balloon angioplasty for the prevention of restenosis: results of the Cutting Balloon Global Randomized Trial.

The cutting balloon (CB) is a specialized device designed to create discrete longitudinal incisions in the atherosclerotic target coronary segment during balloon inflation. Such controlled dilatation theoretically reduces the force needed to dilate an obstructive lesion compared with standard percutaneous transluminal coronary angioplasty (PTCA). We report a multicenter, randomized trial comparing the incidence of restenosis after CB angioplasty versus conventional balloon angioplasty in 1,238 patients.

Long-term outcome of patients treated with repeat percutaneous coronary intervention after failure of gamma-brachytherapy for the treatment of in-stent restenosis.

Background: Although (192)Ir intracoronary brachytherapy has been demonstrated to dramatically reduce the recurrence of in-stent restenosis, up to 24% of these patients will still require repeat target-vessel revascularization. The short- and long-term outcomes of repeat percutaneous intervention in this population have not been characterized.

Methods And Results: Analysis was performed of all patients enrolled in the GAMMA-I and GAMMA-II brachytherapy trials who underwent repeat percutaneous target lesion revascularization (TLR) because of restenosis.