Cardiovascular revascularization medicine : including molecular interventions · 2011
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.
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Saito Shigeru, Prpic Ross, Popma Jeffery J, Alexander John, Krucoff Mitchell W, ENDEAVOR Japan Investigators
Аннотация
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 2.25 and 3.5 mm) selected to enhance statistical comparability to the ENDEAVOR II randomized study as historical control. The primary end point was target vessel failure (TVF) at 9 months.
RESULTS: At 9 months, the TVF rate was 5.2%, compared with 7.9% in the ZES arm of ENDEAVOR II (P=.412). Notable baseline differences between the Endeavor Japan and ENDEAVOR II populations were mean age (68.2 vs. 61.6 years; P<.001), diabetes (38.4% vs. 18.2%; P<.001), and unstable angina (4.6% vs. 30.3%; P<.001). Despite cohort differences, acute, 9-month, and 3-year clinical outcomes were similar in the two groups, as were 8-month angiographic indices. Finally, out to 3 years, no stent thrombosis was observed in Japanese subjects.
CONCLUSIONS: These findings demonstrate that, in a Japanese population, the Endeavor ZES has similar safety and efficacy compared with other geographies, with sustained clinical benefit and safety to 3 years.
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 2.25 and 3.5 mm) selected to enhance statistical comparability to the ENDEAVOR II randomized study as historical control. The primary end point was target vessel failure (TVF) at 9 months.
RESULTS: At 9 months, the TVF rate was 5.2%, compared with 7.9% in the ZES arm of ENDEAVOR II (P=.412). Notable baseline differences between the Endeavor Japan and ENDEAVOR II populations were mean age (68.2 vs. 61.6 years; P<.001), diabetes (38.4% vs. 18.2%; P<.001), and unstable angina (4.6% vs. 30.3%; P<.001). Despite cohort differences, acute, 9-month, and 3-year clinical outcomes were similar in the two groups, as were 8-month angiographic indices. Finally, out to 3 years, no stent thrombosis was observed in Japanese subjects.
CONCLUSIONS: These findings demonstrate that, in a Japanese population, the Endeavor ZES has similar safety and efficacy compared with other geographies, with sustained clinical benefit and safety to 3 years.