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Dr. Takeshi Kimura,
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Takeshi Kimura (Japan)
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List of Authors: Kimura Takeshi, Igarashi Keiichi, Kadota Kazushige, Kozuma Ken, Tanabe Kengo, Morino Yoshihiro, Akasaka Takashi, Takatsu Yoshiki, Nishikawa Hideo, Yamamoto Yoshito, Nakagawa Yoshihisa, Hayashi Yasuhiko, Iwabuchi Masashi, Umeda Hisashi, Okada Hisayuki, Kimura Kazuo, Kawai Kazuya, Morimoto Takeshi
Backgrounds: Everolimus-eluting stent (EES) as compared with paclitaxel-eluting stent consistently demonstrated superior clinical outcomes in previous randomized controlled trials. Several recent randomized trials suggested similar one-year clinical outcomes between EES and sirolimus-eluting stent (SES). However, none of these trials was adequately powered to evaluate the efficacy outcomes after stent implantation such as target-lesion revascularization (TLR) or target-vessel revascularization (TVR). Methods: Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial (RESET) is a prospective randomized multicenter open label trial comparing EES with SES in daily clinical practice in Japan. Patients scheduled for percutaneous coronary intervention using drug-eluting stents were enrolled without any exclusion criteria. Randomization was performed at any time before attempt of stent implantation and was stratified by center, diabetes, and participation in the imaging sub-studies (angiography, intravascular ultrasound, optical coherence tomography, and coronary endothelial function). Primary efficacy endpoint was defined as any TLR. The trial was a sequential non-inferiority and superiority study, which was powered for non-inferiority on the primary efficacy endpoint at 1 year after the index procedure. With the assumption of 6.9% TLR rate based on the data from the j-Cypher registry, a total of 3000 patients would yield 95% power to detect non-inferiority at a level of one-sided type 1 error of 0.025 based on a non-inferiority margin of 3.4%. Primary safety endpoint was defined as a composite of death or myocardial infarction at 3 years after the index procedure. With the assumption of 12.2% event rate at 3 years, the study has 91% power to detect non-inferiority for the primary safety endpoint at a level of one-sided type 1 error of 0.025 based on a non-inferiority margin of 4.3%. Lesions treated at the index PCI procedure were regarded as the target lesions, while lesions treated at the scheduled staged procedures were not included in the target lesions. Adjudication of endpoint events by an independent clinical event committee and data analysis by a statistician was conducted in a blinded fashion regarding the assigned stent type. Clinical outcomes were analyzed according to intention-to-treat principle. Each endpoint was assessed by Kaplan-Meier estimates and compared by log-rank test. Effect of treatment was expressed by hazard ratio with 95% confidence interval and compared by Cox proportional hazard model. The angiographic core laboratory (Cardio Core, Tokyo, Japan) planned to analyze the angiograms at time of the index procedure in all study patients and those follow-up angiograms in patients enrolled in the angiographic sub-study and in patients who had TVR. Data entry was conducted by the clinical research coordinators in the participating centers or by the clinical research coordinators in the independent research organization (Research Institute for Production Development, Kyoto, Japan). Audit for the baseline data was conducted in 810 patients (25%) by the clinical research coordinators in the independent research organization. Results: Between February and July 2010, a total of 3206 patients were enrolled in the trial among 100 participating centers. Excluding 9 patients who withdrew consent, 3197 patients with 3927 lesions were randomly assigned to receive either EES (1597 patients with 1967 lesions) or SES (1600 patients with 1960 lesions). The study population included large proportions of patients with advanced age, diabetes, and prior PCI. However, mean SYNTAX scores were relatively low (EES: 11.3 ± 7.4, and SES: 11.1 ± 7.1, P=0.6), suggesting inclusion of patients with less complex coronary anatomy. The two groups of patients were well balanced in terms of baseline clinical, angiographic and procedural characteristics. EES was non-inferior to SES with respect to the primary clinical endpoint, which occurred in 4.3% and 5.0% of patients, respectively (P<0.0001 for non-inferiority, and P=0.34 for superiority). There were no significant between-group differences in the rate of death, myocardial infarction, clinically-driven TLR, TVR, and a composite of death or myocardial infarction. The rate of stent thrombosis (definite or probable) was very low in both groups (EES: 0.39%, and SES: 0.38%, P=1.0). Among the pre-specified subgroup analyses, EES as compared with SES was associated significantly lower rate of TLR in the subgroup of insulin-treated diabetes (EES [N=175]: 5.4%, and SES [N=163]: 12.3%, P=0.03). EES was also non-inferior to SES with respect to the primary angiographic endpoint (0.07±0.38 mm versus 0.03±0.46 mm, P<0.0001 for non-inferiority, and P=0.26 for superiority). Conclusions: In this large scale randomized controlled trial comparing EES with SES, EES was demonstrated to be non-inferior to SES with respect to TLR rate at 1 year and angiographic in-segment late loss at 8-12 months. One-year clinical outcome after both EES- and SES-use was excellent with low rate of TLR and very low rate of stent thrombosis. Longer-term follow-up is important to address whether EES could positively affect the late adverse events beyond 1 year reported after SES implantation such as late restenosis and very late stent thrombosis.
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