Aoki Jiro, Kozuma Ken, Awata Masaki, Nanasato Mamoru, Shiode Nobuo, Tanabe Kengo, Yamaguchi Junichi, Kusano Hajime, Nie Hong, Kimura Takeshi
Division of Cardiology, Mitsui Memorial Hospital, 1 Kanda-Izumicho, Chiyoda-ku, Tokyo, 101-8643, Japan.
Department of Cardiology, Teikyo University Hospital, Tokyo, Japan.
Cardiovasc Interv Ther. 2019 Jan;34(1):40-46. doi: 10.1007/s12928-018-0515-z. Epub 2018 Feb 26.
The Cobalt Chromium Everolimus-Eluting Stent (CoCr-EES) Post Marketing Surveillance (PMS) Japan study is a prospective multicenter registry designed to evaluate the safety and efficacy of XIENCE V/PROMUS everolimus-eluting stents in routine clinical practice at 47 centers representative of the clinical environment in Japan. We enrolled 2010 consecutive patients (2649 lesions) who underwent percutaneous coronary intervention using CoCr-EES. Clinical outcomes were evaluated through 5 years. Mean age was 68.8 years, 41.9% had diabetes, 4.9% received hemodialysis. Five-year clinical follow up was available for 1704 (84.8%) patients. Major adverse cardiovascular events (MACE) occurred in 10.7% of patients, including cardiac death (3.8%), myocardial infarction (1.8%), and clinically driven target lesion revascularization (TLR) (6.0%). Beyond 1 year, annual incidence of clinically driven TLR was 0.5-0.8%. Definite or probable stent thrombosis occurred in 9 (0.5%) patients at 5 years. After 1 year, definite stent thrombosis occurred in only 1 patient. Significant predictors for MACE were dialysis (ODDs ratio 4.58, 95% CI 2.75-7.64), prior cardiac intervention (ODDs ratio 2.47, 95% CI 1.75-3.49), total stent length (ODDs ratio 1.01, 95% CI 1.01-1.02), and number of diseased vessels (ODDs ratio 1.66, 95% CI 1.08-2.55). Five-year clinical outcomes from the CoCr-EES PMS Japan study demonstrated a low incidence of clinical events in the daily practice up to 5 years.Clinical Trial Registration Information: https://clinicaltrials.gov/ct2/show/NCT01086228 .
钴铬依维莫司洗脱支架（CoCr-EES）上市后监测（PMS）日本研究是一项前瞻性多中心注册研究，旨在评估Xience V/PROMUS依维莫司洗脱支架在日本47个代表临床环境的中心的常规临床实践中的安全性和有效性。我们连续纳入了2010例接受CoCr-EES经皮冠状动脉介入治疗的患者（2649处病变）。对临床结局进行了5年的评估。平均年龄为68.8岁，41.9%患有糖尿病，4.9%接受血液透析。1704例（84.8%）患者获得了5年的临床随访。10.7%的患者发生了主要不良心血管事件（MACE），包括心源性死亡（3.8%）、心肌梗死（1.8%）和临床驱动的靶病变血运重建（TLR）（6.0%）。1年以后，临床驱动的TLR年发生率为0.5%-0.8%。5年时9例（0.5%）患者发生了明确或可能的支架血栓形成。1年以后，仅1例患者发生了明确的支架血栓形成。MACE的显著预测因素为透析（比值比4.58，95%置信区间2.75-7.64）、既往心脏介入治疗（比值比2.47，95%置信区间1.75-3.49）、支架总长度（比值比1.01，95%置信区间1.01-1.02）和病变血管数量（比值比1.66，95%置信区间1.08-2.55）。CoCr-EES PMS日本研究的5年临床结局表明，在长达5年的日常实践中临床事件发生率较低。临床试验注册信息：https://clinicaltrials.gov/ct2/show/NCT01086228 。
