Suzuki Kenichiro, Ishikawa Tetsuya, Mutoh Makoto, Sakamoto Hiroshi, Mori Chikara, Ogawa Takayuki, Hashimoto Koichi, Kubota Takeyuki, Komukai Kimiaki, Yoshimura Michihiro
Division of Cardiology, Department of Internal Medicine, The Jikei University Kashiwa Hospital.
Division of Cardiology, Saitama Cardiovascular Respiratory Center.
Int Heart J. 2017 May 31;58(3):320-327. doi: 10.1536/ihj.16-360. Epub 2017 May 8.
We conducted propensity-score matched comparisons of midterm angiographic outcomes of sirolimus (SES) versus either everolimus- (EES) or biolimus- (BES) eluting stents after placements for coronary stenosis in a daily practice environment since previous randomized trials did not demonstrate the superiority of EES and BES over SES in terms of midterm angiographic outcomes.The present study was a non-randomized, retrospective, and lesion-based study, recruiting angiographically followed-up lesions within 550 days after successful and elective SES (n = 1793), EES (n = 1303), or BES (n = 324) placement for de novo native coronary stenosis during the period from August 2004 to January 2014 at 6 institutes. The endpoint, as an angiographic surrogate marker of clinical efficacy, was the distribution of in-stent follow-up percent diameter stenosis (%DS) which comprised the percentages of 1) follow-up %DS < 20 and 2) follow-up %DS > 50. Propensityscore matched analyses were conducted to adjust 21 baselines.In 1215 baseline adjusted lesions, the endpoints in the EES group [1) 74.1%, and 2) 4.6%] were significantly different from those in the SES group [57.9%; P < 0.001, 7.2%; P = 0.006, respectively). In 307 baseline adjusted lesions, the endpoints in the BES group [1) 80.5%, 2) 2.0%] were significantly different from those in the SES group [59.3%; P < 0.001, 2) 8.1%; P = 0.001, respectively].The present study is the first to confirm the superiority of midterm angiographic outcomes after the placement of EES and BES over SES for de novo coronary stenosis in a clinical setting.
由于先前的随机试验未在中期血管造影结果方面证明依维莫司洗脱支架（EES）和生物可吸收涂层依维莫司洗脱支架（BES）优于西罗莫司洗脱支架（SES），我们在日常临床实践环境中，对冠状动脉狭窄置入支架后，西罗莫司洗脱支架（SES）与依维莫司洗脱支架（EES）或生物可吸收涂层依维莫司洗脱支架（BES）的中期血管造影结果进行了倾向评分匹配比较。本研究为非随机、回顾性、基于病变的研究，于2004年8月至2014年1月期间，在6家机构招募了成功选择性置入SES（n = 1793）、EES（n = 1303）或BES（n = 324）治疗原发性冠状动脉狭窄后550天内进行血管造影随访的病变。作为临床疗效的血管造影替代标志物，终点指标是支架内随访直径狭窄百分比（%DS）的分布，包括1）随访%DS < 20和2）随访%DS > 50的百分比。进行倾向评分匹配分析以调整21个基线。在1215个基线调整后的病变中，EES组的终点指标[1）74.1%，2）4.6%]与SES组[57.9%；P < 0.001，7.2%；P = 0.006]有显著差异。在307个基线调整后的病变中，BES组的终点指标[1）80.5%，2）2.0%]与SES组[59.3%；P < 0.001，2）8.1%；P = 0.001]有显著差异。本研究首次证实在临床环境中，对于原发性冠状动脉狭窄，置入EES和BES后的中期血管造影结果优于SES。
