Hiremath M S
Department of Cardiology, Ruby Hall Clinic, Pune, India.
Indian Heart J. 2017 Nov-Dec;69(6):690-694. doi: 10.1016/j.ihj.2017.05.002. Epub 2017 Jun 23.
The study aims an observational registry of the long and extra-long length (>33mm) Pronova XR stents in patients with long coronary lesions (>30mm) in a prospective real world study.
Current study was conducted at Ruby Hall Clinic Pune, between July 2012 and July 2013 including 30 patients who underwent PTCA using long and extra-long Pronova XR stents. Among the stents used, one stent - 33mm, 2 stents - 38mm, 5 stents - 43mm and 25 stents were of 48mm in length. In particular average stent length for the study was 46.03mm and the average stent diameter was 3.09±0.41mm. For this study coronary angioplasty was performed using femoral approach and standard practice. Lesions were predilated using undersized balloons and study stent was deployed at pressure 7-26atm. (12.8±3.2atm.) The successful delivery of stent at the intended lesion with visual residual stenosis less than 50% was defined as Procedural success. Follow up studies were conducted for all the patients at 30days, 3 months and 6 months intervals. The predefined QCA parameters were calculated using Sanders Data System QCA plus software (Palo Alto, CA, USA). No procedural complication was observed during the whole study. 100% successful stent placement was achieved in all patients. Six months clinical follow-up was available for all patients. No adverse events (Acute closure, angina, REPCI, MI, death, sub acute stent thrombosis) or hospitalization was reported for any of the patients except one. The Quantative Coronary Core Lab analysis post 6 months showed well-flowing stent with average late lumen loss 0.10mm ±0.26.
In patients with long coronary lesions and very long length stent implantation series, Pronova XR showed excellent in 6 months results. This is for the first time reported that use of long length Pronova XR stents has shown so low restenosis rate and absent of mortality in six month period. These results offer a new opportunity to single long length stenting.
在一项前瞻性真实世界研究中，对长冠状动脉病变（>30mm）患者使用长及超长长度（>33mm）的普诺瓦XR支架进行观察性登记。
本研究于2012年7月至2013年7月在浦那鲁比霍尔诊所进行，纳入30例使用长及超长普诺瓦XR支架进行经皮冠状动脉腔内血管成形术（PTCA）的患者。在所使用的支架中，1枚支架长度为33mm，2枚为38mm，5枚为43mm，25枚为48mm。该研究中支架平均长度为46.03mm，平均支架直径为3.09±0.41mm。本研究采用股动脉途径及标准操作进行冠状动脉血管成形术。病变使用小号球囊进行预扩张，研究支架在7 - 26个大气压（12.8±3.2个大气压）下展开。支架在预期病变处成功释放且可视残余狭窄小于50%被定义为手术成功。对所有患者分别在30天、3个月和6个月时进行随访研究。使用桑德斯数据系统QCA plus软件（美国加利福尼亚州帕洛阿尔托）计算预定义的定量冠状动脉造影（QCA）参数。在整个研究过程中未观察到手术并发症。所有患者支架置入均100%成功。所有患者均进行了6个月的临床随访。除1例患者外，未报告任何患者出现不良事件（急性闭塞、心绞痛、再次经皮冠状动脉介入治疗、心肌梗死、死亡、亚急性支架血栓形成）或住院情况。6个月后的定量冠状动脉核心实验室分析显示支架血流良好，平均晚期管腔丢失为0.10mm±0.26。
在长冠状动脉病变及超长长度支架植入系列患者中，普诺瓦XR支架在6个月时显示出优异结果。首次报道使用长长度普诺瓦XR支架在6个月期间显示出如此低的再狭窄率且无死亡病例。这些结果为单长长度支架置入提供了新机会。
