Dani Sameer, Shah Dinesh, Sojitra Prakash, Parikh Keyur, Shetty Ranjan, di Palma Gaetano, Cortese Bernardo
Life Care Institute of Medical Sciences, Ahmedabad, India.
Beaumont Hospital, Royal Oak, MI, USA.
Cardiovasc Revasc Med. 2019 Mar;20(3):235-240. doi: 10.1016/j.carrev.2018.06.003. Epub 2018 Jun 28.
The aim of the Nanoluté registry was to observe the clinical performance of a novel sirolimus coated balloon (SCB) (Concept Medical Research Private Limited, India) for the treatment of coronary de-novo and restenotic lesions.
All patients treated with SCB between July 2012 and September 2015 were enrolled at Indian centres and clinically followed for 1, 3, 6 and 12 months post-procedure. Primary endpoints were procedural success and device-oriented adverse cardiac events (DOCE) at 12 months. DOCE were defined as a composite of cardiac death, target lesion revascularization (TLR) and target vessel-myocardial infarction.
A total of 394 SCB were used in 332 patients to treat 356 lesions. In-stent restenosis and small coronary vessel disease occurred in 46% and 43% of the patients respectively. Mean balloon length and diameter (average ± SD) were 21.83 ± 6.70 mm and 2.69 ± 0.45 mm respectively. All patients with 1 year follow-up were included. Overall DOCE rate was 4.2% (n = 14) which included death 0.3% (n = 1), TLR 3.6% (n = 12) and myocardial infarction 0.3% (n = 1).
The Nanoluté prospective registry, is the first clinical evidence of the safety and feasibility of this type of SCB, both in patients with in-stent restenosis or de novo lesions.
Nanoluté注册研究的目的是观察一种新型西罗莫司涂层球囊（SCB）（印度Concept Medical Research Private Limited公司）治疗冠状动脉初发和再狭窄病变的临床性能。
2012年7月至2015年9月期间接受SCB治疗的所有患者均在印度各中心入组，并在术后1、3、6和12个月进行临床随访。主要终点为术后12个月时的手术成功率和器械相关不良心脏事件（DOCE）。DOCE定义为心源性死亡、靶病变血运重建（TLR）和靶血管心肌梗死的复合事件。
332例患者共使用394个SCB治疗356处病变。分别有46%和43%的患者发生支架内再狭窄和小冠状动脉病变。球囊平均长度和直径（平均值±标准差）分别为21.83±6.70mm和2.69±0.45mm。纳入所有随访1年的患者。总体DOCE发生率为4.2%（n = 14），包括死亡0.3%（n = 1）、TLR 3.6%（n = 12）和心肌梗死0.3%（n = 1）。
Nanoluté前瞻性注册研究是此类SCB在支架内再狭窄或初发病变患者中安全性和可行性的首个临床证据。
