旋磨非标签适应证对冠状动脉斑块旋磨术安全性的影响

Effects of application of coronary rotational atherectomy in off-label leisons on clinical outcomes and safety

目的评价旋磨非标签适应证对冠状动脉斑块旋磨术(CRA)疗效及安全性的影响。方法连续入选2011年11月至2015年7月在南京鼓楼医院行CRA的患者共94例。非标签适应证包括无保护左主干、严重三支病变、严重左心室功能不全、急性心肌梗死、长病变(>25 mm)及成角病变(≥45°)。具有1个以上非标签适应证的患者为非标签组(75例),无上述特征患者为标签组(19例)。观察两组患者手术成功率和院内主要不良心血管事件(MACE,包括心原性死亡、介入相关心肌梗死和靶血管再次血运重建),多因素回归分析院内MACE的危险因素。结果非标签组慢血流发生率显著高于标签组(20.0%比0,P=0.036),介入相关心肌梗死发生率也显著升高(26.7%比0,P=0.005)。多因素回归分析显示成角病变和靶血管支架总长度与院内MACE呈正相关。结论与标签组相比,非标签组慢血流和介入相关心肌梗死发生率显著升高,而成角病变(≥45°)及置入支架总长度是发生院内MACE的独立危险因素。

Objective To assess the safety and effectiveness of coronary rotational atherectomy （CRA） in patients with off-label indicated leisons. Methods From November 2011 to July 2015, 94 consecutive patients with heavily calcified coronary lesions who underwent CRA in Nanjing Drum Tower Hospital were enrolled in this retrospectively study. Off-label indicated leisons included unprotected left main stenosis, 3-vessel disease, severe left ventricular dysfunction, acute myocardial infarction （MI）, long lesion （ 〉 25 mm） , or angulated lesion （ ≥ 45°） . Patients who had more than one of the above leisons were assigned to the off-label group （75 patients）, and patients without these leisons were assigned to the on-label group （19 patients） . Procedure parameters, complications and in-hospital major adverse cardiovascular events （MACE, including cardiac death, non-fatal myocardial infarction, percutanous coronary intervention （PCI） related MI, target vessel revascularization） were analyzed. Results Occurrence of slow flow or PCI related MI in the off-label group was higher than that in the on-label group （ slow flow 20. 0% vs. O, P = 0. 036; PCI related MI 26. 7% vs. O, P =0. 005 ） . Multivariate logistic regression analysis indicated that acute angulated lesion and longer stents implanted in target vessel were positively related to the in-hospital MACEs. Conclusions Application of CRA in off-label leisons had a higher incidence of slow flow and PCI related MI. Acute angulated lesion and longer stents implanted in target vessel were positively related to the in-hospital MACEs.