无保护左主干病变支架置入术预后及影响因素的分析——中国无保护左主干病变支架置入术注册(CHANCE)研究

The immediate and long-term prognosis following unprotected left main coronary artery stenting in Chinese——Chinese Registry of Unprotected Left Main Coronary Artery Stenting(CHANCE Study)

目的评价无保护左主干(LMCA)病变支架置入术后的即刻及长期预后,并探讨影响预后的因素.方法本研究为多中心注册研究,对国内23家医院在1997年5月至2003年3月间完成的连续择期无保护LMCA病变裸金属支架置入术的患者进行注册登记,全部患者均填写固定表格.结果共224例患者进行了注册,年龄22～88岁,平均(60.1±12.0)岁.有既往心肌梗死史患者53例(23.7%),合并糖尿病45例(20.1%).孤立性无保护LMCA126例(56.2%),LMCA合并其他血管病变98例(43.8%).平均左室射血分数(63.9±12.3)%. 223例(99.6%)LMCA病变支架置入术成功,91例(92.9%)非LMCA病变支架置入术成功.住院期间死亡1例(0.45%),非Q波心肌梗死(MI)1例(0.4%).平均随访(15.6±12.3)个月,死亡12例(5.4%),其中心原性死亡10例(4.5%),非心原性死亡2例(0.9%),急性MI 4例(1.8%), LMCA 靶病变血管重建术26例(11.7%),累积主要心脏不良事件(MACE)36例(16.1%).左室射血分数<40%、女性和LMCA合并多支血管病变增加死亡危险,多支病变非完全血管重建增加MACE发生率;多因素回归分析显示:左室射血分数<40%和女性为预测死亡和MACE的独立危险因素.102例(45.7%)患者进行了造影复查,LMCA 再狭窄32例(31.4%).术中有回旋支开口部受累者再狭窄率增加.结论经过选择的无保护LMCA病变支架置入术是可行和安全的,并可取得较好近、远期疗效.目前,无保护LMCA支架置入术应选择孤立性LMCA病变或合并多支病变但能达到完全性血管重建、左室射血分数≥40%的患者或不能行冠状动脉旁路移植术的患者.

Objective To evaluate the immediate and long term outcomes of unprotected left main coronary artery (LMCA) stenting in Chinese patients and to approach the factors affecting the outcomes Methods This was a multicenter retrospective registry study From May 1997 to March 2003 all patients in 23 hospitals undergone elective unprotected LMCA stenting with bare metal stents were enrolled into the registry All patients enrolled were filled in a Case Report Form Results 224 patients were enrolled into the registry, including 166 male (74 1%) and 58 female (25 9%), with mean age of 60 1±12 0 (22 88) years There were 53 cases (23 7%) with prior myocardial infarction (MI) and 45 cases (20 1%) with diabetes mellitus Isolated LMCA stenosis was in 126 cases (56 2%) and combined with multivessel disease in 98 cases (43 8%) Mean left ventricular EF was 63 9%±12 3% Stents were successfully implanted into LMCA in 223 cases (99 6%) and into non LMCA in 91 cases (92 9%) In hospital death developed in 1 case (0 45%), now Q wave MI in 1 case (0 45%) The patients were followed up to 15 6±12 3 months Death developed in 12 cases (5 4%), including cardiac death in 10 cases (4 5%) and non cardiac death in 2 cases (0 9%), MI in 4 cases (1 8%), TLR of LMCA in 26 cases (11 7%)and accumulated MACE in 36 cases (16 1%) LVEF<40%, female and LMCA combined with multivessel disease increased mortality, combined multivessel diseases with incomplete revascularization increased MACE Logistic regression analysis revealed that LVEF<40% and female were independent predictors of cardiac death and MACE Follow up angiography was performed in 102 cases (45 7%) The binary restenosis rate was 31 4% (in 32 cases) Conclusion Stenting for selected patients with unprotected LMCA stenosis is feasible and safe Currently, unprotected LMCA stenting should be performed in patients with LVEF≥40% and isolated LMCA disease or LMCA combined with multivessel diseases in whom complete revascularization could be obtained or inoperable patients