Objective: To explore the value of SYNTAX revascularization index (SRI) on evaluating the long-term prognosis of coronary artery disease (CAD) patients implanted with biodegradable polymer drug-eluting stents (BP-DES) and define the best threshold of SRI for predicting all-cause mortality in these patients. Methods: Data used in this study derived from the I-LOVE-IT 2 trial (evaluate safety and effectiveness of the Tivoli DES and the Firebird DES for treatment of coronary). I-LOVE-IT 2 trial was a prospective, multicenter, randomized, assessor-blinded, non-inferiority study. A total of 1 829 patients implanted with BP-DES were divided into 3 groups, namely SRI=100% group (n=963), 50%≤SRI<100% group (n=527) and SRI<50% group (n=339). The primary endpoint was 48-month patient-oriented composite endpoint (PoCE), a composite of all-cause mortality, myocardial infarction(MI), stroke, and/or any revascularization. The secondary endpoints were components of PoCE and definite/probable stent thrombosis at 48 months. The receiver operating characteristic curve was used to investigate the best cut-off point of SRI for 48-month all-cause mortality. The Cox regression analysis was used to identify independent predictors of the all-cause death and PoCE at 48 months. Results: Incidence of PoCE at 48 months was significantly lower in SRI=100% group than patients with 50%≤SRI<100%(17.34% (167/963) vs. 22.20% (117/527), P<0.05) and SRI<50% (17.34% (167/963) vs. 24.78% (84/339), P<0.05). Comparing with SRI=100% group, the patients with 50%≤SRI<100% suffered higher rates of all MI (7.78% (41/527) vs. 4.26% (41/963), P<0.05) and target vessel MI (6.45% (34/527) vs. 4.26% (41/963), P<0.05); patients with SRI<50% had higher rates of all-cause mortality (5.90% (20/339) vs. 3.12% (30/963), P<0.05) and any revascularization (14.16% (48/339) vs. 3.12% (30/963), P<0.05). The receiver operating characteristic curve analysis showed that the SRI=65% was the best cut-off point to predict the all-cause mortality at 48 months (area under the curve was 0.58, sensitive was 0.47, specificity was 0.70). Meanwhile, SRI<65% was an independent predictor of 48-month all-cause mortality (HR=2.06, 95%CI 1.25-3.38) and PoCE (HR=1.34, 95%CI 1.09-1.66). Conclusions: SRI serves as a good index for predicting long-term prognosis and SRI<65% is an independent predictor of 48-month PoCE and all-cause mortality for CAD patients with BP-DES implantation. Meanwhile, SRI≥65% might be a reasonable threshold of incomplete revascularization.
目的： 探究基于SYNTAX血运重建指数（SRI）进行危险分层、置入生物可降解涂层药物洗脱支架（BP-DES）的冠心病患者的长期临床预后，并探究SRI预测该类患者全因死亡的最佳界值。 方法： 研究对象来自I-LOVE-IT 2研究，I-LOVE-IT 2研究是一项前瞻性、多中心、随机对照、对评价者设盲的非劣效性研究。本研究选取I-LOVE-IT 2研究中置入BP-DES的冠心病患者1 829例，计算纳入患者的SRI值，依据SRI水平将患者分为3组：SRI=100%组（963例）、50%≤SRI<100%组（527例）和SRI<50%组（339例）。置入支架后对患者进行随访，主要终点为48个月患者源性复合终点（PoCE），即包含全因死亡、心肌梗死、缺血性卒中和/或任何血运重建的复合终点；次要终点为48个月PoCE的各组成成分，以及肯定或可能的支架内血栓。使用受试者工作特征（ROC）曲线确定SRI预测48个月全因死亡的最佳界值，并采用多因素Cox回归模型验证该界值是否为48个月全因死亡和PoCE事件的独立危险因素。 结果： SRI=100%组患者的PoCE事件发生率低于50%≤SRI<100%组[17.34%（167/963）比22.20%（117/527），P<0.05]和SRI<50%组[17.34%（167/963）比24.78%（84/339），P<0.05]。与SRI=100%组比较，50%≤SRI<100%组患者全部的心肌梗死和靶血管心肌梗死事件发生率较高[分别为7.78%（41/527）比4.26%（41/963），P<0.05；6.45%（34/527）比4.26%（41/963），P<0.05]；SRI<50%组患者的全因死亡和任何的血运重建发生率较高[分别为5.90%（20/339）比3.12%（30/963），P<0.05；14.16%（48/339）比3.12%（30/963），P<0.05]。ROC曲线显示预测48个月全因死亡的SRI的最佳界值为65%（ROC曲线下面积为0.58，敏感度0.47，特异度0.70）。多因素Cox回归分析结果显示SRI<65%是48个月全因死亡（HR=2.06，95%CI 1.25~3.38）和PoCE事件（HR=1.34，95%CI 1.09~1.66）的独立危险因素。 结论： 在预测置入BP-DES的冠心病患者长期的临床预后上，SRI具有较好的区分度，SRI<65%是48个月PoCE和全因死亡的独立危险因素。对于置入BP-DES的冠心病患者，SRI≥65%可能是一个合理的不完全血运重建的界值。.
Keywords: Biodegradable polymer drug-eluting stents; Coronary artery disease; Percutaneous coronary intervention; SYNTAX revascularization index.