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目的探讨药物洗脱支架(DES)置入术后12个月患者出血事件发生的独立危险因素,并分析出血对患者预后的影响。方法选取由沈阳军区总医院牵头,全国32家中心共同参研的一项前瞻性、单盲、随机对照临床研究(I-LOVE-IT2)中置入DES的2 737例患者,进行1年电话随访,观察DES置入术后1年内出血事件的发生情况,采用多因素COX比例风险回归模型,探索出血事件的独立预测因素,分析出血事件的发生对患者预后的影响。结果本组2 737例患者,电话随访1年,6.10%(167/2 737)患者发生出血事件(BARC 1~5型)。多因素COX比例风险回归模型分析结果显示,女性(HR=1.77,95%可信区间1.21~2.62,P<0.01)、既往心肌梗死或行经皮冠状动脉介入治疗术(HR=1.98,95%可信区间1.42~2.76,P<0.01)和围术期应用抗凝药(HR=1.70,95%可信区间1.22~2.37,P<0.01)为DES置入术后1年出血事件发生的独立预测因素。与未出血患者比较,出血患者主要不良心脑血管事件(MACCE)及全因死亡的风险明显增高,差异均有统计学意义(P<0.01)。结论 DES置入术后1年出血事件并不少见,且与全因死亡及MACCE增加相关,早期应识别出血的危险因素并采取相应的应对措施,以减少出血事件的发生,改善患者预后。
Objective To investigate the independent risk factors of bleeding in patients after drug-eluting stent (DES) implantation at 12 months and analyze the influence of bleeding on the prognosis of patients. Methods A total of 2 737 patients with DES who were led by the General Hospital of Shenyang Military Region and 32 centers nationwide were enrolled in a prospective, single-blind, randomized controlled clinical study (I-LOVE-IT2) Follow-up was performed to observe the incidence of bleeding within 1 year after DES implantation. Multivariate COX proportional hazards regression model was used to explore the independent predictors of bleeding events and analyze the impact of bleeding events on the prognosis of patients. Results A total of 2 737 patients in this group were followed up for 1 year by phone and had bleeding events (BARC type 1 ~ 5) in 6.10% (167/2 737) patients. Multivariate COX proportional hazards regression model analysis showed that women (HR = 1.77, 95% confidence interval 1.21-2.62, P <0.01), previous myocardial infarction or percutaneous coronary intervention (HR = 1.98, 95% (Range, 1.42-2.76, P <0.01), and perioperative anticoagulation (HR = 1.70, 95% confidence interval 1.22-2.37, P <0.01) were independent predictors of bleeding at 1 year after DES insertion factor. Compared with non-hemorrhagic patients, the risk of major adverse cardiovascular and cerebrovascular events (MACCE) and all-cause mortality in patients with hemorrhage was significantly higher (P <0.01). CONCLUSIONS: Bleeding events at 1 year after DES implantation are not uncommon and are associated with all-cause mortality and MACCE increase. Risk factors of hemorrhage should be identified early and corresponding measures should be taken to reduce the incidence of bleeding and improve prognosis.