比较经皮冠状动脉介入治疗中不同出血风险谱的比伐卢定与桡动脉入路：来自全国心血管数据注册的分析。
Comparison of bivalirudin and radial access across a spectrum of preprocedural risk of bleeding in percutaneous coronary intervention: analysis from the national cardiovascular data registry.
机构信息
Division of Cardiology, Saint-Lukes Mid America Heart Institute, Kansas City, MO, USA.
出版信息
Circ Cardiovasc Interv. 2013 Aug;6(4):347-53. doi: 10.1161/CIRCINTERVENTIONS.113.000279. Epub 2013 Aug 6.
BACKGROUND
Bleeding is a common, noncardiac, preventable complication of percutaneous coronary intervention. We compared the relative safety of radial access and bivalirudin in percutaneous coronary intervention.
METHODS AND RESULTS
From CathPCI Registry, we determined the association between the site of arterial access, bivalirudin, and periprocedural bleeding rates in 501 017 patients. Radial access patients receiving heparin (radial group) were compared with those receiving bivalirudin (radial combination group). Femoral access patients who had bivalirudin and a vascular closure device served as a reference group (femoral group). An inverse probability weighting analysis incorporating propensity scores was used to compare groups. The overall rate of bleeding was 2.59%. It was 2.71% in the femoral group, 2.5% in the radial group, and 1.82% in the radial combination groups (P<0.001). When compared with femoral group, the adjusted odds ratio for bleeding was significantly lower for patients with radial combination group (odds ratio, 0.79; 95% confidence interval, 0.72-0.86), but not for radial group (odds ratio, 0.96; 95% confidence interval, 0.88-1.05), unless patients treated with IIb/IIIa were excluded (radial group-IIb/IIIa odds ratio, 0.84; 95% confidence interval, 0.75-0.94).The number needed to treat to prevent 1 bleeding event with radial combination group was 138, whereas the number needed to treat to prevent 1 bleeding event in high-bleeding risk patients was 68.
CONCLUSIONS
In this observational analysis, the combination of bivalirudin and radial access was associated with reduced bleeding event rate. This benefit was present across the entire spectrum of preprocedural risk of bleeding, with or without exposure to IIb/IIIa inhibitors. These data support an adequately powered randomized trial comparing bleeding avoidance strategies.
背景
出血是经皮冠状动脉介入治疗中常见的非心脏、可预防的并发症。我们比较了经桡动脉入路和比伐卢定在经皮冠状动脉介入治疗中的相对安全性。
方法和结果
我们从 CathPCI 注册研究中确定了 501017 例患者的动脉入路部位、比伐卢定与围术期出血率之间的关联。接受肝素的经桡动脉入路患者（桡动脉组）与接受比伐卢定的患者（桡动脉联合组）进行比较。接受比伐卢定和血管闭合装置的股动脉入路患者作为参考组（股动脉组）。采用倾向评分逆概率加权分析比较各组。总的出血率为 2.59%。股动脉组为 2.71%，桡动脉组为 2.5%，桡动脉联合组为 1.82%（P<0.001）。与股动脉组相比，桡动脉联合组出血的调整比值比显著降低（比值比，0.79；95%置信区间，0.72-0.86），但桡动脉组无显著差异（比值比，0.96；95%置信区间，0.88-1.05），除非排除使用 IIb/IIIa 抑制剂的患者（桡动脉组-使用 IIb/IIIa 抑制剂的比值比，0.84；95%置信区间，0.75-0.94）。使用桡动脉联合组预防 1 例出血事件的需要治疗人数为 138，而预防高出血风险患者 1 例出血事件的需要治疗人数为 68。
结论
在这项观察性分析中，比伐卢定联合经桡动脉入路与降低出血事件发生率相关。这种益处存在于整个出血风险的前谱中，无论是否使用 IIb/IIIa 抑制剂。这些数据支持进行一项比较出血避免策略的充分随机试验。
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