University Paris-Descartes; AP-HP; European Georges Pompidou Hospital, Departments of Cardiology and Cardiac Surgery, Paris, France; University Hospital of Rouen, Hospital Charles Nicolle, Departments of Cardiology and Thoracic and Cardiovascular Surgery, INSERM UMR 1096, Rouen, France.
University Paris-Descartes; AP-HP; European Georges Pompidou Hospital, Departments of Cardiology and Cardiac Surgery, Paris, France; Clinique Saint Gatien, Departments of Cardiology and Cardiac Surgery, Tours, France.
Am J Cardiol. 2014 Jan 15;113(2):355-60. doi: 10.1016/j.amjcard.2013.09.033. Epub 2013 Oct 5.
Dual antiplatelet therapy is commonly used in patients undergoing transcatheter aortic valve implantation (TAVI), but the optimal antiplatelet regimen is uncertain and remains to be determined. The objective of this study was to compare 2 strategies of antiplatelet therapy in patients undergoing TAVI. A strategy using monoantiplatelet therapy (group A, n = 164) was prospectively compared with a strategy using dual antiplatelet therapy (group B, n = 128) in 292 consecutive patients undergoing TAVI. The primary end point was a combination of mortality, major stroke, life-threatening bleeding (LTB), myocardial infarction, and major vascular complications at 30 days. All adverse events were adjudicated according to the Valve Academic Research Consortium. The primary end point occurred in 22 patients (13.4%) in the group A and in 30 patients (23.4%) in the group B (hazard ratio 0.51, 95% confidence interval 0.28 to 0.94, p = 0.026). LTB (3.7% vs 12.5%, p = 0.005) and major bleedings (2.4% vs 13.3%, p <0.0001) occurred less frequently in the group A, whereas the incidence of stroke (1.2% vs 4.7%, p = 0.14) and myocardial infarction (1.2% vs 0.8%, p = 1.0) was not significantly different between the 2 groups. The benefit of a strategy using mono versus dual antiplatelet therapy persisted after multivariate adjustment and propensity score analysis (hazard ratio 0.53, 95% confidence interval 0.28 to 0.95, p = 0.033). In conclusion, a strategy using mono versus dual antiplatelet therapy in patients undergoing TAVI reduces LTB and major bleedings without increasing the risk of stroke and myocardial infarction. The results of our study question the justification of dual antiplatelet therapy and require confirmation in a randomized trial.
双重抗血小板治疗常用于经导管主动脉瓣植入术(TAVI)患者,但最佳抗血小板方案仍不确定,有待确定。本研究旨在比较 TAVI 患者两种抗血小板治疗策略。前瞻性比较 292 例连续 TAVI 患者采用单抗血小板治疗策略(A 组,n=164)与采用双联抗血小板治疗策略(B 组,n=128)。主要终点是 30 天内死亡率、主要卒中、致死性出血(LTB)、心肌梗死和主要血管并发症的组合。所有不良事件均根据瓣膜学术研究联盟进行裁决。A 组有 22 例(13.4%)患者和 B 组有 30 例(23.4%)患者发生主要终点事件(风险比 0.51,95%置信区间 0.28 至 0.94,p=0.026)。A 组 LTB(3.7%比 12.5%,p=0.005)和大出血(2.4%比 13.3%,p<0.0001)发生率较低,而卒中(1.2%比 4.7%,p=0.14)和心肌梗死(1.2%比 0.8%,p=1.0)发生率在两组间无显著差异。多变量调整和倾向评分分析后,单药与双联抗血小板治疗策略的获益仍然存在(风险比 0.53,95%置信区间 0.28 至 0.95,p=0.033)。总之,TAVI 患者采用单药与双联抗血小板治疗策略可降低 LTB 和大出血风险,而不增加卒中和心肌梗死风险。本研究结果质疑双联抗血小板治疗的合理性,需要在随机试验中得到证实。