• Chao-Feng Chen, Bin Chen, Jue Zhu, and Yi-Zhou Xu.
• The Affiliated Hangzhou Hospital, Nanjing Medical University, Hang Zhou, Zhe Jiang Province, China.
• Herz. 2015 Dec 1; 40 (8): 1070-83.

AimThe aim of this meta-analysis was to evaluate the benefits and risks of triple therapy (TT) compared with dual therapy (DT) for patients with an indication for anticoagulation who had undergone percutaneous coronary intervention.BackgroundAn increasing number of patients undergoing percutaneous coronary intervention have atrial fibrillation or other indications for oral anticoagulants. For these patients, TT (oral anticoagulants plus aspirin and clopidogrel) is indicated, but this type of treatment increases the risk of bleeding. Thus, it remains controversial whether these patients can benefit more from TT.MethodsWe identified 23 clinical trials that compared TT with DT (aspirin and clopidogrel or oral anticoagulants plus a single antiplatelet drug) after percutaneous coronary intervention in patients undergoing oral anticoagulant (OAC) treatment. The follow-up period ranged from 1 month to 25 months. Two coauthors independently recorded the data on interventions and on the occurrence of major adverse cardiac events (MACE), all-cause death, and major bleeding events.ResultsThe 23 clinical trials comprised 22,212 participants. Our analysis was feasible because the baseline characteristics and grouping criteria were similar in all groups. The results indicated that TT was more efficacious than DT [dual antiplatelet (DAPT) or OAC + single antiplatelet] in reducing MACE/stroke (RR = 0.76, 95 % CI: 0.70-0.83; p < 0.00001 and RR = 0.67, 95 % CI: 0.59-0.75; p < 0.00001, respectively) There was a significant reduction in all-cause death in the TT regimen compared with the DT regimen (RR = 0.64, 95 % CI: 0.56-0.73; p < 0.00001 and RR = 0.48, 95 % CI: 0.39-0.58; p < 0.00001, respectively). In a subgroup analysis without retrospective studies, we found that there was no significant difference between TT and DT with regard to MACE/stroke (RR = 1.06, 95 % CI: 0.88-1.27; p = 0.54 and RR = 0.95, 95 % CI: 0.79-1.14; p = 0.58, respectively) and all-cause death (RR = 0.84, 95 % CI: 0.63-1.12; p = 0.24 and RR = 1.13, 95 % CI: 0.78-1.64; p = 0.51, respectively). We also found that TT significantly increased the risk of major bleeding compared with DAPT (RR  = 1.36; 95 % CI: 1.17-1.58; p < 0.0001). However, there was no difference between TT and OAC + single antiplatelet agent (RR = 0.96; 95 % CI: 0.75-1.21; p = 0.71). Finally, in the comparison between TT and OAC + clopidogrel, there were no differences in major bleeding events, MACE and stroke, and all-cause death.ConclusionOur analysis found no statistically significant difference between TT and DT with regard to all-cause death and MACE/stroke risk. At the same time, the available data demonstrated that TT increased the risk of major bleeding. If the international normalized ratio is in the target range, the risk of bleeding may be lowered. The data from Asian countries were limited, and therefore we could not assess the difference between TT and DT in Asian populations. Finally,on the basis of our analysis, we do not recommend TT as conventional treatment for patients taking OACs and undergoing percutaneous coronary intervention.

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