Incidence of Major Bleeding Complication of Warfarin Therapy in Japanese Patients With Atrial Fibrillation

Combined anticoagulation and antiplatelet therapy for high-risk patients with atrial fibrillation: a systematic review

“…Of these, 14 studies [50][51][52][53][54][55][56][57][58][59][60][61][62][63] (in 14 articles) reported data from observational designs, both prospective [50][51][52][53][54][55] and retrospective [56][57][58][59][60][61][62][63] in nature. The remaining four studies in 10 articles [64][65][66][67][68][69][70][71][72][73] were originally designed to assess the effectiveness of an anticoagulant without additional APT.…”

“…[50][51][52][53][55][56][57][59][60][61][62][63][64][65] One RCT 39 and one non-randomised study 54 reported data on acenocoumarol (Sinthrome ® , Alliance) plus an APT compared with acenocoumarol alone. The remaining one RCT 41 reported data on fluindione plus aspirin compared with fluindione plus placebo.…”

“…Retrospective outcomes (n = 8) [56][57][58][59][60][61][62][63] Prospective outcomes (n = 6) [50][51][52][53][54][55] Of the studies reporting non-randomised comparisons, six were retrospective, [56][57][58][60][61][62][63] and the time of APT use varied between the studies. The majority of these studies consisted of a retrospective review of medical records where prior knowledge of allocation of therapy was not possible.…”

“…The majority of these studies consisted of a retrospective review of medical records where prior knowledge of allocation of therapy was not possible. [50][51][52][53][56][57][58][59][60][61]63 However, all but five studies 50,55,59,62,73 clearly reported the criteria by which APT was used in the study. Of note is the study by Ezekowitz et al 73 [PETRO (Dabigatran with or without concomitant aspirin compared with warfarin alone in patients with non-valvular atrial fibrillation)], in which it was difficult to identify if APT was used at random or indicated in a subgroup.…”

“…[51][52][53][54]56,57,[59][60][61][62][63] The sample size also varied considerably between included studies, from 43 participants in one RCT 40 to 118,606 in a large non-randomised comparison. 63 As a result of the overall sample size, the number of patients receiving combined ACT and APT and the comparator also varied considerably, with only 34 patients receiving the combination therapy in Bover et al, 54 between 21 and 36 patients receiving the various permutations of ACT plus APT in the PETRO study, 73 and 76 patients receiving combination therapy and 81 receiving ACT alone in the FFAACS (Fluindione, Fibrillation Auriculaire, Aspirin et Contraste Spontané) trial, 41 which will have influenced the reported event rates for each outcome.…”