Biscaglia Simone, Tonet Elisabetta, Pavasini Rita, Serenelli Matteo, Bugani Giulia, Cimaglia Paolo, Gallo Francesco, Spitaleri Giosafat, Del Franco Annamaria, Aquila Giorgio, Vieceli Dalla Sega Francesco, Tebaldi Matteo, Tumscitz Carlo, Ferrari Roberto, Campo Gianluca
Cardiovascular Section, Medical Sciences Department, Azienda Ospedaliera Universitaria S.Anna, Ferrara, Italy.
Department of Morphology, Surgery and Experimental Medicine, University of Ferrara, Ferrara, Italy.
PLoS One. 2017 Aug 23;12(8):e0182124. doi: 10.1371/journal.pone.0182124. eCollection 2017.
Nuisance bleeding is a major determinant of quality of life and drug discontinuation in patients on dual antiplatelet therapy (DAPT). However, no randomized trial has been focused on the impact of nuisance bleeding on quality of life.
BATMAN is an investigator-driven, randomized, controlled, single-center, open trial (NCT02554006). Four hundred and forty-eight consecutive patients with indication to at least 6 months of DAPT were randomized to: i) multimodal counseling program focused on nuisance bleedings (interventional arm); ii) usual discharge process (control arm). The primary endpoint was the one-month health-related quality of life assessed by the EuroQol-5 Dimension (EQ-5D) visual analog scale (VAS) score. Secondary endpoints were EQ-5D at 1 and 6 months, EQ-5D VAS at 6 months, DAPT withdrawal, need of information regarding DAPT and/or nuisance bleedings, 6-month ischemic and bleeding adverse events.
The EQ5D-VAS was significantly higher in the interventional arm compared to the control arm at 1 and 6 months (81[74-88] vs. 73[64-80], p < 0.001 at 1 month; 82[76-88] vs. 74[65-81], p < 0.001 at 6 months). Patients in the interventional arm had also significantly lower pain/discomfort and anxiety/depression at the EQ-5D both at 1 and 6 months. Patients in the control arm withdrew DAPT significantly more (7 (3%) vs. 1 (0.4%), p = 0.03) and looked for information regarding DAPT and/or about nuisance bleeding more frequently than those in the interventional arm (178 (79%) vs.19 (8%), p < 0.001).
The systematic utilization of a multimodal counseling program improved quality of life and reduced the DAPT withdrawal rate in patients on DAPT.
在接受双联抗血小板治疗（DAPT）的患者中，轻微出血是生活质量和药物停用的主要决定因素。然而，尚无随机试验关注轻微出血对生活质量的影响。
“蝙蝠侠”（BATMAN）是一项由研究者发起的随机对照单中心开放试验（NCT02554006）。448例连续入选且有至少6个月DAPT指征的患者被随机分为：i）针对轻微出血的多模式咨询项目组（干预组）；ii）常规出院流程组（对照组）。主要终点是通过欧洲五维健康量表（EQ-5D）视觉模拟量表（VAS）评分评估的1个月健康相关生活质量。次要终点包括1个月和6个月时的EQ-5D、6个月时的EQ-5D VAS、DAPT停药、关于DAPT和/或轻微出血的信息需求、6个月时的缺血和出血不良事件。
干预组在1个月和6个月时EQ5D-VAS显著高于对照组（1个月时：81[74-88] 对比 73[64-80]，p<0.001；6个月时：82[76-88] 对比 74[65-81]，p<0.001）。干预组患者在1个月和6个月时EQ-5D中的疼痛/不适和焦虑/抑郁也显著更低。对照组患者DAPT停药显著更多（7例（3%）对比1例（0.4%），p = 0.03），且比干预组患者更频繁地寻求关于DAPT和/或轻微出血的信息（178例（79%）对比19例（8%），p<0.001）。
多模式咨询项目的系统应用改善了接受DAPT患者的生活质量并降低了DAPT停药率。
