A counseling program on nuisance bleeding improves quality of life in patients on dual antiplatelet therapy: A randomized controlled trial

Simone Biscaglia, Elisabetta Tonet, Rita Pavasini, Matteo Serenelli, Giulia Bugani, Paolo Cimaglia, Francesco Gallo, Giosafat Spitaleri, Annamaria Del Franco, Giorgio Aquila, Francesco Vieceli Dalla Sega, Matteo Tebaldi, Carlo Tumscitz, Roberto Ferrari, Gianluca Campo, Simone Biscaglia, Elisabetta Tonet, Rita Pavasini, Matteo Serenelli, Giulia Bugani, Paolo Cimaglia, Francesco Gallo, Giosafat Spitaleri, Annamaria Del Franco, Giorgio Aquila, Francesco Vieceli Dalla Sega, Matteo Tebaldi, Carlo Tumscitz, Roberto Ferrari, Gianluca Campo

Abstract

Background: 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.

Methods: 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.

Results: 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).

Conclusions: The systematic utilization of a multimodal counseling program improved quality of life and reduced the DAPT withdrawal rate in patients on DAPT.

Conflict of interest statement

Competing Interests: RF received grants from Fondazione Anna Maria Sechi per il Cuore (FASC) and from Irbtech, personal fees from Merck Serono, grants and personal fees from Servier, Novartis Pharma, Boehringer Ingelheim; GC received personal fees from Astrazeneca, Abbott Vascular, Menarini and Boston Scientific. All other authors reported no conflict of interest relevant to the contents of this paper to disclose. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1. CONSORT study flow chart.
Fig 1. CONSORT study flow chart.
* were included in the primary endpoint analysis. ** were included in the secondary endpoints 6-month analysis. PCI: percutaneous coronary intervention. DES: drug eluting stent.
Fig 2. Primary endpoint: EQ5D-VAS at one-month.
Fig 2. Primary endpoint: EQ5D-VAS at one-month.
EQ5D-VAS values at one-month in patients of the two groups. The horizontal line shows the median value. The box showed the interquartile range. The vertical line shows the 10–90th percentile. EQ5D: EuroQol-5 Dimension. VAS: visual analog scale score.

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