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A counseling program on nuisance bleeding improves quality of life in patients on dual antiplatelet therapy: A
Simone Biscaglia1, Elisabetta Tonet1, Rita Pavasini1
1Cardiovascular Section, Medical Sciences Department, Azienda Ospedaliera Universitaria S.Anna, Ferrara, Italy.
Insights
A new counseling program significantly improved quality of life for patients on dual antiplatelet therapy (DAPT) by reducing nuisance bleeding concerns. This intervention also lowered drug discontinuation rates, enhancing patient outcomes.
Area of Science:
- Cardiology
- Clinical Trials
- Patient Quality of Life
Background:
- Nuisance bleeding significantly impacts quality of life and adherence in patients on dual antiplatelet therapy (DAPT).
- Previous randomized trials have not specifically evaluated the effect of nuisance bleeding on quality of life.
Purpose of the Study:
- To assess the impact of a multimodal counseling program on quality of life in patients undergoing DAPT.
- To evaluate the effect of this intervention on DAPT withdrawal rates and patient-reported outcomes.
Main Methods:
- The BATMAN trial randomized 448 patients to either a multimodal counseling program or usual care.
- Quality of life was measured using the EuroQol-5 Dimension (EQ-5D) visual analog scale (VAS) at 1 and 6 months.
- Secondary endpoints included DAPT withdrawal, information seeking, and adverse events.
Main Results:
- Patients receiving the counseling program showed significantly higher EQ-5D VAS scores at 1 and 6 months compared to the control group.
- The intervention group reported less pain/discomfort and anxiety/depression.
- DAPT withdrawal rates were significantly lower in the intervention arm (0.4% vs. 3%).
Conclusions:
- A systematic multimodal counseling program effectively improves quality of life for patients on DAPT.
- This intervention also reduces the rate of DAPT discontinuation, suggesting improved patient management and adherence.
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.
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