Arrhythmias & electrophysiologyCohort study
Serious Bleeding in Patients With Atrial Fibrillation Using Diltiazem With Apixaban or Rivaroxaban
- Retrospective cohort study
- overlap weighting
Authors' conclusion
In Medicare patients with atrial fibrillation receiving apixaban or rivaroxaban, diltiazem was associated with greater risk of serious bleeding than metoprolol, particularly for diltiazem doses exceeding 120 mg/d.
Study context
- Population
- Medicare beneficiaries aged ≥65 years with AF initiating apixaban or rivaroxaban and starting diltiazem or metoprolol, 2012–2020
- Participants
- 204,155 beneficiaries
- Exposure
- Diltiazem vs metoprolol in new users of apixaban or rivaroxaban
- Diltiazemn = 53,275
- Metoprololn = 150,880reference
- Outcome
- Composite of:
- Bleeding-related hospitalization
- Death with recent evidence of bleeding
- Follow-up
- Up to 365 days
Main finding
As reported in the abstract
Each group vs metoprololRD, per 1000 PY (95% CI)
Diltiazem
10.6(7.0–14.2)
Each group vs metoprololHazard ratio (95% CI)
Diltiazem
1.21(1.13–1.29)
Observational data: associations, not effects.
Secondary outcomes
| Outcome | RD (per 1000 PY) (95% CI) | |
|---|---|---|
| Bleeding-related hospitalization (component) — Diltiazem vs Metoprolol | 8.2 (5.1–11.4) | |
| Death with recent evidence of bleeding (component) — Diltiazem vs Metoprolol | 2.4 (0.6–4.2) | |
| Primary outcome, by initial diltiazem dose (subgroup) — Diltiazem >120 mg/d vs Metoprolol | 15.1 (10.2–20.1) | |
| Primary outcome, by initial diltiazem dose (subgroup) — Diltiazem lower doses vs Metoprolol | 6.7 (2.0–11.4) | |
| −100102030Difference, per 1000 PY (linear scale) |
| Outcome | HR (95% CI) | |
|---|---|---|
| Bleeding-related hospitalization (component) — Diltiazem vs Metoprolol | 1.22 (1.13–1.31) | |
| Death with recent evidence of bleeding (component) — Diltiazem vs Metoprolol | 1.19 (1.05–1.34) | |
| Primary outcome, by initial diltiazem dose (subgroup) — Diltiazem >120 mg/d vs Metoprolol | 1.29 (1.19–1.39) | |
| Primary outcome, by initial diltiazem dose (subgroup) — Diltiazem lower doses vs Metoprolol | 1.13 (1.04–1.24) | |
| Primary outcome, by initial diltiazem dose (subgroup) — Diltiazem high dose vs Diltiazem low dose | 1.14 (1.02–1.26) | |
| Major ischemic or hemorrhagic events, diltiazem >120 mg/d | 1.14 (1.02–1.27) | |
| 0.512Hazard ratio (log scale) |
Ischemic stroke or systemic embolism; death without recent evidence of bleeding
- No significant change in either dose group
Original publication
Serious Bleeding in Patients With Atrial Fibrillation Using Diltiazem With Apixaban or Rivaroxaban. JAMA. Published 14 May 2024. doi:10.1001/jama.2024.3867
Summarised from the published abstract; every number is checked against it