Coronary disease & ACSSecondary analysis
Role of Combination Antiplatelet and Anticoagulation Therapy in Diabetes Mellitus and Cardiovascular Disease
- Secondary analysis of the COMPASS randomised trial
- prespecified subgroup analysis
Authors' conclusion
In stable atherosclerosis, the combination of aspirin plus rivaroxaban 2.5 mg twice daily provided a similar relative degree of benefit on coronary, cerebrovascular, and peripheral end points in patients with and without diabetes mellitus. Given their higher baseline risk, the absolute benefits appeared larger in those with diabetes mellitus, including a 3-fold greater reduction in all-cause mortality.
Study context
- Population
- Patients with established CAD or PAD, with or without DMwith 6,922 · or without 11,356
- Participants
- 9,152 vs 9,126
- Comparison
- Rivaroxaban plus aspirin vs placebo plus aspirin, in patients with vs without DM
- Rivaroxaban plus aspirinn = 9,152
- Placebo plus aspirinn = 9,126reference
- Primary endpoint
- CV death, MI or stroke
Primary result
As reported in the abstract
CV death, MI or stroke, by DM status (subgroup)
- with DM
- HR 0.74; P = 0.002
- without DM
- HR 0.77; P = 0.005
- Absolute risk reduction at 3 years, with vs without DM
- 2.3% versus 1.4%
Secondary outcomes
| Outcome | HR | P value |
|---|---|---|
| All-cause mortality, by DM status (subgroup) — Rivaroxaban plus aspirin vs Placebo plus aspirin · with DM | 0.81 | P = 0.05 |
| All-cause mortality, by DM status (subgroup) — Rivaroxaban plus aspirin vs Placebo plus aspirin · without DM | 0.84 | P = 0.09 |
- All-cause mortality, by DM status (subgroup) — Absolute risk reduction, with vs without DM
- 1.9% versus 0.6%
- All-cause mortality, by DM status (subgroup): Pinteraction=0.82
- All-cause mortality, by DM status (subgroup): Pinteraction=0.02 (absolute risk reduction)
Major vascular events, by DM status (subgroup)
- Absolute risk reduction, with vs without DM
- 2.7% versus 1.7%
- Pinteraction<0.0001
Net benefit, by DM status (subgroup)
- Net benefit, with vs without DM
- 2.7% versus 1.0%
- prespecified
- Gail-Simon qualitative Pinteraction=0.001
Safety
Major bleeding (modified ISTH)
- Bleeding hazards similar with and without DM
Original publication
Role of Combination Antiplatelet and Anticoagulation Therapy in Diabetes Mellitus and Cardiovascular Disease. Circulation. Published 28 March 2020. doi:10.1161/circulationaha.120.046448
Summarised from the published abstract; every number is checked against it