Impact of Optimal Medical Therapy in the Dual Antiplatelet Therapy Study
Authors' conclusion
Continued thienopyridine therapy reduced the rate of myocardial infarction regardless of OMT status and had consistent effects on reduction in major adverse cardiovascular and cerebrovascular events and increased bleeding.
Study context
- Population
- Patients after coronary stenting who completed 1 year of DAPT without major bleeding or ischemic events; Optimal medical therapy (OMT) = statin, β-blocker and ACEi/ARB where each had an ACC/AHA class I indication11,643 with medication data
- Participants
- 11,648 patients
- Comparison
- Continued thienopyridine vs placebo, by OMT status
- Primary endpoint
- MI, MACCE and GUSTO moderate or severe bleeding
- Follow-up
- Between 12 and 30 months
Methodological detailsdouble-blind, placebo-controlled, subgroup analysis by OMT status
- Double-blind
- Placebo-controlled
- Subgroup analysis by OMT status
Primary result
As reported in the abstract
MI, by OMT status (subgroup)
Thienopyridine vs PlaceboHazard ratio (95% CI)P value
On OMT: 2.1% vs 3.3%
0.64(0.48–0.86)
P = 0.003Off OMT: 2.2% vs 5.2%
0.41(0.29–0.58)
P < 0.001Further findings
| Outcome | Thienopyridine | Placebo | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| MACCE, by OMT status (subgroup)On OMT | 4.2% | 5.0% | 0.82 (0.66–1.02) | P = 0.077 | |
| MACCE, by OMT status (subgroup)Off OMT | 4.5% | 7.0% | 0.63 (0.49–0.82) | P < 0.001 | |
| 0.512Hazard ratio (log scale) |
- MACCE, by OMT status (subgroup): interaction P=0.250
On OMT vs off OMT, overall
- MI, on OMT vs off OMT: 2.7% vs 3.7%
- P = 0.003
- MACCE, on OMT vs off OMT: 4.6% vs 5.7%
- P = 0.007
- Bleeding, on OMT vs off OMT: 1.6% vs 2.5%
- P < 0.001
- Stent thrombosis, on OMT vs off OMT: 0.8% vs 1.0% (did not differ)
- P = 0.171
- Death, on OMT vs off OMT: 1.6% vs 1.9% (did not differ)
- P = 0.155
Safety
| Outcome | Thienopyridine | Placebo | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| GUSTO moderate or severe bleeding, by OMT status (subgroup)On OMT | 2.2% | 1.0% | 2.13 (1.43–3.17) | P < 0.001 | |
| GUSTO moderate or severe bleeding, by OMT status (subgroup)Off OMT | 2.8% | 2.2% | 1.30 (0.88–1.92) | P = 0.189 | |
| 0.20.5125Hazard ratio (log scale) |
- GUSTO moderate or severe bleeding, by OMT status (subgroup): interaction P=0.073
Original publication
Impact of Optimal Medical Therapy in the Dual Antiplatelet Therapy Study. Circulation. Published 30 August 2016. doi:10.
Summarised from the published abstract; every number is checked against it