Table 2.
Safety and efficacy outcomes in patients receiving/not receiving proton pump inhibitors (PPIs) at baseline. Dabigatran dual therapy vs warfarin triple therapy: multivariable-adjusted analyses
| PPI at baseline | Dabigatran 110 mg dual therapy n/N (%) | Warfarin triple therapy n/N (%) | HR (95%) | Dabigatran 150 mg dual therapy n/N (%) | Warfarin triple therapy n/N (%)b | HR (95%) | |
|---|---|---|---|---|---|---|---|
| Adjudicated ISTH MBE/CRNMB | PPI | 89/549 (16.2) | 137/527 (26.0) | 0.64 (0.48–0.85) | 82/417 (19.7) | 106/405 (26.2) | 0.75 (0.54–1.03) |
| No PPI | 48/323 (14.9) | 100/338 (29.6) | 0.52 (0.36–0.74) | 56/273 (20.5) | 73/267 (27.3) | 0.78 (0.54–1.13) | |
| Interaction p value | 0.3476 | 0.8640 | |||||
| Adjudicated ISTH MBE | PPI | 31/549 (5.6) | 45/527 (8.5) | 0.73 (0.44–1.20) | 22/417 (5.3) | 32/405 (7.9) | 0.65 (0.35–1.21) |
| No PPI | 12/323 (3.7) | 32/338 (9.5) | 0.44 (0.22–0.88) | 14/273 (5.1) | 23/267 (8.6) | 0.63 (0.31–1.28) | |
| Interaction p value | 0.2204 | 0.9228 | |||||
| Adjudicated GI bleeding | PPI | 17/549 (3.1) | 24/527 (4.6) | 0.82 (0.42–1.59) | 15/417 (3.6) | 15/405 (3.7) | 0.83 (0.36–1.91) |
| No PPI | 8/323 (2.5) | 15/338 (4.4) | 0.70 (0.29–1.71) | 7/273 (2.6) | 9/267 (3.4) | 0.71 (0.25–2.06) | |
| Interaction p value | 0.7792 | 0.8067 | |||||
| Adjudicated DTE/unplanned revascularization | PPI | 93/544 (17.1) | 71/520 (13.7) | 1.25 (0.92–1.71) | 54/413 (13.1) | 56/398 (14.1) | 0.96 (0.66–1.40) |
| No PPI | 43/327 (13.1) | 45/332 (13.6) | 0.95 (0.62–1.44) | 27/269 (10.0) | 30/265 (11.3) | 0.92 (0.54–1.55) | |
| Interaction p value | 0.2877 | 0.8954 |
CRNMBE clinically relevant non-major bleeding event, DTE death/thromboembolic event, GI gastrointestinal, HR hazard ratio, ISTH International Society on Thrombosis and Haemostasis, MBE major bleeding event
aSee Sect. 2.2 for details
bFor the comparison with dabigatran 150 mg dual therapy, elderly patients outside the USA are excluded