Table 1.
Intervention * | Study, Year | Comparison | No. Patients Enrolled | Patients with Index PE | Treatment Duration | Recurrence Proportion (%) in Intervention * vs. Comparison Group | Recurrence risk: HR; 95% CI | Major or CRNM Bleeding in Intervention * Group: HR; 95% CI |
---|---|---|---|---|---|---|---|---|
Dabigatran | RE-SONATE, 2013 [34] | Placebo vs. dabigatran 150 mg BID |
1343 | 33% | 6–18 months | 0.4% vs. 5.6% | 0.08; 0.02–0.25 | 2.92; 1.52–5.60 |
RE-MEDY, 2013 [34] | Warfarin vs. dabigatran 150 mg BID | 2856 | 35% | 18–36 months | 1.8% vs. 1.3% | 1.44; 0.78–2.64 | 0.54; 0.41–0.71. | |
Rivaroxaban | EINSTEIN Extension, 2010 [35] | Placebo vs. rivaroxaban 20 mg OD | 1196 | 38% | 6–12 months | 1.3% vs. 7.1% | 0.18; 0.09–0.39 | 5.19; 2.3–11.7. |
EINSTEIN Choice, 2017 [36] | Aspirin 100 mg OD vs. rivaroxaban 20 mg OD rivaroxaban 10 mg OD |
3365 | 49% | 12 months | Riva 20 mg: 1.5% Riva 10 mg: 1.2% vs. Aspirin: 4.4%. |
Riva 20 mg vs. aspirin: 0.34; 0.20–0.59. Riva 10 mg vs. aspirin: 0.26; 0.14–0.47. |
1.59; 0.94–2.69. 1.16; 0.67–2.03. |
|
Apixaban | AMPLIFY Extension, 2013 [37] | Placebo vs. apixaban 5 mg BID vs. apixaban 2.5 mg BID | 2486 | 35% | 12 months | Apixaban 5 mg: 1.7% Apixaban 2.5 mg: 1.7% vs. Placebo: 8.8% |
Apixaban 5 mg vs. placebo: 0.36; 0.25–0.53. Apixaban 2.5 mg vs. placebo: 0.33; 0.22–0.48. |
1.62; 0.96–2.73. 1.20; 0.69–2.10. |
Aspirin | WARFASA, 2012 [38] | Placebo vs. aspirin 100 mg OD | 402 | 40% | ≥24 months | 6.6% vs. 11.2% | 0.58; 0.36–0.93. | 0.98; 0.24–3.96. |
ASPIRE, 2012 [39] | Placebo vs. aspirin 100 mg OD | 822 | 30% | 2–4 years | 4.8% vs. 6.5% | 0.74; 0.52–1.05. | 1.1% per year with aspirin (vs. 0.6%). |
BID = twice a day; CI = confidence interval; CRNM = clinically relevant non-major; HR = hazard ratio; OD = once a day; PE = pulmonary embolism; Riva = rivaroxaban; VTE = venous thromboembolism. * ‘Intervention’ denotes the anticoagulant drug tested in the table.