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Rivaroxaban Plus Aspirin Versus Aspirin Alone in Patients With Prior Percutaneous Coronary Intervention (COMPASS-PCI)
Kevin R Bainey1, Robert C Welsh1, Stuart J Connolly2
1Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (K.R.B., R.C.W.).
Insights
Dual pathway inhibition (DPI) with rivaroxaban and aspirin significantly reduced major adverse cardiovascular events (MACE) and mortality in patients with chronic coronary syndromes, regardless of prior percutaneous coronary intervention (PCI). However, DPI also increased major bleeding risk.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Clinical Trials
Background:
- The COMPASS trial established dual pathway inhibition (DPI) with rivaroxaban and aspirin as effective in reducing major adverse cardiovascular events (MACE) and mortality in patients with chronic coronary syndromes or peripheral arterial disease.
- The efficacy and safety of DPI in patients with a history of percutaneous coronary intervention (PCI) remained unaddressed by the primary COMPASS trial findings.
Purpose of the Study:
- To investigate the effectiveness and safety of DPI (rivaroxaban plus aspirin) compared to aspirin alone in patients with chronic coronary syndromes who have undergone previous PCI.
- To analyze the impact of the timing of previous PCI on the outcomes of DPI therapy.
Main Methods:
- A prespecified subgroup analysis of the COMPASS trial was conducted, focusing on patients with chronic coronary syndrome.
- Outcomes were compared between patients treated with DPI and those treated with aspirin alone, specifically examining subgroups with and without prior PCI.
- For patients with prior PCI, treatment effects were assessed based on the time elapsed since the intervention.
Main Results:
- In patients with prior PCI, DPI significantly reduced MACE (4.0% vs. 5.5%) and mortality (2.5% vs. 3.5%) compared to aspirin alone, with consistent benefits observed regardless of the time since PCI.
- These benefits were mirrored in patients without prior PCI, demonstrating consistent efficacy across both groups (MACE: 4.4% vs. 5.7%; mortality: 4.1% vs. 5.0%).
- DPI was associated with an increased risk of major bleeding in both patient groups (PCI: 3.3% vs. 2.0%; no PCI: 2.9% vs. 1.8%).
Conclusions:
- Dual pathway inhibition with rivaroxaban and aspirin provides consistent reductions in MACE and mortality for patients with chronic coronary syndromes, irrespective of prior PCI history or the time elapsed since PCI.
- The increased risk of major bleeding associated with DPI therapy must be carefully considered in both patient populations.
- The findings support the use of DPI in selected patients with chronic coronary syndromes and a history of PCI, balancing efficacy with bleeding risk.
Background:
The COMPASS trial (Cardiovascular Outcomes for People using Anticoagulation Strategies) demonstrated that dual pathway inhibition (DPI) with rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily versus aspirin 100 mg once daily reduced the primary major adverse cardiovascular event (MACE) outcome of cardiovascular death, myocardial infarction, or stroke, as well as, mortality, in patients with chronic coronary syndromes or peripheral arterial disease. Whether this remains true in patients with a history of percutaneous coronary intervention (PCI) is unknown.
Methods:
In a prespecified subgroup analysis from COMPASS, we examined the outcomes of patients with chronic coronary syndrome with or without a previous PCI treated with DPI versus aspirin alone. Among patients with a previous PCI, we studied the effects of treatment according to the timing of the previous PCI.
Results:
Of the 27 395 patients in COMPASS, 16 560 patients with a chronic coronary syndrome were randomly assigned to DPI or aspirin, and, of these, 9862 (59.6%) had previous PCI (mean age 68.2±7.8, female 19.4%, diabetes mellitus 35.7%, previous myocardial infarction 74.8%, multivessel PCI 38.0%). Average time from PCI to randomization was 5.4 years (SD, 4.4) and follow-up was 1.98 (SD, 0.72) years. Regardless of previous PCI, DPI versus aspirin produced consistent reductions in MACE (PCI: 4.0% versus 5.5%; hazard ratio [HR], 0.74 [95% CI, 0.61-0.88]; no PCI: 4.4% versus 5.7%; HR, 0.76 [95% CI, 0.61-0.94], P-interaction=0.85) and mortality (PCI: 2.5% versus 3.5%; HR, 0.73 [95% CI, 0.58-0.92]; no PCI: 4.1% versus 5.0%; HR, 0.80 [95% CI, 0.64-1.00], P-interaction=0.59), but increased major bleeding (PCI: 3.3% versus 2.0%; HR, 1.72 [95% CI, 1.34-2.21]; no PCI: 2.9% versus 1.8%; HR, 1.58 [95% CI, 1.15-2.17], P-interaction=0.68). In those with previous PCI, DPI compared with aspirin produced consistent (robust) reductions in MACE irrespective of time since previous PCI (as early as 1 year and as far as 10 years; P-interaction=0.65), irrespective of having a previous myocardial infarction (P-interaction=0.64).
Conclusions:
DPI compared with aspirin produced consistent reductions in MACE and mortality but with increased major bleeding with or without previous PCI. Among those with previous PCI 1 year and beyond, the effects on MACE and mortality were consistent irrespective of time since last PCI. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01776424.
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