AIMS: To analyse whether the benefits and risks of rivaroxaban plus aspirin vary in patients with comorbidities and receiving multiple drugs. In patients with coronary or peripheral artery disease, adding low-dose rivaroxaban to aspirin reduces cardiovascular events and mortality. Polypharmacy and multimorbidity are frequent in such patients. METHODS AND RESULTS: We describe ischaemic events (cardiovascular death, stroke, or myocardial infarction) and major bleeding in participants from the randomized, double-blind COMPASS study by number of cardiovascular medications and concomitant medical conditions. We compared event rates and hazard ratios (HRs) for rivaroxaban plus aspirin vs. aspirin alone by the number of medications and concomitant conditions, and tested for interaction between polypharmacy or multimorbidity and the antithrombotic regimen. The risk of ischaemic events was higher in patients with more concomitant drugs (HR 1.7, 95% confidence interval 1.5-2.1 for >4 vs. 0-2) and with more comorbidities (HR 2.3, 1.8-2.1 for >3 vs. 0-1). Multimorbidity, but not polypharmacy, was associated with a higher risk of major bleeding. The relative efficacy, safety, and net clinical benefit of rivaroxaban were not affected by the number of drugs or comorbidities. Patients taking more concomitant medications derived the largest absolute reduction in the net clinical outcome with added rivaroxaban (1.1% vs. 0.4% reduction with >4 vs. 0-2 cardiovascular drugs, number needed to treat 91 vs. 250). CONCLUSION: Adding low-dose rivaroxaban to aspirin resulted in benefits irrespective of the number of concomitant drugs or comorbidities. Multiple comorbidities and/or polypharmacy should not dissuade the addition of rivaroxaban to aspirin in otherwise eligible patients.
AIMS: To describe outcomes of patients with chronic coronary artery disease (CAD) and/or peripheral artery disease (PAD) enrolled in the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) randomized trial who were treated with the combination of rivaroxaban 2.5 mg twice daily and aspirin 100 mg once daily during long-term open-label extension (LTOLE). METHODS AND RESULTS: Of the 27 395 patients enrolled in COMPASS, 12 964 (mean age at baseline 67.2 years) from 455 sites in 32 countries were enrolled in LTOLE and treated with the combination of rivaroxaban and aspirin for a median of 374 additional days (range 1-1191 days). During LTOLE, the incident events per 100 patient years were as follows: for the primary outcome [cardiovascular death, stroke, or myocardial infarction (MI)] 2.35 [95% confidence interval (CI) 2.11-2.61], mortality 1.87 (1.65-2.10), stroke 0.62 (0.50-0.76), and MI 1.02 (0.86-1.19), with CIs that overlapped those seen during the randomized treatment phase with the combination of rivaroxaban and aspirin. The incidence rates for major and minor bleeding were 1.01 (0.86-1.19) and 2.49 (2.24-2.75), compared with 1.67 (1.48-1.87) and 5.11 (95% CI 4.77-5.47), respectively, during the randomized treatment phase with the combination. CONCLUSION: In patients with chronic CAD and/or PAD, extended combination treatment for a median of 1 year and a maximum of 3 years was associated with incidence rates for efficacy and bleeding that were similar to or lower than those seen during the randomized treatment phase, without any new safety signals.
- MeSH
- Aspirin MeSH
- cévní mozková příhoda * epidemiologie MeSH
- infarkt myokardu * epidemiologie MeSH
- kojenec MeSH
- kombinovaná farmakoterapie MeSH
- lidé MeSH
- onemocnění periferních arterií * diagnóza farmakoterapie epidemiologie MeSH
- rivaroxaban MeSH
- Check Tag
- kojenec MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- MeSH
- antikoagulancia aplikace a dávkování škodlivé účinky MeSH
- benzimidazoly aplikace a dávkování škodlivé účinky MeSH
- cévní mozková příhoda epidemiologie prevence a kontrola MeSH
- dyspepsie chemicky indukované MeSH
- fibrilace síní farmakoterapie komplikace mortalita MeSH
- játra účinky léků MeSH
- krvácení chemicky indukované MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- prekurzory léčiv terapeutické užití MeSH
- pyridiny aplikace a dávkování škodlivé účinky MeSH
- randomizované kontrolované studie jako téma MeSH
- thrombin antagonisté a inhibitory MeSH
- warfarin aplikace a dávkování škodlivé účinky MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- MeSH
- anticholesteremika aplikace a dávkování farmakokinetika terapeutické užití MeSH
- antihypertenziva aplikace a dávkování farmakokinetika terapeutické užití MeSH
- antikoagulancia aplikace a dávkování farmakokinetika MeSH
- intermitentní klaudikace farmakoterapie prevence a kontrola terapie MeSH
- lidé MeSH
- odvykání kouření metody MeSH
- onemocnění periferních cév diagnóza epidemiologie terapie MeSH
- terapie cvičením metody trendy výchova MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- srovnávací studie MeSH
- MeSH
- bolesti na hrudi diagnóza patologie MeSH
- diagnostické techniky dýchacího ústrojí metody MeSH
- dospělí MeSH
- lidé MeSH
- plicní embolie diagnóza patologie MeSH
- rizikové faktory MeSH
- senioři MeSH
- teorie pravděpodobnosti MeSH
- žilní trombóza diagnóza patologie MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- kazuistiky MeSH
