Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease

. 2017 Oct 05 ; 377 (14) : 1319-1330. [epub] 20170827

Jazyk angličtina Země Spojené státy americké Médium print-electronic

Typ dokumentu časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/pmid28844192

BACKGROUND: We evaluated whether rivaroxaban alone or in combination with aspirin would be more effective than aspirin alone for secondary cardiovascular prevention. METHODS: In this double-blind trial, we randomly assigned 27,395 participants with stable atherosclerotic vascular disease to receive rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg once daily), rivaroxaban (5 mg twice daily), or aspirin (100 mg once daily). The primary outcome was a composite of cardiovascular death, stroke, or myocardial infarction. The study was stopped for superiority of the rivaroxaban-plus-aspirin group after a mean follow-up of 23 months. RESULTS: The primary outcome occurred in fewer patients in the rivaroxaban-plus-aspirin group than in the aspirin-alone group (379 patients [4.1%] vs. 496 patients [5.4%]; hazard ratio, 0.76; 95% confidence interval [CI], 0.66 to 0.86; P<0.001; z=-4.126), but major bleeding events occurred in more patients in the rivaroxaban-plus-aspirin group (288 patients [3.1%] vs. 170 patients [1.9%]; hazard ratio, 1.70; 95% CI, 1.40 to 2.05; P<0.001). There was no significant difference in intracranial or fatal bleeding between these two groups. There were 313 deaths (3.4%) in the rivaroxaban-plus-aspirin group as compared with 378 (4.1%) in the aspirin-alone group (hazard ratio, 0.82; 95% CI, 0.71 to 0.96; P=0.01; threshold P value for significance, 0.0025). The primary outcome did not occur in significantly fewer patients in the rivaroxaban-alone group than in the aspirin-alone group, but major bleeding events occurred in more patients in the rivaroxaban-alone group. CONCLUSIONS: Among patients with stable atherosclerotic vascular disease, those assigned to rivaroxaban (2.5 mg twice daily) plus aspirin had better cardiovascular outcomes and more major bleeding events than those assigned to aspirin alone. Rivaroxaban (5 mg twice daily) alone did not result in better cardiovascular outcomes than aspirin alone and resulted in more major bleeding events. (Funded by Bayer; COMPASS ClinicalTrials.gov number, NCT01776424 .).

Komentář v

PubMed

Komentář v

PubMed

Komentář v

PubMed

Komentář v

PubMed

Komentář v

PubMed

Komentář v

PubMed

Komentář v

PubMed

Komentář v

PubMed

Komentář v

PubMed

Komentář v

PubMed

Citace poskytuje Crossref.org

Nejnovějších 20 citací...

Zobrazit více v
Medvik | PubMed

Comparison of Investigator-Reported vs Centrally Adjudicated Major Adverse Cardiac Events: A Secondary Analysis of the COMPASS Trial

. 2022 Nov 01 ; 5 (11) : e2243201. [epub] 20221101

Rivaroxaban and Risk of Venous Thromboembolism in Patients With Symptomatic Peripheral Artery Disease After Lower Extremity Revascularization

. 2022 Jun 01 ; 5 (6) : e2215580. [epub] 20220601

DCRM Multispecialty Practice Recommendations for the management of diabetes, cardiorenal, and metabolic diseases

. 2022 Feb ; 36 (2) : 108101. [epub] 20211207

Long-Term Ticagrelor in Patients With Prior Coronary Stenting in the PEGASUS-TIMI 54 Trial

. 2021 Sep 07 ; 10 (17) : e020446. [epub] 20210821

Skeletonized vs Pedicled Internal Mammary Artery Graft Harvesting in Coronary Artery Bypass Surgery: A Post Hoc Analysis From the COMPASS Trial

. 2021 Sep 01 ; 6 (9) : 1042-1049.

Cardiovascular consequences of discontinuing low-dose rivaroxaban in people with chronic coronary or peripheral artery disease

. 2021 Jul ; 107 (14) : 1130-1137. [epub] 20210521

Role of Combination Antiplatelet and Anticoagulation Therapy in Diabetes Mellitus and Cardiovascular Disease: Insights From the COMPASS Trial

. 2020 Jun 09 ; 141 (23) : 1841-1854. [epub] 20200328

Efficacy and safety with ticagrelor in patients with prior myocardial infarction in the approved European label: insights from PEGASUS-TIMI 54

. 2019 Oct 01 ; 5 (4) : 200-206.

Zobrazit více v PubMed

ClinicalTrials.gov
NCT01776424, NCT01776424

Najít záznam

Citační ukazatele

Nahrávání dat ...

    Možnosti archivace