Rivaroxaban with or without aspirin in patients with stable coronary artery disease: an international, randomised, double-blind, placebo-controlled trial.

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Fältnamn	Indikatorer	Metadata
000		07527naa a2201153 4500
001		oai:gup.ub.gu.se/279441
003		SwePub
008		240910s2018 \| \|\|\|\|\|\|\|\|\|\|\|000 \|\|eng\|
009		oai:prod.swepub.kib.ki.se:137587819
024	7	a https://gup.ub.gu.se/publication/2794412 URI
024	7	a https://doi.org/10.1016/S0140-6736(17)32458-32 DOI
024	7	a http://kipublications.ki.se/Default.aspx?queryparsed=id:1375878192 URI
040		a (SwePub)gud (SwePub)ki
041		a eng
042		9 SwePub
072	7	a ref2 swepub-contenttype
072	7	a art2 swepub-publicationtype
100	1	a Connolly, Stuart J4 aut
245	1 0	a Rivaroxaban with or without aspirin in patients with stable coronary artery disease: an international, randomised, double-blind, placebo-controlled trial.
264	1	c 2018
520		a Coronary artery disease is a major cause of morbidity and mortality worldwide, and is a consequence of acute thrombotic events involving activation of platelets and coagulation proteins. Factor Xa inhibitors and aspirin each reduce thrombotic events but have not yet been tested in combination or against each other in patients with stable coronary artery disease.In this multicentre, double-blind, randomised, placebo-controlled, outpatient trial, patients with stable coronary artery disease or peripheral artery disease were recruited at 602 hospitals, clinics, or community centres in 33 countries. This paper reports on patients with coronary artery disease. Eligible patients with coronary artery disease had to have had a myocardial infarction in the past 20 years, multi-vessel coronary artery disease, history of stable or unstable angina, previous multi-vessel percutaneous coronary intervention, or previous multi-vessel coronary artery bypass graft surgery. After a 30-day run in period, patients were randomly assigned (1:1:1) to receive rivaroxaban (2·5 mg orally twice a day) plus aspirin (100 mg once a day), rivaroxaban alone (5 mg orally twice a day), or aspirin alone (100 mg orally once a day). Randomisation was computer generated. Each treatment group was double dummy, and the patients, investigators, and central study staff were masked to treatment allocation. The primary outcome of the COMPASS trial was the occurrence of myocardial infarction, stroke, or cardiovascular death. This trial is registered with ClinicalTrials.gov, number NCT01776424, and is closed to new participants.Between March 12, 2013, and May 10, 2016, 27395 patients were enrolled to the COMPASS trial, of whom 24824 patients had stable coronary artery disease from 558 centres. The combination of rivaroxaban plus aspirin reduced the primary outcome more than aspirin alone (347 [4%] of 8313 vs 460 [6%] of 8261; hazard ratio [HR] 0·74, 95% CI 0·65-0·86, p<0·0001). By comparison, treatment with rivaroxaban alone did not significantly improve the primary outcome when compared with treatment with aspirin alone (411 [5%] of 8250 vs 460 [6%] of 8261; HR 0·89, 95% CI 0·78-1·02, p=0·094). Combined rivaroxaban plus aspirin treatment resulted in more major bleeds than treatment with aspirin alone (263 [3%] of 8313 vs 158 [2%] of 8261; HR 1·66, 95% CI 1·37-2·03, p<0·0001), and similarly, more bleeds were seen in the rivaroxaban alone group than in the aspirin alone group (236 [3%] of 8250 vs 158 [2%] of 8261; HR 1·51, 95% CI 1·23-1·84, p<0·0001). The most common site of major bleeding was gastrointestinal, occurring in 130 [2%] patients who received combined rivaroxaban plus aspirin, in 84 [1%] patients who received rivaroxaban alone, and in 61 [1%] patients who received aspirin alone. Rivaroxaban plus aspirin reduced mortality when compared with aspirin alone (262 [3%] of 8313 vs 339 [4%] of 8261; HR 0·77, 95% CI 0·65-0·90, p=0·0012).In patients with stable coronary artery disease, addition of rivaroxaban to aspirin lowered major vascular events, but increased major bleeding. There was no significant increase in intracranial bleeding or other critical organ bleeding. There was also a significant net benefit in favour of rivaroxaban plus aspirin and deaths were reduced by 23%. Thus, addition of rivaroxaban to aspirin has the potential to substantially reduce morbidity and mortality from coronary artery disease worldwide.Bayer AG.
650	7	a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicin0 (SwePub)3022 hsv//swe
650	7	a MEDICAL AND HEALTH SCIENCESx Clinical Medicine0 (SwePub)3022 hsv//eng
653		a Aged
653		a Aspirin
653		a administration & dosage
653		a adverse effects
653		a therapeutic use
653		a Cardiovascular Diseases
653		a mortality
653		a prevention & control
653		a Coronary Artery Disease
653		a drug therapy
653		a epidemiology
653		a Dose-Response Relationship
653		a Drug
653		a Double-Blind Method
653		a Drug Administration Schedule
653		a Drug Therapy
653		a Combination
653		a Factor Xa Inhibitors
653		a administration & dosage
653		a adverse effects
653		a therapeutic use
653		a Female
653		a Hemorrhage
653		a chemically induced
653		a Humans
653		a Male
653		a Morbidity
653		a Myocardial Infarction
653		a epidemiology
653		a prevention & control
653		a Platelet Aggregation Inhibitors
653		a administration & dosage
653		a adverse effects
653		a therapeutic use
653		a Rivaroxaban
653		a administration & dosage
653		a adverse effects
653		a therapeutic use
653		a Stroke
653		a epidemiology
653		a prevention & control
700	1	a Eikelboom, John W4 aut
700	1	a Bosch, Jackie4 aut
700	1	a Dagenais, Gilles4 aut
700	1	a Dyal, Leanne4 aut
700	1	a Lanas, Fernando4 aut
700	1	a Metsarinne, Kaj4 aut
700	1	a O'Donnell, Martin4 aut
700	1	a Dans, Anthony L4 aut
700	1	a Ha, Jong-Won4 aut
700	1	a Parkhomenko, Alexandr N4 aut
700	1	a Avezum, Alvaro A4 aut
700	1	a Lonn, Eva4 aut
700	1	a Lisheng, Liu4 aut
700	1	a Torp-Pedersen, Christian4 aut
700	1	a Widimsky, Petr4 aut
700	1	a Maggioni, Aldo P4 aut
700	1	a Felix, Camilo4 aut
700	1	a Keltai, Katalin4 aut
700	1	a Hori, Masatsugu4 aut
700	1	a Yusoff, Khalid4 aut
700	1	a Guzik, Tomasz J4 aut
700	1	a Bhatt, Deepak L4 aut
700	1	a Branch, Kelley R H4 aut
700	1	a Cook Bruns, Nancy4 aut
700	1	a Berkowitz, Scott D4 aut
700	1	a Anand, Sonia S4 aut
700	1	a Varigos, John D4 aut
700	1	a Fox, Keith A A4 aut
700	1	a Yusuf, Salim4 aut
700	1	a Dellborg, Mikael,d 1954u Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för molekylär och klinisk medicin,Institute of Medicine, Department of Molecular and Clinical Medicine4 aut0 (Swepub:gu)xdelmi
710	2	a Göteborgs universitetb Institutionen för medicin, avdelningen för molekylär och klinisk medicin4 org
773	0	t Lancet (London, England)g 391:10117, s. 205-218q 391:10117<205-218x 1474-547X
856	4 8	u https://gup.ub.gu.se/publication/279441
856	4 8	u https://doi.org/10.1016/S0140-6736(17)32458-3
856	4 8	u http://kipublications.ki.se/Default.aspx?queryparsed=id:137587819

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