PMID- 24733305
OWN - NLM
STAT- MEDLINE
DCOM- 20140812
LR  - 20220330
IS  - 2168-6114 (Electronic)
IS  - 2168-6106 (Linking)
VI  - 174
IP  - 6
DP  - 2014 Jun
TI  - Bleeding risk of patients with acute venous thromboembolism taking nonsteroidal 
      anti-inflammatory drugs or aspirin.
PG  - 947-53
LID - 10.1001/jamainternmed.2014.946 [doi]
AB  - IMPORTANCE: Combined anticoagulant and aspirin therapy is associated with 
      increased bleeding risk in patients with atrial fibrillation, but the bleeding 
      risk of combined use of anticoagulant and nonsteroidal anti-inflammatory drugs 
      (NSAIDs) is poorly documented. OBJECTIVE: To estimate the bleeding risk of 
      combined anticoagulant (rivaroxaban or enoxaparin-vitamin K antagonist [VKA]) and 
      NSAID or aspirin therapy in patients with venous thromboembolism. DESIGN, 
      SETTING, AND PARTICIPANTS: Prospective analysis of observational data from the 
      EINSTEIN deep vein thrombosis and pulmonary embolism clinical trials comparing 
      rivaroxaban with enoxaparin-VKA treatment, trials performed in hospitals and 
      clinics in 8246 patients enrolled from 2007 to 2009. EXPOSURE: Bleeding event 
      rates during exposure to NSAID and aspirin therapy were compared to time without 
      exposure. MAIN OUTCOMES AND MEASURES: Days of NSAID or aspirin use and nonuse, 
      clinically relevant bleeding event and major bleeding event rates by 
      patient-years, and hazard ratios. RESULTS: During NSAID-anticoagulant concomitant 
      treatment, clinically relevant bleeding occurred with an event rate of 37.5 per 
      100 patient-years vs 16.6 per 100 patient-years during anticoagulant use only 
      (hazard ratio [HR], 1.77 [95% CI, 1.46-2.14]). Major bleeding during 
      NSAID-anticoagulant treatment occurred with an event rate of 6.5 per 100 
      patient-years, compared to 2.0 per 100 patient-years during nonuse (HR, 2.37 [95% 
      CI, 1.51-3.75]). For aspirin-anticoagulant concomitant treatment, clinically 
      relevant bleeding occurred with an event rate of 36.6 per 100 patient-years, 
      compared to 16.9 per 100 patient-years during aspirin nonuse (HR, 1.70 [95% CI, 
      1.38-2.11]). Major bleeding in aspirin-anticoagulant-treated patients occurred 
      with an event rate of 4.8 per 100 patient-years, compared to 2.2 per 100 
      patient-years during aspirin nonuse (HR, 1.50 [95% CI, 0.86-2.62]). Increases in 
      risk for clinically relevant and major bleeding were similar for rivaroxaban and 
      enoxaparin-VKA anticoagulation regimens. CONCLUSIONS AND RELEVANCE: Among 
      patients with venous thromboembolism receiving anticoagulant therapy, concomitant 
      use of an NSAID or aspirin is associated with an increased risk of clinically 
      relevant and major bleeding.
FAU - Davidson, Bruce L
AU  - Davidson BL
AD  - Division of Pulmonary and Critical Care Medicine,University of Washington School 
      of Medicine, Seattle, Washington.
FAU - Verheijen, Sara
AU  - Verheijen S
AD  - University of Amsterdam, the Netherlands.
FAU - Lensing, Anthonie W A
AU  - Lensing AW
AD  - Bayer Healthcare, Wuppertal, Germany4Academic Medical Centre, Amsterdam, the 
      Netherlands.
FAU - Gebel, Martin
AU  - Gebel M
AD  - Bayer Healthcare, Wuppertal, Germany.
FAU - Brighton, Timothy A
AU  - Brighton TA
AD  - Haematology Division, Prince of Wales Hospital, Sydney, Australia.
FAU - Lyons, Roger M
AU  - Lyons RM
AD  - Cancer Care Centers of South Texas/US Oncology, San Antonio, Texas.
FAU - Rehm, Jeffrey
AU  - Rehm J
AD  - Pulmonary Associates of Fredericksburg, Fredericksburg, Virginia.
FAU - Prins, Martin H
AU  - Prins MH
AD  - Maastricht University Medical Centre, Maastricht, the Netherlands.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - JAMA Intern Med
JT  - JAMA internal medicine
JID - 101589534
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Anticoagulants)
RN  - 0 (Enoxaparin)
RN  - 0 (Morpholines)
RN  - 0 (Thiophenes)
RN  - 9NDF7JZ4M3 (Rivaroxaban)
RN  - R16CO5Y76E (Aspirin)
SB  - IM
CIN - Praxis (Bern 1994). 2014 Sep 17;103(19):1153-4. PMID: 25228578
CIN - Medsurg Nurs. 2014 Sep-Oct;23(5):Suppl 14-5. PMID: 26292445
MH  - Adult
MH  - Aged
MH  - Anti-Inflammatory Agents, Non-Steroidal/*adverse effects
MH  - Anticoagulants/*adverse effects
MH  - Aspirin/*adverse effects
MH  - Drug Therapy, Combination
MH  - Enoxaparin/adverse effects
MH  - Female
MH  - Hemorrhage/*chemically induced
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Morpholines/adverse effects
MH  - Prospective Studies
MH  - Randomized Controlled Trials as Topic
MH  - Risk Assessment
MH  - Rivaroxaban
MH  - Thiophenes/adverse effects
MH  - Venous Thromboembolism/complications/*drug therapy
EDAT- 2014/04/16 06:00
MHDA- 2014/08/13 06:00
CRDT- 2014/04/16 06:00
PHST- 2014/04/16 06:00 [entrez]
PHST- 2014/04/16 06:00 [pubmed]
PHST- 2014/08/13 06:00 [medline]
AID - 1860497 [pii]
AID - 10.1001/jamainternmed.2014.946 [doi]
PST - ppublish
SO  - JAMA Intern Med. 2014 Jun;174(6):947-53. doi: 10.1001/jamainternmed.2014.946.