Objective To determine the risk and outcomes of serious bleeding events in patients with atherosclerotic vascular disease or risk factors.
Methods 68 375 outpatients with prior ischaemic vascular events or multiple atherosclerotic risk factors were followed in this prospective observational study; 64 977 had 1-year follow-up data. Main outcome measures were rates of serious bleeding events and 1-year outcomes for patients with and without serious bleeding events.
Results The 1-year rate of serious haemorrhage was 0.92%, with a cerebral haemorrhage rate of 0.11%. Patients with symptomatic vascular disease had a haemorrhage rate of 1.0%, compared with 0.59% in those with risk factors only. Risk factors for serious bleeding included age, smoking, hypertension, diabetes, congestive heart failure, use of antithrombotics and polyvascular disease. Bleeding risk increased with the use of anticoagulants (OR 1.99, 95% CI 1.38 to 2.86, p<0.001) or antiplatelet agents combined with anticoagulants (OR 2.54, 95% CI 1.74 to 3.71, p<0.001). By logistic regression analysis, patients with a serious bleed (excluding cerebral haemorrhage) had a more than threefold increased risk (HR 3.25, 95% CI 2.58 to 4.10, p<0.0001) of a significant vascular outcome (myocardial infarction, stroke, vascular death) compared with patients without a serious bleed.
Conclusions Serious bleeding complications were relatively rare, but significant considering the large population at risk. Predictors of increased bleeding were similar to the risk factors for ischaemic events. Patients who experienced a serious bleed had a significantly higher rate of major vascular events.
- Antithrombotic therapy
- vascular disease
- antiplatelet treatment
- delivery of care
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REACH registry global publication committee and national coordinators are listed in appendix 1.
↵* A complete list of the REACH Registry investigators appears in JAMA 2006;295:180–9.
Funding The REACH Registry is sponsored by sanofi-aventis and Bristol-Myers Squibb, and the Waksman Foundation (Tokyo, Japan). The sponsors provide logistical support. All the publication activity is controlled by the REACH Registry Global Publication Committee (Ph Gabriel Steg (co-chair), Deepak L Bhatt (co-chair), Mark J Alberts, Ralph D'Agostino, Kim Eagle, Shinya Goto, Alan T Hirsch, Chisu-Suong Liau, Jean-Louis Mas, E Magnus Ohman, Joachim Röther, Sidney C Smith, Peter W F Wilson). All manuscripts in the REACH Registry are prepared by independent authors who are not governed by the funding sponsors and are reviewed by an academic publication committee before submission. The funding sponsors have the opportunity to review manuscript submissions but do not have authority to change any aspect of a manuscript.
Competing interests MJA has received research grants, speaking honoraria and/or consulting fees from sanofi-aventis, Boehringer-Ingelheim, Bristol-Myers Squibb, Merck/Schering-Plough, Genentech, Pfizer, EKR Therapeutics, WebMD and Lundbeck. He serves on a DSMB for Mitsubishi Pharma. DLB discloses the following relationships: research grants (significant): Astra Zeneca, Bristol-Myers Squibb, Eisai, sanofi-aventis, The Medicines Company. JR discloses the following relationships: speakers bureau (all modest): Boehringer-Ingelheim, Bristol-Myers Squibb, sanofi-aventis, Lundbeck; consulting/advisory board (all modest): Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, sanofi-aventis, Lundbeck. SG has received honoraria and consulting fees from Eisai, sanofi-aventis, Daiichi-Sankyo, GlaxoSmithKline, Bristol-Myers Squibb, Otsuka, Bayer, Schering-Plough, Takeda, Astellas, AstraZeneca, Novartis and Kowa; and research grants from Pfizer, Ono, Eisai, Otsuka, Daiichi-Sankyo, sanofi-aventis, Takeda and Astellas within the last 3 years. ATH has received research grants from Bristol-Myers Squibb and sanofi-aventis. PhGS has received honoraria for advisory board attendance and consulting fees from AstraZeneca, Boehringer-Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, Merck Sharpe and Dohme, Nycomed, sanofi-aventis, Servier, Takeda, The Medicines Company; speakers bureau from Boehringer-Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, Nycomed, sanofi-aventis, Servier, ZLB Behring; and research grant from sanofi-aventis within the last 3 years.
Ethics approval This study was conducted with the approval of the local institutional review boards where appropriate.
Provenance and peer review Not commissioned; externally peer reviewed.