TY - JOUR
T1 - Risk score to predict serious bleeding in stable outpatients with or at risk of atherothrombosis
AU - Ducrocq, Gregory
AU - Wallace, Joshua S.
AU - Baron, Gabriel
AU - Ravaud, Philippe
AU - Alberts, Mark J.
AU - Wilson, Peter W F
AU - Ohman, Erik Magnus
AU - Brennan, Danielle M.
AU - D'Agostino, Ralph B.
AU - Bhatt, Deepak L.
AU - Steg, Philippe Gabriel
N1 - Funding Information:
Conflict of interest: G.D. has no conflicts of interest. J.S.W. has received research grants from sanofi-aventis. G.B. has received research grants from sanofi-aventis. P.R. has received research grants from sanofi-aventis. M.J.A. has received research grants from AGA Medical, AstraZeneca, BMS, Boehringer Ingelheim, Novo Nordisk, Photo Thera, sanofi-aventis, and Schering-Plough; is a consultant for AGA Medical, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Eli Lilly & Co, Genentech, KOS, The Medicines Company, Merck, Novo Nordisk, PDL BioPharma, Inc., Pfizer, and sanofi-aventis; is on the Speaker’s bureau for AstraZeneca, BMS, Boehringer Ingelheim, dia-Dexus, Genentech, The Medicines Company, Medscape, Novo Nordisk, PDL BioPharma Inc., and sanofi-aventis; is an advisory board member for AGA Medical, AstraZeneca, BMS, Boehringer Ingel-heim, Eli Lilly & Co, Genentech, KOS, The Medicines Company, Merck, Novo Nordisk, Pfizer, and sanofi-aventis; and receives honoraria from AGA Medical, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, dia-Dexus, Eli Lilly & Co, Genentech, KOS, The Medicines Company, Medscape, Merck, Novo Nordisk, PDL BioPharma, Inc., Pfizer, sanofi-aventis, TAP Pharmaceuticals-DSMB, and Schering-Plough. P.W.F.W. has received grant support from sanofi-aventis. E.M.O. receives research grants from AstraZeneca, Bristol-Myers Squibb, CV Therapeutics, Inc., Daiichi Sankyo, Datascope, Eli Lilly & Company, Sanofi-Aventis, Schering-Plough Corporation, The Medicines Company, provides consulting or other services for Abiomed, CV Therapeutics, Inc., Datascope, Inovise, Liposcience, Northpoint Domain, Pozen, Inc., Response Biomedical, sanofi-aventis, The Medicines Company, and WebMD (theheart.org), and has equity in Inovise. D.M.B. has no disclosures. R.B.D’A. has received research grants from the NIH/NHLBI and a Framingham contract; honoraria from sanofi-aventis (REACH Registry); and is a consultant/advisory board member for sanofi-aventis (REACH Registry). D.L.B. discloses the following relationships: Research Grants—Bristol Myers Squibb, Eisai, Ethicon, Heartscape, sanofi-aventis, The Medicines Company; Consultant/Advisory Board—Arena, Astellas, Astra Zeneca, Bayer, Bristol Myers Squibb, Cardax, Centocor, Cogentus, Daiichi-Sankyo, Eisai, Eli Lilly, Glaxo Smith Kline, Johnson & Johnson, McNeil, Medtro-nic, Millennium, Molecular Insights, Otsuka, Paringenix, PDL, Philips, Portola, sanofi-aventis, Schering Plough, Scios, Takeda, The Medicines Company, Vertex. Ph.G.S. discloses the following relationships: Research Grant: sanofi-aventis (significant); Speakers bureau (all modest): Boehringer-Ingelheim, BMS, GSK, Medtronic, Nycomed, sanofi-aventis, Servier, The Medicines Company; Consulting/advisory board (all modest): Astellas, AstraZeneca, Bayer, Boehringer-Ingelheim, BMS, Endotis, GSK, Medtronic, MSD, Nycomed, sanofi-aventis, Servier, The Medicines Company. Stockholding: none.
Funding Information:
This work was supported by sanofi-aventis, Bristol-Myers Squibb, and the Waksman Foundation (Tokyo, Japan). Funding to pay the Open Access publication charges for this article was provided by sanofi-aventis and Bristol Myers Squibb.
PY - 2010/5
Y1 - 2010/5
N2 - AimsTo develop a risk score to quantify bleeding risk in outpatients with or at risk of atherothrombosis.Methods and resultsWe studied patients in the REACH Registry, a cohort of 68 236 patients with/at risk of atherothrombosis. The outcome of interest was serious bleeding (non-fatal haemorrhagic stroke or bleeding leading to hospitalization and transfusion) over 2 years. Risk factors for bleeding were assessed using modified regression analysis. Multiple potential scoring systems based on the least complex models were constructed. Competing scores were compared on their discriminative ability via logistic regression. The score was validated externally using the CHARISMA population. From a final cohort of 56 616 patients, 804 (1.42, 95 confidence interval 1.32-1.52) experienced serious bleeding between baseline and 2 years. A nine-item bleeding risk score (0-23 points) was constructed (age, peripheral arterial disease, congestive heart failure, diabetes, hypertension, smoking, antiplatelets, oral anticoagulants, hypercholesterolaemia). Observed incidence of bleeding at 2 years was: 0.46 (score ≤6); 0.95 (7-8); 1.25 (9-10); 2.76 (≥11). The score's discriminative performance was consistent in CHARISMA and REACH (c-statistics 0.64 and 0.68, respectively); calibration in the CHARISMA population was very good (modified Hosmer-Lemeshow c2 = 4.74; P = 0.69). Conclusion Bleeding risk increased substantially with a score >10. This score can assist clinicians in predicting the risk of serious bleeding and making decisions on antithrombotic therapy in outpatients.
AB - AimsTo develop a risk score to quantify bleeding risk in outpatients with or at risk of atherothrombosis.Methods and resultsWe studied patients in the REACH Registry, a cohort of 68 236 patients with/at risk of atherothrombosis. The outcome of interest was serious bleeding (non-fatal haemorrhagic stroke or bleeding leading to hospitalization and transfusion) over 2 years. Risk factors for bleeding were assessed using modified regression analysis. Multiple potential scoring systems based on the least complex models were constructed. Competing scores were compared on their discriminative ability via logistic regression. The score was validated externally using the CHARISMA population. From a final cohort of 56 616 patients, 804 (1.42, 95 confidence interval 1.32-1.52) experienced serious bleeding between baseline and 2 years. A nine-item bleeding risk score (0-23 points) was constructed (age, peripheral arterial disease, congestive heart failure, diabetes, hypertension, smoking, antiplatelets, oral anticoagulants, hypercholesterolaemia). Observed incidence of bleeding at 2 years was: 0.46 (score ≤6); 0.95 (7-8); 1.25 (9-10); 2.76 (≥11). The score's discriminative performance was consistent in CHARISMA and REACH (c-statistics 0.64 and 0.68, respectively); calibration in the CHARISMA population was very good (modified Hosmer-Lemeshow c2 = 4.74; P = 0.69). Conclusion Bleeding risk increased substantially with a score >10. This score can assist clinicians in predicting the risk of serious bleeding and making decisions on antithrombotic therapy in outpatients.
KW - Antithrombotic therapy
KW - Atherothrombosis
KW - Bleeding risk
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U2 - 10.1093/eurheartj/ehq021
DO - 10.1093/eurheartj/ehq021
M3 - Article
C2 - 20181681
AN - SCOPUS:77952397810
SN - 0195-668X
VL - 31
SP - 1257
EP - 1265
JO - European heart journal
JF - European heart journal
IS - 10
ER -