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  1. Article ; Online: Development and validation of a bleeding risk model for patients undergoing elective percutaneous coronary intervention.

    Montalescot, Gilles / Salette, Genevieve / Steg, Gabriel / Cohen, Marc / White, Harvey D / Gallo, Richard / Steinhubl, Steven R

    International journal of cardiology

    2011  Volume 150, Issue 1, Page(s) 79–83

    Abstract: Background: Accurate estimation of bleeding risk in patients undergoing elective percutaneous coronary intervention (PCI) is difficult and not based on widely accepted scores or characteristics. We developed and validated a simple prediction model for ... ...

    Abstract Background: Accurate estimation of bleeding risk in patients undergoing elective percutaneous coronary intervention (PCI) is difficult and not based on widely accepted scores or characteristics. We developed and validated a simple prediction model for major bleeding using the SafeTy and Efficacy of Enoxaparin in PCI patients, an internationaL randomized Evaluation (STEEPLE) trial, which demonstrated the superior safety of enoxaparin over unfractionated heparin (UFH) in 3528 patients undergoing elective PCI.
    Methods and results: Independent predictors of non-coronary artery bypass graft (CABG)-related major bleeding events were determined using stepwise multivariate logistic regression analysis from a development dataset using bootstrap resampling. These predictors were assigned an integer coefficient (risk score) proportional to the estimated coefficient from the logistic model. Risk scores were tested in a validation cohort. Female sex, use of unfractionated heparin (vs. enoxaparin), and use of a glycoprotein IIb/IIIa inhibitor (vs. nonuse) were the strongest independent predictors of bleeding. Extensive testing found that the final model performed well with bootstrap resampling in the development set (c-statistic 0.75; 95% CI: 0.70-0.82; Hosmer-Lemeshow p = 0.29), validation set (c-statistic 0.67; Hosmer-Lemeshow p = 0.12), and subgroups of high-risk patients analysed from the validation set (c-statistic ≥ 0.67).
    Conclusions: Our model for evaluating the risk of non-CABG-related major bleeding in patients undergoing elective PCI identified sex, the type of antithrombin used, and glycoprotein IIb/IIIa inhibitor use as important indicators of bleeding risk, and accurately predicted the incidence of non-CABG-related major bleeding in patients undergoing elective PCI in the STEEPLE trial.
    MeSH term(s) Aged ; Aged, 80 and over ; Angioplasty, Balloon, Coronary/adverse effects ; Cohort Studies ; Elective Surgical Procedures/adverse effects ; Female ; Hemorrhage/diagnosis ; Hemorrhage/epidemiology ; Hemorrhage/etiology ; Humans ; Male ; Middle Aged ; Postoperative Hemorrhage/diagnosis ; Postoperative Hemorrhage/epidemiology ; Postoperative Hemorrhage/etiology ; Prospective Studies ; Risk Factors
    Language English
    Publishing date 2011-07-01
    Publishing country Netherlands
    Document type Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't ; Validation Studies
    ZDB-ID 779519-1
    ISSN 1874-1754 ; 0167-5273
    ISSN (online) 1874-1754
    ISSN 0167-5273
    DOI 10.1016/j.ijcard.2010.02.077
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  2. Article ; Online: Ethnic differences in cardiovascular risks and mortality in atherothrombotic disease: insights from the Reduction of Atherothrombosis for Continued Health (REACH) registry.

    Meadows, Telly A / Bhatt, Deepak L / Cannon, Christopher P / Gersh, Bernard J / Röther, Joachim / Goto, Shinya / Liau, Chiau-Suong / Wilson, Peter W F / Salette, Genevieve / Smith, Sidney C / Steg, Ph Gabriel

    Mayo Clinic proceedings

    2011  Volume 86, Issue 10, Page(s) 960–967

    Abstract: Objective: To determine whether ethnic-specific differences in the prevalence of cardiovascular risk factors and outcomes exist worldwide among individuals with stable arterial disease.: Patients and methods: From December 1, 2003, to June 30, 2004, ... ...

    Abstract Objective: To determine whether ethnic-specific differences in the prevalence of cardiovascular risk factors and outcomes exist worldwide among individuals with stable arterial disease.
    Patients and methods: From December 1, 2003, to June 30, 2004, the prospective, observational REduction of Atherothrombosis for Continued Health (REACH) Registry enrolled 49,602 out-patients with coronary artery disease, cerebrovascular disease, and/or peripheral arterial disease from 7 predefined ethnic/racial groups: white, Hispanic, East Asian, South Asian, Other Asian, black, and Other (comprising any race distinct from those specified). The baseline demographic and risk factor profiles, medication use, and 2-year cardiovascular outcomes were assessed among these groups.
    Results: The prevalence of traditional atherothrombotic risk factors varied significantly among the ethnic/racial groups. The use of medical therapies to reduce risk was comparable among all groups. At 2-year follow-up, the rate of cardiovascular death was significantly higher in blacks (6.1%) compared with all other ethnic/racial groups (3.9%; P=.01). Cardiovascular death rates were significantly lower in all 3 Asian ethnic/racial groups (overall, 2.1%) compared with the other groups (4.5%; P<.001).
    Conclusion: The REACH Registry, a large international study of individuals with atherothrombotic disease, documents the important ethnic-specific differences in cardiovascular risk factors and variations in cardiovascular mortality that currently exist worldwide.
    MeSH term(s) Adult ; Aged ; Atherosclerosis/complications ; Atherosclerosis/ethnology ; Atherosclerosis/mortality ; Atherosclerosis/prevention & control ; Cardiovascular Diseases/ethnology ; Cardiovascular Diseases/mortality ; Female ; Humans ; Male ; Middle Aged ; Prevalence ; Prospective Studies ; Registries ; Risk Assessment ; Risk Factors ; Venous Thrombosis/complications ; Venous Thrombosis/ethnology ; Venous Thrombosis/mortality ; Venous Thrombosis/prevention & control
    Language English
    Publishing date 2011-09-19
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 124027-4
    ISSN 1942-5546 ; 0025-6196
    ISSN (online) 1942-5546
    ISSN 0025-6196
    DOI 10.4065/mcp.2011.0010
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  3. Article ; Online: Physician stated atrial fibrillation management in light of treatment guidelines: data from an international, observational prospective survey.

    Kowey, Peter R / Breithardt, Günter / Camm, John / Crijns, Harry / Dorian, Paul / Le Heuzey, Jean-Yves / Pedrazzini, Laurence / Prystowsky, Eric N / Salette, Geneviève / Schwartz, Peter J / Torp-Pedersen, Christian / Weintraub, William

    Clinical cardiology

    2010  Volume 33, Issue 3, Page(s) 172–178

    Abstract: Background: The Registry on Cardiac Rhythm Disorders Assessing the Control of Atrial Fibrillation (RecordAF) study is the first worldwide, prospective, survey of real-life management of atrial fibrillation (AF) in recently diagnosed patients (n = 5604) ... ...

    Abstract Background: The Registry on Cardiac Rhythm Disorders Assessing the Control of Atrial Fibrillation (RecordAF) study is the first worldwide, prospective, survey of real-life management of atrial fibrillation (AF) in recently diagnosed patients (n = 5604) with a 1-year follow-up.
    Hypothesis: Surveys of AF management have identified a divergence between guidelines and clinical practice, and an overinterpretation of guidelines in low-risk patients.
    Methods: : Physicians' theoretical approaches to rhythm and rate control were investigated using a pre-study questionnaire.
    Results: One cardiologist, from each of the 583 sites in 6 regions, completed a questionnaire on their practice and management of AF patients. In AF patients with structural heart disease (SHD), amiodarone was the most frequent choice of first-line rhythm control agents in all regions. Amiodarone or sotalol tended to be the preferred second-line rhythm control agents, 1 exception being Central/South America. beta-Blockers were the first-line rate control agents for patients with AF and SHD in all regions, and calcium channel blockers and cardiac glycosides were the most common second-line rate control treatments in all regions, except Asia. In lone AF patients, propafenone (30.6%), flecainide (24.1%), and amiodarone (21.7%) were the most common global choices of first-line rhythm control, and amiodarone or sotalol were the preferred second-line rhythm control agents, 1 exception being Central/South America.
    Conclusions: These results highlight points of divergence from the American College of Cardiology (ACC)/ American Heart Association (AHA)/European Society of Cardiology (ESC) guidelines for the management of AF in terms of first-line drug selection in patients with associated SHD or coronary artery disease.
    MeSH term(s) Adrenergic beta-Antagonists/therapeutic use ; Amiodarone/therapeutic use ; Anti-Arrhythmia Agents/therapeutic use ; Atrial Fibrillation/drug therapy ; Calcium Channel Blockers/therapeutic use ; Cardiac Glycosides/therapeutic use ; Cardiotonic Agents/therapeutic use ; Clinical Competence ; Female ; Flecainide/therapeutic use ; Health Care Surveys ; Health Knowledge, Attitudes, Practice ; Heart Rate/drug effects ; Humans ; Internationality ; Male ; Middle Aged ; Practice Guidelines as Topic ; Propafenone/therapeutic use ; Prospective Studies ; Registries ; Sotalol/therapeutic use ; Surveys and Questionnaires
    Chemical Substances Adrenergic beta-Antagonists ; Anti-Arrhythmia Agents ; Calcium Channel Blockers ; Cardiac Glycosides ; Cardiotonic Agents ; Propafenone (68IQX3T69U) ; Sotalol (A6D97U294I) ; Flecainide (K94FTS1806) ; Amiodarone (N3RQ532IUT)
    Language English
    Publishing date 2010-03-08
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 391935-3
    ISSN 1932-8737 ; 0160-9289
    ISSN (online) 1932-8737
    ISSN 0160-9289
    DOI 10.1002/clc.20737
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  4. Article ; Online: Three-year follow-up and event rates in the international REduction of Atherothrombosis for Continued Health Registry.

    Alberts, Mark J / Bhatt, Deepak L / Mas, Jean-Louis / Ohman, E Magnus / Hirsch, Alan T / Röther, Joachim / Salette, Geneviève / Goto, Shinya / Smith, Sidney C / Liau, Chiau-Suong / Wilson, Peter W F / Steg, Ph Gabriel

    European heart journal

    2009  Volume 30, Issue 19, Page(s) 2318–2326

    Abstract: Aims: To determine 3-year event rates in outpatients with vascular disease enrolled in the REduction of Atherothrombosis for Continued Health (REACH) Registry.: Methods and results: REACH enrolled 67 888 outpatients with atherothrombosis [established ...

    Abstract Aims: To determine 3-year event rates in outpatients with vascular disease enrolled in the REduction of Atherothrombosis for Continued Health (REACH) Registry.
    Methods and results: REACH enrolled 67 888 outpatients with atherothrombosis [established coronary artery disease (CAD), cerebrovascular disease, or peripheral arterial disease (PAD)], or with at least three atherothrombotic risk factors, from 44 countries. Among the 55 499 patients at baseline with symptomatic disease, 39 675 were eligible for 3-year follow-up, and 32 247 had data available (81% retention rate). Among the symptomatic patients at 3 years, 92% were taking an antithrombotic agent, 91% an antihypertensive, and 76% were on lipid-lowering therapy. For myocardial infarction (MI)/stroke/vascular death, 1- and 3-year event rates for all patients were 4.2 and 11.0%, respectively. Event rates (MI/stroke/vascular death) were significantly higher for patients with symptomatic disease vs. those with risk factors only at 1 year (4.7 vs. 2.3%, P < 0.001) and at 3 years (12.0 vs. 6.0%, P < 0.001). One and 3-year rates of MI/stroke/vascular death/rehospitalization were 14.4 and 28.4%, respectively, for patients with symptomatic disease. Rehospitalization for a vascular event other than MI/stroke/vascular death was common at 3 years (19.0% overall; 33.6% for PAD; 23.0% for CAD). For patients with symptomatic vascular disease in one vascular bed vs. multiple vascular beds, 3-year event rates for MI/stroke/vascular death/rehospitalization were 25.5 vs. 40.5% (P < 0.001).
    Conclusion: Despite contemporary therapy, outpatients with symptomatic atherothrombotic vascular disease experience high rates of recurrent vascular events and rehospitalizations.
    MeSH term(s) Aged ; Ambulatory Care/standards ; Anticoagulants/therapeutic use ; Antihypertensive Agents/therapeutic use ; Coronary Artery Disease/prevention & control ; Diabetes Complications/complications ; Female ; Follow-Up Studies ; Hospitalization/statistics & numerical data ; Humans ; Hypertension/complications ; Hypoglycemic Agents/therapeutic use ; Male ; Myocardial Infarction/etiology ; Obesity/complications ; Peripheral Vascular Diseases/etiology ; Registries ; Risk Factors ; Secondary Prevention ; Smoking/adverse effects ; Stroke/etiology
    Chemical Substances Anticoagulants ; Antihypertensive Agents ; Hypoglycemic Agents
    Language English
    Publishing date 2009-08-31
    Publishing country England
    Document type Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
    ZDB-ID 603098-1
    ISSN 1522-9645 ; 0195-668X
    ISSN (online) 1522-9645
    ISSN 0195-668X
    DOI 10.1093/eurheartj/ehp355
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  5. Article: Impact of anticoagulation levels on outcomes in patients undergoing elective percutaneous coronary intervention: insights from the STEEPLE trial.

    Montalescot, Gilles / Cohen, Marc / Salette, Genevieve / Desmet, Walter J / Macaya, Carlos / Aylward, Philip E G / Steg, Ph Gabriel / White, Harvey D / Gallo, Richard / Steinhubl, Steven R

    European heart journal

    2008  Volume 29, Issue 4, Page(s) 462–471

    Abstract: Aims: To determine the relationship between anticoagulation levels during percutaneous coronary intervention, and ischaemic events and bleeding.: Methods and results: A sub-analysis from the STEEPLE trial was conducted. Pre-defined target ... ...

    Abstract Aims: To determine the relationship between anticoagulation levels during percutaneous coronary intervention, and ischaemic events and bleeding.
    Methods and results: A sub-analysis from the STEEPLE trial was conducted. Pre-defined target anticoagulation levels were achieved in 86% of patients receiving enoxaparin, compared with 20% receiving unfractionated heparin (UFH) (P < 0.001). A significant relationship was observed between anti-Xa levels > 0.9 IU/mL and covariate-adjusted rate of non-coronary artery bypass graft-related major and minor bleeding [odds ratio (OR) 1.6, 95% CI 1.0-2.5 for each unit of anti-Xa; P = 0.03]; anti-Xa levels and covariate-adjusted incidence of death, myocardial infarction, or revascularization showed no significance (P = 0.47). Major bleeding increased significantly with an activated clotting time (ACT) > 325 s (OR 1.6, 95% CI 1.1-2.2 per 100 s; P = 0.04). A significant relationship with increasing ischaemic events was observed when ACT was < 325 s (OR 0.7, 95% CI 0.2-0.8 per 100 s; P = 0.006) indicating a narrow therapeutic window.
    Conclusion: Target anticoagulation levels were achieved more readily in patients receiving enoxaparin. An anti-Xa level of up to 0.9 IU/mL has a good safety and efficacy profile; poor achievement of target ACT with UFH makes assessing the optimal range difficult.
    MeSH term(s) Aged ; Angioplasty, Balloon, Coronary/methods ; Anticoagulants/administration & dosage ; Anticoagulants/blood ; Coronary Thrombosis/blood ; Coronary Thrombosis/prevention & control ; Enoxaparin/administration & dosage ; Enoxaparin/blood ; Factor Xa Inhibitors ; Female ; Fibrinolytic Agents/administration & dosage ; Fibrinolytic Agents/blood ; Heparin/administration & dosage ; Heparin/blood ; Humans ; Male ; Myocardial Infarction/blood ; Myocardial Infarction/prevention & control ; Myocardial Ischemia/blood ; Myocardial Ischemia/therapy ; Platelet Glycoprotein GPIIb-IIIa Complex/administration & dosage ; Whole Blood Coagulation Time/methods
    Chemical Substances Anticoagulants ; Enoxaparin ; Factor Xa Inhibitors ; Fibrinolytic Agents ; Platelet Glycoprotein GPIIb-IIIa Complex ; Heparin (9005-49-6)
    Language English
    Publishing date 2008-02
    Publishing country England
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 603098-1
    ISSN 1522-9645 ; 0195-668X
    ISSN (online) 1522-9645
    ISSN 0195-668X
    DOI 10.1093/eurheartj/ehn008
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  6. Article ; Online: Comparative determinants of 4-year cardiovascular event rates in stable outpatients at risk of or with atherothrombosis.

    Bhatt, Deepak L / Eagle, Kim A / Ohman, E Magnus / Hirsch, Alan T / Goto, Shinya / Mahoney, Elizabeth M / Wilson, Peter W F / Alberts, Mark J / D'Agostino, Ralph / Liau, Chiau-Suong / Mas, Jean-Louis / Röther, Joachim / Smith, Sidney C / Salette, Geneviève / Contant, Charles F / Massaro, Joseph M / Steg, Ph Gabriel

    JAMA

    2010  Volume 304, Issue 12, Page(s) 1350–1357

    Abstract: Context: Clinicians and trialists have difficulty with identifying which patients are highest risk for cardiovascular events. Prior ischemic events, polyvascular disease, and diabetes mellitus have all been identified as predictors of ischemic events, ... ...

    Abstract Context: Clinicians and trialists have difficulty with identifying which patients are highest risk for cardiovascular events. Prior ischemic events, polyvascular disease, and diabetes mellitus have all been identified as predictors of ischemic events, but their comparative contributions to future risk remain unclear.
    Objective: To categorize the risk of cardiovascular events in stable outpatients with various initial manifestations of atherothrombosis using simple clinical descriptors.
    Design, setting, and patients: Outpatients with coronary artery disease, cerebrovascular disease, or peripheral arterial disease or with multiple risk factors for atherothrombosis were enrolled in the global Reduction of Atherothrombosis for Continued Health (REACH) Registry and were followed up for as long as 4 years. Patients from 3647 centers in 29 countries were enrolled between 2003 and 2004 and followed up until 2008. Final database lock was in April 2009.
    Main outcome measures: Rates of cardiovascular death, myocardial infarction, and stroke.
    Results: A total of 45,227 patients with baseline data were included in this 4-year analysis. During the follow-up period, a total of 5481 patients experienced at least 1 event, including 2315 with cardiovascular death, 1228 with myocardial infarction, 1898 with stroke, and 40 with both a myocardial infarction and stroke on the same day. Among patients with atherothrombosis, those with a prior history of ischemic events at baseline (n = 21,890) had the highest rate of subsequent ischemic events (18.3%; 95% confidence interval [CI], 17.4%-19.1%); patients with stable coronary, cerebrovascular, or peripheral artery disease (n = 15,264) had a lower risk (12.2%; 95% CI, 11.4%-12.9%); and patients without established atherothrombosis but with risk factors only (n = 8073) had the lowest risk (9.1%; 95% CI, 8.3%-9.9%) (P < .001 for all comparisons). In addition, in multivariable modeling, the presence of diabetes (hazard ratio [HR], 1.44; 95% CI, 1.36-1.53; P < .001), an ischemic event in the previous year (HR, 1.71; 95% CI, 1.57-1.85; P < .001), and polyvascular disease (HR, 1.99; 95% CI, 1.78-2.24; P < .001) each were associated with a significantly higher risk of the primary end point.
    Conclusion: Clinical descriptors can assist clinicians in identifying high-risk patients within the broad range of risk for outpatients with atherothrombosis.
    MeSH term(s) Aged ; Atherosclerosis/complications ; Atherosclerosis/epidemiology ; Cardiovascular Diseases/mortality ; Diabetes Mellitus/epidemiology ; Female ; Forecasting ; Humans ; Male ; Middle Aged ; Myocardial Infarction/epidemiology ; Myocardial Infarction/etiology ; Outpatients ; Peripheral Vascular Diseases/epidemiology ; Prognosis ; Registries/statistics & numerical data ; Risk Assessment ; Risk Factors ; Stroke/epidemiology ; Stroke/etiology ; Thrombosis/complications ; Thrombosis/epidemiology
    Language English
    Publishing date 2010-09-22
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2958-0
    ISSN 1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
    ISSN (online) 1538-3598
    ISSN 0254-9077 ; 0002-9955 ; 0098-7484
    DOI 10.1001/jama.2010.1322
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