Risk factors, medical therapies and perioperative events in limb salvage surgery: Observations from the PREVENT III multicenter trial

Michael S. Conte, Dennis F. Bandyk, Alexander W. Clowes, Gregory (Greg) Moneta, Hamid Namini, Lynn Seely

    Research output: Contribution to journalArticle

    120 Citations (Scopus)

    Abstract

    Objectives: Patients who require infrainguinal revascularization for critical limb ischemia (CLI) are at elevated risk for cardiovascular events. The PREVENT III study was a prospective, randomized, multicenter, phase 3 trial of edifoligide for the prevention of vein graft failure in patients with CLI. We examined the baseline characteristics, perioperative medical therapies, and 30-day incidence of major cardiovascular events in the PREVENT III cohort. Methods: Demographics, medical and surgical history, mode of presentation for the index limb, procedural details, and concomitant medications were reviewed for all patients enrolled in PREVENT III (N = 1,404). Major adverse cardiovascular events, including death, myocardial infarction, or cerebrovascular event (stroke or transient ischemic attack) were tabulated. Univariate and multivariate analyses were performed to discern factors that were associated with the utilization of medical therapies and with perioperative events. Results: Demographics and comorbidities reflected a population with diffuse, advanced atherosclerosis. Perioperative mortality was 2.7%, and major morbidity included myocardial infarction in 4.7% and stroke/transient ischemic attack in 1.4%. Among this population of CLI patients, 33% were not on antiplatelet therapy at study entry, and 24% were not receiving antithrombotics of any type. In addition, 54% of patients were not receiving lipid-lowering therapy, and 52% were not prescribed β-blocker medications at study entry. On multivariate analysis, race was a significant determinant of antithrombotic utilization, with African-American patients less frequently treated both at baseline and discharge (adjusted odd ratios, 0.5 and 0.6, P <.0001). Antithrombotic and β-blocker drug usage increased in the overall cohort from baseline (76% and 48%) to discharge (88% and 60%; P <.0001). Patients treated in a university hospital setting were more likely to be prescribed antiplatelet, lipid-lowering, and β-blocker medications. Advanced age (>75 years), coronary artery disease (prior myocardial infarction or revascularization), and dialysis-dependent renal failure were associated with an increased 30-day risk of death, myocardial infarction, or stroke. Protective effects of β-blocker and lipid-lowering medications were noted in these defined subgroups. Conclusions: A significant percentage of the population that undergoes surgical revascularization for CLI is not prescribed therapies of proven benefit in reducing cardiovascular events. Utilization of antithrombotics and β-blockers increases during hospitalization for limb salvage surgery but that of lipid-lowering therapy does not. African-American patients appear to be at greater risk for undertreatment with antithrombotics, and the data suggest that patients undergoing leg bypass surgery in a university hospital setting receive more comprehensive medical treatment of atherosclerosis. Treatment guidelines for medical therapy are needed to standardize care and improve outcomes for patients with CLI.

    Original languageEnglish (US)
    Pages (from-to)456-464
    Number of pages9
    JournalJournal of Vascular Surgery
    Volume42
    Issue number3
    DOIs
    StatePublished - Sep 2005

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    Limb Salvage
    Multicenter Studies
    Extremities
    Ischemia
    Myocardial Infarction
    Therapeutics
    Stroke
    Transient Ischemic Attack
    Lipids
    African Americans
    Atherosclerosis
    Multivariate Analysis
    Demography
    Population
    Myocardial Revascularization
    Renal Insufficiency
    Comorbidity
    Coronary Artery Disease
    Dialysis
    Veins

    ASJC Scopus subject areas

    • Cardiology and Cardiovascular Medicine
    • Surgery

    Cite this

    Risk factors, medical therapies and perioperative events in limb salvage surgery : Observations from the PREVENT III multicenter trial. / Conte, Michael S.; Bandyk, Dennis F.; Clowes, Alexander W.; Moneta, Gregory (Greg); Namini, Hamid; Seely, Lynn.

    In: Journal of Vascular Surgery, Vol. 42, No. 3, 09.2005, p. 456-464.

    Research output: Contribution to journalArticle

    Conte, Michael S. ; Bandyk, Dennis F. ; Clowes, Alexander W. ; Moneta, Gregory (Greg) ; Namini, Hamid ; Seely, Lynn. / Risk factors, medical therapies and perioperative events in limb salvage surgery : Observations from the PREVENT III multicenter trial. In: Journal of Vascular Surgery. 2005 ; Vol. 42, No. 3. pp. 456-464.
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    abstract = "Objectives: Patients who require infrainguinal revascularization for critical limb ischemia (CLI) are at elevated risk for cardiovascular events. The PREVENT III study was a prospective, randomized, multicenter, phase 3 trial of edifoligide for the prevention of vein graft failure in patients with CLI. We examined the baseline characteristics, perioperative medical therapies, and 30-day incidence of major cardiovascular events in the PREVENT III cohort. Methods: Demographics, medical and surgical history, mode of presentation for the index limb, procedural details, and concomitant medications were reviewed for all patients enrolled in PREVENT III (N = 1,404). Major adverse cardiovascular events, including death, myocardial infarction, or cerebrovascular event (stroke or transient ischemic attack) were tabulated. Univariate and multivariate analyses were performed to discern factors that were associated with the utilization of medical therapies and with perioperative events. Results: Demographics and comorbidities reflected a population with diffuse, advanced atherosclerosis. Perioperative mortality was 2.7{\%}, and major morbidity included myocardial infarction in 4.7{\%} and stroke/transient ischemic attack in 1.4{\%}. Among this population of CLI patients, 33{\%} were not on antiplatelet therapy at study entry, and 24{\%} were not receiving antithrombotics of any type. In addition, 54{\%} of patients were not receiving lipid-lowering therapy, and 52{\%} were not prescribed β-blocker medications at study entry. On multivariate analysis, race was a significant determinant of antithrombotic utilization, with African-American patients less frequently treated both at baseline and discharge (adjusted odd ratios, 0.5 and 0.6, P <.0001). Antithrombotic and β-blocker drug usage increased in the overall cohort from baseline (76{\%} and 48{\%}) to discharge (88{\%} and 60{\%}; P <.0001). Patients treated in a university hospital setting were more likely to be prescribed antiplatelet, lipid-lowering, and β-blocker medications. Advanced age (>75 years), coronary artery disease (prior myocardial infarction or revascularization), and dialysis-dependent renal failure were associated with an increased 30-day risk of death, myocardial infarction, or stroke. Protective effects of β-blocker and lipid-lowering medications were noted in these defined subgroups. Conclusions: A significant percentage of the population that undergoes surgical revascularization for CLI is not prescribed therapies of proven benefit in reducing cardiovascular events. Utilization of antithrombotics and β-blockers increases during hospitalization for limb salvage surgery but that of lipid-lowering therapy does not. African-American patients appear to be at greater risk for undertreatment with antithrombotics, and the data suggest that patients undergoing leg bypass surgery in a university hospital setting receive more comprehensive medical treatment of atherosclerosis. Treatment guidelines for medical therapy are needed to standardize care and improve outcomes for patients with CLI.",
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    T1 - Risk factors, medical therapies and perioperative events in limb salvage surgery

    T2 - Observations from the PREVENT III multicenter trial

    AU - Conte, Michael S.

    AU - Bandyk, Dennis F.

    AU - Clowes, Alexander W.

    AU - Moneta, Gregory (Greg)

    AU - Namini, Hamid

    AU - Seely, Lynn

    PY - 2005/9

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    N2 - Objectives: Patients who require infrainguinal revascularization for critical limb ischemia (CLI) are at elevated risk for cardiovascular events. The PREVENT III study was a prospective, randomized, multicenter, phase 3 trial of edifoligide for the prevention of vein graft failure in patients with CLI. We examined the baseline characteristics, perioperative medical therapies, and 30-day incidence of major cardiovascular events in the PREVENT III cohort. Methods: Demographics, medical and surgical history, mode of presentation for the index limb, procedural details, and concomitant medications were reviewed for all patients enrolled in PREVENT III (N = 1,404). Major adverse cardiovascular events, including death, myocardial infarction, or cerebrovascular event (stroke or transient ischemic attack) were tabulated. Univariate and multivariate analyses were performed to discern factors that were associated with the utilization of medical therapies and with perioperative events. Results: Demographics and comorbidities reflected a population with diffuse, advanced atherosclerosis. Perioperative mortality was 2.7%, and major morbidity included myocardial infarction in 4.7% and stroke/transient ischemic attack in 1.4%. Among this population of CLI patients, 33% were not on antiplatelet therapy at study entry, and 24% were not receiving antithrombotics of any type. In addition, 54% of patients were not receiving lipid-lowering therapy, and 52% were not prescribed β-blocker medications at study entry. On multivariate analysis, race was a significant determinant of antithrombotic utilization, with African-American patients less frequently treated both at baseline and discharge (adjusted odd ratios, 0.5 and 0.6, P <.0001). Antithrombotic and β-blocker drug usage increased in the overall cohort from baseline (76% and 48%) to discharge (88% and 60%; P <.0001). Patients treated in a university hospital setting were more likely to be prescribed antiplatelet, lipid-lowering, and β-blocker medications. Advanced age (>75 years), coronary artery disease (prior myocardial infarction or revascularization), and dialysis-dependent renal failure were associated with an increased 30-day risk of death, myocardial infarction, or stroke. Protective effects of β-blocker and lipid-lowering medications were noted in these defined subgroups. Conclusions: A significant percentage of the population that undergoes surgical revascularization for CLI is not prescribed therapies of proven benefit in reducing cardiovascular events. Utilization of antithrombotics and β-blockers increases during hospitalization for limb salvage surgery but that of lipid-lowering therapy does not. African-American patients appear to be at greater risk for undertreatment with antithrombotics, and the data suggest that patients undergoing leg bypass surgery in a university hospital setting receive more comprehensive medical treatment of atherosclerosis. Treatment guidelines for medical therapy are needed to standardize care and improve outcomes for patients with CLI.

    AB - Objectives: Patients who require infrainguinal revascularization for critical limb ischemia (CLI) are at elevated risk for cardiovascular events. The PREVENT III study was a prospective, randomized, multicenter, phase 3 trial of edifoligide for the prevention of vein graft failure in patients with CLI. We examined the baseline characteristics, perioperative medical therapies, and 30-day incidence of major cardiovascular events in the PREVENT III cohort. Methods: Demographics, medical and surgical history, mode of presentation for the index limb, procedural details, and concomitant medications were reviewed for all patients enrolled in PREVENT III (N = 1,404). Major adverse cardiovascular events, including death, myocardial infarction, or cerebrovascular event (stroke or transient ischemic attack) were tabulated. Univariate and multivariate analyses were performed to discern factors that were associated with the utilization of medical therapies and with perioperative events. Results: Demographics and comorbidities reflected a population with diffuse, advanced atherosclerosis. Perioperative mortality was 2.7%, and major morbidity included myocardial infarction in 4.7% and stroke/transient ischemic attack in 1.4%. Among this population of CLI patients, 33% were not on antiplatelet therapy at study entry, and 24% were not receiving antithrombotics of any type. In addition, 54% of patients were not receiving lipid-lowering therapy, and 52% were not prescribed β-blocker medications at study entry. On multivariate analysis, race was a significant determinant of antithrombotic utilization, with African-American patients less frequently treated both at baseline and discharge (adjusted odd ratios, 0.5 and 0.6, P <.0001). Antithrombotic and β-blocker drug usage increased in the overall cohort from baseline (76% and 48%) to discharge (88% and 60%; P <.0001). Patients treated in a university hospital setting were more likely to be prescribed antiplatelet, lipid-lowering, and β-blocker medications. Advanced age (>75 years), coronary artery disease (prior myocardial infarction or revascularization), and dialysis-dependent renal failure were associated with an increased 30-day risk of death, myocardial infarction, or stroke. Protective effects of β-blocker and lipid-lowering medications were noted in these defined subgroups. Conclusions: A significant percentage of the population that undergoes surgical revascularization for CLI is not prescribed therapies of proven benefit in reducing cardiovascular events. Utilization of antithrombotics and β-blockers increases during hospitalization for limb salvage surgery but that of lipid-lowering therapy does not. African-American patients appear to be at greater risk for undertreatment with antithrombotics, and the data suggest that patients undergoing leg bypass surgery in a university hospital setting receive more comprehensive medical treatment of atherosclerosis. Treatment guidelines for medical therapy are needed to standardize care and improve outcomes for patients with CLI.

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