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Impact of bleeding on mortality after percutaneous coronary intervention results from a patient-level pooled analysis of the REPLACE-2 (randomized evaluation of PCI linking angiomax to reduced clinical events), ACUITY (acute catheterization and urgent intervention triage strategy), and HORIZONS-AMI (harmonizing outcomes with revascularization and stents in acute myocardial infarction) trials.
JACC Cardiovasc Interv. 2011 Jun; 4(6):654-64.JC

Abstract

OBJECTIVES

This study sought to develop a risk score predictive of bleeding in patients undergoing percutaneous coronary intervention (PCI) and to investigate the impact of bleeding on subsequent mortality.

BACKGROUND

Bleeding complications after PCI have been independently associated with early and late mortality.

METHODS

This study represents a patient-level pooled analysis including 17,034 patients undergoing PCI from 3 large, randomized trials of bivalirudin versus heparin plus glycoprotein IIb/IIIa inhibitors, including the REPLACE-2 (Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events), ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy), and HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trials. We developed a risk score to predict noncoronary artery bypass graft (CABG)-related TIMI (Thrombolysis In Myocardial Infarction) major bleeding and evaluated the impact of various types of bleeding on 1-year mortality.

RESULTS

A non-CABG-related TIMI major bleed occurred within 30 days in 267 patients (1.6%), and death occurred in 497 patients (2.9%) within 1 year. A risk score was developed to predict the bleeding risk of patients undergoing PCI, consisting of 7 variables (serum creatinine, age, sex, presentation, white blood cell count, cigarette smoking, and randomized treatment). The TIMI major bleeding rates increased by bleeding risk score groups: from 0.4% for those in the lowest to 5.8% for those in the highest risk group. Non-CABG-related TIMI major bleeding and the occurrence of myocardial infarction within 30 days were independent predictors of subsequent mortality, with respective hazard ratios of 4.2 and 2.9, each p < 0.001. Ranked in order of severity, TIMI major bleeding, blood transfusion without TIMI bleed, TIMI minor bleeding requiring blood transfusion, and TIMI minor bleeding not requiring blood transfusion were independent predictors of subsequent mortality with hazard ratios of 4.89, 2.91, 2.73, and 1.66, respectively. Isolated hematomas were not predictive of subsequent mortality.

CONCLUSIONS

Non-CABG-related bleeding within 30 days is strongly associated with an increased risk of subsequent mortality at 1 year in patients undergoing PCI for all indications. A risk score was established to calculate the bleeding risk for patients undergoing PCI, allowing therapeutic decision making to minimize the incidence of bleeding.

Authors+Show Affiliations

Department of Cardiology, Mount Sinai Medical Center, New York, New York, USA. roxana.mehran@mssm.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21700252

Citation

Mehran, Roxana, et al. "Impact of Bleeding On Mortality After Percutaneous Coronary Intervention Results From a Patient-level Pooled Analysis of the REPLACE-2 (randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events), ACUITY (acute Catheterization and Urgent Intervention Triage Strategy), and HORIZONS-AMI (harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) Trials." JACC. Cardiovascular Interventions, vol. 4, no. 6, 2011, pp. 654-64.
Mehran R, Pocock S, Nikolsky E, et al. Impact of bleeding on mortality after percutaneous coronary intervention results from a patient-level pooled analysis of the REPLACE-2 (randomized evaluation of PCI linking angiomax to reduced clinical events), ACUITY (acute catheterization and urgent intervention triage strategy), and HORIZONS-AMI (harmonizing outcomes with revascularization and stents in acute myocardial infarction) trials. JACC Cardiovasc Interv. 2011;4(6):654-64.
Mehran, R., Pocock, S., Nikolsky, E., Dangas, G. D., Clayton, T., Claessen, B. E., Caixeta, A., Feit, F., Manoukian, S. V., White, H., Bertrand, M., Ohman, E. M., Parise, H., Lansky, A. J., Lincoff, A. M., & Stone, G. W. (2011). Impact of bleeding on mortality after percutaneous coronary intervention results from a patient-level pooled analysis of the REPLACE-2 (randomized evaluation of PCI linking angiomax to reduced clinical events), ACUITY (acute catheterization and urgent intervention triage strategy), and HORIZONS-AMI (harmonizing outcomes with revascularization and stents in acute myocardial infarction) trials. JACC. Cardiovascular Interventions, 4(6), 654-64. https://doi.org/10.1016/j.jcin.2011.02.011
Mehran R, et al. Impact of Bleeding On Mortality After Percutaneous Coronary Intervention Results From a Patient-level Pooled Analysis of the REPLACE-2 (randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events), ACUITY (acute Catheterization and Urgent Intervention Triage Strategy), and HORIZONS-AMI (harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) Trials. JACC Cardiovasc Interv. 2011;4(6):654-64. PubMed PMID: 21700252.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Impact of bleeding on mortality after percutaneous coronary intervention results from a patient-level pooled analysis of the REPLACE-2 (randomized evaluation of PCI linking angiomax to reduced clinical events), ACUITY (acute catheterization and urgent intervention triage strategy), and HORIZONS-AMI (harmonizing outcomes with revascularization and stents in acute myocardial infarction) trials. AU - Mehran,Roxana, AU - Pocock,Stuart, AU - Nikolsky,Eugenia, AU - Dangas,George D, AU - Clayton,Tim, AU - Claessen,Bimmer E, AU - Caixeta,Adriano, AU - Feit,Frederick, AU - Manoukian,Steven V, AU - White,Harvey, AU - Bertrand,Michel, AU - Ohman,E Magnus, AU - Parise,Helen, AU - Lansky,Alexandra J, AU - Lincoff,A Michael, AU - Stone,Gregg W, PY - 2011/02/10/received PY - 2011/02/24/accepted PY - 2011/6/25/entrez PY - 2011/6/28/pubmed PY - 2011/11/11/medline SP - 654 EP - 64 JF - JACC. Cardiovascular interventions JO - JACC Cardiovasc Interv VL - 4 IS - 6 N2 - OBJECTIVES: This study sought to develop a risk score predictive of bleeding in patients undergoing percutaneous coronary intervention (PCI) and to investigate the impact of bleeding on subsequent mortality. BACKGROUND: Bleeding complications after PCI have been independently associated with early and late mortality. METHODS: This study represents a patient-level pooled analysis including 17,034 patients undergoing PCI from 3 large, randomized trials of bivalirudin versus heparin plus glycoprotein IIb/IIIa inhibitors, including the REPLACE-2 (Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events), ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy), and HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trials. We developed a risk score to predict noncoronary artery bypass graft (CABG)-related TIMI (Thrombolysis In Myocardial Infarction) major bleeding and evaluated the impact of various types of bleeding on 1-year mortality. RESULTS: A non-CABG-related TIMI major bleed occurred within 30 days in 267 patients (1.6%), and death occurred in 497 patients (2.9%) within 1 year. A risk score was developed to predict the bleeding risk of patients undergoing PCI, consisting of 7 variables (serum creatinine, age, sex, presentation, white blood cell count, cigarette smoking, and randomized treatment). The TIMI major bleeding rates increased by bleeding risk score groups: from 0.4% for those in the lowest to 5.8% for those in the highest risk group. Non-CABG-related TIMI major bleeding and the occurrence of myocardial infarction within 30 days were independent predictors of subsequent mortality, with respective hazard ratios of 4.2 and 2.9, each p < 0.001. Ranked in order of severity, TIMI major bleeding, blood transfusion without TIMI bleed, TIMI minor bleeding requiring blood transfusion, and TIMI minor bleeding not requiring blood transfusion were independent predictors of subsequent mortality with hazard ratios of 4.89, 2.91, 2.73, and 1.66, respectively. Isolated hematomas were not predictive of subsequent mortality. CONCLUSIONS: Non-CABG-related bleeding within 30 days is strongly associated with an increased risk of subsequent mortality at 1 year in patients undergoing PCI for all indications. A risk score was established to calculate the bleeding risk for patients undergoing PCI, allowing therapeutic decision making to minimize the incidence of bleeding. SN - 1876-7605 UR - https://www.unboundmedicine.com/medline/citation/21700252/Impact_of_bleeding_on_mortality_after_percutaneous_coronary_intervention_results_from_a_patient_level_pooled_analysis_of_the_REPLACE_2__randomized_evaluation_of_PCI_linking_angiomax_to_reduced_clinical_events__ACUITY__acute_catheterization_and_urgent_intervention_triage_strategy__and_HORIZONS_AMI__harmonizing_outcomes_with_revascularization_and_stents_in_acute_myocardial_infarction__trials_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1936-8798(11)00288-3 DB - PRIME DP - Unbound Medicine ER -