Bleeding Academic Research Consortium Criteria Research Articles

Incidence and impact on prognosis of bleeding during percutaneous coronary interventions in patients with chronic kidney disease

Limited information exists on the prognostic impact of bleeding after percutaneous coronary intervention (PCI) in patients with chronic kidney disease (CKD). We investigated the impact of bleeding after PCI on the outcome of these patients. The study included 2,934 patients with estimated creatinine clearance <60 ml/min. Bleeding events within 30 days after PCI were assessed using the Bleeding Academic Research Consortium (BARC) criteria. The primary outcome was 1-year mortality. Bleeding events occurred in 485 patients (16.5 %). BARC classes were: class 1 (n = 155), class 2 (n = 73), class 3a (n = 182), class 3b (n = 68), class 3c (n = 6) and class 4 (n = 1). There were 212 deaths over the first year after PCI: 60 deaths in patients who bled and 152 deaths in patients who did not bleed (Kaplan-Meier [KM] estimates, 12.5 and 6.3 %; odds ratio [OR] = 2.11, 95 % confidence interval [CI] 1.57-2.83, P < 0.001). Nonfatal myocardial infarction occurred in 71 patients who bled and in 141 patients who did not bleed (KM estimates, 14.8 and 5.8 %; OR = 2.70 [2.05-3.55], P < 0.001). After adjustment, bleeding was independently associated with increased risk of 1-year mortality (adjusted hazard ratio [HR] = 1.90 [1.33-2.72], P < 0.001) and myocardial infarction (adjusted HR = 2.74 [1.99-3.78], P < 0.001). Bleeding improved the discriminatory power of the multivariable model for prediction of mortality (absolute and relative integrated discrimination improvement [IDI], 0.011 and 15.4 %; P = 0.004) or myocardial infarction (absolute and relative IDI, 0.017 and 70.8 %; P < 0.001). Peri-PCI bleeding in patients with CKD is independently associated with the increased risk of 1-year mortality and nonfatal myocardial infarction.

Bleeding after percutaneous coronary intervention in women and men matched for age, body mass index, and type of antithrombotic therapy

Factors underlying the increased risk of bleeding after percutaneous coronary intervention (PCI) in women compared with men remain incompletely understood. The study included 3,351 women and 3,351 men matched for age, body mass index, and type of antithrombotic therapy. Bleeding within the 30 days after PCI was defined using the Bleeding Academic Research Consortium criteria. The main outcome was 1-year mortality. Bleeding occurred in 518 women and 354 men (15.5% vs 10.6%, odds ratio [OR] 1.55, 95% CI 1.34-1.79, P < .001). Severe (Bleeding Academic Research Consortium class ≥2) bleeds (9.4% vs 6.5%, P < .001) and access site bleeds (10.1% vs 5.4%, P < .001) were more common in women. After adjustment, female sex remained an independent correlate of any bleeding (adjusted OR 1.61 [1.35-1.92], P < .001) and access site (adjusted OR 2.00 [1.59-2.50], P < .001) but not of nonaccess site (adjusted OR 1.18 [0.91-1.54], P = .205) bleeding. There were 248 deaths: 32 deaths among men with bleeding versus 107 deaths among men with no bleeding (9.1% vs 3.6%, OR 2.68 [1.78-4.05], P < .001) and 40 deaths among women with bleeding vs 69 deaths among women with no bleeding (7.8% vs 2.5%, OR 3.35 [2.24-5.01], P < .001). No difference in mortality was observed among women and men who bled (P = .487). Bleeding was independently associated 1-year mortality (adjusted hazard ratio 2.18 [1.68-2.84], P < .001) with no bleeding-by-sex interaction (P = .439). Despite matching for age, body mass index, and type of antithrombotic therapy, bleeding risk after PCI remained significantly higher in women than in men. Bleeding was associated with increased risk of 1-year mortality with no bleeding-by-sex interaction.

Impact of access and nonaccess site bleeding measured by Bleeding Academic Research Consortium (BARC) criteria on long-term outcome in patients treated with primary percutaneous coronary intervention

Purpose: The relative contribution of access versus nonaccess site bleeding to subsequent mortality of pts treated with primary percutaneous coronary intervention (PCI) is poorly understood. The purpose of this study was to investigate the relative incidence of access and nonaccess site bleeding and the association of these events with 1-year mortality in unselected pts with acute ST-elevation myocardial infarction (STEMI) undergoing primary PCI. Methods: We analyzed data about in-hospital bleeding of all consecutive STEMI pts underwent primary PCI between 8/2009 and 1/2011 enrolled in a prospective registry of a high volume tertiary center. Bleeding access and nonaccess site events were assessed using Bleeding Academic Research Consortium (BARC) criteria. BARC class ≥ 2 bleeding were taken into consideration. The primary outcome was 1-year mortality. Results: Of the 1808 STEMI pts with primary PCI, 115 (6.4%) experienced a BARC class ≥ 2 bleeding. Access site bleeding occurred in 3.7%, whereas the rate of nonaccess site bleeding was 2.8%. Unadjusted 1-year mortality rate was more than 2-fold higher in pts with nonaccess versus access site bleeding (Table). After multivariable adjustment for demographic and clinical characteristics of pts, nonaccess site bleeding was the independent predictor of 1-year mortality (OR 3.40, 95% CI 1.71 to 6.76; p<0.001), besides advanced age, heart failure and prior stroke. Access site bleeding was not the independent predictor of 1-year mortality after adjustment. Unadjusted 1-year mortality rates Conclusion: Pts with nonaccess site bleeding complicating primary PCI are at more than 3-fold higher risk of 1-year death compared with pts with access site bleeding and those that no bleed or does not require intervention.

Prognostic Value of Access and Non–Access Sites Bleeding After Percutaneous Coronary Intervention

Little is known about the impact of bleeding site on mortality after percutaneous coronary intervention. The aim of this study was to assess the impact of access and non-access site bleeding within 30 days after percutaneous coronary intervention on mortality. This study represents a pooled patient-level analysis of 14 180 patients recruited in 7 randomized trials. Access and non-access site bleeding were assessed using the Bleeding Academic Research Consortium criteria. The primary outcome was 1-year mortality. Follow-up was complete in 97.5% of the patients. There were 414 deaths within the first year after percutaneous coronary intervention: 44 deaths among patients with access site bleeding, 60 deaths among patients with non-access site bleeding, and 310 deaths among patients without bleeding (Kaplan-Meier estimates of mortality, 4.5%, 10.0%, and 2.5%, respectively; adjusted hazard ratio, 1.72 [95% confidence interval, 1.19-2.47] for access site bleeding versus no bleeding; hazard ratio, 2.78 [2.00-3.86] for non-access site versus no bleeding). The inclusion of non-access site bleeding (the absolute and relative integrated discrimination improvement, 0.005 and 8.9%; P=0.031) but not of access site bleeding (the absolute and relative integrated discrimination improvement, 0.0015 and 2.7%; P=0.084) was associated with an improvement of the discriminatory power of multivariable model for mortality prediction. Both access and non-access site bleeding events occurring within 30 days of a percutaneous coronary intervention are independently associated with an increased risk of 1-year mortality. Non-access site bleeding is a stronger correlate of mortality than access site bleeding, and it improves the discriminatory power of models for mortality prediction.

Abstract 18502: Bleeding Post PCI: Predictors of “ANY” Bleeds: Six Month Results from the PARIS (Patterns of Non-Adherence to Antiplatelet Regimens in Stented Patients) Registry

Introduction. While recent studies have highlighted the clinical importance of minor, or “nuisance” bleeding, the predictors of all bleeding complications including minor bleeding events have not been examined in detail. Methods. The PARIS registry was a multicenter, international, all-comers registry of patients who had undergone successful PCI in 2009-2010 for stable angina, acute coronary syndrome (ACS) or documented silent ischemia. All bleeding events were adjudicated by a Clinical Events Committee according to the Bleeding Academic Research Consortium (BARC) criteria from source documents. We compared baseline clinical and treatment variables in patients who had any versus no bleeding at 6-months. Results. Of 5,033 patients, 235 (4.7%) had a bleeding event in the first 6-months. Of these, 27.7% had BARC type 1 bleeding, 40.4% had BARC type 2 bleeding, 30.2% had type 3, 0.4% had type 4 (CABG-related), and 1.3% had type 5 (fatal) bleeding. Compared to patients with no bleeding, patients who had bleeding were more likely to be older, female, non-smokers, and to be prescribed on warfarin on discharge (Table). After multivariable analysis, independent predictors of 6-month bleeding were age (OR 1.02, 95% CI 1.002 - 1.03), female gender (OR 1.9, 95% CI 1.3 - 2.9), and warfarin therapy (OR 2.6, 95% CI 1.7 - 3.7, all p&lt;0.05), whereas hypertension was associated with reduced risk of bleeding (OR 0.7, 95% CI 0.52 - 0.98, p=0.04). Treatment with prasugrel (vs. clopidogrel) was not a predictor. Conclusion. In this real world, contemporary PCI registry with close evaluation of bleeding events, the 6-month rate of any bleeding was 4.7%. Almost 70% of these bleeding incidents were BARC type 1 and 2, which may be classified as minor or “nuisance” bleeds. Age, female gender, and warfarin were independent predictors of bleeding events. Table.