Prospective validation of the Bleeding Academic Research Consortium classification in the all-comer PRODIGY trial.

The Bleeding Academic Research Consortium (BARC) classification has been proposed by consensus to standardize bleeding endpoint definition and reporting in cardiovascular clinical trials. There are no prospective studies on its prognostic impact. We explored the association of BARC-defined bleeding with mortality and compared its prognostic value against two validated bleeding scales: the Thrombolysis in Myocardial Infarction (TIMI) and the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) scales. Non-coronary artery bypass graft (CABG)-related bleedings within the PRODIGY trial were prospectively adjudicated by a blinded Clinical Event Committee and analysed according to multiple statistical modelling. At 2 years, bleeding occurred in 143 patients (7.1%) according to BARC Type 2, 3, or 5; in 50 patients (2.5%) according to TIMI minor or major; and in 61 patients (3.1%) according to GUSTO moderate or severe. One hundred sixty-three patients died (8.1%). After multivariable modelling, BARC Type 2, 3, or 5 bleeding was associated with increased 2-year mortality [hazard ratio (HR): 3.77; 95% confidence interval (CI): 2.37-5.98]. Bleeding Academic Research Consortium Type 3 or 5 was associated with an increased mortality rate at 2 years (adjusted HR: 7.72; 95% CI: 4.75-12.54) similar to that provided by TIMI (HR: 7.64, 95% CI: 4.53-12.87) or GUSTO (HR: 7.36, 95% CI: 4.38-12.34) criteria. In a contemporary, all-comer percutaneous coronary intervention trial actionable BARC bleedings were associated with increased risk of mortality with BARC Type 3 or 5 bleedings providing a similar mortality risk to that posed by TIMI or GUSTO scales.

Vranckx P ，Leonardi S ，Tebaldi M ，Biscaglia S ，Parrinello G ，Rao SV ，Mehran R ，Valgimigli M ... -  《-》

The prognostic value of bleeding academic research consortium (BARC)-defined bleeding complications in ST-segment elevation myocardial infarction: a comparison with the TIMI (Thrombolysis In Myocardial Infarction), GUSTO (Global Utilization of Streptokina

The aim of the present analysis was to compare 1-year mortality prediction of Bleeding Academic Research Consortium (BARC)-defined bleeding complications with existing bleeding definitions in patients with ST-segment elevation myocardial infarction (STEMI) and to investigate the prognostic value of the individual data elements of the bleeding classifications for 1-year mortality. BARC recently proposed a novel standardized bleeding definition. The in-hospital occurrence of bleeding defined according to the BARC, TIMI (Thrombolysis In Myocardial Infarction), GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries), and ISTH (International Society on Thrombosis and Haemostasis) bleeding classifications was assessed in 2,002 STEMI patients undergoing primary percutaneous coronary intervention between January 1, 2003, and July 31, 2008. BARC types 2, 3, 4, and 5 bleeding occurred in 4.4%, 14.2%, 1.4%, and 0.3% of patients, respectively. By multivariable analysis, GUSTO- and ISTH-defined bleeding was not significantly associated with 1-year mortality, whereas TIMI major and BARC type 3b or 3c bleeding conferred a 2-fold higher risk of 1-year mortality (hazard ratios [HRs]: 2.00 [95% confidence interval (CI): 1.32 to 3.01] and 1.84 [95% CI: 1.23 to 2.77], respectively). Data elements most strongly associated with mortality were a hemoglobin decrease ≥5 g/dl (HR: 1.94 [95% CI: 1.26 to 2.98]), the use of vasoactive agents for bleeding (HR: 2.01 [95% CI: 0.91 to 4.44]), cardiac tamponade (HR: 2.38 [95% CI: 0.56 to 10.1]), and intracranial hemorrhage (HRs for 1-year mortality were not computable because there was only 1 patient with intracranial bleeding). Both the BARC and TIMI bleeding classification identified STEMI patients at risk of 1-year mortality.

Kikkert WJ ，van Geloven N ，van der Laan MH ，Vis MM ，Baan J Jr ，Koch KT ，Peters RJ ，de Winter RJ ，Piek JJ ，Tijssen JG ，Henriques JP ... -  《-》

Validation of BARC Bleeding Criteria in Patients With Acute Coronary Syndromes: The TRACER Trial.

The Bleeding Academic Research Consortium (BARC) scale has been proposed to standardize bleeding endpoint definitions and reporting in cardiovascular trials. Validation in large cohorts of patients is needed. This study sought to investigate the relationship between BARC-classified bleeding and mortality and compared its prognostic value against 2 validated bleeding scales: TIMI (Thrombolysis In Myocardial Infarction) and GUSTO (Global Use of Strategies to Open Occluded Arteries). We analyzed bleeding in 12,944 patients with acute coronary syndromes without ST-segment elevation, with or without early invasive strategy. The main outcome measure was all-cause death. During follow-up (median: 502 days), noncoronary artery bypass graft (CABG) bleeding occurred in 1,998 (15.4%) patients according to BARC (grades 2, 3, or 5), 484 (3.7%) patients according to TIMI minor/major, and 514 (4.0%) patients according to GUSTO moderate/severe criteria. CABG-related bleeding (BARC 4) occurred in 155 (1.2%) patients. Patients with BARC (2, 3, or 4) bleeding had a significant increase in risk of death versus patients without bleeding (BARC 0 or 1); the hazard was highest in the 30 days after bleeding (hazard ratio: 7.35; 95% confidence interval: 5.59 to 9.68; p < 0.0001) and remained significant up to 1 year. The hazard of mortality increased progressively with non-CABG BARC grades. BARC 4 bleeds were significantly associated with mortality within 30 days (hazard ratio: 10.05; 95% confidence interval: 5.41 to 18.69; p < 0.0001), but not thereafter. Inclusion of BARC (2, 3, or 4) bleeding in the 1-year mortality model with baseline characteristics improved it to an extent comparable to TIMI minor/major and GUSTO moderate/severe bleeding. In patients with acute coronary syndromes without ST-segment elevation, bleeding assessed with the BARC scale was significantly associated with risk of subsequent death up to 1 year after the event and risk of mortality increased gradually with higher BARC grades. Our results support adoption of the BARC bleeding scale in ACS clinical trials. (Trial to Assess the Effects of Vorapaxar [SCH 530348; MK-5348] in Preventing Heart Attack and Stroke in Participants With Acute Coronary Syndrome [TRACER] [Study P04736]; NCT00527943).

Vranckx P ，White HD ，Huang Z ，Mahaffey KW ，Armstrong PW ，Van de Werf F ，Moliterno DJ ，Wallentin L ，Held C ，Aylward PE ，Cornel JH ，Bode C ，Huber K ，Nicolau JC ，Ruzyllo W ，Harrington RA ，Tricoci P ... -  《-》

Impact of in-hospital bleeding according to the Bleeding Academic Research Consortium classification on the long-term adverse outcomes in patients undergoing percutaneous coronary intervention.

The aim of this study was to assess the impact of bleeding after percutaneous coronary intervention (PCI) with drug-eluting stents on long-term clinical events according to the newly proposed Bleeding Academic Research Consortium (BARC) classification. Current evidence about the impact of the BARC classification is limited. Out of a total of 6,166 patients who underwent PCI in a prospective IRIS-DES registry, the impact of in-hospital bleeding defined as the BARC classification on major adverse cardiovascular events (MACE) comprising death, myocardial infarction (MI), or stroke was analyzed. In-hospital bleeding occurred in 235 patients (3.8%) according to BARC classification. During the 2-year follow-up, MACE occurred in 599 patients (9.7%). The 2-year incidence of MACE was significantly higher in patients with bleeding (16.7% vs. 8.3%; adjusted hazard ratio [HR], 1.6; 95% confidence interval [CI], 1.2-2.3; P = 0.002) than in those without bleeding. We observed a higher risk of MI (12.4% vs. 6.4%; adjusted HR, 1.7; 95% CI, 1.2-2.6, P = 0.005), stroke (3.0% vs. 0.6%; adjusted HR, 2.9; 95% CI, 1.4-6.2, P = 0.005) in patients with bleeding. Death (3.8% vs. 1.6%; adjusted HR, 1.6; 95% CI, 0.9-3.0, P = 0.120) and target vessel revascularization (4.3% vs. 1.9%; adjusted HR, 1.6; 95% CI, 0.9-2.9, P = 0.108) were statistically insignificant. Incidence, adjusted HR and P-value were similar between BARC and TIMI classification. In-hospital bleeding events according to the newly proposed BARC definition were significantly associated with an increased risk of adverse long-term events in patients undergoing PCI with drug-eluting stents. © 2014 Wiley Periodicals, Inc.

Yoon YH ，Kim YH ，Kim SO ，Lee JY ，Park DW ，Kang SJ ，Lee SW ，Lee CW ，Park SW ，Park SJ ... -  《-》

Prognostic implications of bleeding measured by Bleeding Academic Research Consortium (BARC) categorisation in patients undergoing primary percutaneous coronary intervention.

Matic DM ，Milasinovic DG ，Asanin MR ，Mrdovic IB ，Marinkovic JM ，Kocev NI ，Marjanovic MM ，Antonijevic NM ，Vukcevic VD ，Savic LZ ，Zivkovic MN ，Mehmedbegovic ZH ，Dedovic VM ，Stankovic GR ... -  《-》