“…There are currently around 10 different definitions of major bleeding used in trials and registries of patients undergoing PCI 9 10 and these definitions include various clinical events, such as blood transfusion or retroperitoneal haemorrhage, laboratory parameters, such as differing values of haemoglobin decreases, and clinical outcomes such as mortality 9 resulting in significant differences in bleeding event recording across clinical trials thereby making comparisons between therapeutic strategies difficult. Furthermore, the incidence of major bleeding varies depending on definition used.…”
ObjectivesTo examine the relationship between periprocedural bleeding complications and major adverse cardiovascular events (MACEs) and mortality outcomes following percutaneous coronary intervention (PCI) and study differences in the prognostic impact of different bleeding definitions.MethodsWe conducted a systematic review and meta-analysis of PCI studies that evaluated periprocedural bleeding complications and their impact on MACEs and mortality outcomes. A systematic search of MEDLINE and EMBASE was conducted to identify relevant studies. Data from relevant studies were extracted and random effects meta-analysis was used to estimate the risk of adverse outcomes with periprocedural bleeding. Statistical heterogeneity was assessed by considering the I2 statistic.Results42 relevant studies were identified including 533 333 patients. Meta-analysis demonstrated that periprocedural major bleeding complications was independently associated with increased risk of mortality (OR 3.31 (2.86 to 3.82), I2=80%) and MACEs (OR 3.89 (3.26 to 4.64), I2=42%). A differential impact of major bleeding as defined by different bleeding definitions on mortality outcomes was observed, in which the REPLACE-2 (OR 6.69, 95% CI 2.26 to 19.81), STEEPLE (OR 6.59, 95% CI 3.89 to 11.16) and BARC (OR 5.40, 95% CI 1.74 to 16.74) had the worst prognostic impacts while HORIZONS-AMI (OR 1.51, 95% CI 1.11 to 2.05) had the least impact on mortality outcomes.ConclusionsMajor bleeding after PCI is independently associated with a threefold increase in mortality and MACEs outcomes. Different contemporary bleeding definitions have differential impacts on mortality outcomes, with 1.5–6.7-fold increases in mortality observed depending on the definition of major bleeding used.
“…There are currently around 10 different definitions of major bleeding used in trials and registries of patients undergoing PCI 9 10 and these definitions include various clinical events, such as blood transfusion or retroperitoneal haemorrhage, laboratory parameters, such as differing values of haemoglobin decreases, and clinical outcomes such as mortality 9 resulting in significant differences in bleeding event recording across clinical trials thereby making comparisons between therapeutic strategies difficult. Furthermore, the incidence of major bleeding varies depending on definition used.…”
ObjectivesTo examine the relationship between periprocedural bleeding complications and major adverse cardiovascular events (MACEs) and mortality outcomes following percutaneous coronary intervention (PCI) and study differences in the prognostic impact of different bleeding definitions.MethodsWe conducted a systematic review and meta-analysis of PCI studies that evaluated periprocedural bleeding complications and their impact on MACEs and mortality outcomes. A systematic search of MEDLINE and EMBASE was conducted to identify relevant studies. Data from relevant studies were extracted and random effects meta-analysis was used to estimate the risk of adverse outcomes with periprocedural bleeding. Statistical heterogeneity was assessed by considering the I2 statistic.Results42 relevant studies were identified including 533 333 patients. Meta-analysis demonstrated that periprocedural major bleeding complications was independently associated with increased risk of mortality (OR 3.31 (2.86 to 3.82), I2=80%) and MACEs (OR 3.89 (3.26 to 4.64), I2=42%). A differential impact of major bleeding as defined by different bleeding definitions on mortality outcomes was observed, in which the REPLACE-2 (OR 6.69, 95% CI 2.26 to 19.81), STEEPLE (OR 6.59, 95% CI 3.89 to 11.16) and BARC (OR 5.40, 95% CI 1.74 to 16.74) had the worst prognostic impacts while HORIZONS-AMI (OR 1.51, 95% CI 1.11 to 2.05) had the least impact on mortality outcomes.ConclusionsMajor bleeding after PCI is independently associated with a threefold increase in mortality and MACEs outcomes. Different contemporary bleeding definitions have differential impacts on mortality outcomes, with 1.5–6.7-fold increases in mortality observed depending on the definition of major bleeding used.
“…In fact, BARC type 1 bleeding episodes have good prognosis, with mortality at 30 days and one year similar to that found in patients who have not experienced bleeding. 22 In a patient classified as BARC type 3b, the occurrence of extensive hematoma in the pretibial region was not associated with the vascular puncture and was most likely caused by closed vascular trauma that occurred before the fibrinolysis, which resulted in a decrease in haemoglobin of 5.9 g/dL, but with no clinical repercussion or need for blood transfusion (prior haemoglobin of 16.3 g/dL).…”
background: Fibrinolysis is often used in the treatment of acute coronary syndromes with ST segment elevation (STEMI). Major cardiac outcomes were reduced with antiplatelet therapy intensification, but with increased risk of bleeding. Our objective was to assess the risk of vascular bleeding in patients undergoing early percutaneous coronary intervention after thrombolysis. Methods: Between February 2010 and December 2011, five public emergency rooms in the city of São Paulo and the Emergency Health Care Service (Serviço de Atendimento Móvel de Urgência-SAMU) used tenecteplase (TNK) to treat patients with STEMI. Patients were referred to a single tertiary hospital and were submitted to early cardiac catheterization during hospitalization. All examinations were performed via the femoral artery and BARC criteria were used to classify bleeding. Results: We evaluated 199 patients, of whom 193 had no bleeding of vascular origin (group 1) and 6 (3%) developed this complication (group 2). The median time between the administration of the fibrinolytic agent and catheterization was 24 hours in group 1 and 14.7 hours in group 2. According to BARC criteria, 1 patient had type 3a bleeding (hematoma in the inguinal region with a hemoglobin decrease of 3-5 g/dL), 2 patients had type 3b bleeding (1 not related to vascular access and 1 retroperitoneal hematoma
“…2 The quality of event adjudication is dependent on the completeness of and details in the individual patient accounts, including protocol-driven laboratory examinations. A potential underreporting of BARC 2 and BARC 1 bleeding events should therefore be anticipated.…”
, the newly proposed BARC bleeding definitions rely heavily on adjudication. 2 The quality of event adjudication is dependent on the completeness of and details in the individual patient accounts, including protocol-driven laboratory examinations. A potential underreporting of BARC 2 and BARC 1 bleeding events should therefore be anticipated. This analysis focused on in-hospital bleeding only. How many were access site related? The significance of in-hospital BARC 1 bleeding should be questioned. Moreover, most patients included in this analysis had an elective percutaneous coronary intervention for stable lesions. In this low-risk patient population, the lack of any discriminatory power of BARC 2 or greater on 1-year mortality over existing bleeding scales should not come as a surprise. We strongly believe that the true variation of the prognostic implication of BARC and its discriminatory power to predict a worse cardiovascular outcome comparable to other bleeding scales will be revealed in a prospective analysis.
Disclosures
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