The Use of Aspirin to Reduce the Risk of Thrombotic Events in Patients With End-Stage Renal Disease: Protocol for a Randomized Controlled Trial.

BACKGROUND: End-stage renal disease (ESRD) is the last stage of chronic kidney disease, mainly caused by type 2 diabetes mellitus and characterized by an increased mortality risk related to cardiovascular disease. Low-dose aspirin (acetylsalicylic acid or ASA) seems to effectively prevent cardiovascular events in patients with ESRD. However, the number of interventional studies in this population remains limited and the mechanisms of aspirin-related bleeding remain poorly understood. Aspirin's efficacy and safety may be modified by the presence of type 2 diabetes mellitus or platelet hyperreactivity. OBJECTIVE: The overall objective of this protocol is to (1) evaluate aspirin's safety and efficacy in reducing the risk of thrombotic events in patients with ESRD on hemodialysis and (2) examine whether aspirin's efficacy is modified by the presence of type 2 diabetes mellitus or platelet hyperreactivity. Specifically, the primary objective is to compare the 12-month rate of any thrombotic event (cardiac death, nonfatal myocardial infarction, nonfatal stroke, arteriovenous fistula thrombosis) and Thrombolysis in Myocardial Infarction (TIMI) major bleeding in patients treated with aspirin compared to those on placebo. Secondary objectives are to test for effect modification of treatment by the presence of type 2 diabetes mellitus or platelet hyperreactivity and compare the rate of TIMI minor bleeding between treatment groups. METHODS: We developed a protocol for a phase 2 randomized, single-center, placebo-controlled, triple-blind, superiority clinical trial to assess the prophylactic efficacy and safety of aspirin in patients with ESRD and on hemodialysis. It follows the ethical principles of the Declaration of Helsinki of the World Medical Association. A total of 342 participants would be enrolled over 12 months at a large dialysis center. Patients will be randomized in a 1:1 ratio and stratified by presence of type 2 diabetes mellitus and platelet hyperreactivity to receive either oral aspirin (100 mg/d) or placebo for a treatment period of 12 months. An intention-to-treat statistical analysis will be performed. RESULTS: The randomized clinical trial will be performed after approval by the ethical committee of the participating center and registration at ClinicalTrials.gov. CONCLUSIONS: We provide a protocol for a randomized controlled trial to evaluate the safety and efficacy of treatment with aspirin to reduce the risk of thrombotic events. In addition, such a study would further our understanding of the mechanism of aspirin-related bleeding and help identify subgroups of best-responders and patients with a higher risk of adverse events. REGISTERED REPORT IDENTIFIER: RR1-10.2196/10516.

Reduced Progression of Cardiac Allograft Vasculopathy with Routine Use of Induction Therapy with Basiliximab / Redução da Progressão da Doença Vascular do Enxerto Cardíaco com o Uso Rotineiro da Terapia de Indução com Basiliximab

AbstractIntroduction:Cardiac allograft vasculopathy (CAV) is a major limitation for long-term survival of patients undergoing heart transplantation (HT). Some immunosuppressants can reduce the risk of CAV.Objectives:The primary objective was to evaluate the variation in the volumetric growth of the intimal layer measured by intracoronary ultrasound (IVUS) after 1 year in patients who received basiliximab compared with that in a control group.Methods:Thirteen patients treated at a single center between 2007 and 2009 were analyzed retrospectively. Evaluations were performed with IVUS, measuring the volume of a coronary segment within the first 30 days and 1 year after HT. Vasculopathy was characterized by the volume of the intima of the vessel.Results:Thirteen patients included (7 in the basiliximab group and 6 in the control group). On IVUS assessment, the control group was found to have greater vessel volume (120–185.43 mm3 vs. 127.77–131.32 mm3; p = 0.051). Intimal layer growth (i.e., CAV) was also higher in the control group (27.30–49.15 mm3 [∆80%] vs. 20.23–26.69 mm3[∆33%]; p = 0.015). Univariate regression analysis revealed that plaque volume and prior atherosclerosis of the donor were not related to intima growth (r = 0.15, p = 0.96), whereas positive remodeling was directly proportional to the volumetric growth of the intima (r = 0.85, p < 0.001).Conclusion:Routine induction therapy with basiliximab was associated with reduced growth of the intima of the vessel during the first year after HT.

ResumoFundamento:A doença vascular do enxerto (DVE) constitui uma grande limitação de sobrevida a longo prazo de pacientes submetidos a transplante cardíaco (TxC). Alguns imunossupressores diminuem o aparecimento da DVE.Objetivos:O principal objetivo foi avaliar, através de ultrassonografia intracoronária (USIC), a variação do crescimento volumétrico da camada íntima e comparar, após um ano, o grupo que recebeu basiliximab com um grupo de controle.Métodos:Treze pacientes de um único centro foram analisados retrospectivamente de 2007 a 2009. As análises foram feitas através de USIC, medindo-se o volume de um segmento coronariano nos primeiros 30 dias e um ano após o TxC. A vasculopatia foi caracterizada pelo volume da camada íntima do vaso.Resultados:O estudo incluiu 13 pacientes (7 no grupo com o basiliximab e 6 no grupo de controle). A análise por USIC revelou que o grupo de controle apresentou maior crescimento volumétrico do vaso (131,32 a 127,77 mm3 x 120 a 185,43 mm3 p = 0,051). O crescimento da camada íntima (CCI) também foi maior no grupo de controle [Basiliximab: 20,23 a 26,69 mm3 (∆ 33%); Controle: 27,30 a 49,15 mm3(∆ 80% p = 0,015)]. De acordo com a regressão univariada, o volume da placa aterosclerótica prévia do doador não teve relação com o crescimento da íntima (r = 0,15, p = 0,96), enquanto que o remodelamento positivo do vaso foi diretamente proporcional ao crescimento da íntima (r = 0,85, p < 0,001).Conclusão:A terapia de indução de rotina com basiliximab está associada à redução do crescimento da camada íntima do vaso no primeiro ano após o transplante cardíaco.

Há relação entre custos hospitalares e tempo porta-balão? / Is there an association between hospital costs and door-to-balloon time?

O tempo porta-balão (TPB) tornou-se uma medida de desempenho e é foco de iniciativas de melhoria da qualidade assistencial. Este estudo teve como objetivo avaliar a relação entre o TPB e seu impacto nos custos de internação hospitalar. Métodos: Pacientes tratados com intervenção coronária percutânea primária, entre 2008 e 2013, foram divididos de acordo com o TPB < ou ≥ 90 minutos. Todos os custos registrados na alta hospitalar foram ajustados por meio do Índice de Variação de Custos Médico-Hospitalares.Resultados: Foram incluídos 141 pacientes, agrupados em TPB < 90 minutos (n = 77) e TPB ≥ 90 minutos(n = 64). Os TPB foram 64,0 ± 14,1 minutos e 133,8 ± 35,2 minutos, respectivamente. Não foram observadasdiferenças nos desfechos clínicos entre os grupos. Os custos foram de R$ 34.883,24 ± 27.749,46, sendo ocusto médio para TPB < 90 minutos de R$ 33.194,24 ± 27.387,61, e para TPB ≥ 90 minutos, de R$ 36.947,58± 28.267,80 (p = 0,43). Os custos, segundo a artéria culpada, foram de R$ 29.588,53 ± 16.358,85 para acoronária direita; R$ 48.494,62 ± 44.015,04 para a circunflexa; e de R$ 34.016,96 ± 26.503,94 paraa descendente anterior. Houve diferença entre os custos dos procedimentos relativos à artéria circunflexacomparados aos da coronária direita ou da descendente anterior (p = 0,01), mas não houve diferença entre os custos relativos à coronária direita, comparados à descendente anterior (p = 0,68). Conclusões: Não houve diferença nos custos hospitalares, no âmbito da saúde suplementar, quando os grupos foram divididos de acordo com o TPB. Os desfechos clínicos foram semelhantes, e foi encontrada uma diferença de custos em pacientes com a artéria circunflexa culpada...

Door-to-balloon time (DBT) has become a measure of performance and is the focus in quality of care improvement initiatives. This study aimed to evaluate the association between DBT and its impacton hospital costs. Methods: Patients treated with primary percutaneous coronary intervention between 2008 and 2013 were divided according to the DBT < or ≥ 90 minutes. All costs recorded at hospital discharge were adjusted bythe Medical-Hospital Cost Variation Index. Results: A total of 141 patients were included, grouped as DBT < 90 minutes (n = 77) and DBT ≥ 90 minutes(n = 64). DBT was 64.0 ± 14.1 minutes and 133.8 ± 35.2 minutes, respectively. There were no diferences in clinical outcomes between the groups. The costs were R$ 34,883.24 ± 27,749.46, with the mean cost for DBT < 90 minutes being R$ 33,194.24 ± 27,387.61 and the cost for DBT ≥ 90 minutes R$ 36,947.58 ±28,267.80 (p = 0.43). The costs, according to the culprit artery, were R$ 29,588.53 ± 16,358.85 for the rightcoronary artery; R$ 48,494.62 ± 44,015.04 for the left circumflex artery; and R$ 34,016.96 ± 26,503.94 forthe left anterior descending artery. There was a difference between the costs of procedures related to theleft circumflex artery when compared to the right coronary or left anterior descending arteries (p = 0.01),but there was no difference between the costs related to the right coronary, when compared to the left anterior descending artery (p = 0.68). Conclusions: There was no difference in hospital costs regarding the private health insurance, when the groups were divided according to the DBT. Clinical outcomes were similar and a difference in costs wasfound for patients with the circumflex artery as the culprit vessel...

Reduced progression of cardiac allograft vasculopathy with routine use of induction therapy with basiliximab.

INTRODUCTION: Cardiac allograft vasculopathy (CAV) is a major limitation for long-term survival of patients undergoing heart transplantation (HT). Some immunosuppressants can reduce the risk of CAV. OBJECTIVES: The primary objective was to evaluate the variation in the volumetric growth of the intimal layer measured by intracoronary ultrasound (IVUS) after 1 year in patients who received basiliximab compared with that in a control group. METHODS: Thirteen patients treated at a single center between 2007 and 2009 were analyzed retrospectively. Evaluations were performed with IVUS, measuring the volume of a coronary segment within the first 30 days and 1 year after HT. Vasculopathy was characterized by the volume of the intima of the vessel. RESULTS: Thirteen patients included (7 in the basiliximab group and 6 in the control group). On IVUS assessment, the control group was found to have greater vessel volume (120-185.43 mm3 vs. 127.77-131.32 mm3; p = 0.051). Intimal layer growth (i.e., CAV) was also higher in the control group (27.30-49.15 mm3 [∆80%] vs. 20.23-26.69 mm3[∆33%]; p = 0.015). Univariate regression analysis revealed that plaque volume and prior atherosclerosis of the donor were not related to intima growth (r = 0.15, p = 0.96), whereas positive remodeling was directly proportional to the volumetric growth of the intima (r = 0.85, p < 0.001). CONCLUSION: Routine induction therapy with basiliximab was associated with reduced growth of the intima of the vessel during the first year after HT.

Uso de Intervenções Baseadas em Evidências na Síndrome Coronária Aguda – Subanálise do Registro ACCEPT / Use of Evidence-Based Interventions in Acute Coronary Syndrome - Subanalysis of the ACCEPT Registry

Fundamento: As diretrizes baseiam-se em evidências para pautar suas recomendações; apesar disso, há uma lacuna entre o recomendado e a prática clínica. Objetivo: Descrever a prática de prescrição de tratamentos com indicação baseada em diretrizes para pacientes com síndrome coronariana aguda no Brasil. Métodos: Foi realizada uma subanálise do registro ACCEPT, na qual foram avaliados os dados epidemiológicos e a taxa de prescrição de ácido acetilsalicílico, inibidores P2Y12, antitrombóticos, betabloqueadores, inibidores da enzima conversora de angiotensina/bloqueadores AT1 e estatinas. Além disso, avaliou-se a qualidade da reperfusão coronariana no infarto com supradesnivelamento do segmento ST. Resultados: Foram avaliados 2.453 pacientes. As taxas de prescrição de ácido acetilsalicílico, inibidores de P2Y12, antitrombóticos, betabloqueadores, inibidores da enzima conversora de angiotensina/bloqueadores AT1 e estatinas foram, respectivamente, de 97,6%, 89,5%, 89,1, 80,2%, 67,9%, 90,6%, em 24 horas, e, respectivamente, de 89,3%, 53,6, 0%, 74,4%, 57,6%, 85,4%, em 6 meses. Com relação ao infarto com supradesnivelamento do segmento ST, somente 35,9% e 25,3% dos pacientes foram submetidos a angioplastia primária e trombólise, respectivamente, nos tempos recomendados. Conclusão: Este registro mostrou altas taxas de prescrição inicial de antiplaquetários, antitrombóticos e estatina, bem como taxas mais baixas de betabloqueadores e de inibidores da enzima conversora de angiotensina/bloqueadores AT1. Independentemente da classe, todos apresentaram queda do uso aos 6 meses. A maioria dos pacientes com infarto com supradesnivelamento do segmento ST não foi submetida a reperfusão coronariana no tempo recomendado. .

Background: The recommendations in guidelines are based on evidence; however, there is a gap between recommendations and clinical practice. Objective: To describe the practice of prescribing evidence-based treatments for patients with acute coronary syndrome in Brazil. Methods: This study carried out a subanalysis of the ACCEPT registry, assessing epidemiological data and the prescription rate of acetylsalicylic acid, p2y12 inhibitors, antithrombotic drugs, beta-blockers, angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers (IAT1RB), and statins. In addition, the quality of myocardial reperfusion in ST-segment elevation myocardial infarction was evaluated. Results: This study assessed 2,453 patients. The prescription rates of acetylsalicylic acid, p2y12 inhibitors, antithrombotic drugs, beta-blockers, angiotensin-converting enzyme inhibitors/IAT1RB, and statins were as follows: in 24 hours - 97.6%, 89.5%, 89.1%, 80.2%, 67.9% and 90.6%; and at six months - 89.3%, 53.6%, 0%, 74.4%, 57.6% and 85.4%, respectively. Regarding ST-segment elevation myocardial infarction, only 35.9% and 25.3% of the patients underwent primary angioplasty and thrombolysis, respectively, within the recommended times. Conclusion: This registry showed high initial prescription rates of antiplatelet drugs, antithrombotic drugs, and statins, and lower prescription rates of beta-blockers and angiotensin-converting enzyme inhibitors/IAT1RB. Independently of the class, the use of all drugs decreased by six months. Most patients with ST-segment elevation myocardial infarction did not undergo myocardial reperfusion within the time recommended. .