Cardiovascular prevention in coronary heart disease patients: guidelines implementation in clinical practice

Introdução: apesar das recomendações de todas as diretrizes sobre a doença arterial coronária e das evidências científicas de que o tratamento medicamentoso otimizado acrescido de intervenção sobre os fatores de risco e a melhoria do estilo de vida reduzem eventos cardiovasculares fatais não-fatais, essa terapêutica de prevenção secundária continua a ser subutilizada na prática clínica. Objetivos: Primário: demonstrar que a utilização de um programa de otimização da prática clínica em pacientes com doença arterial coronária estável aumenta a prescrição de medicamentos comprovadamente eficazes na prevenção secundária desta doença. Secundários: a) documentar a prática clínica vigente em termos de terapia medicamentosa e de medidas para a mudança do estilo de vida b) identificar as ferramentas utilizadas na estratégia para a otimização da prática clínica quanto à eficácia e aderência à medicação prescrita. Métodos: trata-se de um estudo de corte transversal para documentar a prática clínica vigente, seguido de componente longitudinal em que a utilização das ferramentas para a otimização da prática clínica foi avaliada por meio de novo corte transversal, com nova coleta de dados. Foram identificados retrospectivamente através dos prontuários, 710 pacientes consecutivos portadores de doença arterial coronária (Fase 1). Após a aplicação das ferramentas, foram incluídos 705 pacientes consecutivos atendidos no serviço com a coleta dos mesmos dados, para a análise comparativa. Além disso, foram selecionados do primeiro grupo, de forma aleatória, 318 prontuários de seis a doze meses após a primeira avaliação, para a coleta dos mesmos dados, que foram comparados com as informações iniciais destes mesmos pacientes. (Fase 3). Resultados: comparação entre Fase 1 e Fase 2: as características demográficas eram comparáveis entre os dois grupos. Quanto aos fatores de risco, houve melhora com diferença significativa para o tabagismo (p=0,019), dislipidemia (p<0,001) hipertensão arterial e atividade física regular (p<0,001). Quanto aos exames laboratoriais, não houve diferença estatisticamente significativa entre as duas populações. Comparando a prescrição dos fármacos recomendados, houve diferença significativa para IECA (67,2% versus 56,8%, p<0,001); ARA II (25,4% versus 32,9%, p=0,002) e betabloqueador (88,7% versus 91,9%, p=0,047). Comparação entre Fase 1 e Fase 3: os dados demográficos foram semelhantes, assim como as características clínicas, com exceção da doença arterial periférica obstrutiva: 31 pacientes (9,7%) e 42 (13,3%), p=0,007. Em relação aos fatores de risco, consideramos apenas os modificáveis tabagismo e atividade física. Para o tabagismo, considerando três categorias (nunca, ex-fumante e atual), não houve diferença significativa entre as duas fases. Para a atividade física, a proporção de pacientes sem informação para esta variável era elevada, 83,9% na primeira fase e 72,8% na terceira fase, dificultando a análise estatística. Quanto às medidas de exame físico, houve redução significativa do peso, p=0,044, pressão arterial sistólica e diastólica, p<0,001. Os exames laboratoriais não mostraram diferenças significativas entre as duas fases. Em relação à prescrição de medicamentos recomendados, houve diferença para IECA (64,8% versus 61,6%, p=0,011) e ARA II (27,0% versus 31,3%, p=0,035). Conclusão: com base nos resultados obtidos, o presente estudo permite concluir: não houve mudança significativa na utilização de medicamentos comprovadamente eficazes na prevenção secundária da DAC entre o período pré- e pós-intervenção; houve melhora significativa em relação ao tabagismo e atividade física na Fase 2; melhora substancial nos níveis de pressão arterial, tanto sistólica como diastólica na comparação tanto entre a Fase 1 e 2 como entre a Fase 1 e 3; a inclusão de enfermeiro treinado para gerenciar o processo é fundamental para a eficácia do programa; programas abrangentes de melhoria de qualidade assistencial em hospitais terciários e acadêmicos, provavelmente devem ser continuados por período de seguimento superior a um ano.Background: despite guidelines recommendations on coronary artery disease treatment and scientific evidence confirming that optimal medical therapy added to risk factors and lifestyle management, reduce both fatal and non-fatal cardiovascular events, these secondary prevention strategies have been underutilized in clinical practice. Objectives: Primary: to demonstrate the utilization of a clinical improvement program in stable coronary artery disease patients would increase the evidence-proved treatment prescription in secondary prevention. Secondaries: a) to describe the ongoing clinical practice on medical therapy and lifestyle change counseling b) to identify tools to be utilized in the strategy to improve clinical practice, assessing efficacy and adherence to prescribed treatment. Methods: cross-sectional study to describe the ongoing clinical practice, followed by a longitudinal component in which the tools utilization to improve clinical practice was assessed by means of additional crosssectional data collection. 710 consecutive coronary artery disease patients were included after chart review following eligibility criteria (Phase 1). After tools implementation, within 6-month period, 705 patients were included (Phase 2) for comparative analysis. Randomly, 318 patients from Phase 1 were selected, 6-12 months after the first evaluation (Phase 3). Results: Phase 1 to Phase 2 comparison: demography was comparable. Concerning to risk factors, there were improvement on smoking (p=0,019), dyslipidemia (p<0,001), hypertension and physical activity (p<0,001). There were no statistical significant differences on laboratory results. By comparing the proven pharmacological treatment prescription, there was significant difference on ACEI (67,2% versus 56,8%, p<0,001); ARB II (25,4% versus 32,9%, p=0,002) and beta-blocker (88,7% versus 91,9%, p=0,047). Phase 1 to Phase 3 comparison: demography was comparable, as well as clinical characteristics, except peripheral artery disease: 31 patients (9,7%) and 42 (13,3%), p=0,007. Regarding risk factors, smoking and physical activity were considered. There was no significant difference on smoking rates taking into account three categories (never, ex-smoker and smoker). The proportion of patients without available data for physical activity was high, 83,9% (Phase 1) and 72,8% (Phase 3), making the data analysis not appropriated. Anthropometric measurement showed significant on weight reduction, p=0,044, both systolic and diastolic blood pressure, p<0,001. Laboratory results did not show significant differences. There was statistical significant difference on ACEI (64,8% versus 61,6%, p=0,011) and ARB II (27,0% versus 31,3%, p=0,035). Conclusion: based upon study results the following might be concluded: there was no significant change on the evidence-based pharmacological treatment utilization on secondary prevention coronary artery disease patients between pre and post-intervention Phases; there was significant improvement concerning smoking and physical activity in Phase 2; substantial improvement on blood pressure levels, both systolic and diastolic in both comparisons (Phase 1 to 2 and Phase 1 to 3); the inclusion of a case-manager for the process management is crucial for program efficacy; comprehensive programs for clinical practice improvement in tertiary academic hospitals should be pursued for longer follow-up period

Cardiovascular prevention in coronary heart disease patients: guidelines implementation in clinical practice

OBJETIVO: Demonstrar a eficácia de um programa de otimização da prática clínica em pacientes com doença arterial coronária para prescrição de medicamentos e documentar a prática clínica vigente quanto aos medicamentos e medidas para a mudança do estilo de vida. MÉTODOS: Estudo de corte transversal, seguido de componente longitudinal. Foram incluídos 710 pacientes consecutivos (Fase 1). Após aplicação de ferramentas para melhoria da prática clínica, foram incluídos, após seis meses, 705 pacientes com coleta dos mesmos dados (Fase 2). Foram selecionados aleatoriamente, a partir do primeiro grupo, 318 prontuários para comparação desses mesmos pacientes (Fase 3). RESULTADOS: Comparação entre as Fases 1 e 2: melhora em relação a tabagismo (P=0,019), dislipidemia (P<0,001), hipertensão arterial e atividade física regular (P<0,001). Diferença significativa para inibidores da enzima de conversão da angiotensina - IECA (67,2% vs. 56,8%, P<0,001); antagonistas do receptor da angiotensina II - ARA II (25,4% vs. 32,9%, P=0,002) e betabloqueador (88,7% vs. 91,9%, P=0,047). Comparação entre as Fases 1 e 3: houve redução do peso (P=0,044) e pressão arterial (P<0,001). Em relação à prescrição de medicamentos recomendados, diferença para IECA (64,8% vs. 61,6%, P=0,011) e ARA II (27,0% vs. 31,3%, P=0,035). CONCLUSÃO: Não houve mudança significativa na utilização de medicamentos; entretanto, observou-se melhora significativa em relação ao tabagismo e atividade física na Fase 2; melhora substancial nos níveis de pressão arterial, na comparação tanto entre as Fases 1 e 2 como entre as Fases 1 e 3. A inclusão de enfermeiro treinado para gerenciar o processo foi fundamental. Programas abrangentes de melhoria de qualidade assistencial, provavelmente, devem ser continuados por período de seguimento maior

Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: an international, randomised, double-blind, placebo-controlled trial

Background Patients with peripheral artery disease have an increased risk of cardiovascular morbidity and mortality. Antiplatelet agents are widely used to reduce these complications. Methods This was a multicentre, double-blind, randomised placebo-controlled trial for which patients were recruited at 602 hospitals, clinics, or community practices from 33 countries across six continents. Eligible patients had a history of peripheral artery disease of the lower extremities (previous peripheral bypass surgery or angioplasty, limb or foot amputation, intermittent claudication with objective evidence of peripheral artery disease), of the carotid arteries (previous carotid artery revascularisation or asymptomatic carotid artery stenosis of at least 50%), or coronary artery disease with an ankle-brachial index of less than 0.90. After a 30-day run-in period, patients were randomly assigned (1:1:1) to receive oral rivaroxaban (2.5 mg twice a day) plus aspirin (100 mg once a day), rivaroxaban twice a day (5 mg with aspirin placebo once a day), or to aspirin once a day (100 mg and rivaroxaban placebo twice a day). Randomisation was computer generated. Each treatment group was double dummy, and the patient, investigators, and central study staff were masked to treatment allocation. The primary outcome was cardiovascular death, myocardial infarction or stroke; the primary peripheral artery disease outcome was major adverse limb events including major amputation. This trial is registered with ClinicalTrials.gov, number NCT01776424, and is closed to new participants. Findings Between March 12, 2013, and May 10, 2016, we enrolled 7470 patients with peripheral artery disease from 558 centres. The combination of rivaroxaban plus aspirin compared with aspirin alone reduced the composite endpoint of cardiovascular death, myocardial infarction, or stroke (126 [5%] of 2492 vs 174 [7%] of 2504; hazard ratio [HR] 0.72, 95% CI 0.57-0.90, p=0.0047), and major adverse limb events including major amputation (32 [1%] vs 60 [2%]; HR 0.54 95% CI 0.35-0.82, p=0.0037). Rivaroxaban 5 mg twice a day compared with aspirin alone did not significantly reduce the composite endpoint (149 [6%] of 2474 vs 174 [7%] of 2504; HR 0.86, 95% CI 0.69-1.08, p=0.19), but reduced major adverse limb events including major amputation (40 [2%] vs 60 [2%]; HR 0.67, 95% CI 0.45-1.00, p=0.05). The median duration of treatment was 21 months. The use of the rivaroxaban plus aspirin combination increased major bleeding compared with the aspirin alone group (77 [3%] of 2492 vs 48 [2%] of 2504; HR 1.61, 95% CI 1.12-2.31, p=0.0089), which was mainly gastrointestinal. Similarly, major bleeding occurred in 79 (3%) of 2474 patients with rivaroxaban 5 mg, and in 48 (2%) of 2504 in the aspirin alone group (HR 1.68, 95% CI 1.17-2.40; p=0.0043). Interpretation Low-dose rivaroxaban taken twice a day plus aspirin once a day reduced major adverse cardiovascular and limb events when compared with aspirin alone. Although major bleeding was increased, fatal or critical organ bleeding was not. This combination therapy represents an important advance in the management of patients with peripheral artery disease. Rivaroxaban alone did not significantly reduce major adverse cardiovascular events compared with asprin alone, but reduced major adverse limb events and increased major bleeding

A Survey of Empirical Results on Program Slicing

International audienceBACKGROUND:Patients with peripheral artery disease have an increased risk of cardiovascular morbidity and mortality. Antiplatelet agents are widely used to reduce these complications.METHODS:This was a multicentre, double-blind, randomised placebo-controlled trial for which patients were recruited at 602 hospitals, clinics, or community practices from 33 countries across six continents. Eligible patients had a history of peripheral artery disease of the lower extremities (previous peripheral bypass surgery or angioplasty, limb or foot amputation, intermittent claudication with objective evidence of peripheral artery disease), of the carotid arteries (previous carotid artery revascularisation or asymptomatic carotid artery stenosis of at least 50%), or coronary artery disease with an ankle-brachial index of less than 0·90. After a 30-day run-in period, patients were randomly assigned (1:1:1) to receive oral rivaroxaban (2·5 mg twice a day) plus aspirin (100 mg once a day), rivaroxaban twice a day (5 mg with aspirin placebo once a day), or to aspirin once a day (100 mg and rivaroxaban placebo twice a day). Randomisation was computer generated. Each treatment group was double dummy, and the patient, investigators, and central study staff were masked to treatment allocation. The primary outcome was cardiovascular death, myocardial infarction or stroke; the primary peripheral artery disease outcome was major adverse limb events including major amputation. This trial is registered with ClinicalTrials.gov, number NCT01776424, and is closed to new participants.FINDINGS:Between March 12, 2013, and May 10, 2016, we enrolled 7470 patients with peripheral artery disease from 558 centres. The combination of rivaroxaban plus aspirin compared with aspirin alone reduced the composite endpoint of cardiovascular death, myocardial infarction, or stroke (126 [5%] of 2492 vs 174 [7%] of 2504; hazard ratio [HR] 0·72, 95% CI 0·57-0·90, p=0·0047), and major adverse limb events including major amputation (32 [1%] vs 60 [2%]; HR 0·54 95% CI 0·35-0·82, p=0·0037). Rivaroxaban 5 mg twice a day compared with aspirin alone did not significantly reduce the composite endpoint (149 [6%] of 2474 vs 174 [7%] of 2504; HR 0·86, 95% CI 0·69-1·08, p=0·19), but reduced major adverse limb events including major amputation (40 [2%] vs 60 [2%]; HR 0·67, 95% CI 0·45-1·00, p=0·05). The median duration of treatment was 21 months. The use of the rivaroxaban plus aspirin combination increased major bleeding compared with the aspirin alone group (77 [3%] of 2492 vs 48 [2%] of 2504; HR 1·61, 95% CI 1·12-2·31, p=0·0089), which was mainly gastrointestinal. Similarly, major bleeding occurred in 79 (3%) of 2474 patients with rivaroxaban 5 mg, and in 48 (2%) of 2504 in the aspirin alone group (HR 1·68, 95% CI 1·17-2·40; p=0·0043).INTERPRETATION:Low-dose rivaroxaban taken twice a day plus aspirin once a day reduced major adverse cardiovascular and limb events when compared with aspirin alone. Although major bleeding was increased, fatal or critical organ bleeding was not. This combination therapy represents an important advance in the management of patients with peripheral artery disease. Rivaroxaban alone did not significantly reduce major adverse cardiovascular events compared with asprin alone, but reduced major adverse limb events and increased major bleeding