Randomized Clinical Trial on Prevention of Radial Occlusion After Transradial Access Using Nitroglycerin: PATENS Trial.

OBJECTIVES: The aim of this study was to evaluate whether administration of nitroglycerin at the beginning or end of a transradial approach (TRA) procedure would preserve radial patency. BACKGROUND: The TRA is becoming the preferred vascular access route in coronary interventions. Radial artery occlusion (RAO) is the most frequent complication. Routine vasodilator treatment aims to reduce spasm and possibly prevent RAO. METHODS: The authors designed a prospective, multicenter, randomized, double-blind, 2-by-2 factorial, placebo-controlled trial encompassing patients undergoing the TRA. Patients were randomized to either 500 µg nitroglycerin or placebo; each arm was also subrandomized to early (upon sheath insertion) or late (right before sheath removal) nitroglycerin administration to evaluate the superiority of nitroglycerin in the prevention of RAO with 24 hours on Doppler ultrasound. RESULTS: A total of 2,040 patients were enrolled. RAO occurred in 49 patients (2.4%). Fifteen of these patients (30.6%) showed re-establishment of flow at 30 days. Nitroglycerin, compared with placebo, did not reduce the risk for RAO at either of the 2 time points (early, 2.5% vs 2.3% [P = 0.66]; late, 2.3% vs 2.5% [P = 0.66]). By multivariable analysis, the presence of spasm (OR: 3.53; 95% CI: 1.87-6.65; P < 0.001) and access achieved with more than 1 puncture attempt (OR: 2.58; 95% CI: 1.43-4.66; P = 0.002) were independent predictors of RAO. CONCLUSIONS: The routine use of nitroglycerin was not associated with a reduction in the rate of RAO, regardless of the time of administration (at the beginning or end of the TRA procedure).

Randomized clinical trial on prevention of radial occlusion after transradial access using Nitroglycerin: PATENS trial

OBJECTIVES: The aim of this study was to evaluate whether administration of nitroglycerin at the beginning or end of a transradial approach (TRA) procedure would preserve radial patency. BACKGROUND: The TRA is becoming the preferred vascular access route in coronary interventions. Radial artery occlusion (RAO) is the most frequent complication. Routine vasodilator treatment aims to reduce spasm and possibly prevent RAO. METHODS: The authors designed a prospective, multicenter, randomized, double-blind, 2-by-2 factorial, placebo-controlled trial encompassing patients undergoing the TRA. Patients were randomized to either 500 µg nitroglycerin or placebo; each arm was also subrandomized to early (upon sheath insertion) or late (right before sheath removal) nitroglycerin administration to evaluate the superiority of nitroglycerin in the prevention of RAO with 24 hours on Doppler ultrasound. RESULTS: A total of 2,040 patients were enrolled. RAO occurred in 49 patients (2.4%). Fifteen of these patients (30.6%) showed reestablishment of flow at 30 days. Nitroglycerin, compared with placebo, did not reduce the risk for RAO at either of the 2 time points (early, 2.5% vs 2.3% [P = 0.66]; late, 2.3% vs 2.5% [P = 0.66]). By multivariable analysis, the presence of spasm (OR: 3.53; 95% CI: 1.87-6.65; P < 0.001) and access achieved with more than 1 puncture attempt (OR: 2.58; 95% CI: 1.43-4.66; P = 0.002) were independent predictors of RAO. Conclusions: The routine use of nitroglycerin was not associated with a reduction in the rate of RAO, regardless of the time of administration (at the beginning or end of the TRA procedure).

Efeito da nitroglicerina pré-cateterismo transradial sobre o espasmo de artéria radial: análise baseada na experiência do operador / Effect of nitroglycerin pre-transradial catheterization on radial artery spasm: analysis based on operator experience

INTRODUÇÃO: O uso da artéria radial como acesso arterial para o cateterismo cardíaco tem sido preferencial devido a vantagens clínicas demonstradas. Um dos limitantes do uso da artéria como via de acesso é a ocorrência de espasmo (EAR), para o qual se recomenda o uso de medicações espasmolíticas profiláticas. A nitroglicerina é uma droga vasodilatadora que tem sido usada para este fim. O benefício da medicação na prevenção do espasmo poderia ser influenciado pela experiência do operador. OBJETIVOS: Avaliar a redução na incidência de EAR, por avaliação clínica, em pacientes submetidos a cateterismo cardíaco por via transradial (ATR) submetidos à pré-medicação com nitroglicerina intra-arterial, comparado àqueles que não receberam pré-medicação com nitroglicerina. MÉTODOS: Ensaio clínico prospectivo, multicêntrico, randomizado, duplo-cego, placebo controlado. Um grupo recebeu nitroglicerina, na dose de 500 μg, diluída em 10ml de soro fisiológico através do introdutor, e um segundo grupo, que recebeu placebo (SF). A avaliação de espasmo foi clínica, através de escala numérica de dor (graduada de 0 a 10), e será definido como presente nos casos em que seja maior que 6. A experiência do operador foi classificada como: inexperiente (I) (menos que 100 procedimento por ATR realizados); experientes (E) (de 100 a 1000 ATR) e altamente experientes (A) (mais que 1000 ATR). RESULTADOS: Foram incluídos 1991 pacientes, com média de 61,8 anos, sendo 61,7% do sexo masculino e 36,6% com diabetes. Operadores I realizaram 454 (22,8%) procedimentos; E, 949 (47,7%) e A, 588 (29,5%). A incidência de espasmo foi de 14,5% no grupo I, 12,5% no grupo E e 9,7% no grupo A (p=0,01 para comparação entre o grupo I e A). A mudança de via de acesso também foi mais comum no grupo I (3,5% vs. 2,5% (E) vs. 0,2% (A), p<0,01). No grupo I, o uso profilático de nitroglicerina reduziu a incidência de espasmo (17,9% vs. 11,1%, p=0,04), o que não ocorreu no grupo E (13,3% vs. 11,8%, p=0,49) ou no grupo A (10,2% vs. 9,2%, p=0,68). O uso de medicação vasodilatadora de resgate também foi mais comum no grupo I (3,1% vs. 2,9% (E) vs. 0,5% (A), p<0,01). CONCLUSÕES: O EAR é mais comum no início da curva de aprendizado do ATR, nesta situação o uso profilático da nitroglicerina, na dose de 500 μg, reduz a ocorrência de EAR, este efeito benéfico da nitroglicerina não é observado com operadores mais experientes.

Prevention of radial artery occlusion after transradial access using nitroglycerin (Patens Trial)

BACKGROUND The use of transradial access (TRA) for coronary catheterization has increased over the years because of the reduced rates of vascular complications and easier postprocedural manage ment. Radial artery occlusion (RAO) remains the Achilles heel of TRA. Intra-arterial nitroglycerin could result in a significant reduction of RAO. The vasodilation may enhance antegrade flow in the artery that reduces stasis-induced thrombosis, but it could also minimize endo thelial trauma when used early in the procedure. The main objective of this study is to evaluate whether nitroglycerin at the beginning or end of TRA may preserve the patency of the artery. METHODS We conducted a prospective, multicenter, randomized, 2 2 factorial, placebo-controlled, 2-blinded study and enrolled patients submitted to catheterization by TRA. Patients received either 500 mg nitroglycerin or placebo given intra-arterially through the sheath at 2 moments: early, after sheath insertion, and late, at the end of the radial procedure. All patients received at least 5,000 UI heparin, sheaths were removed immediately after the catheterization, and a radial pneumatic wristband was applied intending patent or minimum pressure hemostasis. The primary outcome was the incidence of RAO, verified by Doppler evaluation within the first 24 hours, and every patient with confirmed RAO was further evaluated 30 days later. RESULTS A total of 1,894 patients were enrolled, with a mean age of 61.7 10.3 years. The majority (61.6%) were male, and 36.5% had diabetes. The clinical indication was ACS in 47.9%. RAO occurred in 49 patients (2.6%) by Doppler evaluation. Fifteen patients (30.6%) showed re-establishment of flow at 30-day Doppler assessment. Nitroglycerin, as compared with placebo, did not reduce the risk of RAO in either of the 2 moments used (early: 2.4% vs 2.8%, P » 0.65 or late: 2.8% vs 2.4%, P » 0.65, respectively). In the multivariate anal ysis, the size of the radial artery, obtaining access with a single puncture, operator inexperience, and the presence of spasm were associated with RAO. CONCLUSION In the present study, the use of nitroglycerin is not associated with a reduced incidence of RAO regardless of the admin istration time

Prevalência de transtornos mentais não-psicóticos e fatores associados em pessoas com hipertensão arterial sistêmica e/ou diabetes mellitus em Unidades de Saúde da Família em Blumenau, Santa Catarina / Prevalence of non-psychotic mental disorders and associated factors in people with hypertension and/or diabetes from Family Health Units in Blumenau, Santa Catarina, Brazi

Objetivo: Avaliar a prevalência de transtornos mentais não psicóticos (TMNP) e fatores associados em pessoas hipertensas e/ou diabéticas oriundas de Unidades de Saúde da Família de Blumenau, Santa Catarina. Métodos: Trata-se de um estudo transversal com 710 usuários de Unidades da Saúde da Família de Blumenau selecionados após amostragem probabilística, estratificada e por conglomerados. Os selecionados foram submetidos a um questionário domiciliar por entrevistadores treinados e responderam questões pertinentes a características socioeconômicas, pessoais e de medicamentos. O instrumento utilizado para o rastreamento de TMNP foi o Self-Report Questionnaire-20 (SRQ-20). As variáveis estudadas foram submetidas à análise uni e multivariada além de outros testes estatísticos adequados a cada uma delas. Resultados: A prevalência de TMNP encontrada foi de 39,44%. Fatores associados com TMNP, após analise multivariada, foram: sexo feminino (RP= 1,50; 1,12-2,01 IC95%; p<0,01), uso de psicotrópicos (RP=1,74; 1,34-2,26 IC95%; p<0,00), hospitalização e/ou comparecimento ao pronto-socorro no último ano (RP=1,30; 1,02-1,66 IC95%; p<0,03) e classe de consumo E da classificação da Associação Brasileira de Empresas de Pesquisa (ABEP) (RP=2,62; 1,09-6,27IC95%; p<0,03). Conclusões: A grande prevalência de TMNP, relacionados principalmente às mulheres e às pessoas em condições sociais desfavoráveis, suscita uma intervenção organizada e efetiva, enquanto o tratamento adequado da doença de base e a detecção precoce dos TMNP implicariam melhor uso dos recursos de saúde pública.

Objective: Evaluate the prevalence of non-psychotic mental disorders (NPMD) and associated factors in people with hypertension and/or diabetes from family health units in Blumenau, Santa Catarina, Brazil. Methods: Cross-sectional study, conducted in Blumenau, with 710 selected users, after probability sampling, and stratified by conglomerates, from family health basic units. Those selected were submitted to a questionnaire at home by trained interviewers and answered questions about socioeconomic, personal characteristics and medicines. The instrument used to screen NPMD was the Self-Report Questionnaire-20 (SRQ-20). The variables were submitted to univariate and multivariate analysis and other statistical tests appropriate to each variable studied. Results: The prevalence of NPMD was 39.44%. Factors associated with NPMD after multivariate analysis were: female (RP=1.50, 1.12-2.01CI 95%, p<0.01), use of psychotropic drugs (RP=1.74, 1.34-2.26 CI 95%, p <0.00 ), hospitalization and/or show the emergency medical services in the last year (RP=1.30, 1.02-1.66CI 95%, p<0.03) and E class of consumption in the Associação Brasileira de Empresas de Pesquisa (ABEP, in English Brazilian Association of Market Research Companies) classification (RP=2.62, 1.09-6.27CI 95%; p<0.03). Conclusions: The high incidence of NPMD, mostly related to women and to people with lower socioeconomic conditions, raises an organized and effective intervention, while the appropriate treatment of base disease and early detection of NPMD mean better use of public health resources.