Early and Late Outcomes of Diabetic Patients Treated with Drug-Eluting Stents in the Safira Registry
The percutaneous treatment of coronary artery disease has been revolutionized by the use of drug-eluting stents (DES). However, its use in the daily practice involves patients with more complex clinical and angiographic characteristics than those found in randomized trials. This registry was designe...
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Published in: | Revista brasileira de cardiologia invasiva Vol. 21; no. 3; pp. 251 - 257 |
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2013
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Abstract | The percutaneous treatment of coronary artery disease has been revolutionized by the use of drug-eluting stents (DES). However, its use in the daily practice involves patients with more complex clinical and angiographic characteristics than those found in randomized trials. This registry was designed to characterize diabetic patients and their outcomes following DES implantation in our country.
Prospective single-center registry enrolling consecutive patients after DES implantation. Clinical, angiographic and procedurerelated data, as well as early and long-term outcomes were recorded. The primary endpoint, including cardiac death, myocardial infarction or target lesion revascularization, was compared between diabetics and non-diabetics.
We evaluated 1,670 patients treated with DES from 2002 to 2012 with a follow-up of 3.2±2.5years. One third of the patients were diabetic and had lower event-free survival when compared to non-diabetic patients (79.4% vs. 82.6%; P=0.015). The adjusted odds ratio, however, was 1.22 (95% CI, 0.89-1.69) and was not significant. A significantly lower event-free survival was observed in the subgroup of patients receiving insulin, whereas it was similar for diabetic and nondiabetic patients in the subgroup not receiving insulin (68.7% vs. 83.9% vs. 82.8%, respectively; P < 0.01). The adjusted odds ratio was 1.72 (95% CI, 1.13-2.63) higher for diabetic patients receiving insulin when compared to the remaining patients.
The use of DES is beneficial for all diabetic patients, especially those who do not receive insulin.
Resultados Iniciais e Tardios deDiabéticos Tratados com Stents Farmacológicos do Registro Safira
O tratamento percutâneo da doença arterial coronária foi revolucionado pelo uso dos stents farmacológicos (SF). No entanto, sua utilização na prática diária envolve pacientes com características clínicas e angiográficas mais complexas dos que aquelas encontradas em estudos randomizados. Este registro se propôs a caracterizar, em nosso meio, diabéticos e seus desfechos clínicos após implante de SF.
Registro unicêntrico, prospectivo, que arrolou pacientes consecutivos submetidos a implante de SF. Foram registrados dados clínicos, angiográficos e do procedimento, assim como os desfechos hospitalares e tardios. A avaliação do desfecho primário, composto por óbito cardíaco, infarto agudo do miocárdio ou revascularização da lesão-alvo, foi realizada comparando-se pacientes diabéticos e não diabéticos.
Avaliamos 1.670 pacientes tratados com SF no período de 2002 a 2012, com seguimento de 3,2±2,5 anos. Um terço dos pacientes era diabético e apresentou sobrevivência livre de eventos menor que os não diabéticos (79,4% vs. 82,6%; P=0,02). A razão de risco ajustada, no entanto, foi de 1,22 (IC 95%, 0,89-1,69) - não significativa. Ao analisar o subgrupo dos pacientes em uso de insulina, encontramos sobrevivência livre de eventos significativamente menor que a dos demais, enquanto que os diabéticos que não estavam em uso de insulina mostraram comportamento semelhante ao dos não diabéticos (68,7% vs. 83,9% vs. 82,8%, respectivamente; P < 0,01). A razão de risco ajustada foi 1,72 (IC 95%, 1,13-2,63) vez maior para os diabéticos em uso de insulina em comparação aos demais pacientes.
O uso de SF traz benefícios para todos os diabéticos, especialmente para os que não utilizam insulina. |
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AbstractList | The percutaneous treatment of coronary artery disease has been revolutionized by the use of drug-eluting stents (DES). However, its use in the daily practice involves patients with more complex clinical and angiographic characteristics than those found in randomized trials. This registry was designed to characterize diabetic patients and their outcomes following DES implantation in our country.
Prospective single-center registry enrolling consecutive patients after DES implantation. Clinical, angiographic and procedurerelated data, as well as early and long-term outcomes were recorded. The primary endpoint, including cardiac death, myocardial infarction or target lesion revascularization, was compared between diabetics and non-diabetics.
We evaluated 1,670 patients treated with DES from 2002 to 2012 with a follow-up of 3.2±2.5years. One third of the patients were diabetic and had lower event-free survival when compared to non-diabetic patients (79.4% vs. 82.6%; P=0.015). The adjusted odds ratio, however, was 1.22 (95% CI, 0.89-1.69) and was not significant. A significantly lower event-free survival was observed in the subgroup of patients receiving insulin, whereas it was similar for diabetic and nondiabetic patients in the subgroup not receiving insulin (68.7% vs. 83.9% vs. 82.8%, respectively; P < 0.01). The adjusted odds ratio was 1.72 (95% CI, 1.13-2.63) higher for diabetic patients receiving insulin when compared to the remaining patients.
The use of DES is beneficial for all diabetic patients, especially those who do not receive insulin.
Resultados Iniciais e Tardios deDiabéticos Tratados com Stents Farmacológicos do Registro Safira
O tratamento percutâneo da doença arterial coronária foi revolucionado pelo uso dos stents farmacológicos (SF). No entanto, sua utilização na prática diária envolve pacientes com características clínicas e angiográficas mais complexas dos que aquelas encontradas em estudos randomizados. Este registro se propôs a caracterizar, em nosso meio, diabéticos e seus desfechos clínicos após implante de SF.
Registro unicêntrico, prospectivo, que arrolou pacientes consecutivos submetidos a implante de SF. Foram registrados dados clínicos, angiográficos e do procedimento, assim como os desfechos hospitalares e tardios. A avaliação do desfecho primário, composto por óbito cardíaco, infarto agudo do miocárdio ou revascularização da lesão-alvo, foi realizada comparando-se pacientes diabéticos e não diabéticos.
Avaliamos 1.670 pacientes tratados com SF no período de 2002 a 2012, com seguimento de 3,2±2,5 anos. Um terço dos pacientes era diabético e apresentou sobrevivência livre de eventos menor que os não diabéticos (79,4% vs. 82,6%; P=0,02). A razão de risco ajustada, no entanto, foi de 1,22 (IC 95%, 0,89-1,69) - não significativa. Ao analisar o subgrupo dos pacientes em uso de insulina, encontramos sobrevivência livre de eventos significativamente menor que a dos demais, enquanto que os diabéticos que não estavam em uso de insulina mostraram comportamento semelhante ao dos não diabéticos (68,7% vs. 83,9% vs. 82,8%, respectivamente; P < 0,01). A razão de risco ajustada foi 1,72 (IC 95%, 1,13-2,63) vez maior para os diabéticos em uso de insulina em comparação aos demais pacientes.
O uso de SF traz benefícios para todos os diabéticos, especialmente para os que não utilizam insulina. |
Author | Salman, Adnan Ali Mauro, Maria Fernanda Zuliani Oliveira, Fernanda Joslin Soares, Breno Abrahão Maués Erudilho, Eduardo Cunha, Antonio Carvalho Cristóvão, Salvador Andre Bavaresco Garcia, Raphael Moura Marchini, Julio Flávio Meirelles Armando Mangione, J. Elias, Gabriel Gonzalo Penaranda de Mendonça Carnieto, Nadia |
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Copyright | 2013 Sociedade Brasileira de Hemodinâmica e Cardiologia Intervencionista. Published by Elsevier Editora Ltda |
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Keywords | Intervenção coronária percutânea Doença das coronárias Drug-eluting stents Diabetes mellitus tipo 2 Percutaneous coronary intervention Stents farmacológicos Coronary disease Diabetes mellitus type 2 |
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References | Costa, Sousa, Moreira, Costa, Cano, Maldonado (bb0055) 2010; 3 Tamburino, Ciriminna, Barbagallo, Galassi, Ussia, Capranzano (bb0025) 2008; 9 Dominguez Franco, Alonso Briales, Jimenez Navarro, Hernandez Garcia, Garcia Pinilla, Perez Caravante (bb0070) 2008; 31 Simsek, Magro, Boersma, Onuma, Nauta, Gaspersz (bb0085) 2010; 3 Aronson, Johnstone (bb0080) 2001 American Diabetes Association (bb0040) 2002; 25 Mehran, Rao, Bhatt, Gibson, Caixeta, Eikelboom (bb0050) 2011; 123 Thygesen, Alpert, White, Jaffe, Apple, Galvani (bb0045) 2007; 116 Ortolani, Ardissino, Cavallini, Bramucci, Indolfi, Aquilina (bb0065) 2005; 96 Garg, Serruys (bb0005) 2010; 56 Kirtane, Gupta, Iyengar, Moses, Leon, Applegate (bb0010) 2009; 119 Pavao, Marin-Neto, Novaes, Pinto, Figueiredo, Lago (bb0015) 2013; 21 Moreira, Sousa, Costa, Costa, Maldonado, Cano (bb0060) 2008; 16 Mattos, Lemos Neto, Rassi, Marin-Neto, Sousa, Devito (bb0035) 2008; 91 Giolo, Soler, Greenway, Almeida, Andrade, Seidman (bb0020) 2012; 20 Williams, Abbott, Kip (bb0030) 2006; 114 Berenguer, Mainar, Bordes, Valencia, Gomez (bb0075) 2006; 59 |
References_xml | – volume: 25 start-page: 213 year: 2002 end-page: 229 ident: bb0040 article-title: Standards of medical care for patients with diabetes mellitus publication-title: Diabetes Care. contributor: fullname: American Diabetes Association – volume: 31 start-page: 165 year: 2008 end-page: 171 ident: bb0070 article-title: Clinical impact of drug-eluting stents in an unselected population of diabetic patients publication-title: Clin Cardiol contributor: fullname: Perez Caravante – volume: 91 start-page: 1 year: 2008 end-page: 58 ident: bb0035 article-title: Diretrizes da Sociedade Brasileira de Cardiologia – Intervenção Coronária Percutânea e Métodos Adjuntos Diagnósticos em Cardiologia Intervencionista (II Edição – 2008) publication-title: Arq Bras Cardiol contributor: fullname: Devito – volume: 21 start-page: 121 year: 2013 end-page: 127 ident: bb0015 article-title: Avaliação a médio prazo do controle de fatores de risco do doença cardiovascular em coorte prospectiva de pacientes de alto risco, tratados por intervençao coronária percutânea publication-title: Rev Bras Cardiol Invasiva contributor: fullname: Lago – volume: 20 start-page: 111 year: 2012 end-page: 116 ident: bb0020 article-title: Brazilian urban population genetic structure reveals a high degree of admixture publication-title: Eur J Hum Genet contributor: fullname: Seidman – volume: 9 start-page: 161 year: 2008 end-page: 168 ident: bb0025 article-title: Sicilian DES Registry: prospective inhospital and 9-month clinical and angiographic follow-up in selected high restenosis risk patients publication-title: J Cardiovasc Med (Hagerstown) contributor: fullname: Capranzano – volume: 116 start-page: 2634 year: 2007 end-page: 2653 ident: bb0045 article-title: Universal definition of myocardial infarction publication-title: Circulation contributor: fullname: Galvani – volume: 96 start-page: 1393 year: 2005 end-page: 1398 ident: bb0065 article-title: Effect of sirolimus-eluting stent in diabetic patients with small coronary arteries (a SES-SMART substudy) publication-title: Am J Cardiol contributor: fullname: Aquilina – volume: 123 start-page: 2736 year: 2011 end-page: 2747 ident: bb0050 article-title: Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium publication-title: Circulation contributor: fullname: Eikelboom – volume: 16 start-page: 185 year: 2008 end-page: 192 ident: bb0060 article-title: Evolução tardia após intervenção coronária percutânea com stents farmacológicos em pacientes diabéticos do Registro DESIRE (Drug-Eluting Stents In the REal world) publication-title: Rev Bras Cardiol Invasiva contributor: fullname: Cano – volume: 119 start-page: 3198 year: 2009 end-page: 3206 ident: bb0010 article-title: Safety and efficacy of drug-eluting and bare metal stents: comprehensive meta-analysis of randomized trials and observational studies publication-title: Circulation contributor: fullname: Applegate – volume: 3 start-page: 12 year: 2010 end-page: 18 ident: bb0055 article-title: Incidence and predictors of very late (> publication-title: JACC Cardiovasc Interv contributor: fullname: Maldonado – volume: 56 start-page: S1 year: 2010 end-page: S42 ident: bb0005 article-title: Coronary stents: current status publication-title: J Am Coll Cardiol contributor: fullname: Serruys – volume: 3 start-page: 1051 year: 2010 end-page: 1058 ident: bb0085 article-title: The unrestricted use of sirolimus- and paclitaxeleluting stents results in better clinical outcomes during 6-year follow-up than bare-metal stents: an analysis of the RESEARCH (Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital) and T-SEARCH (Taxus-Stent Evaluated At Rotterdam Cardiology Hospital) registries publication-title: JACC Cardiovasc Interv contributor: fullname: Gaspersz – volume: 114 start-page: 2154 year: 2006 end-page: 2162 ident: bb0030 article-title: DEScover Investigators. Outcomes of 6906 patients undergoing percutaneous coronary intervention in the era of drug-eluting stents: report of the DEScover Registry publication-title: Circulation contributor: fullname: Kip – volume: 59 start-page: 117 year: 2006 end-page: 124 ident: bb0075 article-title: Efficacy of sirolimus-eluting stents in diabetics with complex coronary lesions publication-title: Rev Esp Cardiol contributor: fullname: Gomez – start-page: 247 year: 2001 end-page: 279 ident: bb0080 article-title: Coronary artery disease in diabetes publication-title: Diabetes and cardiovascular disease contributor: fullname: Johnstone |
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SubjectTerms | Coronary disease Diabetes mellitus tipo 2 Diabetes mellitus type 2 Doença das coronárias Drug-eluting stents Intervenção coronária percutânea Percutaneous coronary intervention Stents farmacológicos |
Title | Early and Late Outcomes of Diabetic Patients Treated with Drug-Eluting Stents in the Safira Registry |
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