Outcomes of Percutaneous Interventions in Diabetics Treated with
Transcrição
Rev Bras Cardiol Invas 2006; 14(2): 109-114. Chaves ÁJ, et al. Outcomes of Percutaneous Interventions in Diabetics Treated with Drug Eluting Stents or Bare Metal Stents: The SOLACI Registry Results. Rev Bras Cardiol Invas 2006; 14(2): 109-114. Artigo Original Outcomes of Percutaneous Interventions in Diabetics Treated with Drug Eluting Stents or Bare Metal Stents: The SOLACI Registry Results Áurea J. Chaves1, Amanda G. M. R. Sousa1, Daniel Berrocal2, Alexandre Abizaid1, Ernesto Ban Hayashi3, Fausto Buitrón4, Irving Peña5, Eugenio Marchant6, Expedito E. Ribeiro7, Jorge A. Belardi8, Hugo F. Londero9, J. Eduardo Sousa1, on behalf of SOLACI Registry Participants RESUMO SUMMARY Evolução de Pacientes Diabéticos Tratados por Intervenções Percutâneas com Stents Farmacológicos ou Stents Metálicos não Recobertos: Resultados do Registro SOLACI Background: Randomized trials helped clarify the value of drug-eluting stents (DES) in selected diabetic subgroups, but little is known if those results can be generalized to everyday practice. We report the contemporary Latin American experience with coronary DES implantation in diabetics, using the 2003 SOLACI Registry databank. Method and Results: Data were collected on 5,509 diabetics who underwent coronary stent implantation at 67 medical centers in 9 countries. From those, 4,724 (85.8%) patients received bare metal stents (BMS), 440 (8.0%) sirolimus-eluting stents (SES) and 345 (6.3%) paclitaxel-eluting stents (PES). Mean age was 62.1 years; 62.6% were males. Approximately 50% of the patients underwent PCI for unstable coronary syndromes (45.2% with unstable angina and 9.7% with acute myocardial infarction). Average reference diameter was 2.97 mm, and mean lesion length was 17.4 mm. Patients treated with DES had more complex lesions (B2/C), smaller vessels and longer lesions when compared to those treated with BMS. No clinically significant differences were observed in one-year mortality (0.9% SES vs. 0.3% PES vs. 1.2% BMS) or myocardial infarction rates (0.9% SES vs. 0.9% PES vs. 3.7% BMS). Target vessel revascularization, however, was much improved in the DES groups. TVR was reduced due to a decrease in both the need for percutaneous intervention (1.8% SES vs. 2.3% PES vs. 8.3% BMS) and bypass surgery (0.9% SES vs. 0.6% PES vs. 3.4% BMS). Conclusions: This large, Latin American, contemporary database revealed that routine utilization of DES for diabetic patients is safe and improves the 1-year clinical outcome compared to BMS, reducing the need for TVR. These results are similar to those observed in contemporary clinical registries and provide a framework for improved treatment strategies for diabetics with coronary artery disease. Fundamentos: Estudos randomizados ajudaram a elucidar o valor dos stents com eluição de fármacos (SEF) em subgrupos selecionados de pacientes diabéticos, mas pouco se sabe se estes resultados podem ser generalizados para a prática clínica cotidiana. Nós relatamos a experiência latino-americana contemporânea com o implante de SEF em diabéticos, utilizando o banco de dados do Registro SOLACI do ano de 2003. Método e Resultados: Dados foram coletados de 5.509 diabéticos que se submeteram ao implante de stents coronários, em 67 centros médicos de nove países. Destes, 4.724 (85,8%) receberam stents metálicos não recobertos (SM), 440 (8,0%) stents com eluição de sirolimus (SES) e 345 (6,3%) stents com eluição de paclitaxel (SEP). A média das idades foi de 62,1 anos e 62,6% eram do sexo masculino. Aproximadamente metade dos pacientes submeteu-se à intervenção coronária percutânea para tratar síndrome coronária aguda (45,2% com angina instável e 9,7% com infarto agudo do miocárdio). A média dos diâmetros de referência foi de 2,97 mm e a média das extensões da lesão, 17,4 mm. Pacientes tratados com SEF apresentaram lesões mais complexas (B2/C), vasos de menor calibre e lesões mais longas que os tratados com SM. Não foram observadas diferenças clínicas significantes nas taxas de mortalidade (0,9% SES vs. 0,3% SEP vs. 1,2% SM) e infarto do miocárdio (0,9% SES vs. 0,9% SEP vs. 3,7% SM), em um ano. As taxas de revascularização do vaso-alvo (RVA), entretanto, foram menores nos grupos que utilizaram os SEF. A RVA foi reduzida devido à diminuição da necessidade de nova intervenção percutânea (1,8% SES vs. 2,3% SEP vs. 8,3% SM) e cirurgia de revascularização miocárdica (0,9% SES vs. 0,6% SEP vs. 3,4% SM). Conclusões: Este grande banco de dados latino-americano mostrou que a utilização de rotina dos SEF em diabéticos é segura e melhora a evolução clínica em um ano, reduzindo a necessidade de RVA. Estes resultados são similares aos observados em registros clínicos contemporâneos e estabelecem uma plataforma para melhorar as estratégias de tratamento de diabéticos com doença arterial coronária. DESCRITORES: Diabetes mellitus. Stents farmacológicos. Angioplastia transluminal coronária. DESCRIPTORS: Diabetes mellitus, Stents, Percutaneous Coronary Intervention. 1 8 2 9 Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil. Hospital Italiano de Buenos Aires, Buenos Aires, Argentina. 3 Instituto Nacional de Cardiologia Ignacio Chávez, Mexico City, México. 4 Asociación Española Primera de Socorros Mutuos, Montevideo, Uruguay. 5 Policlínica Metropolitana, Caracas, Venezuela. 6 Pontificia Universidad Catolica de Chile, Santiago, Chile. 7 Heart Institute (InCor), São Paulo, Brazil. Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina. Sanatorio Allende, Córdoba, Argentina. Correspondência: Áurea J. Chaves. Invasive Cardiology Section, Instituto Dante Pazzanese de Cardiologia. Av. Dr. Dante Pazzanese, 500. São Paulo, SP, Brazil. CEP 04012 -180. Tel: (55 11) 5085-4215 Fax: (55 11) 5549-7807 • e-mail: [email protected] Recebido em: 30/05/2006 • Aceito em: 19/06/2006 109 Aurea.p65 109 13/7/2006, 21:49 Chaves ÁJ, et al. Outcomes of Percutaneous Interventions in Diabetics Treated with Drug Eluting Stents or Bare Metal Stents: The SOLACI Registry Results. Rev Bras Cardiol Invas 2006; 14(2): 109-114. P atients with diabetes mellitus have higher rates of adverse outcomes after percutaneous coronary interventions. Recently, drug-eluting stent implantation (DES) markedly reduced the incidence of angiographic restenosis and repeat revascularizations in diabetic patients1-5. Although randomized trials have helped to clarify the value of DES in selected diabetic subgroups, little is known about the extent of their use in global clinical practice or whether those results can be generalized to everyday practice. In this publication, we are reporting the contemporary Latin American experience with coronary DES implantation in diabetic patients, by means of a survey involving catheterization laboratories from countries registered in the Sociedad Latinoamericana de Cardiologia Intervencionista (SOLACI) Registry databank. METHOD Study Population and Data Collection The SOLACI Registry was developed to gather data on the management and hospital outcome of patients submitted to cardiac diagnostic and therapeutic procedures in Latin American centers (Table 1). This report focuses on 2003 experience with coronary DES procedures in diabetic patients. At that time, only nine of the Latin American countries had DES for clinical use and contributed patients to this study. For this purpose a specific questionnaire was mailed to participating institutions. Patient data included demographics (eg, age, gender), cardiovascular risk factors (eg, history of diabetes mellitus, hypertension, hyperlipidemia, and smoking), comorbidities (eg, history of myocardial infarction, coronary artery bypass graft surgery or PCI) and clinical presentation (eg, silent ischemia, stable angina, unstable angina, myocardial infarction). Angiographic and procedural data were also available (eg, multivessel disease, left ventricular function, target vessel, ACC/AHA lesion type, reference diameter, lesion length, procedural success and complications). History of diabetes was obtained through patient self-report. Baseline treatment status (insulin or hypoglycemic agent versus diet control) was not recorded by site coordinators. For the 1-year follow-up data, an additional questionnaire was sent to the participating catheterization laboratories and the information was entered into a central database and subsequently analyzed at the SOLACI Registry Coordinating Center at the Instituto Dante Pazzanese de Cardiologia. Data were reported only in aggregate format. Consequently, registry entries contemplated individual center results, not individual patients. Interventions, Adjunctive Drug Therapy and Angiographic Analyses PCI patient eligibility was site-specific, as was periprocedural adjunctive therapy. The available stents included bare metal stents, sirolimus-eluting stents and paclitaxel-eluting stents. All interventions were performed according to current standard guidelines, and the final interventional strategy was entirely left to the discretion of the operator. Core laboratory quantitative coronary angiographic analysis was not available, although onsite analysis was usually performed. The physicians in charge of the patients took care of them according to their usual practice and independently from the study. Endpoints and Definitions Endpoints included hospital and the 1-year major adverse cardiac events, defined as (1) death from any cause, (2) nonfatal myocardial infarction, or (3) target vessel revascularization (coronary bypass surgery or percutaneous intervention). All adverse events were investigator-reported. Myocardial infarction was defined as clinical signs and symptoms of infarction confirmed by new ECG changes or (re)elevation of cardiac enzymes. TABLE 1 Cath labs and interventionalists registered at the SOLACI Database Country Argentina Bolivia Brazil Colombia Costa Rica Cuba Chile Dominican Rep. Ecuador San Salvador Cath Labs (n=618) Interventionalists (n=1278) Country Cath Labs (n=618) Interventionalists (n=1278) 138 004 267 029 006 006 019 008 010 002 263 007 572 053 005 027 050 013 011 004 Guatemala Honduras Mexico Nicaragua Panama Paraguay Peru Puerto Rico Uruguay Venezuela 002 002 069 001 005 005 018 005 007 015 004 003 134 001 006 009 040 008 021 047 110 Aurea.p65 110 13/7/2006, 21:49 Chaves ÁJ, et al. Outcomes of Percutaneous Interventions in Diabetics Treated with Drug Eluting Stents or Bare Metal Stents: The SOLACI Registry Results. Rev Bras Cardiol Invas 2006; 14(2): 109-114. Stent thrombosis was considered when the patient had acute myocardial infarction in the distribution of the treated vessel or had sudden death, within 30 days of index procedure. The SOLACI review board approved of the use of these data for this study. cant. Death occurred in 0.8% (0% SES vs. 0% PES vs. 1.0% BMS); myocardial infarction in 2.5% (0.5% SES vs. 0.3% PES vs. 2.8% BMS) and urgent revascularization in 0.6% (0.5% SES vs. 0% PES vs. 0.6% BMS). Stent thrombosis was observed in 0.9%, 0.6% and 2.9% of diabetics, respectively (Table 6). RESULTS Overall 5,509 diabetics with 7,812 lesions in 6,975 vessels from 67 catheterization laboratories were identified (Table 2). Of these, 4,724 (85.8%) patients received bare metal stents, 440 (8.0%) sirolimus-eluting stents and 345 (6.3%) paclitaxel-eluting stents. Drug-eluting stent implantations varied widely across countries, as manifested by coefficients of variation (SD/mean) >0.3% for all stent groups (Table 3). Demographics, Clinical and Procedural Characteristics The majority of diabetics were males; mean age of 62.1 years. Approximately half of the patients underwent PCI for unstable coronary syndromes (45.2% with unstable angina and 9.7% with acute myocardial infarction). Other high-risk features included multivessel coronary artery disease (35.5%) and impaired left ventricular function (25.1%) - Tables 4 and 5. Treated lesions were class B2 or C in 51.9% according to the American College of Cardiology/American Heart Association classification; the average reference diameter was 2.97 mm, and mean lesion length was 17.4 mm. Patients treated with DES had more complex lesions (B2/C), smaller vessels and longer lesions than those treated with BMS. The angiographic success rate was >97% and similar among groups (Table 5). Thirty-Day Outcomes Thirty-day event rates were low and the differences among groups were not deemed to be clinically signifi- TABLE 2 Number of diabetic patients treated with coronary drug-eluting stents per country in 2003 (SOLACI Database) Country Brazil Argentina Colombia Uruguay Mexico Honduras Chile Venezuela Peru Total SES 248 94 25 6 35 5 2 6 19 440 PES 187 57 74 13 6 2 0 6 0 345 BMS 2471 1030 777 278 67 52 41 8 0 4724 Total 2906 1181 876 297 108 59 43 20 19 5509 TABLE 3 Rates of DES and bare metal stents utilization in diabetic patients (SOLACI Database 2003) Mean (%) Standard deviation (%) Minimum (%) Maximum (%) Coefficient of variation SES PES BMS 21.9 31.4 2.0 100.0 1.43 7.0 9.1 0 30.0 1.29 71.1 32.1 0 95.3 0.45 TABLE 4 Clinical characteristics of diabetic patients treated with stents registered at the SOLACI Database (2003) Characteristics Age (y) Female sex (%) Hypertension (%) Hypercholesterolemia (%) Smokers (%) Previous MI (%) CABG (%) PCI (%) Stable angina/Silent ischemia (%) Unstable angina (%) Myocardial infarction (%) SES (n=440) PES (n=345) BMS (n=4.724) 62.1 35.2 59.1 38.4 23.6 18.6 13.9 21.8 42.3 40.7 05.7 63.6 33.3 53.0 46.7 36.5 26.4 15.1 21.7 53.6 54.8 04.9 63.0 37.9 56.5 45.7 38.2 25.2 11.8 18.7 50.0 44.9 10.4 111 Aurea.p65 111 13/7/2006, 21:49 Chaves ÁJ, et al. Outcomes of Percutaneous Interventions in Diabetics Treated with Drug Eluting Stents or Bare Metal Stents: The SOLACI Registry Results. Rev Bras Cardiol Invas 2006; 14(2): 109-114. TABLE 5 Angiographic and procedural data Characteristics Multivessel disease (%) Impaired LV function (%) Target vessel, n (%) LAD RCA LCX SVG/LIMA LM Target lesion, n (%) A B1 B2 C Reference vessel diameter (mm) Lesion length (mm) Procedural success (%) SES (n=440) PES (n=345) BMS (n=4.724) 40.9 21.6 33.6 32.2 35.2 24.9 235 (44.9) 145 (27.7) 108 (20.7) 27 (5.2) 8 (1.5) 239 (43.6) 158 (28.8) 120 (21.9) 22 (4.0) 9 (1.6) 2,651 (44.9) 1,591 (26.9) 1,331 (22.5) 239 (4.0) 92 (1.6) 83 (14.3) 133 (23.0) 265 (45.8) 98 (16.9) 2.73 20.3 98.2 94 (13.8) 162 (23.8) 318 (46.8) 106 (15.6) 2.82 19.1 99.7 1,297 (19.8) 1,988 (30.3) 2,389 (36.5) 879 (13.4) 3.00 17.1 97.5 TABLE 6 Clinical events at the follow-up Events 30-Day events (%) Death MI Urgent revascularization Stent thrombosis 1-Year events (%) Death MI TVR PCI CABG SES n=440 (%) PES n=345 (%) BMS n=4,724 (%) 0 2 (0.5) 2 (0.5) 4 (0.9) 0 1 (0.3) 0 2 (0.6) 46 (1.0) 132 (2.8) 29 (0.6) 136 (2.9) 4 (0.9) 4 (0.9) 12 (2.7) 8 (1.8) 4 (0.9) 1(0.3) 3 (0.9) 10 (2.9) 8 (2.3) 2 (0.6) 58 (1.2) 173 (3.7) 553 (11.7) 392 (8.3) 161 (3.4) 1-Year Follow-Up Although no relevant differences in mortality (0.9% SES vs. 0.3% PES vs. 1.2% BMS) or myocardial infarction rates (0.9% SES vs. 0.9% PES vs. 3.7% BMS) were observed, the need for target vessel revascularization was much improved in the DES groups (2.7% SES vs. 2.9% PES vs. 11.7% BMS). TVR was reduced due to a decrease in both the need for percutaneous intervention and bypass surgery (Table 6). DISCUSSION The SOLACI Registry allows a contemporary overview of the current treatment patterns and 1-year outcomes for diabetic patients suitable for coronary stent intervention in Latin American countries, providing key information on how innovations are actually used and how they impact clinical practice. This registry has unique strengths including geographic and institutional diversity and a large sample size over a relatively short, contemporary time frame. Little information is available with regard to how drug-eluting stents are actually being implemented for patients in Latin America and, to our knowledge, there has been no report demonstrating the patterns of utilization and the assessment of the effectiveness of sirolimus and paclitaxel-eluting stents in diabetics in those countries. Overall, 14.3% of the diabetics included in the registry in calendar year 2003 had been treated with a sirolimus or a paclitaxel-eluting stent. The main result of this strategy was a marked reduction in the rates of repeat revascularization at 1 year with the 2 drugeluting stents when compared with bare metal stents. 112 Aurea.p65 112 13/7/2006, 21:49 Chaves ÁJ, et al. Outcomes of Percutaneous Interventions in Diabetics Treated with Drug Eluting Stents or Bare Metal Stents: The SOLACI Registry Results. Rev Bras Cardiol Invas 2006; 14(2): 109-114. No clinically relevant differences in the rates of death or MI among the groups were observed. The new stents were used for indications where randomized trials are still needed to achieve higher levels of evidence about safety and efficacy6 (7.9% of myocardial infarctions, 17% of bypass grafts and 15.6% of the left main stenoses). The 1-year death and MI frequency in our patients treated with the sirolimus and paclitaxel eluting stents (0.6% and 0.9%, respectively) lay between the 0.4%4.8% and 0-4.1% ranges reported for diabetics in the drug-eluting arms of recent trials1-5,7-10. One-year target vessel revascularization was lower than values recorded in previously randomized studies, but similar to “realworld” registries. In our patients, we found an incidence of target vessel revascularization of 2.7% in the sirolimus stent group and 2.9% in the paclitaxel stent group. In randomized trials, target vessel revascularizations were in the 6.3%-9.9% range for diabetics treated with sirolimus stent2,4,5 and 11.3%-12.0% for those treated with the paclitaxel stent3,4. In contrast, the figures were 2.1%8.8% and 3.4%-5.7%, respectively, in registries focusing diabetic patients7-10. A mechanism that could explain higher TVR in those randomized trials is the use of mandated angiographic follow-up, elevating TVR by increasing the likelihood of revascularization for patients with moderate angiographic lesions. Concerns have been brought up with the comparison between the SES and PES because it is suggested that there may be differences between the 2 drug-eluting stents regarding prevention of recurrences in patients with diabetes. Evaluation of the results achieved with these 2 drug-eluting stents indicates distinct restenosis rates favoring the sirolimus stent. TLR, on the other hand, was no different between groups4 - a finding concordant with our data. Similar to the comparable antirestenotic efficacy of the two DES, no difference was observed with regard to the safety of these devices. Thirty-day stent thromboses were 0.9% for SES and 0.6% for PES, consistent with the 0.5-2.8% range reported for diabetics in DES registries7,8,10. Observations beyond 1 month were not available, and no conclusions could be drawn regarding ultimate long-term behavior related to stent thromboses. In this multicenter registry of DES implantation in diabetics, all restrictions inherent to this particular study design are relevant. Nevertheless, given the broad inclusion criteria, this cohort of patients precisely reflects the daily practice in the “real world” of interventional cardiology and, in our view the results could be extended to virtually all patients with diabetes. CONCLUSION This large, Latin American, contemporary database reveals that routine utilization of drug-eluting stents for diabetic patients reduced importantly the rate of TVR at 1-year compared to bare metal stents. No relevant differences were found in the rates of death or MI among the groups. These results are similar to that observed in contemporary clinical registries and provide a framework for improved treatment strategies for diabetics with coronary artery disease. SOLACI REGISTRY PARTICIPANTS Argentina: Adrian Rossini, Alberto A. Cristino, Alberto Licheri, Alberto Sampaolesi, Alberto Villegas, Alejandro D. Fernández, Alejandro Daniel Mesples, Alejandro Goldsmit, Alejandro Martorina, Alfedo Bravo, Alfredo Eduardo Rodríguez, Amalia M.E. Descalzo, Andrin Oberdan, Anibal de Sanctis, Anibal Gentiletti, Carlos Alejandro Álvarez Iorio, Carlos E. Mauvecin, Carlos J. Álvarez Iorio, Carlos Rojas Matas, Daniel Berrocal, Eduardo D. Paris, Eduardo Magariños, Eduardo R. Novero, Elisabet Marsiglio, Fabio Säger, Fernando F. Ordóñez, Fernando Tau, Francisco Vrsalovic, Gonzalo Calvo, Guillermo Mulinaris, Guillermo Pacheco, Gustavo Bonzón, Gustavo Caballero, Jaime Poch, Jorge Bordagaray, Jorge Iravedra, Jorge Thomas, Jorge Wisner, José Luis Lazarte, José M. Gabay, José Oscar Gómez Moreno, José Pereyra, José Vaccaro, José Vicario, Juan Carlos Dalmaroni, Juan José Lloberas, Julio A. Pascua, Liliana Grinfeld, Liliana Rojo, Luis Gerardo, Manuel Sanjurjo, Marcelo E. Halac, Marcelo Notrica, Marcelo Pettinari, Mario Daniel Pieroni, Mario Montoya, Nicolas Nitti, Orlando Lepori, Osvaldo Laudano, Osvaldo Navarro, Pablo Luna, Raúl Bretal, Ricardo Arce Cano, Roberto Diaz, Roberto Fernández Viña, Sandra Reyes, Sebastián Araujo, Silvio Martínez, Vasco Galvez; Brasil: Adnan Ali Salman, Alaor Queiroz Araujo Filho, Alexandre A.C. Abizaid, Alexandre Manoel Varela, Alfredo Nunes Ferreira Filho, Anderson Jorge Lima Nascimento, André Cambra, André Labrunie, Antenório Aiolfi, Antonio Forte, Antonio José Muniz, Antonio José Neri Souza, Ari Mandil, Bruno Moulin Machado, Carlos Augusto Arêas, Carlos Eduardo Domingues, Décio Salvadori Jr., Dinaldo Cavalcanti, Edson Alcides Bocchi, Fabio Prudente, Fausto Feres, Flavio A. Aranha Japyassú, Flavio Braga Mota, Flavio Roberto de Oliveira Andrade, Galo A. Maldonado, George Meirelles, Gustavo de Moraes Ramalho, Hélio Roque Figueira, Henrique Ebaid, J. Eduardo M.R. Sousa, Jamil Abdalla Saad, João Baptista Oliveira, João Batista Lopes Loures, Jorge Hayashi, Jorge Roberto Büchler, José Airton de Arruda, José Antonio de Souza Vieira, José Armando Mangione, José Ary Boechat e Salles, José Del Carmen Solano Aliaga, José Henrique Cavalcanti Mota, Júlio Andréa, Leônidas Alvarenga Henriques, Luciano Abreu, Luiz Alberto P. Mattos, Luiz Antonio Gubolino, Maéve de Barros Correia, Manuel Nicolas Cano, Luiz Augusto Lavalle, Marcos César V. de Almeida, Marcos Sumita, Milton Macedo Soares Neto, Mônica Buchalla, Murillo Kenji Furukawa, Norberto Toazza Duda, Pablo Tomé Teixeirense, Roberto Abdalla Filho, Rodolfo Staico, Rogério de Castro Pimentel, Rogério Tadeu Tumelero, 113 Aurea.p65 113 13/7/2006, 21:49 Chaves ÁJ, et al. Outcomes of Percutaneous Interventions in Diabetics Treated with Drug Eluting Stents or Bare Metal Stents: The SOLACI Registry Results. Rev Bras Cardiol Invas 2006; 14(2): 109-114. Rogerio Tiossi, Salvador André B. Cristovão, Sérgio Luiz N. Braga, Tiago Di Tucchi, Ulises Acuña Solorzano, Virgilio Franco Jr., Vitor Gomes Barreto, Walasse Rocha Vieira, Wilson Albino Pimentel Filho; Chile: Carlos Caorsi, Darío Martínez Ojeda, Ivan Luksic Sandoval, Juan Delgado, Lucio León, Marcelo Lindh Ibáñez, Misael Lopetegui Aburto; Colombia: Alberto Suárez Nitola, Carlos Andrés Carvajal, Darío Echeverri, Ebalo Real, Edgar Hurtado, Germán Gómez, Héctor Hernández Gallo, Jorge Villegas, Luis Calderón, Manuel Llevano Triana, Manuel R. Téllez, Mauricio Pineda, Orlando Corzo, Oscar Fernández Gómez, Pablo Castro, Rafael Gonzalez Nino; Honduras: Francisco R. Somoza Alvarenga, Rene Echeverria Romero; Mexico: Carlos Humberto Wabi Dogre, Manuel de los Reyes Barrera Bustillos, Joaquín Jiménez Noh; Peru: Alfredo Gama Medrano, Grace Rojas Pareja, Roberto Kenny Santos Becerra; Uruguay: Alberto Firszt, Alejandro Cuesta, Alfredo Fiandra, Ariel Durán, Bernardo Erramún, Carolina Artucio, César Pardiñas, Daniel Fiandra, Daniel Mallo, Francisco Urrutia, Jorge Musetti, Juan Gaspar, Laura Cáceres, Ricardo Lluberas, Silvia López; Venezuela: Carlos Vásquez Quintero, Freddy García Heres, Gerardo Alvarez, Miguel López Hidalgo, Norberto Deibis, Ramón Cedeño Ecarri, Yourki Tairouz. 3. 4. 5. 6. 7. 8. REFERENCES 1. Abizaid A, Costa MA, Blanchard D, Albertal M, Eltchaninoff H, Guagliumi G et al. Sirolimus-eluting stents inhibit neointimal hyperplasia in diabetic patients: insights from the RAVEL trial. Ravel Investigators. Eur Heart J 2004;25:107-12. 2. Moussa I, Leon MB, Baim DS, O’Neill WW, Popma JJ, Buchbinder M et al. Impact of sirolimus-eluting stents on outcome in diabetic patients: a SIRIUS (SIRolImUS-coated Bx Velocity balloon-expandable stent in the treatment of pa- 9. 10. tients with de novo coronary artery lesions) substudy. Circulation 2004;109:2273-8. Hermiller JB, Raizner A, Cannon L, Gurbel PA, Kutcher MA, Wong SC et al. Outcomes with the polymer-based paclitaxeleluting TAXUS stent in patients with diabetes mellitus: the TAXUS-IV trial. TAXUS-IV Investigators. J Am Coll Cardiol 2005;45:1172-9. Dibra A, Kastrati A, Mehilli J, Pache J, Schuhlen H, von Beckerath N et al. Paclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients. ISAR-DIABETES Study Investigators. N Engl J Med 2005;353:663-70. Sabaté M, Jimenez-Quevedo P, Angiolillo DJ, Gomez-Hospital JA, Alfonso F, Hernandez-Antolin R et al. Randomized comparison of sirolimus-eluting stent versus standard stent for percutaneous coronary revascularization in diabetic patients. The Diabetes and Sirolimus-Eluting Stent (DIABETES) trial. DIABETES Investigators. Circulation 2005;112:2175-83. Silber S, Albertsson P, Aviles FF, Camici PG, Colombo A, Hamm C et al. Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Eur Heart J 2005;26:804-47. Ong AT, Aoki J, van Mieghem CA, Rodriguez Granillo GA, Valgimigli M, Tsuchida K et al. Comparison of short- (one month) and long- (twelve months) term outcomes of sirolimusversus paclitaxel-eluting stents in 293 consecutive patients with diabetes mellitus (from the RESEARCH and T-SEARCH registries). Am J Cardiol 2005;96:358-62. Kuchulakanti PK, Torguson R, Canos D, Rha SW, Chu WW, Clavijo L et al. Impact of treatment of coronary artery disease with sirolimus-eluting stents on outcomes of diabetic and nondiabetic patients. Am J Cardiol 2005;96:1100-6. Yang TH, Park SW, Hong MK, Park DW, Park KM, Kim YH et al. Impact of diabetes mellitus on angiographic and clinical outcomes in the drug-eluting stents era. Am J Cardiol 2005;96:1389-92. Taxus and Cypher comparable in diabetics. Theheart.org. Disponível em: http://www.theheart.org/article/674081.do. Acessado em: 30/04/2006. 114 Aurea.p65 114 13/7/2006, 21:49
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