Stents farmacológicos para o tratamento de coronárias de fino calibre: experiência muito tardia (até 7 anos) do Registro DESIRE / Drug eluting stents for the treatment of small vessels: very late experience (Up to 7 years) of the DESIRE Registry

Introdução: Neste estudo, buscamos avaliar os resultados clínicos de pacientes com lesões coronarias em vasos de fino calibre, numa coorte de pacientes do mundo real submetidos a intervenção coronária percutânea (ICP) com stents farmacológicos. Método: Entre maio de 2002 e dezembro de 2009, 1.380 pacientes consecutivos do Registro DESIRE (Drug Eluting Stents in the Real World), com 1.683 lesões em vasos de fino calibre (< ou igual 2,5 mm de diâmetro), foram submetidos a ICP, eletiva ou de urgência, com implante de 1.818 stents farmacológicos (Cypher(tm), 89 por cento; Taxus(tm), 7,5 por cento; Xience V(tm)/Promus(tm), 3 por cento; Endeavor(tm), 0,33 por cento; Biomatrix(tm), 0,2 por cento) e incluídos neste estudo. O seguimento clínico de até 7 anos (mediana 2,8 anos) foi completo em 98 por cento, sendo obtido com 1, 6 e 12 meses e, então, anualmente. Tivemos como objetivo determinar as taxas de eventos cardíacos adversos maiores (ECAM) ao longo do período do acompanhamento clínico. Resultados: A média de idade foi de 64,5 + ou - 11,7 anos, com predomínio de pacientes do sexo masculino (76,7 por cento). Diabetes melito foi encontrado em 31,6 por cento dos casos e 9,8 por cento eram portadores de insuficiência renal crônica. A artéria descendente anterior foi o vaso mais frequentemente tratado (43,4 por cento) e dois terço das lesões eram de alta complexidade (B2/C). Sucesso angiográfico do procedimento foi obtido em 98,8 por cento dos casos. A taxa de ECAM foi de 12,8 por cento durante o seguimento,...

BACKGROUND: In this study, we sought to evaluate the clinical outcomes of patients with coronary lesions in small vessels in a cohort of real world patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). METHODS: Between May 2002 and December 2009, 1,380 consecutive patients from the DESIRE Registry (Drug Eluting Stents In The Real World), with 1,683 lesions in small vessels (< 2.5 mm in diameter) were consecutively submitted to elective or emergency PCI, with 1,818 DES (CypherTM, 89%; TaxusTM, 7.5%; Xience V TM/PromusTM, 3%; Endeavor, 0.33%; BiomatrixTM, 0.2%) and included in this study. The clinical follow-up of up to 7 years (median, 2.8 years) was completed for 98%, and was obtained at 1, 6, 12 months and then annually. Our objective was to determine the rates of major cardiac events (MACE) during clinical follow-up. RESULTS: Mean age was 64.5 ± 11.7 years, with a prevalence of male patients (76.7%). Diabetes mellitus was observed in 31.6% of the cases and 9.8% had chronic renal failure. Left anterior descending artery was the most frequent vessel treated (43.4%) and two-thirds of the lesions were complex lesions (B2/C). Angiographic success was obtained in 98.8% of the cases. The rate of MACE was 12.8% during follow-up with 4.5% of cardiac death, 4.2% of acute myocardial infarction, 4.5% of repeat target lesion revascularization and 1.5% of stent thrombosis. CONCLUSIONS: In the DESIRE Registry, the use of DES to treat small vessels in non-selected patients was associated with excellent early and late outcomes and low thrombosis rates.

Incidência e preditores de revascularização da lesão-alvo no seguimento clínico de longo prazo: análise crítica do registro DESIRE / Incidence and predictors of target lesion revascularization during the long-term clinical follow-up: a critical analysis of the DESIRE registry

Introdução: Reportamos a incidência e preditores de nova revascularização da lesão-alvo (RLA) numa coorte de pacientes do mundo real tratados com stents farmacológicos (SF). Método: Entre maio de 2002 e fevereiro de 2010, 3.320 pacientes de único centro foram submetidos a intervenção percutânea (ICP), eletiva ou de urgência, com implante de 5.320 SF (Cypher, 83%; Taxus, 9%; Xience V/Promus, 3%; Endeavor, 4%; BioMatrix, 1%). O seguimento clínico de até oito anos (mediana, 3,4 anos) foi completo em 98% do grupo e 129 pacientes (3,88%) foram submetidos a RLA. Resultados: Entre os pacientes com RLA, 33% tinham diabetes, 10% eram portadores de insuficiência renal e 61%, de doença em múltiplos vasos. A artéria descendente anterior foi o vaso mais frequentemente tratado (33%), e 72,3% das lesões eram de alta complexidade (tipo B2/C). Nesse grupo, foram implantados 214 SF em 191 lesões e 45% dos pacientes receberam múltiplos stents. Na análise univariada, os preditores de RLA foram: diabetes melito [razão de risco (RR) 1,88, intervalo de confiança (IC) de 95% 1,08-3,27; P = 0,025), uso do stent Taxus (RR 1,73, IC 95% 1,20-2,50; P = 0,003), lesão ostial (RR 1,82, IC 95% 1,1-2,98; P = 0,018), ponte de safena (RR 2,36; IC 95% 1,55-3,50; p = 0,0001), e lesões reestenóticas (RR 1,95, IC 95% 1,17-3,24; P = 0,009). Após análise multivariada, permaneceram como preditores independentes: diabetes melito, uso do stent Taxus e tratamento de lesões em pontes de safena (RR 1,64, IC 95% 1,14-2,35; P = 0,008). Conclusão: No registro DESIRE, a RLA em pacientes complexos tratados com SF foi baixa, e o diabetes melito, o tratamento de lesões em ponte de safena e o uso de SF Taxus foram os únicos preditores de RLA no acompanhamento clínico de até oito anos.

Background: We report the incidence and predictors of target lesion revascularization (TLR) in a cohort of realworld patients treated with drug eluting stents (DES). Method: From May 2002 to February 2010, 3,320 patients were treated with elective or emergency percutaneous coronaryintervention (PCI) and 5,320 DES (Cypher, 83%; Taxus, 9%; Xience V/Promus, 3%; Endeavor, 4%; BioMatrix, 1%) were implanted in a single center. The clinical follow-up of upto eight years (median time 3.4 years) was concluded in 98% patients of the group and 129 patients (3.88%) weresubmitted to TLR. Results: Of the patients with TLR, 33% had diabetes, 10% had chronic kidney disease and 61% had multivessel disease. The left anterior descending artery was the most frequent target vessel (33%) and 72.3% of the lesions were complex lesions (type B2/C). In this group,214 DES were implanted in 191 lesions and 45% of the patients received multiple stents. In the univariate analysis, TLR predictors were: diabetes mellitus [relative risk (RR) 1.88, 95% confidence interval (CI) 1.08-3.27; P = 0.025], use of Taxus stents (RR 1.73, 95% CI 1.20-2.50; P = 0.003), ostial lesion (RR 1.82, 95% CI 1.1-2.98; P = 0.018), saphenous bypass graft (RR 2.36, 95% CI 1.55-3.50; P = 0.0001), and restenotic lesions (RR 1.95, 95% CI 1.17-3.24; P = 0.009). After the multivariate analysis, the independent predictors were: diabetes mellitus, use of Taxus stents and treatment of lesions in saphenous bypass grafts (RR 1.64, 95% CI, 1.14-2.35; P = 0.008). Conclusion: In the DESIRE registry,TLR in complex patients treated with DES was low and diabetes mellitus, treatment of lesions in saphenous bypass grafts and the use of Taxus stents were the only TLR predictors in the clinical follow-up of up to 8 years.

Incidence and predictors of very late (>or=4 years) major cardiac adverse events in the DESIRE (Drug-Eluting Stents in the Real World)-Late registry.

OBJECTIVES: Our aim was to access the incidence of late major adverse cardiac events (MACE) and stent thrombosis (ST) in nonselected, complex patients followed for a period >/=4 years. BACKGROUND: Despite the efficacy of drug-eluting stents (DES) in reducing repeated target lesion revascularization, concerns regarding the occurrence of late and very late ST have partially obscured the benefits of this novel technology. METHODS: All consecutive patients treated solely with DES between May 2002 and January 2005 were enrolled into this prospective, nonrandomized, single-center registry. The primary end point was long-term occurrence of MACE up to 7 years. Independent predictors of MACE, cardiac death, target lesion revascularization, and ST were obtained by a multivariate Cox proportional hazards regression model. RESULTS: A total of 1,010 patients were enrolled. Most of them were men (77%) with a mean age of 63.7 years. Stent/patient rate was 1.4. Patients were kept in dual antiplatelet therapy for 3 and 6 months after Cypher (Cordis, Johnson & Johnson, Miami Lakes, Florida) and Taxus (Boston Scientific Corp., Natick, Massachusetts) stent implantation, respectively. Follow-up was obtained in 98.2% of the cohort (median 5.01 years). Survival free of MACE and cumulative incidence of definite/probable ST were 84.6% and 1.7%, respectively. Independent predictors of ST were percutaneous coronary intervention in the setting of acute myocardial infarction, DES overlapping, treatment of multivessel disease, presence of moderate-to-severe calcification at lesion site, and in-stent residual stenosis. CONCLUSIONS: The deployment of DES in complex, real-world patients resulted in a low rate of very long-term MACE and ST. However, ST still occurs very long after the index procedure.

Intervenção coronária percutânea em pontes de veia safena com uso de stents farmacológicos: resultados agudos e tardios dos pacientes incluídos no registro DESIRE / Percutaneous coronary intervention en saphenous vein bypass grafts with drug-eluting stents: early and late outcomes of patients in the DESIRE registry

Mesmo com o advento dos stents farmacológicos, a intervenção coronária percutânea em pontes de veia safena permanece desafiadora, com elevada incidência de complicações agudas e incerteza dos resultados clínicos de pacientes com lesões em pontes de veia safena tratados com stents farmacológicos. Método: Entre maio de 2002 e janeiro de 2009, 151 pacientes com 196 lesões em pontes de veia safena foram consecutivamente submetidos a intervenção coronária percutânea com 211 stents farmacológicos e incluídos neste estudo. Os pacientes foram pré-tratados com enoxaparina, clopidogrel e ácido acetilsalicílico por 3 a 5 dias antes da intervenção coronária percutânea. A terapia antiplaquetária dupla (ácido acetilsalicílico + clopidogrel) foi prescrita por 12 meses. Objetivou-se determinar as taxas de eventos cardíacos adversos maiores (ECAM) no período hospitalar e na fase tardia. Seguimento clínicofoi obtido com 1, 6 e 12 meses e, então, anualmente...

Introduction: Despite the advent of drug-eluting stents, percutaneous coronary interventions in saphenous vein bypass grafts remain a challenge, with a high incidence of early complications and uncertainty regarding late outcomes. This study was aimed at evaluating clinical outcomes of patients with saphenous vein graft lesions treated with drug-eluting stents. Method: From May 2002 to January 2009, a total of 151 patients with 196 saphenous vein graft lesions were consecutively submitted to percutaneous coronary intervention with 211 drug-eluting stents and included in this trial. Patients were pretreated with enoxiparin, clopidogrel and acetylsalicylic acid for 3 to 5 days prior to percutaneous coronary intervention. Dual antiplatelet therapy (acetylsalicylic acid + clopidogrel) was prescribed for 12 months. The objective was to determine the rate of major adverse cardiac events (MACE) during hospitalization and in the long-term. Clinical follow-up was obtained at 1, 6 and 12 months and then, yearly after that...

Implante de stent farmacológico para o tratamento da reestenose de outro stent farmacológico: análise tardia do registro DESIRE / Drug-Eluting Stent Implantation for the Treatment of Drug-Eluting Stent Restenosis: Long-Term Analysis of the DESIRE Registry

Fundamentos: Apesar da notória redução nas taxas de reestenose (RIS) com os stents farmacológicos (SF), essa complicação ainda ocorre em 5 por cento a 25 por cento dos casos. A história natural e o melhor tratamento para a reestenose de SF ainda não estão definidos. Método: Entre maio de 2002 e novembro de 2007, todos os pacientes com RIS de SF tratados com outro SF foram consecutivamente incluídos neste registro. O tipo de SF implantado para tratar a RIS ficou a critério do operador. Acompanhamento clínico foi obtido com 1 , 6 e 12 meses e, então, anualmente. O objetivo primário foi avaliar a incidência acumulada de eventos cardíacos maiores (ECAM). Resultados: Dos 45 pacientes (53 lesões) tratados percutaneamente com outro SF, 66,6 por cento eram do sexo masculino. Diabetes melito foi observado em 35,5 por cento desses pacientes. A maioria das reestenosis foi do tipo focal (75 por cento). O diâmetro de referência do vaso tratado e a extensão da lesão foram de 2,99 + - 0,5 mm e 11,33 + - 5,8 mm, respectivamente. Em 28 por cento dos casos optou-se por implantar um SF diferente daquele que apresentou RIS. Sucesso angiográfico foi obtido em 100 por cento dos casos. Seguimento clínico foi obtido em toda a população...

Background: Despite the marked reduction in restenosis rates following drug-eluting stent (DES) use, this complication still happens in 5%-25% of the cases. The natural history and the best treatment for DES in-stent restenosis are still to be defined. Methods: Between May 2002 and November 2007, all consecutive cases of DES restenosis treated with another DES were included in this registry. The type of DES to be deployed was at the surgeon's discretion. Follow-up data were obtained at 1, 6, and 12 months and then annually. The primary endpoint of this study was the incidence of combined major cardiac events (MACE). Results: Of the 45 patients (53 lesions) submitted to new percutaneous coronary intervention (PCI) with DES, 66.6% were men. Diabetes mellitus was observed in 35.5% of the patients. Most in-stent restenosis were focal (75%). Reference vessel diameter and lesion length were 2.99 ± 0.5 mm and 11.33 ± 5.8 mm, respectively. A different type of DES was preferred in 28% of the cases. Angiographic success was achieved in all cases. Clinical data of all population were obtained (mean 2.7 ± 1.1 years). In the long term, the cumulative rate of MACE was 13.3%, and 5 (11.1%) patients manifested recurrent symptoms. Conclusions: The use of a DES to treat a previous DES in-stent restenosis represents a safe and efficient approach, with low rates of adverse events in the short and long terms.

Long-term clinical outcomes of the Drug-Eluting Stents in the Real World (DESIRE) Registry.

BACKGROUND: Recently, cardiologists have treated more complex patients and lesions with drug-eluting stents (DES). However, long-term efficacy and safety of the off-label use of these new devices is yet to be demonstrated. METHODS: The Drug-Eluting Stents in the Real World (DESIRE) registry is a prospective, nonrandomized single-center registry with consecutive patients treated solely with DES between May 2002 and May 2007. The primary end-point was long-term occurrence of major adverse cardiac events (MACE). Patients were clinically evaluated at 1, 3, and 6 months and then annually up to 5 years. RESULTS: A total of 2,084 patients (2,864 lesions and 3,120 DES) were included. The mean age was 63.8 +/- 11.5 years. Diabetes was detected in 28.9% and 40.7% presented with acute coronary syndrome. Cyphertrade mark was the predominant DES in this registry (83.5%). Mean follow-up time was 2.6 +/- 1.2 years and was obtained in 96.5% of the eligible patients. Target lesion revascularization (TLR) was performed in 3.3% of the patients. Q wave myocardial infarction (MI) occurred in only 0.7% of these patients and total stent thrombosis rate was 1.6% (n = 33). Independent predictors of thrombosis were PCI in the setting of MI (HR 11.2; 95% CI, 9.6-12.4, P = 0.001), lesion length (HR 4.6; 95% CI, 3.2-5.3, P = 0.031), moderate to severe calcification at lesion site (HR 13.1; 95% CI, 12.1-16.7, P < 0.001), and in-stent residual stenosis (HR 14.5; 95% CI, 10.2-17.6, P < 0.001). CONCLUSION: The use of DES in unselected population is associated with long-term safety and effectiveness with acceptable low rates of adverse clinical events.