Cantídio Campos

Incidence and Predictors of Very Late (≥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.

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.

Intervenção coronária percutânea em pontes de veia safena com uso de stents farmacológicos: resultados agudos e tardios dos pacientes incluídos no registro DESIRE

INTRODUCTION: Despite the advent of drug-eluting stents, per-cutaneous 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. RESULTS: Mean age was 68.2 years, with a prevalence of male patients (89.1%). Diabetes mellitus was observed in 30.7% cases and mean age of venous grafts was 10.4 years. Angiographic success was obtained in 98.2% of the cases. During hospitalization, MACE rate was 8.7%, especially due to post-procedural enzyme increase (7.1%). In the first follow-up year, the rate of MACE increased to 14.2%, with a 3.9% rate of target-lesion revascularizations. In the late follow-up (mean of 2.6 years), the rate of MACE increased to 28.5%, with 6.0% of cardiac deaths and 16.6% of acute myocardial infarctions. Five cases of thrombosis (all of them definitive) were observed in this population. CONCLUSION: In the present subanalysis of the DESIRE Registry, the use of optimized antithrombotic therapy (acetylsalicylic acid + thienopyridines + low molecular weight heparin, for 3 to 5 days before the intervention) and the use of drug-eluting stents for the treatment of saphenous vein grafts is correlated to excellent early clinical outcomes and in the first year after percutaneous intervention. However, after the first year, these results significantly deteriorate, indicating the more aggressive character of vascular disease in the venous conduits. Thrombosis rates may be considered low, favoring the safety of these devices in such complex scenario.

Stents farmacológicos para o tratamento de coronárias de fino calibre: experiência muito tardia (até 7 anos) do Registro DESIRE

INTRODUCAO: Neste estudo, buscamos avaliar os resultados clinicos de pacientes com lesoes coronarias em vasos de fino calibre, numa coorte de pacientes do mundo real submetidos a intervencao coronaria percutânea (ICP) com stents farmacologicos. METODOS: 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 lesoes em vasos de fino calibre (< 2,5 mm de diâmetro), foram submetidos a ICP, eletiva ou de urgencia, com implante de 1.818 stents farmacologicos (CypherTM, 89%; TaxusTM, 7,5%; Xience VTM/PromusTM, 3%; EndeavorTM, 0,33%; BiomatrixTM, 0,2%) e incluidos neste estudo. O seguimento clinico de ate 7 anos (mediana, 2,8 anos) foi completo em 98%, sendo obtido com 1, 6 e 12 meses e, entao, anualmente. Tivemos como objetivo determinar as taxas de eventos cardiacos adversos maiores (ECAM) ao longo do periodo do acompanhamento clinico. RESULTADOS: A media de idade foi de 64,5 ± 11,7 anos, com predominio de pacientes do sexo masculino (76,7%). Diabetes melito foi encontrado em 31,6% dos casos e 9,8% eram portadores de insuficiencia renal cronica. A arteria descendente anterior foi o vaso mais frequentemente tratado (43,4%) e dois tercos das lesoes eram de alta complexidade (B2/C). Sucesso angiografico do procedimento foi obtido em 98,8% dos casos. A taxa de ECAM foi de 12,8% durante o seguimento, com 4,5% de obito cardiaco, 4,2% de infarto agudo do miocardio, 4,5% de nova revascularizacao da lesao-alvo e 1,5% de trombose do stent. CONCLUSOES: No Registro DESIRE, o tratamento de vasos de pequeno calibre com stents farmacologicos, em pacientes nao-selecionados, associou-se a excelentes resultados agudos e tardios, e a baixas taxas de trombose ao longo da evolucao.

Incidência e preditores de revascularização da lesão-alvo no seguimento clínico de longo prazo: análise crítica do Registro DESIRE

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 coronary intervention (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 up to eight years (median time 3.4 years) was concluded in 98% patients of the group and 129 patients (3.88%) were submitted 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.

PREDICTORS OF EARLY, LATE AND VERY LATE (UP TO 12 YEARS) STENT THROMBOSIS FOLLOWING DRUG-ELUTING STENT IMPLANTATION IN DAILY PRACTICE: A SUBANALYSIS OF THE DESIRE REGISTRY

results: Mean age was 64.6 years, 32% had diabetes, 21.4% had previous myocardial infarction (MI) (≥30 days), and 42% had acute coronary syndrome or recent MI (<30 days). Overall, the incidence of ST was 2.4% (n=133), given that 95% of patients were ST-free up to 12 years follow-up (Kaplan-Meier estimate). The predictors of early (<30 days), late (1 to 12 months) and very late ST (>12 months) are shown in the Table.

Implante de stent farmacológico para o tratamento da reestenose de outro stent farmacológico: análise tardia do Registro DESIRE

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 surgeons 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.