RESUMO
The Killip classification of acute heart failure was developed decades ago to predict short-term mortality in patients with acute myocardial infarction (AMI). The aim of this study was to determine the long-term prognosis of acute heart failure graded according to the Killip classification in 15,235 unselected patients hospitalized for AMI from 2000 to 2005. Vital status for each patient was ascertained, through to March 1, 2012, from linkage with national death records. A stepwise gradient in the adjusted hazard ratio (HR) for 12-year mortality was observed with increasing Killip class: class I (n = 10,123), HR 1.00 (reference group); class II (n = 2,913), HR 1.13 (95% confidence interval [CI] 1.06 to 1.21); class III (n = 1,217) HR 1.49 (95% CI 1.37 to 1.62); and class IV (n = 898), HR 2.80 (95% CI 2.53 to 3.10). Unexpectedly, in a landmark analysis excluding deaths <30 days after admission, patients in Killip class IV had lower adjusted long-term mortality than those in class III. The adjusted HR for 12-year mortality comparing Killip class IV with Killip class III in patients <60 years of age was 1.71 (95% CI 1.33 to 2.19, p <0.001) and in patients >60 years of age was 2.30 (95% CI 2.07 to 2.56, p <0.001). In conclusion, on the basis of simple clinical features, the Killip classification robustly predicted 12-year mortality after AMI. The heterogeneity in early versus late risk in patients with Killip class IV heart failure underscores the importance of appropriate early treatment in cardiogenic shock.
Assuntos
Insuficiência Cardíaca/epidemiologia , Infarto do Miocárdio/complicações , Medição de Risco/métodos , Idoso , Causas de Morte , Eletrocardiografia , Feminino , Seguimentos , Insuficiência Cardíaca/etiologia , Mortalidade Hospitalar/tendências , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/epidemiologia , Prognóstico , Estudos Retrospectivos , Singapura/epidemiologia , Taxa de Sobrevida/tendências , Fatores de TempoRESUMO
OBJECTIVES: This study sought to compare the efficacy and safety results after coronary implantation of a combined sirolimus-eluting CD34 antibody coated Combo stent (OrbusNeich Medical, Ft. Lauderdale, Florida) with the paclitaxel-eluting Taxus Liberté stent (PES) (Boston Scientific, Natick, Massachusetts). This report summarizes the first-in-man randomized, controlled multicenter REMEDEE trial (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt) angiographic, intravascular ultrasound, and clinical results up to 12 months. BACKGROUND: Drug-eluting stents have limited restenosis and reintervention but are complicated by especially late and very late stent thrombosis and accelerated neoatherosclerosis. Alternative or adjunct technologies should address these limitations. METHODS: One hundred eighty-three patients with de novo native coronary artery stenoses were randomized 2:1 to Combo stent or PES implantation. The primary endpoint is the angiographic in-stent late lumen loss at 9 months, which was tested for noninferiority between the 2 stent groups. Secondary endpoints include the occurrence of major adverse cardiac events. RESULTS: The Combo stent was found to be noninferior to the PES in 9-month angiographic in-stent late lumen loss with 0.39 ± 0.45 mm versus 0.44 ± 0.56 mm (pnoninferiority = 0.0012). At 12 months, the occurrence of major adverse cardiac events was 8.9% in the Combo group and 10.2% in the PES group (p = 0.80) with no difference in mortality, occurrence of myocardial infarction, or target lesion revascularization. No stent thrombosis was reported in either group. CONCLUSIONS: In the REMEDEE trial the Combo stent has shown to be effective by meeting the primary noninferiority angiographic endpoint and safe, with an overall low rate of clinical events in both stent groups, including no stent thrombosis up to 12 months.
Assuntos
Anticorpos/administração & dosagem , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Estenose Coronária/terapia , Stents Farmacológicos , Células Endoteliais/patologia , Paclitaxel/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Sirolimo/administração & dosagem , Células-Tronco/patologia , Idoso , Antígenos CD34/imunologia , Ásia , Austrália , Brasil , Angiografia Coronária , Reestenose Coronária/etiologia , Estenose Coronária/imunologia , Estenose Coronária/mortalidade , Estenose Coronária/patologia , Trombose Coronária/etiologia , Células Endoteliais/imunologia , Europa (Continente) , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Desenho de Prótese , Fatores de Risco , Células-Tronco/imunologia , Fatores de Tempo , Resultado do Tratamento , Ultrassonografia de IntervençãoRESUMO
The WISDOM Registry tracked clinical outcomes in patients receiving a slow-release, polymer-based, paclitaxel-eluting stent during the transition from randomized trials to commercial use in everyday interventional cardiology practice. Although randomized trials of drug-eluting stents have demonstrated the safety and effectiveness of these devices in less complicated, de novo lesions, observation of long-term clinical outcomes is required to monitor safety as use of this revolutionary technology expands to broader patient populations. In total, 778 patients were enrolled at 22 sites in 9 countries where the TAXUS paclitaxel-eluting stent first received market approval. Patients with de novo or restenotic coronary lesions eligible for stenting were enrolled. Clinical follow-up was conducted by telephone at 3, 6, 9, and 12 months after the procedure to capture reported stent thrombosis and major cardiac events (death, myocardial infarction, and reintervention on the target lesion). Clinical follow-up at 12 months was completed for 92% of patients. The 12-month rate of physician-reported major cardiac events was 5.2%, with a target lesion reintervention rate of 2.0%. The low overall stent thrombosis rate of 0.6% included no stent thromboses >30 days after the index procedure. Low target lesion reintervention rates were also observed in the high-risk subgroups: patients with diabetes (4.0%), vessels <2.5 mm (2.5%), lesions >20 mm (3.6%), and multiple stents in a lesion (1.4%). In conclusion, the paclitaxel-eluting TAXUS slow-release stent exhibits long-term safety and efficacy in uncomplicated and higher risk patients and lesions seen in everyday clinical practice.
Assuntos
Doença das Coronárias/terapia , Paclitaxel/administração & dosagem , Sistema de Registros , Stents , Moduladores de Tubulina/administração & dosagem , Doença das Coronárias/complicações , Doença das Coronárias/mortalidade , Complicações do Diabetes , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Taxa de Sobrevida , Resultado do TratamentoRESUMO
The WISDOM Registry tracked clinical outcomes in patients receiving a slow-release, polymer-based, paclitaxel-eluting stent during the transition from randomized trials to commercial use in everyday interventional cardiology practice. Although randomized trialsof drug-eluting stents have demonstrated the safety and effectiveness of these devices in less complicated, de novo lesions, observation of long-term clinical outcomes is required to monitor safety as use of this revolutionary technology expands to broader patient populations. In total, 778 patients were enrolled at 22 sites in 9 countries where the TAXUS paclitaxel-eluting stent first received market approval. Patients with de novo or restenotic coronary lesions eligible for stenting were enrolled. Clinical follow-up was conducted bytelephone at 3, 6, 9, and 12 months after the procedure to capture reported stent thrombosis and major cardiac events (death, myocardial infarction, and reintervention on the target lesion). Clinical follow-up at 12 months was completed for 92% of patients. The 12-monthrate of physician-reported major cardiac events was 5.2%, with a target lesion reintervention rate of 2.0%. The low overall stent thrombosis rate of 0.6% included no stent thromboses >30 days after the index procedure. Low target lesion reintervention rates were also observed in the high-risk subgroups: patients with diabetes (4.0%), vessels 20 mm (3.6%), and multiple stents in a lesion (1.4%). In conclusion, the paclitaxeleluting TAXUS slow-release stent exhibits long-term safety and efficacy in uncomplicated and higher risk patients and lesions seen in everyday clinical practice.