RESUMO
AIMS: The British National Institute of Clinical Excellence (NICE) guidelines recommend to use drug-eluting stents (DES) instead of bare-metal stents (BMS) only in lesions >15 mm in length or in vessels <3 mm in diameter. We analyzed the impact of stent length and stent diameter on in-stent restenosis (ISR) in the BASKET-PROVE study population and evaluated the cost-effectiveness of DES compared to BMS. METHODS/RESULTS: The BASKET-PROVE trial compared DES vs BMS in large coronary arteries (≥3 mm). We calculated incremental cost-effectiveness ratios (ICERs) and cost-effectiveness acceptability curves with regard to quality-adjusted life years (QALYs) gained and target lesion revascularizations (TLRs) avoided. A total of 2278 patients were included in the analysis. A total of 74 ISR in 63 patients were observed. In-stent restenosis was significantly more frequent in segments treated with a BMS compared to segments treated with a DES (5.4% vs 0.76%; P<.001). The benefit of a DES compared to a BMS regarding ISR was consistent among the subgroups of stent length >15 mm and ≤15 mm, respectively. With the use of DES in short lesions, there was only a minimal gain of 0.005 in QALYs. At a threshold of 10 000 CHF per TLR avoided, DES had a high probability of being cost-effective. CONCLUSION: In the BASKET-PROVE study population, the strongest predictor of ISR is the use of a BMS, even in patients in need of stents ≥3.0 mm and ≤15 mm lesion length and DES were cost-effective. This should prompt the NICE to reevaluate its recommendation to use DES instead of BMS only in vessels <3.0 mm and lesions >15 mm length.
Assuntos
Doença da Artéria Coronariana/economia , Doença da Artéria Coronariana/terapia , Reestenose Coronária/economia , Reestenose Coronária/prevenção & controle , Stents Farmacológicos/economia , Custos de Cuidados de Saúde , Metais/economia , Intervenção Coronária Percutânea/economia , Intervenção Coronária Percutânea/instrumentação , Stents/economia , Idoso , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/etiologia , Análise Custo-Benefício , Técnicas de Apoio para a Decisão , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Modelos Econômicos , Seleção de Pacientes , Intervenção Coronária Percutânea/efeitos adversos , Desenho de Prótese , Anos de Vida Ajustados por Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Second-generation drug eluting stents (DES) may reduce costs and improve clinical outcomes compared to first-generation DES with improved cost-effectiveness when compared to bare metal stents (BMS). We aimed to conduct an economic evaluation of a cobalt-chromium everolimus eluting stent (Co-Cr EES) compared with BMS in percutaneous coronary intervention (PCI). OBJECTIVE: To conduct a cost-effectiveness analysis (CEA) of a cobalt-chromium everolimus eluting stent (Co-Cr EES) versus BMS in PCI. METHODS: A Markov state transition model with a 2-year time horizon was applied from a US Medicare setting with patients undergoing PCI with Co-Cr EES or BMS. Baseline characteristics, treatment effects, and safety measures were taken from a patient level meta-analysis of 5 RCTs (n = 4,896). The base-case analysis evaluated stent-related outcomes; a secondary analysis considered the broader set of outcomes reported in the meta-analysis. RESULTS: The base-case and secondary analyses reported an additional 0.018 and 0.013 quality-adjusted life years (QALYs) and cost savings of $236 and $288, respectively with Co-Cr EES versus BMS. Results were robust to sensitivity analyses and were most sensitive to the price of clopidogrel. In the probabilistic sensitivity analysis, Co-Cr EES was associated with a greater than 99% chance of being cost saving or cost effective (at a cost per QALY threshold of $50,000) versus BMS. CONCLUSIONS: Using data from a recent patient level meta-analysis and contemporary cost data, this analysis found that PCI with Co-Cr EES is more effective and less costly than PCI with BMS. © 2016 The Authors. Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc.
Assuntos
Fármacos Cardiovasculares/administração & dosagem , Fármacos Cardiovasculares/economia , Ligas de Cromo/economia , Doença da Artéria Coronariana/economia , Doença da Artéria Coronariana/terapia , Stents Farmacológicos/economia , Everolimo/administração & dosagem , Everolimo/economia , Custos de Cuidados de Saúde , Intervenção Coronária Percutânea/economia , Intervenção Coronária Percutânea/instrumentação , Idoso , Fármacos Cardiovasculares/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Análise Custo-Benefício , Custos de Medicamentos , Everolimo/efeitos adversos , Feminino , Humanos , Masculino , Cadeias de Markov , Medicare/economia , Modelos Econômicos , Intervenção Coronária Percutânea/efeitos adversos , Desenho de Prótese , Anos de Vida Ajustados por Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Tempo , Resultado do Tratamento , Estados UnidosRESUMO
OBJECTIVES: This study sought to assess outcomes in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention (PCI) for unprotected left main (LM) disease. BACKGROUND: Limited data are available on outcomes in patients with ST-segment elevation myocardial infarction undergoing LM PCI. METHODS: Of 9,075 patients with ST-segment elevation myocardial infarction enrolled in the AMIS (Acute Myocardial Infarction in Switzerland) Plus registry between 2005 and June 30, 2010, 6,666 underwent primary PCI. Of them, 348 (5.2%; mean age: 63.5 ± 12.6 years) underwent LM PCI, either isolated (n = 208) or concomitant to PCI for other vessel segments (n = 140). They were compared with 6,318 patients (94.8%; mean age: 61.9 ± 12.5 years) undergoing PCI of non-LM vessel segments only. RESULTS: The LM patients had higher rates of cardiogenic shock (12.2% vs. 3.5%; p < 0.001), cardiac arrest (10.6% vs. 6.3%; p < 0.01), in-hospital mortality (10.9% vs. 3.8%; p < 0.001), and major adverse cardiac and cerebrovascular events (12.4% vs. 5.0%; p < 0.001) than non-LM PCI. Rates of mortality and major adverse cardiac and cerebrovascular events were highest for concurrent LM and non-LM PCI (17.9% and 18.6%, respectively), intermediate for isolated LM PCI (6.3% and 8.3%, respectively), and lowest for non-LM PCI (3.8% and 5.0%, respectively). Rates of mortality and major adverse cardiac and cerebrovascular events for LM PCI were higher than for non-LM multivessel PCI (10.9% vs. 4.9%, p < 0.001, and 12.4% vs. 6.4%, p < 0.001, respectively). LM disease independently predicted in-hospital death (odds ratio: 2.36; 95% confidence interval: 1.34 to 4.17; p = 0.003). CONCLUSIONS: Emergent LM PCI in the context of acute myocardial infarction, even including 12% cardiogenic shock, appears to have a remarkably high (89%) in-hospital survival. Concurrent LM and non-LM PCI has worse outcomes than isolated LM PCI.
Assuntos
Angioplastia Coronária com Balão/métodos , Infarto do Miocárdio/terapia , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Intervalos de Confiança , Angiografia Coronária , Feminino , Indicadores Básicos de Saúde , Mortalidade Hospitalar , Humanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Infarto do Miocárdio/complicações , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/patologia , Razão de Chances , Sistema de Registros , Fatores de Risco , Choque Cardiogênico , Estatísticas não Paramétricas , Inquéritos e Questionários , Suíça , Resultado do TratamentoRESUMO
OBJECTIVES: We aimed to assess the predictive value of the SYNTAX score (SXscore) for major adverse cardiac events in the all-comers population of the LEADERS (Limus Eluted from A Durable versus ERodable Stent coating) trial. BACKGROUND: The SXscore has been shown to be an effective predictor of clinical outcomes in patients with multivessel disease undergoing percutaneous coronary intervention. METHODS: The SXscore was prospectively collected in 1,397 of the 1,707 patients enrolled in the LEADERS trial (patients after surgical revascularization were excluded). Post hoc analysis was performed by stratifying clinical outcomes at 1-year follow-up, according to 1 of 3 SXscore tertiles. RESULTS: The 1,397 patients were divided into tertiles based on the SXscore in the following fashion: SXscore
Assuntos
Stents Farmacológicos , Infarto do Miocárdio/diagnóstico por imagem , Infarto do Miocárdio/tratamento farmacológico , Vigilância da População/métodos , Índice de Gravidade de Doença , Idoso , Stents Farmacológicos/efeitos adversos , Stents Farmacológicos/normas , Feminino , Seguimentos , Humanos , Masculino , Estudos Prospectivos , Radiografia , Valores de Referência , Medição de RiscoRESUMO
BACKGROUND: Little is known on the performance of newly initiated carotid artery stenting (CAS) programs. The safety of the procedure is being questioned following the publication of the EVA-3S trial, a study criticized for the limited interventional experience required to enroll patients. METHODS: Within a newly started academic CAS program, patient data and outcomes were collected prospectively. The outcomes of the first 100 consecutive patients treated are reported. A CAS-fellowship-trained interventionalist was involved in all procedures. All patients underwent clinical assessment by a neurologist before and after the procedure, and serial ECG and cardiac enzymes were routinely obtained. Primary outcome measures included 30-day major adverse events (MAE), defined as death, stroke, or myocardial infarction, while on follow-up deaths and ipsilateral strokes were added. RESULTS: Between July 2003 and November 2006, 92 patients had a single internal carotid artery treated, while 7 underwent staged bilateral CAS. In one patient, the procedure was aborted prior to lesion treatment. The 30-day MAE rate per procedure was 1.9% (one major and one minor stroke). By a mean follow-up of 16 months (range 2-42 months), one patient had died of refractory heart failure, while one patient had a minor ipsilateral stroke and three had minor contralateral strokes, corresponding to total MAE per patient of 4%. The rate of any stroke or death was 7%. The rate of restenosis >or=50% per lesion by ultrasound was 3.8%. CONCLUSION: This single center experience suggests that it is safe to start a CAS program following dedicated fellowship.