Why the study?
Does intracoronary beta brachytherapy provide long-term safety and efficacy in patients with diffuse in-stent restenosis?
Does intracoronary beta brachytherapy provide long-term safety and efficacy in patients with diffuse in-stent restenosis?
Intracoronary beta brachytherapy for diffuse in-stent restenosis demonstrated long-term safety with no late radiation-related adverse events, though 10-year MACE-free survival was 42%.
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Long-term safety supported without radiation events in this cohort; leaves open efficacy for diffuse in-stent restenosis pending randomized trials.
Until the development of drug-eluting stents (DES), diffuse in-stent restenosis (ISR) was the main limitation of bare-metal stents in percutaneous coronary intervention (PCI). Among the different treatments available, intracoronary brachytherapy (BT) emerged as one of the most promising, although it was almost abandoned with the increasing use of DES. To assess the Portuguese experience with 90Sr/90Y beta brachytherapy for the treatment of diffuse ISR regarding long-term (>10 years) major adverse cardiac events (MACE) and angiographic restenosis. This single-center, retrospective, observational study included 12 consecutive patients treated between January and June 2001, mean age 58.6±9.9 years (range 43–77 years), 11 male. All had chronic stable angina, 75% had dyslipidemia, 58% had hypertension, 50% had peripheral arterial disease, 42% had diabetes and 50% had multivessel disease. Recurrent ISR was present in half of the patients and 11 had normal left ventricular function. After balloon dilatation, BT was performed using an 90Sr/90Y (Novoste Beta-Cath™) beta radiation source. All patients remained under dual antiplatelet therapy until scheduled nine-month follow-up angiography. Patients were followed for the occurrence of death (all-cause and cardiovascular), non-fatal myocardial infarction (MI), revascularization, stent thrombosis and angiographic restenosis. MACE were defined as the combined incidence of cardiac death, MI and urgent target vessel revascularization. In all cases there was both clinical and angiographic success. In a mean follow-up of 10.9±2.5 years, 19 events occurred in seven patients: death in three (25%), only one cardiac (8.3%); ST-elevation MI in one (related to a non-target vessel) (8.3%); and 15 revascularizations in five (42%), of which nine were of the target vessel (mainly in the first two years). There was only one case of probable stent thrombosis. Angiographic restenosis at nine months was 27% (three out of 11 patients), of which two were total occlusions. Ten-year MACE-free survival was 42% (5 patients). Intracoronary beta brachytherapy for the treatment of diffuse ISR in this small cohort of patients proved to be safe and efficacious, with no late adverse events related to intracoronary radiation. No advento dos stents eluidores de fármaco (DES), a reestenose difusa (>20 mm) intrastent (RDIS) constituía a principal limitação ao uso de stents metálicos na intervenção coronária (PCI). Das várias soluções propostas para o seu tratamento, a braquiterapia intracoronária (BT) revelou-se uma das mais eficazes, sendo praticamente abandonada após a introdução dos DES. Avaliar os resultados clínicos a longo prazo (>10 anos) do uso de BT beta com 90Sr/Y90 para o tratamento RDIS, em termos de eventos cardíacos major (MACE) e reestenose angiográfica. Estudo retrospetivo observacional de centro único incluindo 12 doentes (dts) consecutivos entre janeiro e julho de 2001, 11 homens, com a idade média de 58,6±9,9 anos (43-77 anos). Todos tinham angor estável. Os principais fatores de risco eram dislipidemia (75%), HTA (58%), doença arterial periférica (50%) e diabetes (42%). Havia doença multivaso em seis dts, tratava-se da 2.a ou 3.a reestenose em seis dts e a função ventricular era normal em 11. A BT foi feita após dilatação com balão, usando a fonte emissora de radiação beta 90Sr/Y90 (Beta-Cath™/Novoste). Todos permaneceram sob dupla antiagregação pelo menos até à angiografia de controlo, programada para todos aos nove meses. Foi considerada a ocorrência de morte global e cardiovascular, enfarte do miocárdio não fatal (EAM), revascularização coronária, trombose de stent e reestenose angiográfica. Foi avaliada a incidência do evento hierárquico combinado (MACE) de: morte cardiovascular, EAM, revascularização coronária urgente do vaso alvo (TVRurg). Verificou-se sucesso angiográfico e clínico em 100% dos casos. No seguimento médio de 10,9±2,5 anos, ocorreram 19 eventos em sete dts: morte em três dts (25%), apenas uma cardíaca (8,3%), EAM com elevação de ST (vaso não alvo) num dt (8,3%) e 15 novas revascularizações em cinco dts (42%): nove relacionadas com o vaso alvo (sobretudo nos primeiros dois anos). Apenas se verificou uma trombose de stent, provável. A reestenose angiográfica aos nove meses de seguimento foi de 27% (3/11 dts) com duas oclusões. A taxa de sobrevivência livre de MACE aos dez anos foi de 42% (cincodts). A braquiterapia com radiação beta para RDIS, neste pequeno grupo de dts, demonstrou-se eficaz e segura, sem eventos tardios atribuíveis à radiação intracoronária.
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