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Arq. bras. cardiol ; Arq. bras. cardiol;109(4): 277-283, Oct. 2017. tab, graf
Article in English | LILACS | ID: biblio-887947

ABSTRACT

Abstract Background: The place of drug-eluting balloons (DEB) in the treatment of in-stent restenosis (ISR) is not well-defined, particularly in a population of all-comers with acute coronary syndromes (ACS). Objective: Compare the clinical outcomes of DEB with second-generation drug-eluting stents (DES) for the treatment of ISR in a real-world population with a high proportion of ACS. Methods: A retrospective analysis of consecutive patients with ISR treated with a DEB compared to patients treated with a second-generation DES was performed. The primary endpoint was a composite of major adverse cardiovascular events (MACE: all-cause death, non-fatal myocardial infarction, and target lesion revascularization). Comparisons were performed using Cox proportional hazards multivariate adjustment and Kaplan-Meier analysis with log-rank. Results: The cohort included 91 patients treated with a DEB and 89 patients treated with a DES (74% ACS). Median follow-up was 26 months. MACE occurred in 33 patients (36%) in the DEB group, compared to 17 patients (19%) in the DES group (p log-rank = 0.02). After multivariate adjustment, there was no significant difference between the groups (HR for DEB = 1.45 [95%CI: 0.75-2.83]; p = 0.27). Mortality rates at 1 year were 11% with DEB, and 3% with DES (p = 0.04; adjusted HR = 2.85 [95%CI: 0.98-8.32]; p = 0.06). Conclusion: In a population with a high proportion of ACS, a non-significant numerical signal towards increased rates of MACE with DEB compared to second-generation DES for the treatment of ISR was observed, mainly driven by a higher mortality rate. An adequately-powered randomized controlled trial is necessary to confirm these findings.


Resumo Fundamento: O papel de balões farmacológicos (BFs) no tratamento de reestenose intra-stent (RIS) não está bem definido, particularmente em na síndrome coronária aguda (SCA). Objetivo: Comparar desfechos clínicos do uso de BF com stents farmacológicos (SFs) de segunda geração no tratamento de RIS em uma população real com alta prevalência de SCA. Métodos: Foi realizada uma análise retrospectiva de pacientes consecutivos com RIS tratados com um BF comparados a pacientes tratados com SF de segunda geração. O desfecho primário incluiu eventos cardiovasculares adversos importantes (morte por todas as causas, infarto do miocárdio não fatal, e revascularização da lesão alvo). As comparações foram realizadas pelo modelo proporcional de riscos de Cox ajustado e análise de Kaplan-Meier com log-rank. Resultados: A coorte incluiu 91 pacientes tratados com BF e 89 pacientes tratados com um SF (75% com SCA). O tempo mediano de acompanhamento foi de 26 meses. Eventos cardiovasculares adversos importantes ocorreram em 33 pacientes (36%) no grupo BF, e em 17 (19%) no grupo SF (p log-rank = 0,02). Após ajuste multivariado, não houve diferença significativa entre os grupos (HR para BF = 1,45 [IC95%: 0,75-2,83]; p = 0,27). As taxas de mortalidade de 1 ano foram 11% com BF, e 3% com SF (p = 0,04; HR ajustado = 2,85 [IC95%: 0,98-8,32; p = 0,06). Conclusão: Em uma população com alta prevalência de SCA, observou-se um aumento não significativo nas taxas de eventos cardiovasculares adversos importantes com o uso de BF comparado ao uso de SF de segunda geração para o tratamento de RIS, principalmente pelo aumento na taxa de mortalidade. É necessário um ensaio clínico controlado, randomizado, com poder estatístico adequado para confirmar esses achados.


Subject(s)
Humans , Male , Female , Middle Aged , Aged , Angioplasty, Balloon, Coronary/instrumentation , Paclitaxel/therapeutic use , Coronary Restenosis/therapy , Acute Coronary Syndrome/therapy , Drug-Eluting Stents/adverse effects , Prosthesis Design , Time Factors , Angioplasty, Balloon, Coronary/adverse effects , Angioplasty, Balloon, Coronary/methods , Multivariate Analysis , Reproducibility of Results , Retrospective Studies , Risk Factors , Treatment Outcome , Statistics, Nonparametric , Risk Assessment , Coated Materials, Biocompatible , Coronary Restenosis/mortality , Kaplan-Meier Estimate , Acute Coronary Syndrome/mortality
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