One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients

BACKGROUND: Despite treatment guidance endorsing shortened dual antiplatelet therapy (DAPT) duration in high bleeding risk (HBR) patients after drug-eluting stents, limited evidence exists to support these recommendations. The present study was designed to examine the safety and effectiveness of 1-month DAPT duration following percutaneous coronary intervention with zotarolimus-eluting stents in HBR patients. METHODS: Onyx ONE Clear was a prospective, multicenter, nonrandomized study evaluating the safety and effectiveness of 1-month DAPT followed by single antiplatelet therapy in HBR patients undergoing percutaneous coronary intervention with Resolute Onyx drug-eluting stents. The primary analysis of cardiac death or myocardial infarction between 1 month and 1 year was performed in the prespecified one-month clear population of patients pooled from the Onyx ONE US/Japan study and Onyx ONE randomized controlled trial. One-month clear was defined as DAPT adherence and without major adverse events during the first month following percutaneous coronary intervention. RESULTS: Among patients enrolled in Onyx ONE US/Japan (n=752) and Onyx ONE randomized controlled trial (n=1018), 1506 patients fulfilled one-month clear criteria. Mean HBR characteristics per patient was 1.6 with 44.7% having multiple risks. By 2 months and 1 year, respectively, 96.9% and 89.3% of patients were taking single antiplatelet therapy. Between 1 month and 1 year, the rate of the primary end point was 7.0%. The 1-sided upper 97.5% CI was 8.4%, less than the performance goal of 9.7% (P<0.001). CONCLUSIONS: Among HBR patients who were event free before DAPT discontinuation at 1 month, favorable safety and effectiveness through 1 year support treatment with Resolute Onyx drug-eluting stents as part of an individualized strategy for shortened DAPT duration following percutaneous coronary intervention.

Middle cerebral artery aneurysms: aneurysm angiographic morphology and its relation to pre-operative and intra-operative rupture / Aneurismas da artéria cerebral média: morfologia angiográfica dos aneurismas e sua relação com ruptura pré-operatória e intra-operatória

ABSTRACT Objective Correlate the middle cerebral artery bifurcation aneurysm morphology with the pre-operative and intra-operative risk of rupture. Methods Forty patients with 46 middle cerebral artery bifurcation aneurysms were treated microsurgically by the same surgeon. Aneurysms were classified according to shape and the Fisher test was applied to analyze the effect of morphology on the pre-operative and intra-operative rupture. Results Pre-operative and intra-operative ruptures were observed in 8/46 patients (17.4%) and 14/46 patients (30.4%) respectively. Thirty-two cases (69.6%) had no symptoms postoperatively, modified Rankin score (MRS) of 0; 6.5% had MRS of 1 (no significant disability); 13% had MRS of 2 (slight disability); 4.3% had moderately severe disability (MRS of 4); and there were 3 deaths (6.5%) post-operatively. The morphology was not directly related to the rupture rate. Conclusion In general, ruptures are not affected by the morphology or the studied variables. Larger series are needed to validate these outcomes.

RESUMO Objetivo Correlacionar a morfologia do aneurisma da bifurcação da artéria cerebral média com o risco de ruptura pré-operatória e intra-operatória. Métodos 40 pacientes com 46 aneurismas de bifurcação da artéria cerebral média receberam tratamento microcirúrgico pelo mesmo cirurgião. Os aneurismas foram classificados de acordo com a morfologia e o teste de Fisher foi aplicado para analisar o efeito da morfologia sobre a ruptura pré-operatória e intra-operatória. Resultados As rupturas pré e intra-operatória foram observadas em 8/46 pacientes (17,4%) e 14/46 (30,4%) respectivamente. Trinta e dois casos (69,6%) não apresentaram sintomas pós-operatórios, pontuação de Rankin modificada (MRS) de 0, 6,5% tinham MRS de 1 (sem incapacidade significativa), 13% tinham MRS de 2 (leve incapacidade), 4,3% moderadamente grave (MRS de 4) e houve 3 óbitos (6,5%) durante o pós-operatório. A morfologia não estava diretamente relacionada à taxa de ruptura pré-operatória ou intra-operatória. Conclusão Em geral, as rupturas não são afetadas pela morfologia ou pelas variáveis estudadas. São necessárias séries maiores para validar esses resultados.