关键词: Clinical equipoise Coronary artery disease Heart failure Ischemic cardiomyopathy Revascularization

来  源:   DOI:10.1016/j.ahjo.2023.100263   PDF(Pubmed)

Abstract:
UNASSIGNED: The optimal revascularization approach in patients with heart failure with reduced ejection fraction (HFrEF) and ischemic heart disease (\"ischemic cardiomyopathy\") is unknown. Physician preferences regarding clinical equipoise for mode of revascularization and their willingness to consider offering enrollment in a randomized trial to patients with ischemic cardiomyopathy have not been characterized.
UNASSIGNED: We conducted two anonymous online surveys: 1) a clinical case scenario-based survey to assess willingness to offer clinical trial enrollment for a patient with ischemic cardiomyopathy (overall response rate to email invitation 0.45 %), and 2) a Delphi consensus-building survey to identify specific areas of clinical equipoise (overall response rate to email invitation 37 %).
UNASSIGNED: Among 304 physicians responding to the clinical case scenario-based survey, the majority were willing to offer the opportunity for clinical trial enrollment to a prototypical patient with ischemic cardiomyopathy (92 %), and felt that a finding of non-inferiority for PCI vs. CABG would influence their clinical practice (78 %). Among 53 physicians responding to the Delphi consensus-building survey, the median appropriateness rating for CABG was significantly higher than that of PCI (p < 0.0001). In 17 scenarios (11.8 %), there was no difference in CABG or PCI appropriateness ratings, suggesting clinical equipoise in these settings.
UNASSIGNED: Our findings demonstrate willingness to consider offering enrollment in a randomized clinical trial and areas of clinical equipoise, two factors that support the feasibility of a randomized trial to compare clinical outcomes after revascularization with CABG vs. PCI in selected patients with ischemic cardiomyopathy, suitable coronary anatomy and co-morbidity profile.
摘要:
未经证实:射血分数降低的心力衰竭(HFrEF)和缺血性心脏病(“缺血性心肌病”)患者的最佳血运重建方法未知。医生对血运重建模式的临床平衡偏好以及他们考虑向缺血性心肌病患者提供随机试验的意愿尚未得到表征。
UNASSIGNED:我们进行了两项匿名在线调查:1)一项基于临床病例情景的调查,以评估为缺血性心肌病患者提供临床试验注册的意愿(对电子邮件邀请的总体反应率为0.45%),和2)Delphi共识建立调查,以确定临床平衡的特定领域(对电子邮件邀请的总体响应率为37%)。
未经评估:在对基于临床病例情景的调查做出回应的304名医生中,大多数人愿意为缺血性心肌病的典型患者(92%)提供临床试验登记的机会,并认为PCI的非劣效性与CABG会影响他们的临床实践(78%)。在回答德尔菲共识建立调查的53名医生中,CABG的中位适当性评分显著高于PCI(p<0.0001).在17种情况下(11.8%),CABG或PCI适当性评级无差异,提示在这些设置中的临床平衡。
UNASSIGNED:我们的研究结果表明,我们愿意考虑在随机临床试验和临床平衡领域提供注册,支持一项随机试验比较CABG与CABG血运重建后临床结局的可行性的两个因素部分缺血性心肌病患者的PCI,合适的冠状动脉解剖结构和合并症。
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