Cardiology Unit, Azienda Ospedaliero Universitaria di Ferrara, Italy (G. Campo, S.B.).
Cardiology Unit, Azienda Unità Sanitaria Locale - Istituto di Ricovero e Cura a Carattere Scientifico Reggio Emilia, S. Maria Nuova Hospital, Italy (V.G., S.M.d.).
Circ Cardiovasc Qual Outcomes. 2024 Jul;17(7):e010490. doi: 10.1161/CIRCOUTCOMES.123.010490. Epub 2024 Jun 18.
The FIRE trial (Functional Assessment in Elderly Myocardial Infarction Patients With Multivessel Disease) enrolled 1445 older (aged ≥75 years) patients with myocardial infarction and multivessel disease in Italy, Spain, and Poland. Patients were randomized to physiology-guided complete revascularization or treatment of the only culprit lesion. Physiology-guided complete revascularization significantly reduced ischemic adverse events at 1 year. This prespecified analysis investigated the changes between the 2 study groups in angina status, quality of life, physical performance, and frailty.
Patients underwent validated scales at hospital discharge (baseline) and 1 year later. Angina status was evaluated using the Seattle Angina Questionnaire, health-related quality of life by EQ visual analog scale, physical performance by short physical performance battery, and frailty by the clinical frailty scale. Mixed models for repeated measures analysis were used to study the association between the treatment arms, time, and scales.
Baseline and 1-year Seattle Angina Questionnaire, EQ visual analog scale, short physical performance battery, and clinical frailty scale were collected in around two-thirds of the entire FIRE study population. The mean age was 80.9±4.6 years (female sex, 35.9%). Overall, 35.3% were admitted for ST-segment-elevation myocardial infarction, whereas the others were admitted for non-ST-segment-elevation myocardial infarction. Physiology-guided complete revascularization, compared with culprit-only revascularization, was associated with greater improvement in terms of angina status (Seattle Angina Questionnaire summary score, 7.3 [95% CI, 6.1-8.6] points), health-related quality of life (EQ visual analog scale, 6.2 [95% CI, 4.4-8.1] points), and physical performance (short physical performance battery, 1.1 [95% CI, 0.9-1.3] points). After 1 year, patients randomized to culprit-only revascularization experienced a deterioration in frailty status (clinical frailty scale, 0.2 [95% CI, 0.1-0.3] points), which was not observed in patients randomized to physiology-guided complete revascularization.
The present analysis suggested that a physiology-guided complete revascularization is associated with consistent benefits in terms of angina status, quality of life, physical performance, and the absence of further deterioration of the frailty status.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03772743.
FIRE 试验(多支血管病变老年心肌梗死患者的功能评估)在意大利、西班牙和波兰招募了 1445 名年龄≥75 岁的老年(年龄较大)心肌梗死和多支血管疾病患者。患者被随机分配接受生理学指导的完全血运重建或仅治疗罪犯病变。生理学指导的完全血运重建显著降低了 1 年时的缺血不良事件。本预设分析研究了两组之间在心绞痛状态、生活质量、身体表现和脆弱性方面的变化。
患者在出院时(基线)和 1 年后接受了经过验证的量表。心绞痛状态采用西雅图心绞痛问卷评估,健康相关生活质量采用 EQ 视觉模拟量表,身体表现采用简短身体表现电池,脆弱性采用临床脆弱性量表。重复测量混合模型用于研究治疗臂、时间和量表之间的关系。
FIRE 研究人群中约三分之二的患者收集了基线和 1 年的西雅图心绞痛问卷、EQ 视觉模拟量表、简短身体表现电池和临床脆弱性量表。平均年龄为 80.9±4.6 岁(女性,35.9%)。总体而言,35.3%因 ST 段抬高型心肌梗死入院,其余因非 ST 段抬高型心肌梗死入院。与仅罪犯血运重建相比,生理学指导的完全血运重建在心绞痛状态(西雅图心绞痛问卷综合评分,7.3[95%CI,6.1-8.6]分)、健康相关生活质量(EQ 视觉模拟量表,6.2[95%CI,4.4-8.1]分)和身体表现(简短身体表现电池,1.1[95%CI,0.9-1.3]分)方面有更大的改善。1 年后,随机接受仅罪犯血运重建的患者脆弱状态恶化(临床脆弱性量表,0.2[95%CI,0.1-0.3]分),而随机接受生理学指导的完全血运重建的患者则没有观察到这一情况。
本分析表明,生理学指导的完全血运重建与心绞痛状态、生活质量、身体表现的持续改善以及脆弱状态的进一步恶化无关。