Hospitales y Universidad de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain.
Unidad de Gestión Clínica Área del Corazón, Hospital Universitario Virgen de la Victoria, Málaga, Spain.
BMJ Open. 2022 Feb 28;12(2):e058042. doi: 10.1136/bmjopen-2021-058042.
The incidence of acute coronary syndrome is rising in step with the growth of life expectancy. An increase in the age of patients with coronary artery disease has been related to in-hospital mortality, which has seen an upsurge over a short period of time. However, there is no consensus about the percutaneous coronary angioplasty strategy to follow for older patients with multivessel coronary artery disease (MVCAD). Complete revascularisation (CR) or incomplete revascularisation (ICR) strategy depends on prognosis but this has not yet been accurately described because of geriatric conditions and comorbidities. The aim of this study is to evaluate changes of clinical and biochemical parameters in older patients with MVCAD undergoing revascularisation and to establish a prognostic stratification model for CR and ICR.
This observational, longitudinal, prospective study will include 150 patients with MVCAD and subsequent revascularisation who attend the Hospital Universitario Virgen de la Victoria (Málaga, Spain). Because of the dropout rates, 180 patients will be recruited at the beginning. Sociodemographic characteristics, clinical and angiographic parameters, and biochemical variables, such as cardiovascular, metabolic, inflammatory, stress oxidative biomarkers, will be collected in the admission for coronary revascularisation and three follow-ups at 6, 12 and 18 months. Statistical analyses will be conducted with these data using CR and ICR as the primary exposure variable. Relevant explanatory variables will be selected from a predictive model for their inclusion in a prognostic stratification model. The primary outcome measures will be major adverse cardiovascular events.
Protocols and patient information have been approved by the regional research ethics committee (CEIm Provincial de Málaga-PEIBA (PI0131/2020). The results will be disseminated in international peer-reviewed journals, presented at conferences in Cardiology and Gerontology, and sent to participants, medical and health service managers, clinicians and other researchers.
随着预期寿命的增长，急性冠状动脉综合征的发病率也在上升。冠心病患者年龄的增加与住院死亡率有关，而在短时间内，住院死亡率呈上升趋势。然而，对于多支血管冠状动脉疾病（MVCAD）的老年患者，目前还没有关于经皮冠状动脉血管成形术策略的共识。完全血运重建（CR）或不完全血运重建（ICR）策略取决于预后，但由于老年患者的身体状况和合并症，这一预后尚未得到准确描述。本研究旨在评估接受血运重建的 MVCAD 老年患者的临床和生化参数变化，并建立 CR 和 ICR 的预后分层模型。
这是一项观察性、纵向、前瞻性研究，将包括在西班牙马拉加大学医院（Hospital Universitario Virgen de la Victoria）就诊的 150 例 MVCAD 及随后接受血运重建的患者。由于脱落率，最初将招募 180 例患者。在进行冠状动脉血运重建时，将收集社会人口统计学特征、临床和血管造影参数以及生化变量，如心血管、代谢、炎症、应激氧化生物标志物，在 6、12 和 18 个月时进行 3 次随访。将使用 CR 和 ICR 作为主要暴露变量对这些数据进行统计分析。将从预测模型中选择相关的解释变量，将其纳入预后分层模型。主要结局指标为主要不良心血管事件。
方案和患者信息已获得区域研究伦理委员会的批准（CEIm Provincial de Málaga-PEIBA（PI0131/2020）。研究结果将在国际同行评议期刊上发表，在心脏病学和老年病学会议上报告，并发送给参与者、医疗保健服务管理者、临床医生和其他研究人员。
