Instituto do Coracao (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Duke Clinical Research Institute and Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA.
Int J Cardiol. 2019 Sep 15;291:36-41. doi: 10.1016/j.ijcard.2019.03.029. Epub 2019 Mar 15.
The STICH trial showed superiority of coronary artery bypass plus medical treatment (CABG) over medical treatment alone (MED) in patients with left ventricular ejection fraction (LVEF) ≤35%. In previous publications, percutaneous coronary intervention (PCI) prior to CABG was associated with worse prognosis.
The main purpose of this study was to analyse if prior PCI influenced outcomes in STICH.
Patients in the STICH trial (n = 1212), followed for a median time of 9.8 years, were included in the present analyses. In the total population, 156 had a prior PCI (74 and 82, respectively, in the MED and CABG groups). In those with vs. without prior PCI, the adjusted hazard-ratios (aHRs) were 0.92 (95% CI = 0.74-1.15) for all-cause mortality, 0.85 (95% CI = 0.64-1.11) for CV mortality, and 1.43 (95% CI = 1.15-1.77) for CV hospitalization. In the group randomized to CABG without prior PCI, the aHRs were 0.82 (95% CI = 0.70-0.95) for all-cause mortality, 0.75 (95% CI = 0.62-0.90) for CV mortality and 0.67 (95% CI = 0.56-0.80) for CV hospitalization. In the group randomized to CABG with prior PCI, the aHRs were 0.76 (95% CI = 0.50-1.15) for all-cause mortality, 0.81 (95% CI = 0.49-1.36) for CV mortality and 0.61 (95% CI = 0.41-0.90) for CV hospitalization. There was no evidence of interaction between randomized treatment and prior PCI for any endpoint (all adjusted p > 0.05).
In the STICH trial, prior PCI did not affect the outcomes of patients whether they were treated medically or surgically, and the superiority of CABG over MED remained unchanged regardless of prior PCI.
Clinicaltrials.gov; Identifier: NCT00023595.
STICH 试验表明，在左心室射血分数（LVEF）≤35%的患者中，冠状动脉旁路移植术加药物治疗（CABG）优于单纯药物治疗（MED）。在之前的出版物中，CABG 前的经皮冠状动脉介入治疗（PCI）与预后较差相关。
本研究的主要目的是分析 STICH 中之前的 PCI 是否影响结局。
本研究纳入了 STICH 试验（n=1212）中的患者，中位随访时间为 9.8 年。在总人群中，156 例患者有之前的 PCI（分别有 74 例和 82 例在 MED 和 CABG 组中）。在有和没有之前 PCI 的患者中，全因死亡率的调整后危险比（aHR）分别为 0.92（95%CI=0.74-1.15）、心血管死亡率为 0.85（95%CI=0.64-1.11）、心血管住院率为 1.43（95%CI=1.15-1.77）。在未行之前 PCI 而随机分配至 CABG 组的患者中，全因死亡率的 aHR 为 0.82（95%CI=0.70-0.95）、心血管死亡率为 0.75（95%CI=0.62-0.90）、心血管住院率为 0.67（95%CI=0.56-0.80）。在之前行 PCI 而随机分配至 CABG 组的患者中，全因死亡率的 aHR 为 0.76（95%CI=0.50-1.15）、心血管死亡率为 0.81（95%CI=0.49-1.36）、心血管住院率为 0.61（95%CI=0.41-0.90）。任何终点均未发现随机治疗与之前 PCI 之间存在交互作用（所有调整后 p＞0.05）。
在 STICH 试验中，无论患者接受药物治疗还是手术治疗，之前的 PCI 均不影响结局，并且 CABG 优于 MED 的优势保持不变，无论是否存在之前的 PCI。
Clinicaltrials.gov；标识符：NCT00023595。
