From the Department of Cardiology, Karolinska Institute and Danderyd Hospital, Danderyd (F.B., B.M., R.L.), the Department of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (A.R.), the Department of Cardiology, Linköping University Hospital, Linköping (S.Z.), the Department of Cardiology, Mälarsjukhuset, Eskilstuna (M.H.), the Department of Cardiology, Central Hospital, Karlstad (T.K.), the Department of Cardiology, Ryhov Hospital, Jönköping (J. Lauermann), the Department of Cardiology, Umeå University Hospital, Umeå (J.A.), the Department of Cardiology, Sahlgrenska University Hospital, and the Department of Molecular and Clinical Medicine, Institute of Medicine, Gothenburg University, Gothenburg (O.A.), and the Department of Medical Sciences, Cardiology (H.R., C.H., O.Ö., S.J.), and Uppsala Clinical Research Center (C.H., S.J.), Uppsala University, Uppsala - all in Sweden; the Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen (T.E., J. Lønborg); the University Clinical Center of Serbia and the Faculty of Medicine, University of Belgrade, Belgrade (G.S.), and the Faculty of Medicine, University of Novi Sad, Institute of Cardiovascular Diseases Vojvodina, Sremska Kamenica (I.S.) - all in Serbia; the Heart Hospital, Tampere University Hospital, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), and the Heart and Lung Center, Helsinki University Central Hospital, Helsinki (M.L.) - all in Finland; the Latvian Center of Cardiology, Pauls Stradins Clinical University Hospital, University of Latvia, Riga (A..); the Cardiology Department, Waikato Hospital, Hamilton, New Zealand (M.M.); and the Medical School, University of Western Australia, and the Department of Cardiology, Royal Perth Hospital - both in Perth, WA (C.S.).
N Engl J Med. 2024 Apr 25;390(16):1481-1492. doi: 10.1056/NEJMoa2314149. Epub 2024 Apr 8.
The benefit of fractional flow reserve (FFR)-guided complete revascularization in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease remains unclear.
In this multinational, registry-based, randomized trial, we assigned patients with STEMI or very-high-risk non-STEMI (NSTEMI) and multivessel disease who were undergoing primary percutaneous coronary intervention (PCI) of the culprit lesion to receive either FFR-guided complete revascularization of nonculprit lesions or no further revascularization. The primary outcome was a composite of death from any cause, myocardial infarction, or unplanned revascularization. The two key secondary outcomes were a composite of death from any cause or myocardial infarction and unplanned revascularization.
A total of 1542 patients underwent randomization, with 764 assigned to receive FFR-guided complete revascularization and 778 assigned to receive culprit-lesion-only PCI. At a median follow-up of 4.8 years (interquartile range, 4.3 to 5.2), a primary-outcome event had occurred in 145 patients (19.0%) in the complete-revascularization group and in 159 patients (20.4%) in the culprit-lesion-only group (hazard ratio, 0.93; 95% confidence interval [CI], 0.74 to 1.17; P = 0.53). With respect to the secondary outcomes, no apparent between-group differences were observed in the composite of death from any cause or myocardial infarction (hazard ratio, 1.12; 95% CI, 0.87 to 1.44) or unplanned revascularization (hazard ratio, 0.76; 95% CI, 0.56 to 1.04). There were no apparent between-group differences in safety outcomes.
Among patients with STEMI or very-high-risk NSTEMI and multivessel coronary artery disease, FFR-guided complete revascularization was not shown to result in a lower risk of a composite of death from any cause, myocardial infarction, or unplanned revascularization than culprit-lesion-only PCI at 4.8 years. (Funded by the Swedish Research Council and others; FULL REVASC ClinicalTrials.gov number, NCT02862119.).
在 ST 段抬高型心肌梗死（STEMI）和多支血管病变患者中，应用血流储备分数（FFR）指导的完全血运重建的获益尚不清楚。
在这项多中心、基于注册的随机试验中，我们将接受罪犯病变经皮冠状动脉介入治疗（PCI）的 STEMI 或极高危非 ST 段抬高型心肌梗死（NSTEMI）并伴有多支血管病变的患者随机分为接受 FFR 指导的非罪犯病变完全血运重建或不进行进一步血运重建的两组。主要终点为任何原因导致的死亡、心肌梗死或计划外血运重建的复合终点。两个关键次要终点为任何原因导致的死亡或心肌梗死和计划外血运重建的复合终点。
共 1542 例患者进行了随机分组，764 例患者被分配接受 FFR 指导的完全血运重建，778 例患者被分配接受罪犯病变 PC I。在中位随访 4.8 年（四分位距，4.3 至 5.2）时，完全血运重建组有 145 例（19.0%）患者和仅罪犯病变组有 159 例（20.4%）患者发生了主要终点事件（风险比，0.93；95%置信区间[CI]，0.74 至 1.17；P=0.53）。对于次要终点，在任何原因导致的死亡或心肌梗死的复合终点（风险比，1.12；95%CI，0.87 至 1.44）或计划外血运重建（风险比，0.76；95%CI，0.56 至 1.04）方面，两组间未观察到明显差异。安全性结局方面两组间也无明显差异。
在 STEMI 或极高危 NSTEMI 并伴有多支血管病变的患者中，与仅罪犯病变 PCI 相比，4.8 年时，FFR 指导的完全血运重建并未降低任何原因导致的死亡、心肌梗死或计划外血运重建的复合终点风险。（由瑞典研究理事会和其他机构资助；FULL REVASC ClinicalTrials.gov 注册号：NCT02862119。）
