Results from PROCTOR Announced at TCT 2025 and Published Simultaneously in JACC
SAN FRANCISCO – OCTOBER 28, 2025 – Results from the first-of-its-kind randomized PROCTOR trial found that a strategy of saphenous vein graft (SVG) percutaneous coronary intervention (PCI) had better one-year clinical outcomes compared to native vessel PCI in patients who have previously undergone coronary artery bypass grafting (CABG).
Findings were reported today at TCT® 2025, the annual scientific symposium of the Cardiovascular Research Foundation® (CRF®) and also published simultaneously in the Journal of the American College of Cardiology. TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine.
In patients with prior CABG presenting with graft failure, current guidelines recommend PCI of the bypassed native coronary artery over PCI of the bypass graft. However, this recommendation is not supported by high-quality randomized, data. Therefore, the PROCTOR study aimed to compare clinical outcomes between these two strategies in post-CABG patients presenting with SVG failure.
Between January 2019 and December 2023, a total of 220 patients with prior CABG and significant SVG stenosis were randomized one to one to either a strategy of native vessel PCI (n=108) or SVG PCI (n=112) at 14 centers in Europe. The primary endpoint was one-year MACE, a composite of all-cause mortality, non-fatal target coronary territory myocardial infarction (MI) and clinically driven target coronary territory revascularization. At one year, MACE occurred in 37 (34.3%) patients in the native vessel PCI group and 21 (18.7%) patients in the SVG PCI group (HR 2.14, 95%CI 1.25-3.65, log-rank p=0.004).
No significant differences in rates of all-cause mortality were observed between the two groups (5.6% native vessel versus 3.6% SVG, HR 1.59, 95%CI 0.45-5.64, log-rank p=0.468). However, both non-fatal target coronary territory MI (22.6% native vessel versus 11.7% SVG, HR 2.12, 95%CI 1.08-4.17, log-rank p=0.024) and clinically driven target coronary territory revascularization (18.4% native vessel versus 9.1% SVG, HR 2.19, 95%CI 1.02-4.72, log-rank p=0.039) occurred more frequently in patients assigned to native vessel PCI.
“Our study demonstrated that saphenous vein graft PCI in the high-risk and complex post-CABG patient population led to improved one-year clinical outcomes compared with native vessel PCI,” said Ruben W. de Winter, MD, PhD, Research Fellow, Department of Cardiology, Amsterdam University Medical Centers, The Netherlands. “Mainly due to fewer PCI-related myocardial infarctions and clinically driven target coronary territory revascularization, these results challenge current guidelines at one-year clinical follow-up and long-term data will show if this early advantage continues over time.”
The study was funded by Abbott Vascular International BVBA in Diegem, Belgium.
Dr. de Winter reported grant/research support from Abbott Vascular International BVBA.
