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. 2025 Oct 28:S0735-1097(25)09477-X.
doi: 10.1016/j.jacc.2025.09.1577. Online ahead of print.

PCI of Native Coronary Artery vs Saphenous Vein Graft After Prior Bypass Surgery: A Multicenter, Randomized Trial

Ruben W de Winter  1 , Roel Hoek  1 , Simon J Walsh  2 , Colm G Hanratty  3 , Ralf W Sprengers  4 , Jos W R Twisk  5 , Iris Vegting  1 , Stefan P Schumacher  1 , Michiel J Bom  1 , Niels J Verouden  1 , José P Henriques  1 , Adriaan Wilgenhof  6 , Michele M Viscusi  7 , Koen Teeuwen  8 , Maksymilian P Opolski  9 , Rafał Wolny  9 , Pierfrancesco Agostoni  10 , Jan-Peter van Kuijk  11 , Bas E Schölzel  12 , Adriaan O Kraaijeveld  13 , Robert-Jan M van Geuns  14 , Maurits T Dirksen  15 , Antonius A C M Heestermans  15 , Jo Dens  16 , Johan Bennett  17 , Steven E F Haine  18 , Ronak Delewi  1 , Alexander Nap  1 , James C Spratt  19 , Paul Knaapen  20 ; PROCTOR Trial Investigators
Collaborators, Affiliations

PCI of Native Coronary Artery vs Saphenous Vein Graft After Prior Bypass Surgery: A Multicenter, Randomized Trial

Ruben W de Winter et al. J Am Coll Cardiol. .

Abstract

Background: In patients with prior coronary artery bypass grafting (CABG) presenting with graft failure, current guidelines recommend percutaneous coronary intervention (PCI) of the bypassed native coronary artery over PCI of the bypass graft. However, this recommendation relies solely on observational data.

Objectives: This study compared clinical outcomes between a strategy of native vessel PCI with saphenous vein graft (SVG) PCI in post-CABG patients presenting with SVG failure.

Methods: The multicenter, randomized PROCTOR (Percutaneous Coronary Intervention of Native Coronary Artery versus Saphenous Vein Graft in Patients with Prior Coronary Artery Bypass Graft Surgery) trial included patients with significant SVG stenosis and a heart team-defined clinical indication for revascularization. Patients were randomly assigned (1:1) to either a strategy of native vessel PCI or SVG PCI using an interactive web-based randomization platform. The trial was conducted across 14 centers in Europe. We report the occurrence of major adverse cardiac events at 1 year following the index PCI, defined as the composite of all-cause mortality, nonfatal target coronary territory myocardial infarction (MI), or clinically driven target coronary territory revascularization, analyzed on an intention-to-treat basis. The trial is registered with ClinicalTrials.gov (NCT03805048), and long-term follow-up is ongoing.

Results: Between January 2019 and December 2023, 220 patients (mean age 73 ± 7 years; 84% men [185/220 patients]) were randomized to a strategy of native vessel PCI (n = 108) or SVG PCI (n = 112). At 1 year, major adverse cardiac events occurred in 37 patients (34%) in the native vessel PCI group and 21 patients (19%) in the SVG PCI group (HR: 2.14; 95% CI: 1.25-3.65; P = 0.006). There was no significant difference in all-cause mortality (HR: 1.59; 95% CI: 0.45-5.64; P = 0.472), whereas both nonfatal target coronary territory MI (HR: 2.12; 95% CI: 1.08-4.17; P = 0.029) and clinically driven target coronary territory revascularization (HR: 2.19; 95% CI: 1.02-4.72; P = 0.044) occurred more frequently in patients assigned to native vessel PCI. The incidence of PCI-related MI was 13% in the native vessel PCI group and 1% in the SVG PCI group (HR: 14.85; 95% CI: 1.95-112.96; P = 0.009).

Conclusions: In the randomized PROCTOR trial, SVG PCI was associated with improved 1-year clinical outcomes compared with native vessel PCI, primarily driven by lower rates of PCI-related MI and clinically driven target coronary territory revascularization.

Keywords: percutaneous coronary intervention; prior coronary artery bypass grafting; randomized controlled trial; saphenous vein graft failure.

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Conflict of interest statement

Funding Support and Author Disclosures PROCTOR is an investigator-initiated study funded by a research grant from Abbott Vascular International BVBA and sponsored by the Amsterdam University Medical Center. The funder of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. Dr Walsh has a consultancy agreement with Boston Scientific Corporation. Dr Hanratty has a consultancy agreement with Boston Scientific Corporation, Abbott Vascular, and Medtronic. Drs Wilgenhof and Viscusi have received a research grant from the CardioPaTh PhD Program. Dr Opolski has received a research grant from B.Braun. Dr Agostoni has received consulting fees from Abbott, Boston Scientific, iVascular, Medtronic, Shockwave, Teleflex, and Terumo. Dr Dirksen has received a speakers fee from Abbott Medical. Dr Delewi has received educational grants from Boston Scientific, ABiomed, Edwards Lifesciences, Sanofi, Meril Life Science, Novartis, and Amgen. Dr Knaapen has received research funding from Cleerly Inc and HeartFlow Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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