TY - JOUR
T1 - Percutaneous coronary intervention of native coronary artery versus saphenous vein graft in patients with prior coronary artery bypass graft surgery
T2 - Rationale and design of the multicenter, randomized PROCTOR trial
AU - de Winter, Ruben W.
AU - Walsh, Simon J.
AU - Hanratty, Colm G.
AU - Spratt, James C.
AU - Sprengers, Ralf W.
AU - PROCTOR Trial Research Group
AU - Twisk, Jos W.
AU - Vegting, Iris
AU - Schumacher, Stefan P.
AU - Bom, Michiel J.
AU - Hoek, Roel
AU - Verouden, Niels J.
AU - Delewi, Ronak
AU - Nap, Alexander
AU - Knaapen, Paul
N1 - Funding Information: PROCTOR is an investigator-initiated clinical trial funded by a research grant from Abbott Vascular International BVBA (Diegem, Belgium). The trial will be performed under direct supervision of the Steering Committee. The study sponsor, in collaboration with the Contract Research Organization (KCRI, Kraków, Poland) committed to the trial, are responsible for operational oversight, review of the study protocol and amendments, and trial progression. An independent clinical events committee (CEC) consisting of 3 experienced Interventional Cardiologists will review study adverse events and adjudicate clinical primary and secondary endpoints. Members of the CEC are not involved as investigators in the trial. The CEC will provide regular event adjudication reports to the sponsor investigators and the independent data safety monitoring board (DSMB). The DSMB will consider the consistency of primary and secondary endpoints, provide ongoing safety surveillance and perform interim analyses on the safety data. All members will have no conflict of interest with the sponsor of the study. The DSMB will oversee trial conduct and continuously evaluate the progress of the trial to subsequently give advice about continuation, modification or early termination of the study, as per the DSMB charter. The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper and its final contents. Publisher Copyright: © 2022 The Author(s)
PY - 2023/3/1
Y1 - 2023/3/1
N2 - Background: Patients with prior coronary artery bypass grafting (CABG) frequently require repeat percutaneous revascularization due to advanced age, progressive coronary artery disease and bypass graft failure. Percutaneous coronary intervention (PCI) of either the bypass graft or the native coronary artery may be performed. Randomized trials comparing native vessel PCI with bypass graft PCI are lacking and long-term outcomes have not been reported. Methods: PROCTOR (NCT03805048) is a prospective, multicenter, randomized controlled trial, that will include 584 patients presenting with saphenous vein graft (SVG) failure and a clinical indication for revascularization, as determined by the local Heart Team. The trial is designed to compare the clinical and angiographic outcomes in patients randomly allocated in a 1:1 fashion to either a strategy of native vessel PCI or SVG PCI. The primary study endpoint is a 3-year composite of major adverse cardiac events (MACE: all-cause mortality, non-fatal target coronary territory myocardial infarction [MI], or clinically driven target coronary territory revascularization). At 3-years, after evaluation of the primary endpoint, follow-up invasive coronary angiography will be performed. Secondary endpoints comprise individual components of MACE at 1, 3 and 5 years follow-up, PCI-related MI, MI >48 hours after index PCI, target vessel failure, target lesion revascularization, renal failure requiring renal-replacement therapy, angiographic outcomes at 3-years and quality of life (delta Seattle Angina Questionnaire, Canadian Cardiovascular Society Grading Scale and Rose Dyspnea Scale). Conclusion: PROCTOR is the first randomized trial comparing an invasive strategy of native coronary artery PCI with SVG PCI in post-CABG patients presenting with SVG failure.
AB - Background: Patients with prior coronary artery bypass grafting (CABG) frequently require repeat percutaneous revascularization due to advanced age, progressive coronary artery disease and bypass graft failure. Percutaneous coronary intervention (PCI) of either the bypass graft or the native coronary artery may be performed. Randomized trials comparing native vessel PCI with bypass graft PCI are lacking and long-term outcomes have not been reported. Methods: PROCTOR (NCT03805048) is a prospective, multicenter, randomized controlled trial, that will include 584 patients presenting with saphenous vein graft (SVG) failure and a clinical indication for revascularization, as determined by the local Heart Team. The trial is designed to compare the clinical and angiographic outcomes in patients randomly allocated in a 1:1 fashion to either a strategy of native vessel PCI or SVG PCI. The primary study endpoint is a 3-year composite of major adverse cardiac events (MACE: all-cause mortality, non-fatal target coronary territory myocardial infarction [MI], or clinically driven target coronary territory revascularization). At 3-years, after evaluation of the primary endpoint, follow-up invasive coronary angiography will be performed. Secondary endpoints comprise individual components of MACE at 1, 3 and 5 years follow-up, PCI-related MI, MI >48 hours after index PCI, target vessel failure, target lesion revascularization, renal failure requiring renal-replacement therapy, angiographic outcomes at 3-years and quality of life (delta Seattle Angina Questionnaire, Canadian Cardiovascular Society Grading Scale and Rose Dyspnea Scale). Conclusion: PROCTOR is the first randomized trial comparing an invasive strategy of native coronary artery PCI with SVG PCI in post-CABG patients presenting with SVG failure.
UR - http://www.scopus.com/inward/record.url?scp=85146240989&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.ahj.2022.11.014
DO - https://doi.org/10.1016/j.ahj.2022.11.014
M3 - Article
C2 - 36410442
SN - 1097-6744
VL - 257
SP - 20
EP - 29
JO - American Heart Journal
JF - American Heart Journal
ER -