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Percutaneous coronary intervention of native coronary artery versus saphenous vein graft in patients with prior coronary artery bypass graft surgery: Rationale and design of the multicenter, randomized PROCTOR trial.

Title: Percutaneous coronary intervention of native coronary artery versus saphenous vein graft in patients with prior coronary artery bypass graft surgery: Rationale and design of the multicenter, randomized PROCTOR trial.
Authors: de Winter, RW; Walsh, SJ; Hanratty, CG; Spratt, JC; Sprengers, RW; Twisk, JWR; Vegting, I; Schumacher, SP; Bom, MJ; Hoek, R; Verouden, NJ; Delewi, R; Nap, A; Knaapen, P; PROCTOR Trial Research Group
Publisher Information: Elsevier
Publication Year: 2022
Collection: St George's University of London: Repository
Description: 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.
Document Type: article in journal/newspaper
File Description: application/pdf
Language: English
ISSN: 1097-6744
Relation: https://openaccess.sgul.ac.uk/id/eprint/116537/1/1-s2.0-S0002870322002964-main.pdf; de Winter, RW; Walsh, SJ; Hanratty, CG; Spratt, JC; Sprengers, RW; Twisk, JWR; Vegting, I; Schumacher, SP; Bom, MJ; Hoek, R; et al. de Winter, RW; Walsh, SJ; Hanratty, CG; Spratt, JC; Sprengers, RW; Twisk, JWR; Vegting, I; Schumacher, SP; Bom, MJ; Hoek, R; Verouden, NJ; Delewi, R; Nap, A; Knaapen, P; PROCTOR Trial Research Group (2022) Percutaneous coronary intervention of native coronary artery versus saphenous vein graft in patients with prior coronary artery bypass graft surgery: Rationale and design of the multicenter, randomized PROCTOR trial. Am Heart J, 257. pp. 20-29. ISSN 1097-6744 https://doi.org/10.1016/j.ahj.2022.11.014 SGUL Authors: Spratt, James
DOI: 10.1016/j.ahj.2022.11.014
Availability: https://openaccess.sgul.ac.uk/id/eprint/116537/; https://doi.org/10.1016/j.ahj.2022.11.014
Rights: cc_by_4
Accession Number: edsbas.4BCD7234
Database: BASE