Pulse Brain · Growing Health Evidence Index
Tier 2 — RCT / large cohortPeer-reviewed

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

Ruben W. de Winter, Simon Walsh, Colm G. Hanratty, James Spratt, Ralf W. Sprengers, Jos W. R. Twisk, Iris Vegting, Stefan Schumacher, Michiel J. Bom, Roel Hoek, Niels Verouden, Ronak Delewi, Alexander Nap, Paul Knaapen

American Heart Journal · 2022

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Summary

PROCTOR is the first randomised controlled trial designed to compare invasive strategies of native coronary artery PCI versus saphenous vein graft PCI in patients with prior CABG presenting with graft failure. The multicentre trial will enrol 584 patients and evaluate clinical and angiographic outcomes over 5 years, with repeat coronary angiography performed at 3 years to assess graft patency. This addresses a significant evidence gap, as previous randomised comparisons of these revascularisation strategies in the post-CABG population are lacking.

Regional applicability

The trial is described as multicentre and international in scope, though specific participating countries are not detailed in the abstract. The findings will be directly applicable to United Kingdom cardiology practice, as PCI in post-CABG patients is a common clinical scenario managed in UK cardiac centres, and current evidence-based guidance on optimal revascularisation strategy in this population is limited.

Key measures

Primary endpoint: 3-year composite MACE (all-cause mortality, non-fatal target coronary territory MI, clinically driven target coronary territory revascularisation). Secondary endpoints: individual MACE components at 1, 3, 5 years; PCI-related MI; target vessel failure; target lesion revascularisation; renal failure requiring dialysis; angiographic outcomes; quality of life (Seattle Angina Questionnaire, Canadian Cardiovascular Society Grading Scale, Rose Dyspnea Scale).

Outcomes reported

The trial compares clinical and angiographic outcomes between native coronary artery PCI and saphenous vein graft PCI in post-CABG patients, with primary endpoint being 3-year major adverse cardiac events (all-cause mortality, non-fatal target coronary territory myocardial infarction, or clinically driven target coronary territory revascularisation).

Theme
Policy, governance & rights
Subject
Out of scope / non-food
Study type
Research
Study design
RCT
Source type
Peer-reviewed study
Status
Published
Geography
International
System type
Human clinical
DOI
10.1016/j.ahj.2022.11.014
Catalogue ID
SNmpeyuosy-sx0fqj

Topic tags

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