A new research letter underscores the need to improve long-term survival following lower extremity revascularisation for chronic limb-threatening ischaemia (CLTI), setting out a randomised controlled trial to examine the impact of coronary artery ischaemia testing in these patients.
The letter, authored by Dainis Krievins (Pauls Stradins Clinical University Hospital, Riga, Latvia), Andrejs Erglis (University of Latvia, Riga, Latvia) and HeartFlow’s senior advisor for medical affairs, Christopher K Zarins, was recently published online ahead of print in the European Journal of Vascular and Endovascular Surgery (EJVES).
Krievins and colleagues first detail that patients undergoing lower extremity revascularisation for CLTI or claudication have “poor” long-term survival due to co-existing coronary artery disease (CAD), which they note is “often asymptomatic, undiagnosed and undertreated”.
Diving into the available data on the topic, Krievins et al highlight an “alarmingly high” mortality rate in these patients that is evident throughout the literature. They state, for example, that the recent BASIL-2 and BEST-CLI randomised controlled trials reported a five-year mortality rate for patients with CLTI that exceeded 50% and was three times higher than the risk of amputation. They also note a 10–12% annual mortality rate following lower extremity revascularisation in studies including both patients with CLTI and those with claudication—namely SWEDEPAD, SAFE-PAD and VQI Vision.
The authors point out that the mortality rate in these patients is not only high, but has remained unchanged over the past 40 years, contrasting a “marked decline” in the mortality rate among patients with symptomatic CAD in association with coronary revascularisation as a mainstay of treatment. Current annual mortality for patients with CAD is only 1–2%, the researchers point out, as per the ISCHEMIA, FAME 2 and SCOT-HEART trials.
Krievins and colleagues state that guidelines recommend no cardiac testing of patients without cardiac symptoms prior to vascular surgery procedures, despite patients with PAD with combined CAD having “invariably worse outcomes”.
Against this backdrop, Krievins et al detail that they have embarked on a multicentre, randomised clinical trial to determine whether non-invasive diagnosis of silent coronary ischaemia together with ischaemia-targeted coronary revascularisation can improve the outcome of patients following lower extremity revascularisation.
The SCOREPAD (Selective coronary revascularisation in peripheral artery disease patients after lower extremity revascularisation) trial, will enrol up to 600 patients with CLTI or severe claudication and no known CAD after successful open or endovascular lower extremity revascularisation, Krievins and colleagues share in EJVES. The patients will be randomised to either coronary computed tomography angiography (CTA) plus computed tomography-derived fractional flow reserve (FFRCT; HeartFlow) with ischaemia-targeted coronary revascularisation in addition to best medical therapy (BMT) or BMT alone with no elective coronary revascularisation, which they note is the current guideline-directed standard of care.
The primary endpoint of the trial is a composite of cardiac death, myocardial infarction (MI) and urgent (unplanned) coronary revascularisation during twoyear follow-up, the authors detail. Extended followup will continue out to five years.
“Patient enrolment began in February 2024 and more than 80 patients have been randomised so far,” Krievins et al report in EJVES, who go on to say that the trial is seeking to include up to 10 additional sites in Europe and the USA.
