Dr Felix Böhm
Routine fractional flow reserve (FFR)-guided complete revascularisation in patients with STEMI or very high-risk NSTEMI and multivessel disease is not superior to culprit-lesion-only PCI.
The findings of the FULL REVASC trial, which included sites in Australia and New Zealand, were presented at ACC.24 in Atlanta and concurrently published in the NEJM [link here].
The study, presented by Dr Felix Böhm from the Karolinska Institute and Danderyd Hospital in Stockholm, Sweden, randomised 1,542 patients from 32 centres in seven countries to receive FFR-guided complete revascularisation or culprit-lesion-only PCI.
Patients were eligible if they presented to hospital with STEMI and were undergoing primary PCI or pharmacoinvasive PCI – defined as rescue PCI or PCI for risk evaluation after successful thrombolysis – or if they were undergoing urgent PCI for very-high-risk NSTEMI.
They had to be able to undergo randomisation within 6 hours after successful culprit-lesion PCI and to have multivessel coronary artery disease.
The study found that, after a median follow-up of 4.8 years, a primary outcome event of all-cause death, new MI, or unplanned revascularisation occurred in 19% of the complete-revascularisation group compared to 20.4% in the culprit-lesion-only group (HR 0.93; 95% confidence interval [CI], 0.74 to 1.17; P=0.53).
In key secondary outcomes, there was also no apparent difference between the groups in the composite of death from any cause or myocardial infarction (HR 1.12; 95% CI, 0.87 to 1.44) or unplanned revascularisation (HR 0.76; 95% CI, 0.56 to 1.04)
The results for the primary outcome were consistent across prespecified subgroups defined by age, the presence of diabetes, nonculprit stenosis grade on visual estimation, and the presence of a nonculprit lesion in the proximal left anterior descending coronary artery.
“The only exception appeared to be for the subgroup of patients who received glycoprotein IIb/IIIa inhibitors during the index PCI,” the study said.
Regarding safety, there were no apparent between-group differences in contrast-associated acute kidney injury or neurologic complications during the index hospitalisation.
However the median volume of contrast, the duration of exposure to radiation, and the time in the hospital during the index hospitalisation were significantly higher among patients in the complete-revascularisation group.
Stent thrombosis was also more common in the complete revascularisation group (2.5% v 0.9%; HR 2.80).
There was no apparent between-group differences in the incidence of stroke, major bleeding, or rehospitalisation for heart failure during the entire follow-up period.
“In the absence of a reduction in irreversible events, such as death or myocardial infarction, the clinical relevance of performing early nonculprit-lesion PCI in all patients with multivessel coronary artery disease to prevent later PCI in a smaller number of those patients is debatable,” the study concluded.
An accompanying Editorial in the NEJM [link here] said it was not yet time to “give up” on physiological guidance in patients with acute coronary syndromes.
It noted that given high-risk NSTEMI patients comprised only 9% of the cohort, the results may not apply to this patient group.
“It is also crucial to emphasise the importance of modern-day pharmacotherapy in reducing the risk of subsequent cardiovascular events not only in the context of obstructive epicardial disease but also in the context of nonobstructive disease.”
“In the context of acute coronary syndromes, the combination of physiological guidance and other strategies, such as intracoronary imaging, is essential to optimise the procedure and tailor the treatment approach to the clinical needs of patients.”
FULL REVASC – #ACC24
❌ advantage of FFR-guided complete revascularisation vs culprit-only PCI in myocardial infarction
🔗 https://t.co/hfFjSCPIsO#MedTwitter #MedX #MedEd #FOAMed #cardiotwitter @ACCinTouch pic.twitter.com/zysBJKOzD0
— Dr Rob 🫀🩺 🇦🇺 (@drhungo) April 9, 2024