In clients with ST-elevation myocardial infarction (STEMI) and multivessel illness, fractional circulation reserve (FFR)-assisted total nonculprit revascularization did not decrease death, myocardial infarction (MI) or unintended revascularization compared to perpetrator lesion-only percutaneous coronary intervention (PCI).
“Around half of all clients going through main PCI to the perpetrator sore in STEMI have multivessel illness, with several angiographically substantial nonculprit sores,” Felix Böhm, MD, PhD, Karolinska Institute and Danderyd Hospital, Stockholm, Sweden stated in a discussion on April 8 at the American College of Cardiology (ACC) Scientific Session 2024
“Previous randomized regulated trials have actually revealed that nonculprit-lesion PCI decreases repeat revascularization,” he stated. “But the result on tough endpoints like death and MI have actually varied, and the advantage of FFR-guided total revascularization on difficult endpoints stays uncertain.”
Böhm reported arise from the FULL REVASC trial which, contrary to previous randomized regulated trials with comparable clients, revealed that total revascularization was not exceptional to culprit-only PCI in lowering those difficult endpoints.
The research study was likewise all at once released online in The New England Journal of Medicine
Between-Group Efficacy, Safety Similar
The FULL REVASC trial hired clients from 32 centers in 7 nations. Clients with STEMI or very-high-risk non-STEMI (NSTEMI) and multivessel illness who were going through PCI of the perpetrator sore were randomized to either FFR-guided total revascularization of nonculprit sores or no more revascularization.
The main result was a composite of death from any cause, MI, or unexpected revascularization. Secondary results consisted of a composite of death from any cause or MI and unexpected revascularization.
“The initial strategy was to consist of 4052 clients at 80% power, for a threat ratio (HRR) of 0.75 for death or MI,” Böhm informed conference guests. That altered after publication of the Total trialwhich revealed that in STEMI clients, total revascularization remained in truth remarkable to perpetrator lesion-only PCI in lowering the danger of cardiovascular death or MI, in addition to the danger of cardiovascular death, MI, or ischemia-driven revascularization.
At that point, FULL REVASC, which was still hiring, was stopped for expediency and ethical factors, Böhm stated. The private investigators changed their strategy and followed their currently consisted of 1542 clients at 74% power for HRR for death, MI, or unintended revascularization as the brand-new main endpoint.
In the brand-new trial style, an overall of 1542 clients (indicate age, 65 years; 76%, guys) were designated to FFR-guided total revascularization or perpetrator lesion-only PCI.
At an average follow-up of 4.8 years, a primary-outcome occasion had actually happened in 145 clients (19.0%) in the complete-revascularization group and in 159 (20.4%) in the offender lesion-only group (HR, 0.93; 95% CI, 0.74-1.17; P =.53).
With regard to secondary results, no evident between-group distinctions were seen in the composite of death from any cause or MI (HR, 1.12; 95% CI, 0.87-1.44) or unexpected revascularization (HR, 0.76; 95% CI, 0.56-1.04).
No evident between-group distinctions were observed with regard to many of the other secondary results, with HRs as follows: death from any cause, HR 1.15 (95% CI, 0.83-1.58); death from cardiovascular causes, 0.87 (95% CI, 0.55-1.39); MI, 1.09 (95% CI, 0.76-1.57); and composite of death from cardiovascular causes, MI, or unexpected revascularization, 0.80 (95% CI, 0.62-1.03).
Revascularization took place in 78 clients (10.2%) in the total revascularization group and in 128 (16.5%) in the perpetrator lesion-only group (HR, 0.59; 95% CI, 0.45-0.78).
Stent apoplexy happened in 19 clients (2.5%) in the total group and in 7 (0.9%) in the perpetrator lesion-only group (HR, 2.80; 95% CI, 1.18-6.67).
Outcomes for the main result seemed constant throughout subgroups, consisting of age, diabetes, nonculprit stenosis grade on visual estimate, and the existence of a nonculprit sore in the proximal left anterior coming down coronary artery.
In addition, there were no evident between-group distinctions with regard to security results.
Concerns Remain
The findings triggered numerous concerns from panelist William Fearon, MD, a teacher at Stanford University School of Medicine, California. Concerning nonculprit illness, he questioned whether the seriousness of the sores might discuss a few of the distinctions in between the FULL REVASC findings and other trials, considered that just about 40% of sores needed PCI in the nonculprit vessels, whereas the number in other trials was a bit greater.
Böhm stated about 47% of all sores determined were “substantial,” which is around the like in previous trials. “I’m not encouraged that sore seriousness had much to do with the outcomes. It might be that clients were extremely well treated with guideline-directed drugs, so that the threats were low in both groups.”
Fearon kept in mind that there was more separation in between the result curves at one year, and questioned whether the group took a look at the 1 year follow-up compared to after one year, and if the distinction attenuated with longer follow-up.
A long follow-up may make all-cause death more crucial, Böhm acknowledged. For cardiovascular death, a meta-analysis might assist identify “the genuine value of doing nonculprit sore PCI.”
Fearon then asked why all-cause death was picked as a main endpoint for the trial rather of cardiovascular death. “Was there a factor to select all-cause? Since it was a registry-based trial and simpler to adjudicate?”
Böhm stated yes, among the factors was that it was simpler to inform if the client was dead or alive. “We wished to ensure our endpoints, and we did not wish to adjudicate death.”
Did the pandemic impact the group’s follow-up, Fearon questioned. “Could it have had any effect on repeat revascularization in the culprit-only group, for instance?”
‘We saw in Sweden that in the very first half year or two, the variety of individuals who looked for take care of MI decreased perhaps 25% or 40%,” Böhm stated. “But then we did a project that stated it’s more hazardous to remain at home. I believe the pandemic might have impacted the outcomes just for the very first half year or so.”
Vijay Kunadian, MD, of Newcastle University and Cardiothoracic Centre, Freeman Hospital, Newcastle Upon Tyne Hospitals NHS Foundation Trust, United Kingdom, likewise raised a number of concerns in an accompanying editorial
He composed that PCI was carried out in nonculprit vessels in just 18.8% of vessels in the total revascularization group (94.1% of all nonculprit vessels with an FFR ≤ 0.8), which is lower than in previous trials– ie, total revascularization was accomplished in 90% after nonculprit PCI in the COMPLETE trial.
“Another essential concern … is whether FFR-guided PCI transcends to angiography-guided PCI, which was not checked in the existing trial however was assessed in 2 previous trials with conflicting outcomes,” he composed.
Choice predisposition was likewise possible, since the trial did not consist of sufficient clients with state-of-the-art nonculprit sores and three-vessel illness– ie, those who may benefit most from total revascularization.
And, considered that just 9% of individuals provided with high-risk NSTEMI, he kept in mind, the findings may not use totally to this client group.
“For more conclusive proof on the functions of physiological assistance and imaging in the management of nonculprit sores in clients with severe coronary syndromes, we wait for the outcomes of the continuous COMPLETE-2 trialwhich will hire more than 5000 clients with STEMI and NSTEMI,” Kunadian concluded.
The trial was moneyed by the Swedish Research Council, the Swedish Heart-Lung Foundation, the Stockholm County Council, Abbott and Boston Scientific. Böhm reported institutional grants from Abbott Laboratories and Boston Scientific. Kunadian reported no disclosures.
Marilynn Larkin, MA, is an acclaimed medical author and editor whose work has actually appeared in various publications, consisting of Medscape Medical News and its sibling publication MDedge, The Lancet (where she was a contributing editor), and Reuters Health.