Approximately half of all patients presenting for ST-elevation myocardial infarction (STEMI) and receiving primary percutaneous coronary intervention (PCI) have multivessel coronary artery disease. For non-offender vessels, whether to routinely revascularize or treat conservatively has been a clinical dilemma. In patients with chronic coronary syndromes, the use of fractional flow reserve (FFR)-guided PCI reduces the risk of serious adverse events compared with angiography-guided PCI or conservative management, but studies in patients with acute coronary syndromes (ACS) have shown conflicting results.
Recently, at the 73rd Annual Meeting of the American College of Cardiology (ACC.24) "Featured Clinical Research" session, Professor Felix Bohm from Karolinska Institute and Danderyd Hospital in Stockholm, Sweden, presented the latest results of the FULL REVASC study. The results of the study showed that in patients with STEMI and very high-risk non-ST-elevation myocardial infarction (NSTEMI) with multivessel disease, complete revascularization guided by conventional FFR was not superior to convict-only vascular PCI in reducing the risk of death from any cause, myocardial infarction, or unplanned revascularization composite events. The findings have been published in the New England Journal of Medicine.
Study design
The FULL REVASC study is a multinational, randomized registry trial that includes patients with STEMI who are undergoing PCI for the first time or STEMI/very high-risk NSTEMI patients who are undergoing drug-invasive PCI and have at least one non-offender vascular lesion. All patients were randomized in a 1:1 ratio within 6 hours of successful first offender vascular PCI to receive either FFR-guided complete revascularization or offender-only vascular PCI (Figure 1).
Fig.1 Study design
The primary endpoint is a composite endpoint consisting of all-cause death, new-onset myocardial infarction, or unplanned revascularization. Key secondary endpoints include a composite endpoint of all-cause death or myocardial infarction and unplanned revascularization.
Findings:
A total of 1542 patients were included in the study, including 764 in the FFR-guided complete revascularization group and 778 in the offender-only vascular PCI group (traditional drug therapy was initiated for non-offender lesions).
➤ Baseline characteristics
The mean age of the patients in both groups was 65 years, 76% were male, 88% were on ticagrelor, and 97% were on statins (Table 1).
Table 1 Baseline characteristics
➤ Surgical features
Ninety-one percent of patients were diagnosed with STEMI, nine percent were diagnosed with very high-risk NSTEMI, and left main lesions accounted for 21 percent. FFR-guided complete revascularization of non-offender vascular lesions yielded 94.1% (Table 2).
Table 2 Surgical features
➤Primary endpoint
At a median follow-up of 4.8 years, the primary endpoint event occurred in 145 patients (19.0%) and 159 patients (20.4%) in the FFR-guided complete revascularization group and the criminal-only vascular PCI group, respectively (HR=0.93; 95% CI: 0.74-1.17; P=0.53).
Fig. 2 Primary endpoints
➤ Key secondary endpoints
There was no statistically significant difference between the two groups in the risk of composite events of all-cause death or myocardial infarction (HR=1.12; 95% CI: 0.87-1.44) and unplanned revascularization (HR=0.76; 95% CI: 0.56-1.04).
Fig. 3 Key secondary endpoints
➤ Subgroup analysis
With the exception of the subgroup who received glycoprotein IIb/IIIa inhibitors during the first PCI, the results appeared to be consistent across the preset subgroups (Figure 4).
Fig. 4 Subgroup analysis
➤ Safety endpoints
No statistically significant differences were observed between the two groups in terms of safety of contrast-related acute kidney injury and neurological complications. There was no statistically significant difference in the incidence of stroke, major bleeding, or rehospitalization for heart failure between the two groups throughout the follow-up period (Table 3).
Table 3 Safety endpoints
Conclusions of the study
The results suggest that in patients with STEMI/very high-risk NSTEMI and multivessel disease, complete revascularization guided by conventional FFR is no better than convict-only vascular PCI in reducing the risk of death, myocardial infarction, or unplanned revascularization composite events from any cause. There were no clear differences between the two groups for stroke, haemorrhage, heart failure, or acute kidney injury.
Source: ACC official website
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