Key Points
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- Researchers compared outcomes in patients with STEMI or very-high-risk non-STEMI (NSTEMI) and multivessel disease who were undergoing primary percutaneous coronary intervention (PCI) of the culprit lesion to receive either FFR-guided complete revascularization of nonculprit lesions or no further revascularization.
- There was no significant difference in the composite primary outcome of death, myocardial infarction or unplanned revascularization, between patients randomized to culprit lesion only PCI versus FFR-guided complete revascularization
Although approximately half of the patients who present with an ST-elevation myocardial infarction (STEMI) have multivessel disease, there is no definitive data on the most appropriate management of non-culprit lesions among patients who present with a STEMI. In this international, multi-center, registry-based randomized FULL REVASC trial, the researchers evaluate the potential benefit of incorporating fractional flow reserve (FFR)-guided complete revascularization in the treatment of patients who present with ST-elevation myocardial infarction (STEMI) or high risk non-ST elevation myocardial infarction (NSTEMI) and multivessel coronary disease. To be eligible for enrollment in the trial, patients had to have presented to the hospital with a STEMI or high risk NSTEMI, which included features such as dynamic ST changes, ongoing chest pain, heart failure, and hemodynamic instability. Patients with a history of coronary artery bypass graft surgery, left main disease and cardiogenic shock were excluded. The primary outcome was the composite outcome of death, myocardial infarction and unplanned revascularization.
Among the 1542 patients who were enrolled in the trial between August 2016 and September 2019, the mean age was 65 years old and 76% were men. Within the sample, 91% had presented with STEMI and 9% presented with very-high-risk NSTEMI. Race/ethnicity data was not collected in the trial so it is unclear which external populations this trial would be generalizable to. Of the 764 patients who were randomized to the complete revascularization strategy, 17.1% had complete revascularization during primary PCI and 78.8% underwent complete revascularization during a second procedure during the index hospitalization. Patients were followed for a median follow-up of 4.8 years and the primary outcome occurred in 19.0% of patients in the FFR-guided group compared to 20.4% of patients in the control group (HR: 0.93; 95% C.I.: 0.74-1.17, p = 0.53). There was also no difference between the two groups in the composite of death or myocardial infarction (HR 1.12; CI 0.87-1.44; P=0.37) or the outcome of unplanned revascularization alone (HR 0.76; CI 0.56-1.04; P=0.092). In terms of the other secondary outcomes, there were no differences between the two groups in the rates of death from all cause, death from cardiovascular cause, myocardial infarction, or the composite of death from cardiovascular causes, myocardial infarction or unplanned revascularization. There was a higher rate of stent thrombosis in the complete revascularization group (2.5%) compared to the culprit-lesion only group (0.9%) with a hazard ratio of 2.80 (95% CI, 1.18 to 6.67).
In conclusion, this study did not show a significant difference in outcomes between patients who presented with a STEMI or high risk NSTEMI and underwent culprit lesion only PCI compared to FFR-guided complete revascularization. These findings are in contrast to the findings of the previously-published COMPLETE trial which showed a 26% lower risk of cardiovascular death or myocardial infarction with angiography-guided complete revascularization and FIRE trial, which showed a 36% lower risk of the composite outcome of death from cardiovascular causes or myocardial infarction with physiology-guided complete revascularization. It is possible that the longer follow-up in this study contributes to the lack of benefit seen with complete revascularization. There is ongoing research evaluating the possible benefit of complete revascularization and the upcoming COMPLETE-2 trial will compare outcomes between patients who undergo physiology-guided versus angiography-guided complete revascularization after presenting with acute coronary syndrome.