Article Impact Level: HIGH Data Quality: STRONG Summary of The Lancet, S0140673623003513. https://doi.org/10.1016/S0140-6736(23)00351-3 Dr. Roberto Diletti et al
Points
- In a randomized trial across four European countries, 764 patients were randomly assigned to the immediate complete revascularization group and 761 patients to the staged complete revascularization group.
- The primary outcome at one year occurred in 7.6% of patients in the immediate complete revascularization group and 9.4% in the staged complete revascularization group (HR 0.78, 95% CI 0.55-1.11, pnon-inferiority=0.0011).
- There was no difference in all-cause death between the immediate and staged complete revascularization groups (1.9% vs. 1.2%; HR 1.56, 95% CI 0.68-3.61, p=0.30).
- Myocardial infarction occurred in 1.9% of patients in the immediate complete revascularization group and 4.5% in the staged complete revascularization group (HR 0.41, 95% CI 0.22-0.76, p=0.0045).
- More unplanned ischemia-driven revascularizations were performed in the staged complete revascularization group than in the immediate complete revascularization group (6.7% vs. 4.2%; HR 0.61, 95% CI 0.39-0.95, p=0.030).
- Therefore, the trial found that immediate complete revascularization was non-inferior to staged complete revascularization for the primary composite outcome and was associated with a reduction in myocardial infarction and unplanned ischemia-driven revascularization.
Summary
This research paper investigated whether the percutaneous coronary intervention (PCI) for non-culprit lesions should be attempted immediately during the index procedure or staged in patients with acute coronary syndrome and multivessel coronary disease. The prospective, open-label, non-inferiority, randomized trial was conducted at 29 hospitals across four European countries. Patients aged 18-85 years with ST-segment elevation myocardial infarction or non-ST-segment elevation acute coronary syndrome and multivessel coronary artery disease were included. Patients were randomly assigned (1:1) to undergo immediate or staged complete revascularization. The primary outcome was the composite of all-cause mortality, myocardial infarction, unplanned ischemia-driven revascularisation, or cerebrovascular events one year after the index procedure.
Between June 2018 and October 2021, 764 patients were assigned to the immediate complete revascularization group, and 761 patients were assigned to the staged complete revascularization group. The primary outcome at one year occurred in 7.6% of patients in the immediate complete revascularization group and 9.4% of patients in the staged complete revascularization group, meeting the criteria for non-inferiority (HR 0.78, 95% CI 0.55-1.11, pnon-inferiority=0.0011). There was no significant difference in all-cause death between the two groups. Myocardial infarction occurred less frequently in the immediate complete revascularization group (1.9%) than in the staged complete revascularization group (4.5%). More unplanned ischemia-driven revascularizations were performed in the staged complete revascularization group than in the immediate complete revascularization group.
In conclusion, in patients with acute coronary syndrome and multivessel disease, immediate complete revascularization was non-inferior to staged complete revascularization for the primary composite outcome. It was associated with a reduction in myocardial infarction and unplanned ischemia-driven revascularization. These findings suggest that immediate complete revascularization may be the preferred strategy in this patient population.
Link to the article: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)00351-3/fulltext
References Diletti, R., Den Dekker, W. K., Bennett, J., Schotborgh, C. E., Van Der Schaaf, R., Sabaté, M., Moreno, R., Ameloot, K., Van Bommel, R., Forlani, D., Van Reet, B., Esposito, G., Dirksen, M. T., Ruifrok, W. P. T., Everaert, B. R. C., Van Mieghem, C., Elscot, J. J., Cummins, P., Lenzen, M., … Van Mieghem, N. M. (2023). Immediate versus staged complete revascularisation in patients presenting with acute coronary syndrome and multivessel coronary disease (Biovasc): A prospective, open-label, non-inferiority, randomised trial. The Lancet, S0140673623003513. https://doi.org/10.1016/S0140-6736(23)00351-3
