Dr. Kıvanç Eren

Name of the Study: Optical coherence tomography-guided versus angiography-guided percutaneous coronary intervention for patients with complex lesions (OCCUPI): an investigator-initiated, multicentre, randomised, open-label, superiority trial in South Korea

Published in Congress: ESC 2024

Link:  https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)01454-5/abstract

Background:
Optical Coherence tomography (OCT), provides detailed and valuable imaging information during percutaneous coronary interventions (PCI) however, the clinical benefit and the role of OCT during PCI still remains controversial. The aim of the OCCUPI trial was to assess and compare the clinical benefits of OCT- guided vs angiography guided PCI of complex lesions, assessed as the rate of major cardiac events at 1 year.

Methods:
OCCUPI was as a multi-center, randomized, open-label superiority trial conducted in 20 hospitals in South Korea. Age range of the patients who were enrolled in the trial was between 18 and 85. All of the patients were clinically indicated to undergo PCI with drug eluding stents. Diagnostic angiography was performed to identify the patients who had complex coronary lesions. Patients with complex lesions were divided randomly and equally into two groups, OCT-guidance group consisted of patient who received PCI using OCT guidance and the angiography-guidance group consisted of patients who received PCI without using OCT guidance. Block randomization was used at each center and the allocation sequence was generated by an external programmer who was not associated with the rest of the trial. PCI was performed using everolimus-eluting stents using conventional intervention standards. Primary end point was major adverse cardiac events (cardiac death, myocardial infarction, stent thrombosis or ischemia driven target vessel revascularization), 1 year after the initial PCI. The primary analyses were done in the intention to treat population. The margin used to determine superiority was 1-0 as a hazard ratio. This trial is registered  with  ClinicalTrials.gov (NCT03625908) and is completed.

Results:
1604 patients requiring PCI with drug eluting stents for complex coronary lesions were enrolled in the study. The patients were randomly and split into OCT-guided PCI(n=803) or angiography-guided PCI (n=801) groups. 1290 (80%) of the total 1604 patients were male and 314 (20%) were female. The median age of the patients at randomization was 64 years. 1588(99%) of the patients completed 1 year follow up. The primary end point of major cardiac advers events occurred in 37 (5%) out of 803 patients in the OCT-guided PCI group and in 59 (7%) out of 801 patients in the angiography-guided PCI group, hazard ratio 0·62 [95% CI 0·41 to 0·93]; p=0·023). Minor adverse events (stroke, bleeding events, and contrast-induced nephropathy) were not significantly different across the two groups.

Interpretations:
OCCUPI trial showed clinical and therapeutic benefits, using OCT-guided PCI when compared to angiography-guided PCI. Patients who underwent OCT-guided PCI for complex coronary lesions and were indicated to receive drug eluting stents, had less major cardiac adverse events at 1 year follow up when compared to patients who only received angiography-guided PCI.