Percutaneous coronary intervention (PCI) is considered an equivalent alternative to coronary artery bypass surgery in patients with left main coronary artery (LMCA) stenosis and low to intermediate anatomical complexity. However, it remains a technically challenging procedure, particularly regarding stent expansion and apposition, lesion coverage, and the various bifurcation strategies.
The aim of the OPTIMAL study was to determine whether an IVUS-guided PCI strategy could reduce the risk of ischemic events or death compared with a qualitatively angiography-guided PCI strategy in patients with unprotected LMCA disease.
This was an international, multicenter, randomized, open-label superiority trial conducted across 28 European centers in Italy, Spain, and the United Kingdom. A total of 806 patients were randomized, with 401 assigned to IVUS-guided PCI and 405 to angiography-guided PCI. The primary endpoint was a patient-oriented composite outcome of all-cause death, any stroke, any myocardial infarction, or any revascularization during extended follow-up.
The mean age was 71.1 years, and 78% were male. Clinical presentation included non-ST-elevation myocardial infarction in approximately 39%, unstable angina in about 10%, and chronic coronary syndrome in roughly half of the patients. The anatomical SYNTAX score was 30.10 ± 13.0 in the IVUS arm and 29.29 ± 12.1 in the angiography arm. The stents used were Synergi or Synergi Megatron.
From a procedural standpoint, total procedure time was longer in the IVUS arm (88.6 ± 50.2 min vs 63.9 ± 37.6 min), with similar rates of periprocedural complications (7.4% vs 7.2%).
Regarding outcomes, at a mean follow-up of 2.9 years, the patient-oriented endpoint occurred in 33.7% of patients in the IVUS group and 30.9% in the angiography-guided group (HR 1.11; 95% CI 0.87–1.42; p=0.40). No differences were observed in secondary composite endpoints. The device-oriented endpoint (cardiovascular death, target vessel myocardial infarction, or clinically indicated TLR) occurred in 22.4% of the IVUS arm and 20.5% of the angiography arm (HR 1.10; 95% CI 0.82–1.49).
Conclusions:
In this randomized study of patients with unprotected left main coronary artery disease, IVUS-guided PCI was not associated with a lower risk of the composite endpoint of stroke, myocardial infarction, revascularization, or death compared with angiography-guided PCI at a mean follow-up of 2.9 years. These findings suggest that an angiography-only strategy may be appropriate when procedures are performed by IVUS-experienced operators in high-volume centers.
Presented by Luca Testa in the Late-Breaking Clinical Trials sessions at ACC.26, March 28–30, New Orleans, USA.
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