OCTIVUS: OCT- Guided PCI is non-inferior to IVUS-Guided PCI for Clinical Outcomes

Avatar
By Lucas Marinacci on

Key Points

  • This pragmatic trial randomizing patients to optical coherence tomography (OCT)-guided or intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) found that OCT was non-inferior to IVUS for a composite outcome of cardiovascular death, target vessel myocardial infarction, or ischemia-driven target vessel revascularization.
  • These data indicate that OCT has similar outcomes compared with IVUS in PCI across a broad range of coronary lesions, though patients with chronic kidney disease and ST-elevation myocardial infarction (STEMI) were excluded.

Both OCT and IVUS are used to improve procedural outcomes and reduce complications compared to angiography alone during PCI.  Trials evaluating the comparative effectiveness of these two modalities for PCI guidance are limited.1

On August 27th, 2023 the results of the Optical Coherence Tomography-Guided or Intravascular Ultrasound Guided Percutaneous Coronary Intervention: The OCTIVUS Randomized Clinical Trial were presented in a Hot Line Session at ESC Congress 2023 with simultaneous publication in Circulation.

In this pragmatic, open-label clinical trial across 9 sites in Korea, patients undergoing drug-eluding stent placement or drug coated ballooning for in stent restenosis for significant coronary lesions were randomized in a 1:1 fashion to OCT or IVUS guidance for PCI.2 Patients with ST-segment elevation myocardial infarction, cardiogenic shock, renal dysfunction (defined as serum creatinine > 2.0 mg/dl), or limited overall life expectancy were excluded.  The primary outcome measure was a composite of cardiovascular death, target vessel myocardial infarction, or ischemia-driven target vessel revascularization with a noninferiority margin of 3.1 percentage points.

Overall, 1201 patients were randomized.  The mean age was 65 years, 21% were female, 32% had diabetes, 77% had a chronic coronary syndrome, 23% had an acute coronary syndrome, 57% had diffuse long lesions, and the average total stent length was 47mm.

At one year, the primary composite outcome occurred in 2.5% of the OCT group vs. 3.1% of the IVUS group (HR 0.80, 95% CI 0.47-1.36, p<0.001 for non-inferiority).  There were no differences in secondary outcomes including target lesion failure, death, target vessel MI, or repeat revascularization.  Although more contrast was used in the OCT group, there was no difference in contrast induced nephropathy (1.4% in OCT vs 1.5% in IVUS). The incidence of major procedural complications was lower in the OCT group than in the IVUS group (22 [2.2%] vs. 37 [3.7%], P=0.047), although imaging procedure-related complications were not observed.

According to principal investigator Dr. Duk-Woo Park: “In this large-scale pragmatic trial comparing OCT vs. IVUS-guided PCI for diverse coronary artery lesions, OCT guided PCI was non inferior to IVUS-guided PCI with respect to the primary endpoint of target vessel failure at one year…Both OCT and IVUS can be utilized safely and effectively in the vast majority of PCI procedures, demonstrating comparable acute and long term outcomes.”