St. Jude Medical’s OCT guidance optimizes PCI

Percutaneous coronary intervention using the OCT-based guidance technology made by St. Jude Medical (NYSE:STJ) resulted in similar minimal stent area as intravascular ultrasound-guided PCI, according to results from the Ilumien III study presented at TCT 2016.

Also published in The Lancet, the study compared OCT guidance with intravascular ultrasound and angiography in 450 PCI patients.

The final minimal stent area was 5.79mm² with OCT guidance, 5.89mm² with IVUS guidance and 5.49mm² with angiography; MSA with OCT guidance was non-inferior to IVUS but not superior. Minimal and mean stent expansion and acute procedural success were greater in the imaging-guided arms compared to angiography.

Untreated major dissections were more common after IVUS-guided PCI than OCT-guided PCI (26.1% vs. 13.6%); in the angiography-guided group, the rate of untreated major dissections was 18.6%. Untreated major stent malapposition was higher with IVUS guidance (20.7%) and angiography (31.4%) than with OCT guidance (10.7%).

“The results of the Ilumien III study show that using a specific reference segment EEL-based stent optimization strategy during OCT-guided PCI is safe and resulted in similar MSA compared to IVUS-guided PCI with fewer untreated major dissections and less major malapposition. OCT-guided PCI also led to greater stent expansion and procedural success compared to angiography-guided PCI,” lead investigator Dr. Ziad Ali, of the New York-Presbyterian Hospital/Columbia University Medical Center, said in prepared remarks. “These results are encouraging, but further study is still needed to determine whether the advantages we have identified by utilizing OCT-guidance will impact clinical outcome.”

“These results demonstrate that OCT is an important imaging option to achieve optimal stent deployment to advance the care of patients with coronary artery disease,” added St. Jude Medical’s chief technology officer, Philip Ebeling. “Optical coherence tomography has a superior resolution to detect predictors that can contribute to major adverse events and thus can facilitate the treatment of those conditions, if necessary, to minimize the likelihood of their occurrence.”

“It gives me great pleasure to announce that St. Jude Medical recently committed to sponsoring the Ilumien IV study, a global multi-center trial that will evaluate long term outcomes in patients randomized to angiography-guided PCI alone versus angiography and OCT-guided PCI,” added Dr. Gregg Stone of New York City’s Columbia University. “We will provide more information as it becomes available in the coming weeks and look forward to initiating this trial in 2017.”