OCT-guided PCI noninferior to IVUS-guided PCI

WASHINGTON — Optical coherence tomography-guided PCI was noninferior to IVUS-guided PCI in achieving minimum stent area and in procedural MACE, according to new data from the ILUMIEN III (OPTIMIZE PCI) trial presented at TCT 2016.

The trial included 450 patients aged 18 years and older from 29 hospitals in eight countries who had one or more target lesions in a native coronary artery with a visually estimated reference vessel diameter of 2.25 mm to 3.50 mm and length 40 mm. Its purpose was to determine whether an OCT-based stent sizing strategy would result in a minimum stent area better than that seen with an angiography-guided strategy and similar to or better than an IVUS-guided strategy.

Ziad A. Ali, MD, DPhil, from NewYork-Presbyterian Hospital/Columbia University Medical Center, and colleagues randomly assigned 158 patients to the OCT strategy, 146 to the IVUS strategy and 146 to the angiography strategy. The OCT-guided strategy consisted of a specific protocol in accordance with reference segment external elastic lamina measurements to establish stent length, diameter and expansion. All patients underwent a final OCT image after their initial image.

Ziad A. Ali

The primary efficacy endpoint of the study was post-PCI minimum stent area measured by OCT at a masked independent core laboratory at completion of enrollment. The primary safety endpoint was procedural MACE.

A total of 415 final OCT acquisitions were analyzed for the primary endpoint: 140 (34%) in the OCT group, 135 (33%) in the IVUS group and 140 (34%) in the angiography group, according to the researchers.

The final median minimum stent area was 5.79 mm² (interquartile range [IQR], 4.54-7.34) for OCT guidance, 5.89 mm² (IQR, 4.67-7.8) for IVUS guidance and 5.49mm² (IQR, 4.39-6.59) for angiography guidance.

According to the results, OCT guidance was noninferior to IVUS guidance (one-sided 97.5% lower CI, –0.7 mm²; P for noninferiority = .001), but was also not superior (P for superiority = .42).

Additionally, OCT guidance was not superior compared with angiography guidance (P = .12), Ziad and colleagues found.

Procedural MACE occurred in four of the 158 (3%) patients included in the OCT group, one (1%) of 146 in the IVUS group and one (1%) of 146 in the angiography group (P for OCT vs IVUS = .37; P for OCT vs. angiography = .37).

A large-scaled randomized trial is needed to definitively determine if OCT guidance results in superior clinical outcomes compared with angiography guidance, Ali said during a press conference.

“The efficacy of OCT-guided PCI with the ILUMIEN III stent optimization protocol to improve event-free survival after DES will be evaluated in the upcoming large-scale, randomized, pivotal ILUMIEN IV trial,” he said. – by Dave Quaile

Reference:

Ali ZA, et al. Late-Breaking Clinical Trials 1. Presented at: TCT Scientific Symposium; Oct. 29-Nov. 2, 2016; Washington.

Ali ZA, et al. Lancet. 2016;doi:10.1016/S0140-6736(16)31922-5.

Disclosure: The study was funded by St. Jude Medical. Ali reports receiving grant support or research contracts from Acist Medical, Cardiovascular Systems Inc. and St. Jude Medical; consultant fees, honoraria or speaker’s bureau fees from Acist Medical and St. Jude Medical; and holding equity in Shockwave Medical.