CORA-PCI Study Supports Robotically Assisted PCI in Complex Coronary Lesions
May 4, 2016—The Society for Cardiovascular and Angiographic Interventions (SCAI) announced that results from the 18-month CORA-PCI study of complex robotically assisted percutaneous coronary intervention (PCI) were presented as a late-breaking clinical trial at the SCAI 2016 scientific sessions in Orlando, Florida. Ehtisham Mahmud, MD, is the study’s lead investigator.
The CORA-PCI study evaluated the feasibility of performing PCI in patients with complex coronary lesions using robotic technology to remotely control coronary guidewires and stents. Previous studies were performed largely in patients with simple coronary lesions. In this study, robotically assisted PCI demonstrated similar outcomes compared to manually performed PCI.
In the SCAI announcement, Dr. Mahmud noted that approximately 80% of lesions treated in the CORA-PCI trial were complex, which is more reflective of contemporary interventional cardiology practice. He commented, “For the first time, we’ve shown nearly identical outcomes with a group of very complex patients.” Dr. Mahmud is Division Chief, Cardiovascular Medicine, and Director, Interventional Cardiology and Cardiac Catheterization Lab at the University of California, San Diego School of Medicine in San Diego, California.
As summarized by SCAI, consecutive robotic and manual procedures were performed by a single operator, and a total of 334 PCI procedures were analyzed (108 robotic, 157 lesions; 226 manual, 336 lesions) in 315 patients (age, 67.7 ± 11.8 years; 78% men). Clinical success was similar between the groups (99.1% for robotic PCI vs 99.6% for manual PCI; P = .64).
In the robotically assisted PCI group, more 90% of the procedures were performed entirely robotically or with minimal manual assistance. Procedure time was longer (robotic PCI 44:30 ± 26:04 min vs manual PCI 36:34 ± 23:03 min; P = .005) and remained significant after accounting for Syntax score, primary lesion length, and complexity (P = .026); however, the longer procedure time was limited to the low-complexity lesions. Propensity-matched analysis (n = 94 in each group) confirmed the longer procedure time in the robotic PCI group with comparable clinical success (98.9% vs 100%; P = 1). No increase in resource utilization or patient radiation exposure was reported with robotic PCI.
Furthermore, Dr. Mahmud advised that the data presented show that using robotic technology to perform PCI is a viable alternative to manual PCI, with the potential benefits of reducing radiation exposure and orthopedic injuries to the interventional cardiologist.
The technology of performing robotically assisted PCI is relatively new and was recently approved by the US Food and Drug Administration, advised SCAI.