Real-World PRECISION Registry Evaluates Robotic PCI With Corindus' CorPath 200
May 12, 2017—Final results of the multicenter real-world PRECISION registry, which is evaluating the safety and efficacy outcomes of radial access versus femoral access robotic percutaneous coronary intervention (PCI), were presented as a late-breaking clinical trial at SCAI 2017, the 40th annual Society for Cardiac Angiography and Interventions scientific sessions in New Orleans, Louisiana.
According to the SCAI announcement, PRECISION demonstrated clinical and technical success for patients across multiple sites using multiple operators in the largest real-world study of robotic PCI. Ehtisham Mahmud, MD, the study’s lead author, commented in the announcement, “This is the first time we are demonstrating that the robotic system can be used, with either a radial or femoral approach, with high clinical and technical success in multiple sites with multiple operators.” Dr. Mahmud is Division Chief of Cardiovascular Medicine and Director of Sulpizio Cardiovascular Center at the University of California, San Diego School of Medicine, in San Diego, California.
As summarized by SCAI, the multicenter PRECISION registry enrolled patients at 16 sites in the United States to collect clinical and procedural data of the CorPath 200 system (Corindus Vascular Robotics), the first generation of robotic technology approved by the US Food and Drug Administration (FDA) to remotely control coronary guidewires and stents for PCI patients.
Technical success was defined as a procedural success (residual stenosis < 30%, thrombolysis in myocardial infarction grade 3 flow) with robotic PCI without manual assistance and absence of in-hospital major adverse cardiovascular events (MACEs). Clinical success was determined by procedural success without in-hospital MACEs.
The study was composed of 754 robotic PCI procedures with 949 lesions (63.4% type B2/C) treated with robotic PCI using transradial access (TRA) in 452 procedures and transfemoral access (TFA) in 298 procedures. Results demonstrated high technical (88.6% TRA vs 82.4% TFA; P = .017) and clinical success rates (98.9% TRA vs 94.9% TFA; P = .0012). Eighteen serious adverse events, unrelated to the CorPath 200 System, occurred (1.99% TRA vs 3.02% TFA; P = .47); six were determined to be MACE, all of which occurred with TFA.
Dr. Mahmud explained, “In unadjusted analysis, it appears that there may be slightly better outcomes with the radial approach. However, there were significant baseline demographic and angiographic differences between the two groups with radial access patients being less complicated. After conducting a propensity score matched analysis, no differences were observed between the radial access, it was likely the result of patient selection.”
In addition, Dr. Mahmud noted that the data presented show that using robotic technology to perform PCI in clinical practice via the radial or femoral approach is feasible, safe, and effective. The future iteration of the technology (CorPath GRX), which has recently been approved by the FDA, enables robotic guide catheter control and should reduce the rates of manual assistance or conversion.