A prospective analysis found that patients with significant comorbidities and complex coronary artery anatomy have similar outcomes if they undergo robotically assisted or manual PCI.
Lead researcher Ehtisham Mahmud, MD, of the University of California, San Diego School of Medicine, presented the results of the study during a late-breaking clinical trial session at the Society for Cardiovascular Angiography and Interventions scientific sessions on May 4 in Orlando.
The researchers in the CORA-PCI trial analyzed 334 procedures in 315 patients, including 108 robotically assisted PCIs for 157 lesions and 226 manual PCIs for 336 lesions. A single operator performed all of the robotically assisted PCI procedures during an 18-month period.
At baseline, the groups were similar. The mean age was 67.7 years old, and 78 percent of patients were males.
Patients in the robotically assisted PCI group underwent procedures with the CorPath System (Corindus Vascular Robotics, Inc.), which is the first system designed for robotic-assisted PCIs. In July 2012, the FDA granted 510(k) clearance to the CorPath System for use during PCIs. In October 2015, the FDA gave a 510(k) clearance to the CorPath system for use during PCIs performed via radial access.
In this study, the mean procedure time was 44 minutes and 30 seconds for robotically assisted PCIs and 36 minutes and 34 seconds for manual PCIs. The difference remained statistically significant after controlling for Syntax score, primary lesion length and lesion complexity.
"[The difference] only existed for the simple and lower complexity lesions," Mahmud said at a news conference. "As the procedural and lesion complexity increased, there were no differences with the robotic PCI."
The technical success rate with robotically assisted PCI was 91.7 percent. The researchers defined technical success as successfully performing the procedure robotically or with minimal manual assistance.
The clinical success rate was 99.1 percent with robotically assisted PCI and 99.6 percent with manual PCI. The researchers defined clinical success as completion of the PCI procedure with major adverse cardiovascular events, including nonfatal MI, emergent CABG, target vessel revascularization or death.
A propensity matched analysis that included 94 patients in each group found that the procedure time was longer in the robotically assisted PCI group (43 minutes and 59 seconds vs. 34 minutes and 16 seconds). Meanwhile, the clinical success rate in the propensity matched analysis was 98.9 percent in the robotically assisted PCI group and 100 percent in the manual PCI group.
Mahmud said that robotically assisted PCI did not require additional resource utilization and did not expose patients to more radiation compared with manual PCI.
"We were able to demonstrate safety and feasibility of complex robotically assisted PCI," he said. "We feel that this trial definitively establishes this as an alternative to manual PCI and, importantly, now represents a viable option to address the orthopedic and radiation risk for interventional operators."