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Robotic PCI feasible, safe in complex coronary lesions
ORLANDO, Fla. — Robotically assisted PCI in patients with complex coronary lesions demonstrated comparable clinical success compared with manual PCI, with no increase in resource utilization or patient radiation exposure, according to new data from the CORA-PCI trial.
Ehtisham Mahmud, MD, FACC, FSCAI, and colleagues analyzed 334 consecutive PCI procedures performed in 315 patients by a single operator at a single center over 18 months. Of those, 108 were performed with robotic assistance (157 lesions) and 226 were manual (336 lesions).
Previous research has demonstrated feasibility and safety of robotic PCI (CorPath System, Corindus) in simple coronary lesions. The focus of CORA-PCI was on complex coronary lesions. Approximately 80% of lesions treated in this trial were complex.
“For the first time, we’ve shown nearly identical outcomes with a group of very complex patients,” Mahmud, division chief of cardiovascular medicine and director of interventional cardiology and the cardiac cath lab at University of California, San Diego, School of Medicine, said.
The primary endpoint of clinical success, defined as stent implantation with residual stenosis < 30%, TIMI 3 flow and without in-hospital MACE (death, urgent repeat revascularization and clinical MI), was 99.1% in the robotic PCI group vs. 99.6% in the manual PCI group (P = .64). Freedom from periprocedural MI (CK-MB more than three times the upper limit of normal) was 94.4% vs. 91.6%, respectively (P = .32).
About 82% of procedures were performed exclusively with robotic assistance, 11% required manual assistance and 7.4% required manual conversion, resulting in a robotic technical success of 91.7%, Mahmud said. Sixty percent of the cases requiring manual assistance or conversion were due to technical robotic limitation, 30% were related to inadequate guide catheter or wire support and 10% were related to adverse events.
Overall procedure time was about 8 minutes longer in the robotic PCI group (44:30 minutes vs. 36:34 minutes; P = .005). This remained significant after multivariate analysis controlling for SYNTAX score, primary lesion length and lesion complexity (P = .026). However, the longer procedure time associated with robotic PCI was limited to low-complexity lesions. “As procedural and lesion complexity increased, there were no differences with robotic vs. PCI,” Mahmud said. Mean fluoroscopy time was 18 minutes in the robotic PCI group vs. 19 minutes in the manual PCI group (P = .42).
Propensity-matched analysis of 94 patients in each group confirmed the longer procedure time with robotic PCI (43:59 minutes vs. 34:16 minutes; P = .007) whileclinical success remained similar (98.9% vs. 100%; P = .1).
The mean number of stents deployed was 1.6 and the mean number of lesions treated was 1.54 in both groups.
The patients included in the study had a mean age of 68 years and 78% were men. Most patients also presented with diabetes, dyslipidemia, hypertension and angina. Primary lesion stenosis was 85%, primary lesion length was 22 mm in the robotic PCI group vs. 19.4 mm in the manual PCI group (P = .02) and mean SYNTAX score was 19.6 in the robotic PCI group vs. 15.8 in the manual PCI group (P = .01).
Approval of the robotically assisted PCI system has “significantly changed how the procedure is performed,” Mahmud said. “The key factor with robotic PCI is that we now have the ability to remotely control coronary guidewires, balloons and stents [and are] able to do interventional procedures seated in a cockpit away from the patient’s bedside and out of the radiation zone.”
The CORA-PCI findings “support the concept that robotic PCI is a viable option for addressing both the orthopedic and radiation-associated risks for interventional cardiologists,” he said.
As this study examined PCIs performed by a single operator, Mahmud said, it will be important to replicate these findings with multiple operators at multiple centers and with different levels of expertise. – by Katie Kalvaitis
Reference:
Mahmud E. Late Breaking Clinical Trials Part 1. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 4-7, 2016; Orlando, Fla.
Disclosure: Mahmud reports consulting for and receiving clinical trial support from Corindus, but received no support for this study.
Perspective
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The presentation by Dr. Mahmud at this year's SCAI meeting in Orlando, Florida, describes the advancing opportunity to utilize robotic-assisted PCI in more complex coronary disease. The results are encouraging, but are somewhat limited by the fact that it is not randomized in a traditional fashion, is a single-center study and, importantly a single, experienced-operator study. Despite these limitations, the study demonstrates no increased patient risk or adverse outcomes from the use of robotic-assisted PCI. Furthermore, when the robotic system was not capable, which was uncommon, there was no penalty to patient outcomes.
The advantage of the robotic system is lower operator radiation and back fatigue. While one would like to see less patient radiation, procedure time and reduced contrast use as a benefit of the robot, two factors may have played a significant role. First, this was the complete, initial experience of the operator and, thus, undoubtedly includes a significant learning curve. Second, the operator is an experienced and skilled interventionalist, increasing the challenge for robotic-assisted PCI to be better. One can speculate that one advantage of the robotic system may be making results more homogeneous among operators of variable skills. Thus, further studies are needed with multicenter and multi-operator experience to truly understand the overall effect of this exciting technology.
