A randomised clinical trial investigating robotic-assisted percutaneous coronary intervention: the PARTY trial

Background: Robotic-assisted percutaneous coronary intervention (R-PCI) allows precise control of percutaneous coronary intervention (PCI) equipment with the operator in a radiation-shielded cockpit. Aims: We aimed to address the lack of randomised studies investigating this emerging technology. Methods: In this single-centre, randomised controlled trial, patients with symptomatic coronary disease underwent either R-PCI or manual PCI (M-PCI). The primary endpoint was patient radiation exposure. Secondary outcomes included radiation exposure to the medical team, overall subjective workload, and other procedural characteristics. Results: A total of 148 patients were randomised (72 R-PCI, 76 M-PCI), with a median age of 63.2 years (interquartile range IQR 55.5-69.5), and 82.4% were male. In the intention-to-treat analysis, R-PCI numerically reduced patient radiation exposure (230.7 microsieverts μSv; IQR 104.0-443.7 vs 261.4 µSv IQR 136.5-531.2; p=0.14). This reduction became statistically significant in the as-treated analysis (218.5 µSv IQR 100.0-375.3 vs 264.7 µSv IQR 136.3-534.8; p=0.03). R-PCI significantly reduced operator radiation exposure (0.1 µSv IQR 0.1-0.3 vs 13.6 µSv IQR 6.0-29.2; p<0.0001) and contrast usage (75 mL IQR 50-120 vs 100 mL IQR 70-130; p=0.001). R-PCI did not prolong PCI time (40 mins IQR 25.3-58.8 vs 46 mins IQR 31.0-55.8; p=0.23). Seven R-PCI cases (9.7%) required manual conversion. R-PCI reduced operator workload (NASA Task Load Index 12.5 IQR 9.4-30 vs 25 IQR 11.3-45; p<0.01). There were no major adverse cardiac events at 30 days. Conclusions: Patient radiation exposure was numerically reduced with R-PCI, while operator radiation exposure was significantly reduced, without prolonging PCI time. Furthermore, R-PCI reduced contrast use and was found to be less onerous for the operator. These results are encouraging; however, there are important limitations that must be addressed before wider adoption.