Demonstration of the Safety and Feasibility of Robotically Assisted Percutaneous Coronary Intervention in Complex Coronary Lesions Results of the CORA-PCI Study (Complex Robotically Assisted Percutaneous Coronary Intervention)

OBJECTIVES The aims of this study were to evaluate the feasibility and technical success of robotically assisted percutaneous coronary intervention (R-PCI) for the treatment of coronary artery disease (CAD) in clinical practice, especially in complex lesions, and to determine the safety and clinical success of R-PCI compared with manual percutaneous coronary intervention (M-PCI). BACKGROUND R-PCI is safe and feasible for simple coronary lesions. The utility of R-PCI for complex coronary lesions is unknown. METHODS All consecutive PCI procedures performed robotically (study group) or manually (control group) over 18 months were included. R-PCI technical success, defined as the completion of the procedure robotically or with partial manual assistance and without a major adverse cardiovascular event, was determined. Procedures ineligible for R-PCI (i.e., atherectomy, planned 2-stent strategy for bifurcation lesion, chronic total occlusion requiring hybrid approach) were excluded for analysis from the M-PCI group. Clinical success, defined as completion of the PCI procedure without a major adverse cardiovascular event, procedure time, stent use, and fluoroscopy time were compared between groups. RESULTS A total of 315 patients (mean age 67.7 +/- 11.8 years; 78% men) underwent 334 PCI procedures (108 R-PCIs, 157 lesions, 78.3% type B2/C; 226 M-PCIs, 336 lesions, 68.8% type B2/C). Technical success with R-PCI was 91.7% (rate of manual assistance 11.1%, rate of manual conversion 7.4%, rate of major adverse cardiovascular events 0.93%). Clinical success (99.1% with R-PCI vs. 99.1% with M-PCI; p = 1.00), stent use (stents per procedure 1.59 +/- 0.79 with R-PCI vs. 1.54 +/- 0.75 with M-PCI; p = 0.73), and fluoroscopy time (18.2 +/- 10.4 min with R-PCI vs. 19.2 +/- 11.4 min with M-PCI; p = 0.39) were similar between the groups, although procedure time was longer in the R-PCI group (44: 30 +/- 26: 04 min:s vs. 36: 34 +/- 23: 03 min: s; p = 0.002). Propensity-matched analysis confirmed that procedure time was longer in the robotic group (42: 59 +/- 26: 14 min: s with R-PCI vs. 34: 01 +/- 17: 14 min: s with M-PCI; p = 0.007), although clinical success remained similar (98.8% with R-PCI vs. 100% with M-PCI; p = 1.00). CONCLUSIONS This study demonstrates the feasibility, safety, and high technical success of R-PCI for the treatment of complex coronary disease. Furthermore, comparable clinical outcomes, without an adverse effect on stent use or fluoroscopy time, were observed with R-PCI and M-PCI. (C) 2017 by the American College of Cardiology Foundation.