FCR-08
Safety and Efficacy of the Second Generation Robotic-Assisted System for Percutaneous Coronary Intervention: Final Results of the Multicenter PRECISION GRX Study
Presenter
Ehtisham Mahmud, M.D., MSCAI, The University of California, San Diego, La Jolla, CA
Ehtisham Mahmud, M.D., MSCAI, The University of California, San Diego, La Jolla, CA, Jeffrey M. Schussler, MD, FSCAI, FSCAI, Baylor University Medical Center, Dallas, TX, William J. Nicholson, M.D., Emory HealthCare, York, PA, Tejas M. Patel, M.D., FSCAI, Apex Heart Institute, Ahmedabad, Gujarat, India, William Lombardi, University of Washington Medical Center - Montlake, Seattle, WA, Frances Wood, M.D., WakeMed Health & Hospital Systems, Raleigh, NC, Adam C. Salisbury, M.D., FSCAI, Saint Luke's Mid America Heart Institute, Parkville, MO, Srini Potluri, M.D., FSCAI, Baylor Scott & White The Heart Hospital - Plano, Frisco, TX and Alexandra J. Lansky, M.D., MSCAI, Yale University, Weston, CT
Keywords: Acute Coronary Syndromes (ACS), Complex and High-risk Coronary Intervention (CHIP), Coronary, Drug-eluting Stent (DES) and Left Main and Bifurcations
Background. The robotic-assisted CorPath GRX (Corindus, Waltham, MA) system enables robotic guide catheter, guidewire and balloon/stent delivery for percutaneous coronary intervention (PCI). The PRECISION GRX study (NCT 03278301) evaluated the safety and efficacy of CorPath GRX in treating an all-comers population.
Methods. This prospective international multicenter registry study enrolled patients with obstructive coronary artery disease (>70% stenosis) with clinical indications for PCI treated with robotic PCI. The co-primary endpoints were clinical success (final TIMI 3 flow, <30% residual stenosis without in-hospital major adverse cardiac event) and technical success (robotic clinical success without the need for unplanned manual assistance/conversion).
Results. The study enrolled 980 subjects (65.4 ±11.6 years; 73.5% male; 1233 lesions), 31.6% with acute coronary syndrome and 68.8% with ACC/AHA type B2/C lesions at 20 centers (Table). Clinical success was achieved in 97.8 % (955/976) of subjects and 98.1% (1204/1227) of lesions treated robotically. Device technical success was achieved in 86.5% (848/980) of subjects and 89.2% (1100/1223) of lesions treated robotically. Technical success was higher for type A/B1 lesions as compared to type B2/C lesions (94.5% vs 85.0%, p<0.001). Results using the robotic guide catheter and wire control and the Rotate on Retract function will be presented for complex lesions and chronic total occlusions.
Conclusions. The second generation CorPath GRX System for robotic-assisted PCI is safe, effective and achieves high rates of clinical and technical success across the spectrum of lesion complexity.
