Robotic PCI shows high success rates in real-world setting
A robotic-assisted percutaneous coronary intervention (PCI) approach showed high clinical and technical success rates across all degrees of lesion complexity among patients with coronary artery disease (CAD), according to the final results of the PRECISION GRX* study presented at SCAI 2021.
“[This FDA-approved] robotic-assisted CorPath GRX System enables robotic-guided catheter, guidewire, and balloon/stent delivery for PCI,” said lead author Dr Ehtisham Mahmud from the University of California in San Diego, US. This approach significantly changed the way the procedure is performed, and was associated with high success rates in an all-comers population, he added.
This multicentre, international, single-arm observational study involved 980 patients (median age 65.4 years, 73.5 percent male; 1,233 lesions) with obstructive CAD (>70 percent stenosis) and clinical indications for PCI, such as acute coronary syndrome (n=310), stable angina (n=285), and positive stress test (n=252), who were treated with the second generation robotic-assisted CorPath GRX system. The coprimary outcomes were clinical success (defined as final TIMI** 3 flow and <30 percent residual stenosis without inhospital MACE***) and technical success (defined as robotic clinical success without the need for unplanned manual assistance or conversion). [SCAI 2021, abstract FCR-08]
Half of the participants had AHA/ACC+ type B lesions (28.1 percent and 21.6 percent for type B1 and B2 lesions, respectively). More than a third of the population had type C (36.1 percent), while the remaining 14.3 percent had type A lesions.
High clinical and technical success rates were achieved across all types of lesions treated robotically, such as type B1 (98.3 percent and 95.3 percent, respectively), type B2 (98.4 percent and 88.3 percent), and type C (97.9 percent and 86.7 percent).
Notably, participants with type A lesions had the highest success rates with robotic PCI, both in terms of clinical (98.9 percent) and technical success (95.8 percent).
There were no cases of inhospital MACE reported. Residual stenosis of >30% occurred at a rate of 1.9 percent and other clinical events occurred at 2.3 percent, particularly access site complications (0.9 percent), acute ischaemic stroke (0.1 percent), repeat PCI (0.1 percent), and acute kidney injury (1.2 percent).
Nonetheless, manual assistance or conversion to manual PCI was still warranted in some cases owing to several reasons, noted Mahmud. The most common reason was the inability to cross the lesion (4.6 percent), followed by inability to advance the guidewire and balloon/stent catheter (4.5 percent). Robotic malfunction was reported in 15 participants (1.5 percent), though Mahmud and his team noted that no adverse events were tied to the malfunction.
“With the second-generation of the robotic system [for PCI], we are able to grow the field with a safe and effective PCI approach for not just simple lesions, but very complex lesions as well,” said Mahmud.
“These findings will help fill a significant gap for physicians … [and] support robotic PCI being a viable option for addressing orthopaedic and radiation associated risks for interventional cardiologists, … potentially allowing more physicians to extend their career,” Mahmud noted.
“Moving forward, we plan to study the impact of robotic PCI in a remote setting, to better reach rural areas with advanced care,” he added.
*PRECISION GRX: A multicenter post-market registry for the evaluation of the CorPath® GRX System effectiveness in percutaneous coronary interventions
**TIMI: Thrombolysis in Myocardial Infarction
***inhospital MACE: Cardiac death, myocardial infarction, or clinically drive target vessel revascularization
+AHA/ACC: American Heart Association/American College of Cardiology