In the Journals

Robotic PCI safe, effective in complex coronary disease

Ehtisham Mahmud
Ehtisham Mahmud

Robotic PCI is comparable to manual PCI in terms of safety, feasibility and technical success, and it does not increase stent use or radiation to the patient, according to data from the CORA-PCI study.

The findings were originally presented at the Society for Cardiovascular Angiography and Interventions Scientific Sessions in 2016.

Previous data from the PRECISE study demonstrated safety and feasibility of robotically assisted PCI, but most lesions treated in the study were simple and, therefore, did not accurately represent clinical practice, Ehtisham Mahmud, MD, FACC, FSCAI, director of interventional cardiology and the cardiac cath lab at University of California, San Diego, School of Medicine, and colleagues wrote in JACC: Cardiovascular Interventions.

To fill the knowledge gap, the researchers designed the all-comers CORA-PCI study to evaluate the use of the technology in a broader patient population, including those with complex coronary anatomy.

The single-center study included 315 patients (mean age, 68 years; 78% men) who underwent PCI during 18 months. Of the 413 procedures performed, 108 were performed with robotic assistance (CorPath 200, Corindus) and 305 were performed manually. The researchers included 334 procedures in the study cohort, as 79 of the manual procedures met exclusion criteria.

The groups were similar in terms of the target vessel treated and primary lesion stenosis, but the researchers found longer primary lesion length, more type B2/C lesions and higher SYNTAX score in the robotic vs. manual PCI groups. Overall treated lesion complexity score was comparable between the two groups (5.03 vs. 4.91; P = .4).

High success rates

Results revealed a high rate of clinical success, defined as completion of the procedure without MACE (death, MI, stroke or urgent repeat revascularization), with robotic PCI on par with manual PCI (99.1% vs. 99.1%). Freedom from MACE, which served as the efficacy endpoint, was also comparable between robotic and manual PCI (94.4% vs. 92.5%, respectively).

Similarly, the researchers observed a high rate of technical success, defined as clinical success and the completion of the procedure completely robotically or with partial manual assistance, with robotic PCI (97.1%). The manual assistance rate was 11.1%, the manual conversion rate was 7.4% and the MACE rate was 0.93%, according to the data.

Additionally, results demonstrated no differences between robotic and manual PCI in number of stents used per procedure (1.59 vs. 1.54; P = .73) and fluoroscopy time (18.2 minutes vs. 19.2 minutes; P = .39). However, compared with the manual PCI group, patient radiation exposure was lower in the robotic PCI group (14,048 cGy-cm2 vs. 12,518 cGy-cm2; P = .045), as was contrast volume (202.5 mL vs. 183.4 mL; P = .031).

Procedure time was also longer with robotic vs. manual PCI (44:30 minutes vs. 36:34 minutes; P = .005) and remained higher after multivariate analysis controlling for SYNTAX score, primary lesion length and lesion complexity (P = .026). The increase in procedure time, however, was only higher in the robotic PCI group for procedures with low complexity (39:45 minutes vs. 28:04 minutes; P < .001).

In propensity-matched analysis, procedure time remained longer in the robotic PCI group vs. the manual PCI group (42:59 minutes vs. 34:01 minutes; P = .007), but fluoroscopy time, patient radiation exposure, contrast volume and clinical success were not significantly different between the two groups.

“The study demonstrates the feasibility, safety and high technical success of [robotic] PCI for the treatment of complex coronary disease, with clinical outcomes comparable with [manual] PCI,” the researchers wrote.

Shifted focus

In an accompanying editorial, Hiram G. Bezerra, MD, PhD, from the Harrington Heart & Vascular Institute at University Hospitals Cleveland Medical Center, and Daniel I. Simon, MD, from Case Western Reserve University School of Medicine, noted that robotic technology is attractive for many reasons, including its ability to spark discussion among interventional cardiologists about important issues.

“The central motivation, as discussed by the authors, for ‘first-generation’ robotic PCI is reducing occupational hazards for the operator — namely, radiation exposure and chronic orthopedic conditions,” they wrote. “It is important to highlight that one positive downstream effect of robotic PCI is heightened awareness of radiation exposure overall in the cardiac catheterization laboratory. Unfortunately, the intervention cardiology community has largely neglected to prioritize efforts that can significantly reduce patient and operator radiation exposure.”

However, a change in focus may be necessary, according to Bezerra and Simon.

“We believe that to harness the true potential of robotic PCI, our focus needs to move from the operator to the patient,” they wrote, adding that the integration of new technologies in robotic PCI is essential for moving forward.

Unfortunately, Bezerra and Simon noted, currently approved robotic systems are not equipped with these technologies, including fractional flow reserve and intravascular imaging.

“Future investigative efforts with robotic PCI should focus on designing studies to test whether this technology improves clinical outcomes (ie, [MACE], especially target lesion/vessel revascularization) that are relevant to the patient,” they wrote. “By embracing and facilitating other technologies, robotic PCI is well positioned to add significant procedural and clinical value. The most impactful innovations are those that address unmet (clinical) needs. Imagining the ideal interventional cockpit of the future is easy; demonstrating its value in carefully designed clinical trials will be challenging but worth the journey.” – by Melissa Foster

Disclosures: Bezerra reports receiving honoraria for physician training and advisory board activities for St. Jude/LightLab related to OCT and from Medtronic Vascular for educational activities and being a consultant for Abbott. Mahmud reports receiving consultant fees and research support from Corindus. Simon reports receiving honoraria for educational activities from HeartFlow and Medtronic Vascular. The other researchers report no relevant financial disclosures.

Ehtisham Mahmud
Ehtisham Mahmud

Robotic PCI is comparable to manual PCI in terms of safety, feasibility and technical success, and it does not increase stent use or radiation to the patient, according to data from the CORA-PCI study.

The findings were originally presented at the Society for Cardiovascular Angiography and Interventions Scientific Sessions in 2016.

Previous data from the PRECISE study demonstrated safety and feasibility of robotically assisted PCI, but most lesions treated in the study were simple and, therefore, did not accurately represent clinical practice, Ehtisham Mahmud, MD, FACC, FSCAI, director of interventional cardiology and the cardiac cath lab at University of California, San Diego, School of Medicine, and colleagues wrote in JACC: Cardiovascular Interventions.

To fill the knowledge gap, the researchers designed the all-comers CORA-PCI study to evaluate the use of the technology in a broader patient population, including those with complex coronary anatomy.

The single-center study included 315 patients (mean age, 68 years; 78% men) who underwent PCI during 18 months. Of the 413 procedures performed, 108 were performed with robotic assistance (CorPath 200, Corindus) and 305 were performed manually. The researchers included 334 procedures in the study cohort, as 79 of the manual procedures met exclusion criteria.

The groups were similar in terms of the target vessel treated and primary lesion stenosis, but the researchers found longer primary lesion length, more type B2/C lesions and higher SYNTAX score in the robotic vs. manual PCI groups. Overall treated lesion complexity score was comparable between the two groups (5.03 vs. 4.91; P = .4).

High success rates

Results revealed a high rate of clinical success, defined as completion of the procedure without MACE (death, MI, stroke or urgent repeat revascularization), with robotic PCI on par with manual PCI (99.1% vs. 99.1%). Freedom from MACE, which served as the efficacy endpoint, was also comparable between robotic and manual PCI (94.4% vs. 92.5%, respectively).

Similarly, the researchers observed a high rate of technical success, defined as clinical success and the completion of the procedure completely robotically or with partial manual assistance, with robotic PCI (97.1%). The manual assistance rate was 11.1%, the manual conversion rate was 7.4% and the MACE rate was 0.93%, according to the data.

Additionally, results demonstrated no differences between robotic and manual PCI in number of stents used per procedure (1.59 vs. 1.54; P = .73) and fluoroscopy time (18.2 minutes vs. 19.2 minutes; P = .39). However, compared with the manual PCI group, patient radiation exposure was lower in the robotic PCI group (14,048 cGy-cm2 vs. 12,518 cGy-cm2; P = .045), as was contrast volume (202.5 mL vs. 183.4 mL; P = .031).

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Procedure time was also longer with robotic vs. manual PCI (44:30 minutes vs. 36:34 minutes; P = .005) and remained higher after multivariate analysis controlling for SYNTAX score, primary lesion length and lesion complexity (P = .026). The increase in procedure time, however, was only higher in the robotic PCI group for procedures with low complexity (39:45 minutes vs. 28:04 minutes; P < .001).

In propensity-matched analysis, procedure time remained longer in the robotic PCI group vs. the manual PCI group (42:59 minutes vs. 34:01 minutes; P = .007), but fluoroscopy time, patient radiation exposure, contrast volume and clinical success were not significantly different between the two groups.

“The study demonstrates the feasibility, safety and high technical success of [robotic] PCI for the treatment of complex coronary disease, with clinical outcomes comparable with [manual] PCI,” the researchers wrote.

Shifted focus

In an accompanying editorial, Hiram G. Bezerra, MD, PhD, from the Harrington Heart & Vascular Institute at University Hospitals Cleveland Medical Center, and Daniel I. Simon, MD, from Case Western Reserve University School of Medicine, noted that robotic technology is attractive for many reasons, including its ability to spark discussion among interventional cardiologists about important issues.

“The central motivation, as discussed by the authors, for ‘first-generation’ robotic PCI is reducing occupational hazards for the operator — namely, radiation exposure and chronic orthopedic conditions,” they wrote. “It is important to highlight that one positive downstream effect of robotic PCI is heightened awareness of radiation exposure overall in the cardiac catheterization laboratory. Unfortunately, the intervention cardiology community has largely neglected to prioritize efforts that can significantly reduce patient and operator radiation exposure.”

However, a change in focus may be necessary, according to Bezerra and Simon.

“We believe that to harness the true potential of robotic PCI, our focus needs to move from the operator to the patient,” they wrote, adding that the integration of new technologies in robotic PCI is essential for moving forward.

Unfortunately, Bezerra and Simon noted, currently approved robotic systems are not equipped with these technologies, including fractional flow reserve and intravascular imaging.

“Future investigative efforts with robotic PCI should focus on designing studies to test whether this technology improves clinical outcomes (ie, [MACE], especially target lesion/vessel revascularization) that are relevant to the patient,” they wrote. “By embracing and facilitating other technologies, robotic PCI is well positioned to add significant procedural and clinical value. The most impactful innovations are those that address unmet (clinical) needs. Imagining the ideal interventional cockpit of the future is easy; demonstrating its value in carefully designed clinical trials will be challenging but worth the journey.” – by Melissa Foster

Disclosures: Bezerra reports receiving honoraria for physician training and advisory board activities for St. Jude/LightLab related to OCT and from Medtronic Vascular for educational activities and being a consultant for Abbott. Mahmud reports receiving consultant fees and research support from Corindus. Simon reports receiving honoraria for educational activities from HeartFlow and Medtronic Vascular. The other researchers report no relevant financial disclosures.