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TCT: Primary Results of the ROTACUT Trial - New Combination of Techniques May Improve Stent Expansion for Patients Undergoing PCI
Principal Investigator: Samin Sharma, MD, Director of Interventional Cardiology for the Mount Sinai Health System
Conference: Transcatheter Cardiovascular Therapeutics (TCT 2023) – Featured Science Presentation
Title: Rotational atherectomy combined with cutting balloon to optimize stent expansion in calcified lesions – Primary Results of the ROTACUT Trial
Bottom line of the study: Rotational atherectomy (RA) is an established technique for PCI of moderately or severely calcified coronary lesions. Currently, as the standard treatment, interventional cardiologists perform a rotational atherectomy on these patients followed by high pressure balloon dilation and then drug-eluting stents.
The hypothesis of the study was that using a cutting balloon in addition to rotational atherectomy (RA) would improve coronary stent expansion. While the minimum stent area did not significantly differ between the groups treated with RA plus cutting balloon angioplasty versus the group treated with RA plus non-compliant balloon angioplasty, there was a trend toward improving stent expansion. The important takeaway is that RA plus cutting balloon angioplasty was safe with rare procedural complications and few clinical adverse events at 30 days.
Why this study is important: Calcified coronary lesions remain a challenge for interventional cardiologists and are associated with procedural complications.
Why this study is unique: This is the first randomized control trial investigating combination of two ablative techniques with serial intravascular imaging assessments.
Study findings: There was no significant difference in stent expansion between the group treated with RA plus cutting balloon angioplasty versus the group treated with RA plus non-compliant balloon angioplasty, but there was a trend toward improving stent expansion. The important takeaway is that RA plus cutting balloon angioplasty was safe with rare procedural complications and few clinical adverse events at 30 days.
How the research was conducted? 29 patients from two sites, including The Mount Sinai Hospital in New York City were randomized to RA plus cutting balloon angioplasty group and 31 patients to RA plus non-compliant balloon angioplasty. Procedural outcomes were assessed by an imaging core lab. Clinical follow up was obtained by phone calls.
The results: No differences in minimum stent area or other measures of stent expansion were found on angiography or intravascular ultrasound between the groups. There were rare procedural complications and few clinical adverse events.
What the results mean for physicians: The study findings have important implications. The use of a combination of RA and CBA appears safe in clinical practice and is associated with high procedural success. This study can be the foundation of larger trials to see if outcomes can be improved for patients with calcific lesions using this strategy.
What the results mean for patients: If patients need to undergo PCI for calcified coronary lesions, they there is now an additional strategy that has been proven to be safe to treat these complex abnormalities.
Quote: “Calcific lesions are amongst the most complex lesions for patients undergoing PCI. The ROTACUT study sought to investigate the safety and efficacy of two approved ablative technologies in combination compared with Rotational atherectomy alone. While we did not show improvement of the Stent area by imaging, we did observe trend toward improving stent expansion, and observed no safety issues at all. This will set the stage for a larger randomized trial to evaluate how best to treat calcific lesion,” says Samin Sharma, MD, Director of Interventional Cardiology for the Mount Sinai Health System.
Mount Sinai Heart is one of the nation’s top 4 hospitals in Cardiology/Heart Surgery
Mount Sinai Heart ranks No. 1 in New York and No. 4 globally according to Newsweek’s “The World’s Best Specialized Hospitals.” The Mount Sinai Hospital is also No. 1 in New York for cardiology, cardiac surgery, and vascular surgery and No. 4 nationally, according to U.S. News & World Report®.
It is part of Mount Sinai Health System, which is New York City's largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. We advance medicine and health through unrivaled education and translational research and discovery to deliver care that is the safest, highest-quality, most accessible and equitable, and the best value of any health system in the nation. The Health System includes approximately 7,400 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. Hospitals within the System are consistently ranked by Newsweek’s® “The World’s Best Smart Hospitals” and by U.S. News & World Report's® “Best Hospitals” and “Best Children’s Hospitals.” The Mount Sinai Hospital is on the U.S. News & World Report's® “Best Hospitals” Honor Roll for 2023-2024.
For more information, visit https://www.mountsinai.org or find Mount Sinai on Facebook, Twitter and YouTube.
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