Use of a cutting balloon inflated to high pressure provides significant benefits for patients with significant coronary artery calcifications (CAC) undergoing percutaneous coronary interventions (PCI) by increasing stent area and providing a more symmetric expansion of the stent at the calcium site, report new trial data.
Findings from the trial were reported Monday at Transcatheter Cardiovascular Therapeutics (TCT) 2022 in Boston by Antonio Mangieri, MD, from Humanitas Research Hospital, Milan.
Speaking at TCT 2022, Mangieri noted that CAC represents a challenge to PCI by limiting stent expansion and increasing the probability of stent failure at follow-up.
“In the modern era, calcium modification techniques have been introduced with variable success with the aim to improve acute and long-term outcomes of PCI,” he said, but noted that the use of a cutting balloon inflated at high pressure in CAC “has not been investigated.”
Study setup
Mangieri noted that the Wolverine cutting balloon (Boston Scientific) is a semi-compliant, rapid-exchange balloon with three or four microblades mounted on its surface that facilitate calcium cracking.
“The aim of our study is to evaluate the safety and efficacy of this cutting balloon inflated at high pressure in coronary artery calcification,” he said, noting that the COPS trial investigated the use of the Wolverine cutting balloon inflated at high pressure compared to a normal pressure balloon in significant CAC – defined in this study as more than 100o of calcium.
Mangieri noted that patients eligible for PCI were enrolled in the trial and underwent baseline coronary angiography and intravascular ultrasound (IVUS) to identify those with fibrous and calcified lesions, with calcium arch of greater than 100o and reference vessel diameter of >2.4 mm and >4.0 mm. He said that 100 patients with eligible lesions according to IVUS were randomized 1:1 to either the high-pressure Wolverine cutting balloon treatment arm (CB) or the non-compliant balloon control arm (NCB).
The primary endpoint for the trial was minimal stent area (MSA) at the calcium site, while secondary endpoints included eccentricity index, device failure (including unsuccessful device delivery and/or inflation resulting in inadequate lesion preparation and/or damage of the vessel as consequence of device usage), vessel perforation, rate of major adverse cardiovascular events (MACE) and target lesion revascularization (TLR) at 1-year follow-up.
Key findings
Reporting initial data from the COPS trial, Mangieri reported that use of CB resulted in a larger MSA at the calcium site when compared to NCB (8.1 vs. 7.3 mm2, p=0.035), while CB use was associated with a more symmetric expansion of the stent at the calcium site (eccentricity index: 0.84 vs. 0.8, p=0.013).
He added that CB inflated at high pressure also had a good safety profile, with similar device failure rates (6.8% vs 0%, p=0.517).
“We observed a significant benefit of the cutting balloon, especially among patients with the severe arc calcium,” said Mangieri, noting that the benefit of high-pressure cutting balloon use was significant in patients with a calcium arc of greater than 270o, but not in those of 270o or less (≤270o, p=0.192; >270o, p=0.047).
“This trial can help to increase the knowledge about balloon-assisted techniques to treat CAC,” he said.
Image Credit: Jason Wermers/CRTonline.org