COPS trial shows feasibility of using a cutting balloon at high pressure to modify calcium prior to PCI


Attendees of the 2023 Joint Interventional Meeting (JIM, 9–11 February, Milan, Italy) heard results of a randomised, open-label trial of the non-compliant Wolverine cutting balloon (Boston Scientific) inflated at high pressure as a strategy for “cracking” calcium prior to percutaneous coronary intervention (PCI).

The COPS trial—Cutting balloon to optimise predilatation for stenting—saw physicians at three Italian centres randomise 1:1 100 patients (mean age: 71) with severe de novo calcified coronary lesions to undergo predilatation with either the Wolverine non-compliant, rapid-exchange balloon, inflated at high pressure or a non-compliant balloon.

The investigators, led by Antonio Mangieri (Humanitas Research Hospital, Milan, Italy) who detailed the results at JIM 2023, reported that the treatment of calcified lesions with the high-pressure cutting balloon results in a larger minimal stent area (MSA) at the site of the calcium, as well as more symmetric stent expansion at the level of the calcified segment compared to the non-compliant balloon.

Mangieri offered the conclusion that the use of a cutting balloon compared to standard non-compliant balloon angioplasty appears to be feasible even when inflated at high pressure, noting that the benefit of lesion preparation with the cutting balloon is more pronounced in the presence of severe calcifications.

Larger studies should investigate the use of cutting balloons in different types of lesions, including potentially fibrotic, bifurcation, or mild-to-moderate calcification, Mangieri said.


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