Cutting balloon to optimize predilation for stent implantation: The COPS randomized trial

Abstract

Objectives: The objective of this study is to investigate the use of cutting balloon (CB) inflated at high pressure compared with noncompliant balloon (NCB) for the treatment of calcified coronary lesions.Background: No data are available regarding the safety and efficacy of CB inflated at high pressure in coronary artery calcifications.Methods: Patients with calcified lesions (more than 100°of calcium demonstrated at baseline intravascular ultrasound) were randomized. Primary endpoint of the study was the final minimal stent area (MSA) and stent symmetry in the calcific segment.Secondary endpoints included rate of device failure and the 1-year rate of target lesion revascularization, target vessel revascularization, and major adverse cardiovascular events.Results: From September 2019 to June 2021, a total of 100 patients were included and randomized; 13 patients were excluded for major protocol deviations. Lesions were complex (type B2/C n = 61 [71.2%]) with a mean arch of calcium of 266 ± 84°, a calcium length of 12 ± 6.6 mm. CB was inflated at comparable atmospheres when compared with NCB (18.3 ± 5 vs. 19 ± 4.5, p = 0.46). In the per-protocol population, the final MSA at the level of the calcium site was significantly higher in the CB group (8.1 ± 2 vs. 7.3 ± 2.1, p = 0.035) with a higher eccentricity index achieved in the CB group (0.84 ± 0.07 vs. 0.8 ± 0.08, p = 0.013). Three device failure occurred in the CB group. One-year follow-up outcomes were comparable.Conclusions: Treatment of calcified lesions with high-pressure CB has a good safety profile and is associated with a larger MSA and higher eccentricity of the stent at the level of the calcium site compared with NCB.

Optical coherence tomography‐derived predictors of stent expansion in calcified lesions

“…21 Moreover, in the COPS study no significant difference in MSA was observed between lesions treated with cutting balloons as compared with noncompliant balloons, although the trial did show a significant difference in MSA at the calcium site. 22 In line with the subanalysis on specialty devices in the present study, the small sample size of both studies should be acknowledged and a clear trend toward better stent expansion with more aggressive lesion preparation was consistently observed. Adequately powered randomized trials will be needed to demonstrate the potential superiority of these lesion preparation techniques as compared with routine noncompliant balloons.…”

The role of invasive and non-invasive imaging technologies and calcium modification therapies in the evaluation and management of coronary artery calcifications

“…In an early randomized study of 521 patients undergoing cutting balloon angioplasty or conventional balloon angioplasty before IVUS-guided stenting, the patients undergoing cutting balloon angioplasty had a larger minimal lumen area and lower rate of restenosis ( 55 ). This has been recently replicated in the COPS study ( 56 ).…”

Cut, score, press, shock, or ablate?

“…In this issue of Catheterization Cardiovascular Interventions , Mangieri et al 2 present the results of a multicenter randomized controlled trial comparing a new high‐pressure CB angioplasty protocol with high‐pressure noncompliant balloon (NCB) angioplasty. Their Cutting balloon to Optimize Predilatation for Stent implantation (COP) study included 100 patients with >100° of calcification under IVUS and a reference vessel diameter of 2.5–4.0 mm.…”

“…In this issue of Catheterization Cardiovascular Interventions, Mangieri et al 2 present the results of a multicenter randomized controlled trial comparing a new high-pressure CB angioplasty protocol with high-pressure noncompliant balloon (NCB) angioplasty.…”