Combined rotational atherectomy and cutting balloon angioplasty prior to drug‐eluting stent implantation in severely calcified coronary lesions: The PREPARE‐CALC‐COMBO study

Abstract

Objectives: To evaluate the safety and efficacy of lesion preparation using rotational atherectomy (RA) with consecutive cutting balloon angioplasty (Rota-Cut).Background: Whether the Rota-Cut combination improves stent performance in severely calcified coronary lesions is unknown.Methods: PREPARE-CALC-COMBO is a single-arm prospective trial in which 110 patients were treated with a Rota-Cut strategy before implantation of sirolimuseluting stents and compared with patients treated with modified balloon (MB, scoring or cutting) or RA from a historical cohort (the randomized PREPARE-CALC trial). The study had two primary endpoints: in-stent acute lumen gain (ALG) by quantitative angiographic analysis and stent expansion (SE) on optical coherence tomography.Results: In-stent ALG was significantly higher with Rota-Cut compared to RA or MB alone (1.92 ± 0.45 mm vs. 1.74 ± 0.45 mm with MB vs. 1.70 ± 0.42 mm with RA; p = 0.001 and p < 0.001, respectively). SE was comparable between groups (75.1 ± 13.8% vs. 73.5 ± 13.3 with MB vs. 73.1 ± 12.2 with RA; p = 0.19 and p = 0.39, respectively). The Rota-Cut combination resulted in higher minimal stent area (MSA) (7.1 ± 2.2mm 2 vs. 6.1 ± 1.7mm 2 with MB vs. 6.2 ± 1.9mm 2 with RA; p = 0.003 and p = 0.004, respectively). In-hospital death occurred in one patient.Target vessel failure at 9 months was low and comparable between groups (8.2% vs. 8% with MB vs. 6% with RA; p = 1 and p = 0.79, respectively).

Safety and efficacy of a novel calcified plaque modification technique — Shockwave Intravascular Lithotripsy — in patients with coronary artery disease: Mid-term outcomes

“…The well-established balloon-dependent methods (such as non-compliance, cutting, scoring) [24] together with the atherectomy devices (both, rotational and orbital) [25,26] ensure that the success rate of the procedure can exceed 90%. A combination of the mentioned methods can result in an even higher success rate [27][28][29][30][31]. However, all of them have inherent limitations and may increase the risk of complications.…”

Modified balloons to prepare severely calcified coronary lesions before stent implantation: a systematic review and meta-analysis of randomized trials

“…Consistently, the network meta-analysis performed in this study ranked cutting balloon as the best treatment option, whilst a combination with RA did not improve the ranking of non-compliant or semi-compliant balloons. Noteworthy, recent studies [ 23 , 24 ] and a meta-analysis [ 25 ] suggest a possible benefit of a combination of RA and a modified balloon compared with a modified balloon or conventional balloon angioplasty as stand-alone therapies to improve outcomes in patients with severely calcified lesions undergoing PCI with stent implantation. Further studies are warranted to investigate whether the routine combination of therapies (ablative-, debulking-, balloon-based, etc.)…”

Current role of intravascular imaging in percutaneous treatment of calcified coronary lesions

“…Combination of RA and CB results in better acute lumen gain and stent expansion compared to RA or SB/CB alone. 43 Still under development, the OA technique introduced in 2013 uses a 1.25 mm diamond-coated crown mounted eccentrically and proximally to the tip of the shaft. Depending on the speed of the crown, it can be used in the treatment of vessels from 2.5 to 4 mm.…”