Dual-Prep registry: atherectomy devices and intravascUlAr lithotripsy for the PREParation of heavily calcified coronary lesions registry

Abstract

Evaluation of calcified lesions by intravascular imaging has revealed that atherectomy devices have only limited impact. However, subsequent use of coronary intravascular lithotripsy (IVL) may increase treatment effectiveness without increasing risk of complications. This study was designed to evaluate the safety and effectiveness of IVL use after atherectomy in severely calcified coronary lesions as pre-treatment for drug-eluting stents (DES). The Dual-Prep registry is a multicenter, prospective registry of consecutive image-guided percutaneous coronary interventions (PCI). The primary effectiveness and safety endpoints were procedural success (residual stenosis < 50% by quantitative coronary angiography) without an in-hospital major adverse cardiac event (MACE) and 30-day freedom from MACE, respectively. Baseline vessel calcification score and final DES expansion were evaluated by optical coherence tomography (OCT). A total of 118 patients with 120 lesions were enrolled at 20 sites. The calcification score of lesions after atherectomy by core-lab assessment was 4.0 in all cases. Rotational atherectomy was applied prior to IVL in 83.9% cases with mean burr size of 1.57 ± 0.20 mm; IVL was subsequently successfully delivered in all cases (mean balloon diameter 3.02 ± 0.45 mm), followed by DES deployment (mean diameter 3.19 ± 0.51 mm, length of 36.3 ± 16.0 mm). The primary efficacy and safety endpoints were met in 98.3% and 98.3% of cases, respectively. A DES expansion index < 0.8 was seen in 42.2%, and an eccentricity index < 0.7 was not observed in any patient. In severely calcified lesions, image-guided atherectomy followed by IVL lesion preparation demonstrated high procedural success rates and satisfactory non-eccentric stent expansion. This approach may be considered for lesions where an 'IVL-first' strategy may not be feasible. jRCT1032230384 (Oct 7, 2023).

Keywords: Atherectomy; Calcification; Drug-eluting stent; Lithotripsy; OCT.

Fig. 1

Study flowchart. Patients was enrolled from 20 sites in Japan through Nov 2023 to June 2024. IVL Intravascular Lithotripsy

Fig. 2

Cumulative frequency curve of minimum lumen diameter by quantitative coronary angiography. Cumulative frequency curves of MLD demonstrating increased lumen gain by each step of atherectomy, IVL, and stent implantation

Fig. 3

Representative case of combined use of atherectomy and IVL as a lesion preparation of calcified lesion. In a 59-year-old hemodialysis patient, an RCA lesion with eruptive calcified nodules was treated with OA and IVL prior to DES implantation; the sufficient DES expansion was achieved with a stent expansion of 92%, an eccentricity index of 0.74, and an asymmetry index of 0.27