TY - JOUR
T1 - Combined rotational atherectomy and cutting balloon angioplasty prior to drug-eluting stent implantation in severely calcified coronary lesions
T2 - The PREPARE-CALC-COMBO study
AU - Allali, Abdelhakim
AU - Toelg, Ralph
AU - Abdel-Wahab, Mohamed
AU - Hemetsberger, Rayyan
AU - Kastrati, Adnan
AU - Mankerious, Nader
AU - Traboulsi, Hussein
AU - Elbasha, Karim
AU - Rheude, Tobias
AU - Landt, Martin
AU - Geist, Volker
AU - Richardt, Gert
N1 - Publisher Copyright:
© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.
PY - 2022/11/15
Y1 - 2022/11/15
N2 - 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 sirolimus-eluting 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 ± 2.2mm2 vs. 6.1 ± 1.7mm2 with MB vs. 6.2 ± 1.9mm2 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). Conclusion: Rota-Cut combination resulted in higher ALG and larger MSA compared with historical control of RA or MB alone, but was not associated with higher SE. Despite extensive lesion preparation, this strategy is safe, feasible, and associated with favorable clinical outcome at 9 months.
AB - 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 sirolimus-eluting 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 ± 2.2mm2 vs. 6.1 ± 1.7mm2 with MB vs. 6.2 ± 1.9mm2 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). Conclusion: Rota-Cut combination resulted in higher ALG and larger MSA compared with historical control of RA or MB alone, but was not associated with higher SE. Despite extensive lesion preparation, this strategy is safe, feasible, and associated with favorable clinical outcome at 9 months.
KW - Rota-Cut
KW - complex percutaneous coronary intervention
KW - coronary calcification
KW - cutting balloon
KW - rotational atherectomy
UR - http://www.scopus.com/inward/record.url?scp=85140108421&partnerID=8YFLogxK
U2 - 10.1002/ccd.30423
DO - 10.1002/ccd.30423
M3 - Article
C2 - 36262074
AN - SCOPUS:85140108421
SN - 1522-1946
VL - 100
SP - 979
EP - 989
JO - Catheterization and Cardiovascular Interventions
JF - Catheterization and Cardiovascular Interventions
IS - 6
ER -