Treatment of severely calcified coronary artery disease by intravascular lithotripsy primary outcomes and 180-day follow-up from the Chinese SOLSTICE Trial

Feng TIAN; Shan-Shan ZHOU; Jing-Hua LIU; Hui CHEN; Zhi-Jun SUN; Lian CHEN; Qi WANG; Jing JING; Yun-Dai CHEN

doi:10.26599/1671-5411.2023.01.005

Volume 20 Issue 1

Jan. 2023

Turn off MathJax

Article Contents

Article Navigation > Journal of Geriatric Cardiology > 2023 > 20(1): 32-39

Please cite this article as: TIAN F, ZHOU SS, LIU JH, CHEN H, SUN ZJ, CHEN L, WANG Q, JING J, CHEN YD. Treatment of severely calcified coronary artery disease by intravascular lithotripsy primary outcomes and 180-day follow-up from the Chinese SOLSTICE Trial. J Geriatr Cardiol 2023; 20(1): 32−39. DOI: 10.26599/1671-5411.2023.01.005

Citation:

Please cite this article as: TIAN F, ZHOU SS, LIU JH, CHEN H, SUN ZJ, CHEN L, WANG Q, JING J, CHEN YD. Treatment of severely calcified coronary artery disease by intravascular lithotripsy primary outcomes and 180-day follow-up from the Chinese SOLSTICE Trial. J Geriatr Cardiol 2023; 20(1): 32−39. DOI: 10.26599/1671-5411.2023.01.005

Citation:

PDF( 766 KB)

Treatment of severely calcified coronary artery disease by intravascular lithotripsy primary outcomes and 180-day follow-up from the Chinese SOLSTICE Trial

doi: 10.26599/1671-5411.2023.01.005

1.
Department of Cardiology, Chinese PLA General Hospital, Beijing, China
2.
Department of Cardiology, Capital Medical University Affiliated Anzhen Hospital, Beijing, China
3.
Department of Cardiology, Capital Medical University Affiliated Beijing Friendship Hospital, Beijing, China

^*The authors contributed equally to this manuscript

More Information

Corresponding author: cyundai@vip.163.com
Available Online: 2023-02-06
Publish Date: 2023-01-28

Abstract

Abstract

OBJECTIVE To assess the safety and effectiveness of intravascular lithotripsy (IVL) treatment for de novo coronary lesion involving severely calcified vessels in a Chinese population. METHODS The Clinical Trial of the ShOckwave Coronary IVL System Used to Treat CalcIfied Coronary ArtEries (SOLSTICE) was a prospective, single-arm, multicentre trial. According to the inclusion criteria, patients with severely calcified lesions were enrolled in the study. IVL was used to perform calcium modification prior to stent implantation. The primary safety endpoint was freedom from major adverse cardiac events (MACEs) at 30 days. The primary effectiveness endpoint was procedural success, defined as successful stent delivery with residual stenosis < 50% by core lab assessment without in-hospital MACEs. The morphological changes of calcium modification were assessed by optical coherence tomography (OCT) before and after IVL treatment. RESULTS Patients (n = 20) were enrolled at three sites in China. Severe calcification by core lab assessment was present in all lesions, with a mean calcium angle and thickness of 300 ± 51° and 0.99 ± 0.12 mm (by OCT), respectively. The 30-day MACE rate was 5%. Both primary safety and effectiveness endpoints were achieved in 95% of patients. The final in-stent diameter stenosis was 13.1% ± 5.7% with no patient had a residual stenosis < 50% after stenting. No serious angiographic complications (severe dissection grade D or worse, perforation, abrupt closure, slow flow/no-reflow) observed at any time during the procedure. OCT imaging demonstrated visible multiplane calcium fracture in 80% of lesions with a mean stent expansion of 95.62% ± 13.33% at the site of maximum calcification and minimum stent area (MSA) of 5.34 ± 1.64 mm². CONCLUSIONS The initial coronary IVL experience for Chinese operators resulted in high procedural success and low angiographic complications consistent with prior IVL studies, reflecting the relative ease of use of IVL technology.

FullText(HTML)

References(24)

References

[1]	Wong ND, Kouwabunpat D, Vo AN, et al. Coronary calcium and atherosclerosis by ultrafast computed tomography in asymptomatic men and women: relation to age and risk factors. Am Heart J 1994; 127: 422−430. doi: 10.1016/0002-8703(94)90133-3
[2]	Goel M, Wong ND, Eisenberg H, et al. Risk factor correlates of coronary calcium as evaluated by ultrafast computed tomography. Am Journal Cardiology 1992; 70: 977−980. doi: 10.1016/0002-9149(92)90346-Z
[3]	Kawashima H, Serruys PW, Hara H, et al. 10-year all-cause mortality following percutaneous or surgical revascularization in patients with heavy calcification. JACC Cardiovasc Interv 2022; 15: 193−204. doi: 10.1016/j.jcin.2021.10.026
[4]	Bourantas CV, Zhang YJ, Garg S, et al. Prognostic implications of coronary calcification in patients with obstructive coronary artery disease treated by percutaneous coronary intervention: a patient-level pooled analysis of 7 contemporary stent trials. Heart 2014; 100: 1158−1164. doi: 10.1136/heartjnl-2013-305180
[5]	Kereiakes DJ, Virmani R, Hokama JY, et al. Principles of intravascular lithotripsy for calcific plaque modification. JACC Cardiovasc Interv 2021; 14: 1275−1292.
[6]	Brinton TJ, Ali ZA, Hill JM, et al. Feasibility of shockwave coronary intravascular lithotripsy for the treatment of calcified coronary stenoses. Circulation 2019; 139: 834−836. doi: 10.1161/CIRCULATIONAHA.118.036531
[7]	Ali ZA, Nef H, Escaned J, et al. Safety and effectiveness of coronary intravascular lithotripsy for treatment of severely calcified coronary stenoses: the disrupt CAD II study. Circ Cardiovasc Interv 2019; 12: e008434. doi: 10.1161/CIRCINTERVENTIONS.119.008434
[8]	Hill JM, Kereiakes DJ, Shlofmitz RA, et al. Intravascular lithotripsy for treatment of severely calcified coronary artery disease. J Am Coll Cardiol 2020; 76: 2635−2646. doi: 10.1016/j.jacc.2020.09.603
[9]	Saito S, Yamazaki S, Takahashi A, et al. Intravascular lithotripsy for vessel preparation in severely calcified coronary arteries prior to stent placement- primary outcomes from the Japanese disrupt CAD IV study. Circ J 2021; 85: 826−833. doi: 10.1253/circj.CJ-20-1174
[10]	Kassimis G, Didagelos M, De Maria GL, et al. Shockwave intravascular lithotripsy for the treatment of severe vascular calcification. Angiology 2020; 71: 677−688. doi: 10.1177/0003319720932455
[11]	Valgimigli M, Bueno H, Byrne RA, et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J 2018; 39: 213−260. doi: 10.1093/eurheartj/ehx419
[12]	Abdel-Wahab M, Richardt G, Joachim Buttner H, et al. High-speed rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: the randomized ROTAXUS (Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease) trial. JACC Cardiovasc Interv 2013; 6: 10−19. doi: 10.1016/j.jcin.2012.07.017
[13]	Chambers JW, Feldman RL, Himmelstein SI, et al. Pivotal trial to evaluate the safety and efficacy of the orbital atherectomy system in treating de novo, severely calcified coronary lesions (ORBIT II). JACC Cardiovasc Interv 2014; 7: 510−518. doi: 10.1016/j.jcin.2014.01.158
[14]	De Silva K, Roy J, Webb I, et al. A calcific, undilatable stenosis: lithoplasty, a new tool in the box? JACC Cardiovasc Interv 2017; 10: 304-306.
[15]	Chugh Y, Khatri JJ, Shishehbor MH, et al. Adverse events with intravascular lithotripsy after peripheral and off-label coronary use: a report from the FDA MAUDE database. J Invasive Cardiol 2021; 33: E974−E977.
[16]	Serruys PW, Katagiri Y, Onuma Y. Shaking and breaking calcified plaque: lithoplasty, a breakthrough in interventional armamentarium? JACC Cardiovasc Imaging 2017; 10: 907-911.
[17]	Kini AS, Vengrenyuk Y, Pena J, et al. Optical coherence tomography assessment of the mechanistic effects of rotational and orbital atherectomy in severely calcified coronary lesions. Catheter Cardiovasc Interv 2015; 86: 1024−1032. doi: 10.1002/ccd.26000
[18]	Tomey MI, Sharma SK. Interventional options for coronary artery calcification. Curr Cardiol Rep 2016; 18: 12. doi: 10.1007/s11886-015-0691-8
[19]	Tovar Forero MN, Wilschut J, Van Mieghem NM, et al. Coronary lithoplasty: a novel treatment for stent underexpansion. Eur Heart J 2019; 40: 221. doi: 10.1093/eurheartj/ehy593
[20]	Di Mario C, Chiriatti N, Stolcova M, et al. Lithoplasty-assisted transfemoral aortic valve implantation. Eur Heart J 2018; 41: 942.
[21]	El Jattari H HW, De Roeck F, Cottens D, et al. intracoronary lithotripsy in calcified coronary lesions: a multicenter observational study. J Invasive Cardiol 2022; 34: E24−E31.
[22]	Aziz A, Bhatia G, Pitt M, et al. Intravascular lithotripsy in calcified-coronary lesions: A real-world observational, European multicenter study. Catheter Cardiovasc Interv 2021; 98: 225−235. doi: 10.1002/ccd.29263
[23]	Kassimis G, Didagelos M, Kouparanis A, et al. Intravascular ultrasound-guided coronary intravascular lithotripsy in the treatment of a severely under-expanded stent due to heavy underlying calcification. To re-stent or not? Kardiol Pol 2020; 78: 346−347.
[24]	De Maria GL, Scarsini R, Banning AP. Management of calcific coronary artery lesions: is it time to change our interventional therapeutic approach? JACC Cardiovasc Interv 2019; 12: 1465-1478.