Intravascular Lithotripsy for Vessel Preparation in Calcified Coronary Arteries Prior to Stent Placement ― Japanese Disrupt CAD IV Study 2-Year Results
Background: Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcification to enhance vessel compliance and optimize stent deployment. The Disrupt CAD IV study enrolled patients with severe coronary artery calcification. The primary safety (30-day major adverse coronary eve...
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| Published in | Circulation Reports Vol. 5; no. 12; pp. 437 - 441 |
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| Main Authors | , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Japan
The Japanese Circulation Society
08.12.2023
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| Subjects | |
| Online Access | Get full text |
| ISSN | 2434-0790 2434-0790 |
| DOI | 10.1253/circrep.CR-23-0082 |
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| Abstract | Background: Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcification to enhance vessel compliance and optimize stent deployment. The Disrupt CAD IV study enrolled patients with severe coronary artery calcification. The primary safety (30-day major adverse coronary events [MACE], 6.3%) and effectiveness (procedural success, 93.8%) endpoints were achieved. The present analysis evaluated the 2-year outcomes of the study.Methods and Results: Disrupt CAD IV (NCT04151628) was a prospective, single-arm, multicenter study designed for regulatory approval of the Shockwave Coronary C2IVL system in Japan. Angiographic outcomes were analyzed by an independent core laboratory and adverse events were adjudicated by a Clinical Events Committee. Kaplan-Meier analysis was performed for MACE (composite of cardiac death, MI or target-vessel revascularization [TVR]), target lesion failure (TLF: composite of cardiac death, TV-MI, and target lesion revascularization [TLR]), and stent thrombosis (ST). At 2 years, 62 subjects had completed follow-up. MACE occurred in 12.6% (cardiac death 0.0%, MI 6.3%, TVR 7.9%) and TLF occurred in 7.8% of patients, with both rates driven by non-Q-wave MI events (6.3%). TLR was 3.2%; no ST occurred through 2 years.Conclusions: Treatment with IVL in patients with severely calcified coronary lesions was associated with low rates of MACE, TLR, and ST at 2 years, demonstrating continued durable safety and effectiveness of coronary IVL in a Japanese population. |
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| AbstractList | Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcification to enhance vessel compliance and optimize stent deployment. The Disrupt CAD IV study enrolled patients with severe coronary artery calcification. The primary safety (30-day major adverse coronary events [MACE], 6.3%) and effectiveness (procedural success, 93.8%) endpoints were achieved. The present analysis evaluated the 2-year outcomes of the study.
Disrupt CAD IV (NCT04151628) was a prospective, single-arm, multicenter study designed for regulatory approval of the Shockwave Coronary C
IVL system in Japan. Angiographic outcomes were analyzed by an independent core laboratory and adverse events were adjudicated by a Clinical Events Committee. Kaplan-Meier analysis was performed for MACE (composite of cardiac death, MI or target-vessel revascularization [TVR]), target lesion failure (TLF: composite of cardiac death, TV-MI, and target lesion revascularization [TLR]), and stent thrombosis (ST). At 2 years, 62 subjects had completed follow-up. MACE occurred in 12.6% (cardiac death 0.0%, MI 6.3%, TVR 7.9%) and TLF occurred in 7.8% of patients, with both rates driven by non-Q-wave MI events (6.3%). TLR was 3.2%; no ST occurred through 2 years.
Treatment with IVL in patients with severely calcified coronary lesions was associated with low rates of MACE, TLR, and ST at 2 years, demonstrating continued durable safety and effectiveness of coronary IVL in a Japanese population. Background: Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcification to enhance vessel compliance and optimize stent deployment. The Disrupt CAD IV study enrolled patients with severe coronary artery calcification. The primary safety (30-day major adverse coronary events [MACE], 6.3%) and effectiveness (procedural success, 93.8%) endpoints were achieved. The present analysis evaluated the 2-year outcomes of the study. Methods and Results: Disrupt CAD IV (NCT04151628) was a prospective, single-arm, multicenter study designed for regulatory approval of the Shockwave Coronary C2 IVL system in Japan. Angiographic outcomes were analyzed by an independent core laboratory and adverse events were adjudicated by a Clinical Events Committee. Kaplan-Meier analysis was performed for MACE (composite of cardiac death, MI or target-vessel revascularization [TVR]), target lesion failure (TLF: composite of cardiac death, TV-MI, and target lesion revascularization [TLR]), and stent thrombosis (ST). At 2 years, 62 subjects had completed follow-up. MACE occurred in 12.6% (cardiac death 0.0%, MI 6.3%, TVR 7.9%) and TLF occurred in 7.8% of patients, with both rates driven by non-Q-wave MI events (6.3%). TLR was 3.2%; no ST occurred through 2 years. Conclusions: Treatment with IVL in patients with severely calcified coronary lesions was associated with low rates of MACE, TLR, and ST at 2 years, demonstrating continued durable safety and effectiveness of coronary IVL in a Japanese population.Background: Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcification to enhance vessel compliance and optimize stent deployment. The Disrupt CAD IV study enrolled patients with severe coronary artery calcification. The primary safety (30-day major adverse coronary events [MACE], 6.3%) and effectiveness (procedural success, 93.8%) endpoints were achieved. The present analysis evaluated the 2-year outcomes of the study. Methods and Results: Disrupt CAD IV (NCT04151628) was a prospective, single-arm, multicenter study designed for regulatory approval of the Shockwave Coronary C2 IVL system in Japan. Angiographic outcomes were analyzed by an independent core laboratory and adverse events were adjudicated by a Clinical Events Committee. Kaplan-Meier analysis was performed for MACE (composite of cardiac death, MI or target-vessel revascularization [TVR]), target lesion failure (TLF: composite of cardiac death, TV-MI, and target lesion revascularization [TLR]), and stent thrombosis (ST). At 2 years, 62 subjects had completed follow-up. MACE occurred in 12.6% (cardiac death 0.0%, MI 6.3%, TVR 7.9%) and TLF occurred in 7.8% of patients, with both rates driven by non-Q-wave MI events (6.3%). TLR was 3.2%; no ST occurred through 2 years. Conclusions: Treatment with IVL in patients with severely calcified coronary lesions was associated with low rates of MACE, TLR, and ST at 2 years, demonstrating continued durable safety and effectiveness of coronary IVL in a Japanese population. Background: Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcification to enhance vessel compliance and optimize stent deployment. The Disrupt CAD IV study enrolled patients with severe coronary artery calcification. The primary safety (30-day major adverse coronary events [MACE], 6.3%) and effectiveness (procedural success, 93.8%) endpoints were achieved. The present analysis evaluated the 2-year outcomes of the study.Methods and Results: Disrupt CAD IV (NCT04151628) was a prospective, single-arm, multicenter study designed for regulatory approval of the Shockwave Coronary C2IVL system in Japan. Angiographic outcomes were analyzed by an independent core laboratory and adverse events were adjudicated by a Clinical Events Committee. Kaplan-Meier analysis was performed for MACE (composite of cardiac death, MI or target-vessel revascularization [TVR]), target lesion failure (TLF: composite of cardiac death, TV-MI, and target lesion revascularization [TLR]), and stent thrombosis (ST). At 2 years, 62 subjects had completed follow-up. MACE occurred in 12.6% (cardiac death 0.0%, MI 6.3%, TVR 7.9%) and TLF occurred in 7.8% of patients, with both rates driven by non-Q-wave MI events (6.3%). TLR was 3.2%; no ST occurred through 2 years.Conclusions: Treatment with IVL in patients with severely calcified coronary lesions was associated with low rates of MACE, TLR, and ST at 2 years, demonstrating continued durable safety and effectiveness of coronary IVL in a Japanese population. |
| ArticleNumber | CR-23-0082 |
| Author | Yamazaki, Seiji Namiki, Atsuo Shibata, Yoshisato Nakamura, Shigeru Saito, Shigeru Kawasaki, Tomohiro Otsuji, Satoru Takahashi, Akihiko |
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| Cites_doi | 10.1161/CIRCINTERVENTIONS.120.008993 10.1016/j.jcin.2021.03.036 10.1253/circj.CJ-20-1174 10.1253/circrep.CR-22-0068 10.1002/ccd.27204 10.4070/kcj.2021.0155 10.1016/j.jscai.2021.100001 10.1161/CIRCINTERVENTIONS.119.008434 10.15420/icr.2019.18.R1 10.26599/1671-5411.2023.01.005 10.4244/EIJ-D-17-00473 10.1016/j.jacc.2020.09.603 10.1016/j.jcin.2021.04.015 10.1016/j.jacc.2014.01.017 10.1016/j.jacc.2022.08.208 10.1016/j.jacc.2003.10.039 10.3390/jpm12010097 10.1007/s12928-023-00921-2 10.1007/s11886-022-01674-9 10.25270/jic/20.00526 10.1016/j.jcin.2023.07.010 10.1253/circj.CJ-17-0668 |
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| Keywords | Coronary artery calcification Percutaneous coronary intervention Intravascular lithotripsy Vessel preparation |
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| References_xml | – reference: 22. Muramatsu T, Kozuma K, Tanabe K, Morino Y, Ako J, Nakamura S, et al. Clinical expert consensus document on drug-coated balloon for coronary artery disease from the Japanese Association of Cardiovascular Intervention and Therapeutics. Cardiovasc Interv Ther 2023; 38: 166–176, doi:10.1007/s12928-023-00921-2. – reference: 8. Kereiakes DJ, Di Mario C, Riley RF, Fajadet J, Shlofmitz RA, Saito S, et al. Intravascular lithotripsy for treatment of calcified coronary lesions: Patient-level pooled analysis of the Disrupt CAD studies. JACC Cardiovasc Interv 2021; 14: 1337–1348, doi:10.1016/j.jcin.2021.04.015. – reference: 6. Forero MNT, Daemen J. The coronary intravascular lithotripsy system. Interv Cardiol 2019; 14: 174–181, doi:10.15420/icr.2019.18.R1. – reference: 10. Saito S, Yamazaki S, Takahashi A, Namiki A, Kawasaki T, Otsuji S, 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. – reference: 13. Saito S, Yamazaki S, Takahashi A, Namiki A, Kawasaki T, Otsuji S, et al. Intravascular lithotripsy for vessel preparation in calcified coronary arteries prior to stent placement: Japanese Disrupt CAD IV study 1-year results. Circ Rep 2022; 4: 399–404, doi:10.1253/circrep.CR-22-0068. – reference: 1. Madhavan MV, Tarigopula M, Mintz GS, Maehara A, Stone GW, Genereux P. Coronary artery calcification: Pathogenesis and prognostic implications. J Am Coll Cardiol 2014; 63: 1703–1714, doi:10.1016/j.jacc.2014.01.017. – reference: 15. Copeland-Halperin RS, Baber U, Aquino M, Rajamanickam A, Roy S, Hasan C, et al. Prevalence, correlates, and impact of coronary calcification on adverse events following PCI with newer-generation DES: Findings from a large multiethnic registry. Catheter Cardiovasc Interv 2018; 91: 859–866, doi:10.1002/ccd.27204. – reference: 16. Tian F, Zhou SS, Liu JH, Chen H, Sun ZJ, Chen L, et al. 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: 32–39, doi:10.26599/1671-5411.2023.01.005. – reference: 4. Bittl JA, Chew DP, Topol EJ, Kong DF, Califf RM. Meta-analysis of randomized trials of percutaneous transluminal coronary angioplasty versus atherectomy, cutting balloon atherotomy, or laser angioplasty. J Am Coll Cardiol 2004; 43: 936–942, doi:10.1016/j.jacc.2003.10.039. – reference: 7. Hill JM, Kereiakes DJ, Shlofmitz RA, Klein AJ, Riley RF, Price MJ, et al. Intravascular lithotripsy for treatment of severely calcified coronary artery disease. 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| Snippet | Background: Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcification to enhance vessel compliance and optimize stent... Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcification to enhance vessel compliance and optimize stent deployment. The... |
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| SubjectTerms | Coronary artery calcification Intravascular lithotripsy Percutaneous coronary intervention Vessel preparation |
| Title | Intravascular Lithotripsy for Vessel Preparation in Calcified Coronary Arteries Prior to Stent Placement ― Japanese Disrupt CAD IV Study 2-Year Results |
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