Impact of prolonged drug-coated balloon inflation on residual stenosis and clinical outcomes in coronary artery disease patients: A propensity score matched analysis.
coronary artery disease
drug-coated balloon
intravascular ultrasound
percutaneous coronary intervention
Journal
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139
Informations de publication
Date de publication:
11 2023
11 2023
Historique:
revised:
20
09
2023
received:
28
06
2023
accepted:
30
09
2023
medline:
17
11
2023
pubmed:
19
10
2023
entrez:
19
10
2023
Statut:
ppublish
Résumé
There is a paucity of data regarding the optimal duration of drug-coated balloon (DCB) inflation for coronary lesions. We sought to explore the effect of DCB angioplasty with versus without long inflation time on residual stenosis and clinical outcomes in patients with coronary artery disease. This study included 314 consecutive patients with 445 lesions undergoing paclitaxel DCB angioplasty using different inflation time, divided according to whether the total inflation time of the DCB was ≥180 s (prolonged group) or <180 s (standard group). The primary clinical endpoint, defined as a composite of all-cause death, myocardial infarction, stroke, or target lesion revascularization, was examined in 92 propensity score matched pairs. In the matched cohort, the median clinical follow-up period was 947 days. Postprocedural angiographic diameter stenosis was smaller in the prolonged group than in the standard group (30.0% [22.0-37.0] vs. 33.5% [25.5-40.5]; p = 0.042). Intravascular ultrasound measurements revealed that longer DCB inflation time resulted in smaller area stenosis (66.6 ± 7.8% vs. 69.4 ± 7.0%; p = 0.044) and a less mean increase in percent atheroma volume (-11.2 ± 7.1% vs. -7.4 ± 5.9%; p = 0.004) after angioplasty. The rate of the primary endpoint was lower in the prolonged group than in the standard group (log-rank p = 0.025). The efficacy of prolonged DCB inflation was prominent in patients with in-stent restenosis and longer lesions. Prolonged DCB inflation was associated with reduced residual stenosis and improved clinical outcomes in patients with coronary artery disease undergoing percutaneous coronary intervention. Prospective randomized trials are warranted to validate the benefits of DCB angioplasty with long inflation time.
Sections du résumé
BACKGROUND
There is a paucity of data regarding the optimal duration of drug-coated balloon (DCB) inflation for coronary lesions. We sought to explore the effect of DCB angioplasty with versus without long inflation time on residual stenosis and clinical outcomes in patients with coronary artery disease.
METHODS
This study included 314 consecutive patients with 445 lesions undergoing paclitaxel DCB angioplasty using different inflation time, divided according to whether the total inflation time of the DCB was ≥180 s (prolonged group) or <180 s (standard group). The primary clinical endpoint, defined as a composite of all-cause death, myocardial infarction, stroke, or target lesion revascularization, was examined in 92 propensity score matched pairs.
RESULTS
In the matched cohort, the median clinical follow-up period was 947 days. Postprocedural angiographic diameter stenosis was smaller in the prolonged group than in the standard group (30.0% [22.0-37.0] vs. 33.5% [25.5-40.5]; p = 0.042). Intravascular ultrasound measurements revealed that longer DCB inflation time resulted in smaller area stenosis (66.6 ± 7.8% vs. 69.4 ± 7.0%; p = 0.044) and a less mean increase in percent atheroma volume (-11.2 ± 7.1% vs. -7.4 ± 5.9%; p = 0.004) after angioplasty. The rate of the primary endpoint was lower in the prolonged group than in the standard group (log-rank p = 0.025). The efficacy of prolonged DCB inflation was prominent in patients with in-stent restenosis and longer lesions.
CONCLUSION
Prolonged DCB inflation was associated with reduced residual stenosis and improved clinical outcomes in patients with coronary artery disease undergoing percutaneous coronary intervention. Prospective randomized trials are warranted to validate the benefits of DCB angioplasty with long inflation time.
Substances chimiques
Coated Materials, Biocompatible
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
969-978Informations de copyright
© 2023 Wiley Periodicals LLC.
Références
Scheller B, Hehrlein C, Bocksch W, et al. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006;355:2113-2124. doi:10.1056/NEJMoa061254
Neumann FJ, Sousa-Uva M, Ahlsson A, et al. 2018 ESC/EACTS guidelines on myocardial revascularization. Eur Heart J. 2019;40:87-165. doi:10.1093/eurheartj/ehy394
Jeger RV, Farah A, Ohlow MA, et al. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018;392:849-856. doi:10.1016/S0140-6736(18)31719-7
Kleber FX, Schulz A, Waliszewski M, et al. Local paclitaxel induces late lumen enlargement in coronary arteries after balloon angioplasty. Clin Res Cardiol. 2015;104:217-225. doi:10.1007/s00392-014-0775-2
Scheller B, Rissanen TT, Farah A, et al. Drug-coated balloon for small coronary artery disease in patients with and without high-bleeding risk in the BASKET-SMALL 2 trial. Circ Cardiovasc Interv. 2022;15:e011569. doi:10.1161/CIRCINTERVENTIONS.121.011569
Jeger RV, Eccleshall S, Wan Ahmad WA, et al. Drug-coated balloons for coronary artery disease. JACC Cardiovasc Interv. 2020;13:1391-1402. doi:10.1016/j.jcin.2020.02.043
Muramatsu T, Kozuma K, Tanabe K, 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
Cremers B, Scheller B. From bench to paccocath. EuroIntervention. 2011;7(suppl K):K23-K31. doi:10.4244/EIJV7SKA5
Mintz GS, Nissen SE, Anderson WD, et al. American College of Cardiology clinical expert consensus document on standards for acquisition, measurement and reporting of intravascular ultrasound studies (IVUS). A report of the American College of Cardiology task force on clinical expert consensus documents. JACC. 2001;37:1478-1492. doi:10.1016/s0735-1097(01)01175-5
Suwannasom P, Sotomi Y, Ishibashi Y, et al. The impact of post-procedural asymmetry, expansion, and eccentricity of bioresorbable everolimus-eluting scaffold and metallic everolimus-eluting stent on clinical outcomes in the ABSORB II trial. JACC Cardiovasc Interv. 2016;9:1231-1242. doi:10.1016/j.jcin.2016.03.027
Mintz G, Garcia-Garcia H, Nicholls S, et al. Clinical expert consensus document on standards for acquisition, measurement and reporting of intravascular ultrasound regression/progression studies. EuroIntervention. 2011;6:1123-1130. doi:10.4244/EIJV6I9A195
Thygesen K, Alpert JS, Jaffe AS, et al. Fourth universal definition of myocardial infarction (2018). JACC. 2018;72:2231-2264. doi:10.1016/j.jacc.2018.08.1038
Ohman EM, Marquis JF, Ricci DR, et al. A randomized comparison of the effects of gradual prolonged versus standard primary balloon inflation on early and late outcome. Results of a multicenter clinical trial. Perfusion Balloon Catheter Study Group. Circulation. 1994;89:1118-1125. doi:10.1161/01.cir.89.3.1118
Koch T, Voll F, Xhepa E, et al. Association between duration of drug-coated balloon inflation and efficacy in patients with drug-eluting stent restenosis. Coron Artery Dis. 2022;33:239-241. doi:10.1097/MCA.0000000000001045
Rhee TM, Lee JM, Shin ES, et al. Impact of optimized procedure-related factors in drug-eluting balloon angioplasty for treatment of in-stent restenosis. JACC Cardiovasc Interv. 2018;11:969-978. doi:10.1016/j.jcin.2018.02.002