Comparative long-term efficacy and safety of two paclitaxel-coated balloons with different coating strategies for the treatment of drug-eluting coronary stent restenosis.
drug‐coated balloon (DCB)
drug‐eluting‐stent (DES)
in‐stent restenosis (ISR)
paclitaxel
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:
18 Sep 2024
18 Sep 2024
Historique:
revised:
09
08
2024
received:
13
03
2024
accepted:
04
09
2024
medline:
18
9
2024
pubmed:
18
9
2024
entrez:
18
9
2024
Statut:
aheadofprint
Résumé
We previously showed non-inferiority of a low-dose paclitaxel-coated balloon (PCB) with citrate excipient (Agent PCB) as compared to normal-dose iopromide excipient (SeQuent Please PCB) in terms of angiographic and clinical endpoints at 12 months. The long-term clinical efficacy and safety of Agent PCB is not defined. 262 patients (323 DES-ISR lesions) were enrolled in this study and treated with either Agent PCB (125 patients, 151 lesions) in the ISAR-DESIRE 3a trial or with SeQuent Please PCB (137 patients, 172 lesions) in the setting of the randomized ISAR-DESIRE 3 trial with similar in- and exclusion criteria serving as historical control arm. The follow-up period was extended to 7 years. The efficacy and safety endpoints of this analysis were target-lesion revascularization (TLR), death, myocardial infarction (MI) and target lesion thrombosis (TLT) at 7 years. At 7 years, 206 patients (78.6%) were alive. The risks of TLR (hazard ratio [HR]: 1.29, 95% confidence interval [CI]: 0.87-1.90; p = 0.205), death (HR: 1.38, 95% CI: 0.82-2.35; p = 0.227), MI (HR: 1.10, 95% CI: 0.39-3.15; p = 0.852) and TLT (HR: 2.18, 95% CI: 0.20-24.10; p = 0.523) were comparable between Agent PCB and SeQuent PCB. Multivariate analysis showed comparable risks of TLR, death and MI between both PCB devices. In patients treated for DES-ISR by angioplasty with Agent PCB and SeQuent Please PCB, there was no statistically significant difference in TLR at 7 years. Randomized trials with standardized lesion preparation and long-term follow-up are warranted to further evaluate comparative efficacy of both devices. (ClinicalTrials. gov Identifier: NCT02367495).
Sections du résumé
BACKGROUND
BACKGROUND
We previously showed non-inferiority of a low-dose paclitaxel-coated balloon (PCB) with citrate excipient (Agent PCB) as compared to normal-dose iopromide excipient (SeQuent Please PCB) in terms of angiographic and clinical endpoints at 12 months. The long-term clinical efficacy and safety of Agent PCB is not defined.
METHODS
METHODS
262 patients (323 DES-ISR lesions) were enrolled in this study and treated with either Agent PCB (125 patients, 151 lesions) in the ISAR-DESIRE 3a trial or with SeQuent Please PCB (137 patients, 172 lesions) in the setting of the randomized ISAR-DESIRE 3 trial with similar in- and exclusion criteria serving as historical control arm. The follow-up period was extended to 7 years. The efficacy and safety endpoints of this analysis were target-lesion revascularization (TLR), death, myocardial infarction (MI) and target lesion thrombosis (TLT) at 7 years.
RESULTS
RESULTS
At 7 years, 206 patients (78.6%) were alive. The risks of TLR (hazard ratio [HR]: 1.29, 95% confidence interval [CI]: 0.87-1.90; p = 0.205), death (HR: 1.38, 95% CI: 0.82-2.35; p = 0.227), MI (HR: 1.10, 95% CI: 0.39-3.15; p = 0.852) and TLT (HR: 2.18, 95% CI: 0.20-24.10; p = 0.523) were comparable between Agent PCB and SeQuent PCB. Multivariate analysis showed comparable risks of TLR, death and MI between both PCB devices.
CONCLUSIONS
CONCLUSIONS
In patients treated for DES-ISR by angioplasty with Agent PCB and SeQuent Please PCB, there was no statistically significant difference in TLR at 7 years. Randomized trials with standardized lesion preparation and long-term follow-up are warranted to further evaluate comparative efficacy of both devices. (ClinicalTrials. gov Identifier: NCT02367495).
Banques de données
ClinicalTrials.gov
['NCT02367495']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : Boston Scientific
Informations de copyright
© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by 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(20):2113‐2124. doi:10.1056/NEJMoa061254
Alfonso F, Coughlan JC, Giacoppo D, Kastrati A, Byrne RB. Management of in‐stent restenosis. EuroIntervention. 2022;18(2):e103‐e123.
Authors/Task Force m, Windecker S, Kolh P, et al. 2014 ESC/EACTS guidelines on myocardial revascularization: the task force on myocardial revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio‐Thoracic Surgery (EACTS) developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014;35(37):2541‐2619. doi:10.1093/eurheartj/ehu278
Creel CJ, Lovich MA, Edelman ER. Arterial paclitaxel distribution and deposition. Circ Res. 2000;86(8):879‐884. doi:10.1161/01.res.86.8.879
Jeger RV, Eccleshall S, Wan Ahmad WA, et al. Drug‐coated balloons for coronary artery disease. JACC Cardiovasc Interv. 2020;13(12):1391‐1402. doi:10.1016/j.jcin.2020.02.043
Benezet J, Agarrado A, Gutiérrez‐Barrios A, Ruiz‐Fernandez D, del Río A, Cañadas D. Comparison of two different drug‐coated balloons for the treatment of in‐stent restenosis: a long‐term single‐centre experience. Cardiovasc Revasc Med. 2016;17(3):176‐180. doi:10.1016/j.carrev.2016.01.012
Kufner S, Rai H, Wiebe J, et al. A prospective trial of a novel low‐dose paclitaxel‐coated balloon therapy in patients with restenosis in drug‐eluting coronary stents intracoronary stenting and angiographic results: optimizing treatment of drug eluting stent in‐stent REstenosis 3A (ISAR‐DESIRE 3A). Catheter Cardiovasc Interv. 2022;99(3):754‐762. doi:10.1002/ccd.30014
Yeh RW, Shlofmitz R, Moses J, et al. Paclitaxel‐coated balloon vs uncoated balloon for coronary in‐stent restenosis: the AGENT IDE randomized clinical trial. JAMA. 2024;331:1015. doi:10.1001/jama.2024.1361
Scheller B, Clever YP, Kelsch B, et al. Long‐term follow‐up after treatment of coronary in‐stent restenosis with a paclitaxel‐coated balloon catheter. JACC Cardiovasc Interv. 2012;5(3):323‐330. doi:10.1016/j.jcin.2012.01.008
Giacoppo D, Alvarez‐Covarrubias HA, Koch T, et al. Coronary artery restenosis treatment with plain balloon, drug‐coated balloon, or drug‐eluting stent: 10‐year outcomes of the ISAR‐DESIRE 3 trial. Eur Heart J. 2023;44:1343‐1357. doi:10.1093/eurheartj/ehad026
Byrne RA, Neumann FJ, Mehilli J, et al. Paclitaxel‐eluting balloons, paclitaxel‐eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug‐eluting stent (ISAR‐DESIRE 3): a randomised, open‐label trial. Lancet. 2013;381(9865):461‐467. doi:10.1016/S0140-6736(12)61964-3
Neumann FJ, Sousa‐Uva M, Ahlsson A, et al. 2018 ESC/EACTS guidelines on myocardial revascularization. EuroIntervention. 2019;14(14):1435‐1534. doi:10.4244/EIJY19M01_01
Singh AD, Singal AK, Mian A, et al. Recurrent drug‐eluting stent in‐stent restenosis: a state‐of‐the‐art review of pathophysiology, diagnosis, and management. Cardiovasc Revasc Med. 2020;21(9):1157‐1163. doi:10.1016/j.carrev.2020.01.005
Koch T, Lenz T, Rheude T, et al. Recurrent revascularization at 10 years after percutaneous treatment of drug‐eluting stent restenosis. JACC Cardiovasc Interv. 2024;17(1):1‐13. doi:10.1016/j.jcin.2023.10.031
Giacoppo D, Alfonso F, Xu B, et al. Drug‐coated balloon angioplasty versus drug‐eluting stent implantation in patients with coronary stent restenosis. J Am Coll Cardiol. 2020;75(21):2664‐2678. doi:10.1016/j.jacc.2020.04.006
Liu S, Zhou Y, Shen Z, et al. A randomized comparison of 2 different drug‐coated balloons for in‐stent restenosis. JACC Cardiovasc Interv. 2023;16(7):759‐767. doi:10.1016/j.jcin.2022.12.018
Scheller B, Mangner N, Abdul Kader MASK, et al. Combined analysis of two parallel randomized trials of sirolimus‐coated and paclitaxel‐coated balloons in coronary in‐stent restenosis lesions. Circ Cardiovasc Interv. 2022;15(9):e012305. doi:10.1161/circinterventions.122.012305
Colleran R, Joner M, Kufner S, et al. Comparative efficacy of two paclitaxel‐coated balloons with different excipient coatings in patients with coronary in‐stent restenosis: a pooled analysis of the intracoronary stenting and angiographic results: optimizing treatment of drug eluting stent in‐stent restenosis 3 and 4 (ISAR‐DESIRE 3 and ISAR‐DESIRE 4) trials. Int J Cardiol. 2018;252:57‐62. doi:10.1016/j.ijcard.2017.11.076
Hamm CW, Dörr O, Woehrle J, et al. A multicentre, randomised controlled clinical study of drug‐coated balloons for the treatment of coronary in‐stent restenosis. EuroIntervention. 2020;16(4):e328‐e334.
Alfonso F, Pérez‐Vizcayno MJ, García del Blanco B, et al. Comparison of the efficacy of everolimus‐eluting stents versus drug‐eluting balloons in patients with in‐stent restenosis (from the RIBS IV and V randomized clinical trials). Am J Cardiol. 2016;117(4):546‐554. doi:10.1016/j.amjcard.2015.11.042
Coughlan JJ, Räber L, Brugaletta S, et al. Sex differences in 10‐year outcomes after percutaneous coronary intervention with Drug‐Eluting stents: insights from the DECADE cooperation. Circulation. 2023;147(7):575‐585. doi:10.1161/circulationaha.122.062049
Kufner S, Joner M, Schneider S, et al. Neointimal modification with scoring balloon and efficacy of drug‐coated balloon therapy in patients with restenosis in drug‐eluting coronary stents. JACC Cardiovasc Interv. 2017;10(13):1332‐1340. doi:10.1016/j.jcin.2017.04.024
Miura K, Kadota K, Habara S, et al. Five‐year outcomes after paclitaxel‐coated balloon angioplasty for drug‐eluting stent restenosis. Am J Cardiol. 2017;119(3):365‐371. doi:10.1016/j.amjcard.2016.10.030
Cassese S, Byrne RA, Schulz S, et al. Prognostic role of restenosis in 10 004 patients undergoing routine control angiography after coronary stenting. Eur Heart J. 2015;36(2):94‐99. doi:10.1093/eurheartj/ehu383
Aihara K, Torii S, Ito M, et al. Biological differences of three paclitaxel‐ and sirolimus‐coated balloons on coronary lesions in a rabbit model. EuroIntervention. 2024;20(6):e389‐e398. doi:10.4244/eij-d-23-00425