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Long term outcome after treatment of de novo coronary artery lesions using three different drug coated balloons

Venetsanos, D. ; Omerovic, E. ; Sarno, G. ; Pagonis, C. ; Witt, N. ; Calais, F. ; Böhm, F. LU ; Jurga, J. ; Völz, S. and Koul, S. LU , et al. (2021) In International Journal of Cardiology 325.
Abstract

Objective: To evaluate the long-term efficacy of three currently available drug coated balloons (DCB) for the treatment of de-novo coronary lesions. Methods: This was a retrospective analysis of prospectively collected data from the Swedish Coronary Angiography and Angioplasty Registry. Between 2009 and 2017, three currently available DCB brands used in the treatment of de novo lesions were included. Outcomes were clinically driven restenosis and target lesion thrombosis (TLT) (per device) and major adverse cardiac events (MACE) including death, myocardial infarction or target vessel revascularization (per patient) at 4 years. Multivariable Cox regression models were used to adjust for differences. Results: We included 6715 lesions... (More)

Objective: To evaluate the long-term efficacy of three currently available drug coated balloons (DCB) for the treatment of de-novo coronary lesions. Methods: This was a retrospective analysis of prospectively collected data from the Swedish Coronary Angiography and Angioplasty Registry. Between 2009 and 2017, three currently available DCB brands used in the treatment of de novo lesions were included. Outcomes were clinically driven restenosis and target lesion thrombosis (TLT) (per device) and major adverse cardiac events (MACE) including death, myocardial infarction or target vessel revascularization (per patient) at 4 years. Multivariable Cox regression models were used to adjust for differences. Results: We included 6715 lesions treated with DCBs, 4483 SeQuent® Please (S-DCB), 1071 IN.PACT Falcon (I-DCB) and 1161 Pantera® Lux (P-DCB), in 5670 patients. The mean DCB diameter was 2.4 mm. Bailout stenting occurred in 6.7% of lesions. Angiographic success was 98.5%. The overall cumulative rate of restenosis was 5.5% (299 events). The risk for reported restenosis did not significantly differ between I-DCB vs S-DCB, adjusted hazard ratio (aHR) 0.96; 95% confidence interval (CI) 0.69–1.34, P-DCB vs S-DCB aHR 0.88; 95% CI 0.63–1.23 and I-DCB vs P-DCB aHR 1.10; 95% CI 0.72–1.68. The cumulative risk for TLT was 0.8% in all three DCBs. The risk for MACE or individual components of MACE did not differ between the three patient-groups. Conclusion: In de novo coronary lesions, we found comparable long-term efficacy with three currently available DCB brands. DCB angioplasty was feasible with low risk for long-term restenosis and TLT.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
de novo lesions, Drug-coated balloons, Drug-eluting balloons, Restenosis
in
International Journal of Cardiology
volume
325
publisher
Elsevier
external identifiers
  • scopus:85092016972
  • pmid:32980433
ISSN
0167-5273
DOI
10.1016/j.ijcard.2020.09.054
language
English
LU publication?
yes
id
721b22f7-c3d6-46ec-984c-620f73600883
date added to LUP
2020-10-22 16:42:03
date last changed
2024-06-12 21:54:59
@article{721b22f7-c3d6-46ec-984c-620f73600883,
  abstract     = {{<p>Objective: To evaluate the long-term efficacy of three currently available drug coated balloons (DCB) for the treatment of de-novo coronary lesions. Methods: This was a retrospective analysis of prospectively collected data from the Swedish Coronary Angiography and Angioplasty Registry. Between 2009 and 2017, three currently available DCB brands used in the treatment of de novo lesions were included. Outcomes were clinically driven restenosis and target lesion thrombosis (TLT) (per device) and major adverse cardiac events (MACE) including death, myocardial infarction or target vessel revascularization (per patient) at 4 years. Multivariable Cox regression models were used to adjust for differences. Results: We included 6715 lesions treated with DCBs, 4483 SeQuent® Please (S-DCB), 1071 IN.PACT Falcon (I-DCB) and 1161 Pantera® Lux (P-DCB), in 5670 patients. The mean DCB diameter was 2.4 mm. Bailout stenting occurred in 6.7% of lesions. Angiographic success was 98.5%. The overall cumulative rate of restenosis was 5.5% (299 events). The risk for reported restenosis did not significantly differ between I-DCB vs S-DCB, adjusted hazard ratio (aHR) 0.96; 95% confidence interval (CI) 0.69–1.34, P-DCB vs S-DCB aHR 0.88; 95% CI 0.63–1.23 and I-DCB vs P-DCB aHR 1.10; 95% CI 0.72–1.68. The cumulative risk for TLT was 0.8% in all three DCBs. The risk for MACE or individual components of MACE did not differ between the three patient-groups. Conclusion: In de novo coronary lesions, we found comparable long-term efficacy with three currently available DCB brands. DCB angioplasty was feasible with low risk for long-term restenosis and TLT.</p>}},
  author       = {{Venetsanos, D. and Omerovic, E. and Sarno, G. and Pagonis, C. and Witt, N. and Calais, F. and Böhm, F. and Jurga, J. and Völz, S. and Koul, S. and Olivercrona, G. and James, S. and Alfredsson, J.}},
  issn         = {{0167-5273}},
  keywords     = {{de novo lesions; Drug-coated balloons; Drug-eluting balloons; Restenosis}},
  language     = {{eng}},
  publisher    = {{Elsevier}},
  series       = {{International Journal of Cardiology}},
  title        = {{Long term outcome after treatment of de novo coronary artery lesions using three different drug coated balloons}},
  url          = {{http://dx.doi.org/10.1016/j.ijcard.2020.09.054}},
  doi          = {{10.1016/j.ijcard.2020.09.054}},
  volume       = {{325}},
  year         = {{2021}},
}