open access

Online first
Original article
Published online: 2022-04-21
Get Citation

Long-term outcomes following drug-eluting balloons versus thin-strut drug-eluting stents for treatment of recurrent restenosis in drug-eluting stents

Rafał Wolny1, Ilona Kowalik2, Rafał Januszek3, Jacek Bil4, Tomasz Figatowski5, Marek Milewski6, Brunon Tomasiewicz7, Tomasz Walczak8, Bruno Hrymniak8, Piotr Desperak8, Piotr Niezgoda9, Magdalena Chudzik10, Łukasz Kuźma11, Paweł Kralisz11, Fabrizio D'Ascenzo12, Damian Hudziak13, Miłosz Jaguszewski5, Krzysztof Reczuch7, Jacek Kubica9, Robert J Gil4, Sławomir Dobrzycki11, Stanisław Bartuś3, Mariusz Gąsior8, Andrzej Ochała6, Adam Witkowski1, Wojciech Wojakowski6, Wojciech Wańha6
DOI: 10.33963/KP.a2022.0106
·
Pubmed: 35445739
Affiliations
  1. Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warszawa, Poland
  2. Department of Biostatistics, National Institute of Cardiology, Warszawa, Poland
  3. 2nd Department of Cardiology, Jagiellonian University Medical College, Kraków, Poland
  4. Department of Invasive Cardiology, Center of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration, Warszawa, Poland
  5. 1st Department of Cardiology, Medical University of Gdansk, Gdańsk, Poland
  6. Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
  7. Institute of Heart Diseases, Wroclaw Medical University, Wrocław, Poland
  8. 3rd Department of Cardiology, School of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland
  9. Department of Cardiology and Internal Medicine, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland
  10. Medical University of Warsaw, Warszawa, Poland
  11. Department of Invasive Cardiology, Medical University of Bialystok, Białystok, Poland
  12. Division of Cardiology, Department of Internal Medicine, Città della Salute e della Scienza, University of Turin, Turin, Italy
  13. Department of Cardiac Surgery, Medical University of Silesia, Katowice, Poland

open access

Online first
Original article
Published online: 2022-04-21

Abstract

BACKGROUND: There is limited data on the optimal revascularization strategy in patients with recurrent in-stent restenosis (R-ISR).

AIMS: To compare the long-term outcomes of patients treated with either a thin-strut DES (thin-DES) or a drug-eluting balloon (DEB) for R-ISR in a drug-eluting stent (DES).

METHODS: A multicenter DEB-DRAGON registry was used to retrospectively identify patients with R-ISR who received either a thin-DES or a DEB. Propensity score matching was applied to adjust for baseline differences. Primary outcome was target lesion revascularization (TLR).

RESULTS: Out of 311 patients (mean age 67 years, 63% male) with R-ISR, 86 (27.7%) were treated with a thin-DES and 225 (72.3%) with a DEB. Median follow-up was 2.6 years. TLR occurred in 18 (20.9%) of patients who received thin-DES and 61 (27.1%) patients treated with DEB (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.33–0.98; log-rank P = 0.04). The difference remained significant in a propensity score-matched cohort of 57 patients treated with thin-DES and 57 patients treated with a DEB (17.5 vs. 33.3% respectively; HR, 0.38; 95% CI, 0.17–0.86; P = 0.01). The risks of device oriented adverse cardiac events and all-cause mortality were similar after thin-DES or DEB in both unadjusted and propensity score-matched cohorts. In a multivariable Cox proportional hazard model the treatment with a thin-DES was an independent predictor of a TLR-free survival (HR, 0.33; 95% CI 0.13–0.84; P = 0.02).

CONCLUSIONS: In patients with R-ISR implantation of a thin-DES is associated with lower risk of repeated revascularization compared with angioplasty with a DEB.

Abstract

BACKGROUND: There is limited data on the optimal revascularization strategy in patients with recurrent in-stent restenosis (R-ISR).

AIMS: To compare the long-term outcomes of patients treated with either a thin-strut DES (thin-DES) or a drug-eluting balloon (DEB) for R-ISR in a drug-eluting stent (DES).

METHODS: A multicenter DEB-DRAGON registry was used to retrospectively identify patients with R-ISR who received either a thin-DES or a DEB. Propensity score matching was applied to adjust for baseline differences. Primary outcome was target lesion revascularization (TLR).

RESULTS: Out of 311 patients (mean age 67 years, 63% male) with R-ISR, 86 (27.7%) were treated with a thin-DES and 225 (72.3%) with a DEB. Median follow-up was 2.6 years. TLR occurred in 18 (20.9%) of patients who received thin-DES and 61 (27.1%) patients treated with DEB (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.33–0.98; log-rank P = 0.04). The difference remained significant in a propensity score-matched cohort of 57 patients treated with thin-DES and 57 patients treated with a DEB (17.5 vs. 33.3% respectively; HR, 0.38; 95% CI, 0.17–0.86; P = 0.01). The risks of device oriented adverse cardiac events and all-cause mortality were similar after thin-DES or DEB in both unadjusted and propensity score-matched cohorts. In a multivariable Cox proportional hazard model the treatment with a thin-DES was an independent predictor of a TLR-free survival (HR, 0.33; 95% CI 0.13–0.84; P = 0.02).

CONCLUSIONS: In patients with R-ISR implantation of a thin-DES is associated with lower risk of repeated revascularization compared with angioplasty with a DEB.

Get Citation

Keywords

recurrent in-stent restenosis, drug-eluting stent, drug-eluting balloon, percutaneous coronary intervention, revascularization

Supp./Additional Files (1)
Supplementary material
Download
44KB
About this article
Title

Long-term outcomes following drug-eluting balloons versus thin-strut drug-eluting stents for treatment of recurrent restenosis in drug-eluting stents

Journal

Kardiologia Polska (Polish Heart Journal)

Issue

Online first

Article type

Original article

Published online

2022-04-21

Page views

94

Article views/downloads

61

DOI

10.33963/KP.a2022.0106

Pubmed

35445739

Keywords

recurrent in-stent restenosis
drug-eluting stent
drug-eluting balloon
percutaneous coronary intervention
revascularization

Authors

Rafał Wolny
Ilona Kowalik
Rafał Januszek
Jacek Bil
Tomasz Figatowski
Marek Milewski
Brunon Tomasiewicz
Tomasz Walczak
Bruno Hrymniak
Piotr Desperak
Piotr Niezgoda
Magdalena Chudzik
Łukasz Kuźma
Paweł Kralisz
Fabrizio D'Ascenzo
Damian Hudziak
Miłosz Jaguszewski
Krzysztof Reczuch
Jacek Kubica
Robert J Gil
Sławomir Dobrzycki
Stanisław Bartuś
Mariusz Gąsior
Andrzej Ochała
Adam Witkowski
Wojciech Wojakowski
Wojciech Wańha

References (19)
  1. 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.
  2. Konigstein M, Madhavan MV, Ben-Yehuda O, et al. Incidence and predictors of target lesion failure in patients undergoing contemporary DES implantation-Individual patient data pooled analysis from 6 randomized controlled trials. Am Heart J. 2019; 213: 105–111.
  3. Theodoropoulos K, Mennuni MG, Dangas GD, et al. Resistant in-stent restenosis in the drug eluting stent era. Catheter Cardiovasc Interv. 2016; 88(5): 777–785.
  4. Giacoppo D, Gargiulo G, Aruta P, et al. Treatment strategies for coronary in-stent restenosis: systematic review and hierarchical Bayesian network meta-analysis of 24 randomised trials and 4880 patients. BMJ. 2015; 351: h5392.
  5. Lee JH, Kim U, Kim JS, et al. Clinical implication of neointimal burden in in-stent restenosis treated with drug-coated balloon. Catheter Cardiovasc Interv. 2021; 98(3): 493–502.
  6. Katsanos K, Spiliopoulos S, Kitrou P, et al. Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: a systematic review and meta-analysis of randomized controlled trials. J Am Heart Assoc. 2018; 7(24): e011245.
  7. Neumann FJ, Sousa-Uva M, Ahlsson A, et al. Considerations for the choice between coronary artery bypass grafting and percutaneous coronary intervention as revascularization strategies in major categories of patients with stable multivessel coronary artery disease: an accompanying article of the task force of the 2018 ESC/EACTS guidelines on myocardial revascularization. Eur Heart J. 2019; 40(2): 204–212.
  8. Siontis GCM, Stefanini GG, Mavridis D, et al. Percutaneous coronary interventional strategies for treatment of in-stent restenosis: a network meta-analysis. Lancet. 2015; 386(9994): 655–664.
  9. Garcia-Garcia HM, McFadden EP, Farb A, et al. Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018; 137(24): 2635–2650.
  10. Kubo S, Kadota K, Otsuru S, et al. Optimal treatment of recurrent restenosis lesions after drug-eluting stent implantation for in-stent restenosis lesions. EuroIntervention. 2013; 9(7): 788–796.
  11. Kawamoto H, Ruparelia N, Latib A, et al. Drug-Coated balloons versus second-generation drug-eluting stents for the management of recurrent multimetal-layered in-stent restenosis. JACC Cardiovasc Interv. 2015; 8(12): 1586–1594.
  12. Smits PC, Vlachojannis GJ, McFadden EP, et al. Final 5-Year Follow-Up of a Randomized Controlled Trial of Everolimus- and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice: The COMPARE Trial (A Trial of Everolimus-Eluting Stents and Paclitaxel Stents for Coronary Revascularization in Daily Practice). JACC Cardiovasc Interv. 2015; 8(9): 1157–1165.
  13. Wańha W, Bil J, Januszek R, et al. Long-Term outcomes following drug-eluting balloons versus thin-strut drug-eluting stents for treatment of in-stent restenosis (deb-dragon-registry). Circ Cardiovasc Interv. 2021; 14(9): e010868.
  14. Wang G, Zhao Q, Chen Q, et al. Comparison of drug-eluting balloon with repeat drug-eluting stent for recurrent drug-eluting stent in-stent restenosis. Coron Artery Dis. 2019; 30(7): 473–480.
  15. Fujino A, Mintz GS, Matsumura M, et al. A new optical coherence tomography-based calcium scoring system to predict stent underexpansion. EuroIntervention. 2018; 13(18): e2182–e2189.
  16. Rocha-Singh KJ, Duval S, Jaff MR, et al. Mortality and paclitaxel-coated devices: an individual patient data meta-analysis. Circulation. 2020; 141(23): 1859–1869.
  17. Scheller B, Vukadinovic D, Jeger R, et al. Survival after coronary revascularization with paclitaxel-coated balloons. J Am Coll Cardiol. 2020; 75(9): 1017–1028.
  18. Shlofmitz E, Case BC, Chen Y, et al. Waksman in-stent restenosis classification: a mechanism-based approach to the treatment of restenosis. Cardiovasc Revasc Med. 2021; 33: 62–67.
  19. Zabojszcz M, Januszek R, Siudak Z, et al. Association between the mortality rate and operator volume in patients undergoing emergency or elective percutaneous coronary interventions. Kardiol Pol. 2020; 78(2): 138–146.

Regulations

Important: This website uses cookies. More >>

The cookies allow us to identify your computer and find out details about your last visit. They remembering whether you've visited the site before, so that you remain logged in - or to help us work out how many new website visitors we get each month. Most internet browsers accept cookies automatically, but you can change the settings of your browser to erase cookies or prevent automatic acceptance if you prefer.

By VM Media Sp. z o.o. VM Group Sp.k., ul. Świętokrzyska 73 , 80–180 Gdańsk, Poland

phone:+48 58 320 94 94, fax:+48 58 320 94 60, e-mail: viamedica@viamedica.pl