Drug-coated balloon angioplasty: predicting outcomes based on different patterns of drug-eluting stent restenosis
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Although drug-coated balloon (DCB) angioplasty is an effective therapy for drug-eluting stent- in stent restenosis (DES-ISR) after coronary stenting, recurrent ISR after DCB angioplasty still occurs. Different patterns of DES-ISR responding to DCB are largely unknown. This study sought to assess outcomes of different patterns of DES-ISR treated with DCB. From December 2014 to December 2016, a total of 160 DES-ISR lesions treated with DCB were retrospectively evaluated. Restenosis patterns were classified into two groups according to Mehran classification: focal, defined as < 10 mm, 58 lesions (36.3%); non-focal, which were diffuse, proliferative, or obstructive, 102 lesions (63.7%). The primary endpoint was binary restenosis rate at 9-month angiographic follow-up. Secondary endpoint was major adverse cardiac events (MACE) at 24-month follow-up. Baseline characteristics were comparable between the two groups. Angiographic follow-up rate was 93.7% (93.1% in the focal group and 94.1% in the non-focal group). The focal group had a lower recurrent restenosis rate compared to the non-focal group (3.7% vs. 33.3%, respectively; P = 0.003) at an average angiographic follow-up of 10 (10.4 ± 6.2) months. There was no difference in MACE between the two groups (6.9% vs. 11.8%, respectively; P = 0.70) at (22.7 ± 9.1) months clinical follow-up. On multivariate logistic regression analysis, focal pattern (OR 13.033; 95% CI 2.441–69.573, P = 0.003) and post-procedure DS% (OR 1.142; 95% CI 1.070–1.218, P = 0.000) were predictive factors of binary restenosis after DCB angioplasty. On multivariate analysis, focal pattern of ISR was a predictive factor of MACE (OR 0.260; 95% CI 0.071–0.959, P = 0.043), and diabetes mellitus (DM) was an independent predictor of MACE after DCB angioplasty (OR 5.045; 95% CI 1.179–21.590, P = 0.029). The present study suggests that DCB provides much better clinical, angiographic outcomes in patients with focal DES-ISR than non-focal DES-ISR.
KeywordsIn-stent restenosis Drug-coated balloon Drug-eluting stent Recurrent in-stent restenosis
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Conflict of interest
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
- 5.Byrne RA, Neumann FJ, Mehilli J et al (2013) ISAR-DESIRE 3 investigators. Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3): a randomized, open-label trial. Lancet 381:461–467CrossRefGoogle Scholar
- 7.Kolh P, Windecker S, Alfonso F et al (2014) 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 J Cardiothorac Surg 46:517–592CrossRefGoogle Scholar
- 9.Alfonso F, Pérez-Vizcayno MJ, Hernandez R et al (2006) A randomized comparison of sirolimus-eluting stent with balloon angioplasty in patients with in-stent restenosis: results of the restenosis intrastent: balloon angioplasty versus elective sirolimus-eluting stenting (RIBS-II) trial. J Am Coll Cardiol 47:2152–2160CrossRefGoogle Scholar
- 20.Alfonso F, Pérez-Vizcayno MJ, Cárdenas A, for the RIBS IV Study Investigators (under the auspices of the Interventional Cardiology Working Group of the Spanish Society of Cardiology), et al (2015) A prospective randomized trial of drug-eluting balloons versus everolimus-eluting stents in patients with in-stent restenosis of drug-eluting stents: the RIBS IV randomized clinical trial. J Am Coll Cardiol 66:23–33Google Scholar