ISSN 1016-5169 | E-ISSN 1308-4488
Archives of the Turkish Society of Cardiology
Twelve-Month Outcomes of a Novel Iopromide-Based Paclitaxel-Coated Balloon for the Treatment of Chronic Total Occlusion of Femoropopliteal Arteries [Turk Kardiyol Dern Ars]
Turk Kardiyol Dern Ars. 2023; 51(2): 112-118 | DOI: 10.5543/tkda.2022.25324

Twelve-Month Outcomes of a Novel Iopromide-Based Paclitaxel-Coated Balloon for the Treatment of Chronic Total Occlusion of Femoropopliteal Arteries

Halil Berkan Özpak1, Cihan Aydın2, Aykut Demirkıran2
1Department of Cardiovascular Surgery, Bandırma Education and Research Hospital, Balıkesir, Türkiye
2Department of Cardiology, Faculty of Medicine Namık Kemal University, Tekirdağ, Türkiye


OBJECTIVE
We designed a retrospective study to evaluate the performance and outcomes of a novel iopromide-based paclitaxel-coated balloon for the treatment of chronic total occlusion of femoropopliteal arteries.


METHODS
Patients with femoropopliteal chronic total occlusion (<100 mm) on angiogram were screened from hospital management system and were included in the study. The width and length of the drug-eluting peripheral balloon was chosen to ensure a vessel/balloon ratio of 1: 1 and exceed the lesion by 10 mm on both ends (based on visual estimation).


RESULTS
The proportion of patients with ankle-brachial index improvement was 89.8% (106 of 118). The mean ankle-brachial index was 0.5 (0.4-0.7) at baseline and 0.8 (0.7-0.9) at 12 months (P < 0.001). Changes in the Rutherford category between baseline and 12 months were statistically significant (P < 0.001), with the majority of patients (77.9%, 92/118) having ≥1 level improvement. The rate of clinically driven target lesion revasculariza-tion at 12 months was 13.5%(16/118). Overall, the 1-year primary patency rate was 86.4% (102 of 118). The major adverse limb event rate was 9.8% (16/162). Acute limb ischemia was detected in 14 patients, and amputation was performed in 2 patients.


CONCLUSION
Our study is a non-randomized clinical study focusing on the use of drug-eluting balloon as a single treatment strategy. There was significant clinical benefit to patients, as clearly demonstrated by the improvement in ankle-brachial index and the reduction in Rutherford class in the short term, and these results may offer clear insights on the revascularization strategy outlook of interventionalists.

Keywords: Angioplasty, ankle-brachial index, chronic total occlusion, coated balloon, interventional cardiology, peripheral arterial disease, Rutherford class

How to cite this article
Halil Berkan Özpak, Cihan Aydın, Aykut Demirkıran. Twelve-Month Outcomes of a Novel Iopromide-Based Paclitaxel-Coated Balloon for the Treatment of Chronic Total Occlusion of Femoropopliteal Arteries. Turk Kardiyol Dern Ars. 2023; 51(2): 112-118

Corresponding Author: Aykut Demirkıran, Türkiye
Manuscript Language: English


Journal Metrics

Journal Citation Indicator: 0.18
CiteScore: 1.1
Source Normalized Impact
per Paper:
0.22
SCImago Journal Rank: 0.348

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