Article ; Online: Treatment of Femoropopliteal Artery Disease with Polymer-Coated Drug-Eluting Stent: 5-Year Results of a Prospective, Non-Randomized Study Including the Halo Phenomenon.
Cardiovascular and interventional radiology
2024 Volume 47, Issue 2, Page(s) 177–185
Abstract: Purpose: To investigate the long-term results of the Eluvia drug-eluting stent (DES) implantation for femoropopliteal arterial disease, including the 'halo' phenomenon. Long-term data of DES is scarce. A focal reaction ('halo') following Eluvia DES ... ...
| Abstract | Purpose: To investigate the long-term results of the Eluvia drug-eluting stent (DES) implantation for femoropopliteal arterial disease, including the 'halo' phenomenon. Long-term data of DES is scarce. A focal reaction ('halo') following Eluvia DES deployment has been described. However, the long-term clinical impact of this phenomenon remains unclear. Methods: This prospective, non-randomized, single-arm study included 130 consecutive patients treated with an Eluvia DES for symptomatic femoropopliteal disease between March 2016 and December 2018. Clinical outcomes and imaging were assessed after 6 months and annually thereafter for up to 5 years. The primary outcome measure was primary patency. Secondary outcomes were freedom from clinically driven target lesion revascularization (CD-TLR), freedom from major amputation, overall survival and amputation-free survival rates. Results: The primary patency was 65% at 5 years. The freedom from CD-TLR and from major amputation at 5 years was 79 and 96%, respectively. The overall survival and amputation-free survival rates were 88 and 83% at 60 months, respectively. Out of the 27 patients with a halo sign, two showed an increased (7.4%) and 6 (22.2%) a decreased diameter. In 19 cases (70.4%), the diameter remained unchanged at the latest follow-up. The presence of the 'halo' sign was associated with increased primary patency (87% versus 59%, HR: 2.48, 95%CI 1.19-5.16, P = .015). Conclusions: The presented patient cohort treated with the Eluvia DES for femoropopliteal artery lesions indicates durable efficacy and a good safety profile regardless of the halo phenomenon. The results need to be confirmed in a larger patient cohort. Level of evidence iii: Non-randomized controlled cohort/follow-up study. |
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| MeSH term(s) | Humans ; Femoral Artery/diagnostic imaging ; Femoral Artery/pathology ; Popliteal Artery/diagnostic imaging ; Popliteal Artery/pathology ; Drug-Eluting Stents ; Follow-Up Studies ; Treatment Outcome ; Paclitaxel/therapeutic use ; Prospective Studies ; Polymers ; Peripheral Arterial Disease/diagnostic imaging ; Peripheral Arterial Disease/therapy ; Vascular Patency |
| Chemical Substances | Paclitaxel (P88XT4IS4D) ; Polymers |
| Language | English |
| Publishing date | 2024-01-16 |
| Publishing country | United States |
| Document type | Journal Article |
| ZDB-ID | 603082-8 |
| ISSN | 1432-086X ; 0342-7196 ; 0174-1551 |
| ISSN (online) | 1432-086X |
| ISSN | 0342-7196 ; 0174-1551 |
| DOI | 10.1007/s00270-023-03652-2 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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