PMID- 38084379
OWN - NLM
STAT- Publisher
LR  - 20231212
IS  - 1545-1550 (Electronic)
IS  - 1526-6028 (Linking)
DP  - 2023 Dec 12
TI  - Sirolimus-Coated Balloon in Femoropopliteal Steno-Occlusive Disease: Efficacy, 
      Safety, and 1-Year Outcomes. An All-Comers Registry.
PG  - 15266028231217657
LID - 10.1177/15266028231217657 [doi]
AB  - PURPOSE: The aim of this study was to assess the efficacy and safety of the novel 
      SLR (SELUTION sustained-limus-release) drug-coated balloon (DCB) in the treatment 
      of the femoropopliteal steno-occlusive disease. MATERIALS AND METHODS: From 
      February 2021 to March 2022, 80 consecutive patients (age: 69.5+/-8.23 years; total 
      number of lesions: 80) with a steno-occlusive lesion of superficial femoral 
      artery were enrolled at our center. A total of 60 patients (75%) had 
      claudication, whereas 20 (25%) had chronic limb-threatening ischemia (CLTI). The 
      mean lesion length was 171+/-82.22 mm. The primary efficacy outcome was primary 
      patency at 12 months, defined as freedom from restenosis determined by a duplex 
      ultrasound peak systolic velocity ratio </=2.4. The secondary efficacy outcome was 
      freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 
      months. The primary safety outcome was a composite of freedom from device- and 
      procedure-related mortality, major target limb amputation, and clinically-driven 
      target lesion urgent revascularization (endovascular or bypass graft) at 30 days 
      and 12 months. RESULTS: Device success was achieved in all 80 patients. One death 
      on day 7 from cardiovascular complications was ruled procedure-related because it 
      occurred within the first 30 days from the discharge. Two patients with CLTI 
      experienced planned minor amputations of target limb, and one patient underwent 
      urgent bypass graft of the target vessel for early occlusion at 60 days from the 
      index procedure. The primary safety outcome was 98.7% and 97.5% at 30 days and 12 
      months, respectively. At 1 year, primary patency was 86.3%, and freedom from 
      CD-TLR was 96.2%. CONCLUSION: These findings suggest that using a novel 
      sirolimus-coated balloon is a safe and effective treatment option for 
      femoropopliteal steno-occlusive lesions in a variety of clinical and anatomical 
      settings. These results will need to be confirmed by long-term follow-up and 
      randomized controlled trials. CLINICAL IMPACT: In femoropopliteal steno-occlusive 
      lesions paclitaxel drug-coated devices have been proved to be able to achieve a 
      better vessel patency during follow-up compared with uncoated balloon, but 
      according to a recent meta-analysis they may carry an elevated risk of late 
      mortality. Sirolimus results in a wider therapeutic range with a 3-fold higher 
      margin of safety. Sirolimus coated devices have recently been proposed as an 
      alternative. This study suggests that using a novel sirolimus-coated balloon is a 
      safe and effective treatment option for femoropopliteal steno-occlusive lesions.
FAU - Franzese, Michele
AU  - Franzese M
AUID- ORCID: 0009-0009-4193-3361
AD  - Catheterization Laboratory, Montevergine Clinic, Mercogliano, Italy.
FAU - Pucciarelli, Armando
AU  - Pucciarelli A
AD  - Catheterization Laboratory, Montevergine Clinic, Mercogliano, Italy.
FAU - Spione, Francesco
AU  - Spione F
AD  - Catheterization Laboratory, Montevergine Clinic, Mercogliano, Italy.
AD  - Department of Advanced Biomedical Sciences, University of Naples Federico II, 
      Napoli, Italy.
FAU - Salemme, Luigi
AU  - Salemme L
AD  - Catheterization Laboratory, Montevergine Clinic, Mercogliano, Italy.
FAU - Popusoi, Grigore
AU  - Popusoi G
AD  - Catheterization Laboratory, Montevergine Clinic, Mercogliano, Italy.
FAU - Ferrone, Marco
AU  - Ferrone M
AD  - Catheterization Laboratory, Montevergine Clinic, Mercogliano, Italy.
FAU - Gioia, Giuseppe Di
AU  - Gioia GD
AD  - Catheterization Laboratory, Montevergine Clinic, Mercogliano, Italy.
FAU - Raj, Enrico Rathina
AU  - Raj ER
AD  - Department of Clinical and Molecular Medicine, Sapienza University of Rome, Rome, 
      Italy.
FAU - Verdoliva, Sebastiano
AU  - Verdoliva S
AD  - Catheterization Laboratory, Montevergine Clinic, Mercogliano, Italy.
FAU - Stabile, Eugenio
AU  - Stabile E
AD  - Cardiovascular Department, Azienda Ospedaliera Regionale San Carlo, Potenza, 
      Italy.
FAU - Tesorio, Tullio
AU  - Tesorio T
AD  - Catheterization Laboratory, Montevergine Clinic, Mercogliano, Italy.
FAU - Cioppa, Angelo
AU  - Cioppa A
AUID- ORCID: 0000-0003-4324-4227
AD  - Catheterization Laboratory, Montevergine Clinic, Mercogliano, Italy.
LA  - eng
PT  - Journal Article
DEP - 20231212
PL  - United States
TA  - J Endovasc Ther
JT  - Journal of endovascular therapy : an official journal of the International 
      Society of Endovascular Specialists
JID - 100896915
SB  - IM
OTO - NOTNLM
OT  - LEAD
OT  - femoropopliteal disease
OT  - percutaneous transluminal angioplasty
OT  - sirolimus-coated balloon
COIS- Declaration of Conflicting InterestsThe author(s) declared no potential conflicts 
      of interest with respect to the research, authorship, and/or publication of this 
      article.
EDAT- 2023/12/12 06:42
MHDA- 2023/12/12 06:42
CRDT- 2023/12/12 03:43
PHST- 2023/12/12 06:42 [medline]
PHST- 2023/12/12 06:42 [pubmed]
PHST- 2023/12/12 03:43 [entrez]
AID - 10.1177/15266028231217657 [doi]
PST - aheadofprint
SO  - J Endovasc Ther. 2023 Dec 12:15266028231217657. doi: 10.1177/15266028231217657.