PMID- 36070428
OWN - NLM
STAT- MEDLINE
DCOM- 20240205
LR  - 20240206
IS  - 1708-539X (Electronic)
IS  - 1708-5381 (Print)
IS  - 1708-5381 (Linking)
VI  - 32
IP  - 1
DP  - 2024 Feb
TI  - Efficacy analysis following polymer coated drug eluting stent and bare metal 
      stent deployment for femoropopliteal arterial disease.
PG  - 102-109
LID - 10.1177/17085381221126217 [doi]
AB  - OBJECTIVES: The objective is to assess the performance of the Eluvia polymer 
      coated drug eluting stent (DES) compared to a bare metal stent (BMS) platform in 
      patients with femoropopliteal arterial disease. METHODS: This is a retrospective, 
      single-center analysis. Patients treated with the Eluvia DES (group Eluvia) or 
      the EverFlex BMS (group BMS) for femoropopliteal disease between January 2013 and 
      December 2019 were included. Primary measure outcome of this analysis was the 
      overall mortality. The PTX specific mortality, the primary patency, the 
      amputation free survival (AFS), and the target lesion revascularization (TLR) 
      rates were additionally evaluated. RESULTS: A total of 124 patients were treated 
      by BMS deployment, while the Eluvia platform was preferred in 75 subjects. In 
      both groups the majority presented with lifestyle limiting claudication (BMS: 84% 
      vs Eluvia: 73%, p = 0.73). Chronic total occlusions were more frequent in 
      patients treated by BMS (BMS: 71% vs Eluvia: 84%, p = 0.027), whereas the 
      calcification burden (BMS: 81% vs Eluvia: 76%, p = 0.43) and the median lesion 
      length (in mm, IQR) (BMS: 160 (100 to 240) vs Eluvia: 140 (80 to 229), p = 0.17) 
      were comparable. At 24 months, the overall survival (BMS: 93% vs Eluvia: 89%, 
      hazard ratio (HR): 1.20, 95% confidence interval (CI): 0.55 to 2.64, p = 0.64) 
      and the PTX specific survival (BMS: 95% vs Eluvia: 95%, HR: 1.28, 95% CI: 0.41 to 
      4.02, p = 0.67) did not differ significantly between the two platforms. No 
      significant difference was observed regarding the 24 months primary patency rate 
      (BMS: 66% vs Eluvia: 78%, HR: 0.65, 95% CI: 0.37 to 1.15, p = 0.18), the freedom 
      from TLR (BMS: 83% vs Eluvia: 89%, HR: 0.81, 95% CI: 0.39 to 1.68, p = 0.572), 
      and the AFS (BMS: 93 vs Eluvia: 89%, HR: 1.20, 95% CI: 0.55 to 2.64). The Cox 
      regression analysis revealed a higher mortality risk among patients with chronic 
      limb-threatening ischemia (CLTI) (HR: 3.14, 95% CI: 1.61 to 6.14, p = 0.008), 
      chronic obstructive pulmonary disease (COPD) (HR: 4.65, 95% CI: 2.14 to 10.09, p 
      = 0.001), in octagenerians (HR: 4.40, 95% CI: 1.92 to 10.44, p = 0.005), and in 
      patients not on statins at baseline (HR: 2.44, 95% CI: 1.19 to 4.99, p=0.014). 
      CONCLUSIONS: In this cohort, the use of the Eluvia DES did not increase the risk 
      for mortality compared to BMS deployment. CLTI, COPD, advanced age, and the lack 
      of statin therapy at baseline were associated with a higher risk for death.
FAU - Shehada, Yousef
AU  - Shehada Y
AD  - Department of Vascular and Endovascular Surgery, St. Franziskus Hospital 
      Muenster, Germany. RINGGOLD: 39612
FAU - Bisdas, Theodosios
AU  - Bisdas T
AD  - Department of Vascular Surgery, Athens Medical Center, Athens Greece. RINGGOLD: 
      69046
FAU - Argyriou, Angeliki
AU  - Argyriou A
AD  - Department of Vascular and Endovascular Surgery, Augusta Hospital Duesseldorf, 
      Germany.
FAU - Torsello, Giovanni
AU  - Torsello G
AD  - Department of Vascular and Endovascular Surgery, St. Franziskus Hospital 
      Muenster, Germany. RINGGOLD: 39612
AD  - Department of Vascular and Endovascular Surgery, Augusta Hospital Duesseldorf, 
      Germany.
FAU - Tsilimparis, Nikolaos
AU  - Tsilimparis N
AD  - Department of Vascular and Endovascular Surgery, Ludwig-Maximilians-University 
      Hospital Munich, Germany.
FAU - Beropoulis, Efthymios
AU  - Beropoulis E
AUID- ORCID: 0000-0003-1338-750X
AD  - Department of Vascular and Endovascular Surgery, St. Franziskus Hospital 
      Muenster, Germany. RINGGOLD: 39612
FAU - Stavroulakis, Konstantinos
AU  - Stavroulakis K
AUID- ORCID: 0000-0002-9775-9210
AD  - Department of Vascular and Endovascular Surgery, Ludwig-Maximilians-University 
      Hospital Munich, Germany.
LA  - eng
PT  - Journal Article
DEP - 20220907
PL  - England
TA  - Vascular
JT  - Vascular
JID - 101196722
RN  - 0 (Polymers)
RN  - P88XT4IS4D (Paclitaxel)
SB  - IM
MH  - Humans
MH  - Femoral Artery/diagnostic imaging
MH  - Popliteal Artery/diagnostic imaging
MH  - *Drug-Eluting Stents
MH  - Polymers
MH  - Retrospective Studies
MH  - Paclitaxel
MH  - *Peripheral Arterial Disease/therapy/drug therapy
MH  - Vascular Patency
MH  - Stents
MH  - *Pulmonary Disease, Chronic Obstructive
MH  - Treatment Outcome
PMC - PMC10838477
OTO - NOTNLM
OT  - Mortality
OT  - PAD
OT  - femoropopliteal
OT  - paclitaxel
OT  - scaffolds
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- 2022/09/08 06:00
MHDA- 2024/02/05 06:42
PMCR- 2024/02/04
CRDT- 2022/09/07 14:33
PHST- 2024/02/05 06:42 [medline]
PHST- 2022/09/08 06:00 [pubmed]
PHST- 2022/09/07 14:33 [entrez]
PHST- 2024/02/04 00:00 [pmc-release]
AID - 10.1177_17085381221126217 [pii]
AID - 10.1177/17085381221126217 [doi]
PST - ppublish
SO  - Vascular. 2024 Feb;32(1):102-109. doi: 10.1177/17085381221126217. Epub 2022 Sep 
      7.