PMID- 34984489
OWN - NLM
STAT- MEDLINE
DCOM- 20220316
LR  - 20220316
IS  - 1432-086X (Electronic)
IS  - 0174-1551 (Linking)
VI  - 45
IP  - 3
DP  - 2022 Mar
TI  - Cost-Effectiveness of Urea Excipient-Based Drug-Coated Balloons for Chronic 
      Limb-Threatening Ischemia from Femoropopliteal Disease in the Netherlands and 
      Germany.
PG  - 298-305
LID - 10.1007/s00270-021-03050-6 [doi]
AB  - PURPOSE: Drug-coated balloons (DCBs) for femoropopliteal peripheral artery 
      disease have been shown to be clinically superior and cost-effective compared to 
      conventional percutaneous transluminal angioplasty (PTA). However, few studies 
      enrolled patients with chronic limb-threatening ischemia (CLTI). Our objective 
      was to study the cost-effectiveness of endovascular treatment with versus without 
      DCB in CLTI patient populations in the Netherlands and Germany. MATERIAL AND 
      METHODS: Target lesion revascularization (TLR) and major amputation rates were 
      obtained from the CLTI subgroup of the IN.PACT Global study. Rates for "status 
      quo" treatment involving PTA with primary or bailout stenting were derived from 
      systematic literature search. Costs and cost-effectiveness were calculated using 
      a decision-analytic Markov model considering, in the base case, a 2-year horizon, 
      and strategy-specific quality-adjusted life year (QALY) gains calculated from 
      survival and health state-specific utilities. A willingness-to-pay threshold of 
      euro50,000/QALY was assumed, and extensive sensitivity analyses were performed. 
      RESULTS: Model-projected 24-month probabilities of TLR were 26.2% and 32.8% for 
      treatment with and without DCB, and probabilities for amputation were 2.8% and 
      11.9%, respectively. DCB added 0.017 QALYs while saving euro1,030 in the Dutch 
      setting and euro513 in the German setting, respectively. DCB was found dominant or 
      cost-effective across a wide range of assumptions. CONCLUSION: Urea excipient 
      drug-coated balloon therapy for treating CLTI from femoropopliteal artery disease 
      is associated with improved patient outcomes and expected overall cost savings to 
      payers in the Dutch and German healthcare systems, rendering it a cost-effective 
      and likely dominant treatment strategy.
CI  - (c) 2022. Springer Science+Business Media, LLC, part of Springer Nature and the 
      Cardiovascular and Interventional Radiological Society of Europe (CIRSE).
FAU - Pietzsch, Jan B
AU  - Pietzsch JB
AD  - Wing Tech Inc., Menlo Park, CA, USA.
FAU - Geisler, Benjamin P
AU  - Geisler BP
AD  - Wing Tech Inc., Menlo Park, CA, USA.
AD  - Institute for Social Medicine, Epidemiology and Health Economics, Charite - 
      Universitatsmedizin Berlin, Berlin, Germany.
FAU - Iken, Annabelle R
AU  - Iken AR
AD  - Wing Tech Inc., Menlo Park, CA, USA.
FAU - van Wijck, Iris P S
AU  - van Wijck IPS
AD  - Department of Surgery, Rijnstate Hospital, P.O. Box 9555, 6800, TA, Arnhem, The 
      Netherlands.
FAU - Holewijn, Suzanne
AU  - Holewijn S
AD  - Department of Surgery, Rijnstate Hospital, P.O. Box 9555, 6800, TA, Arnhem, The 
      Netherlands.
FAU - Reijnen, Michel M P J
AU  - Reijnen MMPJ
AD  - Department of Surgery, Rijnstate Hospital, P.O. Box 9555, 6800, TA, Arnhem, The 
      Netherlands. mmpj.reijnen@gmail.com.
AD  - Multi-Modality Medical Imaging Group, TechMed Center, University of Twente, 
      Enschede, The Netherlands. mmpj.reijnen@gmail.com.
LA  - eng
PT  - Journal Article
DEP - 20220104
PL  - United States
TA  - Cardiovasc Intervent Radiol
JT  - Cardiovascular and interventional radiology
JID - 8003538
RN  - 0 (Cardiovascular Agents)
RN  - 0 (Coated Materials, Biocompatible)
RN  - 0 (Excipients)
RN  - 8W8T17847W (Urea)
SB  - IM
MH  - *Angioplasty, Balloon
MH  - *Cardiovascular Agents
MH  - Chronic Limb-Threatening Ischemia
MH  - Coated Materials, Biocompatible
MH  - Cost-Benefit Analysis
MH  - Excipients
MH  - Femoral Artery
MH  - Germany
MH  - Humans
MH  - Netherlands
MH  - *Peripheral Arterial Disease/therapy
MH  - Popliteal Artery
MH  - Treatment Outcome
MH  - Urea
MH  - Vascular Patency
OTO - NOTNLM
OT  - Angioplasty [MeSH terms]
OT  - Cost-benefit analysis [MeSH terms]
OT  - Economic/cost-effectiveness
OT  - Germany [MeSH Terms]
OT  - Peripheral Arterial Disease [MeSH terms]
OT  - The Netherlands [MeSH Terms]
EDAT- 2022/01/06 06:00
MHDA- 2022/03/17 06:00
CRDT- 2022/01/05 06:02
PHST- 2021/09/16 00:00 [received]
PHST- 2021/12/18 00:00 [accepted]
PHST- 2022/01/06 06:00 [pubmed]
PHST- 2022/03/17 06:00 [medline]
PHST- 2022/01/05 06:02 [entrez]
AID - 10.1007/s00270-021-03050-6 [pii]
AID - 10.1007/s00270-021-03050-6 [doi]
PST - ppublish
SO  - Cardiovasc Intervent Radiol. 2022 Mar;45(3):298-305. doi: 
      10.1007/s00270-021-03050-6. Epub 2022 Jan 4.