TY - JOUR
T1 - Comparative Effectiveness Study of Drug-Eluting and Bare-Metal Peripheral Artery Stents in Endovascular Femoropopliteal Artery Revascularization
AU - Jeon-Slaughter, Haekyung
AU - Khalili, Houman
AU - Tsai, Shirling
AU - Armstrong, Ehrin J.
AU - Shammas, Nicolas W.
AU - Jawaid, Omar
AU - Lu, Hua
AU - Addo, Tayo
AU - Gigliotti, Osvaldo
AU - Abu-Fadel, Mazen
AU - Banerjee, Subhash
N1 - Funding Information:
would like to acknowledge the contributions of Mazin Fo-teh, MD, Mujtaba Ali, MD, Ian Cawich, MD, Gerardo Rodriguez, MD, PhD, Dharam Kumbhani, MD, Michael Luna, MD, and Tony S. Das, MD for their contributions to the XLPAD registry. We also acknowledge the support of the University of Texas Southwestern Medical Center for their support in establishing and managing the REDCap database software utilized in the XLPAD registry (Academic Information Systems NIH grant UL1-RR024982).
Publisher Copyright:
© 2018 HMP Communications.
PY - 2018/10
Y1 - 2018/10
N2 - OBJECTIVES: Paclitaxel drug-eluting stents (DESs) have been shown to improve primary patency of femoropopliteal lesions compared to plain balloon angioplasty with provisional bare-metal stents (BMSs) in randomized controlled studies. However, data are lacking on patency outcomes of real-world DES use relative to BMS use. This study compared clinically driven target-lesion revascularization (TLR), target-vessel revascularization (TVR), and target-limb revascularization outcomes at 1 year between DES and BMS treatments in a real-world setting. METHODS: The study identified 174 DES (Zilver PTX; Cook Medical) and 784 BMS femoropopliteal interventions from the available 969 Excellence in Peripheral Artery Disease (XLPAD) registry patients between October 2013 and December 2016. We analyzed both unmatched (174 DES and 784 BMS) and propensity score (PS)-matched datasets (174 for each). RESULTS: This study found that patients who underwent DES femoropopliteal endovascular revascularization had significantly lower TLR rates in both unmatched (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.35-0.91; P≤.02) and matched data (HR, 0.50 95% CI, 0.27-0.91; P≤.02). The DES group had a 43% lower TVR risk than the BMS group in the PS matched cohort (HR, 0.57; 95% CI, 0.33-0.98; P≤.04). Mortality rate in the DES group (5%) was significantly higher than the BMS group in both unmatched (2%; P≤.04) and matched groups (1%; P≤.046) at 1 year. CONCLUSIONS: Patients treated with DES had higher lesion and vessel patency than BMS after adjusting for confounding, which included complexity of lesion characteristics and operators' clinical decision-making regarding selection of treatment modalities, in femoropopliteal endovascular interventions in a real-world registry.
AB - OBJECTIVES: Paclitaxel drug-eluting stents (DESs) have been shown to improve primary patency of femoropopliteal lesions compared to plain balloon angioplasty with provisional bare-metal stents (BMSs) in randomized controlled studies. However, data are lacking on patency outcomes of real-world DES use relative to BMS use. This study compared clinically driven target-lesion revascularization (TLR), target-vessel revascularization (TVR), and target-limb revascularization outcomes at 1 year between DES and BMS treatments in a real-world setting. METHODS: The study identified 174 DES (Zilver PTX; Cook Medical) and 784 BMS femoropopliteal interventions from the available 969 Excellence in Peripheral Artery Disease (XLPAD) registry patients between October 2013 and December 2016. We analyzed both unmatched (174 DES and 784 BMS) and propensity score (PS)-matched datasets (174 for each). RESULTS: This study found that patients who underwent DES femoropopliteal endovascular revascularization had significantly lower TLR rates in both unmatched (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.35-0.91; P≤.02) and matched data (HR, 0.50 95% CI, 0.27-0.91; P≤.02). The DES group had a 43% lower TVR risk than the BMS group in the PS matched cohort (HR, 0.57; 95% CI, 0.33-0.98; P≤.04). Mortality rate in the DES group (5%) was significantly higher than the BMS group in both unmatched (2%; P≤.04) and matched groups (1%; P≤.046) at 1 year. CONCLUSIONS: Patients treated with DES had higher lesion and vessel patency than BMS after adjusting for confounding, which included complexity of lesion characteristics and operators' clinical decision-making regarding selection of treatment modalities, in femoropopliteal endovascular interventions in a real-world registry.
KW - Drug-eluting stent
KW - Endovascular revascularization
KW - Peripheral artery disease
KW - Propensity score matching
KW - Stent
KW - Zilver PTX
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UR - http://www.scopus.com/inward/citedby.url?scp=85054399051&partnerID=8YFLogxK
M3 - Article
C2 - 30279293
AN - SCOPUS:85054399051
SN - 1042-3931
VL - 30
SP - 373
EP - 379
JO - Journal of Invasive Cardiology
JF - Journal of Invasive Cardiology
IS - 10
ER -