The Association of Major Adverse LIMB Events and Combination Stent and Atherectomy in Patients Undergoing Revascularization for Lower Extremity Peripheral Artery Disease

Author(s)

Gressler L1, Marinac-Dabic D2, Dosreis S3, Goodney P4, Mullins CD3, Shaya FT1
1University of Maryland, Baltimore, MD, USA, 2U.S. Food and Drug Administration, Silver Spring, MD, USA, 3University of Maryland School of Pharmacy, Baltimore, MD, USA, 4Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA

OBJECTIVES : The effectiveness of combined atherectomy and stenting relative to use of each procedure alone for the treatment of lower extremity peripheral artery disease has not been evaluated. The objective of this study was to evaluate the short- and long-term major adverse limb event (MALE) following the receipt of stent, atherectomy, and the combination of stent and atherectomy.

METHODS : A retrospective cohort of patients undergoing atherectomy, stent, and combination stent atherectomy for lower extremity peripheral artery disease was derived from the Vascular Quality Initiative (VQI) dataset. The primary outcome was MALE and was assessed in the short-term and long-term. Short-term MALE was assessed immediately following the procedure to discharge and estimated using logistic regression. Long-term MALE was assessed after discharge to end of follow-up and estimated using the Fine-Gray subdistribution hazard model.

RESULTS : Among the 46108 included patients, 6896 (14.95%) underwent atherectomy alone, 35774 (77.59%) received a stent, and 3438 (7.5%) underwent a combination of stent and atherectomy. The adjusted model indicated a significantly higher odds of short-term MALE in the atherectomy group (OR=1.34; 95%CI:1.16-1.56), and not significantly different odds (OR=0.94;95%CI:0.77-1.14) in the combination stent and atherectomy group when compared to stent alone. With regards to long-term MALE, the model indicated that the likelihood of experiencing the outcome was slightly lower (HR=0.90; 95%CI:0.82-0.98) in the atherectomy group, and not significantly different (HR=0.92; 95%CI:0.82-1.04) in the combination stent and atherectomy group when compared to the stent group.

CONCLUSIONS : Patients receiving combination stent and atherectomy do not experience significantly different rates of MALE from stent alone. These findings may indicate that the appropriate patient population is receiving the combined treatment. The combined treatment may be needed to ensure the risk of amputation among these patients is similar to those receiving stent alone.

Conference/Value in Health Info

2021-05, ISPOR 2021, Montreal, Canada

Value in Health, Volume 24, Issue 5, S1 (May 2021)

Code

PMD21

Topic

Clinical Outcomes, Epidemiology & Public Health, Medical Technologies

Topic Subcategory

Clinical Outcomes Assessment, Comparative Effectiveness or Efficacy, Medical Devices, Safety & Pharmacoepidemiology

Disease

Medical Devices, Surgery

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