Defining Thresholds for Meaningful Health Status Changes Following Transfemoral Carotid Artery Stenting

Area of Science:

• Vascular Surgery
• Health Outcomes Research
• Interventional Cardiology

Background:

• Assessing health status changes after transfemoral carotid artery stenting (TF-CAS) is crucial for evaluating success.
• Minimal clinically important differences (MCIDs) for health status after TF-CAS remain largely unknown.
• This study aimed to define MCIDs and quantify health status changes following TF-CAS.

Purpose of the Study:

• To determine minimal clinically important differences (MCIDs) for health status after TF-CAS.
• To quantify the rates of health status improvement or worsening at 30 days post-TF-CAS.
• To utilize data from the Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) registry.

Main Methods:

• The SAPPHIRE registry data (2010-2014) included patients undergoing TF-CAS.
• Health status was assessed using SF-36 (2010-2012) and EQ-5D (2012-2014) at baseline and 30 days.
• Distribution-based MCIDs were calculated (0.5 * SD of baseline), and changes were categorized as improved, unchanged, or worsened.

Main Results:

• Health status was evaluated in 3930 (EQ-5D) and 3018 (SF-36) patients.
• Weighted MCIDs were established: 0.09 (EQ-5D Index), 11.00 (VAS), 4.70 (PCS), and 5.40 (MCS).
• At 30 days, 21.2%-26.1% improved, 10.5%-16.7% worsened, and 57.2%-66.1% remained unchanged.

Conclusions:

• Thresholds for meaningful health status changes after TF-CAS were established using generic instruments.
• Approximately 70%-80% of patients experienced no change or worsening in health status at 30 days post-TF-CAS.
• A carotid artery disease-specific instrument may offer better insights into TF-CAS effects on patient health status.