Health-related quality of life following carotid stenting versus endarterectomy: results from the SAPPHIRE (Stenting and Angioplasty with Protection in Patients at HIgh Risk for Endarterectomy) trial.

Objectives: This study compared health-related quality of life in patients undergoing carotid artery stenting (CAS) versus surgical endarterectomy (CEA).

Background: Carotid artery stenting is approved in the U.S. for treating carotid stenosis in patients at high surgical risk. Whether CAS offers advantages in terms of other patient-centered outcomes is unknown.

Methods: We evaluated health-related quality of life in the SAPPHIRE (Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy) trial, which randomized 334 high-risk patients with carotid stenosis to CAS versus CEA. Health status assessments were obtained at baseline; 2 weeks; and 1, 6, and 12 months after revascularization. Generic measures included the Short-Form-36 (SF-36) (0 to 100 scale), general health rating, and EuroQol (EQ-5D). In addition, we used 6 disease-specific modified Likert scales to assess difficulty with walking, eating/swallowing, driving, headaches, neck pain, and leg pain.

Results: In patients treated according to protocol (n = 159 CAS; n = 151 CEA), CAS patients had better scores at 2 weeks for the SF-36 role physical scale (mean difference: 9.0; 95% confidence interval: 0.9 to 17.1; p = 0.031), but these differences had resolved by 1-month follow-up. For the disease-specific scales, CAS patients reported less difficulty eating/swallowing at 2 weeks, less difficulty driving at 2 weeks, and less neck pain at 2 weeks; each of these differences between groups was no longer present at 1 month. No other scores differed between groups at any time point.

Conclusions: Among patients at high surgical risk, CAS was associated with less health status impairment during the first 2 weeks of recovery when compared with CEA. However, these differences had resolved by 1 month after the procedure, and no other differences between revascularization strategies in health-related quality of life were found.