The Effectiveness and Cost-Effectiveness of Spinal Cord Stimulation for Refractory Angina (RASCAL Study): A Pilot...

Area of Science:

• Cardiovascular Medicine
• Neurosurgery
• Clinical Trial Design

Background:

• Refractory angina (RA) patients face poor quality of life and high hospitalization rates.
• Spinal cord stimulation (SCS) shows promise for angina, but trials comparing it to usual care (UC) are lacking.
• Pilot studies are crucial for addressing uncertainties in definitive trials for SCS in RA.

Purpose of the Study:

• To assess the feasibility of a definitive multicenter trial for SCS in RA patients.
• To evaluate recruitment, retention, and standardization of UC.
• To determine the acceptability of SCS and proposed outcome measures.

Main Methods:

• Randomized pilot study comparing SCS plus UC versus UC alone in RA patients.
• Assessed recruitment, patient retention, and feasibility of standardizing UC.
• Evaluated SCS treatment acceptability and trial outcome measures at baseline and 6 months.

Main Results:

• Recruitment fell short of the target, with 29 patients randomized over 42 months.
• High patient retention and outcome completion rates were observed.
• A trend towards greater improvement in outcomes favored the SCS group.

Conclusions:

• Participant retention, outcome completion, and SCS acceptability were high.
• Patient recruitment for SCS trials in RA presents challenges.
• Lessons learned will inform the design of future definitive pragmatic randomized trials.