Key result
Spinal cord stimulation proves acceptable in refractory angina despite failing pilot recruitment targets.
Why the study?
Patients with refractory angina unsuitable for coronary revascularization have high hospitalization rates and poor quality of life, and no randomized trial has compared spinal cord stimulation with usual care.
Is a definitive multicenter trial of spinal cord stimulation versus usual care feasible in patients with refractory angina?
RCT (n=29)
1:1
Yes
Is a definitive multicenter trial of spinal cord stimulation versus usual care feasible in patients with refractory angina?
A pilot RCT of spinal cord stimulation for refractory angina demonstrated high retention and acceptability despite recruitment challenges, providing lessons for a future definitive trial.
Supports feasibility of definitive SCS trial in refractory angina; leaves open cost-effectiveness versus usual care.
BACKGROUND: Patients with "refractory angina" (RA) unsuitable for coronary revascularization experience high levels of hospitalization and poor health-related quality of life. Randomized trials have shown spinal cord stimulation (SCS) to be a promising treatment for chronic stable angina and RA; however, none has compared SCS with usual care (UC). The aim of this pilot study was to address the key uncertainties of conducting a definitive multicenter trial to assess the clinical and cost-effectiveness of SCS in RA patients, i.e., recruitment and retention of patients, burden of outcome measures, our ability to standardize UC in a UK NHS setting. METHODS: RA patients deemed suitable were randomized in a 1:1 ratio to SCS plus UC (SCS group) or UC alone (UC group). We sought to assess: recruitment, uptake, and retention of patients; feasibility and acceptability of SCS treatment; the feasibility and acceptability of standardizing UC; and the feasibility and acceptability of the proposed trial outcome measures. Patient outcomes were assessed at baseline (prerandomization) and three and six months postrandomization. RESULTS: We failed to meet our planned recruitment target (45 patients) and randomized 29 patients (15 SCS group, 14 UC group) over a 42-month period across four sites. None of the study participants chose to withdraw following consent and randomization. With exception of two deaths, all completed evaluation at baseline and follow-up. Although the study was not formally powered to compare outcomes between groups, we saw a trend toward larger improvements in both primary and secondary outcomes in the SCS group. CONCLUSIONS: While patient recruitment was found to be challenging, levels of participant retention, outcome completion, and acceptability of SCS therapy were high. A number of lessons are presented in order to take forward a future definitive pragmatic randomized trial.
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Eldabe et al. (2015) conducted an RCT in Refractory angina (n=29). Spinal cord stimulation (SCS) vs. Usual care was evaluated on Recruitment, uptake, and retention of patients; feasibility and acceptability of SCS treatment and standardizing usual care. In a pilot trial of 29 patients with refractory angina, spinal cord stimulation showed high acceptability and retention, though the study failed to meet its recruitment target of 45 patients.
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