Article Impact Level: HIGH Data Quality: STRONG Summary of Clinical Cardiology, 46(6), 689–697. https://doi.org/10.1002/clc.24016 Dr. Fabienne E. Vervaat et al.
Points
- The SCRAP trial is a double-blind, placebo-controlled, and cross-over randomized controlled trial investigating the efficacy of high-density spinal cord stimulation (SCS) in patients with refractory angina pectoris (RAP).
- The trial aims to determine if high-density SCS leads to a significant reduction in myocardial ischemia in RAP patients, addressing the ongoing debate surrounding using SCS in this population.
- Eligible patients with RAP-confirmed ischemia and a positive transcutaneous electrical nerve stimulator treadmill test receive an implanted spinal cord stimulator and undergo six months of high-density SCS followed by six months of no stimulation.
- The primary endpoint is the impact of SCS measured by the change in the percentage of myocardial ischemia using myocardial perfusion positron emission tomography scans, with secondary endpoints including patient-related outcome measures, major cardiac adverse events, and safety.
- As of January 2, 2023, the trial has enrolled 18 patients and completed 1-year follow-up for three patients, with primary assessments expected to be completed in June 2025.
Summary
The SCRAP trial is an investigator-initiated, single-center, double-blind, placebo-controlled, and cross-over randomized controlled trial aimed at evaluating the efficacy of high-density spinal cord stimulation (SCS) in patients suffering from refractory angina pectoris (RAP). While previous studies have suggested a positive impact of SCS on the quality of life for RAP patients, the lack of double-blinded randomized controlled trials leaves the issue unresolved. The primary objective of this trial is to determine whether high-density SCS leads to a significant reduction in myocardial ischemia in RAP patients.
To achieve this objective, eligible patients with RAP, confirmed ischemia and a positive transcutaneous electrical nerve stimulator treadmill test are enrolled and implanted with a spinal cord stimulator. The study follows a cross-over design, where patients undergo six months of high-density SCS followed by six months of no stimulation, with the order of treatment options determined through randomization. The trial’s primary endpoint is the effect of SCS, measured by the change in the percentage of myocardial ischemia using myocardial perfusion positron emission tomography scans. Secondary endpoints include patient-related outcome measures, major cardiac adverse events, and safety endpoints. The follow-up period for primary and critical secondary endpoints spans one year.
As of January 2, 2023, the SCRAP trial has successfully enrolled 18 patients, with three completing the 1-year follow-up. The trial began enrollment on December 21, 2021, and primary assessments are set to be completed in June 2025.
The SCRAP trial represents a crucial effort in clarifying the potential benefits of high-density SCS for patients with RAP, contributing valuable data to the ongoing debate surrounding the use of spinal cord stimulation in this specific patient population. The trial’s methodology, which includes double-blinding and randomization, ensures robust and unbiased results, and its registered clinical trial identifier is NCT04915157. Ultimately, the findings from this research may lead to more informed decisions regarding adopting SCS as a therapeutic option for patients with refractory angina pectoris.
Link to the article: https://onlinelibrary.wiley.com/doi/10.1002/clc.24016
References Vervaat, F. E., Van Der Gaag, A., Smetsers, C., Barneveld, P. C., Van’T Veer, M., Teeuwen, K., Van Suijlekom, H., Dekker, L., & Wijnbergen, I. F. (2023). Design and rationale of the efficacy of spinal cord stimulation in patients with refractory angina pectoris (Scrap) trial. Clinical Cardiology, 46(6), 689–697. https://doi.org/10.1002/clc.24016
