Key result
Coronary sinus reducer shows no effect on arrhythmogenic substrate versus sham in refractory angina.
Why the study?
The possible antiarrhythmic effect of coronary sinus reducer implantation in refractory angina patients was unknown.
Does coronary sinus reducer implantation improve arrhythmogenic substrate assessed by hrECG in patients with refractory angina?
RCT (n=24)
Double-blind
Block randomization
No
Does coronary sinus reducer implantation improve arrhythmogenic substrate assessed by hrECG in patients with refractory angina?
Coronary sinus reducer implantation does not significantly alter the arrhythmogenic substrate as assessed by high-resolution ECG in patients with refractory angina.
CSR implantation does not alter hrECG parameters versus sham in refractory angina; challenges hypothesized effects on arrhythmogenic substrate.
Background: Treatment with a coronary sinus reducer (CSR) is a new therapeutic option for refractory angina patients. Preclinical studies have shown antiarrhythmic properties of coronary sinus narrowing. The possible antiarrhythmic effect of CSR implantation is unknown. This study aimed to determine the possible antiarrhythmic effects of CSR implantation as assessed by high-resolution electrocardiogram (hrECG) parameters. Methods: 24 patients from the Crossroad study randomized to either CSR treatment (n = 12) or a sham procedure (n = 12) had hrECG recorded at baseline and after 6 months. T-peak and T-end interval (TpTe) defined as the time difference between the peak amplitude of the T wave and the global end of the T wave, spatial angle between QRS complex and T axis defined as the angle between the ventricular depolarization and repolarization vectors using maximal (QRSTP) and mean (QRSTM) vector amplitudes and spatial ventricular gradient (SVG) calculated as integral of ECG voltages over the entire QRST complex were analyzed. Additionally, we analyzed parameters of QT and heart rate variability using time and frequency domain. Results: At baseline, all analyzed parameters were comparable between both groups and heart rate remained constant. The intragroup analysis did not show any significant change in TpTe, QRSTP, QRSTM, SVG, QT, and heart rate variability at follow-up. Furthermore, intergroup comparison between CSR implantation and sham procedure also did not show any significant difference in the change of analyzed parameters. Conclusions: Compared to the sham procedure, CSR implantation did not demonstrate a significant impact on the arrhythmogenic substrate assessed with hrECG. Clinical Trial Registration: Unique Identifier: NCT04121845, https://classic.clinicaltrials.gov/ct2/show/NCT04121845.
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Mrak et al. (2023) conducted an RCT in Refractory angina pectoris with reversible ischemia (n=24). Coronary sinus reducer (CSR) vs. Sham procedure was evaluated on Change in arrhythmogenic substrate assessed by high-resolution ECG parameters (TpTe, QRS-T angle, SVG, QT variability) at 6 months (p=>0.05). Coronary sinus reducer implantation did not significantly impact the arrhythmogenic substrate assessed with high-resolution ECG compared to a sham procedure in patients with refractory angina.
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