Effectiveness of coronary sinus reducer implantation in routine clinical practice. 12-month outcomes.

Abstract

Introduction: Refractory angina (RA) due to the lack of therapeutic options still remains a significant challenge. Coronary Sinus Reducer (CSR) has been recently introduced in the field of therapy of this advance form of Coronary Artery disease (CAD). However, despite growing evidence data from routine clinical practice are scar.

Objectives: 12-month observation of the efficacy and safety of the Coronary Sinus Reducer (CSR) (ShockWave Medical, Santa Clara, USA), based on the results from the Lower Silesia Sinus Reducer Registry (NCT06288165).

Patients and methods: The study includes data from 67 consecutive patients diagnosed with chronic refractory angina (CCS classes 2-4), despite optimal medical therapy, who underwent CSR implantation. The study endpoints were defined as changes in angina severity (CCS class, SAQ-7), safety outcomes, exercise tolerance (6-MWT), and quality of life assessments (SF-36; EQ-5D-5L, EQ-VAS).

Results: A total of 86.6% of patients showed improvement by at least one CCS class (P <0.001) over the 12 months compared to baseline.  Significant improvement in 12-month angina control was demonstrated, as measured by the SAQ-7 total score (39.9 [15.2] vs. 54.6 [19.7], P <0.001). A similar improvement in the 12-month quality of life assessment measured by the SF-36 total score (112.7 [23.2] vs. 98.4 [31.9]; P <0.001) was noticed. 1-year after CSR implantation, significant improvement in exercise tolerance was observed (mean 6-MWT distance: 265.9 [136.9] vs. 234.9 [109.1], P = 0.03).

Conclusions: 1-year data from our registry indicate that CSR implantation is an effective therapeutic option for patients with refractory angina. Additionally, the present study does not indicate any long-term adverse effects associated with reducer implantation.