Aims: To evaluate the clinical efficacy of the coronary sinus (CS) Reducer in attenuating angina severity in patients suffering from severe refractory angina.
Methods and results: Patients with refractory angina, objective evidence of myocardial ischaemia and no option for revascularisation were treated with CS Reducer implantation at two medical centres. Six-month follow-up evaluation consisted of clinical assessment of angina severity. Objective assessment of ischaemia at six-month follow-up was performed in one of the two centres. Successful CS Reducer implantation was achieved in 21 of 23 eligible patients, at both centres. No device-related adverse effects were observed during the procedure or the follow-up period. Canadian Cardiovascular Society (CCS) score diminished from a mean of 3.3 at baseline to 2.0 at six months (n=20, p<0.01), exercise duration was prolonged from 3:16 to 5:16 min (min:sec; n=8, p=0.05). Thallium SPECT summed stress score and summed difference score were both reduced (n=9, 21.5±10 vs.13.2±9, p=0.01, and 11.1±6 vs. 4.7±4, p=0.007, respectively). Wall motion score index at peak dobutamine infusion was also significantly improved (n=8, 1.9±0.4 vs. 1.4±0.4, p=0.046).
Conclusions: CS Reducer implantation was safe and resulted in significant improvement of angina class. The results of the ongoing randomised sham-control trial will address the concern regarding the possible placebo effect, and hopefully further support our encouraging observations.