In October 2020, a completed mini-method assessment for the coronary sinus reducer stent implantation in refractory angina pectoris treatment was issued within the New Methods framework, which was established in Norway in 2013. In this framework, all innovations should undergo health technology assessment (HTA) before being funded. The Oslo University Hospital carried out the assessment.
A reducer stent (Neovasc) is implanted into the coronary sinus via insertion into the jugular vein to increase myocardial perfusion and oxygen supply to the ischemic heart muscle. It is indicated for refractory coronary heart disease, functional class III and IV, where further arterial revascularization is not possible, and optimal medical treatment is insufficient, and in microvascular coronary heart disease functional class III and IV despite optimal pharmaceutical treatment.
The method is not currently used in Norway. There is no comparator device. Improvement in functional class, quality of life (Seattle Angina Questionnaire (SAQ)), and improvement of myocardial perfusion (PET-CT) were considered as outcomes.
The following conclusions were made based on a literature search:
- Significant symptom reduction compared to the sham treatment controlled group was shown in the various systematic reviews and primary studies
- The Neovasc reducer improves the myocardial supply of oxygen by increasing the resistance on the coronary sinus in a myocardium
- The results were considered transferable to Norwegian clinical reality
- The safety of the method seems good. Very few and no severe complications have been reported by the studies. Implantation of Neovasc reducer has in one case led to a rupture of the coronary sinus
- The method involves increased use of radiation compared to current practice, but to a small extent, only as in a normal coronary angiography
The key conclusion is that the coronary sinus reducer stent has a good level of efficacy and safety in comparison with the current treatment and should be introduced as part of the clinical routine in the hospitals. The method and clinical effect should be followed up over several years, so assess consistency in symptom reduction.
See the full details in Norwegian here.
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