Efficacy of Spinal Cord Stimulation in Patients With Refractory Angina Pectoris

Inclusion Criteria

• •Refractory Angina Pectoris:
• •* Stable angina pectoris CCS class III or IV, with a minimum of 5 episodes of angina pectoris over the course of one week, during a minimum period of three months prior to screening
• •* Coronary angiogram (CAG) performed within the last 12 months showing significant coronary artery disease defined as at least one coronary artery stenosis of \>75% or 50 - 75% with proven ischaemia (see below), not suitable for revascularisation. Confirmed by one (or two in case of doubt) interventional cardiologist based on CAG images.
• •* Optimal anti-anginal medication. Patients should at least use the maximal tolerable dose of a b-blocker, calcium channel blocker and short- and/or long-acting nitrate. If the patient doesn't use one of these groups of medication the reason (side-effects) should be clear.
• •Proven ischemia:
• •* MIBI-SPECT: summed stress score (SSS) of at least 1, in combination with summed difference score (SDS) of at least 1 (1-4 mild ischaemia, \> 4 moderate to severe ischaemia).
• •* FFR: \< 0.80, with no intervention options (determined by interventional cardiologist)
• •* MRI perfusion: ≥ 1 segment of subendocardial hypoperfusion during stress perfusion, not present at rest and no matching fibrosis (using 16 segment AHA heart model)
• •* PET: Semi-quantitative measurement: SSS score of at least 1, in combination with SDS score of at least 1 (1-4 mild ischaemia, \> 4 moderate to severe ischaemia). Quantitative measurement: reduced myocardial perfusion reserve.
• •No revascularisation (PCI and/or CABG) performed between ischaemia testing and study inclusion.
• •Age \> 18 years