Study design
Angina, valvular heart disease, myocardial ischemia, fibrosis, aortic stenosis, reduced myocardial perfusion reserve, ischemia, Acute coronary syndrome, coronary artery disease, subendocardial hypoperfusion, CAD, coronary artery stenosis, regurgitation, angina pectoris, Cognitive Impairment, paresthesia, dementia, RAP, angina complaints
SPINAL CORD DISEASE, ISCHEMIA, PARESTHESIA, ACUTE CORONARY SYNDROME, MYOCARDIAL ISCHEMIA, FIBROSIS, VALVULAR HEART DISEASE, SEVERE MITRAL VALVE STENOSIS, CORONARY ARTERY STENOSIS, SEVERE TRICUSPID VALVE REGURGITATION, AORTIC STENOSIS, STABLE ANGINA PECTORIS, CORONARY ARTERY DISEASE, CAD
The primary objective of this study is to determine the effect of SCS in patients with RAP on the percentage of myocardial ischemia measured using a myocardial perfusion positron emission tomography (PET) scan. Patients with RAP referred to our hospital (Catharina hospital, Eindhoven, the Netherlands) will be screened for eligibility to participate in the study. The inclusion criteria must be met, meaning stable angina pectoris CCS class III or IV during at least the previous 3 months, a coronary angiogram (CAG) performed within the last 12 months with significant CAD not suitable for intervention, optimal antianginal medication and proven ischemia using MIBI‐SPECT, perfusion magnetic resonance imaging (MRI), myocardial perfusion PET scan or a fractional flow reserve (FFR) positive lesion (<0.80) with no intervention options. Tables Inclusion criteria.
Refractory Angina Pectoris:
Stable angina pectoris CCS class III or IV, with a minimum of five episodes of angina pectoris over the course of 1 week, during a minimum period of 3 months before screening;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 ischemia (see below), not suitable for revascularization. Confirmed by one (or two in case of doubt) interventional cardiologist based on CAG images;Optimal antianginal medication. Patients should at least use the maximal tolerable dose of a beta‐blocker, calcium channel blocker and short‐ and/or long‐acting nitrate. If the patient does not use one of these groups of medication the reason (side‐effects) should be clear.
Proven ischemia:
MIBI‐SPECT: SSS of at least 1, in combination with SDS of at least 1 (1–4 mildischemia, >4 moderate to severe ischemia).Fractional flow reserve: <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).Myocardial perfusion PET: Semi‐quantitative measurement: SSS of at least 1, in combination with SDS of at least 1 (1–4 mild ischemia, >4 moderate to severe ischemia). Quantitative measurement: reduced myocardial perfusion reserve.
No revascularization (PCI and/or CABG) performed between ischemia testing and study inclusion.
Age >18 years.Abbreviations: CABG, coronary artery bypass grafting; CAG, coronary angiogram; MIBI‐SPECT, methoxyisobutylisonitrile single photon emission computed tomography; MRI, magnetic resonance imaging; PCI, percutaneous coronary intervention; PET, positron emission tomography; SDS, summed difference score; SSS, summed stress score.Exclusion criteria.
Acute coronary syndrome during the 3‐month period before screening.
Life expectancy less than 12 months.
Inability to perform a 6‐min walking test.
Inability to give informed consent.
No proven ischemia (see Table 
Spinal cord disease which could prevent correct positioning of the lead in the epidural space; to be determined by the anesthesiologist performing the implantation.
Anticoagulation therapy that cannot be stopped/bridged before spinal cord stimulator implantation.
Inadequate paresthesia coverage, during implantation, of the thoracic region where angina complaints are localized.
Pregnancy.
Mild Cognitive Impairment or dementia.
Concomitant symptomatic valvular heart disease including severe aortic stenosis and/or regurgitation, severe mitral valve stenosis and/or regurgitation or severe tricuspid valve regurgitation.