refractory angina pectoris. End stage coronary artery disease
Conditions
Interventions
All patients who participate in this study will receive an implanted spinal 
cord stimulator. The spinal cord stimulator that will be implanted consists of 
one battery, one lead and a remote control. With the remote control the patient 
can change the desired level of stimulation. The lead will be placed in the 
epidural space at the cervico-thoracic level.
After implantation of the spinal cord stimulator an installation programmer 
will be used by the dedicated pain nurse to input the mode of stimulation. When 
the installation programmer is used the spinal cord stimulator will be 
programmed to think that two leads are connected to the battery whilst only one 
lead has been implanted and connected to the battery. When programming the 
spinal cord stimulator it will be possible to a) stimulate the actual lead 
located in the epidural space, b) stimulate the non-existent second lead. What 
this means is that the patient can use the remote control to change the level 
of stimulation in both situations, whilst no stimulation occurs if the 
non-existent second lead has been programmed to stimulate. 
The patient will be informed that during the study he will receive six months 
of high-density neurostimulation, i.e. actual lead, and six months of no 
neurostimulation. The high-density form of stimulation does not usually lead to 
parasthesia. During the entire study period (both in the six months the SCS is 
on and in the 6 months the SCS is off) the patient will be able to use the 
remote control. 
Sponsors
Catharina-ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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; b-blocker and/or calcium channel blocker, 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 intervention 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 or older
Exclusion criteria
Exclusion criteria: - Acute coronary syndrome (ACS) during three month period prior to screening - Life expectancy less than 12 months - Inability to perform a 6-minute walking test - Inability to give informed consent - No proven ischemia (see Inclusion criteria for definition) - Spinal cord disease which could prevent correct positioning of the lead in the epidural space; to be determined by the anaesthesiologist performing the implantation - Anticoagulation therapy that cannot be stopped prior to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of myocardial ischaemia (% of left ventricular myocardium) measured using PET perfusion scan after six months and after twelve months treatment with spinal cord stimulation, compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of spinal cord stimulation treatment in patients with refractory angina pectoris on: - Changes in absolute quantification of myocardial blood flow using PET perfusion scan including myocardial blood flow (MBF) & myocardial flow reserve (MFR) regionally and globally. - Patient condition using the 6-minute walking test - Frequency of angina pectoris attacks using the Seattle Angina Questionnaire - Severity of angina pectoris attacks using the Numeric Rating Scale (NRS) score - Grading of angina pectoris using Canadian Cardiovascular Society (CSS) class - Quality of life using the RAND-36 Questionnaire - Frequency of short-acting nitroglycerin use using the Seattle Angina Questionnaire - Major Adverse Cardiac Events (MACE): - Number of hospital admissions due to acute coronary syndrome (ACS); - Revascularization (CABG and/or PCI); - Number of presentations at the emergency room (ER) due to angina pectoris; - Cardiovascular mortality - Safety endpoints: Number of device infections (lead and/or battery; - Number of device dislocations (lead and/or battery); - Number of lead fractures. Evaluation at six and twelve months after study inclusion. | — |
Countries
Netherlands
Outcome results
None listed