Chronic angina pectoris Circulatory System Angina pectoris
Conditions
Interventions
Trial patients were randomised to either Spinal Cord Stimulation System implant (SCS) or Percutaneous Myocardial Laser Revascularisation (PMR).
The Spinal Cord Stimulation System used for this trial
Sponsors
Medtronic Sàrl (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient with limiting angina (Canadian Cardiovascular Society [CCS] III or IV) despite maximally tolerated medical therapy 2. Documented coronary artery disease (within the last 9 months prior to baseline), which is unsuitable for conventional revascularisation techniques 3. Patient has documented reversible ischaemia on nuclear scan (Tc-99 sestamibi) 4. Patient is limited in daily activities, primarily exercise capability, by their anginal pain 5. Age 18 or older 6. Patient must understand the therapy and give informed consent 7. Patient must be available for appropriate follow-up times for length of study 8. Non-pregnant women (only women who are post menopausal, surgically sterile or those of child bearing potential who are using an acceptable method of contraception) as safety for use of SCS during pregnancy or delivery has not been established. Acceptable methods of contraception include the following: a. Barrier type devices (e.g. female condom, diaphragm and contraceptive sponge) used only in combination with a spermicide b. Intrauterine devices (IDUs) c. Oral contraceptive agent d. Depro-ProveraTM (medroxyprogesterone acetate) e. Levonorgestrel implants f. Naturally sterile (amenorrheic for at least 1 year) in patients over 50 Note: Abstinence, the rhythm method or contraception by the partner alone are NOT acceptable methods of contraception
Exclusion criteria
Exclusion criteria: 1. Patient who is not a candidate for surgical implantation of the spinal cord stimulation system, and/or not a candidate for a PMR procedure and/or unable to use the SCS device appropriately for treatment 2. Patient who has had one or more major cardiac events within the last 2 months 3. Patient with a myocardial wall thickness <8 mm in the ischaemic area to be treated as verified by echocardiography 4. Patient with extensive peripheral vascular disease that precludes vascular access required for PMR 5. Patient on intravenous therapy to control their symptoms 6. Patient who is unlikely to survive for more than 12 months due to non cardiac condition e.g. malignancy 7. Patient who has other diseases that are considered of greater clinical significance than the angina pectoris (e.g. inadequately controlled diabetes mellitus, heart failure) that would impact the ability of the clinician to adequately assess the incremental effects of the trial treatment 8. Patient with ejection fraction of less than 30% as verified by echocardiography 9. Patient with cause of angina other than coronary artery disease (e.g. syndrome "X" patient) 10. Patient who is unable to perform treadmill exercise test per protocol 11. Patient who was previously enrolled in this study, or is currently in another clinical study, which will interfere with this protocol 12. Patient who has had spinal cord stimulation (SCS) therapy, a transmyocardial laser revascularization (TMLR) or PMR procedure in the past 13. Patient with an implanted pacemaker or defibrillator 14. Patient who has medical conditions which may require Magnetic Resonance Imaging (MRI) 15. Patient with a history of dementia or other persisting mental disorders significantly interfering with ability to cooperate or comply with the requirements of the study or comprehend informed consent 16. Patient with history of alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total exercise time on a modified Bruce protocol (ETT) at 12 months after SCS compared with PMR. In this study, all tests were terminated by the subject. Both SCS and PMR aim to reduce the frequency and severity of angina, and exercise tolerance is a comparatively objective method of measuring angina-free functional capacity. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to patient-reported angina during exercise test 2. Angina class as measured by the Canadian Cardiovascular Score angina scale 3. Morbidity and mortality 4. Safety profiles of each therapy 5. Health-related quality of life was assessed using questionnaires administered at 3, 12, 24 and 36 month follow-up (disease-specific Seattle Angina Questionnaire, the generic Short Form 36 health survey , and EuroQoL questionnaires) | — |
Countries
United Kingdom
Outcome results
None listed