Table 1 Summary of included RCT characteristics
Trial Name/author Year, country Setting Design Recruitment dates | Population Age – Mean (SD or range) Sex – % male Class Inclusion criteria | Intervention N patients | Control N patients | Relevant outcomes | Follow up* |
|---|---|---|---|---|---|
de Jongste et al 24,25 1994, Netherlands Single Centre Parallel RCT Jan 1990 to March 1992 | 60 years (5) 71% male NYHA III/IV Angiographically confirmed CAD not suitable for revascularisation. Reversible ischemia on exercise. Receiving optimal drug therapy. | SCS N = 12 | No SCS N = 10 | Primary outcome: exercise capacity (treadmill time). Secondary outcomes: health related quality of life, nitrate drug usage, ischemic burden & adverse events | 2-months |
Di Pede et al 26 2001, Italy Single Centre Cross over RCT Oct 1990 to Sept 1998 | 76 yrs (8) 60% male CCS 3/4 Severe angina despite optimal drug treatment. Revascularisation not possible. Reversible ischemia on exercise. | SCS ON N = 15 | SCS OFF N = 15 | Ischemic burden | 48-hours |
ESBY 19–22 1998, Sweden Single centre Parallel group RCT Oct 1990 to Sept 1998 | 68.9 yrs (40–82) 80% male AHA angina class 3/4 Symptomatic indication for CABG & no prognostic benefit from CABG | SCS N = 53 | CABG N = 51 | Primary outcomes: exercise capacity (workload), angina attacks Secondary outcomes: nitrate drug usage, ischemic burden, health-related quality of life, morbidity, mortality & complications | 6-months, 2-years, 5-years |
Hautvast et al 27 1998, Netherlands Single Centre Parallel group RCT Not reported | 62.5 yrs (7.5 years) 56% male NYHA class III/IV Angiographically confirmed CAD not suitable for revascularisation with proven ischemia. Reversible ischemia on exercise. Receiving optimal drug therapy. | SCS ON N = 13 | SCS OFF N = 12 | Exercise capacity (treadmill time), angina attacks, nitrate drug usage & health-related quality of life | 1.5 months |
Jessurun et al 28 1999, Netherlands Single Centre Parallel group RCT Not reported | 59 yrs (5.5) 67% male NYHA class III/IV Unresponsive to optimal medication. Revascularisation not possible. Reversible ischemia on exercise or equivalent | SCS ON N = 12 | SCS OFF N = 12 | Exercise capacity (treadmill V02max), ischemic burden, & nitrate drug usage | 1-month |
SPiRiT 2006, UK Single centre Parallel group RCT Dec 2000–Dec 2003 | 63.5 yrs (8) 88% male CCS class 3/4 Limiting angina despite optimal drug therapy. Angiography confirmed CAD and reversible ischemia on radionuclide scanning | SCS N = 34 | Percutaneous myocardial laser revascularisation (PMR) N = 34 | Primary outcome: exercise capacity (treadmill time). Secondary outcomes: functional class, mortality, quality of life, morbidity, mortality & complications | 3-months, 12 months |
Eddicks et al 29 2007, Germany Single centre Cross over RCT June 2003 to August 2004 | 65 yrs (8) 67% male CCS 3/4 Proven responders to SCS, angina > 3 months, known CAD, reversible myocardial ischemia, receiving optimal drug therapy with no benefit from revascularisation | SCS ON1 N = 12 | SCS OFF2 N = 12 | Primary outcome: exercise capacity (6-min walk test) Secondary outcomes: number of angina attacks, health-related quality of life (Seattle Angina Questionnaire), CCS class, nitrate drug usage, drop out due to intolerable symptoms | 4 weeks |