Research

Clinical and cost-effectiveness analysis of an open label, single-centre, randomised trial of spinal cord stimulation (SCS) versus percutaneous myocardial laser revascularisation (PMR) in patients with refractory angina pectoris: The SPiRiT trial

M T Dyer^1,6 , KA Goldsmith^2,3,6 , SN Khan^4,6 , LD Sharples^2,3,6 , C Freeman^3,6 , I Hardy^5,6 , MJ Buxton^1,6 and PM Schofield^3,6

¹Health Economics Research Group, Brunel University, Uxbridge, Middlesex, UK

²MRC Biostatistics Unit, Cambridge, UK

³Research and Development Unit, Papworth Hospital NHS Trust, Papworth Everard, Cambridge, UK

⁴Department of Cardiology, Papworth Hospital NHS Trust, Papworth Everard, Cambridge, UK

⁵Department of Anaesthetics, Papworth Hospital NHS Trust, Papworth Everard, Cambridge, UK

⁶Papworth Hospital NHS Trust, Papworth Everard, Cambridge, CB3 8RE, UK

author email corresponding author email

Trials 2008, 9:40doi:10.1186/1745-6215-9-40

Published:	30 June 2008

Abstract

Background

Patients with refractory angina have significant morbidity. This study aimed to compare two of the treatment options, Spinal Cord Stimulation (SCS) and Percutaneous Myocardial Laser Revascularisation (PMR) in terms of clinical outcomes and cost-effectiveness.

Methods

Eligible patients were randomised to PMR or SCS and followed up for exercise tolerance time (ETT), Canadian Cardiovascular Society (CCS) classification and the quality of life measures SF-36, Seattle Angina Questionnaire and the EuroQoL at 3, 12 and 24 months. Utilities were calculated using the EQ-5D and these and costs were compared between groups. The incremental cost-effectiveness ratio (ICER) per QALY for SCS compared to PMR was also calculated.

Results

At 24 months post-randomisation, patients that had SCS and PMR had similar ETT (mean difference 0.05, 95% CI -2.08, 2.18, p = 0.96) and there was no difference in CCS classification or quality of life outcomes. The difference in overall mean costs when comparing SCS to PMR was GBP5,520 (95% CI GBP1,966 to GBP8,613; p < 0.01) and the ICER of using SCS was GBP46,000 per QALY.

Conclusion

Outcomes after SCS did not differ appreciably from those after PMR, with the former procedure being less cost-effective as currently applied. Larger studies could clarify which patients would most benefit from SCS, potentially increasing cost-effectiveness.

Trial registration

Current Controlled Trials ISRCTN09648950