Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2008 Jun 30:9:40.
doi: 10.1186/1745-6215-9-40.

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 , K A Goldsmith, S N Khan, L D Sharples, C Freeman, I Hardy, M J Buxton, P M Schofield
Affiliations

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 et al. Trials. .

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.

PubMed Disclaimer

Figures

Figure 1
Figure 1
CONSORT diagram showing the flow of participants through the trial comparing SCS with PMR.
Figure 2
Figure 2
Mean difference between SCS and PMR in EQ-5D scores at 3, 12 and 24 months post-procedure (values above 0 favour SCS). * Adjusted for baseline.
Figure 3
Figure 3
Mean difference between SCS and PMR in SF-36 and SAQ scales at 3, 12 and 24 months post-procedure, adjusted for baseline scores (values above 0 favour SCS). SF36 – 36-item short form survey; PCS – physical component score; MCS – mental component score; SAQ – Seattle Angina Questionnaire, ECS – Exertional capacity scale; ASS – Anginal stability scale; AFS – Anginal frequency scale; TSS – Treatment satisfaction scale; DPS – Disease perception scale.
Figure 4
Figure 4
Cost-effectiveness acceptability curve.
See this image and copyright information in PMC

References

    1. Mannheimer C, Camici P, Chester MR, Collins A, DeJongste M, Eliasson T, Follath F, Hellemans I, Herlitz J, Luscher T, Pasic M, Thelle D. The problem of chronic refractory angina: a report from the ESC Joint Study Group on the Treatment of Refractory Angina. Eur Heart J. 2002;23:355–370. doi: 10.1053/euhj.2001.2706. - DOI - PubMed
    1. Burkhoff D, Schmidt S, Schulman SP, Myers J, Resar J, Becker LC, Jones JW. Transmyocardial laser revascularisation compared with continued medical therapy for treatment of refractory angina pectoris: a prospective randomised trial. Lancet. 1999;354:885–890. doi: 10.1016/S0140-6736(99)08113-1. - DOI - PubMed
    1. Schofield PM, Sharples LD, Caine N, Burns S, Tait S, Wistow T, Buxton M, Wallwork J. Transmyocardial laser revascularisation in patients with refractory angina: a randomised controlled trial. Lancet. 1999;353:519–24. doi: 10.1016/S0140-6736(98)11478-2. - DOI - PubMed
    1. Campbell HE, Tait S, Buxton MJ, Sharples LD, Caine N, Schofield PM, Wallwork J. A trial-based cost-utility analysis of transmyocardial laser revascularisation compared to continued medical therapy for treatment of refractory angina pectoris. Eur J Cardiothorac Surg. 2001;20:312–318. doi: 10.1016/S1010-7940(01)00801-6. - DOI - PubMed
    1. Oesterle SN, Sanborn TA, Ali N, Resar J, Ramee SR, Heuser R, Dean L, Knopf W, Schofield P, Schaer GL, Reeder G, Masden R, Yeung AC, Burkhoff D. Percutaneous transmyocardial laser revascularisation for severe angina: the PACIFIC randomised trial. Lancet. 2000;356:1705–10. doi: 10.1016/S0140-6736(00)03203-7. - DOI - PubMed

LinkOut - more resources