European Heart Journal Advance Access originally published online on March 22, 2006
European Heart Journal 2006 27(9):1048-1053; doi:10.1093/eurheartj/ehi827
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An open label, single-centre, randomized trial of spinal cord stimulation vs. percutaneous myocardial laser revascularization in patients with refractory angina pectoris: the SPiRiT trial
1 Department of Cardiology, Papworth Hospital NHS Trust, Papworth Everard, Cambridge CB3 8RE, UK
2 MRC Biostatistics Unit, Cambridge, UK
3 Department of Research and Development, Papworth Hospital NHS Trust, Cambridge, UK
4 Department of Anaesthetics, Papworth Hospital NHS Trust, Cambridge, UK
Received 6 October 2005; revised 11 February 2006; accepted 17 February 2006; online publish-ahead-of-print 22 March 2006.
* Corresponding author. Tel: +44 01480 364349; fax: +44 01480 364799. E-mail address: peter.schofield{at}papworth.nhs.uk
See page 1007 for the editorial comment on this article (doi:10.1093/eurheartj/ehi828)
Aims Refractory angina pectoris leads to significant morbidity. Treatment options include percutaneous myocardial laser revascularization (PMR) and spinal cord stimulation (SCS). This study was designed to compare these two treatments.
Methods and results Subjects with Canadian Cardiovascular Society (CCS) class 3/4 angina and reversible perfusion defects were randomized to SCS (34) or PMR (34). The primary outcome was to compare exercise treadmill time on a modified Bruce protocol over 12 months. Thirty subjects in both groups completed 12-month follow-up. The mean total exercise time was 6.38±3.45 min in the SCS group and 7.41±3.68 min in the PMR group at baseline and 7.08±0.67 min in the SCS group and 7.12±0.71 min in the PMR group at 12 months (95% confidence limits for the difference between the groups –1.02 to +2.2 min, P=0.466). There were no differences in angina-free exercise capacity, CCS class, and quality of life between treatments. SCS patients had more adverse events in the first 12 months, mainly angina or SCS system related (P=0.001).
Conclusion There was little evidence of a difference in effectiveness between SCS and PMR in patients with refractory angina.
Key Words: Refractory angina pectoris • Spinal cord stimulation • Laser revascularisation
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