European Heart Journal Advance Access originally published online on June 2, 2006
European Heart Journal 2006 27(13):1631-1632; doi:10.1093/eurheartj/ehl049
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
Department of Cardiology
Thoraxcenter
University Medical Center Groningen
University of Groningen
Postbus 30001
Hanzeplein 1
9700 RB Groningen
The Netherlands
Tel: +31 50 3612355
Fax: +31 50 3614391
E-mail address: j.de.vries{at}thorax.umcg.nl
Department of Cardiology
Thoraxcenter
University Medical Center Groningen
University of Groningen
Postbus 30001
Hanzeplein 1
9700 RB Groningen
The Netherlands
Department of Cardiology
Thoraxcenter
University Medical Center Groningen
University of Groningen
Postbus 30001
Hanzeplein 1
9700 RB Groningen
The Netherlands
McNab et al.1 are to be congratulated to have performed the first randomized controlled trial (RCT) to compare percutaneous myocardial laser revascularization (PMR) with spinal cord stimulation (SCS). The results are encouraging and confirm previous results on both therapy modalities.
In the introduction, they have mentioned the many techniques for patients with refractory angina. They have stated that there is little evidence directly comparing these multiple therapeutic modalities, not mentioning the RCT performed by Tio et al.2 to compare PMR with vascular endothelial growth factor.
We would like to draw the attention to the introduction, where they have stated that SCS is supported by one RCT, however, at the end of the next paragraph they refer to another RCT of SCS, which is one of several RCT's to support SCS.3
This study's primary objective was to compare the effect of SCS vs. PMR on treadmill exercise time (ETT) over a periods of 12 months. They report that the difference in total exercise time at 12 months, adjusted for baseline, was 0.59 min between both groups (P=0.466).
In the methods, they describe that they additionally assessed the change in ETT within each group using a paired Student's t-test. However, these findings are not mentioned in the results. These findings seem important as the ETT within the SCS group increased from 6.38 ± 3.45 to 7.08 ± 0.67, and in the PMR group the ETT decreased from 7.41 ± 3.68 to 7.12 ± 0.71, which in itself is already noteworthy.
Moreover, we do not understand why (only) the ETT duration is not presented consistently [at baseline as mean (SD) and at follow-up as mean (SEM)]. As the SEM gives an idea of the accuracy of the mean and the SD gives an idea of the variability of single observations, it is more appropriate to present data as mean (SEM).
Finally, possible interesting information on the ischaemic burden during ETT is not mentioned in this study. We wonder if this is due to ECG disturbances by active SCS during ETT, and whether they tried to filter these electrical disturbances, as described before by an ambulatory electrocardiographic study.4
It is a well-developed study, giving SpiRiT for future investigations, although it is not quite clear where SPiRiT stands for.
References
- McNab D, Khan SN, Sharples LD, Ryan JY, Freeman C, Caine N, Tait S, Hardy I, Schofield PM. (2006) 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. Eur Heart J 27:1048–1053.
[Abstract/Free Full Text] - Tio RA, Tan ES, Jessurun GA, Veeger N, Jager PL, Slart RH, de Jong RM, Pruim J, Hospers GA, Willemsen AT, De Jongste MJ, van Boven AJ, van Veldhuisen DJ, Zijlstra F. (2004) PET for evaluation of differential myocardial perfusion dynamics after VEGF gene therapy and laser therapy in end-stage coronary artery disease. J Nucl Med 45:1437–1443.
[Abstract/Free Full Text] - Hautvast RW, DeJongste MJ, Staal MJ, van Gilst WH, Lie KI. (1998) Spinal cord stimulation in chronic intractable angina pectoris: a randomized, controlled efficacy study. Am Heart J 136:1114–1120.[Web of Science][Medline]
- De Jongste MJ, Haaksma J, Hautvast RW, Hillege HL, Meyler PW, Staal MJ, Sanderson JE, Lie KI. (1994) Effects of spinal cord stimulation on myocardial ischaemia during daily life in patients with severe coronary artery disease. A prospective ambulatory electrocardiographic study. Br Heart J 71:413–418.
[Abstract/Free Full Text]
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