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.
OBJECTIVE
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.


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).


CONCLUSIONS
There was little evidence of a difference in effectiveness between SCS and PMR in patients with refractory angina.
McNab
Duncan
D
Department of Cardiology, Papworth Hospital NHS Trust, Papworth Everard, Cambridge, UK.
Khan
Sadia N
SN
Sharples
Linda D
LD
Ryan
Judy Y
JY
Freeman
Carol
C
Caine
Noreen
N
Tait
Sue
S
Hardy
Ian
I
Schofield
Peter M
PM
D000787:Angina Pectoris / Q000628:therapy*; D017079:Exercise Tolerance; D005260:Female; D006801:Humans; D053685:Laser Therapy / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009204:Myocardial Revascularization / Q000379:methods*; D011788:Quality of Life; D004561:Transcutaneous Electric Nerve Stimulation / Q000379:methods*; D016896:Treatment Outcome