TY - JOUR
T1 - Spinal cord stimulation for the treatment of refractory angina pectoris
T2 - A multicenter randomized single-blind study (the SCS-ITA trial)
AU - Lanza, Gaetano A.
AU - Grimaldi, Roberto
AU - Greco, Salvatore
AU - Ghio, Stefano
AU - Sarullo, Filippo
AU - Zuin, Guerrino
AU - De Luca, Anna
AU - Allegri, Massimo
AU - Di Pede, Francesco
AU - Castagno, Davide
AU - Turco, Annalisa
AU - Sapio, Monica
AU - Pinato, Giampaolo
AU - Cioni, Beatrice
AU - Trevi, Giampaolo
AU - Crea, Filippo
PY - 2011/1
Y1 - 2011/1
N2 - Spinal cord stimulation (SCS) is believed to be effective in treating refractory angina. The need for SCS-related chest paresthesia, however, has hitherto made impossible placebo-controlled trials. Subliminal (non paresthesic) SCS, however, might be also effective on anginal pain. In this trial we compared subliminal SCS with paresthesic SCS and with sham SCS. Twenty-five refractory angina patients, who had never received SCS before, underwent SCS device implantation and were randomized to three groups: paresthesic SCS (group PS; n = 10), subliminal SCS (group SS; n = 7) or "sham" SCS (group NS; n = 8). After 1 month group NS patients were randomized to either group PS or SS. After 1 month, changes in angina episodes (p = 0.016), nitroglycerin use (p = 0.015), angina class (p = 0.02), quality of life score (p = 0.05), and items 2 (p = 0.008) and 3 (p = 0.009) of Seattle angina questionnaire differed significantly among groups. Group PS showed significant improvement in outcomes compared to group NS, whereas there were no significant differences between groups SS and NS; furthermore, only nitroglycerin use differed significantly between groups PS and SS. At 3 months, a significant difference between groups PS and SS was observed in angina attacks (p = 0.002), but not in other variables. Thus, in this study, paresthesic, but not subliminal SCS was superior to sham SCS in improving clinical status in refractory angina patients. The lack of significant differences between PS and SS groups in this small study suggests that a possible role for subliminal SCS in individual patients deserves to be assessed in larger trials with appropriate statistical power.
AB - Spinal cord stimulation (SCS) is believed to be effective in treating refractory angina. The need for SCS-related chest paresthesia, however, has hitherto made impossible placebo-controlled trials. Subliminal (non paresthesic) SCS, however, might be also effective on anginal pain. In this trial we compared subliminal SCS with paresthesic SCS and with sham SCS. Twenty-five refractory angina patients, who had never received SCS before, underwent SCS device implantation and were randomized to three groups: paresthesic SCS (group PS; n = 10), subliminal SCS (group SS; n = 7) or "sham" SCS (group NS; n = 8). After 1 month group NS patients were randomized to either group PS or SS. After 1 month, changes in angina episodes (p = 0.016), nitroglycerin use (p = 0.015), angina class (p = 0.02), quality of life score (p = 0.05), and items 2 (p = 0.008) and 3 (p = 0.009) of Seattle angina questionnaire differed significantly among groups. Group PS showed significant improvement in outcomes compared to group NS, whereas there were no significant differences between groups SS and NS; furthermore, only nitroglycerin use differed significantly between groups PS and SS. At 3 months, a significant difference between groups PS and SS was observed in angina attacks (p = 0.002), but not in other variables. Thus, in this study, paresthesic, but not subliminal SCS was superior to sham SCS in improving clinical status in refractory angina patients. The lack of significant differences between PS and SS groups in this small study suggests that a possible role for subliminal SCS in individual patients deserves to be assessed in larger trials with appropriate statistical power.
KW - Quality of life
KW - Refractory angina pectoris
KW - Spinal cord stimulation
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UR - http://www.scopus.com/inward/citedby.url?scp=78650414512&partnerID=8YFLogxK
U2 - 10.1016/j.pain.2010.08.044
DO - 10.1016/j.pain.2010.08.044
M3 - Article
C2 - 21084162
AN - SCOPUS:78650414512
VL - 152
SP - 45
EP - 52
JO - Pain
JF - Pain
SN - 0304-3959
IS - 1
ER -