title: Spinal cord stimulation for the treatment of refractory angina pectoris: a multicenter randomized single-blind study (the SCS-ITA trial).
abstract: 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 1month group NS patients were randomized to either group PS or SS. After 1month, 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 3months, 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.
authors.affiliation: Istituto di Cardiologia, Università Cattolica del Sacro Cuore, Roma, Italy Dipartimento di Cardiologia, Ospedale Le Molinette, Torino, Italy Divisione di Cardiologia, Ospedale San Filippo Neri, Roma, Italy Divisione di Cardiologia, Ospedale San Matteo, Pavia, Italy Divisione di Cardiologia and Anestesia, Ospedale Buccheri la Ferla Fatebenefratelli, Palermo, Italy Divisione di Cardiologia, Ospedale Umberto I, Mestre, Italy Dipartimento di Anestesia, Ospedale Le Molinette, Torino, Italy Divisione di Anestesia, Ospedale San Matteo, Pavia, Italy Divisione di Anestesia, Ospedale Umberto I, Mestre, Italy Istituto di Neurochirurgia, Università Cattolica del Sacro Cuore, Roma, Italy.
authors.forename: Gaetano A
authors.initials: GA
authors.lastname: Lanza
authors.forename: Roberto
authors.initials: R
authors.lastname: Grimaldi
authors.forename: Salvatore
authors.initials: S
authors.lastname: Greco
authors.forename: Stefano
authors.initials: S
authors.lastname: Ghio
authors.forename: Filippo
authors.initials: F
authors.lastname: Sarullo
authors.forename: Guerrino
authors.initials: G
authors.lastname: Zuin
authors.forename: Anna
authors.initials: A
authors.lastname: De Luca
authors.forename: Massimo
authors.initials: M
authors.lastname: Allegri
authors.forename: Francesco
authors.initials: F
authors.lastname: Di Pede
authors.forename: Davide
authors.initials: D
authors.lastname: Castagno
authors.forename: Annalisa
authors.initials: A
authors.lastname: Turco
authors.forename: Monica
authors.initials: M
authors.lastname: Sapio
authors.forename: Giampaolo
authors.initials: G
authors.lastname: Pinato
authors.forename: Beatrice
authors.initials: B
authors.lastname: Cioni
authors.forename: Giampaolo
authors.initials: G
authors.lastname: Trevi
authors.forename: Filippo
authors.initials: F
authors.lastname: Crea
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D000787:Angina Pectoris / Q000523:psychology / Q000628:therapy*; D004558:Electric Stimulation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011788:Quality of Life; D016037:Single-Blind Method; D013116:Spinal Cord / Q000502:physiology*; D013997:Time Factors