Table 3.
Qualitative summary of efficacy outcomes
A. SCS vs. active comparator studies | ||||
Trial Name/author | Outcome | Within group difference SCS | Within group difference Control | Between group difference SCS vs. control |
ESBY 1998 (vs CABG) | Nitrate drug usage | 6-mo + | 6-mo + | 6-mo = |
2-yr + | 2-yr + | 2-yr = | ||
Exercise capacity | 6-mo = | 6-mo + | 6-mo -- | |
Total mortality | NR | NR | 6-mo + | |
NR | NR | 2-yr = | ||
NR | NR | 5-yr = | ||
Non fatal morbidity | NR | NR | 6-mo = | |
Ischemic burden | 6-mo = | 6-mo = | 6-mo = | |
HRQoL (QLQ-AP & NHP) | 6-mo + | 6-mo + | 6-mo = | |
2-yr + | 2-yr + | 2-yr = | ||
6-mo + | 6-mo+ | 6-mo = | ||
Angina | ||||
SpiRiT 2006* (vs PMR) | Exercise capacity | 3-mo + | 3-mo = | 3-mo = |
12-mo = | 12-mo = | 12-mo = | ||
CCS class | 3-mo + | 3-mo + | 3-mo + | |
12-mo + | 12-mo + | 12-mo = | ||
HRQoL (SF-36 & | 3-mo + | 3-mo + | 3-mo = | |
SAQ)* | 12-mo + | 12-mo + | 12-mo = | |
B. SCS vs no SCS/SCS OFF studies | ||||
Trial Name/author | Outcome | Within group difference SCS | Within group difference Control | Between group difference SCS vs. control |
DeJongste 1994 | Exercise capacity | + | = | + |
Nitrate drug usage | + | = | + | |
HRQoL (ADL score) | + | = | + | |
Hautvast 1998 | Exercise capacity | + | = | + |
Nitrate drug usage | + | = | = | |
HRQoL (LASA) | + | = | = | |
Ischemic burden | + | = | = | |
Jessurun 1999 | Exercise capacity | NR | NR | = |
Ischemic burden | NR | NR | = | |
Nitrate drug usage | NR | NR | = | |
DiPede 2001 Eddicks 2007 | Ischemic burden | NR | NR | = |
Exercise capacity | NR | NR | + | |
Nitrate drug usage | NR | NR | + | |
HRQoL (SAQ) | NR | NR | +/= | |
(EQ-5D) | NR | NR | + | |
CCS class | NR | NR | + | |
Angina attacks | NR | NR | + |
*additional data supplied by authors
HRQOL: health-related quality of life; ADL: activities of daily living score; SF-35: Short-form 36 questionnaire; NHP: Nottingham Health Profile; QLQ-AP: Quality of Life Questionnaire – Angina Pectoris; SAQ: Seattle Angina Questionnaire; SAS: Social Activity Scale; LASA: Linear Analogue Self Assessment; VAS – visual analogue scale; 6-MWT: 6 minute walk test; NR: not reported
+: within group – improvement (P ≤ 0.05) in outcome with SCS or control at follow up compared to baseline; between group – superior (P ≤ 0.05) outcome at follow up with SCS compared to control
-: within group – worsening (P ≤ 0.05) in outcome with SCS or control at follow up compared to baseline; between group – superior (P ≤ 0.05) outcome at follow up with control compared to SCS
=: within group – no change (P > 0.05) in outcome with SCS or control at follow up compared to baseline; between group – no difference (P > 0.05) outcome at follow up of SCS compared to control