Table 2.
ISSUE-3 and SPAIN trials compared.
| ISSUE-3 | SPAIN | |
|---|---|---|
| Diagnostic tool | Implantable loop recorder | Head-up tilt table |
| Number of patients included | 77 | 54 |
| Design | Double-blind, randomized, placebo-controlled, and parallel | Double-blind, randomized, placebo-controlled, and cross-over |
| Pacing mode | DDD-rate drop response | DDD-closed loop stimulation |
| Follow-up (months) | 24 | 12 |
| Recurrence rate in placebo arm (%) | 57 | 45.7 |
| Recurrence rate in pacing arm (%) | 25 | 8.7 |
| Relative risk reduction (%) | 57 | 89 |
| Absolute risk reduction (%) | Unknown | 37 |
| NNT | Unknown | 2.7 |