Table 6: Clinical Events in the FAME-2 Study.
| Events | Randomly assigned groups n (%) | P value Registry cohort | |||
|---|---|---|---|---|---|
| PCI + OMT (n=447) | OMT alone (n=441) | Hazard ratio with PCI (95 % CI) | (n=166) | ||
| Primary endpoint | 19 (4.3) | 56 (12.7) | 0.32 (0.19–0.53) | <0.001 | 5 (3.0) |
| Components of primary endpoint | |||||
| Death from any cause | 1 (0.2) | 3 (0.7) | 0.33 (0.03–3.17) | 0.31 | 0 |
| Ml | 15 (3.4) | 14 (3.2) | 1.05 (0.51–2.19) | 0.89 | 3 (1.8) |
| Urgent revascularisation | 7 (1.6) | 49 (11.1) | 0.13 (0.06–0.30) | <0.001 | 4 (2.4) |
| Death or MI | 15 (3.4) | 17 (3.9) | 0.61 (0.28–1.35) | 0.22 | 3 (1.8) |
| Cardiac death | 1 (0.2) | 1 (0.2) | 0.96 (0.06–15.17) | 0.98 | 0 |
| Revascularisation | |||||
| Any | 14 (3.1) | 86 (19.5) | 0.14 (0.08–0.26) | <0.001 | 6 (3.6) |
| Non-urgent revascularisation | 7 (1.6) | 38 (8.6) | 0.17 (0.08–0.39) | <0.001 | 2 (1.2) |
| Stroke | 1 (0.2) | 2 (0.5) | 0.49 (0.04–5.50) | 0.56 | 1 (0.6) |
| Definite/probable stent thrombosis | 5 (1.1) | 1 (0.2) | 4.98 (0.59–42.25) | 0.10 | 1 (0.6) |
FAME = Fractional Flow Reserve versus Angiography for Multivessel Evaluation; OMT = optimal medical therapy; PCI = percutaneous coronary intervention. Source: De Bruyne, et al. 2012.