Table 2.
Primary and secondary outcomes at follow-up∗.
| Outcome and analysis | Radiofrequency ablation |
Sham procedure |
Relative risk (95% CI) |
P value | Number needed to treat† |
|---|---|---|---|---|---|
| no./total no. (%) | |||||
| Primary outcome | |||||
| Complete eradication of intestinal metaplasia (all patients) | |||||
| Intention-to-treat | 65/84 (77) | 1/43 (2) | 33.3 (4.8–231.7) | <0.001 | 1.3 |
| Per-protocol | 65/78 (83) | 1/39 (3) | 32.5 (4.6–225.5) | <0.001 | 1.2 |
| Complete eradication of dysplasia (low-grade dysplasia) | |||||
| Intention-to-treat | 38/42 (90) | 5/22 (23) | 4.0 (1.8–10.7) | <0.001 | 1.5 |
| Per-protocol | 38/40 (95) | 5/19 (26) | 3.6 (1.7–7.7) | <0.001 | 1.5 |
| Complete eradication of dysplasia (high-grade dysplasia) | |||||
| Intention-to-treat | 34/42 (81) | 4/21 (19) | 4.2 (1.7–10.4) | <0.001 | 1.6 |
| Per-protocol | 34/38 (90) | 4/20 (20) | 4.5 (1.8–10.8) | <0.001 | 1.4 |
| Secondary outcomes | |||||
| Complete eradication of intestinal metaplasia (high-grade dysplasia) | |||||
| Intention-to-treat | 31/42 (74) | 0/21 | ND | <0.001 | 1.4 |
| Per-protocol | 31/38 (82) | 0/20 | ND | <0.001 | 1.2 |
| Complete eradication of intestinal metaplasia (low-grade dysplasia) | |||||
| Intention-to-treat | 34/42 (81) | 1/22 (4) | 17.8 (2.6–121.5) | <0.001 | 1.3 |
| Per-protocol | 34/40 (85) | 1/19 (5) | 16.1 (2.4–109.3) | <0.001 | 1.3 |
| Complete eradication of dysplasia (all patients) | |||||
| Intention-to-treat | 72/84 (86) | 9/43 (21) | 4.1 (2.3–7.4) | <0.001 | 1.5 |
| Per-protocol | 72/78 (92) | 9/39 (23) | 4.0 (2.2–7.1) | <0.001 | 1.4 |
| Progression of dysplasia | |||||
| Any | 3/84 (4) | 7/43 (16) | 02 (0.1–0.8) | 0.03 | 7.9 |
| Low-grade to high-grade | 2/42 (5) | 3/22 (14) | 0.3 (0.1–1.9) | 0.33 | 11.3 |
| Low-grade to cancer | 0/42 | 0/22 | ND | ND | NA |
| High-grade to cancer | 1/42 (2) | 4/21 (19) | 0.1 (0.01–1.0) | 0.04 | 6.0 |
| High-grade or low-grade to cancer | 1/84 (1) | 4/43 (9) | 0.1 (0.01–1.1) | 0.045 | 12.3 |
| Biopsy specimen free of intestinal metaplasia at 12 mo | |||||
| All patients | 2670/2724 (98) | 673/1164 (58) | 1.7 (l.6–1.8) | <0.001 | NA |
| Low-grade-dysplasia subgroup | 1228/1260 (98) | 313/550 (57) | 1.7 (1.6–1.8) | <0.001 | NA |
| High-grade-dysplasia subgroup | 1442/1464 (98) | 360/614 (59) | 1.7 (1.6–1.8) | <0.001 | NA |
| Secondary outcomes | |||||
| Chest-pain score on day 1‡ | |||||
| All patients | <0.001 | NA | |||
| No. of patients | 81 | 40 | |||
| Median | 23 | 0 | |||
| Interquartile range | 0–51 | 0-0 | |||
| Low-grade dysplasia | <0.001 | NA | |||
| Number of patients | 40 | 20 | |||
| Median | 26 | 0 | |||
| Interquartile range | 4–48 | 0-0 | |||
| High-grade dysplasia | <0.001 | NA | |||
| Number of patients | 41 | 20 | |||
| Median | 22 | 0 | |||
| Interquartile range | 0–57 | 0-0 | |||
*NA denotes not applicable, and ND not done.
†The number needed to treat refers to the number of patients who would need to be treated with radiofrequency ablation to prevent one out-come failure (the inverse of the absolute risk reduction).
‡Chest pain was measured on a visual-analogue scale of 0 to 100, with higher scores indicating a greater severity of pain.
Figure taken with permission from Shaheen et al. [29].