Ablative Therapy for Esophageal Dysplasia and Early Malignancy: Focus on RFA
Table 2
Primary and secondary outcomes at follow-up*.
Outcome and analysis
Radiofrequency ablation
Sham procedure
Relative risk (95% CI)
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].
