Table 3.
12-Month Response at Participant and Lesion Levelsa
| Response | Participants or Lesions, % [95% CI] (No./Total No.) | Risk Difference (95% CI), % | P Valueb | |
|---|---|---|---|---|
| IRC Treatment | AM Arm | |||
| Overall CILC rate (primary end point) | 62 [48–74] (37/60) | 30 [19–43] (18/60) | 32 (13–48) | <.001 |
| Overall CILC/PILC rate | 82 [70–90] (49/60) | 47 [33–60] (28/60) | 35 (16–50) | <.001 |
| Reason for failure | ||||
| HSIL at index biopsy | 25 [15–38] (15/60) | 65 [52–77] (39/60) | −40 (−56 to −22) | <.001 |
| Withdrawal (without prior HSIL) | 8 [3–18] (5/60) | 5 [1–14] (3/60) | … | |
| Not evaluable at pathology or biopsy refused | 5 [1–14] (3/60) | 0 [0–6] (0/60) | … | |
| Free of HSIL (index or metachronous) at 12-mo visitc | 71 [56–83] (36/51) | 28 [17–42] (16/57) | 43 (22–59) | <.001 |
| Incident metachronous lesionsd | 47 [33–61] (25/53) | 21 [11–34] (12/57) | 26 (6–43) | .004 |
| Index lesion–level clearance | 63 [52–74] (51/81 lesions) | 42 [30–54] (41/97 lesions) | … | .001 |
Abbreviations: AM, active monitoring; CI, confidence interval; CILC, complete index lesion clearance; HSIL, high-grade squamous intraepithelial lesion; IRC, infrared coagulation; PILC, partial index lesion clearance.
aThere was no index lesion HSIL recurrence after the initial ablation in IRC arm or regression of index lesion to normal or low-grade squamous intraepithelial lesions absent treatment in the AM arm. All results are at the participant level except for Index lesion level clearance (bottom row).
b P values determined with on stratified (by site) Mantel-Haenszel test or generalized estimating equation relative risk model with adjustment for site (lesion-level analysis).
cCross-sectional estimate at 1 point in time in returning evaluable participants.
eCumulative estimate in returning evaluable participants.