Endometrial ablation plus levonorgestrel-releasing intrauterine system versus endometrial ablation alone in women with heavy menstrual bleeding in The Netherlands (MIRA2): a multicentre, open-label, randomised, controlled, superiority trial.
Tamara J Oderkerk, Jaklien C Leemans, Pleun Beelen et al.
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In 30 seconds
MIRA2 was a multicentre, open-label, randomised controlled superiority trial in women younger than 60 years with heavy menstrual bleeding eligible for endometrial ablation. It compared ablation followed immediately by a levonorgestrel-releasing intrauterine system (LNG-IUS) with ablation alone. At 2 years, hysterectomy occurred in 15 (4%) of 342 participants receiving combined treatment versus 34 (10%) of 331 receiving ablation alone (RR 0·43, 95% CI 0·24 to 0·77; p=0·0050). Serious adverse events were similar between groups.
Key findings
- At 2 years, hysterectomy occurred in 15 (4%) of 342 participants with ablation plus LNG-IUS versus 34 (10%) of 331 with ablation alone.
- The relative risk of hysterectomy with combined treatment was 0·43 (95% CI 0·24 to 0·77; p=0·0050).
- Serious adverse events were reported in 27 (8%) of 346 participants with combined treatment and 26 (8%) of 327 with ablation alone (RR 0·98, 95% CI 0·59-1·65; p=0·94).
Why it matters
Hysterectomy is an important subsequent intervention for some patients after endometrial ablation. In this randomised trial, adding an LNG-IUS immediately after ablation was associated with fewer hysterectomies over 2 years, without an observed increase in serious adverse events. These results inform consideration of an adjunctive approach while keeping the trial’s population and follow-up in view.
What to keep in mind
The trial was open-label, and 42 (6%) participants had missing primary-outcome data at 2 years.