Five-year results from the REST trial which were published in the July edition of BJOG: An International Journal of Obstetrics and Gynaecology show that uterine artery embolization (UAE) is a safe and effective technique for women with symptomatic fibroids who wish to avoid conventional surgery.
The results from the trial show that the complications and adverse event rates of embolization were similar to surgery, but re-intervention rates were higher for the patients who underwent the minimally invasive procedure. Almost a third of the participants in the embolization arm required further invasive treatment and this had direct bearing on the initial cost-benefit at one year being lost at five years.
Jon Moss, principal investigator of the REST trial, told Interventional News that the results showed that: “Uterine artery embolization is an effective uterus-sparing procedure which is successful in the majority of patients. It has advantages and disadvantages over surgery. REST provides five-year data to help patients decide which treatment is best suited to them.”
Other findings from the REST trial were:
- The improvement in quality of life resulting from either surgery or uterine artery embolization seen at one year was maintained. It was equal in both groups at five years with 91% follow-up.
- Uterine artery embolization is a safe and effective technique for women with symptomatic fibroids who wish to avoid conventional surgery.
- The complications and adverse event rates with embolization are similar to surgery, with most of the complications occurring within the first 12 months.
- Symptomatic relief and satisfaction with treatment are excellent in both groups.
Moss et al wrote that “The initial 12-month results of the REST trial showed no difference in the quality of life gain between surgery and embolization. The five-year results show this gain to be durable in both groups, which achieved levels comparable with normative data from an age-matched population. In addition, both treatments are associated with very high patient satisfaction scores of almost 90%. The symptom relief score which was initially significantly better in the surgical arm at 12 months, continued to improve over the next four years in both arms of the study, with ultimately no significant difference between groups.
This may be related to the higher re-intervention rate almost (32%) in the embolization arm, and possibly to a further reduction in the uterine and fibroid volume over time.
Moss, Gartnavel General Hospital, Glasgow, UK, is quick to make the point that the results of REST are not really providing a mixed message about uterine artery embolization as a treatment option. “There are two points: any uterine-sparing operations like myomectomy or endometrial ablation have very similar re-intervention rates to embolization and; minimally invasive techniques can have a downside of increased intervention. This is also seen in other procedures like endovascular aneurysm repair.”
He says the results of REST are important because, it is a randomised controlled trial with a minimum of five-years of follow-up. “The only other randomised, controlled trial with this length of follow-up in uterine artery embolization is the EMMY trial,” he said.
When Interventional News asked Moss how to interpret the fact that satisfaction with treatment was excellent in both groups even though there was a much higher rate of re-intervention in the group which had embolization, he said, “This is not entirely clear. Still, obviously some of those women receiving uterine artery embolization had a further intervention, but that did not appear to adversely affect their quality of life or satisfaction with the procedure.
“It should be remembered that this was an intention to treat analysis and therefore technical failures and procedures not done were included in the analysis.There were several of these in the embolization arm.”
How do the results of REST compare to the literature?
Five-year outcomes of the Dutch randomised EMMY (Uterine artery embolization vs. hysterectomy in the treatment of symptomatic uterine fibroids) trial, which compared clinical outcome and health-related quality of life five years after uterine artery embolization or hysterectomy in the treatment of menorrhagia caused by uterine fibroids, showed that health-related quality of life measures improved significantly and remained stable until the five-year follow-up evaluation, with no differences between the groups.
Published in August 2010 (Van der Kooij et al, American Journal of Obstetrics and Gynecology), it also showed that embolization had a positive impact on urinary and defecation functions. The EMMY trial results showed a 28.4% rate of re-intervention after uterine artery embolization. Five years after treatment, 23 of 81 uterine artery embolization patients had undergone a hysterectomy because of insufficient improvement of complaints. Of these, 24.7% had had successful uterine artery embolization.
“It all boils down to choice”
John Reidy, Guy’s and St Thomas’ NHS Foundation Trust, London, UK, told Interventional News: “For me, it really boils down to a woman’s choice; some women might say, ‘I am 45, I have had my children and I am done with my uterus.’ If they are a straightforward surgical candidate, they might opt for a hysterectomy. However, many women, for a variety of reasons, do not want to have a hysterectomy.
“The advantages of embolization are that it is one night in hospital, there are no scars, and patients can go back to work in two weeks or even earlier, and serious complications are very low. There is also the issue that follow-up over time, as in the REST trial, will show that a number of women are likely to need another treatment due to recurrence of symptoms.
Whether it is REST, EMMY, the HOPEFUL study, or the US registry data, they all show that the longer you follow women who have undergone embolization up, the more likely it is that some of them will need some re-intervention. Having said that, over 80% give or take, are happy with their results, and that is an important point.”
Reidy also made the point that embolization and hysterectomy are “totally different beasts” really. One is a radical treatment which would deal with any other uterine conditions, and there is usually no recurrence. The other is a global, non-invasive treatment,” he said. “The pertinent comparison that I am interested in currently is between uterus-conserving embolization compared with uterus-conserving myomectomy,” he added.
“Several factors can impact the choice between these two procedures and the age of the patient is one of them. At the moment, younger women are more likely to get a myomectomy as there is a general acceptance that the evidence for future fertility (which is a concern with both procedures) is stronger for myomectomy than for embolization. But there are other aspects to consider such as where the fibroids are located. If there are multiple fibroids, this makes myomectomy more difficult. However, when there are localised fibroids, which are easily accessible by surgery, myomectomy becomes a good option,” he said.
“An important factor is that embolization does not interfere with any future surgery. However, with myomectomy, it does make it more difficult to have a second procedure. In my view, with embolization, you are offering a less-invasive, and very acceptable treatment which is going to work in the long-term in approximately three quarters of women. For the women in whom there is recurrence, there is the option of secondary treatment.”
When it comes to skills…
“For interventional radiologists with good vascular skills, embolization does not present particular problems. On the other hand, some gynaecologists are more enthusiastic and active in performing myomectomy than others because it would seem much easier for a gynaecologist in training to do a hysterectomy rather than a myomectomy. There does seem to be quite a variation in the aptitude and skill level of gynaecologists performing myomectomy,” Reidy said.
Embolization is not a “delay to definitive surgery”
“I have always thought myomectomy was the better comparison with embolization, since both procedures leave the uterus intact,” said Bruce McLucas, a gynaecologist at UCLA Medical Center, and one of the pioneers who introduced uterine artery embolization in the USA.
He said, “The EMMY and REST studies both point to a need for recurrent procedures after embolization, in around 25% of the time. If embolization is a delay for further definitive surgery, it would not be described in the gynaecology literature as durable. This debate has raged on for years in cardiology about the value of angioplasty versus coronary artery surgery. Of course, there are also women in whom there is no need for re-intervention. We have patients who are 10 years post-embolization with no re-growth of myomata and still showing relief of symptoms.”
McLucas also said, “In comparing myomectomy with uterine artery embolization, we will report some encouraging information next year about ovarian function in women of child bearing age after embolization. This will be welcome news to patients suffering from myomata under the age of 40. The facts are well established that embolization has a faster recovery time and less immediate complications than major surgery. So the future of uterine artery embolization is robust.”