GLASGOW, Scotland -- Among women with symptomatic fibroids, the faster recovery after uterine-artery embolization must be weighed against the possibility of needing further treatment, researchers here reported.
GLASGOW, Scotland, Jan 24 -- Among women with symptomatic fibroids, the faster recovery after uterine-artery embolization versus surgery must be weighed against the possibility of needing further treatment, according to researchers here.
In a trial comparing embolization with surgery, the embolization patients had a shorter hospital stay, less pain, and a faster return to daily activities, reported Jonathan Moss, M.B., Ch.B., of the University of Glasgow, and colleagues, in the Jan. 25 issue of the New England Journal of Medicine.
At one year, quality-of-life scores were the same for the t groups, the investigators found. However, beginning at one year, about 20% of the embolization patients required a second intervention (re-embolization or hysterectomy) to treat persistent or recurrent symptoms.
The findings came from the REST trial (Randomized Trial of Embolization versus Surgical Treatment for Fibroids) conducted at 27 hospitals in the United Kingdom from 2000 through 2004, with a one year follow-up.
Patients were randomly assigned in a 2:1 ratio to either uterine-artery embolization or surgery. Of the patients, 101 had embolization and 51 had surgery (43 hysterectomies and eight myomectomies). All surgical procedures were done through an abdominal incision.
At one year, there were no significant differences between groups in any of the eight components of the 36 Item Short-Form General Health Survey (SF-36) scores. However at one month, the embolization patients had significantly greater improvement in SF-36 scores compared with the surgery group for the physical function, social function, and physical-role components. Pain scores at 24 hours were significantly higher in the surgery patients.
The embolization group also had a shorter median hospital stay than the surgical group (one day versus five days, P
Four of the pregnancies resulted in miscarriage, three in successful live births (two by cesarean section, including one patient from each group, and one spontaneous vertex delivery), and one intrauterine death of the fetus at 33 weeks with no abnormalities found on postmortem examination.
Among the trial's limitations, the researchers said, was the fact that because the original target of 200 patients was reduced to 150 due to recruitment difficulties, the 95% CIs indicate that the plausible results include as much as a 10-point difference between groups in some of the components.
The small number of patients who had a myomectomy made it difficult to compare the therapy with embolization. Finally, they said, time to recovery and resumption of usual activities must be viewed with caution, because patients' expectations or the presence of caregivers may have affected the timing.
Summing up, the Glasgow investigators said that the results of the study suggest that the advantages of embolization - including a significant reduction in the length of the hospital stay and 24-hour pain level and a more rapid return to usual activities - need to be weighed against the risk of treatment failure requiring a second intervention and the possibility, although infrequent, of major late adverse events.
"Longer-term follow-up is necessary, with attention to the need for repeated intervention, to inform future decision making," Dr, Moss and colleagues concluded.
In an accompanying editorial, Togas Tulandi, M.D., of McGill University in Montreal, asked, "Do these results imply that surgery should be used only as a second-line treatment for uterine fibroids after uterine-artery embolization? Not necessarily," he said. "The answer varies with the clinical situation, including a patient's age, her treatment preference, her wish to conceive, and the type of surgery planned."
Embolization, Dr. Tulandi said, is associated with particular concerns for young women who have not completed childbearing.
Before undergoing uterine-artery embolization, patients should be informed that approximately one in 10 patients so treated may continue to have excessive uterine bleeding or abdominal pain that may require further treatment, such as myomectomy or hysterectomy.
In the REST study, either hysterectomy or repeated embolization was required for recurrent or persistent symptoms in 10 patients in the embolization group during the first 12 months and in 11 others during a median of 22 months of additional follow-up.
If the possible effects of uterine-artery embolization on fertility and pregnancy are considered, myomectomy should be the first line of treatment for women with symptomatic uterine fibroids who wish to conceive, he said.
Conversely, embolization should be offered to women who are at high surgical risk, such as women with previous multiple laparotomies or women with diffuse uterine fibroids in whom myomectomy might not be technically feasible.
Hysterectomy, Dr. Tulandi concluded, remains a "reasonable alternative to embolization for women who want definitive treatment without having to worry about further bleeding or the need for another procedure."
Richard Edwards, M.B., Ch. B., and Dr. Moss reported receiving grants from Cordis and William Cook Europe to fund the United Kingdom Interventional Radiology Course; and Mary Ann Lumsden, M.D., reported receiving lecture fees from Biocompatibles.
Dr. Tulandi, the editorialist, reported receiving lecture fees from Ethicon.