Thursday, April 22, 2010

Stent or surgery?

Two-month old news but I just heard about it. The Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST) was a 9-year, multicenter, mega trial with over 2,500 patients randomized to either stenting or endarterectomy. Adjudicators of the outcomes were blinded. Results shows that placing a stent to dilate a blocked carotid artery and surgical removal of the blockage--the traditional treatment--both have nearly the same efficacy and overall safety.
The overall safety and efficacy of the two procedures was largely the same with equal benefits for both men and for women, and for patients who had previously had a stroke and for those who had not. However, when the investigators looked at the numbers of heart attacks and strokes, they found differences. The investigators found that there were more heart attacks in the surgical group, 2.3 percent compared to 1.1 percent in the stenting group; and more strokes in the stenting group, 4.1 percent versus 2.3 percent for the surgical group in the weeks following the procedure.
The study also found that the age of the patient made a difference. At approximately age 69 and younger, stenting results were slightly better, with a larger benefit for stenting, the younger the age of the patient. Conversely, for patients older than 70, surgical results were slightly superior to stenting, with larger benefits for surgery, the older the age of the patient.

You'd think that's the final word on the matter. However, in March this year the results of the International Carotid Stenting Study (ICSS) came out. ICSS is a multicenter mega trial with over 1,700 participants randomized to either stenting or endarterectomy. As in CREST adjudicators of outcomes were blinded. Unlike CREST the objective of the European study did not include comparison of efficacy, only safety. Researchers found that surgery is safer overall. Incidence of stroke, death, procedural myocardial infarction, and risk of any stroke and all-cause death were all lower in the endarterectomy group. The three heart attacks that occurred during stenting were all fatal, while all four that occurred during endarterectomy were nonfatal. On the other hand,
There was one event of cranial nerve palsy in the stenting group compared with 45 in the endarterectomy group. There were also fewer haematomas of any severity in the stenting group than in the endarterectomy group.

Possible reasons for the difference in findings: the ICSS employed only symptomatic patients (ie., those who've had minor strokes or transient ischemic atttacks) while CREST included both symptomatic and asymptomatic patients; unlike ICSS, CREST limited itself to physicians who had a "high degree of proficiency and safety."

No comments: