麻豆传媒

PARIS -- The SPIRIT family of trials, which compare the everolimus-eluting Xience stent to the paclitaxel-eluting Taxus stent, has once again come up with a victory for the everolimus stent -- this time demonstrating that Xience trumps Taxus for use in diabetic patients using in-stent late loss as an endpoint.

At nine months, the late lumen loss in patients treated with the Xience stent was 0.19 mm versus 0.39 mm in the Taxus group (P=0.0001), said Eberhard Grube, MD, of the Siegburg Heart Center in Siegburg, Germany. Grube reported the SPIRIT V results at a late-breaking clinical trials session at the EuroPCR meeting.

The trial randomized 218 patients to Xience and 106 to Taxus. All patients had a confirmed diagnosis of diabetes and target lesion stenosis of at least 50%.

But Spencer B. King, III, MD, of Saint Joseph's Heart and Vascular Institute in Atlanta, said it was hardly surprising that the results would favor Xience since a well known hallmark of the everolimus-eluting stent is its remarkably low lumen loss. The trial, King said, was designed with an endpoint that would favor Xience.

"We know Xience has a very low late loss, and this study really nails down what it went for: showing late loss is less [with Xience]. I believe that data. I'm skeptical about any clinical data from this very small trial," said King, who served as discussant for the SPIRIT V results.

Moreover, King said, the trial did not advance knowledge about cardiovascular disease in patients with diabetes. Still unknown, he said, is whether "coronary disease really is different in diabetics or just more extensive. Some say it's a different disease. I don't know if that's true."

There is, however, no doubt that, by the numbers, Xience continues to look much better than its chosen competitor, Taxus.

Among the findings from Spirit V:

• At 270 days, in-stent stenosis was 14.3% in the group treated with Xience versus 20.7% in the Taxus group (P<0.001).
• Cardiac death and MI rate was 3.7% for Xience versus 9.6% (P=0.04, but the trial was not powered to answer this question so these results should be considered hypothesis-generating only).
• There were no definite stent thromboses observed in the Xience arm versus a rate of 1.9% in the Taxus arm.

The findings also are likely to allay any lingering concerns that might have been raised by the SPIRIT IV results. In that earlier trial, which was published last month in the New England Journal of Medicine, the rates of target lesion failure among patients with diabetes were 6.4% in the Xience group versus 6.9% in the Taxus group, which did not reach statistical significance.

That slight blip in the Xience success story did raise some eyebrows since target lesion failure (TLF) is the current FDA-preferred endpoint.