Paris, France - Revascularization rates for the paclitaxel-eluting Taxus Liberté stent mirror those of its predecessor, the Taxus Express 2, making it the first second-generation drug-eluting stent (DES) to prove itself noninferior to its DES precursor. Procedural results hint that the new stent may be easier to deliver, despite being used in trickier cases, Dr Mark Turco (Washington Adventist Hospital, Tacoma Park, MD) noted during his presentation of the ATLAS trial here at the EuroPCR 2006 meeting.

"Despite having more complex lesions in the Taxus Liberté group, there was an improved procedural performance and comparable clinical and angiographic outcomes," Turco said.

The Liberté platform has thinner struts and a lower profile than the Express 2, making it more flexible and conformable, with better side-branch access, Turco explained. The Taxus Liberté already has CE Mark approval in Europe; the ATLAS trial, undertaken to win US FDA approval, was conducted at 61 centers in North America and the Asia Pacific region. In all, 871 patients with de novo lesions were treated with the Liberté stent, and clinical outcomes in these patients were compared with a matched control group comprising patients from the Taxus IV and V trials.

As Turco showed today, target vessel revascularization (TVR) at nine months—the primary end point of the trial—was more or less equivalent between the two groups, with the difference falling within the 3% margin for noninferiority specified in the trial design. This similarity was achieved despite a higher proportion of complex lesions, with greater baseline stenosis, length, calcification, angulation, tortuosity, and bifurcation disease. As well, operators managed to shave more than five minutes, on average, off procedural times. Other nine-month event rates, as well as stent thrombosis rates, were not significantly different, Turco said.

While full angiographic results will be presented at a future meeting, a glimpse of the late-loss results showed no significant differences between the two stent groups, he added.

ATLAS outcomes

End point	Taxus Liberté	Taxus Express 2	p
Proportion of complex lesions* (%)	75.5	61.2	<0.0001
Procedure time (min)	47.8	53	0.0052
9-month TVR (%)	8.0	7.1	0.48
6-month late loss, in-stent (mm)	0.4	0.42	NS

According the Turco, the Taxus investigators are also testing the Taxus Liberté's performance in specific complex settings. Meanwhile, the manufacturer, Boston Scientific, announced today that European regulators have already extended the stent's indications for use to include AMI, chronic total occlusions, and in-stent restenosis, making it the first DES for these indications available in Europe.

Commenting on the ATLAS results for heartwire, Dr Sigmund Silber (Dr Müller Hospital, Munich, Germany) said he did not think the advantages of the new Liberté would have any bearing on how physicians choose drug-eluting stents or on drug-eluting-stent performance. Recent studies have hinted that the late loss associated with the Cypher sirolimus stent might give it the edge over the Taxus; Silber, however, disagreed, citing equivalent clinical results from the REALITY trial and STENT registry.

"I do not see 'a gap' between the Cypher and the Taxus—either the Express or Liberté. There are only cosmetic differences, such as late loss, [but] no differences regarding patient outcomes," he told heartwire.

Silber acknowledged that the first-generation Cypher is an "old stent design" and that the Taxus is more frequently used for side-branch access. But in terms of outcomes, the two stents "have the same clinical results, even in diabetics—at least in patients not on insulin," Silber commented.