January 8, 2010 (Rotterdam, the Netherlands) — In a randomized comparison of the everolimus-eluting Xience V (Abbott) and paclitaxel-eluting Taxus Liberté (Boston Scientific) stents, conducted in "unselected patients in real-life practice," the everolimus-eluting stent came out on top with respect to the primary end point of death, MI, or target-vessel revascularization (TVR) at 12 months .
In addition to the 31% relative risk reduction (p=0.02) for that composite end point in patients treated with the Xience V in the trial, called COMPARE, the everolimus-eluting stent was associated with significantly less stent thrombosis (p=0.002), with most of the difference occurring in the first 30 days after the procedure.
In patients with diabetes mellitus, especially depending on the relative cost of the two devices, both stents could be considered acceptable at this time.
"On the basis of our results, we suggest that paclitaxel-eluting stents should no longer be used in everyday clinical practice," write the authors, led by Dr Elvin Kedhi (Maasstad Ziekenhuis, Rotterdam, the Netherlands), in a report published online January 8, 2010 in the Lancet. Their findings had been presented in preliminary form at the TCT 2009 sessions and reported then by heartwire .
Among the new information in the published report is a post hoc subgroup analysis hinting at a significant primary-end-point relative risk reduction (RR 0.61, 95% CI 0.42–0.90) for the everolimus-eluting stent in patients without diabetes, but no such effect in diabetics; the interaction p value, however, was nonsignificant at 0.22.
COMPARE randomized 1800 consecutive patients undergoing elective or emergent PCI to receive one stent or the other; about 18% of the group had diabetes, 60% were undergoing PCI for acute coronary syndromes, and about 25% were receiving it for acute ST-segment-elevation MI.
12-Month Outcomes in COMPARE, Including Relative Risk (95% CI), Everolimus-Eluting vs Paclitaxel-Eluting Stent
|End point||Everolimus-eluting stent, n=897 (%)||Paclitaxel-eluting stent, n=903 (%)||RR (95% CI)||p|
|Primary end pointa||6||9||0.69 (0.50–0·95)||0.02|
|Secondary end pointb||5||8||0.60 (0.42–0.86)||0.005|
|Stent thrombosis||0.7||3||0.26 (0.11–0.64)||0.002|
|Late stent thrombosis (d 30 to 1 y)||0.4||0.9||0.50 (0.25–1.67)||0.25|
b. Cardiac death, nonfatal MI, or clinically justified target-lesion revascularization
Dr Gregg W Stone (Columbia University, New York, NY) told heartwire that, for what it's worth, he thinks the interaction p value in the diabetes subgroup analysis would have reached significance had COMPARE been a larger trial. Parity between the two stents in diabetics but superiority for the everolimus-eluting stent in nondiabetics is also what was seen in another comparison of the two drug-eluting-stent (DES) types, the SPIRIT IV trial, for which Stone was principal investigator and which had about twice as many patients.
As previously reported by heartwire , SPIRIT IV had randomized 3690 patients to receive the Xience V or the paclitaxel-eluting Taxus Express 2 stent. At one year, those who had received the everolimus-eluting stent showed significant reductions in the primary end point of "target-lesion failure" (a composite of cardiac death, target-vessel-related MI, or ischemia-driven target lesion revascularization [TLR]) and ischemia-driven TLR on its own (p<0.001 for both differences). But the two stents performed about equally in diabetics.
So Stone said the COMPARE group's recommendation that "paclitaxel-eluting stents should no longer be used" may be a bit too strongly worded. "I'd have flipped it around to say, certainly in nondiabetic patients, everolimus-eluting stents should be the standard of care, in patients who can tolerate dual-antiplatelet therapy and who need a drug-eluting stent."
But, he said, "in patients with diabetes mellitus, especially depending on the relative cost of the two devices, both stents could be considered acceptable at this time." Still, if the Taxus were to cost significantly less than the Xience V, "then the paclitaxel-eluting stent might at this point be a very reasonable, cost-effective alternative in patients with diabetes, though not in patients without diabetes."
Everolimus-Eluting Stents for Japan
Regulators in Japan have approved the everolimus-eluting coronary stent used in COMPARE, in all its guises [2,3]. Abbott today announced that it expects the Xience V stent to start distribution there within a few weeks . Japan, according to the company, "is the second-largest drug-eluting stent market in the world after the United States, with approximately 200 000 stent procedures performed each year."
Boston Scientific today made a nearly identical announcement regarding its Promus everolimus-eluting stent ; its Taxus Liberté is already available in Japan. The Promus, it notes, is in fact the Abbott-made Xience V that Boston Scientific distributes under an agreement inherited when it acquired Guidant in 2006.
COMPARE was supported by Abbott Vascular and Boston Scientific. Coauthor Dr Eugene McFadden (Maasstad Ziekenhuis) reports receiving honoraria or expenses from Abbott Vascular, Medtronic, Cordis, and Boston Scientific and being on the speaker's bureau for Medtronic; the other authors "declare that they have no conflicts of interest." Stone has reported being on the advisory boards of Abbott and Boston Scientific.
Heartwire from Medscape © 2010 Medscape, LLC
Cite this: COMPARE in Print, Shows Everolimus Stent Advantage Over Paclitaxel - Medscape - Jan 11, 2010.