A randomised comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent:the SPIRIT II trial.
BACKGROUND
Everolimus has been successfully tested in humans using both an erodable and a durable polymer in small previous studies.


METHODS
This single blind multi-centre non-inferiority randomised (3:1) controlled trial evaluated the safety and performance of the XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS) versus the TAXUS Paclitaxel Eluting Coronary Stent System (TAXUS(R) PECSS) in the treatment of patients with a maximum of two de novo native coronary artery lesions located in two different epicardial vessels. Three hundred patients with evidence of myocardial ischaemia were allocated to stent implantation with an everolimus-eluting stent (n=223) or a paclitaxel-eluting stent (n=77). Suitable lesions had a diameter stenosis of <50-99%, a length of <28 mm, and a reference vessel diameter between 2.5 mm and 4.25 mm. The primary endpoint was in-stent late loss (LL) at 180 days. Percentage in-stent volume obstruction (%VO) was measured by intravascular ultrasound (IVUS) in a subset of 152 patients. Clinical secondary endpoints included ischaemia driven major adverse cardiac events (ID-MACE) at 180 days.


RESULTS
At 6 months, the in-stent LL was 0.11+/-0.27 mm in the everolimus-eluting stent arm, as compared to 0.36+/-0.39 mm in the paclitaxel-eluting stent arm (p<0.0001). Percentage VO in the everolimus-eluting stent arm was 2.5+/-4.7% versus 7.4+/-7.0% in the paclitaxel-eluting stent arm (p<0.0001). Hierarchical MACE was 2.7% (6/222) in the everolimus-eluting stent arm vs. 6.5% (5/77) in the paclitaxel-eluting stent arm.


CONCLUSIONS
This non-inferiority randomised trial not only met its primary endpoint, but also demonstrated the superiority of the everolimus-eluting stent over the paclitaxel-eluting stent in terms of in-stent late loss.
Serruys
Patrick W
PW
Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
Ruygrok
Peter
P
Neuzner
Jörg
J
Piek
Jan J
JJ
Seth
Ashok
A
Schofer
Joachim J
JJ
Richardt
Gert
G
Wiemer
Marcus
M
Carrié
Didier
D
Thuesen
Leif
L
Boone
Els
E
Miquel-Herbert
Karine
K
Daemen
Joost
J