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BASKET PROVE: Drug-eluting, bare metal stent efficacy similar in large vessels
Kaiser C. N Engl J Med 2010; 363:2310-2319.
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American Heart Association Scientific Sessions 2010
CHICAGO — Drug-eluting stents and bare metal stents were equally as effective in reducing the rate of death and MI among patients with large coronary arteries, according to data from the BASKET PROVE trial.
“The findings of BASKET PROVE imply that in patients in need of large coronary artery stenting, drug-eluting stents may be used without evidence of increased late cardiac events or late stent thrombosis,” Christoph Kaiser, MD, University Hospital Basel, Switzerland, said during a press conference.
Between 2003 and 2004, Kaiser and colleagues conducted the single-center BASKET trial that examined the difference between first-generation drug-eluting stents and bare metal stents among 826 patients. Results from that trial revealed that drug-eluting stents were associated with an increase in cardiac-related death or non-fatal MI beyond 6 months after the procedure in patients with large coronary arteries. Drug-eluting stents were beneficial, however, in patients with small vessels.
The study aimed to determine prospectively whether first- and second-generation drug-eluting stents reduced target vessel revascularization or increased the risk for late cardiac death or MI in large vessels.
The study included 2,314 patients with vessels ≥3 mm in diameter who were randomly assigned to a first generation sirolimus-eluting stent (Cypher Select, Cordis), a cobalt-chromium bare metal stent (Vision, Abbott Vascular) or a second generation everolimus-eluting stent (Xience V, Abbott Vascular). Follow-up was conducted at 12 and 24 months. The primary endpoint was the occurrence of cardiac death or MI after 24 months; the secondary endpoint was late cardiac death or MI between 7 and 24 months and death, cardiac death, MI, target vessel revascularization, stent thrombosis or major adverse cardiac events.
The event rate for the primary endpoint at 24 months was 2.6% in the sirolimus-eluting stent group, 3.2% in the everolimus-eluting stent group and 4.8% in the bare metal stent group with no significant differences between the three stent types. The rate of target vessel revascularization not related to MI was significantly reduced by more than 50% in both drug-eluting stent groups compared with the bare metal stent group (4.3% for sirolimus and 3.7% for everolimus vs.10.3% for bare metal).
“Since bare metal stents and drug-eluting stents showed similar death and MI rates, bare metal stents can still be used; however, with a higher rate of target vessel revascularization,” Kaiser said. “Since the performance of both first- and second-generation drug-eluting stents was similar, both drug-eluting stents may be used in these patients.” – by Stacey L. Fisher
For more information:
- Kaiser C. LBCT III, Abstract 21711. Presented at: American Heart Association Scientific Sessions 2010; Nov. 13-17; Chicago.
BASKET PROVE cannot be considered to be conclusive. We cannot rule out the existence of smaller than anticipated differences in event rates. However, based on these results, this study is highly reassuring [in terms of] the safety issue which has been noted in BASKET LATE as not being confirmed.
– Marco Valgimigli, MD, PhD
University of
Ferrara, Ferrara, Italy
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