February 9th, 2010
An ENDEAVOR to COMPARE 2nd Generation DES
L. David Hillis, MD
In two recent studies, second-generation drug-eluting stents were compared with first-generation paclitaxel-eluting stents. In COMPARE, the everolimus-eluting stent was superior (31% risk reduction in “target lesion failure”), whereas in ENDEAVOR IV, the zotarolimus-eluting stent showed similar efficacy and safety to the paclitaxel-eluting stent. In light of these data, is there any role for the zotarolimus-eluting stent?
couple of questions
How do interventional cardiologists decide which DES to use? A lot of discussion has focused on DES vs BMS (and maybe even vs POBA) – but how is the decision made about the DES to use. Is it about cost — and what are the cost differences?
And with respect to the trial, it raises an interesting question — is a single study enough to lead us to chose one over the other. And maybe the question should be – should we have been using it at all in the absence of data of clear superiority — assuming it is likely more expensive.
Rationale for DES or BMS
Although DES are superior to BMS in reducing the incidence of restenosis (< 10% of subjects following DES vs 20 to 25% following BMS), their disadvantage is an increased risk of late stent thrombosis, which means the patient needs to take aspirin and clopidogrel for at least a year or maybe even lifelong. So the decision of whether to use a BMS or DES is a tradeoff. In the patient undergoing stenting, a BMS should be used when he or she can’t, won’t, or shouldn’t take uninterrupted dual antiplatelet therapy for a long-time. Conversely, in the patient who can take dual antiplatelet therapy, DES are usually preferable, especially in the patient at high risk of developing restenosis with a BMS.
As Harlan points out, a single study probably shouldn’t change our practice. You’d like to have another study that corroborates the COMPARE results. The results of the SPIRIT IV study – which was presented at the AHA and will soon be published – are remarkably similar to those reported in the COMPARE study.
Choices
Thanks — but if you do decide to put in a DES — how do you decide among the options — and how do you think one ought to decide? And what role does the lesion play in the choice?
Among the DES, there appears to be no significant difference between the paclitaxel and sirolimus DES with regard to CV outcome (i.e., restenosis or thrombosis). The particular stent characteristics (i.e., deliverability) often determine which of these 2 is used. In contrast, the everolimus DES appears superior to the others with regard to CV outcome, except in diabetics. How would I choose now? The diabetic patient receives the less expensive paclitaxel or sirolimus DES, and the remaining patients receive the everolimus DES.