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ZEUS: ZES outperformed BMS in high-risk patients regardless of DAPT duration
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WASHINGTON — A zotarolimus-eluting stent was associated with lower rates of major adverse CV events compared with bare-metal stents in a patient population not typically indicated for drug-eluting stents.
According to data from the ZEUS study presented at the American College of Cardiology Scientific Sessions, patients who received the Endeavor Sprint zotarolimus-eluting stent (ZES; Medtronic) also had lower rates of MI, target vessel revascularization and stent thrombosis compared with those who received BMS.
The patients studied were on personalized regimens of dual antiplatelet therapy and, in many cases, were on short durations of DAPT or no DAPT because they were unlikely to tolerate long-term therapy, presenter Marco Valgimigli, MD, PhD, from Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands, told Cardiology Today.
Marco Valgimigli
“There is low stent thrombosis in patients having received a DES who underwent a very low ration of DAPT,” he said. “We even had patients who never got DAPT because they were not eligible for it. … Our results should be hypothesis-generating because they have so much potential to change the way we practice.”
Not usually indicated for DES
The researchers enrolled 1,606 patients with high risk for bleeding, thrombosis and/or low risk for restenosis from June 2011 to September 2012. They were randomly assigned to the Endeavor Sprint ZES or any type of BMS. The primary outcome was major adverse CV events, defined as death, MI or TVR, at 1 year.
“We had a heterogenous patient population characterized by not having a clear indication to DES implementation,” Valgimigli said.
At 1 year, the primary endpoint occurred in 17.5% of patients implanted with ZES compared with 22.1% patients implanted with BMS (P=.011).
Compared with the BMS group, those implanted with ZES also had lower rates of TVR (5.9% vs. 10.7%; P<.001), MI (2.9% vs. 8.1%; P<.001) and definite/probable stent thrombosis (2% vs. 4.1%; P=.019). There was no difference in bleeding event rates between the two groups, according to the researchers.
Two types of MI reduced
“The superiority was driven by TVR as expected, but also by the lower rate of MI by patients receiving ZES,” Valgimigli said in the interview. “The rate of stent thrombosis was lower in patients receiving ZES, so the type of MIs associated with stent thrombosis, type 4b, was lower (P=.009). The other type of MI that was lower was type 1 (P=.001), which is the so-called spontaneous MI. The reduction in type 1 MI is driven by reduced late loss.”
Now that one DES has been shown to be a viable option in patients considered to be at high risk for DES implantation, further research should be done to see whether other types of DES produce similar results, Valgimigli said.
“As clinicians, we have seen DES as a more effective, but also less safe device,” he said. “Now we are starting to see a completely different paradigm shift; we see DES being both more effective and safer. To be able to free patients from the need to undergo DAPT is a fantastic goal.” – by Erik Swain
For more information:
Valgimigli M. Late-Breaking Clinical Trials V: TCT@ACC-i2. Presented at: American College of Cardiology Scientific Sessions; March 29-31, 2014; Washington, D.C.
Disclosure: The study was funded in part by an institutional grant from Medtronic to University Hospital Ferrara, Italy. Valgimigli reports receiving honoraria for lectures/advisory board from Abbott Vascular, AstraZeneca, CID, Correvio, Eli Lilly, Merck, St. Jude Medical, Terumo and The Medicines Company, and receiving institutional research grants from Medtronic, Terumo and The Medicines Company.
Perspective
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David R. Holmes Jr., MD, MACC
We continue to explore issues of duration of antiplatelet therapy, and we continue to design trials to understand that because it is so important a consideration. Although the incidence of stent thrombosis continues to decline, for that small group of patients who develops it, stent thrombosis is a catastrophic event, with 50% of patients dying or having acute infarction. This has resulted in a whole host of trials aimed at addressing that. The Europeans have done it differently than in the United States. Trials such as this that determine in this group of high-risk patients, with this specific technology, we can get by with very short or potentially no dual antiplatelet therapy, are a huge deal.
Perspective
Back to TopJames B. Hermiller, MD, FACC
The ZEUS trial looked at Endeavor, which has a rapid elution profile, so the drug is gone quickly compared with the other drug-eluting stents that are out there. That may lead to quicker coverage of the metallic frame and may make it safer in the environment of a lack of dual antiplatelet therapy. The benefit was seen in three important groups: those with high bleeds, that you think you’re going to have to take off of DAPT; those at high thrombotic risk, that you’re worried will thrombose even with DAPT; and those you think may not need a DES because they’re not going to restenose. The message was very consistent across all those groups: a 50% reduction in stent thrombosis, a 50% reduction in MI and an overall MACE rate that looked about 25% better. In those groups, I feel much more comfortable about using an Endeavor. What I would like to see is the same trial with the stents that we really use today.
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