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ZES shows promise in patients with high bleeding risk
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Among patients with CAD and high risk for bleeding, implantation of a zotarolimus-eluting stent was associated with reduced MACE and stent thrombosis compared with a bare-metal stent, according to a prespecified analysis of the ZEUS trial.
In the multinational, randomized, single blind trial, researchers evaluated 1,606 patients who were randomly allocated to undergo implantation of a zotarolimus-eluting stent (ZES; Endeavor Sprint, Medtronic) or a BMS. Of these, 828 patients were considered at high bleeding risk based on meeting one of the following criteria: advanced age; need for oral anticoagulants or other medications that may promote bleeding; history of bleeding; or anemia. In total, 51.2% of high bleeding risk patients were randomly assigned ZES. All patients received aspirin and clopidogrel (300- to 600-mg loading dose followed by 75 mg/day) or prasugrel (60-mg loading dose followed by 90 mg/twice daily; Effient, Daiichi Sankyo/Eli Lilly) or ticagrelor (180-mg loading dose followed by 90 mg/twice daily; Brilinta, AstraZeneca). All patients with high bleeding risk received dual antiplatelet therapy for a prespecified 30-day period after DES or BMS.
The primary endpoint was MACE at 12 months, which included death, MI or target vessel revascularization.
Patients with at least one high bleeding risk criterion had a nearly twofold higher incidence of any actionable BARC bleeding compared with patients without any high bleeding risk criteria (7.7% vs. 3.9%; HR = 2.32; 95% CI, 1.49-3.62). Likewise, patients with at least one high bleeding risk criterion had a nearly threefold higher incidence of major BARC bleeding (4.2% vs. 1.5% in patients with no high bleeding risk; HR = 2.93; 95% CI, 1.51-5.7), as well as major or minor TIMI bleeding (2.8% vs. 1%; HR = 2.87; 95% CI, 1.28-6.41).
At 12-month follow-up, 22.6% of the high bleeding risk patients randomly assigned ZES experienced the primary endpoint vs. 29% of patients in the BMS group (HR = 0.75; 95% CI, 0.57-0.98). This was mainly related to the ZES group having lower rates of MI (3.5% vs. 10.4%; HR = 0.33; 95% CI, 0.18-0.6) and TVR (5.9% vs. 11.4%; HR = 0.5; 95% CI, 0.3-0.8), according to the findings.
Patients assigned ZES also had significantly lower rates of definite or probable stent thrombosis (2.6% vs. 6.2%; HR = 0.42; 95% CI, 0.21-0.85) and definite, probable or possible stent thrombosis (6.6% vs 10.6%; HR = 0.61; 95% CI, 0.38-0.98).
“Our study provides proof of concept that in [high bleeding risk] patients who undergo stent implantation, [Endeavor Sprint] ZES, as compared with conventional BMS followed by 30-day DAPT regimen provides superior efficacy and safety,” the researchers wrote. “Future studies are needed to assess the tolerability and safety of more contemporary [drug-eluting stents] when followed by an abbreviated DAPT duration in this challenging patient population.” – by Jennifer Byrne
Disclosure: The ZEUS study was funded in part by Medtronic. Please see the study for a list of all the researchers’ relevant financial disclosures.
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