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A Randomized Controlled Trial in Second-Generation Zotarolimus-Eluting Resolute Stents Versus Everolimus-Eluting Xience V Stents in Real-World Patients: The TWENTE Trial
Study Questions:
What is the safety and efficacy of Resolute zotarolimus-eluting stents (ZES) compared with Xience V everolimus-eluting stents (EES)?
Methods:
The authors randomized 1,391 patients undergoing percutaneous coronary intervention (PCI) to ZES (n = 697) or EES (n = 694). The primary endpoint was target vessel failure (TVF), a composite of cardiac death, myocardial infarction (MI) not clearly attributable to nontarget vessels, and clinically indicated target-vessel revascularization. Patients undergoing PCI for ST-segment elevation MI (primary or rescue) were excluded.
Results:
More than one-half (52%) of the patients underwent PCI for acute coronary syndrome. TVF occurred in 8.2% of patients randomized to ZES and 8.1% of the patients randomized to EES (p for noninferiority = 0.001). There was no significant difference in TVR (3.3% vs. 2.7%, p = 0.54) or cardiac death (1.0% vs. 1.4%, p = 0.46). The definite-or-probable stent thrombosis rates were similar (0.9% for ZES and 1.2% for EES, p = 0.59). Definite stent thrombosis rates were also low and similar (0.58% with ZES and 0% for EES, p = 0.12). Probable stent thrombosis beyond day 8 was observed with EES only in patients not adhering to dual antiplatelet therapy.
Conclusions:
The authors concluded that the Resolute ZES was noninferior to the Xience V EES in this study.
Perspective:
The EES has emerged as the DES with best outcomes based on comparison with the first-generation DES. The results of this study corroborate the results of the Resolute All Comers trial (N Engl J Med 2010;363:136-46), and suggest that the Resolute ZES provides a similar degree of safety and efficacy compared with the EES.
Keywords: Acute Coronary Syndrome, Sirolimus, Stents, Percutaneous Coronary Intervention
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