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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

OBJECTIVES: The aim of this study was to compare the safety and efficacy of Resolute zotarolimus-eluting stents (ZES) (Medtronic Cardiovascular, Santa Rosa, California) with Xience V everolimus-eluting stents (EES) (Abbott Vascular Devices, Santa Clara, California) at 1-year follow-up. BACKGROUND: Only 1 randomized trial previously compared these stents. METHODS: This investigator-initiated, patient-blinded, randomized noninferiority study had limited exclusion criteria (acute ST-segment elevation myocardial infarctions not eligible). Patients (n = 1,391; 81.4% of eligible population) were randomly assigned to ZES (n = 697) or EES (n = 694). Liberal use of stent post-dilation was encouraged. Cardiac biomarkers were systematically assessed. The primary endpoint was target vessel failure (TVF), a composite of cardiac death, myocardial infarction not clearly attributable to non-target vessels, and clinically indicated target-vessel revascularization. An external independent research organization performed clinical event adjudication (100% follow-up data available). Analysis was by intention-to-treat. RESULTS: Acute coronary syndromes were present in 52% and "off-label" feature in 77% of patients. Of the lesions, 70% were type B2/C; the post-dilation rate was very high (82%). In ZES and EES, TVF occurred in 8.2% and 8.1%, respectively (absolute risk-difference 0.1%; 95% confidence interval: -2.8% to 3.0%, p(noninferiority) = 0.001). There was no significant between-group difference in TVF components. The definite-or-probable stent thrombosis rates were relatively low and similar for ZES and EES (0.9% and 1.2%, respectively, p = 0.59). Definite stent thrombosis rates were also low (0.58% and 0%, respectively, p = 0.12). In EES, probable stent thrombosis beyond day 8 was observed only in patients not adhering to dual antiplatelet therapy. CONCLUSIONS: Resolute ZES were noninferior to Xience V EES in treating "real-world" patients with a vast majority of complex lesions and "off-label" indications for drug-eluting stents, which were implanted with liberal use of post-dilation. (The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting SteNt Study: Head-to-head Comparison of Clinical Outcome After Implantation of Second Generation Drug-eluting Stents in a Real World Scenario; NCT01066650).

Trial
Journal Ref. von Birgelen C, Basalus MWZ, Tandjung K, van Houwelingen KG, Stoel MG, Louwerenburg JHW, Linssen GCM, Said SAM, Kleijne MAWJ, Sen H, et al: A randomized controlled trial in second-generation zotarolimus-eluting Resolute stents versus everolimus-eluting Xience V stents in real-world patients: the TWENTE trial. Journal of the American College of Cardiology 2012, 59:1350-1361.
Intervention Drug - Zotarolumus-eluting Resolute stents
Number of sites 1
Countries involved The Netherlands
Sample size 1391
Type of statistical analyses ITT
Risk of bias Overall: Low Risk details
Participant characteristics Age: 64.2 ± 10
Condition: coronary syndromes
Baseline severity: Undergoing PCI and stent insertion
Duration of trial 15 months: June 2008 - August 2010
Primary outcome Acute coronary syndromes at 12 months
Effect Measures
Events Intervention Total Events Control Total Risk Diff.
57 695 56 692 0.11 %
p=0.94 Primary Outcome used in Effect size calculation: target vessel failure (TVF) within 1 year, defined as (in hierarchical order) cardiac death, target vessel–related myocardial infarction (MI), or clinically driven target vessel revascularization (TVR) by re-PCI or surgery.
Show Score Ranges

Scores:

(shows median if more than one score was entered)

Elig. Recr. Setting Org. Int. Flex. Del. Flex. Adherence Follow-Up Prim. Out. Prim. An.
3 5 2 3 4 -1 4 3 4