2nd-generation drug-eluting stents, results for “real” patients at two years

Original title: Clinical Outcome Following Stringent Discontinuation of Dual Anti-Platelet Therapy After 12 Months in Real-World Patients Treated With Second-Generation Zotarolimus-Eluting Resolute and Everolimus-Eluting Xience V Stents: Two-Year Follow-up of the Randomized TWENTE Trial. Reference: Keneth T, Hanim S, et al. J Am Coll Cardiol 2013. Article in press.


In recent years there have been new drug-eluting stents in order to minimize the main drawbacks of 1st generation stents such as restenosis, thrombosis and the consequent need for target vessel revascularization. The aim of this study was to compare the efficacy and safety of two second-generation stents, the RESOLUTE zotarolimus-eluting stent (ZES) and the everolimus-eluting stent Xience V (EES).

The novelty of this work is that the authors chose a patient population that closely resembles real life, with virtually no exclusion criteria, (only patients with ST elevation AMI admitted, were excluded), with follow-up at two years and a strict suspension of dual antiplatelet therapy after a year of the procedure. A total of 1,391 patients were randomized in a 1:1 ratio to receive treatment with either Resolute ZES (n = 697) or Xience V EES (n = 694). The primary endpoint was established as cardiovascular death, myocardial infarction related to the target vessel or target vessel revascularization. At this point there were no significant differences between the two groups analyzed, (10.8% versus 11.6%, p = .65). Also evaluated as secondary endpoints were definitive, probable or very late thrombosis. The results were similar for both groups with no significant differences and encouragingly low rates, (0.9% versus 0.1%, p = 0.12), (1.2% versus 1.4%, p = 0.63) and (0.3% vs 0.3%, p = 1 ) respectively. These results were consistent across all the subgroups analyzed.


Considering that the percentage of patients who continued dual antiplatelet therapy beyond one year was as low as 5.4% of the patients randomized, this study shows that the use of second generation drug-eluting stents is effective and safe with no clinically relevant differences between the two stents studied, even after discontinuation of dual antiplatelet therapy.


This work provides useful information because it was conducted in a population selected with out specific requirements, regardless of the length, morphology or the number of lesions, including off-label patients with indications for implantation of drug-eluting stents. It gives us results much more akin to what happens in real life than usually found in classical studies. The results are encouraging, since they show a very low rate of thrombosis and infarction that are generally most feared events when using these stents to treat vessels. So again, this is good news for interventional cardiologists. Although we have to keep in mind that this is not applicable to patients with ST elevation AMI. 

Courtesy Dra. María Sol Andrés.
University Hospital Favaloro Foundation – Argentina.

Dra. María Sol Andrés para SOLACI.ORG