Long-term TWENTE results support the use of newer-generation stents
medwireNews: Five-year follow-up data from TWENTE trial participants and nonenrolled eligible patients suggest “favorable and similar” outcomes with zotarolimus-eluting (ZES) and everolimus-eluting (EES) stents among patients with non-ST-elevation acute coronary syndromes or stable angina.
These findings present “a strong case for the long-term safety and efficacy of the newer-generation [drug-eluting stents],” say the researchers in JAMA Cardiology.
The researchers found that target vessel failure (TVF) at 5-year follow-up – a composite of cardiac death, target vessel-related myocardial infarction (MI), or target vessel revascularization – occurred in 16.1% of 697 patients who were randomly assigned to receive ZES implantation in the TWENTE trial, and in 18.1% of 694 patients in the EES group, a nonsignificant difference.
Furthermore, there were no significant differences in the incidence of the individual components of the TVF endpoint between the two groups (cardiac death: 3.7 vs 5.2%; target vessel-related MI: 6.8 vs 6.6%; target vessel revascularization: 8.9 vs 10.5%), report Clemens von Birgelen (Thoraxcentrum Twente, Enschede, the Netherlands) and colleagues.
Rates of definite stent thrombosis were also similar in the ZES and EES groups (1.0 vs 0.6%), and occurred after more than 1 year in 0.4% and 0.6% of patients, respectively.
Dean Kereiakes (The Christ Hospital Heart and Vascular Center, Cincinnati, Ohio, USA) notes in an accompanying editorial that the stent thrombosis rates are “excellent considering the clinical and angiographic complexity of the study population and reflect both stent platform and deployment technique.”
The researchers also analyzed 5-year follow-up data from 308 eligible patients who were not enrolled in the TWENTE trial but were treated with either ZES or EES using the same routine clinical and procedural strategies.
These patients were older than the TWENTE trial participants, at 66.0 versus 64.2 years, and had more advanced disease. They also had a higher incidence of TVF (23.3 vs 17.1%), which the authors note was “partly attributable to a difference in cardiac death,” at 7.7% versus 4.5%.
However, nonenrolled patients and those included in the TWENTE trial had “quite similar” overall rates of target vessel-related MI (7.2 vs 6.7%) and target vessel revascularization (11.4 vs 9.7%).
When results from the trial participants and nonenrolled eligible patients were combined, the overall 5-year rate of TVF was 18.3%, compared with 17.1% in the trial participants only.
Although Kereiakes points out that “the nonrandomized, proportional allocation of EES vs ZES among the nonenrolled, eligible cohort is not provided and remains a limitation of the study,” he emphasizes that the use of both patient cohorts “mitigates investigator selection bias among eligible patients.”
And he concludes that the study “provides invaluable insights into absolute and relative efficacy and safety of these devices over time.”
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