TWENTE: ZES, EES Convey Similar Safety, Efficacy Results at 5 Years
At 5-year follow-up, a zotorolimus-eluting stent (ZES) and an everolimus-eluting stent (EES) demonstrated similar safety and efficacy in a real-world patient population characterized by complex lesions and off-label indications for DES. Clemens von Birgelen, MD, PhD, of Thoraxcentrum Twente in Enschede, the Netherlands, presented results from the TWENTE trial in a Featured Clinical Research session at TCT 2015.
In this large trial conducted at a single high-volume cardiac intervention center, investigators randomized 1,391 patients undergoing PCI to the Resolute ZES (Medtronic CardioVascular; n = 697) or the Xience V EES (Abbott Vascular; n = 694) between June 2008 and August 2010.
The study population included a wide range of patients and lesion complexities, including off-label indications. There also were no limits on lesion length or reference vessel size in patients.
At 5 years, there was no difference between the two stents in the primary endpoint of target vessel failure (TVF; composite of cardiac death, target vessel MI and clinically driven target vessel revascularization), or for major adverse cardiac events or stent thrombosis (Figure).
Similarly, in a subgroup analysis for TVF according to patient and lesion characteristics, ZES and EES exhibited no statistically significant differences except in one comparison, which suggested that single-vessel treatment favored ZES, while treatment of multivessel disease favored EES. However, Von Birgelen dismissed that result saying, “I think in this kind of multiple testing, the risk of false-positive findings is increased, and we should not overestimate these kinds of findings.”
Value of long-term data
In a panel discussion, Von Birgelen said he believes follow-up should continue.
“There’s a tendency to focus very much on just the first year and only look at stent thrombosis, while this is an event that is quite rare. At the end of the day, the patients are treated and living, hopefully, a long life with the stent that we implant,” he said. “With the durable polymer and DES of the early generation, we are seeing increased risk [for adverse events], so I feel it’s important to show that it is not the case [with second-generation stents].”
- Von Birgelen reports receiving grant/research support from AstraZeneca, Biotronik, Boston Scientific Corporation and Medtronic, and consultant/honoraria fees from AstraZeneca.