SAN FRANCISCO—In a head-to-head comparison, the Resolute zotarolimus-eluting stent (Medtronic) and Xience V everolimus-eluting stent (Abbott Vascular) performed almost identically in terms of safety and efficacy for treating patients with complex lesions, according to data from the TWENTE trial presented at a late breaking clinical trial session Nov. 11 at this year’s Transcatheter Cardiovascular Therapeutics (TCT) conference.
While first generation drug-eluting stents (DES) helped reduce repeat interventions, they did not decrease mortality, Clemens von Birgelen, MD, PhD, of the University of Twente in Enschede, the Netherlands, said during a press conference. This could be due to the fact that these stents had suboptimal biocompatibility of stent coating, he noted. Second generation stents have shown much improvement, with thinner, more novel drug coatings, which aid in biocompatibility.
While there are more than two million DES implanted globally each year, there are few head-to-head comparisons of second generation DES in real-world scenarios, von Birgelen noted.
To help bolster these data, von Birgelen et al conducted the TWENTE trial, a prospective, randomized clinical trial comparing a zotarolimus-eluting stents (ZES) and an everolimus-eluting stents (EES) in patients with coronary artery disease. The researchers enrolled 1,391 patients at a 1:1 ratio to receive either the Resolute ZES stent (697 patients) or the Xience V EES stent (694 patients). The researchers used target vessel failure at 12 months as the study’s primary endpoint.
All patients in the trial had either stable angina or non-ST-elevation acute coronary syndrome (ACS); the oldest patient enrolled was 93 years. Fifty percent of patients presented with ACS and nearly 22 percent were diabetic. All had very complex lesions.
Von Birgelen reported that rates of target vessel failure at one-year were similar in both arms; 8.1 percent for the Xience V stent and 8.2 percent for the Resolute stent. “Non-inferiority of the Resolute stent to the Xience stent was demonstrated,” von Birgelen offered.
Additionally, rates of cardiac death, target vessel-MI and clinically indicated target vessel revascularization were similar between the two groups. While the rate of cardiac death was 1.4 percent in patients who received the Xience V stent and 1 percent for those who received the Resolute stent, these rates for target vascular revascularization was 2.7 percent vs. 3.3 percent, respectively.
Von Birgelen called the stent thrombosis rate “relatively low" in terms of definite plus probable stent thrombosis; 0.86 percent for Resolute and 1.16 percent Xience V. While there were four probable lethal event rates in the Xience arm, one lethal event occurred in the Resolute arm. There were also low definite stent thrombosis rates for Resolute and Xience stents without a significant difference between the two groups (0.58 percent vs. 0 percent).
“Zotarolimus-eluting Resolute stents were non-inferior to everolimus-eluting Xience V stents in terms of safety and efficacy for treating 'real-world' patients with a vast majority of complex lesions 'off-label' indications for drug-eluting stents, which were implanted with liberal use of post dilatation,” von Birgelen concluded.
“We have the RESOLUTE All Comers trial in the NEJM … how are these results any different?” asked panel moderator Roxana Mehran, MD, director of interventional research and clinical trials at Mount Sinai Medical Center in New York City.
“We compared our findings with the RESOLUTE All Comers trial,” von Birgelen said. “Actually all the trends that you see in the RESOLUTE All Comers trial come back in our population. Numerically, our event rate is a little bit lower, not significantly lower, but it is a little lower.”
While the RESOLUTE All Comers trial was a multisite trial performed at 15 centers, the current TWENTE trial was a single-center trial performed by five operators. Von Birgelen offered that a liberal use and post dilution strategy was used during the trial, but said that he could not pinpoint whether this contributed to the numbers seen.
Ron Waksman, MD, director of experimental angioplasty at the Washington Hospital Center in Washington D.C., offered that it is currently “very hard to differentiate between the two stent platforms.
“This will really become a question of length, price, etc., not in terms of performance,” Waksman summed.