TCT: Promus Element, Resolute Integrity offer similar outcomes

SAN FRANCISCO—Two third-generation polymer-based drug-eluting stents performed comparably in DUTCH PEERS (TWENTE II), an all-comers trial that compared the flexible-design stents. The results were presented Oct. 31 at the Transcatheter Cardiovascular Therapeutics (TCT) scientific session in San Francisco.

“I expected both stents to be similar in terms of outcomes,” Clemens von Birgelen, MD, PhD, the lead investigator and co-director of the cardiology department at Thoraxcentrum Twente in The Netherlands, told Cardiovascular Business. “I am a clinician. All of the trials I perform come from a clinical questions that I and my colleagues have.”

The study was designed as a noninferiority trial to compare the Promus Element (Boston Scientific) and the Resolute Integrity (Medtronic) stents. Researchers have published outcome data on the former but until the TCT conference, they had not provided outcome data the latter.

DUTCH PEERS investigators enrolled 1,811 patients, which von Birgelen said represented 56 percent of all eligible patients at the four participating centers. Patient characteristics included STEMI, MI and acute coronary syndrome rates of almost 20 percent, 45 percent and 60 percent, respectively.

“We had lesions in very small vessels included,” he said at a press conference. “Our average reference diameter vessel was 2.7, which is very low compared to other trials.”

Patients were randomized to either zotarolimus-eluting stents (Resolute Integrity, 906 patients and 1,205 lesions) or everolimus-eluting stents (Promus Element, 905 patients and 1,166 lesions). At one-year follow-up, the target vessel failure rate was 6.1 percent in the zotarolimus/Resolute Integrity group and 5.2 percent in the everolimus/Promus Element group.

He noted that outcomes for cardiac death, target vessel-related MI and clinically indicated target vessel revascularization were similarly low. “I think this is a clear safety signal for both devices,” von Birgelen said.

The results showed no stent thrombosis beyond three months. On angiogram, they noted longitudinal stent deformation in nine patients in the Promus Element group and none in the Resolute Integrity group.

“The use of third-generation zotarolimus-eluting Resolute Integrity stents and the everolimus-eluting Promus Element stents in an all-comers results in excellent clinical outcomes, especially in view of the large number of patients treated for myocardial infarction,” von Birgelen said. He added that the data showed efficacy and safety was similar for both stents.  

At the press conference, von Birgelen explained that the flexible design of the third-generation stents gives interventional cardiologists the potential to stent difficult anatomies. “When you are standing there in the middle of the night fighting with a right coronary artery that is tortuous and calcified, it matters,” he said.

When asked about potential cost differences between the two stents, von Birgelen and discussants said cost varied across countries and, in the U.S., healthcare systems, making it difficult to determine.

Results from DUTCH PEERS (TWENTE II) were published simultaneously in The Lancet.

The study was funded by Boston Scientific and Medtronic.