麻豆传媒

The novel polymer-free Cre8 EVO stent improved vessel outcomes compared with a conventional polymer stent among people with diabetes mellitus, the SUGAR trial showed.

The thin-strut, amphilimus-eluting stent cut target-lesion failure at 1-year by a relative 35% compared with the zotarolimus-eluting Resolute Onyx stent (7.2% vs 10.9%), which met criteria for both non-inferiority and superiority at P=0.03.

The difference in that composite of cardiac death, target-vessel myocardial infarction (MI), and clinically indicated target-lesion revascularization was driven by numerically fewer non-fatal events, Rafael Romaguera, MD, of Bellvitge University Hospital in Barcelona, reported at the Transcatheter Cardiovascular Therapeutics (TCT) meeting.

Along with his presentation at the late-breaking clinical trial session of the hybrid virtual and live event from Orlando, the study appeared simultaneously in the .

Results of current drug-eluting stents in diabetes mellitus are "far from good," Romaguera noted at the meeting, pointing to the twofold higher risk of events for these patients with contemporary drug-eluting stents (DES).

"These are astounding results, almost too good to be true," said TCT press conference moderator Roxana Mehran, MD, of the Icahn School of Medicine at Mount Sinai in New York City.

"This study is sweet like sugar for us, because now we have a stent that is dedicated and is fitted for a diabetes population," commented session study discussant Gennaro Sardella, MD, of Sapienza University of Rome, pointing to similar results in terms of target-lesion failure in prior smaller studies and .

The Cre8 EVO stent releases sirolimus with an amphiphilic carrier from wells on the vessel-facing surface of the stent.

Commenting from the online audience, study co-investigator Pablo Salinas, MD, of the Hospital Clinico San Carlos in Madrid, Spain, noted that endothelial cells in diabetes patients have an increased amount of fatty acid receptors. "The unique amphilimus formulation facilitates a higher dose of anti-proliferative drug in the patient with diabetes."

However, while the mechanism of the stent makes sense in this population and the results look promising for accelerated endothelialization and less inflammation from a durable polymer, longer-term follow-up is needed, argued Shmuel Banai, MD, of Tel Aviv Medical Center in Israel, as a panelist at the TCT press conference. "One-year follow-up is never sufficient."

"For us to adopt one particular stent in a diabetic population," not only is biologic plausibility needed, said panelist David Kandzari, MD, of Piedmont Heart Institute in Atlanta, but also "a theme of data, a larger evidence basis to then make that change" given the risk of chance findings by a single trial when so many trials are being done.

The SUGAR trial had a nearly all-comer design with few exclusion criteria. It randomized 1,548 patients with diabetes by American Diabetes Association criteria (95.5% type 2 diabetes) who were getting percutaneous coronary intervention (PCI) at 23 hospitals in Spain to have either the Cre8 EVO or Resolute Onyx stent implanted. More than half of the group had multivessel coronary artery disease, and 12% were done in the setting of an ST-segment elevation MI.

While operators couldn't be blinded to these visually distinct stents, outcome assessors were blinded to study arm allocation.

While stent thrombosis rates were similar between groups at 1 year, Romaguera noted that the differential in target-vessel MI had a larger divergence between groups after 6 to 8 months. Dual antiplatelet therapy (DAPT) was similar at around 85% at that point, but dropped off more in the Cre8 EVO group at 12 months (54% vs 59%), a borderline significant difference. (In Europe, Cre8 EVO is approved with when clinically indicated.)

That difference likely reflected the borderline more ischemic events with the Onyx stent, which would have prompted further DAPT, Romaguera said at the session.

And that could affect bleeding risk, noted Sardella. "Efficacy and safety are very interconnected."

The next question is how Cre8 EVO will do in large trials of patients without diabetes, noted TCT session moderator Gregg Stone, MD, also of Mount Sinai.

In patients with diabetes, "we need to do everything we can to reduce these event rates," he said. "Hopefully we will see more studies in non-diabetic patients, so we'll find out if these similar attributes transfer to a broader group of patients so it won't be relegated just to diabetic patients. I would expect that, but of course, we'll need more trials to find that out."

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