ReCre8: Polymer-Free Drug-Eluting Stent Passes 1-Year Test

Patrice Wendling

September 28, 2018

SAN DIEGO — A new polymer-free amphilimus-eluting stent was noninferior to a permanent-polymer zotarolimus-eluting stent for target lesion failure (TLF) at 12 months in an all-comers population in the physician-initiated ReCre8 study.

The TLF rate was 6.2% with Alvimedica's polymer-free Cre8 stent and 5.6% with Medtronic's Resolute Integrity stent (noninferiority = .0086), Pieter R. Stella, MD, PhD, University Medical Center, Utrecht, the Netherlands, reported at Transcatheter Cardiovascular Therapeutics 2018.

The study, simultaneously published in Circulation , is the first head-to-head comparison between the two drug-eluting stents in an all-comers patient population.

Equally compelling were two exploratory subanalyses that examined the safety of short-duration dual-antiplatelet therapy (DAPT) and whether the polymer-free stent could deliver on the promise of positive outcomes in patients with diabetes.

One of the incentives to improve on early permanent-polymer stent technology and the evolution to biodegradable polymers and polymer-free DES was to reduce the risk of inflammation and late stent thrombosis, Stella observed. The thin-strut (80 microns) cobalt chromium Cre8 stent uses an abluminal reservoir to elute an amphilimus formulation of sirolimus and a fatty acid.

The nonindustry-sponsored trial randomly assigned 1532 European patients (mean age, 65 years) between November 2014 and July 2017 to percutaneous coronary intervention with the Cre8 stent or Resolute Integrity stent. Patients who were troponin-positive at baseline received 12 months DAPT, whereas those who were troponin-negative were treated with 1 month of DAPT.

Stella emphasized that this was "a real, true all-comers population," with almost 60% of patients having at least one complex lesion, 25% at least one bifurcation, 7% chronic total occlusions, 26% moderately or severely calcified lesions, 40% long lesions, and almost a quarter had small vessels (<2.75 mm).

At 12 months, the net adverse clinical events rate was 12.2% in the Cre8 group and 11.6% in the Resolute Integrity group. The results were consistent across all subgroups.

In the 892 patients treated with 1-month DAPT, the overall rate of definite stent thrombosis was 0.9%, or just eight events. Six of the eight events occurred after 1-month DAPT cessation and 50% occurred in complex lesions.

"Three of these stent thromboses occurred very late, so probably would not have been protected by prolonged DAPT," Stella said.

TLF rates, however, were "a little disappointing," he noted, at 6.8% overall, 7.1% in the Cre8 group, and 6.5% in the Resolute Integrity group.

In the 304 patients with diabetes, the 12-month TLF rate was 7.3% for Cre8 and 7.8% for Resolute Integrity (P = .84). Neither of the subanalyses were powered for outcomes, Stella emphasized.

During a discussion of the results, panelist Didier Carrié, MD, PhD, Hôpital Rangueil, Toulouse, France, said the 1-month DAPT results were somewhat reassuring but that he was "a little bit disappointed by the diabetic population" because "the results were exactly the same."

"We need to keep in mind again that this is an all-comers study and a big box of data, and we really still need to start to look into it," Stella responded. "One of the explanations could be that results of the diabetic arm could have been negatively influenced by the short DAPT. We still don't know if short DAPT is safe."

Secondly, it is possible that the higher TLF rate found in the overall Cre8 group could have had effects on the diabetic population, Stella said. It also may be that the "clinical efficacy of this polymer-free stent will be shown at 3-year follow-up, not this 1-year follow-up."

Session moderator, Gregg W. Stone, MD, New York–Presbyterian/Columbia University Medical Center, New York CIty, told theheart.org | Medscape Cardiology that more studies are needed of the Cre8 stent but that "it looks like a very good stent from this preliminary report."

As for the 1-month DAPT, he said, "I don't think we're ready to move to short DAPT in all-comer patients. There still is a background stent thrombosis rate."

"Event rates in the United States tend to be higher than in Europe and I think part of that is ascertainment," Stone said. "So I would stick with the guidelines right now for most patients with troponin-negative presentations for 6 months of DAPT, if they're not at excess risk of bleeding."

Panelist Tullio Palmerini, MD, Policlinico S. Orsola, Bologna, Italy, said the individual patient must be considered but cautioned against giving 1-month DAPT in patients with complex, multivessel coronary disease, even if they are stable and troponin-negative, when implanting a long stent, full-metal stent, or multiple stents.

"This is consistent with the data of this trial, in which four out of eight stent thromboses occurred in complex patients treated with 1-month DAPT," he said.

Concluding the discussion, Stella said, "If you want to stop DAPT at 1 month in a patient with a simple lesion, it seems to be safe regarding stent thrombosis. Target lesion failure is something else. So be very cautious."

Stella reports serving on the speaker's bureau for Alvimedica, as an advisory board member for Keystone Heart, and as a consultant for Dekra CE. Carrié reports having no relevant disclosures. Stone reports personal fees from Claret, Ablative Solutions, Matrizyme, Miracor, Neovasc, V-Wave, Shockwave, Valfix, TherOx, Reva, Vascular Dynamics, Robocath, HeartFlow, Gore; and equity in Ancora, Cagent, Qool Therapeutics, Aria, Caliber, SpectraWave, the Biostar family of funds, and the Medfocus family of funds. Palmerini reports consultant fee/honoraria/speaker's bureau fees from Abbott Vascular.

Transcatheter Cardiovascular Therapeutics (TCT) 2018. Presented September 22, 2018.

Circulation. Published online September 22, 2018. Article

Follow Patrice Wendling on Twitter: @pwendl. For more from theheart.org | Medscape Cardiology, follow us on Twitter and Facebook.

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