Patrice Wendling

May 18, 2016

PARIS, FRANCE — In ACS patients at high risk of bleeding, a drug-coated polymer-free stent provides significantly better outcomes than a similar bare-metal stent when coupled with 1-month dual-antiplatelet therapy (DAPT), according to results of the LEADERS FREE ACS substudy[1].

At 1 year, use of the drug-eluting stent (BioFreedom, Biosensors International) resulted in a 59% reduction in clinically driven target lesion revascularization compared with the bare-metal stent (Gazelle, Biosensors) (hazard ratio [HR] 0.41; P=0.009).

The composite primary safety end point of cardiac death, MI, and definite or probable stent thrombosis was also reduced by 52% (HR 0.48; P=0.001). This was driven by significantly lower cardiac mortality and MI. Bleeding (BARC 3–5) was "remarkably high" at about 10% but was not different between groups, lead investigator Dr Christoph Naber (University Hospital Essen, Germany) reported during a late-breaking session at EuroPCR 2016. The data were also simultaneously published in the European Heart Journal.

Dr Christoph Naber

"We believe that current guidelines and clinical practice needs to change. Bare-metal stents can no longer be recommended, and the [BioFreedom] drug-coated stent has currently the best evidence for this indication," he said during a press briefing at the meeting.

The 2015 European Society for Cardiology guidelines for the management of ACS patients without persistent ST-segment elevation recommend 3 to 6 months DAPT after implantation of a drug-eluting stent (DES).

Advantages of the BioFreedom stent, which is approved in Europe but not in the US, are that it avoids any polymeric adverse effects and has rapid drug transfer to the vessel wall, with 98% of the umirolimus (also known as biolimus A9) coating delivered within 1 month, he said.

Safe to Shorten DAPT?

As previously reported by heartwire from Medscape and published in the New England Journal of Medicine in 2015, the prospective double-blind LEADERS FREE study also favored the DES over a bare-metal stent for safety and efficacy in 2466 all-comer high-bleeding-risk patients undergoing PCI. All patients received 1 month DAPT followed by long-term single antiplatelet therapy.

The 662 patients in the prespecified ACS substudy were well matched, except previous stroke was more frequent in the DES arm (14.1 vs 7.9%) and AF more common in the bare-metal-stent arm (25.5% vs 33.1%).

Naber said the trial was the "last chance" to show a good indication for bare-metal stents and "has shown that it is safe to reduce dual antiplatelet therapy to 4 weeks."

Invited discussant Dr Thomas Cuisset (Hôpital de la Timone, Marseille, France) said LEADERS FREE was a device trial and not designed for nor does it answer the question of whether it is safe or not to use 1-month DAPT in all ACS patients treated with a DES.

"The main conclusion from LEADERS FREE is that a drug-eluting stent is better than a bare-metal stent in one specific population requiring 1-month dual APT," he said.

Cuisset observed that bare-metal stents are no longer the "gold standard" in high-bleeding-risk patients and said more evidence is needed from DAPT trials comparing drug-eluting stents with new-generation DES that have shorter drug-release times.

Panelist Dr Ron Waksman (MedStar Heart & Vascular Institute, Washington, DC) told heartwire , "We should replace bare-metal stents with drug-eluting stents, period. That's across the board, because in any study you look at DES performs better than bare-metal stents—ACS, non-ACS, across the board."

He agreed the study does not show that DAPT can be stopped safety at 4 weeks for ACS patients treated with any stent. "The overall message is that ACS patients should still be treated with long-term antiplatelet therapy."

Naber told reporters the findings cannot be extrapolated to other DES because the BioFreedom stent is unique with a unique drug and that only registry data are available for other DES showing patients can be treated with DAPT for just 1 month. "I think we will have to show for each single device its efficacy and the safety."

Naber reports reports grants and personal fees from Biotronik, and personal fees from Medtronic, from Abbott, Biosensors, Elixir, REVA, and Microport and owning shares in the European Cardiovascular Research Center, the clinical research organization responsible for the trial. Disclosures for the coauthors are listed in the article.

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