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Trial of COMBO dual therapy stent begins enrollment

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Investigators announced enrollment of the first patient in the REDUCE trial, which will evaluate use of the COMBO dual therapy stent in patients with ACS.

The multicenter, prospective trial will include a total of 1,500 adult patients with ACS, all of whom will receive treatment with a COMBO stent (OrbusNeich), across 30 hospitals throughout Asia and Europe, according to a press release. Participants will be randomly assigned to receive either 3 months or 12 months of dual antiplatelet therapy, with clinical follow-up at 3, 6, 12 and 24 months.

The primary endpoint of the trial is a composite of MI, stent thrombosis, stroke, target vessel revascularization or bleeding and all-cause mortality at 12 months.

“The optimal duration of dual antiplatelet therapy in ACS patients treated with [drug-eluting stents] is still under debate,” the researchers stated in the release. “This is especially true for STEMI patients in the era of new anticoagulants and antiplatelet agents. … The COMBO dual therapy stent, being associated with early re-endothelialization, may allow for a reduction of the duration of [dual antiplatelet therapy] without increasing the thrombotic risk, while reducing the risk of severe bleeding complications.”