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Polymer based stent with short DAPT effective in high risk patients
A polymer based stent together with short-duration dual antiplatelet therapy (DAPT) was a safe and effective strategy in patients with high bleeding risk, researchers showed in the randomized ONYX ONE trial.
Polymer-free drug-coated stents provide superior clinical outcomes to bare-metal stents in patients at high bleeding risk who undergo percutaneous coronary intervention (PCI) and are treated with 1 month of dual antiplatelet therapy. Data on the use of polymer-based drug-eluting stents, as compared with polymer-free drug-coated stents, in such patients are limited.
Percutaneous coronary intervention (PCI) in patients at high risk for bleeding is challenging because conventional, polymer-based, drug-eluting stents (DES) require prolonged dual antiplatelet therapy (DAPT). Traditionally, these patients have been treated with bare-metal stents requiring only 1 month of DAPT, but recently a non–polymer-based drug-coated stent (DCS) was shown to be both safer and more effective than bare-metal stents for patients treated with only 1 month of DAPT. To investigate outcomes with a widely available, current-generation DES, researchers in an industry-sponsored trial (NCT03344653) randomized 1996 patients at high bleeding risk to either durable polymer-based zotarolimus-eluting stents (DES; Resolute Onyx) or polymer-free umirolimus-coated stents (DCS; BioFreedom).
Patients averaged 1.6 risk factors for bleeding, most commonly age ≥75 and need for long-term oral anticoagulation. Most patients received DAPT for 1 month and single antiplatelet therapy thereafter, although some patients on oral anticoagulants received only single antiplatelet therapy. Over the 12-month follow-up, the primary safety endpoint (cardiovascular death, myocardial infarction [MI], or stent thrombosis) occurred in 17.1% of the DES group and 16.9% of the DCS group, which met the prespecified noninferiority margin of 4.1%. The secondary endpoint (target-lesion failure: cardiovascular death, target-vessel MI, or target-lesion revascularization) also met formal noninferiority criteria. Stent thrombosis occurred in 1.3% of DES patients and 2.1% of DCS patients, mainly within 1 month.
The researchers concluded that among patients at high bleeding risk who received 1 month of dual antiplatelet therapy after PCI, use of polymer-based zotarolimus-eluting stents was noninferior to use of polymer-free drug-coated stents with regard to safety and effectiveness composite outcomes. (Funded by Medtronic; ONYX ONE ClinicalTrials.gov number,
Windecker S et al. Polymer-based or polymer-free stents in patients at high bleeding risk. N Engl J Med 2020 Feb 12; [e-pub]. (https://doi.org/10.1056/NEJMoa1910021)
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751