Polymer based stent with short DAPT effective in high risk patients

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)