Site‐Specific Antithrombotic Therapy: 24‐Month Outcomes of the Randomized DESyne BDS Plus Trial Using a Novel Triple‐Drug Eluting Coronary Implant With Two Anticoagulants and Sirolimus

Background DESyne BDS Plus represents a novel triple drug therapy (TRx) applied on a coronary stent platform eluting the antiproliferative drug Sirolimus along with two anticoagulants (Rivaroxaban and Argatroban) to reduce the site‐specific thrombotic risk. Aims To assess the feasibility and safety of this novel device against a contemporary drug‐eluting stent. Methods This prospective, multicenter randomized (1:1) trial included 202 patients assigned between the device group (DESyne BDS Plus) and the control group (DESyne X2). A subgroup of 58 patients underwent imaging follow‐up at 6 months. The blood pharmacokinetics of Sirolimus and both anticoagulants were assessed in 11 nonrandomized patients. Results The primary endpoint, target lesion failure (TLF) at discharge or 3‐day postprocedure, whichever occurred first, was 0.0% (0/98) in the device and 5.0% (5/100) in the control group ( p noninferiority < 0.001). The secondary endpoint, late lumen loss at 6 months, was 0.14 mm [90% CI: 0.06; 0.23] and 0.09 mm [90% CI: 0.01; 0.18] in the device ( n = 28) and control group ( n = 27), respectively ( p noninferiority < 0.001). Through 24 months, stent thrombosis (definite/probable) was 0.0% (0/97) versus 1.0% (1/96) in the control, p = 0.497, and TLF was 2.1% (2/97) versus 11.3% (11/97), p = 0.010, respectively. Optical coherence tomography findings including strut coverage and neointimal hyperplasia thickness/volume were similar between the groups. The pharmacokinetic study indicated median maximum blood concentrations (C max ) of Rivaroxaban and Argatroban of 1.38 ng/mL and 1.99 ng/mL, respectively. Conclusions This is the first clinical evidence of the feasibility of site‐specific antithrombotic therapeutic with two anticoagulants and an antiproliferative mTOR inhibitor.