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.