The DESyne BDS Plus stent was developed as a thin-strut, bioabsorbable polymer drug-eluting stent that combines sirolimus release with two anticoagulant agents (rivaroxaban and argatroban) delivered directly at the implantation site. The goal of this device is to generate a localized antithrombotic effect during the first months after the procedure, aiming to reduce thrombotic events without significantly increasing systemic exposure to anticoagulants.
The primary endpoint was Target Lesion Failure (TLF), defined as the composite of cardiovascular death, target vessel myocardial infarction, and repeat revascularization. Secondary endpoints included late lumen loss, stent thrombosis, and pharmacokinetic parameters of the drugs released by the device.
The study randomized 202 patients across 14 international centers to DESyne BDS Plus (100 patients) or a conventional control DES (102 patients). Mean age was 63 years, and nearly one-third presented with acute coronary syndrome. Twenty-eight percent of patients in the DESyne group were diabetic. Clinical follow-up at 3 years reached 95%.
In the initial phase of the study, the primary non-inferiority endpoint was achieved, with a TLF rate of 0% in the DESyne group versus 5% in the control group during the first days after the procedure (p<0.001 for non-inferiority). Long-term results at 3 years showed a significant reduction in TLF with the DESyne BDS Plus stent (3.1% vs 12.1%; log-rank p=0.016). The benefit was mainly driven by a marked reduction in early ischemic events. No target vessel myocardial infarctions or definite/probable stent thrombosis were reported in the DESyne group, whereas the control group presented 8 target vessel-related myocardial infarctions and 2 episodes of stent thrombosis.
Read also: EuroPCR 2026 | Restoring vascular physiology: 4-year results of the BIOADAPTOR-RCT.
The pharmacokinetic substudy demonstrated subtherapeutic systemic levels of rivaroxaban and argatroban, suggesting that the anticoagulant effect remained predominantly localized at the implantation site. In addition, no TLF events or stent thrombosis were observed in this cohort during the 3-year follow-up.
Conclusion: DESyne BDS Plus reduced ischemic events without increasing systemic anticoagulation
The DESyne BDS Plus study demonstrated promising 3-year results, with a significant reduction in lesion-related events and absence of stent thrombosis using a localized antithrombotic therapy strategy. These findings suggest that local anticoagulant delivery may become an attractive alternative to reduce post-PCI ischemic events without significantly increasing systemic bleeding risk.
Original Title: Site-specific Antithrombotic Therapy: DESyne BDS Plus Trial 3-Year Outcomes.
Reference: Presentado por Alexandre Abizaid en EuroPCR 2026.
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