Evidence map›Paper›PMID 40873231›Full record

Trial reportCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions2025

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.

Stefan Verheye, Bert Ferdinande, Johan Bennett, Rodolfo Staico, Seif El-Jack, Pim A L Tonino, Alexandre Abizaid, Ian Buysschaert, Douglas Scott, Madhav Menon and 10 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Stefan VerheyeInterventional Cardiology, ZAS Cardiovascular Center Middelheim, Antwerp, Belgium.ORCID https://orcid.org/0000-0002-2182-1065
Bert FerdinandeDepartment of Cardiology, Ziekenhuis Oost-Limburg, Campus Sint Jan, Genk, Belgium.
Johan BennettDepartment of Cardiovascular Medicine, Universitaire Ziekenhuizen Leuven, Leuven, Belgium.ORCID https://orcid.org/0000-0002-8301-4517
Rodolfo StaicoInstituto Dante Pazzanese, São Paulo, Brazil.
Seif El-JackCardiovascular Unit, North Shore Hospital, Auckland, New Zealand.
Pim A L ToninoHeart Center, Catharina Hospital, Eindhoven, the Netherlands.
Alexandre AbizaidInstituto do Coração, São Paulo, Brazil.
Ian BuysschaertInterventional Cardiology, AZ Sint Jan Brugge AV, Bruges, Belgium.
Douglas ScottDepartment of Cardiology, Middlemore Hospital, Auckland, New Zealand.
Madhav MenonDepartment of Cardiology, Waikato Hospital, Hamilton, New Zealand.
Gerard WilkinsCardiology Department, Dunedin Hospital, Dunedin, New Zealand.
Dougal McCleanCardiology Department, Christchurch Hospital, Christchurch, New Zealand.
Tomas Kovarnik2nd Department of Medicine - Department of Cardiovascular Medicine, First Faculty of Medicine, General University Hospital in Prague, Charles University, Prague, Czech Republic.
Uwe ChristiansiC42 Integrated Solutions in Systems Biology for Clinical Research & Development, University of Colorado, Aurora, Colorado, USA.
Antoinette NeylonCERC (Cardiovascular European Research Center), Massy, France.
Zlatko MehmedbegovicCERC (Cardiovascular European Research Center), Massy, France.
Pieter C SmitsCERC (Cardiovascular European Research Center), Massy, France.
Marie-Claude MoriceCERC (Cardiovascular European Research Center), Massy, France.
Mark WebsterCardiac Investigation Unit, Auckland City Hospital, Auckland, New Zealand.ORCID https://orcid.org/0000-0002-7661-7694
DESyne BDS Plus RCT Investigators

Funding

The study was funded by Elixir Medical.
6 · The paper itself

Abstract

backgroundDESyne 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.

aimsTo assess the feasibility and safety of this novel device against a contemporary drug-eluting stent.

methodsThis 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.

resultsThe 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

conclusionsThis is the first clinical evidence of the feasibility of site-specific antithrombotic therapeutic with two anticoagulants and an antiproliferative mTOR inhibitor.

Indexed as

Cardiovascular AgentsCoronary Artery DiseaseCoronary ThrombosisDrug-Eluting StentsFactor Xa InhibitorsFibrinolytic AgentsPercutaneous Coronary InterventionPipecolic AcidsRivaroxabanSirolimusAgedArginineCoronary AngiographyDrug Therapy, CombinationFeasibility StudiesFemaleargatrobanArginineCardiovascular AgentsFactor Xa InhibitorsFibrinolytic AgentsPipecolic AcidsRivaroxabanSirolimusSulfonamidesanticoagulantdrug‐eluting stentstent thrombosis

Identifiers

PMID40873231
PMCPMC12502012

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.