Evidence map›Paper›PMID 38106564›Full record

ArticleEClinicalMedicine2023

First randomised controlled trial comparing the sirolimus-eluting bioadaptor with the zotarolimus-eluting drug-eluting stent in patients with

Shigeru Saito, Johan Bennett, Holger M Nef, Mark Webster, Atsuo Namiki, Akihiko Takahashi, Tsunekazu Kakuta, Seiji Yamazaki, Yoshisato Shibata, Douglas Scott and 10 more

Open access · goldAbstract read
In one paragraph

Article in EClinicalMedicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
8.9field-weighted citation impact, top 1% of its field
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

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. 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.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2025
    Trial
  3. Article
  4. Review
  5. Article
  6. Review
  7. Revisiting Bioresorbable Scaffolds in Light of the SCAAR Study.Journal of the Society for Cardiovascular Angiography & Interventions · 2025
    Article
  8. Coronary Bifurcation PCI-Part II: Advanced Considerations.Journal of cardiovascular development and disease · 2025
    Review
  9. Review
  10. Long-Term Outcome of Percutaneous Coronary Intervention Using Absorb Bioresorbable Scaffold: A SCAAR Study.Journal of the Society for Cardiovascular Angiography & Interventions · 2025
    Article
  11. Review
  12. Article
  13. Article
  14. 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 at 15 institutions in 5 countries.

Shigeru SaitoHeart Center, Iryohojin Tokushukai Shonan Kamakura General Hospital, Kamakura City, Japan.
Johan BennettDepartment of Cardiovascular Medicine, UZ Leuven, Leuven, Belgium.
Holger M NefDepartment of Cardiology and Angiology, University of Giessen, Giessen, Germany.
Mark WebsterCardiac Investigation Unit, Auckland City Hospital, Auckland, New Zealand.
Atsuo NamikiDepartment of Cardiology, Kanto Rosai Hospital, Nakahara-ku, Kawasaki-shi, Japan.
Akihiko TakahashiDepartment of Cardiology, Takahashi Hospital, Kobe City, Japan.
Tsunekazu KakutaCardiovascular Medicine, Tsuchiura Kyodo Hospital, Tsuchiura City, Japan.
Seiji YamazakiDepartment of Cardiology, Sapporo Higashi Tokushukai Hospital, Sapporo, Japan.
Yoshisato ShibataDepartment of Cardiology, Miyazaki Medical Association Hospital, Miyazaki City, Japan.
Douglas ScottDepartment of Cardiology, Middlemore Hospital, Auckland, New Zealand.
Mathias VrolixDepartment of Cardiology, Ziekenhuis Oost-Limburg, Campus Sint Jan, Genk, Belgium.
Madhav MenonDepartment of Cardiology, Waikato Hospital, Hamilton, New Zealand.
Helge MöllmannDepartment of Cardiology, St. Johannes Hospital Dortmund, Dortmund, Germany.
Nikos WernerDepartment of Cardiology, Krankenhaus der Barmherzigen Brüder Trier, Trier, Germany.
Antoinette NeylonCERC (Cardiovascular European Research Center) ICPS Ramsay, Massy, France.
Zlatko MehmedbegovicCERC (Cardiovascular European Research Center) ICPS Ramsay, Massy, France.
Pieter C SmitsCERC (Cardiovascular European Research Center) ICPS Ramsay, Massy, France.
Marie-Claude MoriceCERC (Cardiovascular European Research Center) ICPS Ramsay, Massy, France.
Stefan VerheyeInterventional Cardiology, ZNA Cardiovascular Center Middelheim, Antwerp, Belgium.
BIOADAPTOR-RCT Collaborators
Cardiovascular European Research Center · FRAuckland City Hospital · NZJapan Organization of Occupational Health and Safety · JPJustus-Liebig-Universität Gießen · DEKobe Asahi Hospital · JPKrankenhaus der Barmherzigen Brüder Trier · DEMiddlemore Hospital · NZSapporo Higashi Tokushukai Hospital · JPShonan Kamakura General Hospital · JPSt.-Johannes-Hospital Dortmund · DETsuchiura Kyodo General Hospital · JPUniversitair Ziekenhuis Leuven · BEWaikato Hospital · NZZiekenhuis Oost-Limburg · BEZNA Middelheim Hospital · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The DynamX™ bioadaptor is the first coronary implant technology with a unique mechanism of unlocking the bioadaptor frame after polymer resorption over 6 months, uncaging the vessel while maintaining a dynamic support to the vessel. It aims to achieve the acute performance of drug-eluting stents (DES) with the advantages of restoration of vessel function. Methods: This international, single blinded, randomised controlled (1:1) trial compared a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent (DES) in 34 hospitals in Europe, Japan and New Zealand. Patients with Findings: 445 patients were randomised between January 2021 and February 2022. Device, lesion and procedural success rates, and acute gain were similar amongst the groups. The primary endpoint, 12-month target lesion failure, was 1.8% [95% CI: 0.5; 4.6] (n = 4) versus 2.8% [95% CI: 1.0; 6.0] (n = 6), p Interpretation: This is the first randomised controlled trial comparing the novel bioadaptor technology against a contemporary DES. The bioadaptor demonstrated similar acute performance and 12-month clinical outcomes, and superior imaging endpoints including restoration of vessel function. Funding: The study was funded by Elixir Medical.

Indexed as

BioadaptorCoronary artery diseaseCyclic pulsatilityDrug-eluting stentsPercutaneous coronary interventionVessel function

Identifiers

PMID38106564
PMCPMC10725075
OpenAlexW4387894231

What OpenQuestion holds

Textmetadata
LicenceCC BY
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 OpenQuestion graph.