Evidence map›Paper›PMID 34357673›Full record

Trial reportCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions2021

Comparison of 6-month vascular healing response after bioresorbable polymer versus durable polymer drug-eluting stent implantation in patients with acute coronary syndromes: A randomized serial optical coherence tomography study.

Masahiko Noguchi, Tomotaka Dohi, Shinya Okazaki, Mitsuaki Matsumura, Mitsuhiro Takeuchi, Hirohisa Endo, Yoshiteru Kato, Iwao Okai, Hiroki Nishiyama, Shinichiro Doi and 10 more

Open access · hybridAbstract readRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.3field-weighted citation impact, top 20% 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

3 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
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 4 institutions in 2 countries.

Masahiko NoguchiDepartment of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.ORCID 0000-0003-4501-3449
Tomotaka DohiDepartment of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.ORCID 0000-0002-6646-468X
Shinya OkazakiDepartment of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Mitsuaki MatsumuraClinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.ORCID 0000-0002-2082-0247
Mitsuhiro TakeuchiDepartment of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Hirohisa EndoDepartment of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Yoshiteru KatoDepartment of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Iwao OkaiDepartment of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Hiroki NishiyamaDepartment of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Shinichiro DoiDepartment of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Hiroshi IwataDepartment of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Kikuo IsodaDepartment of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Eisuke UsuiClinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.
Tatsuhiro FujimuraClinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.
Fumiyasu SeikeClinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.
Gary S MintzClinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.
Katsumi MiyauchiDepartment of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Hiroyuki DaidaDepartment of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Tohru MinaminoDepartment of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Akiko MaeharaClinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA.ORCID 0000-0002-1910-8447
Juntendo University · JPNewYork–Presbyterian Hospital · USCardiovascular Research Foundation · USJapan Agency for Medical Research and Development · JP

Funding

Boston Scientific Japan
6 · The paper itself

Abstract

objectivesThis study was conducted to use optical coherence tomography (OCT) to compare vascular healing between bioresorbable polymer (BP) and durable polymer (DP) everolimus-eluting stents (EES) in patients with acute coronary syndromes (ACS).

backgroundWhether BP-EES induce better vascular healing compared to contemporary DP-EES remains controversial, especially for ACS.

methodsIn this prospective, randomized, non-inferiority trial, we used OCT to compare 6-month vascular healing in patients with ACS randomized to BP versus DP-EES: percent strut coverage (primary endpoint, non-inferiority margin of 2.0%) and neointimal thickness and percent neointimal hyperplasia (NIH) volume. As an exploratory analysis, morphological factors related to the endpoints and the effect of underlying lipidic plaque on stent healing were evaluated.

resultsA total of 104 patients with ACS were randomly assigned to BP-EES (n = 52) versus DP-EES (n = 52). Of these, 86 patients (40 BP-EES and 46 DP-EES) were included in the final OCT analyses. Six-month percent strut coverage of BP-EES (83.6 ± 11.4%) was not non-inferior compared to those of DP-EES (81.6 ± 13.9%), difference 2.0% (lower 95% confidence interval-2.6%), p

conclusionsSix-month strut coverage of BP-EES was not non-inferior compared to those of DP-EES in ACS patients. Good stent apposition and expansion were independently associated with better vascular healing.

Indexed as

Acute Coronary SyndromeDrug-Eluting StentsPercutaneous Coronary InterventionAbsorbable ImplantsHumansPolymersProspective StudiesSirolimusTomography, Optical CoherenceTreatment OutcomePolymersSirolimusacute coronary syndromebioresorbable polymerdurable polymereverolimus-eluting stentsoptical coherence tomography

Identifiers

PMID34357673
PMCPMC9292175
OpenAlexW3189374274

What OpenQuestion 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 OpenQuestion graph.