Evidence map›Paper›PMID 33275200›Full record

ArticleCardiology and therapy2021

Impact of Coronary Stent Architecture on Clinical Outcomes: Do Minor Changes in Stent Architecture Really Matter?

Amin Ariff Bin Nuruddin, Wan Azman Wan Ahmad, Matthias Waliszewski, Tay Mok Heang, Liew Houng Bang, Ahmad Khairuddin Mohamed Yusof, Imran Zainal Abidin, Ahmad Syadi Zuhdi, Florian Krackhardt

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Cardiology and therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 42% 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.

NCT02629575 completednot on this map

Coroflex ISAR 2000 Postmarket Surveillance Non-Interventional Study

Typeobservational_patient_registrySponsorB. Braun Melsungen AGRan2014 to 2017Enrolled2,877ConditionsCoronary Artery Disease (CAD)Armsstenting with the Coroflex ISAR sirolimus-eluting stent
NCT02905214 completednot on this map

Coroflex ISAR 2000 Extended Postmarket Surveillance Non-Interventional Study

TypeobservationalSponsorB. Braun Melsungen AGRan2016 to 2021Enrolled4,369ConditionsCoronary Artery Disease (CAD)Armsstenting with the Coroflex ISAR sirolimus-eluting stent
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Observational
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

9 authors at 6 institutions in 3 countries.

Amin Ariff Bin NuruddinNational Heart Institute Cardiology Department, Kuala Lumpur, Malaysia. dramin@ijn.com.my.
Wan Azman Wan AhmadUniversity Malaya Medical Centre, Kuala Lumpur, Malaysia.
Matthias WaliszewskiMedical Scientific Affairs, B. Braun Melsungen AG, Berlin, Germany.
Tay Mok HeangPantai Hospital Ayer Keroh, Ayer Keroh, Melaka, Malaysia.
Liew Houng BangHospital Queen Elizabeth II, Kota Kinabalu, Sabah, Malaysia.
Ahmad Khairuddin Mohamed YusofNational Heart Institute Cardiology Department, Kuala Lumpur, Malaysia.
Imran Zainal AbidinUniversity Malaya Medical Center, Kuala Lumpur, Malaysia.
Ahmad Syadi ZuhdiUniversity Malaya Medical Center, Kuala Lumpur, Malaysia.
Florian KrackhardtDepartment of Internal Medicine and Cardiology, Charité-Universitätsmedizin Berlin, Campus Virchow, Berlin, Germany.
University Malaya Medical Centre · MYNational Heart Institute · MYB. Braun (Germany) · DECharité - Universitätsmedizin Berlin · DEQueen Elizabeth Hospital · MYUniversity Hospital Ayr · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe objective of this study was to compare the accumulated clinical outcomes of two Malaysian all-comers populations, each treated with different polymer-free sirolimus-eluting stents (PF-SES) of similar stent design.

methodsThe Malaysian subpopulation of two all-comers observational studies based on the same protocol (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were combined and compared to a Malaysian-only cohort which was treated with a later-generation PF-SES. The PF-SES's used differed only in their bare-metal backbone architecture, with otherwise identical sirolimus coating. The primary endpoint was the accumulated target lesion revascularization (TLR) rate at 12 months. The rates of major adverse cardiac events (MACE), stent thrombosis (ST) and myocardial infarction (MI) were part of the secondary endpoints.

resultsA total of 643 patients were treated with either the first-generation PF-SES (413 patients) or second-generation PF-SES (230 patients). Patient demographics were similar in terms of age (p = 0.744), male gender (0.987), diabetes mellitus (p = 0.293), hypertension (p = 0.905) and acute coronary syndrome (ACS, 44.8% vs. 46.1%, p = 0.752) between groups. There were no differences between treatment groups in terms of lesion length (20.8 ± 7.3 mm vs. 22.9 ± 7.9, p = 0.111) or vessel diameter (2.87 ± 0.39 vs. 2.93 ± 0.40, p = 0.052) despite numerically smaller diameters in the first-generation PF-SES group. The second-generation PF-SES tended to have more complex lesions as characterized by calcification (10.3% vs. 16.2%, p = 0.022), severe tortuosity (3.5% vs. 6.9%, p = 0.041) and B2/C lesions (49.2% vs. 62.8%, p < 0.001). The accumulated TLR rates did not differ significantly between the first- and second-generation PF-SES (0.8% vs. 0.9%, p = 0.891). The accumulated MACE rates were not significantly different (p = 0.561), at 1.5% (6/413) and 2.2% (5/230), respectively.

conclusionsModifications in coronary stent architecture which enhance the radial strength and radiopacity without gross changes in strut thickness and design do not seem to impact clinical outcomes. CLINICAL

trial registrationClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214.

Indexed as

MACEPolymer-freeSirolimusStent architectureTLR

Identifiers

PMID33275200
PMCPMC8126533
OpenAlexW3107185029

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.