Evidence map›Paper›PMID 35776144›Full record

ArticleClinical research in cardiology : official journal of the German Cardiac Society2023

Prospective, single-centre evaluation of the safety and efficacy of percutaneous coronary interventions following a decision tree proposing a no-stent strategy in stable patients with coronary artery disease (SCRAP study).

Ludovic Meunier, Matthieu Godin, Géraud Souteyrand, Benoît Mottin, Yann Valy, Vincent Lordet, Christian Benoit, Ronan Bakdi, Virginie Laurençon, Philippe Genereux and 2 more

Erratum issued Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Clinical research in cardiology : official journal of the German Cardiac Society, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03893396 (Safety Assessment of Angioplasty Procedures), which is not on this map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
1.1field-weighted citation impact, top 23% 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.

NCT03893396 completednot on this map

Safety Assessment of Angioplasty Procedures

Typeobservational_patient_registrySponsorGroupe Hospitalier de la Rochelle Ré AunisRan2019 to 2023Enrolled983ConditionsAngiospastic, DisorderArmsCoronary angioplasty
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 2 syntheses or guidelines pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Drug-coated balloons for treatingWorld journal of clinical cases · 2023
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 4 institutions in 3 countries.

Ludovic MeunierCardiology Department, Centre Hospitalier La Rochelle, La Rochelle, France.ORCID http://orcid.org/0000-0002-1929-6898
Matthieu GodinCardiology Department, Clinique St-Hilaire, Rouen, France.ORCID http://orcid.org/0000-0002-8249-9161
Géraud SouteyrandDépartement de Cardiologie, CHU Clermont-Ferrand, ISIT, CaVITI, CNRS (UMR-6284), Université d'Auvergne, Clermont-Ferrand, France.ORCID http://orcid.org/0000-0002-5226-6076
Benoît MottinCardiology Department, Centre Hospitalier La Rochelle, La Rochelle, France.ORCID http://orcid.org/0000-0002-2543-7757
Yann ValyCardiology Department, Centre Hospitalier La Rochelle, La Rochelle, France.ORCID http://orcid.org/0000-0001-8273-0960
Vincent LordetCardiology Department, Centre Hospitalier La Rochelle, La Rochelle, France.ORCID http://orcid.org/0000-0001-9923-8104
Christian BenoitCardiology Department, Centre Hospitalier La Rochelle, La Rochelle, France.
Ronan BakdiCardiology Department, Centre Hospitalier La Rochelle, La Rochelle, France.ORCID http://orcid.org/0000-0002-6356-5346
Virginie LaurençonClinical Trials Unit, Centre Hospitalier La Rochelle, La Rochelle, France.
Philippe GenereuxClinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA.ORCID http://orcid.org/0000-0002-5507-3712
Matthias WaliszewskiMedical Scientific Affairs, B.Braun Melsungen AG, Berlin, Germany.ORCID http://orcid.org/0000-0002-8689-4505
Caroline Allix-BéguecClinical Trials Unit, Centre Hospitalier La Rochelle, La Rochelle, France. caroline.allix-beguec@ght-atlantique17.fr.ORCID http://orcid.org/0000-0001-7642-4844
Centre Hospitalier de La Rochelle · FRB. Braun (Germany) · DECentre National de la Recherche Scientifique · FRMorristown Medical Center · US

Funding

B Braun Paris (FR) L-FR-2019-0184/MEDAG-19-00166Groupe Hospitalier de la Rochelle Ré Aunis 2018P02283
6 · The paper itself

Abstract

aimWe evaluated a decision algorithm for percutaneous coronary interventions (PCI) based on a no-stent strategy, corresponding to a combination of scoring balloon angioplasty (SCBA) and drug-coated balloon (DCB), as a first line approach. Stents were used only in unstable patients, or in case of mandatory bailout stenting (BO-stent).

methodsFrom April 2019 to March 2020, 984 consecutive patients, including 1922 lesions, underwent PCI. The 12-month primary end-point was a composite of major adverse cardiac events (MACE) defined as all-cause death, nonfatal myocardial infarction, nonfatal stroke, and target lesion revascularization. Patients were classified into conventional or no-stent strategy groups according to the PCI strategy. In the no-stent strategy group, they were further classified into BO-stent or DCB-only groups. Their metal index was calculated by stent length divided by the total lesion length.

resultsThe no-stent strategy was applied in 85% of the patients, and it was successful for 65% of them. MACE occurred in 7.1% of the study population, including 4.2% of all-cause death. Target lesion revascularization was required in 1.4%, 3.6%, and 1.5% of patients in the conventional DES, BO-stent, and DCB-only groups, respectively. MACE occurred more often in the elderly and in those treated with at least one stent (metal index greater than 0).

conclusionsThe no-stent strategy, i.e., revascularization of coronary lesions by SCBA followed by DCB and with DES bailout stenting, was effective and safe at 1 year. This PCI approach was applicable on a daily practice in our cath lab.

trial registrationThis study was registered with clinicaltrials.gov (NCT03893396, first posted on March 28, 2019). Feasibility, safety and efficacy of percutaneous coronary interventions following a decision tree proposing a no-stent strategy in stable patients with coronary artery disease. DES: drug eluting stent; SCBA: scoring balloon angioplasty; BO-stent: at least one stent; DCB: drug coated balloon; BMS: bare metal stent; Bailout (dash lines); MACE: major adverse cardiac event.

Indexed as

Coronary Artery DiseaseDrug-Eluting StentsPercutaneous Coronary InterventionAgedDecision TreesHumansProspective StudiesTreatment OutcomeAngioplastyCoronary artery diseaseDrug-coated balloonDrug-eluting stentPatient outcome assessmentPercutaneous coronary intervention

Identifiers

PMID35776144
PMCPMC10449686
OpenAlexW4283746889

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.