Evidence map›Paper›PMID 25461690›Full record

Trial reportJournal of the American College of Cardiology2015

6- versus 24-month dual antiplatelet therapy after implantation of drug-eluting stents in patients nonresistant to aspirin: the randomized, multicenter ITALIC trial.

Martine Gilard, Paul Barragan, Arif A L Noryani, Hussam A Noor, Talib Majwal, Thomas Hovasse, Philippe Castellant, Michel Schneeberger, Luc Maillard, Erwan Bressolette and 30 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of the American College of Cardiology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01476020 (Is There A LIfe for DES After Discontinuation of Clopidogrel), which is not on this map. Cited by 108 papers, 23 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
108citing papers in PubMed, 23 pooled it
62.8field-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.

NCT01476020 unknown statusnot on this map

Is There A LIfe for DES After Discontinuation of Clopidogrel:The ITALIC PLUS Trial

TypeobservationalSponsorGilard, MartineRan2011 to 2015Enrolled1,240ConditionsRestenosis
3 · Its place in the literature

Who cites it

108 citing papers in PubMed, 23 syntheses or guidelines pooled it, 349 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Abbreviated versus Standard Duration of DAPT after PCI: A Systematic Review and Network Meta-analysis.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2022
    Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Guideline
  12. Pooled it
  13. Pooled it
  14. Pooled it
  15. Pooled it
  16. Pooled it
  17. Pooled it
  18. Prolonged dual antiplatelet therapy after drug-eluting stenting: meta-analysis of randomized trials.Clinical research in cardiology : official journal of the German Cardiac Society · 2015
    Pooled it
  19. Pooled it
  20. Pooled it

48 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

40 authors at 20 institutions in 4 countries.

Martine GilardDepartment of Cardiology, Brest University, Brest, France. Electronic address: Martine.gilard@chu-brest.fr.
Paul BarraganPolyclinique les Fleurs, Ollioules, France.
Arif A L NoryaniAl Qassimi Hospital, Sharjah, United Arab Emirates.
Hussam A NoorBahrain Defence Force West, Riffa, Bahrain.
Talib MajwalDubai Hospital, Dubai, United Arab Emirates.
Thomas HovasseGénérale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France.
Philippe CastellantDepartment of Cardiology, Brest University, Brest, France.
Michel SchneebergerHôpital Albert Schweitzer, Colmar, France.
Luc MaillardClinique Axium, Aix en Provence, France.
Erwan BressoletteNouvelles Cliniques Nantaises, Nantes, France.
Jaroslaw WojcikKlinika Kardiologii SPSK4, Lublin, Poland.
Nicolas DelarcheCentre Hospitalier Mitterrand, Pau, France.
Didier BlanchardClinique Saint Gatien, Tours, France.
Bernard JouveCentre Hospitalier, Aix en Provence, France.
Olivier OrmezzanoCentre Hospitalier Universitaire de Grenoble, Grenoble, France.
Franck PaganelliCentre Hospitalier Universitaire, Hôpital Nord, Marseille, France.
Gilles LevyClinique du Millénaire, Montpellier, France.
Joël SainsousClinique Rhône Durance, Avignon, France.
Didier CarrieCentre Hospitalier Universitaire, Toulouse, France.
Alain FurberCentre Hospitalier Universitaire, Angers, France.
Jacques BerlandClinique Saint Hilaire, Rouen, France.
Oliver DarremontClinique Saint Augustin, Bordeaux, France.
Hervé Le BretonCentre Hospitalier Universitaire, Rennes, France.
Anne Lyuycx-BoreCentre Hospitalier, Compiègne, France.
Antoine GommeauxPolyclinique de Bois, Bernard, France.
Claude CassatCentre Hospitalier Universitaire, Limoges, France.
Alain KermarrecCentre Hospitalier, Vannes, France.
Pierre CazauxCentre Hospitalier, Lorient, France.
Philippe DruellesPoly de Saint Laurent, Rennes, France.
Raphael DauphinHôpital de la Croix Rousse, Lyon France.
Jean ArmengaudClinique Esquirol, Agen, France.
Patrick DupouyHôpital Privé, Antony, France.
Didier ChampagnacClinique Tonkin, Villeurbanne, France.
Patrick OhlmannCentre Hospitalier Universitaire, Strasbourg, France.
Knut EndresenOslo Universitetssykehus, Oslo, Norway.
Hakim BenamerHôpital La Roseraie, Aubervilliers, France.
Robert Gabor KissMH Egrszsegugyi Kozpont, Budapest, Hungary.
Imre UngiHonvéd Kórház, Budapest, Hungary, and University of Szeged, Szent-Györgyi Albert, Szeged, Hungary.
Jacques BoschatDepartment of Cardiology, Brest University, Brest, France.
Marie-Claude MoriceGénérale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France.
Centre Hospitalier Régional Universitaire de Brest · FRInstitut Cardiovasculaire Paris Sud · FRSaint Laurent Polyclinique · FRBahrain Center for Strategic International and Energy Studies · BHBM Központi Kórház · HUCentre hospitalier Bretagne Atlantique · FRCentre Hospitalier Compiègne-Noyon · FRCentre Hospitalier de Bretagne Sud · FRCentre Hospitalier De Pau · FRCentre Hospitalier du Pays d'Aix · FRCentre Hospitalier Esquirol de Limoges · FRCentre Hospitalier Universitaire d'Angers · FRCentre Hospitalier Universitaire de Grenoble · FRCentre Hospitalier Universitaire de Limoges · FRCentre Hospitalier Universitaire de Rennes · FRCentre Hospitalier Universitaire de Toulouse · FRClinique du Millénaire · FRDubai Hospital · AEHôpital de la Croix-Rousse · FRHôpital Lapeyronie · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe currently recommended duration of dual antiplatelet therapy (DAPT) in drug-eluting stent (DES) recipients is 12 months to reduce the risk of late stent thrombosis, particularly in those with acute coronary syndrome (ACS).

objectivesThis study hypothesized that antiplatelet treatment with DAPT for 6 months may be noninferior to 24-month DAPT in aspirin-sensitive patients.

methodsA multicenter, randomized study assigned patients undergoing implantation of everolimus-eluting stents with confirmed nonresistance to aspirin to receive 6- or 24-month DAPT. The primary endpoint was a composite of death, myocardial infarction, urgent target vessel revascularization, stroke, and major bleeding at 12 months post-stenting.

resultsA total of 2,031 patients were enrolled in 70 European and Middle Eastern centers. The trial was prematurely terminated due to recruitment problems, leaving 941 patients randomized to 24-month DAPT and 953 to 6-month DAPT. The 2 treatment groups had similar baseline and procedural characteristics. There was no significant difference in the primary endpoint (24-month: 1.5% vs. 6-month: 1.6%; p = 0.85). Noninferiority was demonstrated for 6- versus 24-month DAPT, with an absolute risk difference of 0.11% (95% confidence interval: -1.04% to 1.26%; p for noninferiority = 0.0002). There were no significant differences in stent thrombosis or bleeding complications. In the 792 (44%) high-risk patients with ACS, primary and secondary endpoints did not significantly differ (hazard ratio: 1.7 [95% confidence interval: 0.519 to 6.057; p = 0.361]).

conclusionsRates of bleeding and thrombotic events were not significantly different according to 6- versus 24-month DAPT after PCI with new-generation DES in good aspirin responders. (Is There A LIfe for DES After Discontinuation of Clopidogrel [ITALICplus]; NCT01476020).

Indexed as

AspirinCoronary RestenosisHemorrhagePercutaneous Coronary InterventionAgedClopidogrelCoronary Artery DiseaseCoronary VesselsDrug-Eluting StentsEarly Termination of Clinical TrialsEuropeEverolimusFemaleHumansImmunosuppressive AgentsMaleAspirinClopidogrelEverolimusImmunosuppressive AgentsPlatelet Aggregation InhibitorsSirolimusTiclopidinedouble antiplatelet durationpercutaneous coronary angioplasty

Identifiers

PMID25461690
OpenAlexW194894827

What OpenQuestion holds

Textmetadata
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.