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, Jaroslaw Wojcik, Nicolas Delarche, Didier Blanchard, Bernard Jouve, Olivier Ormezzano, Franck Paganelli, Gilles Levy, Joël Sainsous, Didier Carrie, Alain Furber & 20 others Jacques Berland, Oliver Darremont, Hervé Le Breton, Anne Lyuycx-Bore, Antoine Gommeaux, Claude Cassat, Alain Kermarrec, Pierre Cazaux, Philippe Druelles, Raphael Dauphin, Jean Armengaud, Patrick Dupouy, Didier Champagnac, Patrick Ohlmann, Knut Endresen, Hakim Benamer, R. Kiss, Imre Ungi, Jacques Boschat, Marie Claude Morice

Research output: Contribution to journalArticle

239 Citations (Scopus)

Abstract

Background The 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). Objectives This study hypothesized that antiplatelet treatment with DAPT for 6 months may be noninferior to 24-month DAPT in aspirin-sensitive patients. Methods A 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. Results A 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]). Conclusions Rates 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)

Original languageEnglish
Pages (from-to)777-786
Number of pages10
JournalJournal of the American College of Cardiology
Volume65
Issue number8
DOIs
Publication statusPublished - Mar 3 2015

Fingerprint

Drug-Eluting Stents
Aspirin
Multicenter Studies
Stents
Therapeutics
clopidogrel
Acute Coronary Syndrome
Hemorrhage
Thrombosis
Confidence Intervals
Stroke
Myocardial Infarction

Keywords

  • double antiplatelet duration
  • percutaneous coronary angioplasty

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

Cite this

6-versus 24-month dual antiplatelet therapy after implantation of drug-eluting stents in patients nonresistant to aspirin : The randomized, multicenter ITALIC trial. / Gilard, Martine; Barragan, Paul; Noryani, Arif A L; Noor, Hussam A.; Majwal, Talib; Hovasse, Thomas; Castellant, Philippe; Schneeberger, Michel; Maillard, Luc; Bressolette, Erwan; Wojcik, Jaroslaw; Delarche, Nicolas; Blanchard, Didier; Jouve, Bernard; Ormezzano, Olivier; Paganelli, Franck; Levy, Gilles; Sainsous, Joël; Carrie, Didier; Furber, Alain; Berland, Jacques; Darremont, Oliver; Le Breton, Hervé; Lyuycx-Bore, Anne; Gommeaux, Antoine; Cassat, Claude; Kermarrec, Alain; Cazaux, Pierre; Druelles, Philippe; Dauphin, Raphael; Armengaud, Jean; Dupouy, Patrick; Champagnac, Didier; Ohlmann, Patrick; Endresen, Knut; Benamer, Hakim; Kiss, R.; Ungi, Imre; Boschat, Jacques; Morice, Marie Claude.

In: Journal of the American College of Cardiology, Vol. 65, No. 8, 03.03.2015, p. 777-786.

Research output: Contribution to journalArticle

Gilard, M, Barragan, P, Noryani, AAL, Noor, HA, Majwal, T, Hovasse, T, Castellant, P, Schneeberger, M, Maillard, L, Bressolette, E, Wojcik, J, Delarche, N, Blanchard, D, Jouve, B, Ormezzano, O, Paganelli, F, Levy, G, Sainsous, J, Carrie, D, Furber, A, Berland, J, Darremont, O, Le Breton, H, Lyuycx-Bore, A, Gommeaux, A, Cassat, C, Kermarrec, A, Cazaux, P, Druelles, P, Dauphin, R, Armengaud, J, Dupouy, P, Champagnac, D, Ohlmann, P, Endresen, K, Benamer, H, Kiss, R, Ungi, I, Boschat, J & Morice, MC 2015, '6-versus 24-month dual antiplatelet therapy after implantation of drug-eluting stents in patients nonresistant to aspirin: The randomized, multicenter ITALIC trial', Journal of the American College of Cardiology, vol. 65, no. 8, pp. 777-786. https://doi.org/10.1016/j.jacc.2014.11.008
Gilard, Martine ; Barragan, Paul ; Noryani, Arif A L ; Noor, Hussam A. ; Majwal, Talib ; Hovasse, Thomas ; Castellant, Philippe ; Schneeberger, Michel ; Maillard, Luc ; Bressolette, Erwan ; Wojcik, Jaroslaw ; Delarche, Nicolas ; Blanchard, Didier ; Jouve, Bernard ; Ormezzano, Olivier ; Paganelli, Franck ; Levy, Gilles ; Sainsous, Joël ; Carrie, Didier ; Furber, Alain ; Berland, Jacques ; Darremont, Oliver ; Le Breton, Hervé ; Lyuycx-Bore, Anne ; Gommeaux, Antoine ; Cassat, Claude ; Kermarrec, Alain ; Cazaux, Pierre ; Druelles, Philippe ; Dauphin, Raphael ; Armengaud, Jean ; Dupouy, Patrick ; Champagnac, Didier ; Ohlmann, Patrick ; Endresen, Knut ; Benamer, Hakim ; Kiss, R. ; Ungi, Imre ; Boschat, Jacques ; Morice, Marie Claude. / 6-versus 24-month dual antiplatelet therapy after implantation of drug-eluting stents in patients nonresistant to aspirin : The randomized, multicenter ITALIC trial. In: Journal of the American College of Cardiology. 2015 ; Vol. 65, No. 8. pp. 777-786.
@article{2a86ffa4432e42e9b7335d57e89ba079,
title = "6-versus 24-month dual antiplatelet therapy after implantation of drug-eluting stents in patients nonresistant to aspirin: The randomized, multicenter ITALIC trial",
abstract = "Background The 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). Objectives This study hypothesized that antiplatelet treatment with DAPT for 6 months may be noninferior to 24-month DAPT in aspirin-sensitive patients. Methods A 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. Results A 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]). Conclusions Rates 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)",
keywords = "double antiplatelet duration, percutaneous coronary angioplasty",
author = "Martine Gilard and Paul Barragan and Noryani, {Arif A L} and Noor, {Hussam A.} and Talib Majwal and Thomas Hovasse and Philippe Castellant and Michel Schneeberger and Luc Maillard and Erwan Bressolette and Jaroslaw Wojcik and Nicolas Delarche and Didier Blanchard and Bernard Jouve and Olivier Ormezzano and Franck Paganelli and Gilles Levy and Jo{\"e}l Sainsous and Didier Carrie and Alain Furber and Jacques Berland and Oliver Darremont and {Le Breton}, Herv{\'e} and Anne Lyuycx-Bore and Antoine Gommeaux and Claude Cassat and Alain Kermarrec and Pierre Cazaux and Philippe Druelles and Raphael Dauphin and Jean Armengaud and Patrick Dupouy and Didier Champagnac and Patrick Ohlmann and Knut Endresen and Hakim Benamer and R. Kiss and Imre Ungi and Jacques Boschat and Morice, {Marie Claude}",
year = "2015",
month = "3",
day = "3",
doi = "10.1016/j.jacc.2014.11.008",
language = "English",
volume = "65",
pages = "777--786",
journal = "Journal of the American College of Cardiology",
issn = "0735-1097",
publisher = "Elsevier USA",
number = "8",

}

TY - JOUR

T1 - 6-versus 24-month dual antiplatelet therapy after implantation of drug-eluting stents in patients nonresistant to aspirin

T2 - The randomized, multicenter ITALIC trial

AU - Gilard, Martine

AU - Barragan, Paul

AU - Noryani, Arif A L

AU - Noor, Hussam A.

AU - Majwal, Talib

AU - Hovasse, Thomas

AU - Castellant, Philippe

AU - Schneeberger, Michel

AU - Maillard, Luc

AU - Bressolette, Erwan

AU - Wojcik, Jaroslaw

AU - Delarche, Nicolas

AU - Blanchard, Didier

AU - Jouve, Bernard

AU - Ormezzano, Olivier

AU - Paganelli, Franck

AU - Levy, Gilles

AU - Sainsous, Joël

AU - Carrie, Didier

AU - Furber, Alain

AU - Berland, Jacques

AU - Darremont, Oliver

AU - Le Breton, Hervé

AU - Lyuycx-Bore, Anne

AU - Gommeaux, Antoine

AU - Cassat, Claude

AU - Kermarrec, Alain

AU - Cazaux, Pierre

AU - Druelles, Philippe

AU - Dauphin, Raphael

AU - Armengaud, Jean

AU - Dupouy, Patrick

AU - Champagnac, Didier

AU - Ohlmann, Patrick

AU - Endresen, Knut

AU - Benamer, Hakim

AU - Kiss, R.

AU - Ungi, Imre

AU - Boschat, Jacques

AU - Morice, Marie Claude

PY - 2015/3/3

Y1 - 2015/3/3

N2 - Background The 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). Objectives This study hypothesized that antiplatelet treatment with DAPT for 6 months may be noninferior to 24-month DAPT in aspirin-sensitive patients. Methods A 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. Results A 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]). Conclusions Rates 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)

AB - Background The 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). Objectives This study hypothesized that antiplatelet treatment with DAPT for 6 months may be noninferior to 24-month DAPT in aspirin-sensitive patients. Methods A 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. Results A 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]). Conclusions Rates 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)

KW - double antiplatelet duration

KW - percutaneous coronary angioplasty

UR - http://www.scopus.com/inward/record.url?scp=84923348829&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84923348829&partnerID=8YFLogxK

U2 - 10.1016/j.jacc.2014.11.008

DO - 10.1016/j.jacc.2014.11.008

M3 - Article

VL - 65

SP - 777

EP - 786

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

SN - 0735-1097

IS - 8

ER -