6-Versus 24-Month Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents in Patients Nonresistant to Aspirin The Randomized, Multicenter ITALIC Trial

被引：300

作者：

Gilard, Martine ^{[1
]}

Barragan, Paul ^{[2
]}

Noryani, Arif A. L. ^{[3
]}

Noor, Hussam A. ^{[4
]}

Majwal, Talib ^{[5
]}

Hovasse, Thomas ^{[6
]}

Castellant, Philippe ^{[1
]}

Schneeberger, Michel ^{[7
]}

Maillard, Luc ^{[8
]}

Bressolette, Erwan ^{[9
]}

Wojcik, Jaroslaw ^{[10
]}

Delarche, Nicolas ^{[11
]}

Blanchard, Didier ^{[12
]}

Jouve, Bernard ^{[13
]}

Ormezzano, Olivier ^{[14
]}

Paganelli, Franck ^{[15
]}

Levy, Gilles ^{[16
]}

Sainsous, Joel ^{[17
]}

Carrie, Didier ^{[18
]}

Furber, Alain ^{[19
]}

Berland, Jacques ^{[20
]}

Darremont, Oliver ^{[21
]}

Le Breton, Herve ^{[22
]}

Lyuycx-Bore, Anne ^{[23
]}

Gommeaux, Antoine ^{[24
]}

Cassat, Claude ^{[25
]}

Kermarrec, Alain ^{[26
]}

Cazaux, Pierre ^{[27
]}

Druelles, Philippe ^{[28
]}

Dauphin, Raphael ^{[29
]}

Armengaud, Jean ^{[30
]}

Dupouy, Patrick ^{[31
]}

Champagnac, Didier ^{[32
]}

Ohlmann, Patrick ^{[33
]}

Endresen, Knut ^{[34
]}

Benamer, Hakim ^{[35
]}

Kiss, Robert Gabor ^{[36
]}

Ungi, Imre ^{[37
,38
]}

Boschat, Jacques ^{[1
]}

Morice, Marie-Claude ^{[6
]}

机构：

[1] Brest Univ, Dept Cardiol, Brest, France

[2] Polyclin Fleurs, Ollioules, France

[3] Al Qassimi Hosp, Sharjah, U Arab Emirates

[4] Bahrain Def Force West, Riffa, Bahrain

[5] Dubai Hosp, Dubai, U Arab Emirates

[6] Inst Cardiovasc Paris Sud, Massy, France

[7] Hop Albert Schweitzer, Colmar, France

[8] Clin Axium, Aix En Provence, France

[9] Nouvelles Clin Nantaises, Nantes, France

[10] Klin Kardiol SPSK4, Lublin, Poland

[11] Ctr Hosp Mitterrand, Pau, France

[12] Clin St Gatien, Tours, France

[13] Ctr Hosp, Aix En Provence, France

[14] CHU Grenoble, F-38043 Grenoble, France

[15] Ctr Hosp Univ, Hop Nord, Marseille, France

[16] Clin Millenaire, Montpellier, France

[17] Clin Rhone Durance, Avignon, France

[18] Ctr Hosp Univ, Toulouse, France

[19] CHU Angers, Angers, France

[20] Clin St Hilaire, Rouen, France

[21] Clin St Augustin, Bordeaux, France

[22] Ctr Hosp Univ, Rennes, France

[23] Ctr Hosp Univ, Compiegne, France

[24] Polyclin Bois, Bernard, France

[25] Ctr Hosp Univ, Limoges, France

[26] Ctr Hosp, Vannes, France

[27] Ctr Hosp, Lorient, France

[28] Poly St Laurent, Rennes, France

[29] Hop Croix Rousse, F-69317 Lyon, France

[30] Clin Esquirol, Agen, France

[31] Hop Prive, Antony, France

[32] Clin Tonkin, Villeurbanne, France

[33] CHU Strasbourg, F-67000 Strasbourg, France

[34] Oslo Univ Sykehus, Oslo, Norway

[35] Hop La Roseraie, Aubervilliers, France

[36] MH Egrszsegugyi Kozpont, Budapest, Hungary

[37] Honved Korhaz, Budapest, Hungary

[38] Univ Szeged, Szeged, Hungary

来源：

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY | 2015年 / 65卷 / 08期

关键词：

double antiplatelet duration; percutaneous coronary angioplasty; BARE-METAL STENTS; PERCUTANEOUS CORONARY INTERVENTION; MYOCARDIAL-INFARCTION; CLINICAL-OUTCOMES; PLATELET REACTIVITY; POOLED ANALYSIS; FOLLOW-UP; THROMBOSIS; RISK; IMPACT;

D O I：

10.1016/j.jacc.2014.11.008

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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) (C) 2015 by the American College of Cardiology Foundation.

引用

页码：777 / 786

页数：10

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