6-Versus 24-Month Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents in Patients Nonresistant to Aspirin Final Results of the ITALIC Trial (Is There a Life for DES After Discontinuation of Clopidogrel)

被引：49

作者：

Didier, Romain ^{[1
]}

Morice, Marie Claude ^{[2
]}

Barragan, Paul ^{[3
]}

Noryani, Arif A. L. ^{[4
]}

Noor, Hussam A. ^{[5
]}

Majwal, Talib ^{[6
]}

Hovasse, Thomas ^{[2
]}

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
]}

Berlan, Jacques ^{[20
]}

Darremont, Olivier ^{[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
]}

Ben Amer, Hakim ^{[34
]}

Kiss, Robert G. ^{[35
]}

Ungi, Irme ^{[36
]}

Gilard, Martine ^{[1
]}

机构：

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

[2] ICPS, Massy, France

[3] Clin Fleurs, Ollioules, France

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

[5] Bahrain Def Force, West Riffa, Bahrain

[6] Dubai Hosp, Dubai, U Arab Emirates

[7] Hop Albert Schweitzer, Colmar, France

[8] Clin Axium, Aix En Provence, France

[9] NCN, Nantes, France

[10] Klin Kardiol SPSK4, Lublin, Poland

[11] CH Mitterrand, Pau, France

[12] Clin St Gatien, Tours, France

[13] CH Aix en Provence, Aix En Provence, France

[14] CHU Grenoble, Grenoble, France

[15] CHU Hop Nord, Marseille, France

[16] Clin Millenaire, Montpellier, France

[17] Clin Rhone Durance, Avignon, France

[18] CHU, Toulouse, France

[19] CHU Angers, Angers, France

[20] Clin St Hilaire, Rouen, France

[21] Clin St Augustin, Bordeaux, France

[22] CHU, Rennes, France

[23] CH Compiegne, Compiegne, France

[24] Polyclin Bois, Bernard, France

[25] CHU, Limoges, France

[26] CH Vannes, Vannes, France

[27] CH Lorient, Lorient, France

[28] Poly St Laurent, Rennes, France

[29] Hop Croix Rousse, Lyon, France

[30] Clin Esquirol, Agen, France

[31] Hop Prive, Antony, France

[32] Clin Tonkin, Villeurbanne, France

[33] CHU Strasbourg, Strasbourg, France

[34] Hop Roseraie, Aubervilliers, France

[35] Honved Korhaz, Budapest, Hungary

[36] SZTE Szent Gyorgyi Albert, Szeged, Hungary

来源：

JACC-CARDIOVASCULAR INTERVENTIONS | 2017年 / 10卷 / 12期

关键词：

drug-eluting stent(s); dual antiplatelet therapy; percutaneous coronary intervention; MYOCARDIAL-INFARCTION; TASK-FORCE; DURATION; ASSOCIATION; GUIDELINES; THROMBOSIS; EFFICACY; SOCIETY; 6-MONTH; SAFETY;

D O I：

10.1016/j.jcin.2017.03.049

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

OBJECTIVES The aim of this study was to test the hypothesis that 6-month dual antiplatelet therapy (DAPT) is non-inferior to 24-month DAPT in aspirin-sensitive patients. BACKGROUND The ITALIC (Is There a Life for DES After Discontinuation of Clopidogrel) trial showed that rates of bleeding and thrombotic events at 1 year were much the same with 6 versus 12 months of DAPT after percutaneous coronary intervention with second-generation drug-eluting stents. In this report, 2-year follow-up is presented. METHODS In a multicenter randomized study, patients with confirmed nonresistance to aspirin undergoing drug-eluting stent implantation were allocated to 6 or 24 months of DAPT. The primary endpoint was a composite of death, myocardial infarction, urgent target vessel revascularization, stroke, and major bleeding at 12 months post-percutaneous coronary intervention. The secondary endpoints comprised the same composite endpoint at 24 months and each individual component. RESULTS Overall, 2,031 patients from 70 centers were screened; 926 were randomized to 6-month and 924 to 24-month DAPT. Noninferiority was demonstrated for 6-versus 12-month DAPT, with an absolute risk difference of 0.11% (95% confidence interval: -1.04% to 1.26%; p = 0.0002). At 2 years, the composite endpoint was unchanged, at 3.5% for 6 months and 3.7% for 24 months (p = 0.79), and rates of myocardial infarction (1.3% vs. 1.0%; p = 0.51), stroke (0.6% vs. 0.8%; p = 0.77), and target vessel revascularization (1.0% vs. 0.3%; p = 0.09) were likewise similar. There was a trend toward higher mortality with longer DAPT (2.2% vs. 1.2%; p = 0.11). Four patients (0.4%) in the 24-month group and none in the 6-month group had major bleeding. CONCLUSIONS Two-year outcomes in the ITALIC trial confirmed the 1-year results and showed that patients receiving 6-month DAPT after percutaneous coronary intervention with second-generation drug-eluting stent have similar outcomes to those receiving 24-month DAPT. (C) 2017 by the American College of Cardiology Foundation.

引用

页码：1202 / 1210

页数：9

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