Efficacy and Safety of Dual Antiplatelet Therapy After Complex PCI

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:68

Article

Giustino, Gennaro^1,2,3  Chieffo, Alaide³  Palmerini, Tullio⁴  Valgimigli, Marco⁵  Feres, Fausto⁶  Abizaid, Alexandre⁶  Costa, Ricardo A.⁶  Hong, Myeong-Ki^7,8  Kim, Byeong-Keuk^7,8  Jang, Yangsoo^7,8  Kim, Hyo-Soo⁹  Park, Kyung Woo⁹  Gilard, Martine¹⁰  Morice, Marie-Claude¹¹  Sawaya, Fadi¹¹  Sardella, Gennaro¹²  Genereux, Philippe²  Redfors, Bjorn²  Leon, Martin B.^3,13  Bhatt, Deepak L.^14,15  Stone, Gregg W.^2,13  Colombo, Antonio³ 

[1] Icahn Sch Med Mt Sinai, Zena & Michael A Wiener Cardiovasc Inst, New York, NY 10029 USA

[2] Cardiovasc Res Fdn, New York, NY USA

[3] Ist Sci San Raffaele, Intervent Cardiol Unit, Milan, Italy

[4] Univ Bologna, Dipartimento Cardiotoracovasc, Bologna, Italy

[5] Erasmus MC, Ctr Thorax, Rotterdam, Netherlands

[6] Ist Dante Pazzanese Cardiol, Sao Paulo, Brazil

[7] Yonsei Univ, Severance Cardiovasc Hosp, Coll Med, Seoul, South Korea

[8] Yonsei Univ, Inst Sci, Coll Med, Seoul, South Korea

[9] Seoul Natl Univ Hosp, Dept Internal Med, Seoul, South Korea

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

[11] Inst Cardiovasc Paris Sud, Gen Sante, Massy, France

[12] Sapienza Univ Rome, Policlin Umberto 1, Dept Cardiovasc Resp Nephrol & Geriatr Sci, Rome, Italy

[13] Columbia Univ, New York Presbyterian Hosp, Med Ctr, New York, NY USA

[14] Brigham & Womens Hosp, Heart & Vasc Ctr, 75 Francis St, Boston, MA 02115 USA

[15] Harvard Med Sch, Boston, MA USA

关键词: bleeding;    drug-eluting stents;    myocardial infarction;    stent thrombosis;   

DOI  :  10.1016/j.jacc.2016.07.760

来源: Elsevier

【 摘 要 】

BACKGROUND Optimal upfront dual antiplatelet therapy (DAPT) duration after complex percutaneous coronary intervention (PCI) with drug-eluting stents (DES) remains unclear. OBJECTIVES This study investigated the efficacy and safety of long-term (>= 12 months) versus short-term (3 or 6 months) DAPT with aspirin and clopidogrel according to PCI complexity. METHODS The authors pooled patient-level data from 6 randomized controlled trials investigating DAPT durations after PCI. Complex PCI was defined as having at least 1 of the following features: 3 vessels treated, >= 3 stents implanted, >= 3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or chronic total occlusion. The primary efficacy endpoint was major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction, or stent thrombosis. The primary safety endpoint was major bleeding. Intention-to-treat was the primary analytic approach. RESULTS Of 9,577 patients included in the pooled dataset for whom procedural variables were available, 1,680 (17.5%) underwent complex PCI. Overall, 85% of patients received new-generation DES. At a median follow-up time of 392 days (interquartile range: 366 to 710 days), patients who underwent complex PCI had a higher risk of MACE (adjusted hazard ratio [HR]: 1.98; 95% confidence interval [CI]: 1.50 to 2.60; p < 0.0001). Compared with short-term DAPT, long-term DAPT yielded significant reductions in MACE in the complex PCI group (adjusted HR: 0.56; 95% CI: 0.35 to 0.89) versus the noncomplex PCI group (adjusted HR: 1.01; 95% CI: 0.75 to 1.35; p(interaction) = 0.01). The magnitude of the benefit with long-term DAPT was progressively greater per increase in procedural complexity. Long-term DAPT was associated with increased risk for major bleeding, which was similar between groups (p(interaction) = 0.96). Results were consistent by per-treatment landmark analysis. CONCLUSIONS Alongside other established clinical risk factors, procedural complexity is an important parameter to take into account in tailoring upfront duration of DAPT. (C) 2016 by the American College of Cardiology Foundation.

【 授权许可】

Free