Major Adverse Limb Events and Mortality in Patients With Peripheral Artery Disease

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:71

Article

Anand, Sonia S.¹  Caron, Francois^1,2  Eikelboom, John W.¹  Bosch, Jackie^3,4  Dyal, Leanne⁴  Aboyans, Victor⁵  Abola, Maria Teresa⁶  Branch, Kelley R. H.⁷  Keltai, Katalin⁸  Bhatt, Deepak L.⁹  Verhamme, Peter¹⁰  Fox, Keith A. A.¹¹  Cook-Bruns, Nancy¹²  Lanius, Vivian¹²  Connolly, Stuart J.¹  Yusuf, Salim¹ 

[1] McMaster Univ, Populat Hlth Res Inst, Dept Med, Hamilton Hlth Sci, Hamilton, ON, Canada

[2] CISSS Bas St Laurent, Rimouski, PQ, Canada

[3] McMaster Univ, Sch Rehabil Sci, Hamilton Hlth Sci, Hamilton, ON, Canada

[4] McMaster Univ, Populat Hlth Res Inst, Hamilton Hlth Sci, Hamilton, ON, Canada

[5] Dupuytren Univ Hosp, Dept Cardiol, Limoges, France

[6] Univ Philippines, Dept Med, Philippine Heart Ctr, Manila, Philippines

[7] Univ Washington, Dept Med, Seattle, WA USA

[8] Semmelweis Univ, Dept Med, Budapest, Hungary

[9] Harvard Med Sch, Brigham & Womens Hosp, Dept Med, Heart & Vasc Ctr, Boston, MA USA

[10] Univ Leuven, Dept Med, Leuven, Belgium

[11] Univ Edinburgh, Edinburgh, Midlothian, Scotland

[12] Bayer AG, Wuppertal, Germany

关键词: amputation;    antithrombotic therapy;    death;    major adverse limb events;    peripheral artery disease;   

DOI  :  10.1016/j.jacc.2018.03.008

来源: Elsevier

【 摘 要 】

BACKGROUND Patients with lower extremity peripheral artery disease (PAD) are at increased risk of major adverse cardiovascular events (MACE) and major adverse limb events (MALE). There is limited information on the prognosis of patients who experience MALE. OBJECTIVES Among participants with lower extremity PAD, this study investigated: 1) if hospitalizations, MACE, amputations, and deaths are higher after the first episode of MALE compared with patients with PAD who do not experience MALE; and 2) the impact of treatment with low-dose rivaroxaban and aspirin compared with aspirin alone on the incidence of MALE, peripheral vascular interventions, and alt peripheral vascular outcomes over a median follow-up of 21 months. METHODS We analyzed outcomes in 6,391 patients with lower extremity PAD who were enrolled in the COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) trial. COMPASS was a randomized, double-blind placebo-controlled study of low-dose rivaroxaban and aspirin combination or rivaroxaban alone compared with aspirin alone. MALE was defined as severe limb ischemia leading to an intervention or major vascular amputation. RESULTS A total of 128 patients experienced an incident of MALE. After MALE, the 1-year cumulative risk of a subsequent hospitalization was 61.5%; for vascular amputations, it was 20.5%; for death, it was 8.3%; and for MACE, it was 3.7%. The MALE index event significantly increased the risk of experiencing subsequent hospitalizations (hazard ratio [HR]: 7.21; p < 0.0001), subsequent amputations (HR: 197.5; p < 0.0001), and death (HR: 3.23; p < 0.001). Compared with aspirin alone, the combination of rivaroxaban 2.5 mg twice daily and aspirin lowered the incidence of MALE by 43% (p = 0.01), total vascular amputations by 58% (p = 0.01), peripheral vascular interventions by 24% (p = 0.03), and all peripheral vascular outcomes by 24% (p = 0.02). CONCLUSIONS Among individuals with lower extremity PAD, the development of MALE is associated with a poor prognosis, making prevention of this condition of utmost importance. The combination of rivaroxaban 2.5 mg twice daily and aspirin significantly lowered the incidence of MALE and the related complications, and this combination should be considered as an important therapy for patients with PAD. (C) 2018 by the American College of Cardiology Foundation.

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