Evaluation and Treatment of Patients With Lower Extremity Peripheral Artery Disease Consensus Definitions From Peripheral Academic Research Consortium (PARC)

被引：299

作者：

Patel, Manesh R. ^{[1
]}

Conte, Michael S. ^{[2
]}

Cutlip, Donald E. ^{[3
,4
]}

Dib, Nabil ^{[5
]}

Geraghty, Patrick ^{[6
]}

Gray, William ^{[7
,8
]}

Hiatt, William R. ^{[9
,10
]}

Ho, Mami ^{[11
]}

Ikeda, Koji ^{[12
]}

Ikeno, Fumiaki ^{[13
]}

Jaff, Michael R. ^{[14
]}

Jones, W. Schuyler

Kawahara, Masayuki ^{[11
]}

Lookstein, Robert A. ^{[15
]}

Mehran, Roxana ^{[15
]}

Misra, Sanjay ^{[16
]}

Norgren, Lars ^{[17
]}

Olin, Jeffrey W. ^{[15
]}

Povsic, Thomas J. ^{[1
]}

Rosenfield, Kenneth ^{[18
]}

Rundback, John ^{[19
]}

Shamoun, Fadi ^{[20
]}

Tcheng, James ^{[1
]}

Tsai, Thomas T. ^{[21
]}

Suzuki, Yuka ^{[22
]}

Vranckx, Pascal ^{[23
]}

Wiechmann, Bret N. ^{[24
]}

White, Christopher J. ^{[25
]}

Yokoi, Hiroyoshi ^{[26
]}

Krucoff, Mitchell W. ^{[1
]}

机构：

[1] Duke Univ, Duke Clin Res Inst, Durham, NC 27710 USA

[2] Univ Calif San Francisco, San Francisco, CA 94143 USA

[3] Harvard Clin Res Inst, Boston, MA USA

[4] Beth Israel Deaconess Med Ctr, Boston, MA 02215 USA

[5] Univ Calif San Diego, San Diego, CA 92103 USA

[6] Washington Univ, Sch Med, St Louis, MO USA

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

[8] Columbia Univ, Med Ctr, New York, NY USA

[9] Univ Colorado, Sch Med, Aurora, CO USA

[10] CPC Clin Res, Aurora, CO USA

[11] Pharmaceut & Med Devices Agcy, Office Med Devices 1, Tokyo, Japan

[12] Tohoku Univ Hosp, Sendai, Miyagi, Japan

[13] Stanford Univ, Palo Alto, CA 94304 USA

[14] Massachusetts Gen Hosp, VasCore, Boston, MA 02114 USA

[15] Mt Sinai Med Ctr, New York, NY 10029 USA

[16] Mayo Clin, Rochester, MN USA

[17] Univ Hosp, Orebro, Sweden

[18] Massachusetts Gen Hosp, Boston, MA 02114 USA

[19] Holy Name Med Ctr, Teaneck, NJ USA

[20] Mayo Clin Arizona, Phoenix, AZ USA

[21] Univ Colorado, Kaiser Permanente Colorado Inst Hlth Res, Denver, CO 80202 USA

[22] Pharmaceut & Med Devices Agcy, Off Med Devices 2, Tokyo, Japan

[23] Cardialysis, Rotterdam, Netherlands

[24] Vasc & Intervent Phys, Gainesville, FL USA

[25] Ochsner Med Ctr, New Orleans, LA USA

[26] Kokura Mem Hosp, Kitakyuku, Japan

来源：

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY | 2015年 / 65卷 / 09期

基金：

美国医疗保健研究与质量局; 美国国家卫生研究院;

关键词：

amputation; foot; intermittent claudication; leg; myocardial infarction; stroke; AORTIC-VALVE IMPLANTATION; INTER-SOCIETY CONSENSUS; END-POINT DEFINITIONS; STENT THROMBOSIS; CLINICAL-OUTCOMES; TRIALS; MANAGEMENT; QUESTIONNAIRE; ISCHEMIA; IMPACT;

D O I：

10.1016/j.jacc.2014.12.036

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

The lack of consistent definitions and nomenclature across clinical trials of novel devices, drugs, or biologics poses a significant barrier to accrual of knowledge in and across peripheral artery disease therapies and technologies. Recognizing this problem, the Peripheral Academic Research Consortium, together with the U.S. Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, has developed a series of pragmatic consensus definitions for patients being treated for peripheral artery disease affecting the lower extremities. These consensus definitions include the clinical presentation, anatomic depiction, interventional outcomes, surrogate imaging and physiological follow-up, and clinical outcomes of patients with lower-extremity peripheral artery disease. Consistent application of these definitions in clinical trials evaluating novel revascularization technologies should result in more efficient regulatory evaluation and best practice guidelines to inform clinical decisions in patients with lower extremity peripheral artery disease. (C) 2015 by the American College of Cardiology Foundation.

引用

页码：931 / 941

页数：11

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