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DOI: 10.1160/TH11-12-0844
Long-term risk of vascular events after peripheral bypass surgery
A cohort study Financial support: This study was funded by the Foundation Lijf en Leven in Rotterdam, the Netherlands.Publication History
Received:
08 December 2011
Accepted after minor revision:
30 May 2012
Publication Date:
25 November 2017 (online)
Summary
Patients with peripheral arterial disease (PAD) are at high risk of major ischaemic events. Long-term data of all major ischaemic events in PAD patients are scarce and outdated, especially for patients with severe PAD requiring bypass surgery. Our objective was to define their longterm prognosis and develop a prediction model which quantifies this risk up to a decade after surgery. We conducted a retrospective cohort study in patients from the Dutch Bypass Oral anticoagulants or Aspirin (BOA) Study; a multicentre randomised trial comparing oral anticoagulants with aspirin after infrainguinal bypass surgery. The primary outcome was the composite event of nonfatal myocardial infarction, non-fatal ischaemic stroke, major amputation, and vascular death. Cumulative risks were assessed by Kaplan-Meier analysis and independent determinants by multivariable Cox regression models. From 1995 until 2009, 482 patients were followed for a median period of 7.8 years. Follow-up was complete in 94%. Overall 60% of patients experienced a primary outcome event, of which the majority was a vascular death (30%), followed by major amputations (12%). The primary cause of vascular death was a cardiovascular event (29%), whereas the minority was due to complications directly related to PAD (6%). Within five years after bypass surgery vascular death occurred in about a quarter of patients and within 10 years in nearly half of patients. This was double the rate as for non-vascular death. The primary outcome event occurred in over a third and over half of patients in 5 and 10 years after bypass surgery, respectively. From four independent determinants for the primary outcome event: age, diabetes, critical limb ischaemia, and prior vascular interventions, we developed a risk chart, which systematically classifies the 10-year risks of the primary outcome event, ranging from 25% to 85%. This study provided a detailed insight in the course of PAD long after peripheral bypass surgery and enables individual risk assessment of major fatal and non-fatal ischaemic events by means of cumulative incidences and a risk chart.
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References
- 1 Norgren L, Hiatt WR, Dormandy JA. et al. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg 2007; 33 (Suppl. 01) S1-75.
- 2 Mamode N, Scott RN. Graft type for femoro-popliteal bypass surgery. Cochrane Database Syst Rev 2000; 02: CD001487.
- 3 Feinglass J, Pearce WH, Martin GJ. et al. Postoperative and amputation-free survival outcomes after femorodistal bypass grafting surgery: findings from the Department of Veterans Affairs National Surgical Quality Improvement Program. J Vasc Surg 2001; 34: 283-290.
- 4 Nasr MK, McCarthy RJ, Budd JS. et al. Infrainguinal bypass graft patency and limb salvage rates in critical limb ischemia: influence of the mode of presentation. Ann Vasc Surg 2003; 17: 192-197.
- 5 Klinkert P, Post PN, Breslau PJ. et al. Saphenous vein versus PTFE for above-knee femoropopliteal bypass. A review of the literature. Eur J Vasc Endovasc. Surg 2004; 27: 357-362.
- 6 Dorffler-Melly J, Buller HR, Koopman MM. et al. Antithrombotic agents for preventing thrombosis after infrainguinal arterial bypass surgery. Cochrane Database Syst Rev 2003; 04: CD000536.
- 7 Collins TC, Souchek J, Beyth RJ. Benefits of antithrombotic therapy after infrainguinal bypass grafting: a meta-analysis. Am J Med 2004; 117: 93-99.
- 8 CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). Lancet. 1996 348. 1329-1339.
- 9 Antithrombotic Trialists’Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. Br Med J. 2002 324. 71-86.
- 10 The Dutch BOA Study Group. Efficacy of oral anticoagulants compared with aspirin after infrainguinal bypass surgery (The Dutch Bypass Oral Anticoagulants or Aspirin Study): a randomised trial. Lancet. 2000 355. 346-351.
- 11 Criqui MH, Langer RD, Fronek A. et al. Mortality over a period of 10 years in patients with peripheral arterial disease. N Engl J Med 1992; 326: 381-386.
- 12 Steg PG, Bhatt DL, Wilson PW. et al. REACH Registry Investigators. One-year cardiovascular event rates in outpatients with atherothrombosis. J Am Med Assoc 2007; 297: 1197-1206.
- 13 Tangelder MJ, van Hattum ES. Antithrombotic therapy in peripheral artery dis-ease--antiplatelet therapy, anticoagulants, both or none. Thromb Haemost 2010; 104: 196-199.
- 14 Achterberg S, Cramer MJ, Kapelle LJ. et al. SMART study Group. Patients with coronary, cerebrovascular or peripheral arterial obstructive disease differ in risk for new vascular events and mortality. The SMART study. Eur J Cardiovasc Prev Rehabil 2010; 17: 424-430.
- 15 Dawson I, Sie RB, van der Wall EE. et al. Vascular morbidity and mortality during long-term follow-up in claudicants selected for peripheral bypass surgery. Eur J Vasc Endovasc Surg 1998; 16: 292-300.
- 16 van Wijk I, Kappelle LJ, van Gijn J. et al. LiLAC study group. Long-term survival and vascular event risk after transient ischaemic attack or minor ischaemic stroke: a cohort study. Lancet 2005; 365: 2098-2104.
- 17 The Dutch TIA Trial Study Group. A comparison of two doses of aspirin (30 mg vs. 283 mg a day) in patients after a transient ischemic attack or minor ischemic stroke. N Engl J Med 1991; 325: 1261-1266.
- 18 Steyerberg EW, Eijkemans MJ, Harrell FE. et al. Prognostic modeling with logistic regression analysis: in search of a sensible strategy in small data sets. Med Decis Making 2001; 21: 45-56.
- 19 Harrell Jr FE, Lee KL, Mark DB. Multivariable prognostic models: issues in developing models, evaluating assumptions and adequacy, and measuring and reducing errors. Stat Med 1996; 15: 361-387.
- 20 Van Houwelingen JC, Le Cessie S. Predictive value of statistical models. Stat Med 1990; 09: 1303-1325.
- 21 Albert MJ, Bhatt DL, Mas JL. et al. Three-year follow-up and event rates in the international REduction of Atherothrombosis for Continued Health Registry. Eur Heart J 2009; 30: 2297-2299.
- 22 Goto S. Cardiovascular risk factors in patients at high risk of atherothrombosis: what can be learned from registries?. Thromb Haemost 2008; 100: 611-613.
- 23 Dawson I, van Bockel JH, Brand R. Late nonfatal and fatal cardiac events after infrainguinal bypass for femoropopliteal occlusive disease during a thirty-one-year period. J Vasc Surg 1993; 18: 249-260.
- 24 Dawson I, van Bockel JH, Ferrari MD. et al. Ischemic and hemorrhagic stroke in patients on oral anticoagulants after reconstruction for chronic lower limb ischemia. Stroke 1993; 24: 1655-1663.
- 25 Schanzer A, Mega J, Meadows J. et al. Risk stratification in critical limb ischemia: derivation and validation of a model to predict amputation-free survival using multicenter surgical outcomes data. J Vasc Surg 2008; 48: 1464-1471.
- 26 Feinglass J, Sohn MW, Rodriguez H. et al. Perioperative outcomes and amputation-free survival after lower extremity bypass surgery in California hospitals, 1996-1999, with follow-up through 2004. J Vasc Surg 2009; 50: 776-783.
- 27 Tangelder MJ, McDonnel J, Van Busschbach JJ. et al. Quality of life after infrainguinal bypass grafting surgery. Dutch Bypass Oral Anticoagulants or Aspirin (BOA) Study Group. J Vasc Surg 1999; 29: 913-919.
- 28 Hirsch AT, Haskal ZJ, Hertzer NR. et al. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation 2006; 113: e463-654.
- 29 Van Hattum ES, Tangelder MJ, Huisin’t Veld MA. et al. Medical treatment after peripheral bypass surgery over the past decade. Eur J Vasc Endovasc Surg 2011; 41: 805-813.
- 30 Cacoub PP, Abola MT, Baumgartner l. et al. Cardiovascular risk factor control and outcomes in peripheral artery disease patients in the Reduction of Atherothrombosis for Continued Health (REACH) Registry. Atherosclerosis 2009; 204: e86-92.
- 31 Feringa HH, Bax JJ, Hoeks S. et al. A prognostic risk index for long-term mortality in patients with peripheral arterial disease. Arch Intern Med 2007; 167: 2482-2489.
- 32 Rutherford RB, Baker JD, Ernst C. et al. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg 1997; 26: 517-538.
- 33 van Swieten JC, Koudstaal PJ, Visser MC. et al. Interobserver agreement for the assessment of handicap in stroke patients. Stroke 1988; 19: 604-607.
- 34 Halkes PH, van Gijn J, Kappelle LJ. et al. Classification of cause of death after stroke in clinical research. Stroke 2006; 37: 1521-1524.
- 35 Schulman S, Kearon C. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in nonsurgical patients. J Thromb Haemost 2005; 03: 692-694.