Impact of critical limb ischemia on long-term cardiac mortality in diabetic patients undergoing percutaneous coronary revascularization

Francesco Liistro, Paolo Angioli, Simone Grotti, Rossella Brandini, Italo Porto, Lucia Ricci, Danilo Tacconi, Kenneth Ducci, Giovanni Falsini, Guido Bellandi, Leonardo Bolognese, Francesco Liistro, Paolo Angioli, Simone Grotti, Rossella Brandini, Italo Porto, Lucia Ricci, Danilo Tacconi, Kenneth Ducci, Giovanni Falsini, Guido Bellandi, Leonardo Bolognese

Abstract

Objective: Development of critical limb ischemia (CLI) has been reported as an independent predictor of cardiac mortality in diabetic patients. We aimed to determine whether CLI, managed in a structured setting of close collaboration between different vascular specialists and treated with early endovascular intervention, has any impact on long-term cardiac mortality of diabetic patients initially presenting with symptomatic coronary artery disease (CAD).

Research design and methods: We designed a prospective observational study of 764 consecutive diabetic patients undergoing percutaneous coronary intervention (PCI) in whom development of CLI was assessed by a dedicated diabetic foot clinic. Cardiac mortality at 4-year follow-up was the primary end point of the study.

Results: Among the 764 patients, 111 (14%) developed CLI (PCI-CLI group) and underwent revascularization of 145 limbs, with procedural success in 140 (96%). PCI-CLI patients at baseline had lower left ventricular ejection fraction (51 ± 11% vs. 53 ± 10%, P = 0.008), higher prevalence of dialysis (7% vs. 0.3%, P < 0.0001), and longer diabetes duration (13 ± 8 vs. 11 ± 7 years, P = 0.02) compared with PCI-only patients. At 4-year follow-up, cardiac mortality occurred in 10 (9%) PCI-CLI patients vs. 42 (6%) PCI-only patients (P = 0.2). Time-dependent Cox regression model for cardiac death revealed that CLI was not associated with an increased risk of cardiac mortality (hazard ratio 1.08 [95% CI 0.89-3.85]; P = 0.1).

Conclusions: The development of promptly assessed and aggressively treated CLI was not significantly associated with increased risk of long-term cardiac mortality in diabetic patients initially presenting with symptomatic CAD.

Trial registration: ClinicalTrials.gov NCT01676519.

Figures

Figure 1
Figure 1
Cox survival model for total mortality and cardiac mortality at 4-year follow-up in the overall study population.
Figure 2
Figure 2
Time-sensitive Cox proportional hazard regression model for independent predictors of cardiac death at 4-year follow-up in the overall study population. HR is reported with relative 95% CI. LVEF, left ventricular ejection fraction.

References

    1. Creager MA, Lüscher TF, Cosentino F, Beckman JA. Diabetes and vascular disease: pathophysiology, clinical consequences, and medical therapy: Part I. Circulation 2003;108:1527–1532
    1. Lüscher TF, Creager MA, Beckman JA, Cosentino F. Diabetes and vascular disease: pathophysiology, clinical consequences, and medical therapy: Part II. Circulation 2003;108:1655–1661
    1. Franco OH, Steyerberg EW, Hu FB, Mackenbach J, Nusselder W. Associations of diabetes mellitus with total life expectancy and life expectancy with and without cardiovascular disease. Arch Intern Med 2007;167:1145–1151
    1. Gu K, Cowie CC, Harris MI. Mortality in adults with and without diabetes in a national cohort of the U.S. population, 1971-1993. Diabetes Care 1998;21:1138–1145
    1. Hackam DG, Tan MK, Honos GN, Leiter LA, Langer A, Goodman SG, Vascular Protection registry investigators How does the prognosis of diabetes compare with that of established vascular disease? Insights from the Canadian Vascular Protection (VP) Registry. Am Heart J 2004;148:1028–1033
    1. Resnick HE, Valsania P, Phillips CL. Diabetes mellitus and nontraumatic lower extremity amputation in black and white Americans: the National Health and Nutrition Examination Survey Epidemiologic Follow-up Study, 1971-1992. Arch Intern Med 1999;159:2470–2475
    1. 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
    1. Uccioli L, Gandini R, Giurato L, et al. Long-term outcomes of diabetic patients with critical limb ischemia followed in a tertiary referral diabetic foot clinic. Diabetes Care 2010;33:977–982
    1. Schofield CJ, Libby G, Brennan GM, MacAlpine RR, Morris AD, Leese GP, DARTS/MEMO Collaboration Mortality and hospitalization in patients after amputation: a comparison between patients with and without diabetes. Diabetes Care 2006;29:2252–2256
    1. Resnick HE, Carter EA, Lindsay R, et al. Relation of lower-extremity amputation to all-cause and cardiovascular disease mortality in American Indians: the Strong Heart Study. Diabetes Care 2004;27:1286–1293
    1. Norman PE, Davis WA, Bruce DG, Davis TM. Peripheral arterial disease and risk of cardiac death in type 2 diabetes: the Fremantle Diabetes Study. Diabetes Care 2006;29:575–580
    1. Leibson CL, Ransom JE, Olson W, Zimmerman BR, O’fallon WM, Palumbo PJ. Peripheral arterial disease, diabetes, and mortality. Diabetes Care 2004;27:2843–2849
    1. Hambleton IR, Jonnalagadda R, Davis CR, Fraser HS, Chaturvedi N, Hennis AJ. All-cause mortality after diabetes-related amputation in Barbados: a prospective case-control study. Diabetes Care 2009;32:306–307
    1. Flu HC, Lardenoye JH, Veen EJ, Aquarius AE, Van Berge Henegouwen DP, Hamming JF. Morbidity and mortality caused by cardiac adverse events after revascularization for critical limb ischemia. Ann Vasc Surg 2009;23:583–597
    1. Faglia E, Clerici G, Clerissi J, et al. Early and five-year amputation and survival rate of diabetic patients with critical limb ischemia: data of a cohort study of 564 patients. Eur J Vasc Endovasc Surg 2006;32:484–490
    1. de Virgilio C, Toosie K, Lewis RJ, et al. Cardiac morbidity and operative mortality following lower-extremity amputation: the significance of multiple Eagle criteria. Ann Vasc Surg 1999;13:204–208
    1. Belmont PJ, Jr, Davey S, Orr JD, Ochoa LM, Bader JO, Schoenfeld AJ. Risk factors for 30-day postoperative complications and mortality after below-knee amputation: a study of 2,911 patients from the national surgical quality improvement program. J Am Coll Surg 2011;213:370–378
    1. Criqui MH, Denenberg JO. The generalized nature of atherosclerosis: how peripheral arterial disease may predict adverse events from coronary artery disease. Vasc Med 1998;3:241–245
    1. Saw J, Bhatt DL, Moliterno DJ, et al. The influence of peripheral arterial disease on outcomes: a pooled analysis of mortality in eight large randomized percutaneous coronary intervention trials. J Am Coll Cardiol 2006;48:1567–1572
    1. Eagle KA, Rihal CS, Foster ED, Mickel MC, Gersh BJ, The Coronary Artery Surgery Study (CASS) Investigators Long-term survival in patients with coronary artery disease: importance of peripheral vascular disease. J Am Coll Cardiol 1994;23:1091–1095
    1. Liistro F, Grotti S, Venturuzzo G, et al. [Clinical outcome of percutaneous revascularization by stent-assisted balloon angioplasty of femoro-popliteal and tibial vessels in diabetic patients with critical limb ischemia]. Italian. G Ital Cardiol (Rome) 2009;10:713–717
    1. Oyibo SO, Jude EB, Tarawneh I, Nguyen HC, Harkless LB, Boulton AJ. A comparison of two diabetic foot ulcer classification systems: the Wagner and the University of Texas wound classification systems. Diabetes Care 2001;24:84–88
    1. Mauri L, Hsieh WH, Massaro JM, Ho KK, D’Agostino R, Cutlip DE. Stent thrombosis in randomized clinical trials of drug-eluting stents. N Engl J Med 2007;356:1020–1029
    1. Goldfine AB, Fonseca V. Management of diabetes mellitus in patients with cardiovascular disease in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial. Circulation 2010;121:2447–2449
    1. Ghanassia E, Villon L, Thuan Dit Dieudonné JF, Boegner C, Avignon A, Sultan A. Long-term outcome and disability of diabetic patients hospitalized for diabetic foot ulcers: a 6.5-year follow-up study. Diabetes Care 2008;31:1288–1292
    1. McDermott MM, Hahn EA, Greenland P, et al. Atherosclerotic risk factor reduction in peripheral arterial disease: results of a national physician survey. J Gen Intern Med 2002;17:895–904
    1. McDermott MM, Mehta S, Ahn H, Greenland P. Atherosclerotic risk factors are less intensively treated in patients with peripheral arterial disease than in patients with coronary artery disease. J Gen Intern Med 1997;12:209–215
    1. Hirsch AT, Criqui MH, Treat-Jacobson D, et al. Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA 2001;286:1317–1324
    1. Conte MS, Bandyk DF, Clowes AW, Moneta GL, Namini H, Seely L. Risk factors, medical therapies and perioperative events in limb salvage surgery: observations from the PREVENT III multicenter trial. J Vasc Surg 2005;42:456–464; discussion 464–465
    1. Schanzer A, Hevelone N, Owens CD, Beckman JA, Belkin M, Conte MS. Statins are independently associated with reduced mortality in patients undergoing infrainguinal bypass graft surgery for critical limb ischemia. J Vasc Surg 2008;47:774–781
    1. Faglia E, Clerici G, Caminiti M, Quarantiello A, Curci V, Morabito A. Advantages of myocardial revascularization after admission for critical limb ischemia in diabetic patients with coronary artery disease: data of a cohort of 564 consecutive patients. J Cardiovasc Med (Hagerstown) 2008;9:1030–1036
    1. Bundó Vidiella M, Pérez Pérez C, Montero Alia JJ, Cobos Solórzano MD, Aubà Llambrich J, Cabezas Peña C. [Peripheral artery disease of the lower limbs and morbidity/mortality in type 2 diabetics]. Aten Primaria 2006;38:139–144
    1. Cassar A, Poldermans D, Rihal CS, Gersh BJ. The management of combined coronary artery disease and peripheral vascular disease. Eur Heart J 2010;31:1565–1572
    1. Schwartz L, Bertolet M, Feit F, et al. Impact of completeness of revascularization on long-term cardiovascular outcomes in patients with type 2 diabetes mellitus: results from the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D). Circ Cardiovasc Interv 2012;5:166–173
    1. Murcia AM, Hennekens CH, Lamas GA, et al. Impact of diabetes on mortality in patients with myocardial infarction and left ventricular dysfunction. Arch Intern Med 2004;164:2273–2279
    1. Boudina S, Abel ED. Diabetic cardiomyopathy revisited. Circulation 2007;115:3213–3223
    1. Koch M, Trapp R, Kulas W, Grabensee B. Critical limb ischaemia as a main cause of death in patients with end-stage renal disease: a single-centre study. Nephrol Dial Transplant 2004;19:2547–2552
    1. Laiteerapong N, Karter AJ, Liu JY, et al. Correlates of quality of life in older adults with diabetes: the diabetes & aging study. Diabetes Care 2011;34:1749–1753

Source: PubMed

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