Esiti del trattamento con Esiti del trattamento con angioplastica transluminale angioplastica transluminale

percutanea (PTA) agli arti inferiori percutanea (PTA) agli arti inferiori nei pazienti diabetici in trattamento nei pazienti diabetici in trattamento

dialitico con ischemia critica dialitico con ischemia critica dell’artodell’arto

Dr. Marco Meloni

Dipartimento di Medicina Interna

Università degli Studi di Roma Tor Vergata

Peripheral arterial Peripheral arterial diseasedisease

Diabetes and chronic Diabetes and chronic kidney disease are kidney disease are strong risk factors for strong risk factors for peripheral arterial peripheral arterial disease (PAD)disease (PAD)

The prevalence of The prevalence of PAD among patients PAD among patients with end stage renal with end stage renal disease (ESRD) has disease (ESRD) has been reported in up been reported in up to 77% to 77% Scheiffer T. et al J Diabetes

Compl 1998

Peripheral arterial Peripheral arterial diseasedisease

Uraemia has a strong impact on endothelial function and passive properties of the

arterial wall

ESRD is a strong risk factor for both ulceration and amputation in diabetic patientsLuksha N. et Al, Clinical

Science 2011

Impaired resistance artery Impaired resistance artery function in patientsfunction in patients

with end-stage renal diseasewith end-stage renal disease Flow mediated Flow mediated

dilatation is dilatation is attenued in ESRD attenued in ESRD patientspatients

Dilatation in Dilatation in response to response to acetylcholine was acetylcholine was reducedreduced

Luksha N. et Al, Clinical Science 2011

RevascularizationRevascularization

recent data indicate that by proper selection, favourable results can be obtained even in ESRD patients, with the majority of studies reporting 1-year limb salvage rates of 65–75% after revascularization among survivors. High 1-year mortality of 38% is reported in a recent review has to be taken into considerationTypically, half of the patients are reported to lose their legs despite open bypass.

Is PTA a right approach Is PTA a right approach in diabetic patients with in diabetic patients with

ESRD?ESRD?The aim of our study is to assess The aim of our study is to assess the outcomes after percutaneus the outcomes after percutaneus transluminal angioplasty (PTA) transluminal angioplasty (PTA) in diabetic patients with ESRD in diabetic patients with ESRD

and PAD. and PAD.

Materials and methodsMaterials and methods

456 patients (292 M, 164 W) were 456 patients (292 M, 164 W) were enrolledenrolled

They presented diabetes, peripheral They presented diabetes, peripheral arterial disease complicated by critical arterial disease complicated by critical limb ischaemia (CLI) and diabetic foot limb ischaemia (CLI) and diabetic foot lesionslesions

Follow-up: 12 monthsFollow-up: 12 months

Materials and methodsMaterials and methods

Each patient was assessed for:Each patient was assessed for:- diabetes, diabetes complications and other diabetes, diabetes complications and other

risk factors and were divided in two risk factors and were divided in two groups according to the presence of groups according to the presence of dyalisis treatement :dyalisis treatement :

patients with ESRD (ESRD +) (n=60)patients with ESRD (ESRD +) (n=60)

patients without ESRD (ESRD -) (n=396)patients without ESRD (ESRD -) (n=396)

- Lesion features: dimension, deep, infection - Lesion features: dimension, deep, infection according to Texas wound classificationaccording to Texas wound classification

Materials and methodsMaterials and methods Every patients performed morfological Every patients performed morfological

evaluation before PTA: US color duplex evaluation before PTA: US color duplex scan or CT or MR angiography based on scan or CT or MR angiography based on the renal function, in order to establish the renal function, in order to establish the road map during the the road map during the revascularizationrevascularization

All patients were routinaly on double All patients were routinaly on double antiplatelet therapy (cardioaspirin plus antiplatelet therapy (cardioaspirin plus clopidogrel) before PTA and for one clopidogrel) before PTA and for one month after.month after.

Materials and methodsMaterials and methods

Primary endpoint (at 12 months): Primary endpoint (at 12 months): - Alive without major amputation Alive without major amputation - Alive with major amputationAlive with major amputation- DeathDeath

Secondary endpoint :Secondary endpoint :- Analyses of patients who needed Re-Analyses of patients who needed Re-

PTAPTA- Outcomes after Re-PTAOutcomes after Re-PTA

PTA in 396 no ESRD PTA in 396 no ESRD diabetic patientsdiabetic patients

77.6 %

11,5%

10,9%

Outcomes 12 months

PTA in 60 ESRD PTA in 60 ESRD diabetic patientsdiabetic patients

60%

21.7%

18.3%

Outcomes 12 months

Re-pta and radiological Re-pta and radiological outcomesoutcomes

0102030405060708090

100

Re-PTA Rad. Outc.

ESRD +

ESRD -

* 0.043

* 0.01

ConclusionsConclusions Diabetes and Chronic Kidney disease are Diabetes and Chronic Kidney disease are

two strong risk factor for PADtwo strong risk factor for PAD

ESRD is a strong risk factor for both ESRD is a strong risk factor for both ulceration and amputation in diabetic ulceration and amputation in diabetic patientspatients

PAD and ESRD increase the risk of PAD and ESRD increase the risk of hospitalisation, treatment failure and hospitalisation, treatment failure and deathdeath

ConclusionsConclusions Lower limbs revascularization in Lower limbs revascularization in

diabetic patients with ESRD has a diabetic patients with ESRD has a low success due to difficulty to treat low success due to difficulty to treat steno-obstructions, high risk of steno-obstructions, high risk of infections, poor healing and deathinfections, poor healing and death

Several studies have poor evidence Several studies have poor evidence on effectiveness of PTA treatment in on effectiveness of PTA treatment in diabetic patients with ESRDdiabetic patients with ESRD

ConclusionsConclusions

In our study PTA allows a limbs salvage In our study PTA allows a limbs salvage no different from results obtained with no different from results obtained with by-pass but in unselected patients and by-pass but in unselected patients and with a reduced 1-year mortality (22% vs with a reduced 1-year mortality (22% vs 38%)38%)

Our data, after comparative evaluation, Our data, after comparative evaluation, support PTA as first approach for support PTA as first approach for treatment of PAD in patients with treatment of PAD in patients with diabetes and ESRDdiabetes and ESRD