To report a 5-year observational parallel group study comparing the effectiveness of subintimal angioplasty (SIA) to bypass grafting (BG) for treatment of TASC II type C/D lesions in the lower limb arteries of patients with critical limb ischemia (CLI).
Methods:
Of 1076 patients referred with PVD from 2002 to 2007, 206 SIAs in 190 patients (104 women; mean age 73±13 years) and 128 bypass grafts in 119 patients (77 men; mean age 70±14 years) were enrolled in the study. All patients had Rutherford classification 4–6 ischemia manifested as rest pain and/or tissue loss. Primary endpoints were (1) survival free from amputation and (2) sustained clinical improvement [+2 Rutherford category and/or ABI increase >0.15 without target lesion revascularization (TLR)]. Secondary endpoints were major adverse events (MAE), the binary restenosis rate, freedom from TLR, and a special quality-adjusted life year (QALY) endpoint (Q-TWiST) that incorporated both length and quality of life to evaluate treatments. A cost analysis was also performed.
Results:
At 5 years, clinical improvement was sustained in 82.8% of the SIA group versus 68.2% of the BG patients (p=0.106). Five-year all-cause survival was similar for SIA (78.6%) and BG (80.1%; p=0.734), as was amputation-free survival (SIA 72.9% versus BG 71.2%; p=0.976). Hyperfibrinogenemia (p=0.009) and C-reactive protein (p=0.019) had negative effects on survival without amputation. Five-year freedom from binary restenosis rates were 72.8% for SIA versus 65.3% for BG (p=0.700). While the 5-year freedom from TLR rates (SIA 85.9% versus BS 72.1%, p=0.262) were not statistically significant, the risk of MAE (p<0.002) and length of hospital stay (p<0.0001) were significantly reduced in the SIA group. Q-TWiST significantly improved (p<0.001) and cost-per-QALY (SIA €5663 versus BG €9172, p<0.002) was reduced with SIA. The 5-year risk of re-intervention (p>0.05) and mean number of procedures (p=0.078) were similar.
Conclusion:
Five-year freedom from MAE was enhanced by 20% in the SIA group, with substantial cost reduction and better Q-TWiST. SIA is a minimally invasive technique that expands amputation-free and symptom-free survival. SIA is poised to bring about a paradigm shift in the management of CLI.
NorgrenLHiattWRDormandyJA. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007;45Suppl S:S5–67.
2.
SultanSHynesN.Recent trends in the management of peripheral vascular disease in high risk patients. Diabetes Wise. 2006;3(2):15–19.
3.
HynesNSultanS.The influence of subintimal angioplasty on level of amputation and limb salvage rates in lower limb critical ischaemia: a 15-year experience. Eur J Vasc Endovasc Surg. 2005;30:291–299.
4.
FowkesFLengGC. Bypass surgery for chronic lower limb ischemia. Cochrane Database Syst Rev. 2008;(2):CD002000.
5.
SultanSHynesN.Recent trends in the management of peripheral vascular disease in high risk patients. Heart Wise. 2007;10(2):21–25.
6.
KhanSMBeardJD. Management of critical leg ischaemia and quality of life. In: EarnshawJJMurieJA, eds. The Evidence for Vascular Surgery. Shropshire, UK: TFM Publishing Ltd; 2007:73–79.
7.
HynesNAkhtarYManningB. Subintimal angioplasty as a primary modality in the management of critical limb ischemia: comparison to bypass grafting for aortoiliac and femoropopliteal occlusive disease. J Endovasc Ther. 2004;11:460–471.
8.
AkessonMRivaLIvancevK. Subintimal angioplasty of infrainguinal arterial occlusions for critical limb ischemia: long-term patency and clinical efficacy. J Endovasc Ther. 2007;14:444–451.
9.
LazarisAMTsiamisACFishwickG. Clinical outcome of primary infrainguinal subintimal angioplasty in diabetic patients with critical lower limb ischemia. J Endovasc Ther. 2004;11:447–453.
10.
RutherfordRBBakerJDErnstC. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997;26:517–538.
11.
OaikhinanKSultanS.An observational parallel group comparative study with and without the “Magic Bullet” (MB: Aspirin, cardio selective beta-blocker, pravastatin and clopidogrel) in the peri-operative and postoperative period for abdominal aortic aneurysms surgery and femoral-popliteal segment revascularisation. Does the “Magic Bullet” improve the 30-day morbidity and mortality outcome?Br J Surg. 2004;91:113–114.
12.
DiehmNBaumgartnerIJaffM. A call for uniform reporting standards in studies assessing endovascular treatment for chronic ischaemia of lower limb arteries. Eur Heart J.2007;28:798–805.
13.
GelberRDGelmanRSGoldhirshA.A quality-of-life-orientated endpoint for comparing therapies. Biometrics. 1989;45:781–795.
14.
BrothersTERobisonJGElliottBM. Prospective decision analysis for peripheral vascular disease predicts future quality of life. J Vasc Surg. 2007;46:701–708.
15.
HynesNSultanS.A prospective clinical, economic, and quality-of-life analysis comparing endovascular aneurysm repair (EVAR), open repair, and best medical treatment in high-risk patients with abdominal aortic aneurysms suitable for EVAR: the Irish patient trial. J Endovasc Ther. 2007;14:763–776.
16.
LoweryAJHynesNSultanS.A prospective feasibility study of duplex ultrasound arterial mapping, digital-subtraction angiography, and magnetic resonance angiography in management of critical lower limb ischemia by endovascular revascularization. Ann Vasc Surg. 2007;21:443–451.
17.
MarksNAAscherEHingoraniAP. Grayscale median of the atherosclerotic plaque can predict success of lumen re-entry during subintimal femoral-popliteal angioplasty. J Vasc Surg. 2008;47:109–115.
18.
JämsénTManninenHTullaH. The final outcome of primary infrainguinal percutaneous transluminal angioplasty in 100 consecutive patients with chronic critical limb ischemia. J Vasc Interv Radiol. 2002;13:455–463.
19.
KudoTChandraFAAhnSS. The effectiveness of percutaneous transluminal angioplasty for the treatment of critical limb ischemia: a 10-year experience. J Vasc Surg. 2005;41:423–435.
20.
DeRubertisBGPierceMChaerRA. Lesion severity and treatment complexity are associated with outcome after percutaneous infrainguinal intervention. J Vasc Surg. 2007;46:709–716.
21.
DeRubertisBGPierceMRyerEJ. Reduced primary patency rate in diabetic patients after percutaneous intervention results from more frequent presentation with limb threatening ischemia. J Vasc Surg. 2008;47:101–108.
22.
RodgersGMKaneWH. Activation of endogenous factor V by a homocysteine-induced vascular endothelial cell activator. J Clin Invest. 1986;77:1909–1916.
23.
FryerRHWilsonBDGublerDB. Homocysteine, a risk factor for premature vascular disease and thrombosis, induces tissue factor activity in endothelial cells. Arterioscler Thromb. 1993;13:1327–1333.
24.
TsaiJCPerrellaMAYoshizumiM. Promotion of vascular smooth muscle cell growth by homocysteine: a link to atherosclerosis. Proc Natl Acad Sci USA. 1994;91:6369–6373.
25.
HeneghanHMSultanS.Homocysteine, the cholesterol of the 21st century. Impact of hyperhomocysteinemia on patency and amputation-free survival after intervention for critical limb ischemia. J Endovasc Ther. 2008;15:399–407.
26.
SchnyderGRoffiMPinR. Decreased rate of coronary restenosis after lowering of plasma homocysteine levels. N Engl J Med. 2001;345:1593–1600.
27.
LaxdalEWirschingJPedersenG. Homocysteine levels, haemostatic risk factors and patency rates after endovascular treatment of the common iliac arteries. Eur J Vasc Endovasc Surg. 2006;31:244–250.
28.
HerrmannW.Homocysteine research: alive and kicking. Clin Chem Lab Med. 2007;45:1571–1574.
29.
IhnatDMDuongSTTaylorZC. Contemporary outcomes after superficial femoral artery angioplasty and stenting: the influence of TASC classification and runoff score. J Vasc Surg. 2008;47:967–974.
30.
TawfickWSultanS.Tibial balloon angioplasty (TBA) vs cool excimer laser assisted angioplasty (CELA) in management of infragenicular tibial arterial occlusion in critical lower limb ischaemia (CLI): An observational parallel group comparative study. J Cardiovasc Surg (Torino). 2008;49:S22–23.
31.
LazarisAMSalasCTsiamisAC. Factors affecting patency of subintimal infrainguinal angioplasty in patients with critical lower limb ischemia. Eur J Vasc Endovasc Surg. 2006;32:668–674.
32.
CejnaMTurnherSIlliaschH. PTA versus Palmaz stent in femoropopliteal artery obstructions: a multicenter prospective randomized study. J Vasc Interv Radiol. 2001;12:23–31.
33.
GrimmJMuller-HulsbeckSJahnkeT. Randomized study to compare PTA alone versus Palmaz stent placement for femoropopliteal lesions. J Vasc Interv Radiol. 2001;12:935–942.
34.
BecqueminJPFavreJPMarzelleJ. Systematic versus selective stent placement after superficial femoral artery balloon angioplasty: a multicenter prospective randomized study. J Vasc Surg. 2003;37:487–494.
35.
NishinoMHoshidaSKatoH. Preprocedural statin administration can reduce thrombotic reaction after stent implantation. Circ J.2008;72:232–237.
36.
SchillingerMExnerMMlekuschW. Fibrinogen predicts restenosis after endovascular treatment of the iliac arteries. Thromb Haemost. 2002;87:959–965.
37.
OtsukaMHayashiYUedaH. Predictive value of preprocedural fibrinogen concerning coronary stenting. Atherosclerosis. 2002;164:371–378.
38.
JasterMHorstkotteDWillichT. The amount of fibrinogen-positive platelets predicts the occurrence of in-stent restenosis. Atherosclerosis. 2008;197:190–196.
39.
KomatsuRUedaMNarukoT. Neointimal tissue response at sites of coronary stenting in humans: macroscopic, histological, and immunohistochemical analyses. Circulation. 1998;98:224–233.
40.
CutlipDE. Stent thrombosis: historical perspectives and current trends. J Thromb Thrombolysis. 2000;10:89–101.
41.
TaylorSMKalbaughCABlackhurstDW. Determinants of functional outcome after revascularization for critical limb ischemia: An analysis of 1000 consecutive vascular interventions. J Vasc Surg. 2006;44:747–756.
42.
GoshimaKRMillJLHughesJD. A new look at outcomes after infrainguinal bypass surgery: traditional reporting standards systematically underestimate the expenditure of effort required to attain limb salvage. J Vasc Surg. 2004;39:330–335.
43.
ChungJBartelsonBBHiattWR. Wound healing and functional outcomes after infrainguinal bypass with reversed saphenous vein for critical limb ischemia. J Vasc Surg. 2006;43:1183–1190.
44.
NehlerMRMcDermottMMTreat-JacobsonD. Functional outcomes and quality of life in peripheral arterial disease: current status. Vasc Med. 2003;8:115–126.
O'Brien-IrrMSHarrisLMDosluogluHH. Lower extremity endovascular interventions: can we improve cost-efficiency?J Vasc Surg. 2008;47:982–987.
47.
JansenRMde VriesSOCullenKA. Cost-identification analysis of revascularization procedures on patients with peripheral arterial occlusive disease. J Vasc Surg. 1998;28:617–623.
48.
Janne d'OthéeBLangdonDRBellGK. Operating expenses for the diagnosis and treatment of peripheral vascular disease in an academic interventional radiology department: cost calculations according to a microeconomic method. J Vasc Interv Radiol. 2006;17:85–94.
49.
Janne d'OthéeBMorrisMFPowellRJ. Cost determinants of percutaneous and surgical interventions for treatment of intermittent claudication from the perspective of the hospital. Cardiovasc Intervent Radiol. 2008;31:56–65.
50.
StonerMCdeFreitasDJPhadeSV. Midterm results with laser atherectomy in the treatment of infrainguinal occlusive disease. J Vasc Surg. 2007;46:289–295.
