Nitinol Stent Implantation vs. Balloon Angioplasty for Lesions in the Superficial Femoral and Proximal Popliteal Arteries of Patients With Claudication: Three-Year Follow-up From the RESILIENT Randomized Trial

Laird, John R.; Katzen, Barry T.; Scheinert, Dierk; Lämmer, Johannes; Carpenter, Jeffrey P.; Buchbinder, Maurice; Davé, Rajesh; Ansel, Gary M.; Lansky, Alexandra J.; Cristea, Ecaterina; Collins, Tyrone J.; Goldstein, Jeffrey A.; Cao, Annie Y.; Jaff, Michael R.

doi:10.1583/11-3627.1

Cited by 274 publications

(199 citation statements)

References 27 publications

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“…To date, there remains no clear-cut de facto gold therapy for endovascular applications in the lower limb with the best outcomes that we can apply to most if not all our patients who present with symptomatic lower limb disease (Table). Current data from numerous trials at various lengths of outcome duration (ranging from 12 to 60 months) [2][3][4][5][6][7][8][9][10][11][12][13] have shown that there remains a consistent but steady decline in primary patency with all devices over time. There has been a robust interest in what should be the default therapy for lower extremity disease.…”

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confidence: 99%

Endovascular Therapy for Femoropopliteal Disease: Drug-Eluting Stents Are Not the Default Therapy

Garcia

2016

Circulation

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confidence: 99%

Endovascular Therapy for Femoropopliteal Disease: Drug-Eluting Stents Are Not the Default Therapy

Garcia

2016

Circulation

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“…The reduced need for stenting has distinct advantages. Although stenting improves patency compared with PTA, [18][19][20][21] TLR rate has remained high on follow-up ranging from 19 to 37% 18,19,22,23 at 1 year and up to 49% at 2 years. 20 The main mechanism of reducing restenosis with stenting is the reduction of elastic recoil and negative remodeling with no impact on SMC proliferation.…”

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confidence: 99%

An Overview of Optimal Endovascular Strategy in Treating the Femoropopliteal Artery: Mechanical, Biological, and Procedural Factors

Shammas¹

2013

Int J Angiol

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ReviewPeripheral arterial disease is highly prevalent in the general population affecting 12 to 14% of people and leading to claudication or threatened limb ischemia. 1 Endovascular lower extremity arterial interventions have increased exponentially over the past decade. 2 The femoropopliteal (FP) segment represents 40% of vessels treated and its treatment continues to be a challenge to the endovascular specialist. Despite a high rate of acute procedural success, target lesion revascularization (TLR) and target vessel revascularization remain elevated. 3,4 We have previously proposed a triad of optimal peripheral vascular revascularization strategy (►Fig. 1) 5 with an emphasis on three key principles: (1) Mechanical, improve vessel compliance to allow dilatation of a stenotic segment at low balloon inflation pressure and reduce dissection and recoil. Low balloon inflation pressure would theoretically preserve vessel integrity by minimizing barotrauma and bailout stenting. (2) Biological, inhibit smooth muscle cell (SMC) proliferation to improve patency rates and reduce repeat revascularization. (3) Procedural, preserve the outflow vessels by minimizing distal embolization (DE) and reduce procedural time and radiation exposure to both operator and patient.In this overview, we examine these principles to determine whether current data support their validity. We recognize the lack of uniform performance criteria and reporting standards in clinical trials in peripheral arterial disease. This unfortunately makes comparisons across studies difficult. Mechanical FactorsThe concept of improving vessel compliance as a prerequisite to a more definitive treatment of the FP artery has gained more attention over the past few years. Measurement of vessel compliance in vivo is difficult to obtain. One surrogate endpoint is the minimum balloon pressure (MBP) needed to fully stretch the artery to a lumen diameter equal to a normal reference segment with the use of a noncompliant balloon sized 1:1 to the reference vessel. The balloon is typically inflated to two atmospheres then the inflation pressure is increased by increment of one atmosphere at a time until full balloon expansion is achieved. 6,7 According to Laplace's law, tension (T) in the vessel wall is equal to (pressure (P) gradient across the arterial wall * radius (R) of artery)/wall thickening (M), or (T¼ [P * R]/M). In order for MBP change to reflect on compliance, the segments under comparison need to have similar radius and lesion Keywords AbstractTreatment of the femoropopliteal (FP) artery remains a challenge to the endovascular specialist. Long-term patency is low with a high rate of target lesion revascularization. The true patency rate varies considerably between studies partly because there is a lack of uniform performance criteria and reporting standards in peripheral arterial interventions. Literature review supports three principles that emerge as important components of an optimal strategy in treating the FP artery: (1) improving vessel compliance and sub...

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“…Based on a systematic literature review of clinical measures 17 , 12 publications including registries and clinical trials were used to estimate the TLR rates associated with each endovascular procedure studied [19][20][21][22][23][24][25][26][27][28][29]. More detailed information about TLR probabilities indicated in each study is shown in Table 3.…”

Section: Resultsmentioning

confidence: 99%

An analysis of the economic impact of drug-coated balloon use for the treatment of peripheral artery disease

Micari

Vadalà

Corbo

et al. 2015

ICFJ

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Background: Drug-coated balloons (DCBs) are an alternative for patients with peripheral arterial disease. Costs and re-intervention rates are potentially reduced compared to other technologies. We assessed the economic impact of these endovascular therapies.Methods: An Italian National Healthcare Service-perspective budget impact model with a 5-year horizon was developed to compare relative costs of 4 index procedures (plain old balloon angioplasty (POBA), DCBs, and bare-metal and drug-eluting stents (BMSs, DESs)) based on 1-year repeat-procedure rates (target-lesion revascularization (TLR)). A published systematic review of TLR rates in patients with femoral-popliteal disease undergoing these treatments was used to measure effectiveness. Costs associated with each treatment were derived from diagnosis-related group tariffs. A decision analytic model was developed to estimate 1-year costs for index procedures and possible revascularizations. Results: Pooled TLR rates show clear patient benefits for DCBs (6.9%) compared with POBA (21.6%) and BMSs (14.2%) and non-inferiority vs. DESs (7.3%). One-year payments for index and repeat interventions (by TLR rate) showed that DCBs were the least costly strategy, saving ~€1,000/patient vs. POBA. The potential savings were €8.7M, assuming 5% annual increase in DCB adoption over 5 years. Conclusions: Despite initial higher investment, DCB represent a cost-saving alternative to other technologies.

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Nitinol Stent Implantation vs. Balloon Angioplasty for Lesions in the Superficial Femoral and Proximal Popliteal Arteries of Patients With Claudication: Three-Year Follow-up From the RESILIENT Randomized Trial

Abstract: In this multicenter trial, primary implantation of a nitinol stent for moderate-length lesions in the femoropopliteal segment of patients with claudication was associated with better long-term results vs. balloon angioplasty alone.

Cited by 274 publications

References 27 publications

Endovascular Therapy for Femoropopliteal Disease: Drug-Eluting Stents Are Not the Default Therapy

Endovascular Therapy for Femoropopliteal Disease: Drug-Eluting Stents Are Not the Default Therapy

An Overview of Optimal Endovascular Strategy in Treating the Femoropopliteal Artery: Mechanical, Biological, and Procedural Factors

An analysis of the economic impact of drug-coated balloon use for the treatment of peripheral artery disease

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