Superficial Femoral Artery Disease Research Articles

Nitinol Self-Expanding Stents for the Treatment of Obstructive Superficial Femoral Artery Disease: Three-Year Results of the RELIABLE Japanese Multicenter Study.

Objective: To assess the use of a nitinol stent to treat symptomatic stenoses or occlusions of the native superficial femoral artery (SFA).Materials and Methods: Seventy-four patients were treated at 12 Japanese sites. The primary endpoint, freedom from target-limb failure (TLF), was a composite of device- or procedure-related death, target-limb amputation, target-vessel revascularization (TVR), or restenosis compared to an objective performance goal (OPG) at 12 months. Secondary endpoints, including primary patency, freedom from TVR/target-lesion revascularization (TLR), improvements in clinical parameters, and major adverse events (MAEs) were evaluated through 36 months.Results: The mean overall lesion length was 80.7±38.9 mm (mean stented length: 98.8±46.1 mm). Freedom from TLF was 81.2% (p<0.001 compared to OPG) with a Kaplan–Meier estimate of 84.2% [95% confidence interval (95%CI) 73.3%, 90.9%] at 12 months. Primary patency was 71.0% at 12 months and 67.8% at 36 months. A total of 94.7% of patients improved by at least one Rutherford category and 70.2% of patients improved ankle–brachial indices ≧0.10 from baseline to 36 months. Freedom from TVR/TLR (Kaplan–Meier) was 90% at 12 months and 79.5% at 36 months. Four MAEs were reported; none were found to be device or procedure related.Conclusion: A self-expanding stent was used safely to treat stenotic and occlusive lesions of the SFA in a Japanese patient population. The composite endpoint, freedom from TLF, was superior to an historical control at one year, with low rates of revascularization and good functional and clinical outcomes through three years.

TCT-778 Impact of ticagrelor and aspirin versus clopidogrel and aspirin in symptomatic patients with peripheral arterial disease: Thrombus burden assessed by optical coherence tomography

To compare OCT identified white thrombus decline, neointimal hyperplasia and clinical outcomes of patients treated with ticagrelor plus aspirin with those patients treated with clopidogrel plus aspirin after peripheral interventions. We enrolled 18 patients with superficial femoral artery disease

Long-Term Clinical Outcomes of Percutaneous Transluminal Angioplasty with Optional Stenting in Patients with Superficial Femoral Artery Disease: A Retrospective, Observational Analysis

The recent ESC guideline advises primary stent placement in superficial femoral arterial disease (SFAD). The aim of this study was to compare clinical outcomes of SFAD patients selected for stent placement with plain percutaneous transluminal angioplasty (PTA). A single centre retrospective, observational analysis was performed of all consecutive patients undergoing endovascular treatment for SFAD from 2004 to 2015. Primary endpoints were primary and secondary clinical patency rates in patients with or without stent placement. Secondary endpoints were recurrence rates and number of amputations. Kaplan-Meier curves were used to compare patency rates. Multivariable Cox regression analysis was performed to adjust for confounding variables and to identify variables associated with loss of patency. A total of 389 patients were analysed with a median follow up of 42 months. Two hundred and fifty one patients (64.5%) were stented. Primary clinical patency rates at 1, 3, and 5 years were 82.8%, 71.0%, and 65.6% after PTA and 76.3%, 65.7%, and 58.1% after stent placement (PTA-S), respectively (p=.30). Secondary patency rates were also comparable for the PTA and PTA-S group resulting in 1, 3 and 5 year clinical secondary patency of 89.1%, 81.0%, and 76.3% in the PTA group versus 87.8%, 78.5%, and 71.9% in the PTA-S group (p=.58). Multivariable analysis revealed equal primary and secondary clinical patency between the treatment groups. The absolute re-intervention rate was 29.3%. The number of re-interventions and amputation rate did not significantly differ between the two groups (p=.41 and p=.75). Selective stenting in patients with SFAD shows comparable results in long-term clinical outcomes in patients who were treated with plain PTA as well as patients who are selected for stent placement. An approach of selective stenting is justified.

Impact of Goal-Directed Statin Therapy on Open and Endovascular Interventions for Claudication Owing to Superficial Femoral Artery Disease

Controlling lipids, in particular cholesterol and low-density lipoprotein cholesterol, has been identified as a key intervention to prevent adverse systemic events in patients with a high atherosclerotic burden and claudication. It is unclear if goal-directed therapy of to achieve a decrease in cholesterol (<200 mg/dL) and in low-density lipoprotein (<100 mg/dL) will influence outcomes. The aim of study was to determine the incidence and effectiveness of statin therapy on patient and procedural outcomes after SFA interventions for claudication. A database of patients with claudication undergoing open and endovascular intervention for TransAtlantic Inter-Society Consensus II C and D femoropopliteal lesions between 2001 and 2017 was retrospectively queried. All patients were on statins at the time of the procedure. Patients were subdivided into those based on serum cholesterol and low-density lipoprotein goals: neither goal met (no effect), one of two goals met (partial), or both goals met (full). Kaplan-Meier survival analyses were performed to assess time-dependent outcomes. Factor analyses were performed using a Cox proportional hazard model for time-dependent variables. There were 1973 patients (68% male; average age, 67 years) who underwent Open and endovascular treatment for symptomatic superficial femoral artery disease. Only 52% were on statins before the procedure. Both partial and full efficacy influenced 30-day outcomes and was associated with improved freedom from major adverse limb events and amputation-free survival at 5 years (Table). Partial or fully effective goal directed statin therapy has a significant effect on 30-day and long term outcomes in patients presenting with claudication and advanced femoropopliteal disease.TableThirty-day outcomesStatin efficacyNo effectPartial effectFull effect30-day MACE (%)21a0b,c30-day MALE (%)62b1b,c30-day amputation (%)21a0b,cFreedom from MALE (%)46 ± 673 ± 8b81 ± 9a,bAmputation-free survival (%)59 ± 788 ± 8b93 ± 9a,bMACE, Major adverse cardiac events; MALE, major adverse limb events.aP < .05 and bP < .01 compared with Full cP < .05 and dP < .01 compared with Partial. Open table in a new tab

Implementation of drug-eluting stents for the treatment of femoropopliteal disease provides significant cost-to-system savings in a single-state outpatient simulation

ObjectivesInitial data on drug-eluting stents (DES) shows that they may increase the durability of endovascular treatment of superficial femoral artery disease compared with traditional bare-metal stents (BMS). Observed decreased target lesion revascularization (TLR) rates have potential for cost savings despite an increased initial cost. The purpose of this study was to run a simulation model of progressive transition from BMS to DES over 5 years evaluating the overall cost impact of that transition. MethodsFlorida State Ambulatory Databases were searched for all patients undergoing superficial femoral artery stenting in 2013 using Current Procedural Terminology codes 37226 and 37227. A simulation model was developed to estimate the impact of a progressive transition from BMS to DES over a 5-year horizon in this patient population. Cost estimates were determined from available cost charge ratio data. For the 5-year model, 2013 served as the initial year with each subsequent year based on the expected number of interventions per year. Up to one TLR per patient was assumed for the model. The 5-year TLR rates for DES and other parameter estimates were based on pooled data from the literature. Institutional data were used to estimate that up to 48% of superficial femoral artery lesions would fit the instructions for use for the Zilver PTX (Cook Medical, Bloomington, Ind), which is currently the only DES approved by the U.S. Food and Drug Administration for peripheral interventions. The net budget impact was expressed as the difference in total costs (primary stenting and reinterventions) for a scenario where BMS is progressively replaced by Zilver PTX compared with a scenario of BMS only. Multiple sensitivity analyses were performed on the base scenario. ResultsWe identified 4107 peripheral interventions in the first year that fit our study. The overall cost for these procedures in Florida database was $51,362,142.00. In the base case scenario, DES was introduced slowly into the population at a rate of 8% per year up to 48% at the end of the model. This strategy resulted in an overall cost savings of $1,688,953.72 compared with the model with BMS alone. Sensitivity analyses including slower adoption of DES up to only 24% at 5 years, a 20% increase in TLR rates per year for the DES, and a 10% reduction in TLR rates per year for BMS still resulted in a net savings. As long as the additional cost of a DES compared with BMS is less than $677, the DES model remains less expensive. ConclusionsThe adoption of DES in lieu of traditional BMS can lead to significant cost savings in a single state model over a short time horizon.

Adventitial Drug Delivery of Dexamethasone to Improve Primary Patency in the Treatment of Superficial Femoral and Popliteal Artery Disease: 12-Month Results From the DANCE Clinical Trial

ObjectivesThis study was designed to evaluate outcomes of adventitial dexamethasone delivery adjunctive to standard endovascular revascularization in femoropopliteal peripheral artery disease. BackgroundDrug-coated balloons and drug-eluting stents improve patency of endovascular interventions with passive diffusion of antiproliferative drugs. Adventitial dexamethasone delivery targets the initial triggers of the inflammatory reaction to injury, thus potentially providing a potent antirestenotic strategy. MethodsThe single-arm DANCE (Dexamethasone to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization) trial enrolled 262 subjects (283 limbs) with symptomatic peripheral artery disease (Rutherford category 2 to 4) receiving percutaneous transluminal angioplasty (PTA) (n = 124) or atherectomy (ATX) (n = 159) in femoropopliteal lesions ≤15 cm in length. A mixture of dexamethasone/contrast medium (80%/20%) was delivered to the adventitia and perivascular tissues surrounding target lesions in all subjects. Thirty-day assessments included major adverse limb events (MALE) and post-operative death. Twelve-month assessments included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), Rutherford scoring, and walking impairment questionnaire. ResultsAt 12 months, primary patency rates in DANCE-ATX and -PTA per-protocol populations were 78.4% (74.8% intent-to-treat [ITT]) and 75.5% (74.3% ITT), respectively. Rates of CD-TLR in DANCE-ATX and -PTA subjects were 10.0% (13.1% ITT) and 11.0% (13.7% ITT), respectively. There were no 30-day MALE + post-operative death events nor 12-month device- or drug-related deaths or MALE. ConclusionsDirect adventitial delivery of dexamethasone appears to be an effective and safe therapy to prevent restenosis. Randomized studies are needed to further test this possibility. (Dexamethasone to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization [DANCE]; NCT01983449)

Commentary: All That Glitters Is Not Zilver: Promises and Disappointments of Endovascular Devices for Superficial Femoral Artery Disease

Commentary: All That Glitters Is Not Zilver: Promises and Disappointments of Endovascular Devices for Superficial Femoral Artery Disease

Long-term clinical and quality of life outcomes after stenting of femoropopliteal artery stenosis: 3-year results from the STROLL study.

To evaluate the clinical and health status outcomes of patients undergoing superficial femoral artery (SFA) revascularization using the Shape Memory Alloy Recoverable Technology (S.M.A.R.T.®) nitinol self-expanding stent through 3 years of follow-up. Limited long-term data are available describing the durability of benefits after femoropopliteal revascularization. In a multicenter, prospective, core-lab adjudicated study, 250 subjects with de novo or restenotic femoropopliteal arterial lesions were treated with the S.M.A.R.T.® stent. The primary endpoint of target vessel patency, a composite of ultrasound-assessed patency and freedom from clinically driven target lesion revascularization (TLR), was evaluated through 3 years. Secondary endpoints included stent fracture and health status. Health status was measured using generic and disease-specific instruments, including the Peripheral Artery Questionnaire (PAQ). At 3-year follow-up, Kaplan-Meier estimated target vessel patency was 72.7%, freedom from clinically driven TLR was 78.5%, and the incidence of stent fracture was 3.6%. The PAQ summary score was markedly impaired at baseline (mean 37.3 ± 19.6 points) and improved substantially at 1 month (mean change from baseline of 31.4 points, 95% CI: 28.5-34.3; P < 0.001). Disease-specific health status benefits assessed by the PAQ were largely preserved through 3 years of follow-up (mean change from baseline, 28.0 points, 95% CI: 24.3-31.7; P < 0.0001). In patients undergoing revascularization for moderately complex SFA disease, use of the self-expanding S.M.A.R.T® stent was associated with a high rate of target vessel patency through 3 years and led to substantial and sustained health status benefits.

Primary Stenting of the Superficial Femoral Artery in Patients with Intermittent Claudication Has Durable Effects on Health-Related Quality of Life at 24 Months: Results of a Randomized Controlled Trial

BackgroundIntermittent claudication (IC) is commonly caused by lesions in the superficial femoral artery (SFA), yet invasive treatment is still controversial and longer term patient-reported outcomes are lacking. This prospective randomized trial assessed the 24-month impact of primary stenting with nitinol self-expanding stents compared to best medical treatment (BMT) alone in patients with stable IC due to SFA disease on health-related quality of life (HRQoL).MethodsOne hundred patients with stable IC due to SFA disease treated with BMT were randomized to either stent (n = 48) or control (n = 52) group. HRQoL assessed by Short Form 36 Health Survey (SF-36) and EuroQoL 5-dimensions (EQ5D) 24 months after treatment were primary outcome measures. Walking Impairment Questionnaire, ankle–brachial index (ABI), and walking distance were secondary outcomes.ResultsSignificantly better SF-36 Physical Component Summary (P = 0.024) and physical domain scores such as Physical Function (P = 0.012), Bodily Pain (P = 0.002), General Health (P = 0.037), and EQ5D (P = 0.010) were reported in intergroup comparison between the stent and the control group. Both ABI (from 0.58 ± 0.11 to 0.85 ± 0.18; P < 0.001 in the stent group and from 0.63 ± 0.17 to 0.69 ± 0.18; P = 0.036 in the control group) and walking distance (from 170 ± 90 m to 616 ± 375 m; P < 0.001 in the stent group and from 209 ± 111 m to 331 ± 304 m; P = 0.006 in the control group) improved significantly in intragroup comparisons.ConclusionsIn patients with IC caused by lesions in the SFA, primary stenting compared to BMT alone was associated with significant improvements in HRQoL, ABI, and walking distance durable up to 24 months of follow-up.Clinical Trial Registrationhttp://www.clinicaltrials.gov. Unique Identifier:NCT01230229

Retrograde popliteal access to treat femoropopliteal artery occlusive disease

ObjectiveRetrograde popliteal artery (RPA) access to treat superficial femoral artery and popliteal artery disease is an option when treatment through common femoral artery (CFA) access is not possible. Our goal was to compare the safety and efficacy of RPA access with CFA access for treatment of femoral and popliteal artery lesions. MethodsThe Vascular Quality Initiative was queried for all patients undergoing RPA access from 2010 to 2016 for symptomatic peripheral arterial disease. These were compared with standard CFA access. Patients with acute limb ischemia were excluded. Preoperative, operative, and postoperative data were analyzed. Perioperative and 6-month outcomes were analyzed. Multivariable analysis was used to assess the effect of RPA access on amputation or death, major adverse limb event (MALE) or death, patency, and death. ResultsThere were 30,074 patients with isolated superficial femoral and popliteal artery disease treated, 148 of whom had RPA access. Indications overall included claudication (56.3%), rest pain (13.9%), and tissue loss (29.8%). RPA access had a significantly lower rate of technical success compared with CFA access (80.4% vs 93.8%; P < .001). RPA access and CFA access were similar for rates of arterial dissection (8.3% vs 6.3%; P = .333), distal embolization (0% vs 1.2%; P = .183), access site hematoma (3.4% vs 3.1%; P = .849), and 30-day mortality (1.4% vs 1.1%; P = .789). There were no differences between RPA access and CFA access for unadjusted 6-month amputation-free survival (94.8% vs 96%; P = .747) or survival (934.3% vs 95.6%; P = .845). MALE-free survival (74.5% vs 83.5%; P = .016) and patency (70.3% vs 83.1%; P < .001) were significantly lower in the RPA access group. Multivariable analysis showed no differences between patients who were successfully treated by RPA access and CFA access for amputation-free survival (hazard ratio [HR], 1.24; 95% confidence interval [CI], 0.46-3.32; P = .669), MALE-free survival (HR, 1.57; 95% CI, 0.99-2.5; P = .057), and survival (HR, 0.86; 95% CI, 0.43-1.73; P = .675). RPA access was independently associated with loss of primary patency (HR, 1.91; 95% CI, 1.24-2.94; P = .003). ConclusionsRPA access had lower technical success and primary patency compared with antegrade access at 6 months. There were no differences demonstrated between the two access techniques in perioperative morbidity and mortality or 6-month amputation, MALE, and survival. This technique should be considered when CFA access cannot be accomplished.

Drug-coated balloon in superficial femoral artery in-stent restenosis.

The femoropopliteal artery is one of the commonest sites of involvement in peripheral artery disease (PAD) leading to intermittent claudication and/or critical limb ischemia. Endovascular therapy for superficial femoral artery (SFA) disease has been recognized as a safe and efficient therapy and is recommended by current guidelines as the first-line approach. Although the widespread use of new-generation, self-expanding, nitinol stents in SFA stenosis has reduced the shortcomings associated with plain old balloon angioplasty (POBA), lumen renarrowing at the stented (in-stent restenosis – ISR) level still represents a relevant clinical problem, because of higher risk of recurrent ISR, occlusion and surgical revascularization compared to de-novo lesions. In this setting, different treatment options are available and drug-coated balloons (DCBs) have shown good results in terms of safety and effectiveness. In this review we examine the results of different trials exploring the outcome of using DCBs for the treatment of SFA ISR. The available data demonstrate that SFA ISR can be safely treated with percutaneous transluminal angioplasty with a DCB, with a reduction in recurrent restenosis and target lesion revascularization (TLR) at least at 1 year after POBA. The consistent and positive results of different registries and randomized trials support the use of DCB to reduce SFA ISR recurrence.

Percutaneous transradial artery approach for femoro- popliteal artery intervention in the current era in Japan

The percutaneous transradial artery approach for coronary angiography and intervention has been recognized as a safe and effective method, however, it is limited for endovascular therapy (EVT) for femoro-popliteal artery because of lack of devices with longer shaft. Herein, we report two EVT cases for superficial femoral artery disease treated with a long shaft balloon through the radial artery. Although femoro-popliteal artery intervention with this approach has several limits for available devices and technical issues, it is effective for particular patients who are impossible in EVT with femoral artery approach.

Endovascular Therapy of the Superficial Femoral Artery Via a Stand-Alone Transradial Access: A Single-Center Experience.

We describe our experience in transradial recanalization of the superficial femoral artery (SFA), and we provide a stepwise approach accounting for the patient's height and optimizing the yield of currently available devices. Fifteen patients with simple SFA disease, including 4 patients with total SFA occlusions <15 cm, were selected for stand-alone transradial recanalization. A 6F, 125-cm multipurpose guiding catheter was used to cannulate the limb of interest and support device delivery. The procedure was successful in all patients and consisted of balloon angioplasty (using 0.014″, 200-cm shaft monorail balloons) in all patients, and orbital atherectomy in 6 patients. We illustrate the steps and challenges of the transradial approach, namely the limited support in complex disease and the limited reach of current equipment. In patients with simple SFA disease, transradial recanalization appears feasible and safe but currently limited to balloon angioplasty ± orbital atherectomy. Proximal SFA stenting may be feasible in patients <160 cm in height.

Early Experience with a New Concept of Angioplasty Nitinol-Constrained Balloon Catheter (Chocolate®) in Severely Claudicant Patients.

To report our experience in treating severely claudicant patients, employing a "nitinol-constrained" balloon (Chocolate, TriReme Medical Inc., Pleasanton, CA-USA) before drug-coated balloon (DCB) in a standardized protocol. Eighty-one (84 limbs) consecutive Rutherford category (RC) 3 patients treated between December 2014 and December 2016 for superficial femoral artery (SFA) and popliteal arterial (PA) disease by nitinol-constrained balloon followed by DCB were enrolled. Bailout stenting was performed by Zilver PTX implantation. Intraoperative technical success and bailout-stenting rates were assessed as well as clinical improvement, ankle-brachial index (ABI) modification, primary patency (PP), and secondary patency (SP) rates at follow-up. Sixty-eight patients (83.9%) were male and 31 (38.2%) diabetics. Fifty-five limbs (65.5%) presented occlusion (CTO); in 18 limbs CTO was longer than 150mm. Bailout stenting rate was 9.5% (8/84). All patients completed 30-day follow-up: PP 100%, 61 patients completely asymptomatic (RC=0). Mean follow-up was 12.3±5.6months; overall PP was 98.8%, and SP was 98.8%. At mid-term analysis, no differences in outcomes were recorded between stenosis and CTOs with a PP of 96.5 and 96%, respectively (p=0.725). CTO length impacted early results: in cases of CTOs<150mm, PP was 100%, while in CTOs>150mm, it was 83.3% (p=0031). ABI at 12-month was significantly higher with respect to preoperative values (p<0.001). In this preliminary experience, our protocol seems to be safe and effective in treating SFA and PA lesions in claudicant patients with satisfactory early and 12-month results.

Acute procedural outcomes of orbital atherectomy for the treatment of common femoral artery disease: Sub-analysis of the CONFIRM Registries

This analysis compared the angiographic outcomes of patients treated with orbital atherectomy for calcified common femoral artery (CFA) and superficial femoral artery (SFA) disease. The ideal revascularization strategy for CFA disease is unknown. Endarterectomy has been considered the standard of care for CFA disease for over 50 years. Endovascular intervention is becoming more commonly used to revascularize the CFA given the advances in technology and the less invasive nature of the procedure. Patient demographics, lesion characteristics, and procedure data for all CONFIRM patients with at least one CFA lesion location ( n=147 patients; n=200 lesions) were compared to patients with at least one SFA lesion location ( n=1508 patients; n=2367 lesions). The primary endpoint was angiographic complication, defined as the composite of dissection, perforation, slow flow, closure, spasm, embolism, or thrombosis. The CFA group had more patients with Rutherford class 4 and shorter lesion length. The CFA group had a higher final residual stenosis, shorter total run time, and shorter total inflation time. The primary endpoint was lower in the CFA group compared with the SFA group (17% vs 24%, p=0.02), driven by a lower dissection rate (10% vs 15%, p=0.04). Plaque modification of the CFA with orbital atherectomy was safe and compared favorably with SFA disease. The need for bail-out stenting was low. A randomized trial is needed to determine the ideal treatment strategy for calcified CFA disease.

VESS22. Implementation of Drug-Eluting Stents for the Treatment of Femoropopliteal Disease Provides Significant Cost-to-System Savings: A Single-State Outpatient Simulation

Initial data on drug-eluting stents (DES) shows they may increase durability of endovascular treatment of superficial femoral artery (SFA) disease compared to traditional bare-metal stents (BMS). Observed decreased target lesion revascularization (TLR) rates have potential for savings despite increased initial costs. The purpose of this study was to simulate a transition from BMS to DES over 5 years, evaluating the overall cost impact of that transition. Florida state ambulatory databases were searched for patients undergoing SFA stenting in 2013 (Current Procedural Terminology codes 37226 and 37227). A model was developed to estimate the impact of progressive transition from BMS to DES over a 5-year horizon in this population. Cost estimates were determined from available cost-to-charge ratios. 2013 was the initial year for the model with each subsequent year based on the expected number of interventions per year. Up to one TLR per patient was assumed for the model. TLR rates for DES and other parameter estimates were based on pooled data from the literature. Institutional data were used to estimate that up to 48% of lesions would fit the instructions for use for the Zilver PTX, currently the only United States Food and Drug Administration-approved DES for peripheral interventions. Net budget impact was expressed as difference in total costs (primary stenting and reinterventions) for a scenario where BMS is progressively replaced by Zilver PTX compared to a scenario of BMS only. Multiple sensitivity analyses were performed on the base scenario. A total of 4107 peripheral interventions fit our study. Overall cost for these procedures in the Florida database was $51,362,142.00. In the base case, DES was introduced at a rate of 8% per year up to 48% at the end of the model. This resulted in an overall cost savings of $1,688,953.72 compared to the model with BMS alone. Net budget impact by year with DES vs BMS only is illustrated in the Fig, where a negative net budget impact indicates savings. Sensitivity analyses, including slower adoption of DES up to 24% at 5 years, a 20% increase in TLR rates per year for the DES, and a 10% reduction in TLR rates per year for BMS still resulted in a net savings. As long as the additional cost of a DES compared to BMS is less than $677, the DES model remains less expensive. The adoption of drug eluting stents in lieu of traditional BMS can lead to significant cost savings in a single state system over a short time horizon.

PC158 Long-Term Outcomes After Endovascular Stent Placement for Symptomatic, Long-Segment Superficial Femoral Artery Lesions

Endovascular intervention is commonly pursued for the treatment of symptomatic, long-segment superficial femoral artery (SFA) disease. The relative effectiveness and comparative long-term outcomes among bare-metal stents (BMS), covered stents (CS), and drug-eluting (DES) stents for long-segment SFA lesions remain uncertain. A retrospective cohort study identified consecutive patients with symptomatic SFA occlusions measuring at least 15 cm who received an endovascular stent (BMS, CS, or DES). The primary outcome of interest was patency, while secondary outcomes included postoperative presentation with acute limb ischemia (ALI), number of reoperations, and limb salvage. Patency rates were compared using time-to-event analysis and log-rank tests. From 186 patients that were identified, a total of 215 procedures were analyzed (BMS: 113 [52%]; CS: 75 [35%]; DES: 27 [13%]) with a median follow-up time of 56 months (although the follow-up for DES was less: median, 10 months; P < .001). There were no significant differences among the groups with respect to mean age, diabetes status, renal dysfunction, and lower extremity runoff (mean 2.0 ± 0.7 vessels). The mean length of the SFA lesion being treated in this series was 27 ± 8 cm (also similar across all groups, P = .165). Although primary and secondary patency rates were not significantly different among the stent types, DES is associated with an improved short-term primary-assisted patency, with 6-, 12-, and 24-month rates of 92%, 92%, and 83%, respectively. This is compared to 80%, 57%, and 47% for BMS, and 80%, 49%, and 41% for CS, respectively (log-rank test: P = .009; Fig 1). In comparing only BMS with CS, 5- and 8-year primary-assisted patency rates are also higher among BMS: 60% and 60% vs 33% and 33% for CS, respectively (P = .011; Fig 2). Zero DES patients have presented postoperatively with ALI compared to 3% of BMS patients and 13% of CS patients (P = .004). Similarly, the CS group had a higher rate of subsequent open revascularization (32%) compared with BMS (24%) and DES (7%; P = .038). Although long-term primary-assisted patency is greater in BMS as compared to CS, primary and secondary patency rates among all stent types are similar. CSs are associated with an increased risk of postoperative acute limb ischemia and subsequent open revascularization.Fig 2View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Primary Stenting of the Superficial Femoral Artery in Intermittent Claudication Improves Health Related Quality of Life, ABI and Walking Distance: 12 Month Results of a Controlled Randomised Multicentre Trial

Invasive treatment of intermittent claudication (IC) because of severe atherosclerotic stenosis or occlusion in the superficial femoral artery (SFA) is controversial. This prospective randomised trial was performed to assess the impact on health related quality of life (HRQoL) of primary stenting with nitinol self expanding stents compared with best medical treatment alone in patients suffering from stable IC due to SFA disease. One hundred patients with stable IC caused by SFA disease from seven Swedish hospitals treated with best medical treatment (BMT) were randomised to either the stent (n=48) or the control (n=52) group. Change in HRQoL assessed by the Short Form 36 Health Survey (SF-36) and EuroQoL 5 dimensions (EQ5D) 12 months after treatment was the primary outcome measure. Improvement in the Walking Impairment Questionnaire (WIQ), ankle brachial index (ABI), and walking distance were secondary outcomes. HRQoL improved significantly. In the stent group the following SF-36 domains improved: Physical Function, 19 points (p<.001); Bodily Pain, 14 points (p=.001); General Health, 6 points (p=.019); Vitality, 10 points (p=.004); Physical Component Summary, 6.5 points (p<.001); EQ5D, 0.14 points (p=.008); and WIQ 22 points (p<.001). They were unchanged in the control group. Both ABI (from 0.58±0.11 to 0.86±0.19, p<.001, in the stent group and from 0.63±0.17 to 0.70±0.20, p=.005, in the control group) and walking distance (WD) (from 171±90 meters to 613±381 meters, p<.001, in the stent group and from 209±106m to 335±321 meters, p=.012, in the control group) improved, and at 12 months both the ABI (p<.001) and the WD (p=.001) were higher in the stent group. In patients with IC caused by lesions in the SFA, the addition of primary stenting to BMT was associated with significant improvement in HRQoL, ABI, and walking distance after 12 months follow-up compared with BMT alone.

Angiographic Dissection Patterns and Patency Outcomes After Balloon Angioplasty for Superficial Femoral Artery Disease

Purpose: To investigate the angiographic dissection patterns after balloon angioplasty for superficial femoral artery (SFA) lesions, the clinical outcome associated with each dissection pattern, and the predictive factors for severe dissection. Methods: A retrospective, multicenter analysis examined 621 patients (mean age 72.8±9.5 years; 414 men) with 748 symptomatic de novo SFA lesions treated with endovascular therapy. Vessel dissection after the initial balloon angioplasty procedure was graded into 7 types according to a modified version of the coronary artery classification types A to F. Severe vessel dissection patterns were defined as type C or higher. Nitinol stent implantation was performed in 555 (74.2%) lesions for residual stenosis >30% or flow-limiting dissection; 193 lesions (25.8%) were treated with balloon angioplasty only. To determine the clinical outcomes associated with each dissection pattern and identify predictive factors for severe dissection, 2-year follow-up data for the 193 lesions treated with balloon angioplasty only were analyzed for primary patency and clinically driven target lesion revascularization (TLR). Results: No dissection was found in 16% (120/748) of lesions, and types A and B dissections were seen in 19% (142/748) and 23% (172/748), respectively. Dissection grades above type C were observed in 42% of cases, most frequently type D (180/748, 24%) and less often type C (37/748, 5%), type E (67/748, 9%), and type F (30/748, 4%). The bailout stent implantation rate increased according to dissection severity. At up to 2 years, the severe dissection group (types C–F) showed a significantly lower patency rate (p<0.001) and higher clinically driven TLR (p<0.001) compared to the nonsevere group (no dissection and types A and B dissections). Severe dissection was a significant risk factor for restenosis, which rose progressively from types C to F. Multivariate analysis identified a small reference vessel diameter <5 mm (p=0.001), lesion length >15 cm (p=0.001), and chronic total occlusion (p<0.001) as independent predictors of severe dissection. In subgroup analysis, vessels with a small reference diameter and TASC II C and D lesions had a higher prevalence of severe dissection. Conclusion: Severe dissection was found in 42% of cases after PTA. A small vessel diameter and/or TASC II C/D lesions were related to a high incidence of dissection. Severe dissection during procedures employing balloon angioplasty only could affect long-term patency.

French multicenter experience with the GORE TIGRIS Vascular Stent in superficial femoral and popliteal arteries

BackgroundPreliminary results in small single-center studies after stenting with the GORE TIGRIS Vascular Stent (W. L. Gore & Associates, Flagstaff, Ariz) show promising short-term primary patency rates, but larger, multicenter studies are needed. This study therefore investigated the performance of the GORE TIGRIS Vascular Stent at three different centers in France in patients with symptomatic peripheral artery disease. MethodsThis retrospective, single-arm, multicenter cohort study included 215 patients with peripheral artery disease (Rutherford-Becker category 2-6) who were treated with the GORE TIGRIS Vascular Stent, a dual-component stent consisting of a nitinol wire frame combined with a fluoropolymer-interconnecting structure. The efficacy end point was primary patency defined by freedom from binary restenosis as derived by duplex ultrasound imaging until 2 years after the intervention. Primary, secondary, and primary assisted patency rates at 3, 6, 12, 18, and 24 months were estimated by Kaplan-Meier analysis. ResultsThe GORE TIGRIS Vascular Stent was used to successfully treat 239 lesions, of which 141 lesions were located in the superficial femoral artery and 98 in the popliteal artery. Patients were a mean age of 74 ± 12 years. Mean lesion length was 86.8 ± 44.7 mm. After 12 and 24 months, the overall primary patency rates were 81.5% and 67.2%, respectively, and primary assisted patency was 94.9% and 84.8%. Secondary patency was achieved in 99.1% at 24 months. ConclusionsOur multicenter experience with the GORE TIGRIS Vascular Stent demonstrates continued good results at 2 years for endovascular treatment of challenging obstructive superficial femoral artery and popliteal artery disease.