Primary Sustained Clinical Improvement Research Articles

Drug-Coated Balloon Angioplasty of Infrapopliteal Lesions in Chronic Limb-Threatening Ischemia: Six-month Outcomes of PRIME-WIFI.

To evaluate 6-month outcomes of drug-coated balloon (DCB) angioplasty of infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). We analyzed 6-month follow-up data from the 10-center PRIME-WIFI prospective registry on 300 consecutive patients (33.000% female) with CLTI who underwent DCB angioplasty for infrapopliteal arterial lesions. The primary outcome was freedom from major adverse event (MAE), a composite of major amputation, all-cause death, and clinically-driven target limb reintervention (CD-TLR). Secondary outcomes included amputation-free survival (AFS), freedom from each primary outcome component, primary sustained clinical improvement, and quality of life (QOL) score. Independent risk factors of MAE were determined using Cox proportional hazards regression analysis. A total of 409 infrapopliteal lesions in 312 limbs were treated with DCB, with 54.167% of the limbs being treated for isolated infrapopliteal lesions. By Kaplan-Meier analysis, at 6 months post- procedure (follow-up rate, 85.000%), freedom from MAE was 86.353%; AFS was 90.318%; and freedom from major amputation, all-cause death, and CD-TLR were 96.429%, 93.480%, and 95.079%, respectively. At 6-month follow-up, 83.590% of patients showed primary sustained clinical improvement, and QOL score (4.902±1.388) improved compared with that before procedure (2.327±1.109; p<0.001). Chronic renal insufficiency, chronic obstructive pulmonary disease, Rutherford grade, and postoperative infrapopliteal runoff score were independent risk factors for MAE within 6 months. In CLTI, DCB angioplasty of infrapopliteal lesions yields acceptable early efficacy and safety. This study evaluated the 6-month outcomes of DCB angioplasty in infrapopliteal lesions in CLTI patients by analyzing multicenter prospective data, showing that infrapopliteal DCB angioplasty can be performed with acceptable freedom from MAE rate, amputation-free survival rate, freedom from major amputation rate, survival rate, and freedom from CD-TLR rate. No patient experienced DCB-related intraoperative distal embolism. Chronic renal insufficiency, chronic obstructive pulmonary disease, Rutherford grade and postoperative infrapopliteal runoff score were independent risk factors for MAE within 6 months. Comparative real-world studies are needed.

Treatment of Long Femoropopliteal Occlusive Lesions With Self-expanding Interwoven Nitinol Stent: 24 Month Outcomes of the STELLA-SUPERA-SIBERIA Register Trial.

The efficacy and safety of the Supera stent in superficial femoral artery (SFA) have been reported mostly in shorter lesions with relatively low proportion of occlusions. There are little data on the effectiveness of the Supera stent in long lesions. The aim of this study was to assess the clinical safety and efficiency of the Supera stent in the treatment of long femoropopliteal occlusive lesions (Trans-Atlantic Inter-Society Consensus [TASC] C/D) in patients with symptomatic peripheral artery disease. The STELLA-SUPERA-SIBERIA is a prospective, single-center, single-arm study. Patients with symptomatic (Rutherford stages 3-6) de novo and TASC C/D occlusive lesions of the femoropopliteal segment were treated with Supera stent. The primary endpoint was the 12 month rate of primary sustained clinical improvement (upward shift on the Rutherford classification to a one level without the need for repeated target lesion revascularization (TLR) in surviving patients without the need for unplanned amputation). Secondary endpoints were the 24 month of primary sustained clinical improvement, MALE, limb salvage, the primary patency, the secondary patency, 24 month MACE. Follow-up included clinical examination, duplex scan, and biplane x-ray up to 24 months. Between April 2019 and January 2020, 52 symptomatic patients with 55 long femoropopliteal occlusive lesions (52.7% TASC D lesions and 47.3% TASC C lesions) were treated. The mean target lesion length was 205±72 mm. All patients had total occlusions. The mean lesion length of the implanted Supera stents was 198±82 mm. At 12 and 24 months, the primary sustained clinical improvement rate was 80.2% and 63.6%, respectively. The Rutherford category assessment was significantly improved at 24 months compared with baseline (p=0.02). The primary patency rate at 12 and 24 months was 78.1% and 60.0%, respectively. At 12 and 24 months, freedom from TLR was 83.5% and 81.8%, respectively. There were no stent fractures at 24 months. Supera Stent implantation for TASC C/D femoropopliteal lesions revascularization appears to be a safe and efficient implant given the complexity of the treated lesions. Head-to-head studies are mandatory to establish Supera Stent as an alternative tool to open surgery for long femoropopliteal lesions. Our study indicated, that using self-expanding interwoven nitinol stent for TASC C/D femoropopliteal lesions revascularization appears to be a safe and efficient implant given the complexity of the treated lesions. Although bypass grafting is recommended for prolonged femoropopliteal lesions, open surgery is more traumatic and is associated with greater risks than endovascular procedures. Our findings suggest that the use of interwoven nitinol stents can overcome the disadvantages of traditional stents in such cases, which may help to improve patients' outcomes and reduce the risk of adverse events.

Bypass Versus Interwoven Nitinol Stents for Long Femoro-Popliteal Occlusions: A Propensity Matched Analysis.

To compare femoro-popliteal bypass and interwoven nitinol stenting for long occlusions of the femoro-popliteal segment. Single center retrospective propensity matching analysis of the symptomatic patients with long occlusion of the femoro-popliteal segment (> 20cm), who underwent stenting with interwoven nitinol stent or femoro-popliteal bypass from 2012 to 2020. primary patency, primary-assisted patency, secondary patency. Secondary endpoints: major adverse cardiovascular events, major adverse limb events, primary sustained clinical improvement, survival. A total of 437 patients were enrolled: 294 in the bypass group and 143 in the endovascular therapy (EVT) group. After propensity score matching, 264 and 113 patients remained in the groups, respectively. A median occlusion length was 250mm. One-year and two-year primary and secondary patency rates were comparable in both groups (two-year primary patency: 68.5% for bypass vs. 68.9% for EVT, p = 1.00). In the "above the knee" subgroup analysis, two-year secondary patency was higher in the EVT group than in the bypass group (90.9% vs. 77.5%, p = 0.048). In "below-the-knee" subgroup analysis, primary and primary assisted patency were statistically significantly higher in the EVT group than in artificial bypass subgroup (66.7% vs. 42.4%, p = .046 and 76.7% vs. 45.5%, p = .011, respectively). However, compared to autovenous bypass, the EVT group showed lower primary patency rates, although the differences are not significant. A nonselective endovascular strategy can allow for regular successful treatment of femoro-popliteal lesions longer than 25cm.

Treatment of Long Femoropopliteal Lesions With Self-Expanding Interwoven Nitinol Stent: 24 Month Outcomes of the STELLA-SUPERA Trial

Purpose: The performance of self-expanding interwoven nitinol stent (Supera) in femoropopliteal interventions has been proven through trials with short lesions and with relatively low proportion of occlusions. There is limited evidence of Supera stent in long lesions. The aim of this study was to assess the clinical safety and efficiency of the Supera stent in the treatment of long femoropopliteal lesions (Trans-Atlantic Inter-Society Consensus [TASC] C/D) in patients with symptomatic peripheral arterial disease (PAD). Methods: The STELLA SUPERA (STEnting Long de L’Artère fémorale superficielle par le stent métallique Supera) is a prospective, 2-center, single-arm study. Patients with symptomatic (Rutherford stages 2–6) de novo and TASC C/D lesions of the femoropopliteal segment were treated with Supera stent. The primary endpoint was the primary sustained clinical improvement at 12 months. Follow-up included clinical examination, duplex scan, and biplane X-ray up to 24 months. Results: Between December 2016 and October 2018, 48 symptomatic patients with 49 femoropopliteal lesions (TASC D = 32, 65%) were treated. The mean lesion length was 234 ± 123 mm, and 78% were total occlusion. The mean stented lesion length was 273 ± 127 mm. At 12 and 24 months, the primary sustained clinical improvement rate was 87.2% and 79.7%, respectively. The Rutherford category assessment was significantly improved at 24 months compared with baseline (p=0.02). At 24 months, the primary patency and freedom from target lesion revascularization (TLR) rates were 77.9% and 86.9%, respectively. The ankle-brachial pressure index increased from 0.62 ± 0.15 at baseline to 0.93 ± 0.15 at 24 months (p<0.0001). There were no stent fractures at 24 months. Conclusion: The use of Supera stent in long lesions (TASC C/D) is a safe and effective endovascular alternative. These results reinforce the need for randomized clinical trials to assess the value of interwoven stents for long femoropopliteal lesions.

Bare Stents for Iliac Chronic Total Occlusions (“TELIS”): A Prospective Cohort Study with a Midterm Follow-up

This study aims to assess primary bare stenting for iliac chronic total occlusions (CTOs) with midterm follow-up. From April 2013 to May 2016, all patients presenting with symptomatic iliac CTO were treated endovascularly and included in a prospective single-center cohort. Common iliac CTOs were treated with balloon-expandable bare-metal stents. External iliac lesions were treated with bare self-expandable nitinol stents. Primary end point was primary sustained clinical improvement. A total of 49 iliac CTOs were treated in 46 patients. A total of 22 lesions were located at the level of the common iliac artery (45%), 20 at the external iliac artery (41%), and 7 extending to both (14%). Mean stenting length was 114.4±49.8mm. Technical success was 98%. Primary sustained clinical improvement was achieved for 93.4±3.7% of patients at 12months and 87.7±5.2% at 24months. Three in-stent thrombosis were observed with no restenosis in the remaining patients at 24months. Freedom from target lesion revascularization was 93.3%±3.7% at 24months. Three stent fractures were noted, none were symptomatic. Mean quality of life (EQ5D-3L) was significantly improved at 24months (71.2±20.3 vs. 52.4±22.6, P=0.001). Our results showed that primary bare-metal stenting for iliac CTO is safe and efficient at 24months and could be considered as a first-line strategy.

Endovascular treatment of atherosclerotic lesions in the superficial femoral artery and proximal popliteal artery using the sinus-SuperFlex-635 stent: twelve-month results from the HERO Registry.

The aim of this study was to evaluate the safety and performance of the sinus-SuperFlex-635 self-expandable nitinol stent (Optimed GmbH) for the treatment of steno-occlusive lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA). The prospective, multicenter, observational HERO study recruited 117 eligible patients (83 men; mean age 69.4±9.7y) from 7 centers in Belgium. A total of 129 stents were successfully deployed in 121 lesions in 117 patients (100%). The patients presented with symptomatic ≥50% stenosis or chronic total occlusion (CTO) (30.6%). Mean lesion length was 71.4±56.3 mm. Moderate to severe calcification was present in 82.6% of the lesions. Acute lesion success (<30% residual stenosis) was achieved in 96.0%. There were no in-hospital serious adverse events. Duplex ultrasound-driven primary patency at 12 months was recorded in 84 of 107 (78.5%) lesions. The overall target lesion revascularization (TLR) rate was 8.4% at 12 months; the target extremity revascularization (TER) rate was 4.7%. Clinical assessment at 12 months demonstrated improvement by at least 1 Rutherford class, without the need for TLR (i.e. primary sustained clinical improvement) in 83.9% of patients and with the need for TLR in 90.6% of patients (i.e. secondary sustained clinical improvement). Based on the high primary patency, low stent fracture rate and significant clinical improvement, combined with refined stent design and long stent availability, the sinus-SuperFlex-635 self-expandable nitinol stent proves its value in the treatment of complex femoropopliteal lesions.

The Common Femoral Artery Bifurcation Lesions: Clinical Outcome of Simple Versus Complex Stenting Techniques – An Analysis Based on the TECCO Trial

Common femoral artery (CFA) stenting appears as a promising alternative treatment to the open surgery for de novo CFA stenosis. The stenting of lesions just located at the CFA is simple, whereas stenting of CFA bifurcation lesions is more complex, and outcomes are still matter of debate. The aim of this study was to describe and to compare clinical outcomes of techniques used to treat simple over complex lesions for the stenting of CFA lesions. From the French randomized controlled trial, TECCO, a total of 54 patients underwent stenting intervention and were enrolled in this study. Patients were excluded if they had CFA thrombosis, restenosis, and nonatheromatous lesions. Patients were classified by simple and complex lesions based on the type of lesion. The primary end point was the primary sustained clinical improvement. Eighteen patients were included in the simple lesion group, and 36 patients, in the complex lesion group. Baseline characteristics of patients were comparable between the 2 groups. The technical success was 100% in the simple lesion group and 91.7% in the complex lesion group. There was no significant difference between the 2 groups, regarding the primary sustained clinical improvement. The primary patency rates at 24months for simple and complex lesion groups were 86.3% and 79%, respectively (P=0.66). Freedom from target lesion revascularization was of 93.3% and 82% in the simple and complex lesion group, respectively (P=0.34). The stenting technique for CFA bifurcation lesions is a safe and effective technique. More trials with a large number of patients are needed to define the optimal stenting technique.

TCT-60 Stent Versus Non-Stent Strategies For Endovascular Treatment of Femoropopliteal Peripheral Artery Disease: Insights From the XLPAD Registry

A wide variety of treatment options exist for endovascular treatment of femoropopliteal (FP) peripheral artery disease. Herein, we compare primary sustained clinical improvement defined as freedom from death, target limb amputation and target vessel revascularization (TVR; endovascular or surgical)

Bare Metal Versus Paclitaxel-Eluting Stents for Long Femoropopliteal Lesions: Prospective Cohorts Comparison Using a Propensity Score–Matched Analysis

The study aims to compare outcomes of primary stenting of long femoropopliteal (FP) lesions with bare metal stent (BMS) versus paclitaxel eluting stent (PES). In a single centre study, we established 2 consecutive and prospective cohorts with TASC C/D FP de novo lesions. The inclusion and exclusion criteria were similar. Bare metal stent (LifeStent®, Bard Peripheral) and PES (Zilver® PTX®, Cook Peripheral Vascular) were implanted. Prospective clinical and morphological follow-ups were carried out at 1, 3, 6, 12, and 18months. Propensity score (inverse probability of treatment weighted method) stratification was used to minimize bias. In total, 110 limbs were treated (STELLA: n=62; STELLA PTX: n=48). We noted some difference between both cohorts regarding type 2 diabetes (P=0.05), vitamin K antagonist use (P=0.05), and angiotensin II receptor blocker use (P=0.002). More stents were implanted in the STELLA PTX cohort (P<0.0013). At 12months, in univariate analysis, freedom from target lesion revascularization (TLR) was higher in the STELLA cohort (P=0.005). No differences were found between both cohorts in terms of primary sustained clinical improvement (P=0.25), primary patency (P=0.07), and survival (P=0.79). With the propensity score, no difference was observed in terms of primary sustained clinical improvement (P=0.79), freedom from TLR (P=0.59), and primary patency (P=0.69). With Cox logistic regression, the number of implanted stents influenced the primary sustained clinical improvement, the freedom from TLR, and the primary patency. Paclitaxel-eluting stents do not seem to provide benefits in terms of clinical and morphological outcomes for TASC C/D lesions compared to BMS.

Treatment of TASC C and D Femoropoliteal Lesions with Paclitaxel eluting Stents: 12 month Results of the STELLA-PTX Registry

The aim was to evaluate the safety and the efficacy of primary stenting with paclitaxel eluting stents for TASC C and D femoropopliteal lesions. Patients with TASC C/D de novo femoropopliteal lesions were treated by implanting paclitaxel eluting stents. Patients were included in a single center registry and prospectively followed by clinical and ultrasound evaluation. X-ray of the stented zone was systematically performed 12 months after implantation. The primary endpoint was primary sustained clinical improvement after 12 months. A total of 45 patients (48 limbs) suffering from claudication (25 limbs) or CLI (23 limbs) were enrolled. Lesions were either TASC C (28 limbs) or TASC D (20 limbs). The mean length of the treated segment was 252±90mm. The mean number of stents was 2.9±1 (2-5). Mean follow up was 12.7 months. No patient was lost to follow up. At 1 year post procedure, primary and secondary sustained clinical improvements were 56.3±7.4% and 80.1±5.9% respectively. Freedom from target lesion and target extremity revascularization were 63.6% and 90.1%, respectively. Primary and secondary patency rates were 52.5% and 79.6%. One year primary sustained clinical improvement rates for TASC C/D were 63.3±9.2% and 45.6±11.7%, respectively (p=.34). One year primary sustained clinical improvement rates for claudication/CLI patients were 68±9.3% and 41.6±11.1%, respectively (p=.13). The incidence of in stent re-stenosis and in stent thrombosis were 25% and 14%, respectively. The incidence of stent fracture was 12.5% on a limb basis and 9% on a per stent basis. The paclitaxel eluting stent did not achieve its goal in terms of prevention of in stent re-stenosis for TASC C/D femoropopliteal lesions. It requires frequent re-interventions during the first year to maintain satisfactory clinical results.

Clinically-Driven Need for Secondary Interventions After Endovascular Revascularization of Tibial Arteries in Patients With Critical Limb Ischemia

To assess the need for clinically-driven secondary revascularization in critical limb ischemia (CLI) patients subsequent to tibial angioplasty during a 2-year follow-up. Between 2008 and 2010, a total of 128 consecutive CLI patients (80 men; mean age 76.5±9.8 years) underwent tibial angioplasty in 139 limbs. Rutherford categories, ankle-brachial index measurements, and lower limb oscillometries were prospectively assessed. All patients were followed at 3, 6, 12 months, and annually thereafter. Rates of death, primary and secondary sustained clinical improvement, target lesion (TLR) and target extremity revascularization (TER), as well as major amputation, were analyzed retrospectively. Primary clinical improvement was defined as improvement in Rutherford category to a level of intermittent claudication without unplanned amputation or TLR. All-cause mortality was 8.6%, 14.8%, 22.9%, and 29.1% at 3, 6, 12, and 24 months. At the same intervals, rates of primary sustained clinical improvement were 74.5%, 53.0%, 42.7%, and 37.1%; for secondary improvement, the rates were 89.1%, 76.0%, 68.4%, and 65.0%. Clinically-driven TLR rates were 14.6%, 29.1%, 41.6%, 46.2%; the rates for TER were 3.0%, 13.6%, 17.2%, and 27.6% in corresponding intervals, while the rates of major amputation were 1.5%, 5.5%, 10.1%, and 10.1%. Clinically-driven TLR is frequently required to maintain favorable functional clinical outcomes in CLI patients following tibial angioplasty. Dedicated technologies addressing tibial arterial restenosis warrant further academic scrutiny.

One-year Clinical Outcome after Primary Stenting for Trans-Atlantic Inter-Society Consensus (TASC) C and D Femoropopliteal Lesions (The STELLA “STEnting Long de L'Artère fémorale superficielle” Cohort)

ObjectiveThe study aims to evaluate the safety and the efficacy of primary stenting for Trans-Atlantic Inter-Society Consensus Document II on Management of Peripheral Arterial Disease (TASC) C and D femoropopliteal lesions. DesignProspective cohort study. MethodsPatients with TASC C and D de novo femoropopliteal lesions were treated with the same endovascular technique by implanting a primary nitinol self-expanding stent (LifeStent®, Bard Peripheral Vascular, Tempe, AZ, USA). Patients were included in a single-centre registry and prospectively followed up. The primary end point was primary sustained clinical improvement after 12 months. Secondary end points were secondary sustained clinical improvement, primary and secondary patency rates, freedom from target lesion revascularisation (TLR), freedom from target extremity revascularisation (TER) and stent fracture rate. ResultsWe enrolled 58 patients (62 limbs) suffering from either claudication (40.3%) or critical limb ischaemia (59.7%). Lesions were either TASC C (62.9%) or TASC D (37.1%). Median length of the treated segment was 220 ± 160 mm. The mean number of stents was 2.2. Mean follow-up was 17 months, with one patient lost to follow-up. At 1 year, the primary end point was 68.6% while secondary sustained clinical improvement was 82.6%. Freedom from TLR and TER rates were 81.1% and 96.3%. Primary and secondary patencies were 66% and 80.9%. One-year primary and secondary sustained clinical improvement rates were 76.7% ± 7.2 for TASC C and 46.3% ± 11.1 for TASC D (p = 0.03) and 87.6% ± 5.9 for TASC C and 67.3% ± 11.3 for TASC D (p = 0.09), respectively. The ankle–brachial pressure index increased from 0.58 to 0.94 (p = 0.001) at 1 year and the incidence of in-stent restenosis (ISR) was 19.3%. Stent fracture and disconnection rate was 17.7%. ConclusionsPrimary stenting of TASC C and D lesions appears to be safe and efficient given the high-sustained clinical improvement and the low rate of ISR observed in our study. Endovascular treatment of such long and severe lesions exposes to high rate of stent fractures, which should not be a concern given their low clinical impact.

Single-Center Experience in Endovascular Treatment for Infrainguinal Bypass Obstructions

PurposeTo evaluate patency and clinical efficacy of endovascular therapy for infrainguinal bypass obstructions. Materials and MethodsPatients were categorized with regard to symptoms (asymptomatic/intermittent claudication [IC] vs critical limb ischemia [CLI]), bypass graft material used (autologous vs prosthetic graft), and localization of distal anastomoses (femoropopliteal vs femorodistal bypass). Primary patency was defined as absence of sonographically verified stenosis greater than 50%. Assisted primary patency was applied to secondary revisions to prevent impending occlusion. Secondary patency refers to repeat interventions aimed at restoring bypass patency after occlusion. Primary sustained clinical improvement in IC was defined as an upward shift of at least one category per Rutherford classification, accordingly to a level of claudication in patients with CLI. ResultsA total of 54 patients (54 limbs, 12 with CLI) were included. At 1 year, primary patency rates were 74% in IC and 27% in CLI (P = .001), primary assisted patency rates were 85% in IC and 68% in CLI (P = .05), and secondary patency rates were 89% in IC and 100% in CLI (P = .32). Accordingly, primary sustained clinical improvement rates were 64% in IC and 25% in CLI (P = .018). After adjustment for confounding factors, CLI (hazard ratio [HR], 7.8; 95% CI, 2.3–26.32; P = .001) and impaired patent runoff (ie, less than three crural runoff vessels; HR, 0.16; 95% CI, 0.03–0.96; P = .045) were independently associated with impaired primary patency. ConclusionsEndovascular revascularization is a reasonable treatment option to prevent impending bypass occlusion. Presence of CLI and impaired crural runoff are independent risk factors for lower patency rates.

Endovascular Revascularization of Below-the-Knee Arteries: Prospective Short-Term Angiographic and Clinical Follow-Up

Purpose To evaluate arterial lesion characteristics and their impact on angiographic and clinical outcomes after endovascular below-the-knee (BTK) revascularization. Materials and Methods Between April 2008 and June 2009, 33 patients (mean age 74.9 years) with 34 limbs and 50 arterial segments (mean lesion length 59.3 mm) undergoing endovascular BTK revascularization agreed to undergo prospective clinical and intraarterial angiographic 6-month follow-up evaluation. Clinical indication for BTK revascularization was critical limb ischemia (CLI) in 18 patients and delayed wound healing without hemodynamic evidence of CLI and intermittent claudication (IC) in 15 patients. Results Binary restenosis was observed in 40% of treated segments at 6 months. Primary sustained clinical improvement was 82.4% and 55.9% at 3 months and 6 months. Lesion length was independently associated with binary restenosis (hazard ratio [HR] 1.013, 95% confidence interval [CI] 1.000–1.016, P = .05) and lower rates of primary sustained clinical improvement (HR 1.024, 95% CI 1.006–1.042, P = .008). Conclusions Endovascular BTK revascularization yields clinical and angiographic benefits both for patients with IC and for patients with CLI. Although arterial lesion length adversely affects angiographic and clinical outcomes after endovascular revascularization, limb salvage rates were substantially higher compared with the comparatively low patency rates after BTK angioplasty.

Endovascular Treatment of Common Femoral Artery Lesions

Currentbias is CFA lesions shouldbe treatedwithopen surgery, based on excellent results, minimal complications, concern over stent fracture and limitation of future CFA access from stents. DrGoueffic challenges the “lowrate”of complications, citing 18%minor, 3.6%major by Cardon (2001), and 5%major/ 9% minor from Kang, suggesting these numbers may be low. However, more current series show 0% major/6.6% minor complication rates for CFA endarterectomy. Dr Goueffic presents CFA stenting in 40 limbs, 90.7% ASA class 3 or lower, 30% CLI without major tissue loss, with no comparative arm. Primary outcomes were subjective rather than objective. A variety of levels of disease, 20% EIA disease extending to CFA, and 12.5% stenoses of prior graft anastomoses, as well as both self expanding and balloon expandable stents were included. In addition, 1 patient underwent concomitant open bypass, while 60% had multilevel endovascular work. They report a peri-procedure major complication rate of 5%, including 1 amputation. Primary sustained clinical improvement was 80% and secondary 90% at 1 year, with 85% freedom fromTLR. He concludes that endovascular treatment of the CFA is feasible and safe. However, 20% of those with instent restenosis at 1 year required additional interventions, including 1 with stent fracture. Two required bypass within 6 monthswith alteration of theproximal anastomosis to thePFA. Baumann evaluated endovascular CFA intervention and found primary sustained clinical improvement rates of 55% at 3 months dropping to 40% by 12 and 0% by 24 months, and

Endovascular treatment of common femoral artery obstructions

To evaluate the clinical efficacy of endovascular therapy of symptomatic obstructions of the common femoral artery (CFA). Consecutive series of patients undergoing endovascular therapy of chronic CFA obstructions between 1995 and 2009 and who were followed systematically within a prospectively maintained database. Clinical assessment was based on current guidelines including ankle-brachial index (ABI) and was performed at baseline and the day of discharge and then repeated at 3, 6, and 12 months and annually thereafter. Technical success of intervention was defined as a final residual diameter stenosis of <30%. Sustained clinical improvement was defined as a sustained upward shift of at least one category on the Rutherford classification compared with baseline without the need for repeated target lesion revascularization (TLR) or amputation in surviving patients. Limb salvage was defined as absence of a major (ie, above the ankle) amputation. Survival analysis was performed using the Kaplan-Meier method. Ninety-eight patients (38 women, mean age 72 ± 11 years) presented with 104 ischemic limbs, 20 of which (19%) were classified as having critical limb ischemia (CLI). Technical success rate was 98%. Stents were placed in eight CLI patients (40%) and in 20 claudicants (24%). Mean ABI improved from 0.28 to 0.54 (P < .001) in CLI patients and from 0.61 to 0.85 (P < .001) in claudicants. Mean follow-up was 16 months. Primary sustained clinical improvement rates at 3, 6, 12, and 24 months were 55%, 55%, 40%, and 0% in CLI patients and 81%, 75%, 68%, and 52% in claudicants, respectively. Limb salvage rates at 24 months were 94% in CLI patients and 100% in claudicants. After adjustment for confounding factors, presence of ischemic ulcers (hazard ratio [HR], 4.7; 95% confidence interval [CI], 1.49-14.85; P = .009), obstruction of the femoropopliteal arterial tract (HR, 3.9; 95% CI, 1.66-9.16; P = .002) and diabetes mellitus (HR, 2.3; 95% CI, 1.02-5.28; P = .045) were independently associated with lower rates of sustained clinical improvement. Endovascular therapy of CFA obstruction is associated with high rates of sustained clinical success in claudicants with patent femoropopliteal outflow. Presence of ischemic skin ulcers and diabetes mellitus, however, are associated with impaired efficacy of endovascular CFA treatment.