Drug-Coated Balloon Angioplasty in Atherosclerosis Patients With Popliteal Artery Involvement.

PURPOSE: To investigate outcomes of drug-coated balloon (DCB) angioplasty in endovascular interventions including or restricted to the popliteal artery. METHODS: A retrospective analysis was conducted of 266 patients [median age 72 years, interquartile range (IQR) 62, 78; 166 men] treated with DCB angioplasty in 281 de novo lesions including the popliteal artery between December 2011 and January 2015 at a single center. The median lesion length was 270 mm (IQR 150, 373). The study outcomes were primary patency and predictors of restenosis [reported as the hazard ratio (HR) with 95% confidence interval (CI)]. RESULTS: The primary patency was 77.4% at a median 12.2 months (IQR 5.7, 18.8). Independent variables associated with restenosis included baseline Rutherford category (HR 1.36, 95% CI 1.05 to 1.77, p=0.02), reference vessel diameter (HR 0.77, 95% CI 0.63 to 0.95, p=0.02), dissection (HR 1.69, 95% CI 1.022.79, p=0.04), and standard nitinol stent use (HR 2.08, 95% CI 1.14 to 3.79, p=0.02). CONCLUSION: Outcomes after DCB angioplasty in lesions including the popliteal artery were acceptable compared with previous studies. Further investigation with long-term follow-up is needed to confirm these results.

Six-Month Results From the Initial Randomized Study of the Ranger Paclitaxel-Coated Balloon in the Femoropopliteal Segment.

PURPOSE: To evaluate the performance of the Ranger paclitaxel-coated balloon vs uncoated balloon angioplasty for femoropopliteal lesions. METHODS: Between January 2014 and October 2015, the prospective, randomized RANGER SFA study ( ClinicalTrials.gov identifier NCT02013193) enrolled 105 patients with symptomatic lower limb ischemia (Rutherford category 2-4) and stenotic lesions in the nonstented femoropopliteal segment at 10 European centers. Seventy-one patients (mean age 68±8 years; 53 men) were enrolled in the Ranger drug-coated balloon (DCB) arm and 34 patients (mean age 67±9 years; 23 men) were assigned to the control group. Six-month analysis included angiographic late lumen loss and safety and clinical outcomes assessments. RESULTS: Baseline characteristics of the DCB and control groups were similar, as were lesion lengths (68±46 vs 60±48 mm; p=0.731), severity of calcification (p=0.236), and the prevalence of occlusions (34% vs 34%; p>0.999). At 6 months, late lumen loss was significantly less for the DCB group vs controls (-0.16±0.99 vs 0.76±1.4; p=0.002). The DCB group had significantly greater freedom from binary restenosis (92% vs 64%; p=0.005) and primary patency rates (87% vs 60%; p=0.014). Target lesion revascularization rates were 5.6% in the DCB group and 12% in the control group (p=0.475). No target limb amputations or device-related deaths occurred in either group. CONCLUSION: Six-month results suggest that Ranger DCB treatment effectively inhibited restenosis in symptomatic femoropopliteal disease, resulting in improved vessel patency and a low revascularization rate in the short term compared with uncoated balloon angioplasty.

Midterm Patency After Femoropopliteal Interventions: A Comparison of Standard and Interwoven Nitinol Stents and Drug-Coated Balloons in a Single-Center, Propensity Score-Matched Analysis.

PURPOSE: To describe and compare primary patency rates in patients undergoing endovascular femoropopliteal interventions with standard or interwoven nitinol stents or drug-coated balloons. METHODS: A cohort of 1292 patients was treated for symptomatic femoropopliteal occlusive disease classified as Rutherford category ≥ 1 at a large vascular center between June 2006 and August 2013 using either standard nitinol stents (SNS; n=432), interwoven nitinol stents (INS; n=470), or drug-coated balloons (DCB; n=390). Primary patency rates were assessed by ultrasound or angiographic readings for over 3 years of follow-up. Propensity score-matched pairs were formed to compare each treatment with another using survival analysis. RESULTS: Survival curves of primary patency favored INS compared with SNS in 368 propensity score-matched pairs (p<0.001). Kaplan-Meier estimates at 1, 2, and 3 years were 86.6%, 76.4%, and 68.9%, respectively, in the INS group vs 60.5%, 46.1%, and 42.1%, respectively, in the SNS group. No significant difference (p=0.232) was seen for the comparison of SNS vs DCB in 284 matched pairs over long-term follow-up (primary patency estimates at 1, 2, and 3 years were 79.8%, 53.8%, and 32.9%, respectively, in the DCB group vs 60.5%, 44.8%, and 40.3%, respectively, in the SNS group). Survival curves of primary patency favored INS over DCB in 254 matched pairs (p<0.001). Kaplan-Meier estimates at 1, 2, and 3 years were 79.0%, 51.2%, and 30.1%, respectively, in the DCB group vs 89.0%, 76.9%, and 66.2%, respectively, in the INS group. CONCLUSION: Propensity score-based analysis of primary patency suggests profound differences in restenosis rates between various treatment modalities for femoropopliteal disease for over 3 years of follow-up.

Single-Center Experience With Lutonix Drug-Coated Balloons in Infrapopliteal Arteries.

PURPOSE: To examine patient outcomes following the use of the Lutonix drug-coated balloon (DCB) in patients undergoing endovascular intervention in below-the-knee (BTK) arteries. METHODS: A retrospective chart review identified 248 patients who were treated for symptomatic peripheral artery disease with the Lutonix DCB between May 2013 and October 2014. Forty patients were lost to follow-up, leaving 208 patients (mean age 74.1±9.7 years; 138 men) with evaluable data for outcome analysis. The patient cohort suffered from either severe claudication (38.6%) or critical limb ischemia (CLI; 61.4%) in 220 limbs. Almost two-thirds (140, 63.6%) of the 220 target lesions were total occlusions, and 37 (17.8%) of all patients had occlusion of all 3 BTK vessels before intervention. RESULTS: Over a median 9-month follow-up, target lesion revascularization occurred in 15.9% of patients with an average time to first reintervention of 8 months. In total, 39 amputations were performed in 31 limbs. However, 17 of these amputations were preplanned minor amputations below the ankle; only 9 (4.1%) major amputations occurred corresponding to 6.6% of the CLI cohort. Freedom from the composite of death or major amputation was estimated as 92% and 85% at 6 and 12 months, respectively, by Kaplan-Meier analysis. In the full cohort, improvement of at least 1 Rutherford category was seen in 130 (59.1%) limbs after 1 year or at the last follow-up, with 104 (80.0%) of those limbs showing an improvement of ≥2 categories. CONCLUSION: From this single-center experience, the Lutonix DCB shows therapeutic promise in a disease state where new treatment options are needed.

Evaluation of the Biodegradable Igaki-Tamai Scaffold After Drug-Eluting Balloon Treatment of De Novo Superficial Femoral Artery Lesions: The GAIA-DEB Study.

PURPOSE: To evaluate the safety and efficacy of the Igaki-Tamai biodegradable scaffold after drug-eluting balloon (DEB) angioplasty in patients with occlusive superficial femoral artery (SFA) disease. METHODS: A prospective, single-center, nonrandomized study enrolled 20 patients (mean age 66.7±11.6 years; 14 men) with symptomatic de novo SFA lesions undergoing angioplasty with the In.Pact Admiral paclitaxel-coated balloon and subsequent implantation of the Igaki-Tamai bioresorbable scaffold. All patients were claudicants. The average diameter stenosis was 89.7%, and the mean length was 43.6 mm. Clinical examinations with duplex sonography were performed after 1, 6, 9, and 12 months. The main study outcomes were technical success, restenosis, target lesion revascularization (TLR), ankle-brachial index (ABI) improvement, and changes in quality of life evaluated with the walking impairment questionnaire. Safety was assessed by monitoring the occurrence of adverse events. RESULTS: Angioplasty with a paclitaxel-coated balloon was performed in all patients, resulting in an average diameter stenosis of 24%. Subsequent implantation of the Igaki-Tamai scaffold reduced the average diameter stenosis to 3.5%. In the first 6 months, 2 cases of restenosis were reported, with no TLRs within that period. However, by the 12-month follow-up in 19 patients, 11 patients had lost in-stent patency. Among these patients, 8 had TLRs, which were the only adverse events recorded that were referable to the procedure. Quality-of-life assessments showed improvement in the majority of patients. CONCLUSION: The GAIA-DEB study shows that DEB treatment of the femoral artery prior to the implantation of the biodegradable Igaki-Tamai scaffold is safe. However, the antiproliferative actions of paclitaxel in the vessel wall were not effective in preventing restenosis. In-stent restenosis occurred predominantly after 6 months.

A novel self-expanding interwoven nitinol stent for complex femoropopliteal lesions: 24-month results of the SUPERA SFA registry.

PURPOSE: To examine the efficacy and integrity of a novel interwoven self-expanding nitinol stent system for the treatment of complex femoropopliteal lesions in a "real world" medical practice. METHODS: This retrospective analysis included 107 consecutive patients (77 men; mean age 68.9 years) with atherosclerotic femoropopliteal lesions (occlusions in 31%) who underwent implantation of 137 SUPERA stents. The patients were followed for up to 24 months by Doppler ultrasound examinations, radiography of the stent, and assessments of Rutherford-Becker class and ankle-brachial index (ABI). RESULTS: The mean implanted stent length was 111±50 mm (range 40-270). Procedure success (residual stenosis <30%) was achieved in 99% of procedures. The 6-, 12-, and 24-month cumulative primary patency rates (± standard error) were 93.1%±2.5%, 84.7%±3.6%, and 76.1%±4.5%, respectively, and the secondary patency rates were 99.0%±0.1%, 94.8%±0.2% and 91.9%±0.3%, respectively. Between baseline and 24 months, mean ABI increased from 0.68±0.14 to 0.87±0.10 and the mean Rutherford-Becker class decreased from 3.3±0.7 to 2.0±1.0 (p<0.0001 for both). Radiographs performed in 91 patients at a mean of 16.8±7.0 months found no stent fractures. CONCLUSION: Over a 2-year surveillance period, excellent durability without stent fractures was documented after implantation of the SUPERA stent in complex femoropopliteal lesions. In addition, significant improvements were observed in symptom classification and hemodynamics.

Drug-Eluting Stent Versus Drug-Coated Balloon Revascularization in Patients With Femoropopliteal Arterial Disease.

BACKGROUND: Randomized trials of drug-eluting stents (DES) and drug-coated balloons (DCB) for femoropopliteal interventions reported superior patency rates for both strategies compared to standard balloon angioplasty. To date, head-to-head comparisons are missing. OBJECTIVES: The authors sought to compare DES versus DCB for femoropopliteal lesions through 36 months. METHODS: Within a multicenter, randomized trial, 150 patients with symptomatic femoropopliteal disease were randomly assigned to primary DES implantation or DCB angioplasty with bailout stenting after stratification for lesion length (≤10 cm, >10 cm to ≤20 cm, and >20 cm to ≤30 cm). The primary effectiveness endpoint was primary patency at 12 months assessed by Kaplan-Meier. Secondary endpoints comprised major adverse events including death, major amputations, and clinically driven target lesion revascularization, and clinical outcomes. RESULTS: More than one-half of lesions were total occlusions, and the stenting rate was 25.3% in the DCB group. Kaplan-Meier estimates of primary patency were 79% and 80% for DES and DCB at 12 months (p = 0.96) but decreased to 54% and 38% through 36 months (p = 0.17), respectively. Freedom from clinically driven target lesion revascularization was >90% at 12 months but dropped to around 70% at 36 months in both groups. Overall, the mortality rate through 36 months was 7.3%, with 1 procedure-related death in the DCB group. Improvement of clinical outcomes was sustained through 36 months. CONCLUSIONS: Patency rates at 12 months suggest comparable effectiveness and safety of DES versus DCB plus bailout stenting in femoropopliteal interventions; a trend in favor of the DES was observed up to 36 months. (Randomized Evaluation of the Zilver PTX Stent vs. Paclitaxel-Eluting Balloons for Treatment of Symptomatic Peripheral Artery Disease of the Femoropopliteal Artery [REAL PTX]; NCT01728441).

Drug-Coated Balloons for Complex Femoropopliteal Lesions: 2-Year Results of a Real-World Registry.

OBJECTIVES: The authors sought to investigate the efficacy of a drug-coated balloon (DCB) for treatment of complex femoropopliteal lesions. BACKGROUND: Superiority of DCBs compared with uncoated balloon angioplasty for femoropopliteal interventions has been demonstrated in randomized trials for short lesions. Their performance in complex lesions with higher restenosis rates is unclear. METHODS: Patency, target lesion revascularization (TLR) rate, clinical improvement, and safety endpoints of femoropopliteal lesions in 288 limbs (n = 260) treated with the In.Pact Pacific or Admiral DCB (Medtronic, Minneapolis, Minnesota) were retrospectively analyzed for up to 2 years of follow-up. Predictors of restenosis were identified by logistic regression. RESULTS: Lesions were de novo in 51.7%, restenosis in 11.1%, and in-stent restenosis in 37.2%. Mean lesion length was 24.0 ± 10.2 cm, and 65.3% were occluded. Stent implantation was performed in 23.3%. Kaplan Meier estimates of primary patency were 79.2% and 53.7% for all lesions at 1 and 2 years, respectively, whereas freedom from TLR was 85.4% and 68.6%. Primary patency for in-stent restenosis treatment was 76.6% and 48.6%, and freedom from TLR was 83.0% and 58.7% at 1 and 2 years, respectively. Rutherford category improved from a median 3.3 to 1.2 at 1 year, and to 1.1 at 2 years. Major amputation rate was 2.1% at 2 years. No adverse events were thought to be attributable to the coating of the balloon. CONCLUSIONS: These results suggest that DCB are safe and effective in delaying rather than preventing restenosis in long, complex lesions and restenosis of the femoropopliteal tract. Further studies are recommended to confirm these results.

Treatment of complex atherosclerotic popliteal artery disease with a new self-expanding interwoven nitinol stent: 12-month results of the Leipzig SUPERA popliteal artery stent registry.

OBJECTIVES: We examined the efficacy and durability of a new interwoven self-expanding nitinol stent system in the treatment of complex popliteal artery lesions in unselected patients. BACKGROUND: The optimal endovascular treatment strategy for atherosclerotic popliteal artery disease is not known. METHODS: We retrospectively analyzed the data gathered in 101 consecutive patients presenting with atherosclerotic, popliteal arterial disease, who underwent implantation of 125 stents. The patients were followed for 12 months by Doppler ultrasound examinations, stent roentgenograms, and estimation of Rutherford-Becker class (RBC) and ankle-brachial index (ABI). RESULTS: The mean age of the patients was 73.1 years, and 52.5% were men. Total occlusions were present in 48 patients (47.5%). The mean stent length was 84.3 ± 45.1 mm (range 40 to 240 mm). A <30% residual stenosis was achieved in 98.0% of procedures. The 6- and 12-month primary patency rates were 94.6 ± 2.3% and 87.7 ± 3.7%, respectively, and the secondary patency rates 97.9 ± 1.5% and 96.5 ± 2.0%, respectively. Between baseline and 12 months of follow-up, mean ABI increased from 0.58 ± 0.15 to 0.97 ± 0.18, and mean RBC decreased from 3.1 ± 0.9 to 1.4 ± 0.8 (p < 0.001 for both comparisons). Radiographs performed on 51 patients, at a mean of 15.2 months, confirmed the absence of stent fractures in 100% of examinations. CONCLUSIONS: Over a 12-month observation period, the patency rate and durability of SUPERA stents implanted for severe popliteal artery disease were high.