German multicenter real-world registry of stenting for superficial femoral artery disease: clinical results and predictive factors for revascularization.

PURPOSE: To investigate nitinol stent treatment of superficial femoral artery (SFA) lesions and the impact of different risk factors on the need for clinically driven target lesion revascularization (TLR) in a large, real-world population of claudicants. METHODS: Patients presenting with symptomatic SFA stenosis >70% were consecutively enrolled in the 13-center MARIS prospective registry (ClinicalTrials.gov identifier NCT01067885). There was no restriction on lesion length, thus leading to the inclusion of a real-world as well as high-risk patient cohort. The 998 participating patients (657 men; mean age 67.4±9.2 years) had 1050 lesions treated with the same nitinol stent type. The mean lesion length was 9.5±9.6 cm (range 0.5-44; median 8.0); more than a third of the lesions (450, 42.9%) were total occlusions. The primary endpoint was the need for clinically driven target lesion revascularization (TLR) at 12 months. RESULTS: Acute technical success was achieved in 1042 (99.2%) lesions. Restenosis occurred in 187 (23.7%) and reocclusion in 79 (10.0%) lesions at 12 months. The primary endpoint of TLR at 12 months was reached by 136 (17.2%) patients. The periprocedural complication rate was 5.4%. Independent predictors of TLR were female gender [odds ratio (OR) 0.5, 95% confidence interval (CI) 0.3 to 0.7, p<0.001] and lesion length >20 cm vs. 10 cm (OR 2.7, 95% CI 1.1 to 6.6, p=0.029) and 10-20 cm vs. 10 cm (OR 1.9, 95% CI 1.0 to 4.1, p=0.047). CONCLUSION: Stent implantation in the SFA is safe and associated with favorable acute and midterm results in a real-world setting. Lesion length and female gender were identified as independent risk factors for TLR.

The 1-year clinical impact of rotational aspiration atherectomy of infrainguinal lesions.

The present study was carried out to provide information about outcome of the Jetstream atherectomy device for treatment of infrainguinal arteries. From February 2006 to February 2007, 172 patients with Rutherford class 1 to 5 lower limb ischemia were enrolled at 9 study sites. The endpoints were evaluation of quality of life according to the walking impairment questionnaire (WIQ) besides technical parameters. In the total study cohort, the WIQ scale maintained improved up to 12-month follow-up. Furthermore, target lesion revascularization rate was 26% (42/162), ankle-brachial index (ABI) increased from 0.59 ± 0.21 at baseline to 0.82 ± 0.27 (P < 0.05), and mean Rutherford class dropped from 3.0 ± 0.9 at baseline to 1.5 ± 1.3 at 1 year (P < .05). The results of this prospective, multicenter, clinical study demonstrate that the Jetstream atherectomy device is a potential treatment alternative for the endovascular management to improve clinical outcome in patients with peripheral arterial occlusive disease.

One-year outcome after percutaneous rotational and aspiration atherectomy in infrainguinal arteries in patient with and without type 2 diabetes mellitus.

BACKGROUND: To compare the safety and efficacy of a rotational aspiration atherectomy system (Jetstream) for the treatment of infrainguinal arteries in diabetic versus nondiabetic patients. METHODS: A total of 172 patients with Rutherford stage 1-5 lower limb ischemia were treated with rotational aspiration atherectomy between February 2006 and February 2007. Of these, 80 patients with type 2 diabetes mellitus (DM: 46.5%) were compared with 92 nonDM (53.5%) patients. Overall, 210 target lesions (99 DM; 111 nonDM) were treated, located in the superficial femoral (67% DM; 61% nonDM), popliteal (25% DM; 30% nonDM), and tibial (8% DM; 9% nonDM) arteries. Lesion characteristics were comparable in both groups, mean lesion length was 28.5 mm (DM) and 26.2 mm (nonDM); total occlusions were present in 29% (DM) and 32% (nonDM), and 15% (DM) and 14% (nonDM) were restenotic. RESULTS: In the entire cohort, device success was 99% (all but two lesions). The major adverse event (MAE) rate (death, index limb amputation, myocardial infarction, target lesion revascularization [TLR] and target vessel revascularization) in DM at 30 days was 2.5% (n = 2 planned amputations) and 0% in nonDM. At 6 and 12 months, MAE in DM was seen in 13.8% (11/80) and 25% (20/80) compared with 21.7% (20/92) and 31.5% (29/92) in nonDM, respectively. TLR rate through 12 months was 20% (16/80) in DM and 28% in nonDM (26/92). Overall, 1 year restenosis rate was 38.2% based on duplex. The ankle-brachial index, mean Rutherford categories, and walking impairment questionnaire did not differ between groups at baseline and were increased significantly in both study cohorts at 12 months. CONCLUSION: Jetstream-assisted atherectomy in infrainguinal arteries is safe and effective in DM compared with nonDM patients. In this short-lesion cohort, vessel patency in diabetics was as good as for non-DM at 1 year. TLR and MAE were higher by trend in nonDM, although planned amputations were seen only in DM. The clinical benefit was similar in both groups.

One-year outcome of percutaneous rotational atherectomy with aspiration in infrainguinal peripheral arterial occlusive disease: the multicenter pathway PVD trial.

PURPOSE: To report a safety and efficacy study of a novel rotational atherectomy system with aspiration capabilities for the treatment of infrainguinal arterial lesions. METHODS: From February 2006 to January 2007, 172 patients (88 women; mean age 72 years, range 51-93; 47% diabetics) with Rutherford class 1-5 lower limb ischemia were enrolled at 9 study sites. Inclusion criteria were atherosclerotic stenoses >70% and up to 10 cm long in the femoropopliteal segment or up to 3 cm long in the infrapopliteal vessels (reference vessel diameter 3.0-5.0 mm). In the study, 210 lesions (mean length 2.7 cm) were treated with the Pathway PV System, including total occlusions (31%), lesions with a moderate to high calcium score (51%), and post-angioplasty (non-stent) restenotic lesions (15%). The primary study endpoint was the 30-day major adverse event (MAE) rate. RESULTS: Device success was 99% (208/210 lesions). MAE at 30 days was 1% (2 preplanned amputations). Clinically driven target lesion revascularization rates at 6 and 12 months were 15% (25/172) and 26% (42/162), respectively. The 1-year restenosis rate was 38.2% based on duplex imaging. The ankle-brachial index increased significantly from 0.59+/-0.21 at baseline to 0.82+/-0.27 (p<0.05) at 12 months. Mean Rutherford class improved from 3.0+/-0.9 at baseline to 1.5+/-1.3 at 1 year (p<0.05). CONCLUSION: The use of the Pathway PV System in atherosclerotic lesions appears to be safe and effective in improving stenosis severity, even in the presence of challenging lesion conditions. Vessel patency following intervention appears to be good up to 12 months, and these results translate into clinical benefit.

Nitinol stent implantation in TASC A and B superficial femoral artery lesions: the Femoral Artery Conformexx Trial (FACT).

PURPOSE: To investigate the impact of nitinol stenting of superficial femoral artery (SFA) lesions with a maximum length of 10 cm (TASC-II A or B) on 1-year outcomes compared to a historical study cohort from the Femoral Artery Stent Trial (FAST). METHODS: Between January 2004 and August 2005, 6 study sites enrolled 110 symptomatic patients (75 men; mean age 68+/-9 years) with a single de novo >70% SFA lesion <10 cm long treated with the self-expanding nitinol Conformexx stent. The primary study endpoint was binary restenosis determined by duplex ultrasound at 12 months. Secondary 12-month endpoints were target lesion revascularization (TLR), ankle-brachial index (ABI), mean Rutherford category, >1-class change in Rutherford category, and major adverse events. Data were analyzed according to the intention-to-treat principle and according to the actual treatment received ("on treatment" analysis). Outcomes were compared to the historical balloon angioplasty (BA) arm and the Luminexx 3 stent arm of the randomized FAST study. RESULTS: Technical success was achieved in 106 (96%) patients; at 1 year, the primary endpoint of ultrasound-assessed binary restenosis was reached in 14 (23.3%) of 60 patients (95% CI 13.4% to 36%). This restenosis rate was lower versus the historical BA (38.6%, p=0.057) or Luminexx 3 stent controls (31.7%, p=0.284) from FAST. The clinically driven TLR was 7.4% (7 of 94 clinically controlled patients), which was also lower compared to 18.3% (p=0.098) and 14.9% (p=0.267) for the historical BA and Luminexx 3 stent groups, respectively. The mean Rutherford category was reduced from 2.75+/-0.79 to 0.94+/-1.38 (p<0.0001); 85.1% were improved by at least 1 Rutherford category. The ABI increased from 0.62+/-0.15 to 0.85+/-0.20 (p<0.0001). CONCLUSION: This study of patients with SFA lesions documented favorable outcomes using nitinol stents in TASC-II A or B lesions after 1 year. The study was underpowered to prove superiority of the Conformexx nitinol stent design compared to historical balloon only or Luminexx 3 stent groups.

Treatment of critical limb ischemia using ultrasound-enhanced thrombolysis (PARES Trial): final results.

PURPOSE: To evaluate the safety and performance of ultrasound-enhanced thrombolysis in the treatment of acute thrombotic or embolic occlusion of the lower limb arteries. METHODS: From April 2005 to July 2006, 25 patients (15 men; mean age 64.1 years, range 37-82) presenting with acute (<14 days old) occlusions of the lower limb arteries were treated with local thrombolysis [recombinant tissue plasminogen activator (rtPA)] in a dosage of 1.0 mg/h using the EKOS Lysus Peripheral Catheter System with an ultrasound core. No bolus injection of rtPA was given. The mean occlusion length was 25.1 cm (range 2-70). RESULTS: The technical success rate was 100%. Total clot removal was achieved in 22 (88%) patients after 16.9 hours (range 5-24) using a mean 17 mg (range 5-25) of rtPA. In 8 cases, total clot removal of the main lesion was achieved after 6 hours (6 mg of rtPA). In 1 patient, lysis was stopped after 2.5 hours because of bleeding due a dislocation of the introducer sheath. In 2 cases, total clot removal could not be achieved; these patients were successfully treated with thromboaspiration. At the 1-month follow-up, the treated vessel was still patent in 20 patients. Two reocclusions occurred; 1 was treated with a bypass graft and the other with conservative therapy. There were no cases of amputation or death during follow-up. There were no side effects related to rtPA or the catheter system. CONCLUSION: This study demonstrates that local lysis of acute arterial occlusions using the Lysus Peripheral Catheter System is safe and effective. Blood flow is restored quickly.

Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the femoral artery stenting trial (FAST).

BACKGROUND: Endoluminal treatment of superficial femoral artery lesions is a matter of controversy. The present study was designed to investigate the impact of nitinol stenting of superficial femoral artery lesions with a maximum length of 10 cm on restenosis and clinical outcomes at 1 year. METHODS AND RESULTS: Two hundred forty-four patients (168 men; 66+/-9 years) with a single superficial femoral artery lesion and chronic limb ischemia were randomized to implantation of a single Bard Luminexx 3 stent (123 patients) or stand-alone percutaneous transluminal angioplasty (PTA) (121 patients). Mean lesion length was 45 mm. Technical success (residual stenosis <50% for PTA, <30% for stenting) was achieved in 96 patients assigned to PTA (79%) and 117 patients assigned to stenting (95%); 13 PTA group patients (11%) "crossed over" to stenting. At 1 year, the primary end point of ultrasound-assessed binary restenosis was reached in 39 of 101 PTA group patients (38.6%) and 32 of 101 stent group patients (31.7%; absolute treatment difference, -6.9%; 95% CI, -19.7% to 6.2%; P=0.377). Target lesion revascularization rates at 1 year were 18.3% and 14.9%, respectively (absolute treatment difference, -3.3%; 95% CI, -13.0% to 6.4%; P=0.595). No statistically significant difference between treatment groups was observed at 12 months in the improvement by at least 1 Rutherford category of peripheral arterial disease. CONCLUSIONS: In the present study of patients with short superficial femoral artery lesions, the hypothesized absolute difference of 20% in binary restenosis at 1 year between the implantation of a single Luminexx nitinol stent and stand-alone PTA could not be demonstrated. A smaller difference requiring a larger trial might have been missed.

Technical report and preliminary clinical data of a novel catheter for luminal re-entry after subintimal dissection.

RATIONALE AND OBJECTIVES: The objective of this study was to evaluate the safety and the effectiveness of the Outback catheter for intraluminal re-entry after subintimal dissection in the crossing of chronic arterial occlusions. METHODS: This study was a proof-of-concept feasibility. Ten patients with totally occluded arteries in the iliac artery to the distal femoral artery (mean occlusion length, 13.1 cm; range, 5-25 cm) were treated with the novel catheter. After successful re-entry, PTA or PTA plus stenting was performed. RESULTS: No perforations, dissections, lacerations, or device complications occurred. The procedural re-entry success rate with the Outback catheter was 50% (5/10 patients). CONCLUSIONS: Although the Outback catheter is safe, the percentage of intraluminal reaccess should be ameliorated through engineering improvements because there is some evidence to suggest that subintimal recanalization could produce improved long-term results.

Primary stent placement for infrarenal aortic stenosis: immediate and midterm results.

PURPOSE: To evaluate the safety and the long-term clinical and hemodynamic results of primary stent placement of atherosclerotic calcified stenosis of the infrarenal aorta. MATERIAL AND METHODS: Between July 1996 and July 1999, 15 patients (nine male, si- female; mean age, 53.9 years) with symptomatic, calcified aortic stenosis were treated with primary stent placement. Patients underwent abdominal aortography and bilateral lower extremity arteriography. Follow-up was performed in all 15 patients. Technical success was defined as residual stenosis of less than 30% or a resting trans-systolic pressure gradient of less than 10 mm Hg after stent placement. Clinical patency was defined as the absence or improvement of symptoms after stent placement. Hemodynamic patency was defined as a normal triphasic Doppler waveform in the common femoral artery, an ankle-brachial index greater than 0.90, or the absence of a thigh-brachial pressure gradient at rest in either limb. RESULTS: Technical success was achieved in 13 of 15 patients. The two patients considered to be technical failures had resting trans-systolic pressure gradients of 12 and 13 mm Hg, respectively, after stent placement. After the mean follow-up of 36 months, primary clinical and hemodynamic patency rates were 85% and the secondary hemodynamic patency rate was 100%. Two of five symptomatic recurrences during the 36-month follow-up period (range, 12-46 months) were a result of aortic restenosis and were treated with repeated percutaneous transluminal angioplasty. None of the patients required aortic surgery. Complications of the primary procedure included one puncture site infection, one pseudoaneurysm, and one distal embolization, which delayed discharge of three patients. There was no morbidity during the secondary interventions. CONCLUSION: Primary stent placement as treatment of calcified infrarenal aortic stenosis proved to be safe and also provided durable long-term clinical improvement.

Percutaneous transluminal laser angioplasty versus balloon dilation for treatment of popliteal artery occlusions.

PURPOSE: To compare the immediate results, complication rates, and long-term outcomes of percutaneous transluminal laser angioplasty (PTLA) versus balloon dilation alone in the treatment of popliteal artery occlusions. METHODS: In a prospective nonrandomized study conducted between December 1994 and June 2000, 215 symptomatic patients with unilateral popliteal occlusions were treated with either dilation alone (88 patients: 52 men; mean age 62 years, range 48-83) or PTLA (127 patients: 70 men; mean age 64 years, range 49-86) using a 308-nm excimer laser followed by dilation. The average occlusion length was 10.4 cm (range 3-14). RESULTS: PTLA was successful in recanalizing 105 (82.7%) arteries, while the recanalization rate for dilation alone was only 70.4% (62/88; p=0.045). After a mean follow-up of 36 months (range 6-52), the primary and secondary patency rates were 21.7% and 50.8%, respectively, in patients with PTLA and 16.3% and 35.2% in the angioplasty group (p=0.762). The complication rates associated with both techniques were similar. CONCLUSIONS: Although initial recanalization may be better with PTLA, it does not appear to add any long-term benefit over balloon dilation alone.