Evaluation of safety and efficacy of the S.M.A.R.T.® Flex Vascular Stent System (OPEN study).

OBJECTIVES: The OPEN study evaluated the safety and efficacy of the S.M.A.R.T.® Flex Vascular Stent System in patients with femoropopliteal arterial disease. BACKGROUND: Long-term data on endovascular treatments of femoropopliteal arterial disease are required to establish the repair durability. METHODS: The OPEN study was a multicenter, single-arm, prospective study comparing primary safety and efficacy outcomes to performance goals (PG) developed for bare nitinol stents. Patients with symptoms due to a single, ≤180 mm length, de novo femoropopliteal arterial lesion with >70% stenosis were enrolled and followed for 36 months. Subjects with lesions ≤150 mm served as the initial comparison cohort for the PG (other cohorts were analyzed if the PG was met). RESULTS: 257 subjects with lesions ≤180 mm were enrolled. The mean lesion length was 71 ± 46 mm, and 52.5% had severe claudication. The primary safety endpoint (freedom from all-cause death, index limb amputation, and target lesion revascularization [TLR] through 30 days) was met in 98.8% (96.5%, 99.6%) of subjects in the comparison cohort, meeting the PG (88.0%). The primary efficacy endpoint (comparison cohort vessel patency at 12 months) was 68.4% (61.1%, 74.8%), where the lower limit of the 95% confidence interval did not meet the 66.0% PG. Freedom from TLR in the per-protocol cohort at 12-, 24-, 36-month was 84.7%, 74.6%, and 72.8%, respectively. The 24-month stent fracture rate was 4.3%, with no new fractures identified at 36 months. CONCLUSION: The results show promising long-term safety and effectiveness for the S.M.A.R.T.® Flex Vascular Stent System in patients with femoropopliteal arterial disease.

Treating Post-Angioplasty Dissection in the Femoropopliteal Arteries Using the Tack Endovascular System: 12-Month Results From the TOBA II Study.

OBJECTIVES: The aim of this study was to evaluate the Tack Endovascular System (Intact Vascular, Wayne, Pennsylvania) for treating dissections following angioplasty in the superficial femoral artery and/or proximal popliteal artery. BACKGROUND: Dissection after angioplasty of femoropopliteal arteries with either a plain balloon or a drug-coated balloon (DCB) can negatively affect both short- and long-term outcomes. METHODS: TOBA (Tack Optimized Balloon Angioplasty) II is a prospective, single-arm, multicenter study enrolling 213 patients, all with dissection following angioplasty. Eligibility included Rutherford classification 2 to 4 with a de novo or nonstented restenotic lesion in the superficial femoral artery or proximal popliteal artery undergoing plain balloon or DCB angioplasty. Following dilation, lesions with <30% residual stenosis and presence of ≥1 dissection were enrolled. The 12-month efficacy endpoint was primary patency (freedom from duplex-derived binary restenosis and clinically driven target lesion revascularization. RESULTS: Patients' mean age was 68 ± 9 years, and 43.2% had diabetes. Twenty-three percent of lesions were chronic total occlusions, and ∼60% had moderate to severe calcium. The mean lesion length was 74.3 ± 40.6 mm. Severe dissection (grade ≥C) was present in 69.4%. By operator choice, 57.7% of patients underwent DCB angioplasty. Most (92.1%) dissections resolved completely, and only 1 bailout stent was required. There were no 30-day major adverse events. The 12-month efficacy endpoint was met, with Kaplan-Meier primary patency and freedom from clinically driven target lesion revascularization of 79.3% and 86.5%, respectively. At 12 months, there were no device fractures or clinically significant migrations, and significant improvements were noted in Rutherford category, ankle-brachial index, and quality of life. CONCLUSIONS: TOBA II demonstrated the safety and efficacy of the Tack Endovascular System for focal dissection repair following standard and DCB angioplasty.

Stellarex Drug-Coated Balloon for Treatment of Femoropopliteal Disease: Twelve-Month Outcomes From the Randomized ILLUMENATE Pivotal and Pharmacokinetic Studies.

BACKGROUND: Drug-coated balloons (DCBs) are a predominant revascularization therapy for symptomatic femoropopliteal artery disease. Because of the differences in excipients, paclitaxel dose, and coating morphologies, varying clinical outcomes have been observed with different DCBs. We report the results of 2 studies investigating the pharmacokinetic and clinical outcomes of a new DCB to treat femoropopliteal disease. METHODS: In the ILLUMENATE Pivotal Study (Prospective, Randomized, Single-Blind, U.S. Multi-Center Study to Evaluate Treatment of Obstructive Superficial Femoral Artery or Popliteal Lesions With A Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon), 300 symptomatic patients (Rutherford class 2-4) were randomly assigned to DCB (n=200) or standard angioplasty (percutaneous transluminal angioplasty [PTA]) (n=100). The primary safety end point was freedom from device- and procedure-related death through 30 days, and freedom from target limb major amputation and clinically driven target lesion revascularization through 12 months. The primary effectiveness end point was primary patency through 12 months. In the ILLUMENATE PK study (Pharmacokinetic Study of the Stellarex Drug-Coated Angioplasty Balloon), paclitaxel plasma concentrations were measured after last DCB deployment and at prespecified times (at 1, 4, 24 hours and at 7 and 14 days postprocedure) until no longer detectable. RESULTS: In the ILLUMENATE Pivotal Study, baseline characteristics were similar between groups: 50% had diabetes mellitus, 41% were women, mean lesion length was 8.3 cm, and 44% were severely calcified. The primary safety end point was met (92.1% for DCB versus 83.2% for PTA, P=0.025 for superiority) and the primary patency rate was significantly higher with DCB (76.3% for DCB versus 57.6% for PTA, P=0.003). Primary patency per Kaplan-Meier estimates at day 365 was 82.3% for DCB versus 70.9% for PTA (P=0.002). The rate of clinically driven target lesion revascularization was significantly lower in the DCB cohort (7.9% versus 16.8%, P=0.023). Improvements in ankle-brachial index, Rutherford class, and quality of life were comparable, but the PTA cohort required twice as many revascularizations. Pharmacokinetic outcomes showed that all patients had detectable paclitaxel levels after DCB deployment that declined within the first hour (54.4±116.9 ng/mL to 1.4±1.0 ng/mL). CONCLUSIONS: The data demonstrate superior safety and effectiveness of the Stellarex DCB in comparison with PTA, and plasma levels of paclitaxel fall to low levels within 1 hour. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov. Unique identifiers: NCT01858428 and NCT01912937.

Midterm outcomes from the TALON Registry: treating peripherals with SilverHawk: outcomes collection.

PURPOSE: To determine midterm clinical outcomes among patients with lower extremity peripheral arterial disease who underwent revascularization with catheter-based plaque excision (PE). METHODS: Between August 2003 and February 2005, 19 institutions participating in the observational, nonrandomized, multicenter TALON registry enrolled 601 consecutive patients (353 men; mean age 70+/-11, range 36-98) with 1258 symptomatic lower extremity atherosclerotic lesions (748 limbs) treated by plaque excision with the SilverHawk catheter. Approximately 50% of the patients had diabetes, and nearly one third of the procedures were indicated for Rutherford ischemia category > or =4. Mean lesion lengths above and below the knee, respectively, were 62.5+/-68.5 mm (interquartile range [IQR], 20.0-80.0) and 33.4+/-42.7 mm (IQR 15.0-37.5). The primary endpoints of the study were target lesion revascularization (TLR) at 6 and 12 months. RESULTS: The device achieved < or =50% residual diameter stenosis in 94.7% of lesions; procedural success was 97.6%. Nearly half (41.9%) of the procedures involved PE of > or =2 lesions. Nearly three quarters (73.3%) of the lesions did not require adjunctive therapy, and stent placement following PE occurred in only 6.3% of lesions. The 6- and 12-month rates of survival free of TLR were 90% and 80%, respectively. Rates of TLR were similar among patients with diabetes (11%) and without diabetes (9%). In the multivariate analysis, significant predictors of TLR at 6 months were a history of MI or coronary revascularization (HR 5.49, 95% CI 1.87 to 16.10, p=0.0008), multiple (> or =2) lesions (HR 1.37, 95% CI 1.11 to 1.70, p=0.0019), and increasing Rutherford category (HR 1.84, 95% CI 1.28 to 2.65, p=0.0003). Lesion length >50 mm was associated with a 2.9-fold increased risk for TLR (HR 2.88, 95% CI 1.18 to 7.01, p=0.012); lesion length >100 mm was associated with a 3.3-fold increase in TLR (HR 3.32, 95% CI 1.15 to 9.56, p=0.016). CONCLUSION: In patients undergoing revascularization for lower extremity atherosclerotic disease, catheter-based PE achieves favorable procedural success and avoids the need for repeat revascularization at midterm follow-up. These findings support PE as a primary endovascular therapy for patients undergoing lower extremity arterial revascularization.

Procedural and clinical outcomes with catheter-based plaque excision in critical limb ischemia.

PURPOSE: To examine the safety and efficacy of catheter-based plaque excision as an alternative therapy to surgery, conventional angioplasty, and/or stenting in high-risk patients with critical limb ischemia (CLI). METHODS: Between August 2003 and August 2004, a prospective evaluation was conducted of consecutive patients with CLI (Rutherford category>or=5) who were treated with endovascular plaque excision at 7 institutions. This study enrolled 69 patients (37 women; mean age 70+/-12 years, range 43-93) with CLI involving 76 limbs. Clinical outcomes were prospectively followed for 6 months. The primary endpoint was major adverse events (death, myocardial infarction, unplanned amputation, or repeat target vessel revascularization) at 30 days. Visible healing of ulcerated tissue, avoidance of any amputation, and performance of less extensive amputation than initially planned were also assessed. RESULTS: Procedural success was achieved in 99% of cases. Major adverse events occurred in 1% of patients at 30 days and 23% at 6 months. The target lesion revascularization rate was 4%, and there were no unplanned limb amputations. Amputation was less extensive than initially planned or avoided altogether in 92% of patients at 30 days and 82% at 6 months. CONCLUSION: Catheter-based plaque excision is a safe and effective revascularization method for patients with CLI. These findings support further study of this modality as a singular or adjunctive endovascular therapy for limb salvage in CLI.