Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort.

Purpose: To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study (ClinicalTrials.gov identifier NCT01609296) evaluating the performance of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with femoropopliteal occlusive disease. Materials and Methods: The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09±9.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee. Results: The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank p<0.001). Predictors of CD-TLR through 36 months included increased lesion length, reference vessel diameter ≤4.5 mm, in-stent restenosis, bilateral disease, CLTI, and hyperlipidemia. Conclusion: DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease in a diverse and complex real-world population is associated with sustained clinical efficacy and low rates of reinterventions at 3 years after the initial procedure.

The IN.PACT DEEP Clinical Drug-Coated Balloon Trial: 5-Year Outcomes.

OBJECTIVES: The goal of this study was to evaluate the 5-year follow-up data of the IN.PACT DEEP (Randomized IN.PACT Amphirion Drug-Coated Balloon [DCB] vs. Standard Percutaneous Transluminal Angioplasty [PTA] for the Treatment of Below-the-Knee Critical Limb Ischemia [CLI]) trial. BACKGROUND: Initial studies from randomized controlled trials have shown comparable short-term outcomes of DCB angioplasty versus PTA in patients with CLI with infrapopliteal disease. However, the long-term safety and effectiveness of DCB angioplasty remain unknown in this patient population. METHODS: IN.PACT DEEP was an independently adjudicated prospective, multicenter, randomized controlled trial that enrolled 358 subjects with CLI. Subjects were randomized 2:1 to DCB angioplasty or PTA. Assessments through 5 years included freedom from clinically driven target lesion revascularization, amputation, and all-cause death. Additional assessments were conducted to identify risk factors for death and major amputation, including paclitaxel dose tercile. RESULTS: Freedom from clinically driven target lesion revascularization through 5 years was 70.9% and 76.0% (log-rank p = 0.406), and the incidence of the safety composite endpoint was 59.8% and 57.5% (log-rank p = 0.309) in the DCB angioplasty and PTA groups, respectively. The rate of major amputation was 15.4% for DCB angioplasty compared with 10.6% for PTA (log-rank p = 0.108). Given the recent concern regarding a late mortality signal in patients treated with paclitaxel-coated devices, additional analyses from this study showed no increase in all-cause mortality with DCB angioplasty (39.4%) compared with PTA (44.9%) (log-rank p = 0.727). Predictors of mortality included age, Rutherford category >4, and previous revascularization but not paclitaxel by dose tercile. CONCLUSIONS: Tibial artery revascularization in patients with CLI using DCB angioplasty resulted in comparable long-term safety and effectiveness as PTA. Paclitaxel exposure was not related to increased risk for amputation or all-cause mortality at 5-year follow-up. (Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia [INPACT-DEEP]; NCT00941733).

Female sex is associated with comparable 5-year outcomes after contemporary endovascular aneurysm repair despite more challenging anatomy.

BACKGROUND: Women with abdominal aortic aneurysms less often meet anatomic criteria for endovascular repair and experience worse perioperative and long-term survival. METHODS: We compared long-term survival, aneurysm-related mortality, and rates of endoleaks and reinterventions between male and female patients in the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE) using 2:1 propensity score matching. RESULTS: There were 1130 male patients and 133 female patients, yielding 399 patients after matching (266 male patients, 133 female patients). Female patients were older, with smaller aneurysms, smaller iliac arteries, and shorter, more angulated necks, and they were more often treated outside the device instructions for use (all P < .001). Through 5 years, female patients experienced overall mortality comparable to that of well-matched male patients (34% vs 38%, respectively; hazard ratio, 0.89 [0.61-1.29]; P = .54) and lower aneurysm-related mortality (0% vs 3%; P = .047). Female patients experienced higher rates of any postoperative type IA endoleak through 5 years (10% vs 1%; P < .001) but comparable rates of secondary endovascular procedures (14% vs 16%; P = .40). Female sex was independently associated with significantly higher risk of long-term type IA endoleaks (hazard ratio, 4.8 [1.2-20.8]; P = .04), even after accounting for anatomic factors. No female patient experienced aneurysm rupture during follow-up, and only one female patient underwent conversion to open repair. CONCLUSIONS: Despite more challenging anatomy, female patients in the ENGAGE registry had long-term outcomes comparable to those of male patients. However, female patients experienced higher rates of type IA endoleaks. Although standard endovascular aneurysm repair remains a viable solution for most women, whether high-risk patients may be better served with open surgery, custom-made devices, EndoAnchors (Aptus Endosystems, Sunnyvale, Calif), or chimneys is worthy of further study.

Endograft treatment of ruptured abdominal aortic aneurysms using the Talent aortouniiliac system: an international multicenter study.

OBJECTIVE: To understand the potential of endovascular aneurysm repair (EVAR) in patients presenting with a ruptured abdominal aortic aneurysm (rAAA), the proportion in whom this procedure was applicable was assessed. Mortality and morbidity was also determined in patients treated with emergency EVAR (eEVAR) when anatomic and hemodynamic conditions allowed (ie, in the entire cohort with patients receiving endovascular and open repair combined). In addition, a comparison was made between the treatment group with eEVAR and open repair. METHODS: Between February 2003 and September 2004, 10 participating institutions enrolled a representative sample of 100 consecutive patients in whom eEVAR was considered. Patients in the New Endograft treatment in Ruptured abdominal aortic Aneurysm (ERA) trial were offered eEVAR or open repair in accordance with their clinical condition or anatomic configuration. Written informed consent was obtained from all patients or their legal representatives. The study included patients who were treated by stent-graft technique or by open surgery in the case of adverse anatomy for endoluminal stent-grafting or severe hemodynamic instability, or both. Data were collated in a centralized database for analysis. The study was sponsored and supported by Medtronic, and eEVAR was uniquely performed with a Talent aortouniiliac (AUI) system in all patients. Crude and adjusted 30-day or in-hospital and 3-month mortality rates were assessed for the entire group as a whole and the EVAR and open repair category separately. Complication rates were also assessed. RESULTS: Stent-graft repair was performed in 49 patients and open surgery in 51. No significant differences were observed between these treatment groups with regard to comorbidity at presentation, hemodynamic instability, and the proportion of patients who could be assessed by preoperative computed tomography scanning. Patients with eEVAR more frequently demonstrated a suitable infrarenal neck for endovascular repair, a longer infrarenal neck, and suitable iliac arteries for access than patients with open repair. The primary reason to perform open aneurysm repair was an unfavorable configuration of the neck in 80% of the patients. In patients undergoing eEVAR, operative blood loss was less, intensive care admission time was shorter, and the duration of mechanical ventilation was shorter (P < or = .02, all comparisons). The 30-day or in-hospital mortality was 35% in the eEVAR category, 39% in patients with open repair, and 37% overall. There was no statistically significant difference between the treatment groups with regard to crude mortality rates or rates adjusted for age, gender, hemodynamic shock, and pre-existent pulmonary disease. The cumulative 3-month all-cause mortality was 40% in the eEVAR group and 42% in the open repair group (no significant differences at crude and adjusted comparisons). The 3-month primary complication rate in the two treatment groups was similar at 59%. CONCLUSIONS: In approximately half the rAAA patients, eEVAR appeared viable. An unsuitable infrarenal neck was the most frequent cause to select open repair. In dedicated centers using a Talent AUI system, eEVAR appeared to be a feasible method for treatment of a rAAA. The overall first-month mortality did not differ across treatment groups (patients with endovascular and open repair combined), yet was somewhat lower than observed in a recent meta-analysis reporting on open repair.