VIVA Physicians, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, announced the first five of 19 highly anticipated late-breaking clinical trial results on Tuesday morning at VIVA 18, hosted at Wynn Las Vegas.
Below are highlights from the first round of late-breaking clinical trial presentations.
IN.PACT SFA RANDOMIZED TRIAL 5-YEAR RESULTS SHOW SUPERIOR OUTCOMES
Presenter: John R. Laird, MD
The IN.PACT SFA trial is a prospective, multicenter, randomized, single-blinded trial that enrolled 331 patients with symptomatic (Rutherford 2-4) femoropopliteal lesions. Eligible patients were randomly assigned in a 2:1 ratio to treatment with the In.Pact Admiral drug-coated balloon (DCB, Medtronic) or standard percutaneous transluminal angioplasty (PTA). Assessments through 5 years included freedom from clinically driven target lesion revascularization (CD-TLR) and primary safety endpoints. The primary safety endpoint is defined as freedom from device- and procedure-related death through 30 days post procedure, and freedom from target limb major amputation and clinically driven target vessel revascularization (CD-TVR) within 5 years. Major adverse events (composite of all-cause death, CD-TVR, target limb major amputation, and thrombosis) were assessed through 5 years.
Patients treated with the In.Pact Admiral DCB demonstrated a sustained treatment effect with superior freedom from CD-TLR when compared to PTA (74.5% for DCB vs 65.3% for PTA; P = .020) through 5 years. The time to first CD-TLR was significantly longer in the DCB group (807.5 ± 433.9 days) as compared to PTA (474.9 ± 484.3 days; P < .001). The primary safety composite was achieved in 70.7% of subjects in the DCB group and 59.6% in the PTA group (P = .068). The major adverse event rate was 42.9% for DCB and 48.1% for PTA (P = .459). The CD-TLR rate through 5 years was 10.1% lower for the DCB cohort compared to PTA (25.5% for DCB vs 35.6% for PTA). There were no device- or procedure-related deaths in either group as adjudicated by an independent and blinded clinical events committee.
The IN.PACT SFA randomized trial demonstrates that the In.Pact Admiral DCB continues to perform better than PTA through 5 years with a higher rate of freedom from CD-TLR and a longer time to first reintervention. The sustained safety and effectiveness profile of this DCB further supports its use as a first-line treatment choice for femoropopliteal lesions.
TOBA II TRIAL 1-YEAR RESULTS
Presenter: William A. Gray, MD
Dissections are a frequent, clinically problematic outcome of percutaneous transluminal angioplasty (PTA). TOBA II evaluated the Tack Endovascular System (Intact Vascular, Inc.) for treating post-PTA dissection in the superficial femoral (SFA) and/or proximal popliteal (PPA) arteries.
TOBA II is a prospective, single-arm US and European clinical trial that enrolled 213 patients. Eligibility included Rutherford classification 2 to 4 with de novo or non-stented restenotic target SFA/PPA lesion(s) undergoing standard PTA or drug-coated balloon dilation (Lutonix, BD Interventional). After balloon treatment, lesions with < 30% residual stenosis and presence of ≥ one dissection by angiographic visual estimate were treated with the Tack Endovascular System. The system consists of six preloaded self-expanding nitinol Tack implants on a 6-F catheter. Each implant is 6 mm in length, self-sizes to vessels 2.5 mm to 6 mm in diameter, and uses low radial force to appose dissected tissue against the vessel wall. The 12-month efficacy endpoint of primary patency (freedom from duplex-assessed binary restenosis and clinically driven target lesion revascularization [CD-TLR]) was compared to a performance goal derived from historical outcomes of standard and drug-coated balloons.
Mean age (± SD) was 68 ± 9 years; 42% of patients were diabetic; 23% of lesions were total occlusions; and > 60% had moderate/severe calcium. Mean lesion length was 74.3 ± 40.6 mm, and more than 69.4% of subjects had a post-PTA dissection ≥ grade C.
The safety endpoint was met with zero major adverse events at 30 days (P < .0001). The 12-month efficacy endpoint was met (P = .0005), and Kaplan-Meier primary patency and freedom from CD-TLR were 79.3% and 86.5%, respectively; 92.1% of all dissections resolved to none.
In conclusion, the TOBA II trial met its primary endpoints of safety and efficacy in a 100% dissected vessel population. High rates of dissection resolution, patency, and freedom from CD-TLR present Tack as an ideal adjunct to PTA.
STELLAREX DCB FOR TREATMENT OF FEMOROPOPLITEAL ARTERY DISEASE: DOES SEX AFFECT OUTCOMES?
Presenter: Maureen Kohi, MD
The purpose of this trial was to evaluate sex-related differences in the outcomes of the Stellarex drug-coated balloon (DCB, Philips) for the treatment of femoropopliteal arterial disease. A subgroup analysis of the DCB cohort of the Europe and United States ILLUMENATE trial was performed. The study endpoints included primary safety and efficacy at 12 months and were compared between men and women. To identify predictive factors for patency, a multivariable predictor analysis was performed.
The study included a total of 418 patients with 269 men (64%) and 149 women (36%). The female subgroup was significantly older compared to men. The mean reference vessel diameter was significantly smaller and the lesion length was significantly longer in the female subgroup compared to the male subgroup.
There was no significant difference in the 12-month primary patency rate or clinically driven target lesion revascularization rate between men and women. The multivariate analysis demonstrated that reference vessel diameter, lesion length, previous intervention in study limb, severe calcification, and geographic miss were predictors of patency.
Based on this study, despite older age, more comorbidities, and worse vessel and lesion characteristics, women had similar patency outcomes compared to men after treatment with the Stellarex DCB. As a result, further evaluation of the efficacy of DCBs is necessary to understand the disparate nature of the disease progression and to optimize treatment outcomes in women with peripheral artery disease.
1-YEAR OUTCOMES FOR ELUVIA IN LONG LESIONS: IMPERIAL LONG LESION SUBSTUDY
Presenter: William A. Gray, MD
The clinical effect of a drug-eluting stent (DES) in the femoropopliteal segment has not been investigated in a randomized trial with a contemporary comparator. The IMPERIAL randomized study sought to compare the safety and efficacy of the polymer-coated, paclitaxel-eluting Eluvia stent (Boston Scientific Corporation) with the polymer-free, paclitaxel-coated Zilver PTX stent (Cook Medical) for the treatment of femoropopliteal artery segment lesions. Results of that trial were recently published and demonstrated superiority of the Eluvia DES over Zilver PTX in lesions of approximately 8 cm in length, with 88.5% patency and 4.5% target lesion revascularization (TLR) rates at 1 year.
In this nonrandomized, single-arm substudy of IMPERIAL, 50 patients with symptomatic lower limb ischemia manifesting as claudication (Rutherford category 2, 3, or 4) with atherosclerotic lesions between 14 cm and 19 cm in length in the native superficial femoral artery or proximal popliteal artery were enrolled and treated with Eluvia. The primary efficacy endpoint was primary patency (defined as a peak systolic velocity ratio ≤ 2.4, without clinically driven TLR or bypass of the target lesion), and the primary safety endpoint was major adverse events (all causes of death through 1 month, major amputation of target limb through 12 months, and TLR through 12 months).
The average lesion length was 16.2 cm, approximately twice as long as the main IMPERIAL trial cohort. No deaths, stent thrombosis, or target limb major amputation were reported in this group. One patient had two stent fractures (2.1% of total stents placed). The primary patency at 1 year was 87.9%, with a TLR rate of 6.5%.
In conclusion, in the long lesion subset of the IMPERIAL trial, the device maintained its safety and efficacy profiles similar to the main IMPERIAL study, demonstrating no decrement in this more complex patient cohort.
THE TOTAL IN.PACT DRUG-COATED BALLOON INITIATIVE POOLED ANALYSIS OF ALL SUBJECTS THROUGH 1 YEAR
Presenter: Mehdi Shishehbor, DO, MPH, PhD
This analysis sought to examine clinical safety and efficacy of the In.Pact Admiral drug-coated balloon (DCB, Medtronic) compared to percutaneous balloon angioplasty (PTA) in nearly 2,000 patients pooled from two randomized controlled trials (RCTs) and two prospective single-arm studies conducted at 147 sites across six continents and 28 countries. Patient level data from the IN.PACT SFA RCT, IN.PACT SFA Japan RCT, IN.PACT SFA China prospective, multicenter, single-arm study, and IN.PACT Global real-world, prospective, multicenter, single-arm study were combined. A total of 1,837 patients were treated with In.Pact Admiral DCB and 143 with PTA. The primary efficacy endpoint was clinically driven target lesion revascularization (CD-TLR), primary safety was defined as freedom from device- and procedure-related death through 30 days, and freedom from target limb major amputation and CD-TLR within 12 months as adjudicated by an independent clinical events committee in all studies. Kaplan-Meier estimates were used to assess safety and efficacy at 1 year. A subgroup analysis compared the efficacy of DCB to PTA by retrospectively dividing the subjects meeting standard inclusion/exclusion criteria typical of an investigational device exemption trial into one standard group, and the remaining subjects were assigned to the broader group.
Subjects treated with the In.Pact Admiral DCB in comparison to those treated with PTA had more advanced symptoms per Rutherford category classification and lower ankle-brachial indexes. Furthermore, DCB-treated patients had more occlusions (35.3% vs 16.1%; P < .001) and longer lesion lengths (11.53 cm vs 9.55 cm, P < .001) compared to those who underwent PTA. The 12-month Kaplan-Meier curve demonstrated significantly higher freedom from CD-TLR for the In.Pact Admiral DCB (93.8% vs 80.2%, P < .001). After dividing the patients into the standard and broader use as defined previously, In.Pact Admiral DCB remained clinically superior to PTA in both groups with excellent freedom from CD-TLR.
In the largest multiethnic, pooled, angiographic, and independently adjudicated DCB series to date, In.Pact Admiral DCB demonstrated significantly higher freedom from CD-TLR and safety composite at 1 year compared to PTA.