Final Five Unpublished Late-Breaking Clinical Trial Results Announced at VIVA20

SAN JOSE, Calif., Nov. 7, 2020 /PRNewswire/ -- VIVA Physicians, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, announces the final round of anticipated late-breaking clinical trial results presented at the VIVA20 virtual meeting.

Below are highlights of today's late-breaking clinical trial presentations:

Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes from the Randomized Disrupt PAD III Trial
Presented by William A. Gray, MD

Endovascular treatment of calcified peripheral artery lesions may be associated with suboptimal vessel expansion, increased complication risk, and reduced long-term patency. Single-arm studies have reported promising results with intravascular lithotripsy (IVL) in the presence of moderate and severe calcium, yet comparative evidence from randomized trials is lacking.

The purpose of this study is to compare acute outcomes in patients receiving vessel preparation with IVL or percutaneous transluminal angioplasty (PTA) prior to drug-coated balloon (DCB) treatment for peripheral artery disease (PAD) in calcified femoropopliteal arteries. The Disrupt PAD III randomized trial enrolled PAD patients with moderate and severe calcification in a femoropopliteal artery who underwent vessel preparation with IVL or PTA. The primary effectiveness endpoint was procedural success, defined as core-lab adjudicated residual stenosis ≤30% without flow-limiting dissection prior to DCB or stenting. Secondary endpoints evaluated at 30 days included major adverse events (MAE) and clinically-driven target lesion revascularization (CD-TLR).

In patients receiving IVL (n=153) or PTA (n=153), the primary effectiveness endpoint of procedural success was significantly greater in the IVL group (65.8% vs. 50.4%, p=0.007). Post-treatment balloon dilatation (measured prior to DCB) residual diameter stenosis (27.3 ± 11.5% vs. 30.5 ± 13.9%, p=0.04), freedom from any dissection (81.5% vs. 67.7%, p=0.009), flow-limiting dissection (1.4% vs. 6.8%, p=0.03), and provisional stent placement (4.6% vs. 18.3%, p<0.001) were also significantly lower in the IVL group. Secondary outcomes, including rates of MAE and CD-TLR at 30 days, were comparable between groups.

The Disrupt PAD III study provides the largest level I evidence for the treatment of heavily calcified femoropopliteal arteries, a cohort often excluded from endovascular treatment studies. IVL resulted in improved procedural success compared to PTA prior to DCB treatment, demonstrating better lesion dilatation, lower dissections and reduced the need for provisional stent placement.   

Drug-Coated Devices & Limb Outcomes After Endovascular Peripheral Artery Revascularizations: Insights from VOYAGER 
Presented by Connie N. Hess, MD, MHS

Endovascular lower extremity revascularization (LER) is used to treat symptomatic peripheral artery disease (PAD) but is limited by restenosis. Although paclitaxel drug-coated devices (DCD) improve patency, they have been associated with long-term mortality. Recent data from VOYAGER PAD, a trial demonstrating benefit of rivaroxaban plus aspirin versus aspirin alone in reducing severe cardiovascular and limb outcomes after lower extremity revascularization for PAD, showed no association between DCD use and mortality.  Given the absence of a safety signal, the current analysis examined the potential benefit of DCD versus non-DCD treatment for reducing limb outcomes. 

The co-primary outcomes for this analysis were unplanned index limb revascularization and major adverse limb events (MALE), defined as acute limb ischemia or major amputation of vascular cause.  As DCD use was not randomized, inverse probability treatment weighting was used to account for known confounders. Use of DCD was associated with a significant 16% reduction in relative risk of clinically-driven unplanned index limb revascularization (HR 0.84, 95% CI 0.76-0.92) but was not associated with a reduction in MALE (hazard ratio [HR] 1.08, 95% confidence interval [CI] 0.90-1.30).  Rivaroxaban plus aspirin also reduces the risk of unplanned index limb revascularization, in addition to risk of major adverse events of the heart, limb, and brain, irrespective of device type.  These observations suggest that a "pharmaco-invasive" approach in PAD combining innovative devices with effective medical therapy may optimize outcomes in PAD.

24-Month Outcomes from the DETOUR 1 Trial for Percutaneous Femoropopliteal Bypass
Presented by Ehrin Armstrong, MD

The DETOUR1 Trial was designed to evaluate the safety and effectiveness of the Detour System for percutaneous fem-pop bypass, which received FDA's Breakthrough Device Designation. Using the novel PQ Crossing Device and a series of specially designed Torus Stent Grafts, the Detour procedure was created to route blood flow around severe lesions caused by complex peripheral artery disease found in the SFA. The procedure uses the femoral vein as a pathway for a Torus stent graft conduit and travels from the artery to the vein and back into the artery.

Now reporting 24-month data, the trial enrolled an extremely complex patient cohort with an average lesion length of 371 mm; 96% of lesions had a confirmed CTO and 80% had evidence of moderate to severe calcification. At 12 and 24 months post-procedure, the study is reporting an 81% and 79% primary patency rate, respectively, as well as a rate of freedom from major adverse events of 83.7% and 82.1% at 12 and 24 months, respectively.

2-Year Outcomes of a Multi-Centre Study on Infrapopliteal Bioresorbable Vascular Scaffold 
Presented by Steven Kum, MD

Chronic Limb Threatening Ischemia (CLTI) continues to plague many patients worldwide and is associated with complex comorbidities, poor vessel patency, and major lower extremity amputations. Plain balloon angioplasty is still the mainstay of treatment although metallic drug-eluting stents have shown promise. This multi-center pooled analysis investigates the mid-term outcomes of a drug-eluting Bioresorbable Vascular Scaffold (BVS) in the treatment of CLTI and represents the largest series analyzed in the infra-popliteal arteries.

Consecutive patients with de novo infra-popliteal lesions were treated with Absorb BVS (Abbott Vascular) at three centers (in Singapore, Chicago, and Sydney) between August 2012 and May 2017. Restenosis was defined on color-flow doppler examination with a sensitive peak systolic velocity (PSV) ratio >2.0 or PSV >2 m/s (equivalent to >50% stenosis).

A total of 121 patients with 161 lesions were treated with 189 Absorb BVS in 126 limbs.

The mean age of the patients was 73 years. 57% of patients had diabetes and 75% had tissue loss.  Of the 161 lesions treated, 63% were calcified and 22% were occlusions. Median lesion length was 21 mm (4–88 mm). Successful deployment was achieved with all scaffolds.

There was no mortality in 30 days. Primary patency was 90.3% and 86.6%, and freedom from clinically driven target lesion revascularization (CD-TLR) was 97.2% and 96.6% at 12 and 24 months respectively. Major amputation occurred in 1.6% of the limbs. Overall survival was 85.8% at 24 months.

This study shows that Absorb BVS can be used for the treatment of CLTI patients in infra-popliteal arteries with no safety concerns and favorable patency, rates of re-interventions and amputations at a mid-term follow up of 24 months. The current LIFE-BTK randomized multi-center trial with the novel Esprit BTK drug-eluting resorbable scaffold (DRS) will help further assess the significance of our findings. 

4-Year DCB Mortality Across ILLUMENATE RCTs
Presented by Sean Lyden, MD

The Stellarex (Philips) drug-coated balloon (DCB) is a unique low-dose 2mcg/dl paclitaxel-coated balloon using polyethylene glycol as an excipient. The Stellarex DCB has been studied in 7 above-the-knee popliteal studies in over 2900 patients treated with independent clinical event committee for adverse event adjudications.

The ILLUMENATE EU RCT and ILLUMENATE pivotal randomized trials were pooled to compare mortality through 4 years between Stellarex DCB and the PTA (control) cohorts. An independent, 3rd party was used to make a systematic assessment of mortality data from these 2 trials at 4 years. We set a pre-specified pooled data analysis of patients treated with Stellarex DCB for ATK lesions with a test for homogeneity (I2 = 0%). 419 subjects were treated with DCB and 170 received PTA. The only pooled baseline characteristic differences in subjects were: the PTA arm was 2 years older, and the DCB arm had 8% more smokers.

There was no difference in survival between Stellarex DCB and PTA through 4 years, 85.7% vs 85.6% respectively. The was no difference in all-cause, cardiovascular or non-cardiovascular mortality. This confirms the safety of Stellarex at 4 years.

About VIVA Physicians
VIVA Physicians, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, strives to be the premier educator in the field. Our team of specialists in vascular medicine, interventional cardiology, interventional radiology, and vascular surgery is driven by the passion to advance the field and improve patient outcomes. Educational events presented by VIVA Physicians have a distinct spirit of collegiality attained by synergizing collective talents to promote awareness and innovative therapeutic options for vascular disease worldwide. To learn more about VIVA Physicians, visit www.vivaphysicians.org.

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