October 5, 2021

First Round of Late-Breaking Clinical Trial Results Announced at VIVA21

LAS VEGAS, Oct. 5, 2021 /PRNewswire/ -- The VIVA Foundation, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, announces the first round of 16 highly anticipated late-breaking clinical trial results at VIVA121 hosted at Wynn Las Vegas.

VIVA (Vascular InterVentional Advances) is an annual vascular education symposium that brings together a global, multispecialty faculty to present a variety of talks and live case presentations from clinical centers around the world. Attendees include an audience of interventional cardiologists, interventional radiologists, vascular surgeons, and endovascular medicine specialists.

Below are highlights of this morning's 4 late-breaking clinical trial presentations.

5-Year Results From the IN.PACT Global Study Prespecified Cohorts: Chronic Total Occlusions, Long Lesions, and In-Stent Restenosis
Presented by Gunnar Tepe, MD

Outcomes from the IN.PACT Global Study have demonstrated the clinical effectiveness and safety of IN.PACT Admiral drug-coated balloon (DCB; Medtronic) angioplasty through 1 year for prespecified cohorts of femoropopliteal chronic total occlusion (CTO), long lesion (LL), and de novo in-stent restenosis (ISR) in real-world patients. This presentation is the first report on the long-term safety and effectiveness follow-up outcomes of these independent prespecified cohorts. The IN.PACT Global Study was a prospective, multicenter, single-arm study conducted at 64 international sites that enrolled 1,535 participants, including some with complex lesions. Assessments through 5 years included freedom from clinically driven target lesion revascularization (CD-TLR), safety composite, and major adverse events.

The mean lesion lengths were 22.8 ± 9.7 cm, 26.4 ± 8.6 cm, and 17.1 ± 10.5 cm in the CTO, LL, and de novo ISR cohorts, respectively. The majority of lesions were calcified. Kaplan-Meier estimates of freedom from CD-TLR through 5 years were 69.8% for CTO, 67.3% for LL, and 58.0% for de novo ISR. The cumulative incidences of the composite safety endpoint were 69.8%, 65.7%, and 56.0 % in the CTO, LL, and de novo ISR cohorts, respectively. The number of major target limb amputations were very low in all three cohorts, with no amputations in the CTO, two in the LL, and one in the de novo ISR. Kaplan-Meier estimates of 5-year freedom from all-cause mortality rates with vital status were 78.2% (CTO), 75.2% (LL), and 81.4% (de novo ISR).

Results demonstrated long-term clinical effectiveness of IN.PACT Admiral DCB in all three cohorts, with high freedom from CD-TLR in LL and CTO through 5 years but slightly lower in de novo ISR, highlighting the challenging nature of ISR lesions. There were no safety issues observed, supporting use of the IN.PACT Admiral DCB in the management of femoropopliteal disease.

2-Year Results of the RANGER II SFA Randomized Trial: RANGER Drug-Coated Balloon vs Uncoated Balloons Overall and for Women, Patients With Occlusions, or Moderate/Severe Calcification
Presented by Ravish Sachar, MD

Patients in the global, randomized RANGER II SFA study received treatment for superficial femoral artery and/or proximal popliteal artery lesions up to 180 mm in length with the Ranger drug-coated balloon (DCB; Boston Scientific Corporation) or uncoated percutaneous transluminal angioplasty (PTA; 3:1 randomization). Subgroup analyses were performed to describe results among patients who historically have had poorer outcomes after endovascular treatment (i.e., women, patients with baseline chronic total occlusions [CTOs] or moderate/severe calcification).

Through 2 years, Kaplan-Meier curves showed separation between the Ranger DCB and PTA arms of the overall randomized controlled trial for primary patency (log-rank P = .0129) and freedom from target lesion revascularization (TLR; log rank P = .0316), with 24-month rates of 84.0% versus 71.4% and 87.4% versus 79.5%, respectively. All-cause death rates were similar between the groups (5.7% [15/261] for Ranger DCB vs 3.2% [3/93] for PTA; P = .4218) through 24 months.

Patients with Peripheral Artery Calcification Scoring System calcification grade 3/4 who were treated with Ranger DCB (n = 133) demonstrated an improvement in primary patency (89.1% vs 72.4%; log-rank P = .0052) and freedom from TLR (90.9% vs 79.6%; log-rank P = .0246) versus PTA (n = 61).

Among patients with CTO at baseline (n = 51 for Ranger DCB and n = 29 for PTA), Kaplan-Meier estimates of primary patency were 76.6% vs 58.6% (log-rank P = .1038), and estimates of freedom from TLR were 85.6% vs 62.8% (log-rank P = .0172).

In Kaplan-Meier analysis, time to TLR was similar between women and men through 2-year follow-up (log-rank P = .1415). Two-year analysis showed that improved primary patency was sustained with Ranger DCB treatment. Subgroup analyses suggest consistent benefit of DCB versus PTA among patients with historically poorer lesion subtypes, with greater freedom from TLR among patients with moderate/severe calcification or CTO and with no reintervention disadvantage based on gender.

Racial Differences in Presentation and Outcomes After Peripheral Vascular Interventions: Insights from the NCDR-PVI Registry
Presented by Howard M. Julien, MD, MPH, ML

The association between Black race and higher prevalence of peripheral artery disease (PAD) has been well established. Among PAD patients, Black race is independently associated with a greater likelihood of undergoing lower extremity amputation compared with surgical revascularization. After accounting for sociodemographic community distress, comorbid conditions, clinical presentation, and hospital characteristics, we aimed to evaluate whether the employment of drug-eluting technologies, atherectomy, and intravascular imaging during peripheral vascular intervention (PVI) procedures differed between Black and White patients in the NCDR-PVI registry.

Among 63,150 patient cases, Black patients were younger (67.9 vs 70.0 years), had higher rates of hypertension (94.4% vs 89.5%) and diabetes (63.0% vs 46.2%), were less likely to report being able to walk 200 meters (29.1% vs 24.8%), and had higher DCI scores (65.1 vs 50.6). Black patients had higher use of drug-eluting technologies (adjusted odds ratio [aOR], 1.14; 95% CI, 1.06-1.23), with no difference in atherectomy use (aOR, 0.98; 95% CI, 0.91-1.05) or intravascular imaging use (aOR, 1.03; 95% CI, 0.88-1.22).

In Centers for Medicare & Medicaid Services–linked analyses of 7,429 cases (11.8%), Black patients had nonsignificantly greater adjusted hazard ratio (aHR) for major amputation (aHR, 2.50; 95% CI, 0.82-7.63) and were less likely to have surgical (aHR, 0.40; 95% CI, 0.17-0.96) or repeat PV revascularization (aHR, 0.42; 95% CI, 0.30-0.59) at 1 year compared to White patients.

Overall, after controlling for demographic and socioeconomic factors, Black patients were younger and had higher rates of comorbidities and lower socioeconomic status. Black patients had significantly higher rates of drug-eluting technology use but were less likely to have surgical or repeat PVI revascularization in the year after index PVI.

Real-World Evaluation of Disparities in Critical Limb Ischemia Management Associated With Major Limb Amputation
Presented by Eric A. Secemsky, MD, MSc

Well-established disparities in care exist for patients with critical limb ischemia (CLI). We aimed to determine whether (1) patient, hospital, and geographic fac-tors are associated with different intensities of vascular care received prior to major amputation and (2) the intensity of vascular care received in the year before major amputation is associated with differences in outcomes postamputation.

We used Medicare claims data from 2016 to 2019 to identify patients with a CLI diagnosis who underwent a major lower limb amputation. To understand the fac-tors associated with the intensity of vascular care received in the year prior to amputation, intensity was categorized as low (no angiography or revascularization), medium (angiography only), or high (revascularization by any method: surgical, endovascular, or hybrid). We then examined the association of patient (demographics, comorbidities), hospital, and geographic characteristics with receiving low- (reference group) versus medium- versus high-intensity vascular care before amputation using ordered multivariable logistic regression. Secondary endpoints examined included mortality and readmission.

Of 7,904 Medicare beneficiaries who underwent major amputation, 46% were above-the-knee amputations. Among the study cohort, 5,090 (63.4%) received low-intensity vascular care, 442 (5.5%) received medium-intensity care, and 2,500 (31.1%) received high-intensity vascular care. After multivariable adjustment, being male, being low income, or receiving care at a safety-net hospital were all strongly associated with receiving lower-intensity vascular care prior to amputation. Patients who received high-intensity care died at a frequency of 19% versus 23% among those who received low-intensity vascular care in the 2 years following amputation. In addition, by 12 months postamputation, 40%, 50%, and 48% of patients receiving high-, medium-, and low-intensity care, respectively, were readmitted. These data emphasize the importance of vascular care before amputation and the continued disparities that exist in contemporary vascular practice.

About the VIVA Foundation
The VIVA Foundation, 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 the 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 the VIVA Foundation, visit https://thevivafoundation.org/.