First Round of Late-Breaking Clinical Trial Results Announced at VIVA24

The VIVA Foundation, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, announces the results for the first of four rounds of Late-Breaking Clinical Trials presented at the VIVA24 conference, 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 lectures and live case presentations from clinical centers around the world. The audience is comprised of interventional cardiologists, interventional radiologists, vascular surgeons, and endovascular medicine specialists. Below are highlights of this morning's 5 late-breaking clinical trial presentations.

Two-Year Outcomes of the LIFE-BTK Randomized Controlled Trial Evaluating the Esprit™ BTK Drug-Eluting Resorbable Scaffold for Treatment of Infrapopliteal Lesions

Presented by: Brian DeRubertis, MD

The 2-year results from the LIFE-BTK randomized controlled trial highlight the sustained benefits of the Esprit Below-the-Knee (BTK) Drug-Eluting Resorbable Scaffold (Abbott) in treating patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal lesions. Esprit BTK demonstrated superior long-term outcomes compared to percutaneous transluminal angioplasty (PTA), particularly in terms of vessel patency and limb salvage.

At 2 years, 61.5% of patients treated with Esprit BTK achieved the combined endpoint of limb salvage and primary patency, compared to 32.8% in the PTA group. This marked an absolute risk difference (ARD) of 28.66% and a hazard ratio of 0.48 (P = .0004), confirming the scaffold’s superior efficacy in maintaining open arteries and preventing disease progression. The scaffold’s biological efficacy was evident in its ability to significantly reduce binary restenosis, with rates of 35.2% for Esprit BTK compared to 57.8% for PTA (ARD, -22.57%; P = .0054), ensuring continued vessel patency over time.

The composite of freedom from major adverse limb events at 2 years and perioperative death at 30 days was comparable between the two arms, with Esprit BTK achieving a 90.4% safety rate versus a 95.9% safety rate with PTA (P = .16), demonstrating that the scaffold offers a safe alternative for infrapopliteal interventions.

The 2-year outcomes of the LIFE-BTK trial suggest durable performance and long-term benefits with Esprit BTK. Its ability to maintain vessel patency and reduce restenosis presents a promising treatment option for CLTI patients, with efficacy and safety outcomes that compare favorably to PTA.

First Clinical Use of an Innovative Forward-Shifted Peripheral Intravascular Lithotripsy System: Late-Breaking Primary Outcomes of the Mini S/FORWARD PAD IDE Study

Presented by: JD Corl, MD

Successful endovascular treatment of peripheral artery disease is dependent on the modification of challenging lesion morphologies. The Shockwave Javelin Peripheral Intravascular Lithotripsy (IVL) catheter (Shockwave Medical) has a forward-shifted IVL emitter designed to modify calcium in subtotal occlusions or extremely narrowed calcified vessels.

The premarket, prospective, single-arm Mini S feasibility and FORWARD PAD IDE studies were pooled, and this analysis includes 103 lesions in 90 patients treated at 19 sites in Australia, New Zealand, and the United States. The primary effectiveness endpoint was defined as residual stenosis ≤ 50% without flow-limiting dissection at final angiography, and the primary safety endpoint was major adverse events at 30 days. Endpoints were adjudicated by an angiographic core laboratory and a clinical events committee.

Lesion characteristics included preprocedural stenosis of 82.9% ± 16.7%, severe calcification present in 82.5%, and 38% chronic total occlusions. The Javelin catheter was able to fully cross the target lesion in 93% of cases. The primary effectiveness (99%; P < .0001) and primary safety endpoints (1.1%; P = .0012) both met prespecified performance goals. Baseline stenosis was reduced to 23% ± 9.1% at final angiography, and there were no perforations or embolization events through 30 days.

In this 30-day analysis, the Shockwave Javelin Peripheral IVL catheter met prespecified efficacy and safety performance goals, with marked target lesion stenosis reduction without perforations or distal embolization. Further follow-up will assess longer-term outcomes with the Javelin Peripheral IVL catheter.

Thirty-Day Outcomes From the Disrupt PAD BTK II Study of the Shockwave Intravascular Lithotripsy System for Treatment of Calcified Below-the-Knee PAD

Presented by: Venita Chandra, MD

Below-the-knee (BTK) lesions may be particularly challenging to treat owing to length, diffuse disease, and extent of calcification. The Disrupt PAD BTK II study is a core lab–adjudicated, prospective, multicenter, single-arm study of patients with moderately to severely calcified BTK lesions treated with the Shockwave Peripheral Intravascular Lithotripsy (IVL) System (Shockwave Medical).

Disrupt PAD BTK II enrolled 250 patients with calcified infrapopliteal lesions and Rutherford category 3 to 5 presentation from 38 sites in the United States and Europe. The primary safety endpoint was major adverse limb events (MALE) or postoperative death at 30 days. The primary effectiveness endpoint was procedural success, defined as ≤ 50% residual stenosis for all treated target lesions without serious core lab–adjudicated serious angiographic complications. Follow-up is planned through 2 years.

A total of 305 lesions in 250 patients were treated with a procedural success of 97.9%. Mean target lesion length was 76.3 ± 65.2 mm, diameter stenosis was 77.7% ± 17.9%, and 84.8% had moderate or severe calcification as assessed by an independent angiographic core lab. After IVL, residual stenosis was reduced to 29% and to 25.5% after optional postdilatation and/or stent implantation. At 30 days, there were no deaths, the MALE rate was 0.8%, and mean improvement in VascuQoL scores was 4 ± 5 (P < .0001). Of the patients with baseline wounds, 15.8% healed and 53.4% were improved at 30 days.

IVL treatment of patients with moderately to severely calcified BTK lesions resulted in high procedural success, significant reduction in residual stenosis, and improvements in patient quality of life and wound healing, with minimal adverse events at 30-day follow-up. These outcomes support the safety and effectiveness of IVL in the treatment of patients with complex calcified BTK lesions.

Laser and Optics-Based Peripheral Intravascular Lithotripsy System for the Treatment of Above-the-Knee and Below-the-Knee Calcified Lesions: Results of the RESTORE ATK and RESTORE BTK Trials

Presented by: Thomas Zeller, MD

Arterial calcification portends poor procedural success for peripheral vascular interventions and suboptimal long-term outcomes. These studies aimed to evaluate the initial safety and efficacy of a novel laser and optics-based intravascular lithotripsy (IVL) system for calcified lesions in the peripheral vasculature (Bolt IVL, Bolt Medical).

The RESTORE ATK and RESTORE BTK trials were prospective, nonrandomized, multicenter studies conducted in Europe. Patients were treated with IVL and followed to 6 months (above the knee [ATK]) and 30 days (below the knee [BTK]). The primary safety endpoints were freedom from major adverse events (MAEs) (composite of death, clinically driven target limb revascularization [CD-TLR], and unplanned major amputation) within 30 days following the index procedure. Efficacy endpoints included procedural success (residual diameter stenosis < 50%) evaluated by an independent core laboratory.

Ninety-five (ATK) and 20 (BTK) patients were enrolled. The mean age for ATK and BTK was 70 ± 8 years and 73 ± 10 years, with 33% and 30% females, respectively. The superficial femoral and anterior tibial arteries were the most treated in each trial, with a mean vessel diameter of 5.5 ± 0.7 mm and 2.9 ± 0.4 mm, respectively, and percent diameter stenosis of 93.7% ± 7.2% and 91.4% ± 8.8%, respectively. The efficacy endpoint was achieved in 100% of patients in both studies. Residual diameter stenosis postprocedure was 21.2% ± 8.4% (ATK) and 22.8% ± 11.5% (BTK) with no MAEs occurring within 30 days. No cases of perforation, abrupt closure, no reflow, distal embolization, or dissections meeting serious AE criteria were observed. No stents were placed in BTK, and only three were placed in ATK despite the lesion complexity, length, and chronic total occlusions. Ninety-two ATK patients completed 6-month follow-up, and 18 BTK patients completed 30-day follow-up, with 2.2% and 0% CD-TLR, respectively, and no deaths or limb amputations.

These studies demonstrate the safety and effectiveness of a novel laser and optics-based IVL catheter for treatment of severely calcified ATK and BTK peripheral lesions.

Total REALITY: Comparison of Directional Atherectomy vs Balloon Predilatation Prior to Drug-Coated Balloon Treatment of Long, Calcified Femoropopliteal Lesions

Presented by: Venita Chandra, MD

Drug-coated devices provide good long-term outcomes for femoropopliteal revascularization, but calcification can limit drug uptake. Vessel preparation with atherectomy may provide better periprocedural results than standard predilatation, reducing the need for permanent scaffolds and preserving future treatment options. However, there are limited randomized trial data supporting its use.

The single-arm, prospective, multicenter VIVA REALITY study evaluated directional atherectomy (DA) prior to use of drug-coated balloons (DCBs) in highly calcified lesions. In an updated analysis, investigators used pooled data from the REALITY study and data from prospective, multicenter studies evaluating DCB with standard predilatation to determine whether DA prior to DCB would result in less provisional stent use and comparable safety and effectiveness versus percutaneous transluminal angioplasty (PTA) followed by DCB.

In the Total REALITY analysis, patients in the REALITY study treated with DA plus DCB (n = 84) were matched by propensity scores to eligible patients treated with PTA plus DCB from the Total IN.PACT data set (n = 143). All studies included angiographic and duplex ultrasound (DUS) core laboratories and event adjudication by independent clinical event committees.

Significant differences in severe calcification (PACSS 4) persisted after matching (71.4% for DA + DCB vs 5.9% for PTA + DCB; P < .001). As expected, 12-month primary patency (freedom from both clinically driven target lesion revascularization and DUS-derived restenosis) did not differ between groups. In the DA plus DCB arm, there was a trend toward higher stent-free patency through 12 months using Kaplan-Meier estimates (79.1% vs 68.1%; P = .09) and a significantly lower provisional stent rate (9.5% vs 21.1%; P = .014). Major adverse limb events did not differ between groups.

The Total REALITY analysis underscores the complexity of lesions included in the REALITY study, particularly the high prevalence of severe calcification. Nevertheless, DA plus DCB achieved a significantly lower provisional stent rate and trended toward higher stent-free patency. DA plus DCB is a viable, safe, and effective alternative to PTA plus DCB in treating long and highly calcified lesions while reducing the need for permanent implants.

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 VIVA Foundation have a distinct spirit of collegiality attained by synergizing collective talents to promote awareness and innovative therapeutic options for vascular disease worldwide.