Figura 1. The Elixir DynamX coronary bioadaptor stent technology uses a bioresorbable polymer that d...

Figura 2. Coronary angiography images showing significant lesions in the distal LMCA and proximal LA...

Introduction

The percutaneous treatment of complex coronary artery disease in elderly patients with significant comorbidities is still a therapeutic challenge. In calcified lesions, adequate plaque preparation is essential in order to achieve optimal expansion of the implanted device and to reduce late adverse events.

Intravascular lithotripsy (IVL) has emerged as an effective and safe tool for modifying coronary calcium through shock waves, facilitating stent or bioadaptor expansion with minimal damages to healthy tissue.

In parallel, bioadaptors constitute a new generation of devices designed to combine the advantages of drug-eluting stents with the restoration of vascular physiology after bioresorbable polymer resorption, allowing for the recovery of target vessel pulsatility and vasomotion.

In this context, we describe the case of a patient treated with the DynamX™ Bioadaptor system (Figure 1) after lesion preparation with LithiX lithotripsy, an innovative approach to distal left main bifurcation disease.

Clinical case

An 82-year-old male patient with a history of hypertension, dyslipidemia, type 2 diabetes mellitus, and stage 3a chronic kidney disease went to the Emergency Department with recent-onset progressive angina. An electrocardiogram showed ST-segment depression in inferior and lateral leads, and troponin T levels rose to 677 ng/L. Echocardiography revealed preserved systolic function of the left ventricle with no segmental wall-motion abnormalities.

Coronary angiography showed significant distal left main coronary artery (LMCA) disease and critical lesions in the proximal segments of the LAD and circumflex (Cx) arteries (Figure 2a–b). A decision was made to conduct percutaneous coronary intervention of the LMCA and LAD using a LithiX Hertz Contact IVL lithotripsy balloon (3.0 × 14 mm), followed by implantation of two overlapping DynamX™ bioadaptor devices (3.5 × 23 mm and 4.0 × 23 mm) between the proximal LAD and the distal LMCA. Subsequent post-dilation was performed with a non-compliant balloon (4 × 16 mm).

The proximal Cx artery was treated with lithotripsy (2.5 × 14 mm) and a drug-coated balloon (2.5 × 15 mm). The angiographic result was optimal, with TIMI III flow and adequate device expansion confirmed by intracoronary imaging (optical coherence tomography, OCT) (Figure 2c–d).

The patient had a favorable clinical course, remaining asymptomatic and hemodynamically stable, and was discharged early under dual antiplatelet therapy for 12 months.

Discussion

This clinical case describes a complex intervention in an octogenarian patient with multiple comorbidities and multivessel coronary artery disease, highlighting the combined use of two innovative technologies: the LithiX intravascular lithotripsy system and the DynamX™ bioadaptor.

The selection of the LithiX system was key for the treatment of calcified lesions, particularly in the proximal LAD segment. Unlike conventional lithotripsy balloons, LithiX uses metallic hemispheres integrated within a semi-compliant balloon that, when inflated at low pressure, generate contact stress points that effectively fracture calcium with minimal damage to healthy vascular tissue1. The PINNACLE I study supports its efficacy, demonstrating a clinical success rate of 98.3%, an angiographic success rate of 100%, and extensive deep calcium fractures confirmed by OCT in over 90% of cases, along with optimal stent expansion2.

The DynamX™ bioadaptor consists of three cobalt–chromium helical strands connected by unlockable elements coated with a bioresorbable polymer. This structure allows the strands to separate after polymer resorption at approximately six months, while maintaining dynamic support of the treated vessel. The design aims to combine the acute performance of drug-eluting stents with the additional advantage of enabling restoration of vascular compliance and natural cyclic vessel motion3.

BIOADAPTOR-RCT is the first randomized clinical trial comparing a sirolimus-eluting bioadaptor (DynamX™) with a contemporary zotarolimus-eluting stent (Resolute Onyx™) in patients with de novo coronary lesions. This multicenter study, which included 445 patients, demonstrated non-inferiority in 12-month target lesion failure (TLF) (1.8% vs. 2.8%; p < 0.001), as well as superiority in imaging endpoints, including lower in-stent late lumen loss (0.09 mm vs. 0.25 mm; p=0.038) and greater cyclic vessel pulsatility (7.5% vs. 2.7%; p< 0.001), supporting functional treated vessel restoration3.

The INFINITY-SWEDEHEART trial, a large registry-based randomized clinical trial including 2399 patients with chronic or acute coronary syndromes, showed that the DynamX bioadaptor was non-inferior to contemporary zotarolimus-eluting stents for 12-month target lesion failure (TLF), with event rates of 2.4% vs. 2.8%. Notably, in the prespecified 6- to 12-month landmark analysis, the bioadaptor showed lower rates of TLF (0.3% vs. 1.7%; hazard ratio [HR]: 0.19; 95% confidence interval [CI]: 0.06–0.65) and target vessel failure (0.8% vs. 2.5%; HR: 0.35; 95% CI: 0.16–0.79), suggesting a potential benefit in reducing late device-related events. Device thrombosis rates were low and similar across groups4.

Imaging studies have confirmed the ability of the bioadaptor to preserve lumen area while allowing for positive vessel remodeling and cyclic pulsatility restoration at 12 months, further supporting the mechanistic rationale of device design5.

In summary, the DynamX bioadaptor has shown non-inferior safety and efficacy compared with contemporary DES at 1–2 years, with signals of reduced late adverse events and vascular physiology restoration. Ongoing long-term follow-up will clarify its impact on clinical outcomes beyond two years3-5.

In our patient, the selection of both technologies was justified by the anatomical complexity of the lesion and the clinical context (advanced age and chronic kidney disease), with the aim of maximizing procedural effectiveness and reducing long-term adverse event risk. The intervention was successful, with low contrast volume, no immediate complications, and favorable angiographic and intracoronary imaging results, reflecting both the technical feasibility and the acute safety profile of the devices used.

Conclusion

The combination of intravascular lithotripsy and bioadaptor stenting is an innovative and safe therapeutic alternative for the treatment of complex calcified coronary lesions. Our case demonstrates the technical feasibility, safety profile, and potential physiological benefits of the DynamX™ bioadaptor in the pursuit of functional coronary vessel restoration following percutaneous intervention.

1. Verheye S, Hamer B, Paradies V, Tonino P, Bataille Y, Bennett J. TCT-383 Mechanistic Effects of Coronary Hertz Contact Intravascular Lithotripsy on Treatment of Calcified Lesions: PINNACLE I OCT Substudy Procedural Imaging Outcomes. JACC. 2024 Oct, 84 (18_Supplement) B104.

2. Elixir Medical. EuroPCR 2024: Primary outcomes from PINNACLE I clinical trial establish safety and effectiveness of Elixir Medical’s Hertz Contact Intravascular Lithotripsy System . Elixir Medical; 2024 May 14, citado 2025 Jul 21. Disponible en: https://elixirmedical.com/europcr-2024-primary-outcomes-from-pinnacle-i-clinical-trial-establish-safety-and-effectiveness-of-elixir-medicals-hertz-contact-intravascular-lithotripsy-system-for-calcium-fragmentation-in-moderate/

3. Saito S, Bennett J, Nef HM, et al. First randomised controlled trial comparing the sirolimus-eluting bioadaptor with the zotarolimus-eluting drug-eluting stent in patients with de novo coronary artery lesions: 12-month clinical and imaging data from the multicentre, international BIOADAPTOR-RCT. eClinicalMedicine. 2023;65:102304.

4. Erlinge D, Andersson J, Fröbert O, et al. Bioadaptor Implant Versus Contemporary Drug-Eluting Stent in Percutaneous Coronary Interventions in Sweden (INFINITY-SWEDEHEART): A Single-Blind, Non-Inferiority, Registry-Based, Randomised Controlled Trial. Lancet (London, England). 2024;404(10464):1750-9. 

5. Verheye S, Vrolix M, Montorfano M, et al.Twelve-Month Clinical and Imaging Outcomes of the Uncaging Coronary DynamX Bioadaptor System.EuroIntervention: Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2020;16(12):e974-81. 

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