Prevail clinical data with case illustration: SCAAR, Prevail Global, and EBC DCB – Kambis Mashayekhi

Prevalence of Clinical Data in Drug-Eluting Balloons

Overview of Prevalent Clinical Investigations

• The discussion begins with the effectiveness of drug-eluting balloons (DEBs) in treating various cardiovascular conditions, including bifurcation lesions and chronic total occlusions.

• There is a growing trend towards using DEBs for diabetic patients and acute coronary syndromes, indicating an expansion in treatment applications.

Key Studies and Trials

• Three major investigations are highlighted: the PREL Global Study, EBCB trial, and data from the SCAR registry. These studies provide substantial evidence regarding the efficacy of DEBs.

• The ABCDCB trial involves a one-to-one randomization of 750 patients with long-term follow-up extending up to eight years, focusing on bifurcation-oriented composite endpoints.

Safety and Efficacy Insights from SCAR Registry

• The SCAR registry evaluated the safety and efficiency of PREL DCB against competitive drug-eluting balloons, involving 6,488 patients with low event rates observed during follow-ups.

• Notably low all-cause mortality rates were reported at one and two years post-treatment, suggesting favorable outcomes for patients treated with PREL DCB.

Bifurcation Treatment Strategies

• A significant portion (23%) of SCAR patients had bifurcations; however, there was no discussion on simultaneous bifurcation DCB treatments that could potentially enhance proximal vessel wall effects.

• The study revealed that 60% of lesions were classified as complex (B2 and C), emphasizing the challenging nature of these cases in clinical practice.

Outcomes Associated with Drug-Eluting Balloons

Event Rates and Complications

• Low myocardial infarction rates (2.3%) were recorded among patients treated with PREL balloons across various subgroups, indicating a safe profile for this device in bifurcation cases.

• There were also low target lesion revascularization (TLR) rates reported alongside zero defined thrombosis events during follow-ups, reinforcing the balloon's safety profile.

Case Examples Demonstrating Treatment Techniques

• Several case examples illustrate practical applications of DCB techniques such as scoring angioplasty combined with kissing balloon techniques to manage complex lesions effectively.

• Follow-up results showed significant improvements over time for treated lesions despite initial challenges like slow flow or diffuse disease patterns post-procedure.

Innovative Approaches to Complex Lesions

Hybrid Concepts in Treatment

• Hybrid approaches combining stenting with DCB have shown promising results in managing large vessels with significant calcification while maintaining patient stability post-treatment.

Angina Treatment and Vascular Healing

Initial Treatment Challenges

• The patient presented with angina, but the true lumen could only be accessed distally in the circumflex artery. A drug-coated balloon (DCB) was applied to the proximal part, but conservative management failed.

• After five months, the patient returned with instant restenosis and outflow issues from the stent in the main branch. Notably, some vascular healing was observed in the circumflex artery.

Surgical Intervention and Complications

• Consultation with a surgeon led to an open procedure on the main branch, where two kissing DCB procedures were performed.

• A significant calcified nodule was identified in the circumflex artery; initial attempts to cross it were suboptimal due to calcium obstruction.

Follow-Up and Further Procedures

• After 22 months of follow-up due to persistent angina, vascular structures had healed completely. New intima and media layers formed over the stent.

• The treatment approach evolved to address intra-plaque crossing using rotational techniques on calcified nodules, leading to successful outcomes after shockwave therapy.

Key Takeaways

• The case illustrates a strategy for deferring stenting while managing plaque modification challenges when optimal results cannot be achieved initially.