BOSTON SCIENTIFIC - Drug Coated balloons in Modern PCI: DCB therapy in practice – Fernando Alfonso

Overview of Angiography and Intravascular Imaging

The Role of Angiography in Drug-Coated Balloon Procedures

• The speaker thanks Tom and Boston for organizing the symposium, emphasizing that angiography provides sufficient information for effective drug-coated balloon procedures.

• However, it is suggested that angiography alone may not be enough; additional insights could be gained from intravascular imaging and physiological assessments.

Insights from Intravascular Imaging

• In patients with internal stenosis, imaging offers unique insights into tissue expansion types, which can be corrected.

• Intravascular imaging can help identify underlying substrates to improve lesion preparation through plaque modification and accurate measurements of device severity, length, and size.

Clinical Trials and Data on Intravascular Imaging

Importance of Randomized Clinical Trials

• There is limited data supporting the value of intravascular imaging in drug-coated balloon angioplasty; one key randomized trial involved high bleeding risk patients.

• This trial demonstrated that using intravascular ultrasound (IVUS) allowed for selecting larger devices, resulting in greater acute gain and reduced late lumen loss.

Observational Studies on Intravascular Imaging

• A review highlighted 10 observational studies emphasizing the role of intravascular imaging but noted weak data quality.

• New findings suggest that IVUS can provide critical information about residual plaque, dissection strength, and lumen status post-intervention.

Mechanisms Behind Lumen Loss Reduction

Understanding Acute Gain vs. Late Lumen Loss

• The paradox between acute gain and late lumen loss may be explained by advancements in balloon efficacy.

• A small study indicated both total vessel enlargement and plaque regression as mechanisms contributing to improved outcomes after drug-coated balloon therapy.

Recent Studies on Lesion Preparation Techniques

Comparison of Different Strategies

• Recent trials have compared complex lesion preparation strategies such as cutting balloons versus standard techniques like plain old balloon angioplasty (POBA).

• Results showed that drug-coated balloons were more beneficial following complex lesion preparations due to underlying calcification or complexity factors.

Special Balloons in DCB Era

• The speaker expresses a shift in perspective regarding special balloons' utility before stent implantation during the DCB era.

• An observational study found superior results when using scoring balloons prior to DCB application; these were independent predictors of favorable angiographic outcomes.

Conclusion: Evolving Perspectives on Intervention Techniques

Personal Experiences with Balloon Techniques

• Anecdotal evidence suggests that utilizing scoring or cutting balloons can lead to significant improvements before considering bailout stenting options.

Nature Trial Findings

• A recent randomized clinical trial compared cutting balloon angioplasty with standard balloons, aiming for optimal angiographic criteria. Results are anticipated to contribute valuable insights into best practices.

Cutting Balloon Technology in Clinical Trials

Overview of Clinical Trial Findings

• The assessment of two strategies showed no significant difference, based on a small randomized clinical trial. A notable trend indicated better minimal lumen diameter (MLD) after cutting balloon preparation.

• There was also a trend suggesting improved MLD post-procedure with the cutting balloon, raising questions about the long-term effects of plaque modification and drug efficacy at the vessel wall.

Late Lumen Enlargement Insights

• Late lumen enlargement is characterized by negative lumen loss, particularly relevant when comparing paclitaxel versus limus drug-coated balloons. This phenomenon may be attributed to increased total vessel area and plaque regression.

• Observations indicate that late lumen enlargement is more common in cases involving dissection, whether assessed angiographically or via intravascular ultrasound, correlating with better late geographic and clinical outcomes.

Meta-analysis Results

• A meta-analysis conducted last year compiled data from six randomized clinical trials comparing paclitaxel-coated balloons with limus-type drug-coated balloons.

• The analysis revealed that paclitaxel-coated balloons resulted in superior minimal lumen diameter and reduced late lumen loss, contributing to an explanation for late lumen enlargement.