Session 1: Current and Emerging Indications in ISR and de novo Lesions – Fernando Alfonso
Introduction and Setting the Stage
Opening Remarks
- The speaker expresses pleasure in being at the event, noting an impressive setting that balances tradition with modern knowledge.
- Emphasizes the importance of two major papers: the third report of the consensus group and a recently published ARC document addressing current issues.
Overview of ISR and Drug-Eluting Stents
Key Concepts in Revascularization
- Discusses two subsets in coronary interventions: ISR (In-Stent Restenosis) and noble lesions, highlighting their differentiation.
- References European Society of Cardiology guidelines recommending drug-eluting stents (DES) or drug-coated balloons for patients with bare metal or DES stenosis.
Clinical Evidence
- Mentions a pivotal study by Bruno Sheller involving 52 randomized patients showing significant differences in outcomes between paclitaxel-coated balloons and POBA (plain old balloon angioplasty).
- Highlights findings from a study published in JACC demonstrating sustained superior results with stents over time, translating into better clinical outcomes.
Meta-analysis Insights
Dataloo Meta-analysis Findings
- Introduces Adam Castrai's meta-analysis including nearly 2,000 patients, indicating reduced target lesion revascularization rates with drug-eluting stents compared to paclitaxel-coated balloons.
- Notes that superiority was primarily observed in patients with drug-eluting stent restenosis; no clear benefit was found for bare metal stenosis cases.
Safety Considerations
Risk Assessment
- Discusses safety signals regarding higher risks associated with first-generation drug-eluting stents but notes no risk detected when comparing second-generation stents to paclitaxel-coated balloons.
Current Trends and Guidelines
Evolving Recommendations
- Describes growing interest in using drug-coated balloons for treating stenosis, referencing recent European guidelines emphasizing this approach as a strong recommendation (1A indication).
Clinical Decision-Making
- Stresses that target revascularization is not the only consideration; other factors like patient history and lesion characteristics should guide treatment choices.
Importance of Imaging Techniques
Role of Intravascular Imaging
- Highlights how intravascular imaging is crucial for assessing lesion types, preparation strategies, and final treatment decisions between drug-eluting stents or drug-coated balloons.
Mechanisms Behind Stenosis
Understanding Under-expansion
Drug Coated Balloons vs. Stents: Clinical Insights
Overview of Drug Coated Balloons (DCB) in Small Vessels
- Drug coated balloons have shown superiority over first and second generation stents in patients with small vessels, highlighting their significance in clinical outcomes.
- In high bleeding risk patients, avoiding the implantation of a new metal layer is crucial, leading to intense research on DCB effectiveness.
Meta-Analysis Findings
- A meta-analysis involving 14 trials and 2500 patients revealed no significant difference in target revascularization between drug coated balloons and alternative strategies.
- The case-free trial indicated that non-inferiority was not met for certain vessel sizes, suggesting variability in treatment efficacy based on anatomical factors.
Long-Term Outcomes and Recent Evidence
- A recent meta-analysis by Bernardo Cortez included patient-level data from four randomized trials, showing benefits regarding major adverse cardiovascular events (MACE) when comparing DCB with drug-eluting stents.
- New evidence presented at a conference indicated that the primary endpoint of target vessel failure showed less than 1% risk difference after one year, meeting the pre-specified non-inferiority margin.
Clinical Implications and Practice Changes
- There is an observed increase in clinically driven revascularization associated with novel drug-coated balloons; however, implications for clinical practice need further evaluation.
- Data from Spain indicates a plateauing number of stent procedures while the use of DCB—either as a hybrid strategy or standalone—is dramatically increasing across regions.
Conclusion on Current Trends