CORDIS - DCB after SELUTION DeNovo RCT: Welcome & Opening Remarks – Fernando Alfonso

Overview of the Solution DeNovo Trial

Introduction to the Session

• This session is organized by Cordis, featuring a summary of the Solution DeNovo study followed by a case presentation from David Hil Smith and a panel discussion with experts including Alexander Lanski, Thomas Risan, and Maro GTO.

One-Year Results of the Solution DeNovo Trial

• The one-year results were presented at TCT by Christian Spalding. The speaker disclosed their involvement in the study to TCT organizers for transparency.

• Previous studies indicated that drug-coated balloons (DCBs) are clinically comparable to drug-eluting stents (DES), supported by early meta-analysis findings. However, some trials like Red Cage Free did not meet non-inferiority endpoints due to vessel size interactions.

Clinical Practice Guidelines and DCB Usage

• Current clinical practice guidelines do not recommend DCB for novel issues despite evidence suggesting similar outcomes compared to DES. Plitaxel remains preferred for DCB due to its lipophilic properties.

• A randomized meta-analysis comparing plitaxel with early-generation limus drug-eluting stents showed superior late angiographic findings with plitaxel use. Newer cerolimus DCB technology has shown promise in reducing neointimal hyperplasia in animal studies.

Study Design and Methodology

• The Solution DeNovo trial is noted as the largest DCB study conducted, involving over 3,000 patients across more than 60 sites over three years, powered for clinical endpoint target failure at one year with a 90% power for non-inferiority at five years.

• Randomization occurred before lesion preparation without limitations on vessel size; provisional stenting was not considered crossover treatment within this design framework. Predefined flexible non-inferiority margins were established prior to the trial's commencement.

Key Findings and Outcomes

• The primary endpoint of non-inferiority regarding target vessel failure was met with an absolute risk difference of less than 1%, indicating successful outcomes for DCB usage in this context. Provisional stenting was required in 21% of cases, particularly among patients with multi-vessel disease or complex lesions treated during the trial period.

• Notably higher rates of clinically driven target revascularization were observed after using cerolimus-coated balloons compared to traditional methods; subgroup analyses revealed varying performance based on patient demographics such as gender and bleeding risk factors.

Limitations and Considerations

Discussion on Cerolimus Drug-Eluting Balloons

Overview of Study Findings

• The study indicates no requirement for latent geographic follow-up, lacking data on binary restorative rates and other key metrics such as late lumen diameter and potential late lumen enlargement in the context of cerolimus drug-eluting balloons (DCBS).

• There was a noted low usage of special balloons prior to the introduction of the cerolimus balloon, suggesting that treatment protocols could be improved. Additionally, intra-coronary imaging was underutilized in both arms at only 17%.

• Intra-coronary imaging is now classified as a 1A indication for complex lesions; thus, its limited use in the study may have affected outcomes, particularly in the cerolimus arm.

• The higher rate of target vessel revascularization observed in the cerolimus balloon arm raises questions about statistical significance and clinical implications. The per-protocol results are still pending and are crucial for non-inferiority trials.

• Conclusions drawn suggest that cerolimus drug-eluting balloons are non-inferior to current generation drug-eluting stents regarding target vessel failure across most lesions encountered in clinical practice.

Implications for Clinical Practice

• The findings emphasize a pragmatic approach to DCBS treatment strategies. It is important to note that there is no class effect associated with this technology, indicating variability in outcomes based on specific circumstances.

• The information gathered from this study should inform not only clinical practices but also future updates to clinical practice guidelines.

Next Steps