DCB in small vessels including DAPT considerations, PARIS trial update – Ignacio Amat-Santos

Understanding the Use of Stents in Interventional Cardiology

The Challenge of Overusing Stents

• The speaker discusses their experience with stent usage, noting a significant increase in use that became disproportionate.

• Emphasizes the importance of observation in research, contrasting it with the proactive nature of interventional cardiologists who prefer immediate action over contemplation.

Evolution and Current Practices

• Highlights a historical perspective on outcomes related to stent use, indicating initial improvements followed by declines due to overuse.

• Introduces DCB (Drug-Coated Balloons) as a potential solution, mentioning its initial success in ISR (In-Stent Restenosis) and ongoing trials for broader applications.

Ongoing Trials and Research Focus

• Describes two key trials: the Paris study focusing on acute and chronic coronary syndromes using DCB, sponsored by Medtronic.

• Notes that the Paris study involves over 20 centers across Europe and has been running for more than a year without final results yet.

Trial Design and Patient Selection

• Discusses challenges in selecting appropriate devices for the trial, emphasizing that not all drug-coated balloons are equal.

• Details inclusion criteria for high bleeding risk patients defined by specific scores or concurrent anticoagulation therapy while excluding ISR cases.

Preliminary Findings from Patient Data

• Shares insights into patient demographics within their hospital's participation, highlighting a significant number of high bleeding risk patients included.

• Reports similar bleeding event rates between high-risk and low-risk groups during follow-up, suggesting DCB benefits may extend across different patient categories.

Clinical Outcomes and Case Study Presentation

• Mentions serious clinical events such as acute occlusion and sudden death observed during follow-ups, raising concerns about acute thrombosis.

• Presents a case study involving a 71-year-old male patient with multiple health issues who underwent treatment under the Paris study protocol.

This structured summary captures key discussions from the transcript while providing timestamps for easy reference.

Patient Management and Treatment Outcomes

Overview of Patient Case

• The patient initially on antiplatelet therapy (AP) with Tagalor developed hematuria, necessitating endoscopic treatment and cessation of dual antiplatelet therapy (DAP). Monotherapy was continued, leading to stable asymptomatic status.

• Six months post-percutaneous coronary intervention (PCI), the patient experienced new angina. Angiographic evaluation revealed a severe lesion proximal to the stent in the circumflex artery, although the left anterior descending artery appeared normal.

Follow-Up Procedures

• Physiological assessment using fractional flow reserve (FFR) showed a value of 82. Optical coherence tomography (OCT) indicated minor dissection distally but overall healing of the vessel.

• Notable edge restenosis in the circumflex required balloon dilation followed by placement of a 3.5 mm Prevail stent at the osteal circumflex, resulting in improved physiological outcomes.

Long-Term Results and Future Studies

• One year post-procedure, the patient remains active and asymptomatic without further bleeding incidents.

• Discussion on the Compare Copernican trial involving STEMI patients randomized to either stenting or reduced stent strategy based on initial results; funded by an EU grant with participation from centers in Italy and France for clinical investigation and cost analysis.