Drug Coated balloons in Modern PCI: From Mechanism of Action to Real Life Practice – Tuomas Rissanen

Introduction to DCB and Patient Case

Overview of DCB Technology

• The agent DCB by Boston Scientific is a paclitaxel-coated balloon with a crystalline structure, containing 2 micrograms per square millimeter of paclitaxel and citrate ester as an excipient.

• Preclinical studies indicate that the crystalline formulation allows for sustained drug concentration in tissue, contrasting with amorphous coatings.

Patient Case Presentation

• A case involving an ostial lesion was discussed, characterized by a tight lesion with small minimal lumen area (MLA) and healthy left main artery.

• The recommended approach included using a cutting balloon for multiple inflations followed by DCB angioplasty at a 1:1 ratio, resulting in successful outcomes without crossover stenting.

Clinical Trials and Registry Analysis

Comparison of DCB Technologies

• A randomized trial compared agent DCP to Sequent police DCP in patients with in-stent restenosis (ISR), showing similar effectiveness regarding instant lumen loss at six months.

Registry Findings

• An analysis from 2014 involved 338 patients undergoing PCI with agent balloons; over half had high bleeding risk, and TLR rates were noted at 56% after one year.

• The registry highlighted that recoil is a significant factor contributing to restenosis; optimizing treatment can reduce TLR rates to as low as 1–2%.

Insights from Additional Registries

Efficacy of Agent Balloons

• Another Italian registry study involving 450 patients confirmed the real-world efficacy of agent balloons, reporting an overall TLR rate of just 4%.

Japanese Registry Outcomes

• A recent Japanese registry showed promising results with nearly all cases utilizing intravascular imaging; it reported low target lesion failure rates (4.7%) among complex patient populations.

Conclusion on Safety and Efficacy

Summary of Findings

• Pitel crystal-coated balloons demonstrate good safety profiles according to meta-analysis findings. Paclitaxel promotes positive remodeling compared to other drugs.

• For de novo lesions, agent DCP has shown effective clinical outcomes in observational studies while randomized trials support its use for ISR.