Clinical Performance of a Paclitaxel Drug-Coated Balloon in Real-World Percutaneous Coronary Intervention Practice:...

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Medical Devices

Background:

• Randomized trials show promise for drug-coated balloons (DCB) in small vessels, but real-world data are limited.
• In-stent restenosis (ISR) and de novo lesions in small coronary arteries remain challenging clinical scenarios.
• Evaluating DCB use in routine percutaneous coronary intervention (PCI) practice is crucial for understanding its broader applicability.

Purpose of the Study:

• To assess the safety and efficacy of a paclitaxel DCB in a real-world PCI setting.
• To evaluate outcomes in patients treated for both in-stent restenosis (ISR) and de novo coronary lesions.
• To provide data from the PEARL (Paclitaxel-Eluting Angioplasty Balloon in the Real-World) registry.

Main Methods:

• Prospective registry of 513 patients treated with Protégé paclitaxel DCB between 2014-2019 in the Netherlands.
• Primary endpoint: 2-year major adverse cardiac event (MACE), including cardiac death, target-vessel MI, and target-lesion revascularization (TLR).
• Analysis included lesion characteristics (ISR vs. de novo, lesion type) and procedural details (predilation, DCB compliance).

Main Results:

• DCB was used in 382 ISR and 131 de novo lesions; 58.9% of patients presented with acute coronary syndrome.
• Low rates of DCB-related complications (3.3%) and bailout stenting (3.1%) were observed.
• Two-year MACE rates were 17.1% for ISR and 9.7% for de novo lesions; TLR rates were 11.7% and 2.9%, respectively.

Conclusions:

• The Protégé paclitaxel DCB demonstrated safety and effectiveness in real-world PCI for both ISR and de novo lesions.
• Favorable 2-year outcomes support the use of this DCB technology in routine clinical practice.
• Predictors of MACE in ISR patients included prior coronary artery bypass grafting and longer lesion length.