Author + information
- Georgios Bouras1,
- Alexandre Abizaid2,
- Carlos Garcia - Lithgow3,
- Ecaterina Cristea1 and
- Alexandra Lansky1
Drug eluting stents (DES) have become the mainstay of percutaneous coronary interventions (PCI). However, late and very late stent thrombosis remain a concern. We investigate whether the Paclitaxel Drug-Coated Chocolate Heart Balloon (DCB) is a safe and effective alternative to DES in the treatment of select patients with de novo native coronary artery lesions.
This first-in-human study aims to evaluate the safety and feasibility of Chocolate DCB with a primary endpoint of Late Lumen Loss (LLL) at 6 and 24 months and Major Adverse Cardiac Events (MACE) at 6, 12 and 24 months. Independent Core Labs assessed all angiograms and Intravascular Ultrasound (IVUS) images at 6 and 24 months.
A total of 19 subjects were enrolled: mean age 59 years, 73% male, 100% hypertension, 48% diabetes and 32% smokers. The mean lesion length was 12.1 mm and reference vessel diameter 2.6 ± 0.4mm. Lesion complexity was Type A/B in 94.7%. Procedure success was 100%, defined as a final diameter stenosis <30% with no angiographic complications, dissections or need for bail-out stent placement. The mean late lumen loss was -0.01 ± 0.35 mm at 6 months and -0.06 ± 0.27 mm at 24 months. Results confirmed by IVUS data at 6 months: minimum lumen diameter was 2.1mm and minimum lumen area was 4.7mm2. IVUS analysis on the 24-month data is currently underway. There was no MACE at 30-day follow-up and a single Target Lesion Revascularization (TLR) was reported at 6-months, but no other complication. No additional MACE were reported at 12 or 24 months for 17 patients with complete clinical evaluation.
This feasibility study demonstrates that the Chocolate DCB is safe and provides effective treatment for patients with simple de novo lesions in native coronary arteries. These promising results provide evidence for an alternative therapeutic option for coronary artery disease and will need to be confirmed in a larger scale trial.
CORONARY: Drug-Eluting Balloons and Local Drug Delivery