DEB vs Thin-DES in DES-ISR: Long Term Outcomes (DEB Dragon Registry) (DEB-DRAGON)

Medical University of Silesia

Status: Completed

Conditions: In Stent Restenosis

Treatments: Device: percutaneous coronary intervention

Study type: Observational

Funder types: Other

Identifiers

NCT04415216

02

Details and patient eligibility

About

Data regarding the usefulness of percutaneous coronary intervention (PCI) with drug eluting balloon (DEB) vs. thin struts drug eluting stents (thin-DES) for treating in-stent restenosis (ISR) in every day clinical practice is scarce. We aimed to evaluate comparing the efficacy and safety profile of DEB and thin-DES in DES-ISR.

Enrollment: 1,369 patients

Sex

Volunteers: No Healthy Volunteers

Inclusion criteria

• All consecutive patients with DES-ISR who were treated with either paclitaxel-DEB or thin-DES.

Exclusion criteria

• PCI with DES struts thickness >100μm
• PCI with DEB and thin-DES in the same procedure
• PCI of other vascular territories during the same procedure
• PCI in saphenous vain graft or internal mammary artery

Trial design

1,369 participants in 2 patient groups

ISR PCI with thin-DES

Treatment:

Device: percutaneous coronary intervention

ISR PCI with DEB

Treatment:

Device: percutaneous coronary intervention