NCT04814212

Drug-Coated Balloon in Anticoagulated and Bleeding Risk Patients Undergoing PCI

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 546 (estimated)
• Sponsor: North Karelia Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare DCB with DES in stable CAD or ACS patients who are at high risk of bleeding. The hypothesis of the DEBATE trial is that the strategy using DCB and a shorter DAPT regimen is non-inferior to the treatment using DES and longer DAPT duration on patients with high bleeding risk. If non-inferiority is shown, the superiority of the DCB strategy over DES strategy will be tested.

Detailed description

Implantation of a drug-eluting stent (DES) has become a standard of percutaneous coronary intervention (PCI) during the last two decades. However there are still significant drawbacks in using DES as a permanent coronary implant. Most importantly, bleeding remains a significant complication of PCI, especially in elderly patients. The number of PCI patients having OAC:s is already significant, and will grow in the future, as the volume of PCIs in octogenarians increases, and so does the incidence of atrial fibrillation by age. After stenting at least one month lasting dual antiplatlet treatment (DAPT) is mandatory, and it cannot be safely terminated in case of a bleed. The optimal duration of DAPT on patients at bleeding risk is not known. Balloon coated with paclitaxel and iopromide (drug-coated balloon, DCB) was originally developed for the treatment of in-stent restenosis, but later its potential for the treatment of de-novo coronary artery leasons has become clear in large registry trials. So far, the randomized controlled studies have shown the non-inferiority of PCI using DCB in comparison to DES in de novo leasons in small vessels. Also the non-inferiority of PCI using DCB in comparison to BMS was shown in the DEBUT trial in large vessels on patients at high bleeding risk. These results need to be confirmed in comparison of DCB to DES as the use of BMS is diminishing. The hypothesis of the DEBATE trial is that the strategy using DCB and a shorter DAPT regimen is non-inferior to the treatment using DES and longer DAPT duration in the treatment of stable CAD or in ACS (UAP or NSTEMI) in patients on anticoagulation medication or otherwise on high bleeding risk. If non-inferiority is shown, the superiority of the DCB strategy over DES strategy will be tested.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Percutaneous coronary intervention using drug-coated balloon	SeQuent Please (BBraun) + tailored antithrombotic regimen: 1. Stable patients without OAC: perioperative SAPT (preferably) or perioperative DAPT followed by lifelong SAPT 2. Stable patients with OAC: perioperative SAPT (preferably) or perioperative DAPT and lifelong OAC 3. ACS patients without OAC: 1-month DAPT followed by lifelong SAPT 4. ACS patients with OAC: perioperative DAPT followed by 1-month SAPT and lifelong OAC
DEVICE	Percutaneous coronary intervention using drug-eluting stent	Biofreedom (Biosensors), Synergy (Boston Scientific), Ultimaster Tansei (Terumo) and Integrity Onyx (Medtronic), Xience Pro S (Abbott) or Promus Elite (Boston Scientific) or any other DES can also be used provided that it has a CE mark for 1-month DAPT, combined with tailored antithrombotic regimen: 1. Stable patients without OAC: 1-month DAPT followed by lifelong SAPT 2. Stable patients with OAC: perioperative DAPT followed by 6 months SAPT (ADP receptor blocker) and life-long OAC 3. ACS patients without OAC: 3-month DAPT followed by lifelong SAPT 4. ACS patients with OAC: perioperative DAPT followed by 6 months SAPT (ADP receptor blocker) and lifelong OAC

Timeline

• Start date: 2022-09-01
• Primary completion: 2026-01-01
• Completion: 2028-01-01
• First posted: 2021-03-24
• Last updated: 2023-11-09

Locations

14 sites across 4 countries: Finland, France, Germany, United Kingdom