Drug-coated Balloons and Drug-eluting Stents in Diabetic Patients

Active, not recruiting

• Conditions: Angioplasty, Balloon; Coronary Heart Disease
• Interventions: Device: Drug-coated balloon; Device: Drug-eluting stents

• Registration Number: NCT05937230
• Lead Sponsor: Xijing Hospital

Brief Summary

Drug-eluting stents (DES) have long been recommended as the default device for patients undergoing percutaneous coronary intervention (PCI). Drug-Coated Balloon (DCB) angioplasty is similar to plain old balloon angioplasty procedurally, but there is an anti-proliferative medication paclitaxel-coated on the balloon.

DCB angioplasty has the following advantages compared to DES implantation: Firstly, the drug in DCB is uniformly distributed and released, whereas the drug release of DES via the stent platform is uneven -85% of the vascular wall is not covered by the stent strut. Secondly, there is no alloy in the vessel after DCB angioplasty, while the coronary stent platform and polymer might cause temporal or persistent inflammatory response leading to intimal hyperplasia. Finally, there is no metal cage restraining vessel motion after DCB, and the physiological function of coronary arteries would be maintained.

Currently, DCB constitutes an important treatment option in ISR, which is endorsed by the 2018 European Society of Cardiology Guidelines on myocardial revascularization. In addition, some interventional cardiologist has also applied DCB in de novo lesions in their clinical practice.

Diabetes is associated with worse outcomes after coronary revascularization and has been identified as an independent predictor of adverse events in patients with cardiovascular disease. Although some small sample size RCTs and observational studies have suggested that the clinical prognosis of DCB is non-inferior to the drug-eluting stent (DES), there is still a lack of evidence comparing the DCB versus DES for de novo or ISR coronary lesions in diabetic patients. The current study aims to compare the long-term efficacy of DCB to DES in de novo or ISR coronary lesions in diabetic patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-01
• Primary Completion: 2023-03-01
• Study First Submitted: 2023-06-29
• Study First Submitted QC: 2023-06-29
• Study First Posted: 2023-07-10
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-12
• Last Update Posted: 2023-10-13
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

1. Patients with diabetes mellitus
2. Received PCI by a drug-coated balloons only strategy or drug-eluting stents only strategy

Exclusion Criteria

1. Under the age of 18
2. Unable to give informed consent
3. Currently participating in another trial or participants unable to comply to follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Drug-coated balloon	Drug-coated balloon	Paclitaxel coated balloon
Drug-eluting stent	Drug-eluting stents	Second-generation eluting stents

Primary Outcome Measures

Name	Time	Method
Device-oriented Composite Endpoint (DoCE)	24 months	DoCE is a composite clinical endpoint of Cardiac cause death, Target vessel myocardial infarction (TV-MI), and clinically indicated target lesion revascularization (CI-TLR).

Trial Locations

Locations (1)

Ling Tao; 🇨🇳 Xi'an, Shannxi, China