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

Long-Term Performance of Drug-coated Balloons and Drug-eluting Stents in Diabetic Patients: a Real-world, Prospective Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05937230

Enrollment

1500

Registered

2023-07-10

Start date

2015-06-01

Completion date

2026-03-01

Last updated

2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angioplasty, Balloon, Coronary Heart Disease

Keywords

Drug-eluting stents, Drug-coated balloons, Diabetic, De-novo, In-stent stenosis, All-comers

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.

Interventions

DEVICEDrug-coated balloon

Paclitaxel is a pharmacologically active substance for anti-neointima.

DEVICEDrug-eluting stents

Drug-eluting stent is composed of a metal stent, primer, and drug coating.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

China

Contacts

STUDY_CHAIRLing Tao, MD, Ph.D.

Xijing Hospital

STUDY_CHAIRChao Gao, MD, Ph.D.