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

Sponsor

Xijing Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05937230

Collaborator

(none)

1,500

Enrollment

Location

129

Anticipated Duration (Months)

11.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease Angioplasty, Balloon	Device: Drug-coated balloon Device: Drug-eluting stents

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

1500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Drug-coated balloon Paclitaxel coated balloon	Device: Drug-coated balloon Paclitaxel is a pharmacologically active substance for anti-neointima.
Drug-eluting stent Second-generation eluting stents	Device: Drug-eluting stents Drug-eluting stent is composed of a metal stent, primer, and drug coating.

Arm

Intervention/Treatment

Drug-coated balloon

Paclitaxel coated balloon

Device: Drug-coated balloon

Paclitaxel is a pharmacologically active substance for anti-neointima.

Drug-eluting stent

Second-generation eluting stents

Device: Drug-eluting stents

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

Outcome Measures

Primary Outcome Measures

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).

Other Outcome Measures

POCE [1, 12, or 24 months]
POCE is a composite clinical endpoint of all-cause death, any stroke, non-fatal myocardial infarction (MI), any revascularization
All-cause death [1, 12, or 24 months]
Rates of individual components of PoCE
Non-fatal myocardial infarction (MI) [1, 12, or 24 months]
Rates of individual components of PoCE
Any stroke [1, 12, or 24 months]
Rates of individual components of PoCE
Any revascularization [1, 12, or 24 months]
Rates of individual components of PoCE
Device-oriented Composite Endpoint (DoCE) [1 or 12 months]
Rates of the DoCE beside the time point of primary endpoint
Cardiac cause death [1, 12, or 24 months]
Rates of individual components of the DoCE
Target vessel myocardial infarction (TV-MI) [1, 12, or 24 months]
Rates of individual components of the DoCE
Clinically indicated target lesion revascularization (CI-TLR) [1, 12, or 24 months]
Rates of individual components of the DoCE
Target vessel failure (TVF) [1, 12, or 24 months]
Target vessel failure, defined as cardiovascular death, TV MI and clinically-indicated target vessel revascularisation