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

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05937230
• Other study ID #: CAGE-FREE DM registry
• Status: Active, not recruiting
• Start date: June 1, 2015
• Est. completion date: March 1, 2026

Study information

• Verified date: October 2023
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angioplasty, Balloon
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Device:
• Drug-coated balloon
Paclitaxel is a pharmacologically active substance for anti-neointima.
• Drug-eluting stents
Drug-eluting stent is composed of a metal stent, primer, and drug coating.

Locations

Country	Name	City	State
China	Ling Tao	Xi'an	Shannxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

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