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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Heart Disease; Angioplasty, Balloon
• Intervention / Treatment: Device: Drug-coated balloon; Device: Drug-eluting stents

• Study Type: Observational
• Enrollment (Actual): 1500

Contacts and Locations

Study Locations

• China
  • Shannxi
    • Xi'an, Shannxi, China, 710032
      • Ling Tao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All diabetic patients who received PCI with one or more drug-coated balloons only or drug-eluting stents only to treat ISR or de novo lesions

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death	Rates of individual components of PoCE	1, 12, or 24 months
Non-fatal myocardial infarction (MI)	Rates of individual components of PoCE	1, 12, or 24 months
Any stroke	Rates of individual components of PoCE	1, 12, or 24 months
Any revascularization	Rates of individual components of PoCE	1, 12, or 24 months
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
Device-oriented Composite Endpoint (DoCE)	Rates of the DoCE beside the time point of primary endpoint	1 or 12 months
Cardiac cause death	Rates of individual components of the DoCE	1, 12, or 24 months
Target vessel myocardial infarction (TV-MI)	Rates of individual components of the DoCE	1, 12, or 24 months
Clinically indicated target lesion revascularization (CI-TLR)	Rates of individual components of the DoCE	1, 12, or 24 months
Target vessel failure (TVF)	Target vessel failure, defined as cardiovascular death, TV MI and clinically-indicated target vessel revascularisation	1, 12, or 24 months

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Study Chair: Ling Tao, MD, Ph.D., Xijing Hospital; Study Chair: Chao Gao, MD, Ph.D., Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): March 1, 2023
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: June 29, 2023
• First Submitted That Met QC Criteria: June 29, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Diabetic; Drug-coated balloons; Drug-eluting stents; De-novo; All-comers; In-stent stenosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: CAGE-FREE DM registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No