Clinical trial NCT05937230: Drug-coated Balloons and Drug-eluting Stents in Diabetic Patients
Official title: Long-Term Performance of Drug-coated Balloons and Drug-eluting Stents in Diabetic Patients: a Real-world, Prospective Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Heart Disease
Angioplasty, Balloon
Keywords: Drug-eluting stents
Drug-coated balloons
Diabetic
De-novo
In-stent stenosis
All-comers
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Device-oriented Composite Endpoint (DoCE)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
measure: POCE
timeFrame: 1, 12, or 24 months
measure: All-cause death
timeFrame: 1, 12, or 24 months
measure: Non-fatal myocardial infarction (MI)
timeFrame: 1, 12, or 24 months
measure: Any stroke
timeFrame: 1, 12, or 24 months
measure: Any revascularization
timeFrame: 1, 12, or 24 months
measure: Device-oriented Composite Endpoint (DoCE)
timeFrame: 1 or 12 months
measure: Cardiac cause death
timeFrame: 1, 12, or 24 months
measure: Target vessel myocardial infarction (TV-MI)
timeFrame: 1, 12, or 24 months
measure: Clinically indicated target lesion revascularization (CI-TLR)
timeFrame: 1, 12, or 24 months
measure: Target vessel failure (TVF)
timeFrame: 1, 12, or 24 months
Locations:
city: Xi'an
country: China
facility: Ling Tao
state: Shannxi
Study officials:
affiliation: Xijing Hospital
name: Ling Tao, MD, Ph.D.
role: STUDY_CHAIR
affiliation: Xijing Hospital
name: Chao Gao, MD, Ph.D.
role: STUDY_CHAIR
References: