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

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronary Heart Disease, Angioplasty, Balloon

Intervention / Treatment
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* Device: Drug-coated balloon
* Device: Drug-eluting stents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with diabetes mellitus Received PCI by a drug-coated balloons only strategy or drug-eluting stents only strategy Exclusion Criteria: Under the age of 18 Unable to give informed consent Currently participating in another trial or participants unable to comply to follow-up

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-eluting stents, Drug-coated balloons, Diabetic, De-novo, In-stent stenosis, All-comers