Drug Coated Balloon Only vs Drug Eluting Stent Angioplasty

Study Overview
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Brief Summary
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Drug coated balloon (DCB) is a relatively new technology which allows the treatment of coronary artery disease without permanent implantation of a metallic scaffold (stent) in the coronary artery. It is recommended by international guidelines for the treatment of in-stent restenosis (i.e. when a previously implanted stent in the coronary artery develops narrowings again). Data on patient outcomes of patients treated with DCB for de novo coronary artery disease (narrowings in artery supplying blood to the heart that has not been previously treated with a stent) are limited to relatively small studies. In our institution, DCBs have been used over the last 10 years and we have developed a large clinical database. We intend to compare the outcomes of all our patients treated clinically with DCB vs patients treated with drug eluting stent (DES). We will, incorporate all patients presenting either with myocardial infarction (heart attack) or stable angina. Our main outcomes will be: Primary 1) mortality Secondary 1) cardiac mortality 2) cardiac rehospitalisation3) composite of cardiac mortality and cardiac rehospitalisation

Official Title
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Outcomes of Drug Coated Balloon Angioplasty, A UK Real Life Experience

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: DCB
* Procedure: DES


Participation Criteria
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Eligibility Criteria
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Patients with coronary artery disease being treated with DCB or DES

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| DCB<br>DCB group: Patients treated with drug coated balloon (DCB) only angioplasty (all-comers: STEMI, NSTEMI, Stable angina) | Procedure: DCB<br>* Angioplasty with DCB is an angioplasty technique which allows drug delivery to the coronary artery without stent implantation.<br>|
| DES<br>DES group: Patients treated with drug eluting stent (DES) angioplasty (all-comers:STEMI, NSTEMI, Stable angina) | Procedure: DES<br>* Angioplasty with DES is an angioplasty technique which permits drug delivery to the coronary artery and permanent implantation of a stent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | All cause death will be defined as death due to any cause | Through study completion, an average of 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac mortality - either MI, TVR, Acute Vessel Closure or TLR | An MI is defined as per MINAP definition (a hospital diagnosis reported as a troponin positive MI). A TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The latter is defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself. Acute vessel closure is defined as an event where a patient had to be taken back to cardiac catheterisation lab and require repeat angioplasty (during the same hospital stay) for a complete or partial occlusion of the artery due to a dissection. A TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal and 5 mm distal to the treated lesion (by visual assessment). | Through study completion, an average of 10 years | 
| Cardiac rehospitalisation | Any hospital record of admission due to cardiac complications | Through study completion, an average of 10 years | 
| Composite of cardiac death and cardiac rehospitalisation | Any hospital record of admission and death due to cardiac complications | Through study completion, an average of 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug coated balloon, Drug eluting stent