Drug Coated Balloon Compared to Bare Metal Stent for de Novo Coronary Artery Lesions

Study Overview
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Brief Summary
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This randomized trial will assess the efficacy of Drug Coated Balloon (DCB) compared to Bare Metal Stent (BMS) using Fractional Flow Reserve (FFR) guidance for de novo coronary artery lesions in patients unable to tolerate dual antiplatelet therapy and at high risk of bleeding. Patients will be randomized after balloon angioplasty to receive either DCB or BMS. Endpoints are late luminal loss at 9 months, and major adverse cardiac events including arterial thrombosis at 1, 9 and 12 months.

Detailed Description
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Although the use of drug-eluting stents (DES) has reduced in-stent restenosis when compared to bare metal stents (BMS) and decreased the incidence of adverse clinical events (1-2), DES therapy is limited by delayed arterial healing, late acquired malapposition and neo-atherosclerosis leading to an increased risk of late stent thrombosis and late restenosis (3-4). Conceptually, a permanent stent inhibits advantageous vascular remodeling and durable polymer provokes excessive inflammation (5). Non-stent based local drug delivery using paclitaxel-coated balloon has emerged as a new clinical treatment alternative by maintaining the anti-proliferative properties of DES (6). There is limited data on the efficacy of Drug Coated Balloon (DCB) treatment for de novo coronary lesions when compared to BMS. To avoid the risk of abrupt closure of target lesion after balloon angioplasty, a reliable predictor of coronary flow is necessary especially in de novo lesions of major coronary arteries. Therefore, using fractional flow reserve (FFR) after angioplasty as a good indicator of immediate functional improvement and reduced restenosis (7), the aim of this study is to assess the efficacy of DCB treatment compared to BMS in patients with de novo coronary artery lesions. Patients with de novo coronary artery lesions with > 50% stenosis in a single vessel and at high risk of bleeding with the inability to tolerate dual antiplatelet therapy (DAPT) will be included in this trial. Patients will undergo balloon angioplasty and if the FFR post balloon angioplasty is > 0.80, they will be randomized to receive either DCB or BMS. Patients will receive Quantitative Coronary Angiography (QCA) analysis at 9 months follow-up. Endpoints are late luminal loss at 9 months and major adverse events including arterial thrombosis at 1, 9 and 12 months and these endpoints will be compared between DCB and BMS groups.

Official Title
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Randomized Controlled Trial of Drug Coated Balloon Compared to Bare Metal Stent Using FFR-guidance for the Treatment of de Novo Coronary Artery Lesions

Conditions
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Stable Angina, Unstable Angina

Intervention / Treatment
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* Device: Drug Coated Balloon
* Device: Bare Metal Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stable Angina and Unstable angina single de novo coronary artery lesions in a single vessel with > 50% diameter stenosis with a reference diameter > 2.75mm Patients at high risk of bleeding and whom cannot tolerate dual antiplatelet therapy for > 1 month are inclusion criteria for the study and are listed here: Unexplained anemia Atrial fibrillation with CHADSVASC > or equal to 1 Patients awaiting for non cardiac surgery within a year History of massive hemorrhage requiring transfusion History of upper GI bleeding Malignancy Poor compliance with medication Exclusion Criteria: STEMI/NSTEMI within the preceding 72 hours Multivessel disease, chronic total occlusion, long lesions and left main disease heart failure with ejection fraction < 35% and/or cardiogenic shock Previous history of or planned coronary artery bypass grafting life expectancy of less than 1 year

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug Coated Balloon<br>PCB (SeQuent Please®, paclitaxel-coated balloon catheter, B. Braun, Melsungen, Germany) | Device: Drug Coated Balloon<br>* If post balloon angioplasty FFR is more than 0.80, either DCB treatment or BMS implantation will be carried out based on randomization of 1:1. DCB (SeQuent Please paclitaxel-coated balloon catheter, B. Braun, Melsungen, Germany) will be applied at the predilated lesions. PCB will be delivered rapidly and inflated for 60 seconds with nominal pressure.<br>|
| Active Comparator: Bare Metal Stent<br>BMS (Vision®) | Device: Bare Metal Stent<br>* BMS (Vision®) will be applied at the predilated lesions after angiographic confirmation of the target lesion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late luminal loss |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular events (MACE) (death, myocardial infarction, repeat revascularization, recurrent ischemic symptoms) |  | Post procedure (up to 1 hour), 1 month, 9 months and 12 months | 
| Arterial thrombosis | Any stent thrombosis - acute, subacute/late stent thrombosis | Post procedure (up to 1 hour), 1 month, 9 months and 12 months | 
| Fractional Flow Reserve | FFR is the ratio of the pressure measured at the distal portion of the target lesion and the aortic ostium at maximal hyperemia | Post procedure (up to 1 hour) and 9 months |