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| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
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The primary aim of the trial is to determine whether preventive PCI with bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) plus optimal medical therapy (OMT) on functionally insignificant (FFR > 0.80) vulnerable coronary plaque, as determined by intracoronary imaging, would result in a significant reduction of the primary composite outcome of death from cardiac causes, target-vessel myocardial infarction (MI), target-vessel revascularization (TVR), and hospitalization for unstable or progressive angina at 2 years, when compared with OMT alone.
Sub-analysis for each imaging test will be performed as below;
Extended follow-up:
Considering the nature of functionally insignificant coronary stenosis with vulnerable plaque, most subjects are watched for extended follow-up after the planned 2-year follow-up time point.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary intervention | Experimental | bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) +Optimal Medical Treatment |
|
| Optimal Medical Treatment | Active Comparator | Optimal Medical Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary intervention | Device | bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) + Optimal Medical Treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target vessel failure | target-vessel failure, which was defined a composite of death from cardiac causes, target-vessel myocardial infarction, ischemic-driven target-vessel revascularization, or hospitalization for unstable or progressive angina | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Death from cardiac causes | 2 years | |
| Target-vessel myocardial infarction | 2 years | |
| Ischemic-driven target-vessel revascularization |
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Inclusion Criteria:
Patients aged ≥18 years
Patients with suspected or known Coronary artery disease who are undergoing invasive cardiac catheterization
Patients with at least one significant stenosis (diameter stenosis >50%) with Fractional Flow Reserve (FFR) >0.80 and meeting two of the following criteria:
Eligible for percutaneous coronary intervention with Absorb Bioresorbable Vascular Scaffold or Everolimus Eluting Stent
Reference vessel diameter 2.75-4.0
Lesion length ≤ 40mm
Willing and able to provide informed written consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Duk-woo Park, MD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | United States | |||
| Kyoto University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38604213 | Derived | Park SJ, Ahn JM, Kang DY, Yun SC, Ahn YK, Kim WJ, Nam CW, Jeong JO, Chae IH, Shiomi H, Kao HL, Hahn JY, Her SH, Lee BK, Ahn TH, Chang KY, Chae JK, Smyth D, Mintz GS, Stone GW, Park DW; PREVENT Investigators. Preventive percutaneous coronary intervention versus optimal medical therapy alone for the treatment of vulnerable atherosclerotic coronary plaques (PREVENT): a multicentre, open-label, randomised controlled trial. Lancet. 2024 May 4;403(10438):1753-1765. doi: 10.1016/S0140-6736(24)00413-6. Epub 2024 Apr 8. | |
| 37271356 |
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| Optimal Medical treatment | Drug |
|
| 2 years |
| Hospitalization for unstable or progressive angina | 2 years |
| Death from all, cardiac, or noncardiac causes | 2 years |
| Myocardial infarction | Periprocedural or spontaneous, target-vessel or non-target-vessel related | 2 years |
| Repeat revascularization | Repeat revascularization (target-vessel or non-target-vessel, ischemia-driven or non-ischemia-driven) | 2 years |
| Any hospitalization for cardiac or noncardiac causes | 2 years |
| Target-lesion failure | cardiac death, target-vessel myocardial infarction or ischemia-driven target-lesion revascularization | 2 years |
| Major adverse cardiac event | defined as death from cardiovascular causes, nonfatal myocardial infarction, or unplanned rehospitalization due to unstable or progressive angina | 2 years |
| Composite of any death, myocardial infarction, or repeat revascularization | A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed. | 2 years |
| Rate of Scaffold or stent thrombosis | 2 years |
| Rate of Stroke | 2 years |
| Rate of Bleeding events | life-threatening or disabling, major or minor | 2 years |
| Rate of Nonurgent revascularization procedures | 2 years |
| Functional class | It is assessed by the Canadian Cardiovascular Society (CCS) Classification at each point in time. The Canadian Cardiovascular Society (CCS) classification has four categories; the minimum and maximum values are 1 and 4 respectively. A higher score means a worse outcome. | 2 years |
| Number of anti-anginal medications administered | Number of anti-anginal medication at each point in time | 2 years |
| Kyoto |
| Japan |
| Christchurch Hospital and Canterbury DHB, University of Otago | Christchurch | New Zealand |
| Asan Medical Center | Seoul | Songpa-gu | 138-736 | South Korea |
| Hallym University Sacred Heart Hospital | Anyang | South Korea |
| Gangwon National Univ. Hospital | Chuncheon | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | South Korea |
| Chungnam National University Hospital | Daejeon | South Korea |
| The Catholic University of Korea, Daejeon ST. Mary's Hospital | Daejeon | South Korea |
| Chonnam National University Hospital | Gwangju | South Korea |
| Gachon University Gil Hospital | Incheon | South Korea |
| ChonBuk National University Hospital | Jeonju | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University hospital | Seoul | South Korea |
| The Catholic University of Korea Seoul St. Mary's Hospital | Seoul | South Korea |
| Bundang Cha Medical Center | Sŏngnam | South Korea |
| Seoul National University Bundang hospital | Sŏngnam | South Korea |
| National Taiwan University Hospital | Taipei | Taiwan |
| Derived |
| Ahn JM, Kang DY, Lee PH, Ahn YK, Kim WJ, Nam CW, Jeong JO, Chae IH, Shiomi H, Kao PHL, Hahn JY, Her SH, Lee BK, Ahn TH, Chang K, Chae JK, Smyth D, Stone GW, Park DW, Park SJ; PREVENT Investigators. Preventive PCI or medical therapy alone for vulnerable atherosclerotic coronary plaque: Rationale and design of the randomized, controlled PREVENT trial. Am Heart J. 2023 Oct;264:83-96. doi: 10.1016/j.ahj.2023.05.017. Epub 2023 Jun 2. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D058226 | Plaque, Atherosclerotic |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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