Routine Coronary Catheterization in Low Extremity Artery Disease Undergoing Percutaneous Transluminal Angioplasty

Study Overview
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Brief Summary
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The prevalence of significant and complex obstructive coronary artery disease (CAD) is high in patients who have low extremity artery disease (LEAD). Long-term prognosis of LEAD undergoing percutaneous transluminal angioplasty (PTA) remains poor and CAD is an independent predictor of total mortality after PTA. This prospective randomized controlled trial will evaluate the prognostic effects of routine versus selective coronary angiography before PTA for LEAD and elucidate the potential mechanism.

Detailed Description
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participants eligible participants are randomly assigned to systemic strategy or selective strategy participants allocated to systemic strategy will receive routine coronary angiography before PTA without a previous non-invasive stress test subjects allocated to selective strategy will undergo non-invasive evaluation of possible myocardial ischemia by using dobutamine stress echocardiography (DSE) or dipyridamole thallium 201 myocardial perfusion scintigraphy (dTS) followed by coronary angiography if the test is positive for ischemia participants who are not willing to be randomized will be included in the registration group revascularization a staged approach (myocardial revascularization first followed by PTA) and simultaneous approach (percutaneous coronary intervention immediately followed by PTA at the same time if clinically suitable) are both allowed the duration from revascularization to PTA should be within 60 days percutaneous coronary intervention is performed at the time of coronary angiography, using bare metal or drug-eluting stents blood sampling, genotyping, and measurement of biomarkers and microRNA a. bood samples (20 mL) are obtained from peripheral arteries in all study subjects before PTA and 10 mL after PTA and are prepared and stored for enzyme-linked immunosorbent assay (ELISA), genotyping and measurement of microRNAs in plasma and peripheral blood mononuclear cells outcome follow-up a. clinical outcomes are obtained by chart review if the patient is still in the hospital and followed up by clinic visit, telephone call or direct contact with participants or subjects' family at 30 days after indexed PTA if the patient has been discharged from the hospital and every 6 months thereafter

Official Title
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Prognostic Impact of ROUtine Coronary CathETerization in Low Extremity ArTEry Disease Undergoing Percutaneous Transluminal Angioplasty (PIROUETTE-PTA Study)

Conditions
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Peripheral Artery Disease, Coronary Artery Disease

Intervention / Treatment
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* Procedure: Systemic Strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Known LEAD (documented by previous angiography or sonography performed by the operators) admitted for elective PTA Exclusion Criteria: Known CAD or unstable angina within past 3 months Acute myocardial infarction within past 6 months Known CAD status posterior percutaneous coronary intervention or bypass surgery within past 6 months Planning to do bypass surgery for known LEAD\ Pregnancy Documented active malignancy Needing emergency PTA

Ages Eligible for Study
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Minimum Age: 20 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Selective Strategy<br>non-invasive evaluation of possible myocardial ischemia by using DSE or dTS followed by coronary angiography if the test is positive for ischemia | Procedure: Systemic Strategy<br>* Significant CAD needing further revascularization is defined as patients who have luminal stenosis > 70% of the major epicardial vessels and bypass graft vessel or their major branches (> 50% for left main trunk or in-stent restenotic lesion) with reference vessel larger than 2.5 mm in diameter and moderate area of vulnerable myocardium for ischemia. Intermediate stenotic lesions should be determined if they are hemodynamic significant by fractional flow reserve (FFR) (<=0.8). The choice of revascularization procedure, either percutaneous coronary intervention or coronary artery bypass surgery, depends on operator's or cardiovascular team's suggestion and patient's decision.<br>* Other names: Routine Coronary Angiography before PTA;|
| No Intervention: Registry<br>Clinical decisions are reached by consensus of operators, patients and family as usual care | |
| Active Comparator: Systemic Strategy<br>Routine coronary angiography before PTA without a previous non-invasive stress test | Procedure: Systemic Strategy<br>* Significant CAD needing further revascularization is defined as patients who have luminal stenosis > 70% of the major epicardial vessels and bypass graft vessel or their major branches (> 50% for left main trunk or in-stent restenotic lesion) with reference vessel larger than 2.5 mm in diameter and moderate area of vulnerable myocardium for ischemia. Intermediate stenotic lesions should be determined if they are hemodynamic significant by fractional flow reserve (FFR) (<=0.8). The choice of revascularization procedure, either percutaneous coronary intervention or coronary artery bypass surgery, depends on operator's or cardiovascular team's suggestion and patient's decision.<br>* Other names: Routine Coronary Angiography before PTA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Composite of Major Adverse Cardiac Event (MACE) | cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and any unplanned coronary revascularization | up to 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE between the Screening and 30 days after PTA | cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and any unplanned coronary revascularization | 30 days after indexed PTA | 
| Time to Composite of major coronary events | fatal or nonfatal myocardial infarction, recurrent angina pectoris, and any unplanned coronary revascularization | Up to 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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revascularization, microRNAs, coronary artery disease, peripheral artery disease, percutaneous transluminal angioplasty, coronary angiography, gene polymorphisms