PROSPECT II & PROSPECT ABSORB - an Integrated Natural History Study and Randomized Trial.

Launched by UPPSALA UNIVERSITY · Jun 19, 2014

Keywords

ClinConnect Summary

Methodology:

PROSPECT II: Multicenter, prospective, natural history study of troponin positive patients with acute coronary syndromes (ACS) examined with angiography and intended for PCI for the initial culprit lesion(s). Prior to PCI all target lesions (those lesions for which PCI is planned) will be examined (if possible) by IVUS/NIRS. After successful PCI of all flow-limiting lesions determined angiographically and/or by FFR/iFR intended to be treated (termed "culprit lesions," whether responsible for the original ACS or otherwise flow-limiting and requiring PCI for complete revasculari...

Gender

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Eligibility criteria

• • PROSPECT II
• Inclusion Criteria:
• • 1. Troponin positive ACS (STEMI \>12 h or NSTEMI) occurring within the prior 4 weeks of enrollment, with symptoms consistent with acute ischemia lasting \>10 minutes, intended for angiography and Percutaneous Coronary Intervention (PCI) if appropriate.
• • 2. Patient must have one-vessel, two-vessel or three-vessel disease in native coronary arteries requiring PCI.
• • 3. Successful PCI
• Exclusion Criteria:
• • 1. Known estimated creatinine clearance \<30 ml/min.
• • 2. Cardiogenic shock, decompensated hypotension or heart failure requiring intubation, inotropes, intravenous diuretics or a hemodynamic support device.
• • 3. Patient has a known hypersensitivity, allergy or contraindication to any of the following: aspirin, both heparin and bivalirudin, all 3 of clopidogrel, prasugrel and ticagrelor, or to contrast that cannot be adequately pre-medicated.
• • 4. Refractory ventricular arrhythmias (e.g. ventricular tachycardia or fibrillation) requiring either intravenous pharmacologic treatment or defibrillation during the index PCI procedure.
• • 5. Persistent acute conduction system disease requiring temporary pacemaker insertion during the index PCI procedure.
• • 6. Prior Coronary Artery Bypass Graft (CABG) at any time or planned CABG.
• • 7. PCI is required of the left main coronary artery, or a left main stenosis is present with a visually estimated angiographic Diameter Stenosis (DS) of \>30%.
• • 8. Angiographic evidence of severe calcification and/or marked tortuosity of the target (culprit) or a non-culprit vessel is present that would preclude the feasibility of safe imaging of at least the proximal 6 cm of all vessels.
• • 9. The presence of a chronic total occlusion of a major epicardial coronary vessel that is not successfully recanalized during the PCI procedure, and thus would preclude intravascular imaging.
• • PROSPECT ABSORB
• Inclusion Criteria:
• if one or more eligible lesions are identified which meet all of the following angiographic criteria:
• • 1. The lesion is a de novo lesion (may be located in either the target or non-target vessel)
• • 2. The lesion has an angiographic diameter stenosis \<70%, and is not intended for revascularization based on angiographic criteria and Fractional Flow Reserve/Instantaneous wave-free ratio (FFR/iFR).
• • Note: FFR/iFR should be performed on all noncritical lesions of greater than 40% visually estimated angiographic stenosis that are candidates for the ABSORB substudy.
• • 3. The lesion has a site-determined IVUS plaque burden in at least one frame ≥65%. Note: Such a lesion may or may not be angiographically evident; i.e. the visually estimated angiographic diameter stenosis may range between 0% - \<70%.
• • 4. The reference vessel diameter of an eligible lesion is ≥2.5 mm - ≤4.0 mm (visually estimated) capable of being treated with a 2.5 mm, 3.0 mm, or 3.5 mm diameter BVS.
• • 5. The lesion length of an eligible lesion is ≤50 mm (visually estimated), capable of being treated by no more than two BVS (maximum length of each BVS 28 mm), allowing for 2 mm BVS overlap and 2 mm of "normal" reference segment treatment at each edge.
• • 6. The lesion must be at least 10 mm from a previously implanted stent/scaffold and an intervening 10 mm segment must not have plaque burden (PB) \>50%
• • 7. A bifurcation lesion may be enrolled only if the side branch is a) ≤2.5 mm in reference vessel diameter, AND b) has either no lesion requiring treatment, or atherosclerotic disease limited to within 5 mm of its origin from the parent vessel such that the operator believes that the side branch can be successfully treated with balloon angioplasty only (without a stent). If a stent subsequently becomes necessary, only a metallic drug-eluting stent (DES) may be used to treat the side branch with a T-stent technique.
• • 8. Randomization must occur immediately after the 3-vessel imaging run in the PROSPECT II protocol. If the patient randomizes to BVS, BVS placement must be performed immediately after randomization.
• Exclusion Criteria:
• • 1. The randomized lesion cannot be within 10 mm of a lesion previously treated by PCI .
• • 2. The randomized lesion may not be in the left main coronary artery.
• • 3. The randomized lesion may not be an ostial Left Anterior Descending Coronary Artery (LAD) or ostial Left Circumflex Coronary Artery (LCX) lesion (defined as within 3 mm of the left main coronary artery).
• • 4. The randomized lesion may not be an ostial Right Coronary Artery (RCA) lesion (defined as within 3 mm of the aorto-ostium).
• • 5. Angiographic evidence of severe calcification and/or marked tortuosity of the target vessel and/or lesion intended for randomization is present that would make it unlikely that the BVS could be advanced to or across the lesion or be adequately expanded.