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

NCT02171065 | Completed Results DMC

• 1 other identifier: PROSPECT II & PROSPECT ABSORB
• Study Type: interventional
• Target: 902
• Locations: 1 country
• Sites: 1

Brief Summary

The present study has two components, an overall prospective observational study using multimodality imaging (PROSPECT II) that will examine the natural history of patients with unstable atherosclerotic coronary artery disease with the specific goal to establish the utility of low-risk intracoronary imaging modalities, IVUS and NIRS, to identify plaques prone to future rupture and clinical events. The randomized PROSPECT ABSORB substudy will examine whether treatment of vulnerable plaques with the Absorb Bioresorbable vascular scaffold (BVS) plus GDMT safely increases the minimum lumen area (MLA) at 24 months compared with GDMT alone. The cutoff for inclusion in PROSPECT ABSORB will be a site-determined PB ≥65% (rather than the 70% cutoff identified in the original PROSPECT analysis (Stone et al., New England Journal of Medicine, 2011(5)) to account for an observed tendency for sites to underestimate plaque burden during acute treatment of ACS patients. Nonetheless, in PROSPECT, a core laboratory determined PB ≥65% was also associated with a high (7.0%) rate of major adverse cardiac event (MACE) during 3-year follow-up, a rate which may be reduced with a bioresorbable scaffold.

Conditions

Acute Coronary Syndrome (ACS)

Keywords

NIRS/IVUS; multimodality imaging; PROSPECT

Outcome Measures

Primary Outcomes (2)

• Prospect II: Patient Level Non-culprit Lesion Related Non-Culprit Major Adverse Cardiac Event (NC-MACE) Adjudicated to an Originally Untreated Non-culprit Lesion During the Entire Study Duration

  Patient-level rate of non-culprit lesion-related MACE (NC-MACE) evaluated at the longest follow-up available, assessed at the time when the last patient enrolled reaches at least 24 months. NC-MACE is defined as an event arising from an originally untreated NC lesion consisting of the composite of 1) cardiac death, 2) myocardial infarction, 3) unstable angina, or 4) progressive angina or anginal equivalent symptoms either 4a) requiring revascularization by coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI), and/or 4b) with angiographic core lab-confirmed rapid lesion progression.(NC-MACE).

  Median follow-up of 3.7 (first quartile, third quartile; 3.0, 4.4) years

• Prospect Absorb: The Minimum Luminal Area (MLA) at the Randomized Non-culprit Lesion Site in Patients Treated With the ABSORB BVS + GDMT Compared to GDMT Only Measured at 25 Months

  The MLA at the randomized non-culprit lesion site in patients treated with Absorb BVS + GDMT compared to GDMT only as measured at 25 months.

  25 month

Study Arms (2)

Guideline Directed Medical Therapy

SHAM COMPARATOR

Guideline Directed Medical Therapy

Device: sham

ABSORB BVS + Guideline Directed Medical Therapy

ACTIVE COMPARATOR

ABSORB BVS + Guideline Directed Medical Therapy

Device: ABSORB BVS

Interventions

sham DEVICE

Guideline Directed Medical Therapy

ABSORB BVS DEVICE

ABSORB BVS + Guideline Directed Medical Therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patient must have one-vessel, two-vessel or three-vessel disease in native coronary arteries requiring PCI.
• Successful PCI

You may not qualify if:

• Known estimated creatinine clearance \<30 ml/min.
• Cardiogenic shock, decompensated hypotension or heart failure requiring intubation, inotropes, intravenous diuretics or a hemodynamic support device.
• 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.
• Refractory ventricular arrhythmias (e.g. ventricular tachycardia or fibrillation) requiring either intravenous pharmacologic treatment or defibrillation during the index PCI procedure.
• Persistent acute conduction system disease requiring temporary pacemaker insertion during the index PCI procedure.
• Prior Coronary Artery Bypass Graft (CABG) at any time or planned CABG.
• 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%.
• 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.
• 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
• if one or more eligible lesions are identified which meet all of the following angiographic criteria:
• The lesion is a de novo lesion (may be located in either the target or non-target vessel)
• 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.
• 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%.

Sponsors & Collaborators

• Uppsala University: lead
• Abbott Medical Devices: collaborator
• Infraredx: collaborator
• The Medicines Company: collaborator

Study Sites (1)

David Erlinge

Lund, 221 85, Sweden

Location

Related Publications (8)

• Thrane PG, Maeng M, Maehara A, Botker HE, Mintz GS, Kjoller-Hansen L, Engstrom T, Matsumura M, Kotinkaduwa LN, Frobert O, Persson J, Wiseth R, Larsen AI, Jensen LO, Nordrehaug JE, Bleie O, Held C, James SK, Ali ZA, Erlinge D, Stone GW. Nonculprit Vulnerable Plaques and Prognosis in Myocardial Infarction With Versus Without ST-Segment Elevation: A PROSPECT II Substudy. Circulation. 2025 Jun 24;151(25):1767-1779. doi: 10.1161/CIRCULATIONAHA.124.071980. Epub 2025 Jun 23.

  PMID: 40549845 DERIVED

• Erlinge D, Tsimikas S, Maeng M, Maehara A, Larsen AI, Engstrom T, Kjoller-Hansen L, Matsumura M, Ben-Yehuda O, Botker HE, Frobert O, Persson J, Wiseth R, Jensen LO, Nordrehaug JE, Trovik T, Jensen U, Bleie O, Omerovic E, James SK, Rylance R, Sharma T, Ali ZA, Stone GW. Lipoprotein(a), Cholesterol, Triglyceride Levels, and Vulnerable Coronary Plaques: A PROSPECT II Substudy. J Am Coll Cardiol. 2025 Jun 3;85(21):2011-2024. doi: 10.1016/j.jacc.2025.04.013.

  PMID: 40436465 DERIVED

• Frobert O, Stone GW, Larsen AI, Zhou Z, Kotinkaduwa LN, Engstrom T, Kjoller-Hansen L, Maeng M, Matsumura M, Ben-Yehuda O, Botker HE, Persson J, Wiseth R, Jensen LO, Nordrehaug JE, Trovik T, Jensen U, Bleie O, James SK, Ali ZA, Omerovic E, Erlinge D, Maehara A. Relationships of hsCRP to High-Risk Vulnerable Plaque After NSTEMI: Insights From the PROSPECT II Trial. JACC Cardiovasc Interv. 2025 May 26;18(10):1217-1228. doi: 10.1016/j.jcin.2025.01.440. Epub 2025 Apr 23.

  PMID: 40272345 DERIVED

• Arslani K, Engstrom T, Maeng M, Kjoller-Hansen L, Maehara A, Zhou Z, Ben-Yehuda O, Botker HE, Matsumura M, Mintz GS, Frobert O, Persson J, Wiseth R, Larsen AI, Jensen LO, Nordrehaug JE, Bleie O, Omerovic E, Held C, James SK, Ali ZA, Erlinge D, Stone GW. Association Between Physiological Significance and Vulnerable Plaque Characteristics in Patients With Myocardial Infarction: A Prospect II Substudy. JACC Cardiovasc Imaging. 2025 Jun;18(6):696-706. doi: 10.1016/j.jcmg.2024.11.002. Epub 2025 Feb 24.

  PMID: 39998456 DERIVED

• Kjoller-Hansen L, Maehara A, Kelbaek H, Matsumura M, Maeng M, Engstrom T, Frobert O, Persson J, Wiseth R, Larsen AI, Jensen LO, Nordrehaug JE, Omerovic E, Held C, James S, Mintz GS, Ali ZA, Stone GW, Erlinge D. Impact of Lipidic Plaque on In-Stent and Stent Edge-Related Events After PCI in Myocardial Infarction: A PROSPECT II Substudy. Circ Cardiovasc Interv. 2024 Oct;17(10):e014215. doi: 10.1161/CIRCINTERVENTIONS.124.014215. Epub 2024 Sep 25.

  PMID: 39319453 DERIVED

• Gyldenkerne C, Maeng M, Kjoller-Hansen L, Maehara A, Zhou Z, Ben-Yehuda O, Erik Botker H, Engstrom T, Matsumura M, Mintz GS, Frobert O, Persson J, Wiseth R, Larsen AI, Jensen LO, Nordrehaug JE, Bleie O, Omerovic E, Held C, James SK, Ali ZA, Rosen HC, Stone GW, Erlinge D. Coronary Artery Lesion Lipid Content and Plaque Burden in Diabetic and Nondiabetic Patients: PROSPECT II. Circulation. 2023 Feb 7;147(6):469-481. doi: 10.1161/CIRCULATIONAHA.122.061983. Epub 2022 Dec 16.

  PMID: 36524476 DERIVED

• Erlinge D, Maehara A, Ben-Yehuda O, Botker HE, Maeng M, Kjoller-Hansen L, Engstrom T, Matsumura M, Crowley A, Dressler O, Mintz GS, Frobert O, Persson J, Wiseth R, Larsen AI, Okkels Jensen L, Nordrehaug JE, Bleie O, Omerovic E, Held C, James SK, Ali ZA, Muller JE, Stone GW; PROSPECT II Investigators. Identification of vulnerable plaques and patients by intracoronary near-infrared spectroscopy and ultrasound (PROSPECT II): a prospective natural history study. Lancet. 2021 Mar 13;397(10278):985-995. doi: 10.1016/S0140-6736(21)00249-X.

  PMID: 33714389 DERIVED

• Stone GW, Maehara A, Ali ZA, Held C, Matsumura M, Kjoller-Hansen L, Botker HE, Maeng M, Engstrom T, Wiseth R, Persson J, Trovik T, Jensen U, James SK, Mintz GS, Dressler O, Crowley A, Ben-Yehuda O, Erlinge D; PROSPECT ABSORB Investigators. Percutaneous Coronary Intervention for Vulnerable Coronary Atherosclerotic Plaque. J Am Coll Cardiol. 2020 Nov 17;76(20):2289-2301. doi: 10.1016/j.jacc.2020.09.547. Epub 2020 Oct 15.

  PMID: 33069847 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Results Point of Contact

• Title: Principal Investigator: David Erlinge, MD, PhD
• Organization: Lund University

david.erlinge@gmail.com

+46-733746165

Study Officials

• David Erlinge, MD, PhD

  Lund University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: June 23, 2014
• Study Start: June 1, 2014
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: August 10, 2021
• Results First Posted: August 10, 2021

Record last verified: 2021-07

Locations

SE (1)