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Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization (PRIMULTI)

Primary Purpose

ST-elevation Myocardial Infarction, Multi Vessel Disease

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Percutaneous coronary intervention
FFR
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST-elevation Myocardial Infarction focused on measuring STEMI, MVD, Full revascularization, Culprit lesion revascularization only, Primary PCI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years.
  • Acute onset of chest pain of < 12 hours' duration.
  • ST-segment elevation ≥ 0.1 millivolt in ≥ 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block.
  • Culprit lesion in a major native vessel.
  • MVD (non-culprit vessels with angiographic stenosis >50%)
  • Successful primary PCI

Exclusion Criteria:

  • Pregnancy.
  • Known intolerance of acetylsalicylic acid, clopidogrel, heparin or contrast.
  • Inability to understand information or to provide informed consent.
  • Haemorrhagic diathesis or known coagulopathy.
  • Stent thrombosis
  • Significant left main stem stenosis
  • Cardiogenic shock at admittance

Sites / Locations

  • Aalborg University Hospital
  • Rigshospitalet, University of Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Culprit lesion revascularization

Full revascularization

Arm Description

Only the culprit lesion is treated whereas other study lesions are left un-treated.

Culprit lesion is treated initially and all other lesions with diameter stenosis angiographically >50% and FFR <0.80 are treated in a separate procedure within the index hospitalization. Stenoses > 90% are treated without prior FFR.

Outcomes

Primary Outcome Measures

All cause death, myocardial infarction or revascularization
Composite of all cause mortality, myocardial infarction, or ischemia (either subjective or objective) driven revascularization of non-culprit coronary lesions eligible for and randomized to either of the two treatment arms at the time of the index procedure

Secondary Outcome Measures

Cardiac death or myocardial infarction
Hospitalization for acute coronary syndrome or acute heart failure
Angina status and quality of life
Infarct size in relation to area at risk as determined by MRI
Cardiac death, myocardial infarction, repeat revascularisation or occurrence of definite stent thrombosis (according to ARC definition) of non culprit lesions
Wall motion index (WMI) determined by echocardiography

Full Information

First Posted
October 9, 2013
Last Updated
June 1, 2022
Sponsor
Rigshospitalet, Denmark
Collaborators
Aalborg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01960933
Brief Title
Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization
Acronym
PRIMULTI
Official Title
Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization (DANAMI-3-PRIMULTI) A Randomised Comparison of the Clinical Outcome After Complete Revascularisation Versus Treatment of the Infarct-related Artery Only During Primary Percutaneous Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 2011 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Aalborg University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In patients with ST-elevation myocardial infarction (STEMI) the primary treatment is acute angioplasty of the acute occlusion (culprit lesion). In STEMI patients with multi vessel disease (MVD) no evidence based treatment of the non-culprit lesions exists. We aim to provide evidence as to whether full revascularization or revascularization of the culprit lesion only provides the best prognosis for the patient.
Detailed Description
STEMI patients with MVD (30% of total STEMI population) are - following successful primary angioplasty - randomized to either no additional percutaneous coronary intervention (PCI) of other lesions or full revascularisation guided by fractional flow reserve (FFR). Eligible coronary arteries must be >2.0 mm in diameter and at the discretion of the operator suitable for PCI. Only arteries with angiographically stenoses > 50% can be randomized. All randomized lesions with diameter stenosis > 50% and < 90% are evaluated by FFR and a FFR value < 0.80 is considered significant and treated. Stenoses >90% are treated without prior FFR. Full revascularization is a priori obtained by means of PCI. If, however, PCI is considered inferior to coronary artery bypass grafting the latter option can be chosen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-elevation Myocardial Infarction, Multi Vessel Disease
Keywords
STEMI, MVD, Full revascularization, Culprit lesion revascularization only, Primary PCI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
650 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Culprit lesion revascularization
Arm Type
Active Comparator
Arm Description
Only the culprit lesion is treated whereas other study lesions are left un-treated.
Arm Title
Full revascularization
Arm Type
Active Comparator
Arm Description
Culprit lesion is treated initially and all other lesions with diameter stenosis angiographically >50% and FFR <0.80 are treated in a separate procedure within the index hospitalization. Stenoses > 90% are treated without prior FFR.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous coronary intervention
Intervention Type
Procedure
Intervention Name(s)
FFR
Primary Outcome Measure Information:
Title
All cause death, myocardial infarction or revascularization
Description
Composite of all cause mortality, myocardial infarction, or ischemia (either subjective or objective) driven revascularization of non-culprit coronary lesions eligible for and randomized to either of the two treatment arms at the time of the index procedure
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Cardiac death or myocardial infarction
Time Frame
1 year
Title
Hospitalization for acute coronary syndrome or acute heart failure
Time Frame
1 year
Title
Angina status and quality of life
Time Frame
1 year
Title
Infarct size in relation to area at risk as determined by MRI
Time Frame
3 months
Title
Cardiac death, myocardial infarction, repeat revascularisation or occurrence of definite stent thrombosis (according to ARC definition) of non culprit lesions
Time Frame
2 years
Title
Wall motion index (WMI) determined by echocardiography
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years. Acute onset of chest pain of < 12 hours' duration. ST-segment elevation ≥ 0.1 millivolt in ≥ 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block. Culprit lesion in a major native vessel. MVD (non-culprit vessels with angiographic stenosis >50%) Successful primary PCI Exclusion Criteria: Pregnancy. Known intolerance of acetylsalicylic acid, clopidogrel, heparin or contrast. Inability to understand information or to provide informed consent. Haemorrhagic diathesis or known coagulopathy. Stent thrombosis Significant left main stem stenosis Cardiogenic shock at admittance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steffen Helqvist, MD, DMSci
Organizational Affiliation
Rigshospitalet, University of Copenhagen, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Thomas Engstrøm, MD, DMSci
Organizational Affiliation
Rigshospitalet, University of Copenhagen, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Henning Kelbæk, MD. DMSci
Organizational Affiliation
Rigshospitalet, University of Copenhagen, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lars Køber, MD, Prof., DMSci
Organizational Affiliation
Rigshospitalet, University of Copenhagen, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Rigshospitalet, University of Copenhagen
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
35990971
Citation
Mazhar J, Ekstrom K, Kozor R, Grieve SM, Nepper-Christensen L, Ahtarovski KA, Kelbaek H, Hofsten DE, Kober L, Vejlstrup N, Vernon ST, Engstrom T, Lonborg J, Figtree GA. Cardiovascular magnetic resonance characteristics and clinical outcomes of patients with ST-elevation myocardial infarction and no standard modifiable risk factors-A DANAMI-3 substudy. Front Cardiovasc Med. 2022 Aug 3;9:945815. doi: 10.3389/fcvm.2022.945815. eCollection 2022.
Results Reference
derived
PubMed Identifier
33951923
Citation
Ekstrom K, Nielsen JVW, Nepper-Christensen L, Ahtarovski KA, Kyhl K, Goransson C, Bertelsen L, Ghotbi AA, Kelbaek H, Hofsten DE, Kober L, Schoos MM, Vejlstrup N, Lonborg J, Engstrom T. Ischemia From Nonculprit Stenoses Is Not Associated With Reduced Culprit Infarct Size in Patients with ST-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Imaging. 2021 May;14(5):e012290. doi: 10.1161/CIRCIMAGING.120.012290. Epub 2021 May 5.
Results Reference
derived
PubMed Identifier
31005537
Citation
Ekstrom K, Nepper-Christensen L, Ahtarovski KA, Kyhl K, Goransson C, Bertelsen L, Ghotbi AA, Kelbaek H, Helqvist S, Hofsten DE, Kober L, Schoos MM, Vejlstrup N, Lonborg J, Engstrom T. Impact of Multiple Myocardial Scars Detected by CMR in Patients Following STEMI. JACC Cardiovasc Imaging. 2019 Nov;12(11 Pt 1):2168-2178. doi: 10.1016/j.jcmg.2019.01.032. Epub 2019 Apr 17.
Results Reference
derived
PubMed Identifier
30823897
Citation
Wang LJ, Han S, Zhang XH, Jin YZ. Fractional flow reserve-guided complete revascularization versus culprit-only revascularization in acute ST-segment elevation myocardial infarction and multi-vessel disease patients: a meta-analysis and systematic review. BMC Cardiovasc Disord. 2019 Mar 1;19(1):49. doi: 10.1186/s12872-019-1022-6.
Results Reference
derived
PubMed Identifier
30354595
Citation
Nepper-Christensen L, Lonborg J, Hofsten DE, Ahtarovski KA, Bang LE, Helqvist S, Kyhl K, Kober L, Kelbaek H, Vejlstrup N, Holmvang L, Engstrom T. Benefit From Reperfusion With Primary Percutaneous Coronary Intervention Beyond 12 Hours of Symptom Duration in Patients With ST-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Interv. 2018 Sep;11(9):e006842. doi: 10.1161/CIRCINTERVENTIONS.118.006842.
Results Reference
derived
PubMed Identifier
30213322
Citation
Kobayashi Y, Lonborg J, Jong A, Nishi T, De Bruyne B, Hofsten DE, Kelbaek H, Layland J, Nam CW, Pijls NHJ, Tonino PAL, Warnoe J, Oldroyd KG, Berry C, Engstrom T, Fearon WF; DANAMI-3-PRIMULTI, FAME, and FAMOUS-NSTEMI Study Investigators. Prognostic Value of the Residual SYNTAX Score After Functionally Complete Revascularization in ACS. J Am Coll Cardiol. 2018 Sep 18;72(12):1321-1329. doi: 10.1016/j.jacc.2018.06.069.
Results Reference
derived
PubMed Identifier
29776961
Citation
Falkentoft AC, Rorth R, Iversen K, Hofsten DE, Kelbaek H, Holmvang L, Frydland M, Schoos MM, Helqvist S, Axelsson A, Clemmensen P, Jorgensen E, Saunamaki K, Tilsted HH, Pedersen F, Torp-Pedersen C, Kofoed KF, Goetze JP, Engstrom T, Kober L. MR-proADM as a Prognostic Marker in Patients With ST-Segment-Elevation Myocardial Infarction-DANAMI-3 (a Danish Study of Optimal Acute Treatment of Patients With STEMI) Substudy. J Am Heart Assoc. 2018 May 18;7(11):e008123. doi: 10.1161/JAHA.117.008123.
Results Reference
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PubMed Identifier
28404623
Citation
Lonborg J, Engstrom T, Kelbaek H, Helqvist S, Klovgaard L, Holmvang L, Pedersen F, Jorgensen E, Saunamaki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aaroe J, Jensen SE, Raungaard B, Kober L, Hofsten DE; DANAMI 3-PRIMULTI Investigators. Fractional Flow Reserve-Guided Complete Revascularization Improves the Prognosis in Patients With ST-Segment-Elevation Myocardial Infarction and Severe Nonculprit Disease: A DANAMI 3-PRIMULTI Substudy (Primary PCI in Patients With ST-Elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization). Circ Cardiovasc Interv. 2017 Apr;10(4):e004460. doi: 10.1161/CIRCINTERVENTIONS.116.004460.
Results Reference
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PubMed Identifier
26347918
Citation
Engstrom T, Kelbaek H, Helqvist S, Hofsten DE, Klovgaard L, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aaroe J, Jensen SE, Raungaard B, Kober L; DANAMI-3-PRIMULTI Investigators. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3-PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015 Aug 15;386(9994):665-71. doi: 10.1016/s0140-6736(15)60648-1.
Results Reference
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PubMed Identifier
25965708
Citation
Hofsten DE, Kelbaek H, Helqvist S, Klovgaard L, Holmvang L, Clemmensen P, Torp-Pedersen C, Tilsted HH, Botker HE, Jensen LO, Kober L, Engstrom T; DANAMI 3 Investigators. The Third DANish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction: Ischemic postconditioning or deferred stent implantation versus conventional primary angioplasty and complete revascularization versus treatment of culprit lesion only: Rationale and design of the DANAMI 3 trial program. Am Heart J. 2015 May;169(5):613-21. doi: 10.1016/j.ahj.2015.02.004. Epub 2015 Feb 14.
Results Reference
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Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization

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