Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization
NCT ID: NCT01960933
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
650 participants
INTERVENTIONAL
2011-05-31
2024-02-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Culprit lesion revascularization
Only the culprit lesion is treated whereas other study lesions are left un-treated.
Percutaneous coronary intervention
Full revascularization
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.
Percutaneous coronary intervention
FFR
Interventions
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Percutaneous coronary intervention
FFR
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Aalborg University Hospital
OTHER
Rigshospitalet, Denmark
OTHER
Responsible Party
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Thomas Engstrom
MD, Senior Consultant, DMSCi
Principal Investigators
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Steffen Helqvist, MD, DMSci
Role: STUDY_CHAIR
Rigshospitalet, University of Copenhagen, Denmark
Thomas Engstrøm, MD, DMSci
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, University of Copenhagen, Denmark
Henning Kelbæk, MD. DMSci
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, University of Copenhagen, Denmark
Lars Køber, MD, Prof., DMSci
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, University of Copenhagen, Denmark
Locations
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Aalborg University Hospital
Aalborg, , Denmark
Rigshospitalet, University of Copenhagen
Copenhagen, , Denmark
Countries
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References
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Marquard JM, Beske RP, Kelbaek H, Holmvang L, Pedersen F, Clemmensen P, De Backer O, Raungaard B, Eftekhari A, Islam U, Kober L, Tilsted HH, Glinge C, Jabbari R, Scheike T, Hofsten DE, Lonborg JT, Engstrom T. 10-Year Outcome of Complete or Infarct Artery-Only Revascularization in STEMI With Multivessel Disease: The DANAMI-3-PRIMULTI Study. J Am Coll Cardiol. 2025 Jul 15;86(2):119-129. doi: 10.1016/j.jacc.2025.05.013. Epub 2025 May 20.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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DANAMI-3-PRIMULTI
Identifier Type: -
Identifier Source: org_study_id