Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock
NCT ID: NCT01927549
Last Updated: 2017-11-09
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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COMPLETED
PHASE4
706 participants
INTERVENTIONAL
2013-04-30
2017-10-31
Brief Summary
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The main study hypothesis is to explore if culprit vessel only PCI with potentially subsequent staged revascularization in comparison to immediate multivessel revascularization by PCI in patients with cardiogenic shock complicating acute myocardial infarction reduces the incidence of 30- day mortality and/or severe renal failure requiring renal replacement therapy.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Immediate multivessel PCI
After diagnostic angiography the culprit lesion is identified and PCI should be performed using standard techniques. The use of drug-eluting stents is recommended but not mandatory. All additional lesions in other major coronary arteries defined by a diameter \>2 mm with high grade stenoses (\>70% by visual assessment) should be intervened using standard techniques. Other major coronary arteries are defined by stenoses of other vessels and are not confined to a diagonal branch if the left anterior descending coronary artery was identified as the culprit lesion.
Immediate multivessel PCI
Culprit lesion only PCI
After diagnostic angiography the culprit lesion is identified and PCI of the culprit lesion should be performed using standard techniques. The use of drug-eluting stents is recommended but not mandatory. All other lesions should be left untreated in the acute setting. Complete revascularization of the non-culprit lesions may be performed at a later time point as staged procedure depending on remaining ischemia (as per guideline recommendations either by PCI or CABG).
Culprit Lesion only PCI
Interventions
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Immediate multivessel PCI
Culprit Lesion only PCI
Eligibility Criteria
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Inclusion Criteria
I) Planned early revascularization by PCI II) Multivessel coronary artery disease defined as more than 70% stenosis in at least 2 major vessels (more than 2 mm diameter) with identifiable culprit lesion III)
1. Systolic blood pressure less than 90 mmHg for more than 30 min or
2. catecholamines required to maintain pressure more than 90 mmHg during systole and IV) Signs of pulmonary congestion V) Signs of impaired organ perfusion with at least one of the following criteria
a) Altered mental status b) Cold, clammy skin and extremities c) Oliguria with urine output less than 30 ml/h d) Serum-lactate more than 2.0 mmol/l VI) Informed consent
Exclusion Criteria
* No intrinsic heart action
* Cerebral deficit with fixed dilated pupils (not drug-induced)
* Need for primary urgent bypass surgery (to be determined after diagnostic angiography)
* Single vessel disease
* Mechanical cause of cardiogenic shock
* Onset of shock more than 12 h
* Massive lung emboli
* Age more than 90 years
* Shock of other cause (bradycardia, sepsis, hypovolemia, etc.)
* Other severe concomitant disease with limited life expectancy \<6 months
* Pregnancy
* Known severe renal insufficiency (creatinine clearance \<30 ml/kg)
18 Years
90 Years
ALL
No
Sponsors
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European Commission
OTHER
German Cardiac Society
OTHER
Deutsche Stiftung für Herzforschung
OTHER
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
OTHER
University of Luebeck
OTHER
Responsible Party
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Holger Thiele
Coordinator
Principal Investigators
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Holger Thiele, MD
Role: STUDY_CHAIR
Heart Center Leipzig - University Hospital
Locations
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University of Goettingen
Göttingen, , Germany
Heart Center Leipzig - University Hospital
Leipzig, , Germany
University of Leipzig - Heart Center
Leipzig, , Germany
Countries
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References
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Jung C, Lang A, Duse D, Bruno RR, Poss J, Wolff G, Ceglarek U, Zeymer U, Fuernau G, Zweck E, Desch S, Freund A, Isermann B, Pfeiler S, Wernly B, Kelm M, Thiele H, Gerdes N. Plasma Proteome Analysis Identifies Vascular Endothelial Growth Factor Receptor 1 as a Prognostic Biomarker in Cardiogenic Shock. Circ Heart Fail. 2025 Oct 1:e012890. doi: 10.1161/CIRCHEARTFAILURE.125.012890. Online ahead of print.
Zeymer-von Metnitz D, Ouarrak T, Huber K, Noc M, Desch S, Freund A, Zeymer U, Thiele H, Poss J. Mild Induced Hypothermia in Patients with Infarct-Related Cardiogenic Shock and Cardiac Arrest: Insights from the CULPRIT-SHOCK Trial. Eur Heart J Acute Cardiovasc Care. 2025 Sep 23:zuaf124. doi: 10.1093/ehjacc/zuaf124. Online ahead of print.
Zeymer U, Alushi B, Noc M, Mamas MA, Montalescot G, Fuernau G, Huber K, Poess J, de Waha-Thiele S, Schneider S, Ouarrak T, Desch S, Lauten A, Thiele H. Influence of Culprit Lesion Intervention on Outcomes in Infarct-Related Cardiogenic Shock With Cardiac Arrest. J Am Coll Cardiol. 2023 Mar 28;81(12):1165-1176. doi: 10.1016/j.jacc.2023.01.029.
Bohme M, Desch S, Rosolowski M, Scholz M, Krohn K, Buttner P, Cross M, Kirchberg J, Rommel KP, Poss J, Freund A, Baber R, Isermann B, Ceglarek U, Metzeler KH, Platzbecker U, Thiele H. Impact of Clonal Hematopoiesis in Patients With Cardiogenic Shock Complicating Acute Myocardial Infarction. J Am Coll Cardiol. 2022 Oct 18;80(16):1545-1556. doi: 10.1016/j.jacc.2022.08.740.
Ceglarek U, Schellong P, Rosolowski M, Scholz M, Willenberg A, Kratzsch J, Zeymer U, Fuernau G, de Waha-Thiele S, Buttner P, Jobs A, Freund A, Desch S, Feistritzer HJ, Isermann B, Thiery J, Poss J, Thiele H. The novel cystatin C, lactate, interleukin-6, and N-terminal pro-B-type natriuretic peptide (CLIP)-based mortality risk score in cardiogenic shock after acute myocardial infarction. Eur Heart J. 2021 Jun 21;42(24):2344-2352. doi: 10.1093/eurheartj/ehab110.
Hauguel-Moreau M, Barthelemy O, Farhan S, Huber K, Rouanet S, Zeitouni M, Guedeney P, Hage G, Vicaut E, Zeymer U, Desch S, Thiele H, Montalescot G. Culprit lesion location and outcomes in patients with multivessel disease and infarct-related cardiogenic shock: a core laboratory analysis of the CULPRIT-SHOCK trial. EuroIntervention. 2021 Aug 6;17(5):e418-e424. doi: 10.4244/EIJ-D-20-00561.
Sag CM, Zeymer U, Ouarrak T, Schneider S, Montalescot G, Huber K, Fuernau G, Freund A, Feistritzer HJ, Desch S, Thiele H, Maier LS. Effects of ON-Hours Versus OFF-Hours Admission on Outcome in Patients With Myocardial Infarction and Cardiogenic Shock: Results From the CULPRIT-SHOCK Trial. Circ Cardiovasc Interv. 2020 Sep;13(9):e009562. doi: 10.1161/CIRCINTERVENTIONS.120.009562. Epub 2020 Sep 4.
Farhan S, Vogel B, Montalescot G, Barthelemy O, Zeymer U, Desch S, de Waha-Thiele S, Maier LS, Sandri M, Akin I, Fuernau G, Ouarrak T, Hauguel-Moreau M, Schneider S, Thiele H, Huber K. Association of Culprit Lesion Location With Outcomes of Culprit-Lesion-Only vs Immediate Multivessel Percutaneous Coronary Intervention in Cardiogenic Shock: A Post Hoc Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2020 Dec 1;5(12):1329-1337. doi: 10.1001/jamacardio.2020.3377.
Rubini Gimenez M, Zeymer U, Desch S, de Waha-Thiele S, Ouarrak T, Poess J, Meyer-Saraei R, Schneider S, Fuernau G, Stepinska J, Huber K, Windecker S, Montalescot G, Savonitto S, Jeger RV, Thiele H. Sex-Specific Management in Patients With Acute Myocardial Infarction and Cardiogenic Shock: A Substudy of the CULPRIT-SHOCK Trial. Circ Cardiovasc Interv. 2020 Mar;13(3):e008537. doi: 10.1161/CIRCINTERVENTIONS.119.008537. Epub 2020 Mar 10.
Feistritzer HJ, Desch S, Zeymer U, Fuernau G, de Waha-Thiele S, Dudek D, Huber K, Stepinska J, Schneider S, Ouarrak T, Thiele H. Prognostic Impact of Atrial Fibrillation in Acute Myocardial Infarction and Cardiogenic Shock. Circ Cardiovasc Interv. 2019 Jun;12(6):e007661. doi: 10.1161/CIRCINTERVENTIONS.118.007661. Epub 2019 Jun 6.
Thiele H, Akin I, Sandri M, de Waha-Thiele S, Meyer-Saraei R, Fuernau G, Eitel I, Nordbeck P, Geisler T, Landmesser U, Skurk C, Fach A, Jobs A, Lapp H, Piek JJ, Noc M, Goslar T, Felix SB, Maier LS, Stepinska J, Oldroyd K, Serpytis P, Montalescot G, Barthelemy O, Huber K, Windecker S, Hunziker L, Savonitto S, Torremante P, Vrints C, Schneider S, Zeymer U, Desch S; CULPRIT-SHOCK Investigators. One-Year Outcomes after PCI Strategies in Cardiogenic Shock. N Engl J Med. 2018 Nov 1;379(18):1699-1710. doi: 10.1056/NEJMoa1808788. Epub 2018 Aug 25.
Thiele H, Akin I, Sandri M, Fuernau G, de Waha S, Meyer-Saraei R, Nordbeck P, Geisler T, Landmesser U, Skurk C, Fach A, Lapp H, Piek JJ, Noc M, Goslar T, Felix SB, Maier LS, Stepinska J, Oldroyd K, Serpytis P, Montalescot G, Barthelemy O, Huber K, Windecker S, Savonitto S, Torremante P, Vrints C, Schneider S, Desch S, Zeymer U; CULPRIT-SHOCK Investigators. PCI Strategies in Patients with Acute Myocardial Infarction and Cardiogenic Shock. N Engl J Med. 2017 Dec 21;377(25):2419-2432. doi: 10.1056/NEJMoa1710261. Epub 2017 Oct 30.
Quayyum Z, Briggs A, Robles-Zurita J, Oldroyd K, Zeymer U, Desch S, Waha S, Thiele H. Protocol for an economic evaluation of the randomised controlled trial of culprit lesion only PCI versus immediate multivessel PCI in acute myocardial infarction complicated by cardiogenic shock: CULPRIT-SHOCK trial. BMJ Open. 2017 Aug 18;7(8):e014849. doi: 10.1136/bmjopen-2016-014849.
Thiele H, Desch S, Piek JJ, Stepinska J, Oldroyd K, Serpytis P, Montalescot G, Noc M, Huber K, Fuernau G, de Waha S, Meyer-Saraei R, Schneider S, Windecker S, Savonitto S, Briggs A, Torremante P, Vrints C, Schuler G, Ceglarek U, Thiery J, Zeymer U; CULPRIT-SHOCK Investigators. Multivessel versus culprit lesion only percutaneous revascularization plus potential staged revascularization in patients with acute myocardial infarction complicated by cardiogenic shock: Design and rationale of CULPRIT-SHOCK trial. Am Heart J. 2016 Feb;172:160-9. doi: 10.1016/j.ahj.2015.11.006. Epub 2015 Dec 1.
AbouEzzeddine OF, Lala A, Khazanie PP, Shah R, Ho JE, Chen HH, Pang PS, McNulty SE, Anstrom KJ, Hernandez AF, Redfield MM; NHLBI Heart Failure Clinical Research Network. Evaluation of a provocative dyspnea severity score in acute heart failure. Am Heart J. 2016 Feb;172:34-41. doi: 10.1016/j.ahj.2015.10.009. Epub 2015 Oct 20.
Other Identifiers
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CULPRIT-SHOCK1.2
Identifier Type: -
Identifier Source: org_study_id