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Am Heart J. 2016 Feb;172:160-9. doi: 10.1016/j.ahj.2015.11.006. Epub 2015 Dec 1.

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.

Author information

1
University Heart Center Luebeck, Luebeck, Germany; German Center for Cardiovascular Research (DZHK), Luebeck, Germany. Electronic address: holger.thiele@uksh.de.
2
University Heart Center Luebeck, Luebeck, Germany; German Center for Cardiovascular Research (DZHK), Luebeck, Germany.
3
Academic Medical Center, Amsterdam, The Netherlands.
4
Institute of Cardiology, Warsaw, Poland.
5
Western Infirmary, Glasgow, UK.
6
Vilnius University Hospital, Vilnius, Lithuania.
7
ACTION study group, Centre Hospitalier Universitaire Pitié-Salpêtrière, Paris, France.
8
University Medical Center Ljubljana, Ljubljana, Slovenia.
9
Wilhelminenspital der Stadt Wien, Vienna, Austria.
10
Institut für Herzinfarktforschung, Ludwigshafen, Germany.
11
University of Bern, Inselspital, Bern, Switzerland.
12
Manzoni Hospital, Lecco, Italy.
13
Institute of Health & Wellbeing, University of Glasgow, Glasgow, UK.
14
GABO:milliarium mbH & Co KG, Munich, Germany.
15
Universitair Ziekenhuis Antwerp, Antwerp, Belgium.
16
University of Leipzig-Heart Center, Leipzig, Germany.
17
University of Leipzig-Institute of Laboratory Medicine, Leipzig, Germany.
18
Institut für Herzinfarktforschung, Ludwigshafen, Germany; Klinikum Ludwigshafen, Ludwigshafen, Germany.

Abstract

BACKGROUND:

In acute myocardial infarction complicated by cardiogenic shock (CS), up to 80% of patients present with multivessel coronary artery disease. Currently, the best revascularization strategy is unknown. Therefore, a prospective randomized adequately powered clinical trial is warranted.

STUDY DESIGN:

The CULPRIT-SHOCK study is a 706-patient controlled, international, multicenter, randomized, open-label trial. It is designed to compare culprit lesion only percutaneous coronary intervention (PCI) with possible staged non-culprit lesion revascularization versus immediate multivessel PCI in patients with CS complicating acute myocardial infarction. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary efficacy endpoint of CULPRIT-SHOCK is 30-day mortality and severe renal failure requiring renal replacement therapy. Secondary outcome measures such as hemodynamic, laboratory, and clinical parameters will serve as surrogate endpoints for prognosis. Furthermore, an intermediate- and long-term follow-up at 6 and 12 months will be performed. Safety endpoints include the assessment of bleeding and stroke.

CONCLUSIONS:

The CULPRIT-SHOCK trial will address the question of optimal revascularization strategy in patients with multivessel disease and acute myocardial infarction complicated by CS.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01927549.

PMID:
26856228
DOI:
10.1016/j.ahj.2015.11.006
[Indexed for MEDLINE]

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