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

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• 作者：Holger Thiele ; MD^a ; ^b ; ^{holger.thiele@uksh.de" class="auth_mail" title="E-mail the corresponding author} ; Steffen Desch ; MD^a ; ^b ; Jan J. Piek ; MD ; PhD^c ; Janina Stepinska ; MD^d ; Keith Oldroyd ; MD^e ; Pranas Serpytis ; MD^f ; Gilles Montalescot ; MD^g ; Marko Noc ; MD^h ; Kurt Huber ; MDⁱ ; Georg Fuernau ; MD^a ; ^b ; Suzanne de Waha ; MD^a ; ^b ; Roza Meyer-Saraei ; PhD^a ; ^b ; Steffen Schneider ; PhD^j ; Stephan Windecker ; MD^k ; Stefano Savonitto ; MD^l ; Andrew Briggs ; PhD^m ; Patrizia Torremanteⁿ ; Christiaan Vrints ; MD^o ; Gerhard Schuler ; MD^p ; Uta Ceglarek ; PhD^q ; Joachim Thiery ; MD^q ; Uwe Zeymer ; MD^j ; ^r ; on behalf of the CULPRIT-SHOCK Investigators
• 刊名：American Heart Journal
• 出版年：2016
• 出版时间：February 2016
• 年：2016
• 卷：172
• 期：Complete
• 页码：160-169
• 全文大小：915 K

文摘

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.