Treating the culprit lesion associated with decreased mortality versus immediate multi-vessel PCI in cardiogenic shock Galvanizing results from the CULPRIT-SHOCK trial: 1 year follow-up results presented at ESC 2018

Syed Hassan Kazmi M.D.
By Syed Hassan Kazmi M.D. on

 In a randomized multi-center clinical trial that enrolled more than 700 patients with multi-vessel coronary artery disease and acute myocardial infarction (MI) with cardiogenic shock, it was shown that percutaneous coronary intervention (PCI) of the culprit lesion only (with the option of staged revascularization of nonculprit lesions) was associated with better clinical outcomes compared to immediate multi-vessel PCI. It was found that at 30 days, there was a 9.5% absolute reduction in the rate of the primary endpoint of death or renal replacement therapy in patients randomized to culprit-lesion only revascularization. Previously DANAMI-3-PRIMULTI, PRAMI, and CvLPRIT trials have suggested that there may be a benefit to complete revascularization but those studies did not enroll patients with hemodynamic instability or cardiogenic shock. Consequently, this led to the inclusion of immediate multi-vessel PCI in the 2015 ACC/AHA/SCAI STEMI guidelines as a Class II-b recommendation (can be considered).

The results from the possibly guideline-changing CULPRIT-SHOCK trial (which did involve patients with cardiogenic shock) showed that at 30 days, the rate of the composite primary endpoint of death or renal replacement therapy (primary outcomes) was significantly lower in the culprit-lesion-only PCI group than in the multi-vessel PCI group (45.9% vs. 55.4%; relative risk [RR], 0.83; 95% confidence interval [CI], 0.71 to 0.96; P=0.01). Moreover, the authors were able to show that the Thrombolysis in Myocardial Infarction (TIMI) grades for blood flow obtained before and after PCI of the culprit artery did not differ significantly between the two groups.

“The reduced mortality in the patients who underwent culprit lesion only PCI challenge the current ACC guidelines and hint at a prospective change in the guidelines”, the trial lead Dr. Holger Thiele, MD, from the Heart Center Leipzig at the University of Leipzig, Leipzig, Germany said in an interview.

These potentially practice-changing results were sustained up to 1 year of follow-up and presented in the 2018 ESC congress held in Munich, Germany. In a post hoc analysis, results published in New England Journal Of Medicine (NEJM), the authors revealed that the rates of primary outcome of a composite of death or renal-replacement therapy for culprit-lesion-only vs. multi-vessel PCI were 52.0% vs. 59.5%, respectively (RR 0.87, 95% CI 0.76-0.99). Interestingly, the rates of heart failure and repeat revascularization were higher among the culprit-only PCI group compared to multi-vessel PCI (Heart failure: 5.2% vs. 1.2% [HR 4.46, 95% CI 1.53-13.04]; repeat revascularization: 32.3% vs. 9.4% [HR 3.44, 95% CI 2.39-4.95]). Previous nonrandomized, retrospective, and observational studies may have advocated multi-vessel PCI, but CULPRIT-SHOCK trial is the only randomized clinical trial performed showing that routine multi-vessel PCI during the index procedure in STEMI patients and cardiogenic shock is not safe. This outcome was mainly driven by lower mortality among patients who underwent culprit-lesion-only PCI.

The trial had some limitations, firstly, the unblinded nature of the study; secondly, a patient withdrawal rate of 3% and finally, cross-over of participants from their assigned treatment group, which implies an intention-to-treat (ITT) approach to provide unbiased comparisons among the treatment groups.

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