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CULPRIT-SHOCK: Culprit lesion only may be superior to immediate multivessel PCI
The 30-day risk for composite death or severe renal failure leading to renal-replacement therapy in patients with multivessel CAD and acute MI with cardiogenic shock was lower among those who underwent PCI of the culprit lesion only compared with those who received immediate multivessel PCI, according to the results of the CULPRIT-SHOCK trial, presented at TCT 2017.
The study results, presented by Holger Thiele, MD, from the Heart Center Leipzig and the University Hospital, Leipzig, Germany, were simultaneously published in The New England Journal of Medicine.
According to Thiele and colleagues, the researchers conducted a 706-patient, multicenter, randomized trial to assess whether PCI of the culprit lesion only with the option of staged revascularization of non-culprit lesions would confer better clinical outcomes when compared with immediate multivessel PCI among patients who have multivessel CAD and acute MI with cardiogenic shock.
The study’s primary endpoint was a composite of death or severe renal failure leading to renal-replacement therapy up to 30 days after revascularization and safety endpoints included bleeding rates defined as type 2, 3, or 5 on the Bleeding Academic Research Consortium scale, and stroke.
The researchers found the composite primary endpoint of death or renal-replacement therapy at 30 days had occurred in 45.9% of patients in the culprit-lesion-only group and 55.4% in the multivessel PCI group (RR = 0.83; 95% CI, 0.71-0.96).
Compared with the multivessel PCI group, the RR for death in the culprit-lesion-only cohort was 0.84 (95% CI, 0.72-0.98), and the RR of renal-replacement therapy was 0.71 (95% CI, 0.49-1.03).
According to the presentation, the two groups showed no significant difference in the time to hemodynamic stabilization, the risk of catecholamine therapy and the duration of such therapy, the levels of troponin T and creatine kinase, and the rates of bleeding and stroke.
Although the European guidelines suggest multivessel PCI of class IIa, level of evidence C lesions, there is no specific recommendation in the U.S. for how to treat these patients. However, recently, there has been appropriate use criteria published suggesting immediate PCI in these patients. Regardless of recommendation, the presentation panel said this important study will be practice-changing.
“Keep it simple is the major message from our trial,” Thiele said in his presentation. “Keep it simple, do PCI of the infarct-related artery and then look how the patient does later, and then you can do stent revascularization.”
In an accompanying editorial, Judith S. Hochman, MD, and Stuart Katz, MD, both from NYU Langone Health, wrote: “The consistent risk estimates for the primary endpoint in the intention-to-treat, per-protocol and as-treated analysis support the robustness of the findings. The CUPLRIT-SHOCK trial provides compelling evidence that a strategy of culprit-lesion-only PCI is preferred over initial multivessel PCI for patients with cardiogenic shock.” – by Dave Quaile
References:
Hochman JS, et al. New Engl J Med. 2017;doi:10.1056/NEJMe1713341.
Thiele H, et al. Late Breaking Clinical Trials 1. Presented at: TCT Scientific Symposium; Oct. 29-Nov. 2, 2017; Denver.
Thiele H, et al. New Engl J Med. 2017;doi:10.1056/NEJMoa1710261.
Disclosure: Hochman reports she receives grant support from American Regent and Janssen and receives personal fees from Regeneron. Katz reports no relevant financial disclosures. Thiele reports he receives grant and research support from the European Union and German Cardiac Society German Heart Research Foundation.
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The CULPRIT-SHOCK trial randomly assigned 706 patients with acute MI, cardiogenic shock and multivessel CAD (at least 2 major vessels with > 70% stenosis of the diameter) to one of two revascularization strategies: PCI of the culprit lesion only (with the option of staged revascularization of nonculprit lesions) or immediate multivessel PCI. At 30 days, the composite primary endpoint of death or renal-replacement therapy had occurred in 45.9% in the culprit-lesion-only PCI group and in 55.4% in the multivessel PCI group (RR = 0.83; P = .01). This difference was primarily driven by a decrease in mortality (RR = 0.84; P = .03), with a trend towards a decrease in the rate of renal-replacement therapy within the culprit lesion only revascularization group (RR = 0.71; P = .07).
Given that approximately 80% of patients with cardiogenic shock have multivessel coronary disease and multivessel disease is associated with higher mortality, arguments have been made that immediate multivessel revascularization of all important coronary stenoses may provide best outcomes by improving myocardial perfusion and ventricular function. Recent appropriate-use criteria have suggested that it is appropriate to perform immediate revascularization of a nonculprit artery if cardiogenic shock persists after revascularization of the culprit artery. In the SHOCK trial, where a large number of patients had multivessel disease, the mortality rate was similar between PCI and CABG, despite a much higher rate of complete revascularization with CABG. Furthermore, a post-hoc analysis of the ISAR-SHOCK II trial did not observe a difference in mortality between immediate multivessel PCI vs. culprit lesion intervention strategies. A recent meta-analysis of cardiogenic shock patients observed an increase in 30-day mortality in those undergoing multivessel PCI compared to culprit vessel PCI.
The CULPRIT-SHOCK trial is the first randomized trial examining two revascularization strategies in those with MI and cardiogenic shock, expanding our understanding of shock in the setting of STEMI and NSTEMI patients and including CTOs in the non-culprit lesions. This trial suggests that routine immediate revascularization of culprit and non-culprit lesions in cardiogenic shock and MI is associated with higher composite rate of death or renal-replacement therapy as well as higher mortality. Importantly, staged revascularization was not counted as a disadvantage of the culprit-lesion-only PCI strategy and thus may still be of benefit in patients with persistent cardiogenic shock, but initially the focus should be on PCI of the infarct-related artery.
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The CULPRIT-SHOCK trial is the latest in large, randomized trials of immediate PCI in cardiogenic shock. The results clearly show that there is not significant benefit to immediate multivessel intervention, once the acute MI culprit lesion is addressed.
This sends a message that if you are doing PCI alone, you should only do the culprit lesion. The CULPRIT-SHOCK results support treatment of other vessels later during hospitalization.
For 30 years, we have known that PCI in patients with cardiogenic shock results in a 50% survival. In CULPRIT-SHOCK, the mortality rate is still about 50%. So while the decision to do the culprit lesion only vs. multivessel intervention is helpful, it does not address the overall problem that even with optimal PCI strategy, we still have 50% mortality.
In the Detroit Cardiogenic Shock initiative, we reported at TCT that a 76% survival rate can be achieved with use of immediate mechanical circulatory support prior to PCI. The incidence of acute MI with cardiogenic shock continues to increase in the U.S. And in the Medicare population, the incidence is climbing even faster. The CULPRIT-SHOCK trial helps in determining the optimal PCI strategy, but it does not move the ball forward in the big picture of this population. This is a national crisis and needs urgent, U.S.-wide attention. For this reason, we at Henry Ford and a coalition of the willing have started the National Cardiogenic Shock Initiative. Our aim is to decrease mortality from 50% to 20% on a nationwide basis.