The New England Journal of Medicine DECEMBER 21, 2017

PCI Strategies in Patients with Acute Myocardial Infarction and Cardiogenic Shock

Holger Thiele, Ibrahim Akin, Marc Sandri, et al.

Bottom Line

In patients with acute myocardial infarction complicated by cardiogenic shock and multivessel disease, an initial strategy of culprit-lesion-only percutaneous coronary intervention (PCI) significantly reduces the composite risk of 30-day mortality or severe renal failure compared to immediate multivessel PCI.

Key Findings

1. At 30 days, the composite primary endpoint of all-cause mortality or severe renal failure requiring renal-replacement therapy occurred in 45.9% of the culprit-lesion-only PCI group compared to 55.4% in the immediate multivessel PCI group (relative risk 0.83; 95% CI 0.71–0.96; P=0.01).

2. The benefit was primarily driven by a significant reduction in all-cause mortality (43.3% in the culprit-lesion-only group vs. 51.5% in the multivessel PCI group; relative risk 0.84; 95% CI 0.72–0.98; P=0.03).

3. There was no statistically significant difference between the two groups in the rate of severe renal failure requiring renal-replacement therapy (11.6% vs. 16.4%; P=0.07).

4. At one-year follow-up, the primary composite endpoint remained lower in the culprit-lesion-only group (52.0% vs. 59.5%; hazard ratio 0.87; 95% CI 0.76–0.99).

Study Design

Design

RCT

Open-Label

Sample

706

Patients

Duration

1 yr

Median

Setting

Multicenter, Europe

Population Patients with acute myocardial infarction complicated by cardiogenic shock and multivessel coronary artery disease.

Intervention Initial percutaneous coronary intervention (PCI) of the culprit lesion only, with the option for staged revascularization of non-culprit lesions.

Comparator Immediate multivessel percutaneous coronary intervention (PCI) of all major coronary arteries with stenosis >70%.

Outcome Composite of 30-day all-cause mortality or severe renal failure requiring renal-replacement therapy.

Study Limitations

• The trial was open-label, which may introduce observer bias, although the objective nature of the primary endpoints (death and dialysis) mitigates this risk.

• The study did not specifically address the potential benefit of staged revascularization in all subsets, and the higher rates of repeat revascularization and heart failure rehospitalization in the culprit-only arm reflect the strategy's reliance on secondary procedures.

• The study findings are specifically applicable to patients with cardiogenic shock and multivessel disease and may not be generalizable to all-comer populations without shock.

• A significant proportion of patients in the culprit-only arm crossed over to urgent revascularization, which reflects the pragmatic challenges of treating this unstable population.

Clinical Significance

The CULPRIT-SHOCK trial provides robust evidence that immediate multivessel PCI should not be the routine strategy for patients with acute myocardial infarction and cardiogenic shock. Instead, initial PCI of only the culprit lesion, with staged revascularization as needed, is the preferred approach, as it significantly improves early survival and reduces the risk of acute renal failure.

Historical Context

Prior to this trial, management of multivessel disease in the setting of cardiogenic shock was controversial. While some earlier guidelines advocated for complete revascularization during the initial procedure—based on the rationale of restoring global perfusion—the CULPRIT-SHOCK trial provided the first large-scale, randomized evidence challenging this practice, ultimately leading to a change in international clinical guidelines to favor a culprit-only strategy.

Guided Discussion

High-yield insights from every perspective

Med Student

Medical Student

Why does performing percutaneous coronary intervention (PCI) on non-culprit lesions during the acute phase of cardiogenic shock potentially increase the risk of severe renal failure compared to a culprit-lesion-only strategy?

Key Response

In the state of cardiogenic shock, patients already suffer from precarious systemic perfusion and 'shock kidney.' The addition of a higher volume of iodinated contrast media required for multivessel PCI, combined with the hemodynamic stress of a prolonged procedure, significantly increases the risk of contrast-induced acute kidney injury and the subsequent need for renal-replacement therapy.

Resident

A patient presents with an inferior STEMI, cardiogenic shock, and multivessel disease including a 100% RCA occlusion (culprit) and an 85% LAD stenosis. Based on the CULPRIT-SHOCK trial, what is the most appropriate immediate management of the LAD lesion?

Key Response

The trial demonstrated that an initial strategy of culprit-lesion-only PCI (treating only the RCA) significantly reduced 30-day mortality and the need for renal-replacement therapy compared to immediate multivessel PCI. Therefore, the LAD should be left alone during the index procedure, with the option for staged revascularization later once the patient has stabilized.

Fellow

How should the findings of CULPRIT-SHOCK be reconciled with the results of trials like COMPLETE or PRAMI, which suggest a benefit for routine multivessel PCI in patients with ST-segment elevation myocardial infarction?

Key Response

The key differentiator is the presence of cardiogenic shock. In hemodynamically stable MI patients (as in COMPLETE), the benefit of preventing future events via complete revascularization outweighs the procedural risks. However, in the setting of shock, the immediate 'procedural burden' (contrast load, inflammatory response, and time) of multivessel PCI is poorly tolerated and increases acute mortality, making a staged approach safer.

Attending

CULPRIT-SHOCK led to a paradigm shift in the cath lab. When teaching fellows, how do you balance the 'intention-to-treat' findings with the fact that nearly 18% of the culprit-only group underwent 'cross-over' to multivessel PCI due to clinical necessity?

Key Response

This highlights that while 'routine' multivessel PCI is harmful, 'selective' multivessel PCI remains a clinical necessity for some. The trial teaches that the default strategy should be culprit-only, but the physician must remain vigilant for patients with multiple unstable lesions or intractable ischemia who may still require immediate intervention on non-culprit vessels to achieve hemodynamic stability.

Scholarly Review

Critical appraisal through the lens of expert reviewers and guideline development

PhD

Evaluate the implications of using a composite primary endpoint of 30-day death or severe renal failure requiring dialysis. How does the 'competing risk' of early mortality influence the interpretation of the renal failure component?

Key Response

In cardiogenic shock trials, early mortality acts as a competing risk for non-fatal events like dialysis. If a patient dies very early, they cannot develop or be treated for renal failure. This can lead to an underestimation of the renal failure rate in the higher-mortality arm. However, because both components of the composite moved in the same direction (favoring culprit-only), the trial's primary conclusion remains robust despite the complexity of competing risks.

Journal Editor

The 1-year follow-up of CULPRIT-SHOCK showed that mortality rates between the two groups eventually converged, losing the statistical significance seen at 30 days. How does this 'catch-up' effect influence the editorial assessment of the study's long-term clinical impact?

Key Response

As an editor, the 1-year data suggests that while the culprit-only strategy provides a crucial early survival advantage during the acute 'danger zone' of shock, the long-term prognosis of these patients is ultimately driven by the extent of myocardial damage and underlying heart failure. The 30-day benefit remains the primary justification for the practice change, as surviving the index event is the prerequisite for any long-term recovery.

Guideline Committee

How did the CULPRIT-SHOCK trial specifically alter the Class of Recommendation for multivessel PCI in shock within the ESC and ACC/AHA guidelines?

Key Response

Prior to this trial, multivessel PCI in shock was often given a Class IIa (should be considered) or IIb recommendation based on observational data. Following CULPRIT-SHOCK, the 2017 ESC Guidelines and subsequent 2021 ACC/AHA/SCAI Coronary Artery Revascularization Guidelines downgraded routine multivessel PCI during the index procedure for cardiogenic shock to Class III (Harm), emphasizing that staged PCI of non-culprit lesions is the preferred approach.

Clinical Landscape

Noteworthy Related Trials

1999

SHOCK Trial

n = 302 · NEJM

Tested

Emergency revascularization (PCI or CABG)

Population

Patients with acute myocardial infarction complicated by cardiogenic shock

Comparator

Initial medical stabilization

Endpoint

30-day mortality

Key result: Emergency revascularization resulted in significantly lower 30-day mortality compared to initial medical management in patients younger than 75 years.

2012

IABP-SHOCK II Trial

n = 600 · NEJM

Tested

Intraaortic balloon pump (IABP) support

Population

Patients with acute myocardial infarction complicated by cardiogenic shock undergoing early revascularization

Comparator

Standard medical therapy without IABP

Endpoint

30-day all-cause mortality

Key result: The use of IABP did not significantly reduce 30-day mortality compared to standard therapy alone.

2024

DanGer Shock Trial

n = 355 · NEJM

Tested

Impella CP percutaneous microaxial flow pump

Population

Patients with ST-elevation myocardial infarction complicated by cardiogenic shock

Comparator

Standard of care alone

Endpoint

180-day all-cause mortality

Key result: The use of the Impella microaxial pump resulted in significantly lower 180-day mortality compared to standard care alone.

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