CULPRIT-SHOCK: Benefits Remain at 1 Year for Culprit-Lesion-Only PCI in MI With Shock

Patrice Wendling

August 25, 2018

MUNICH — The early benefit of treating the culprit lesion only in patients with acute myocardial infarction (MI) complicated by cardiogenic shock was maintained at 1 year in the CULPRIT-SHOCK trial, although with a surprising uptick in rehospitalizations for congestive heart failure (HF).

Compared with immediate multivessel percutaneous coronary intervention (PCI), culprit-lesion-only PCI with the possibility for staged revascularization of nonculprit lesions lowered the risk for the primary composite endpoint of death from any cause or renal replacement therapy by 13% at 1 year (P = .048). This was down slightly from a 16% reduction at 30 days.

The relative risk for rehospitalization for HF, however, was more than fourfold higher in the culprit-lesion group (5.2% vs 1.2%; relative risk [RR], 4.46; P = .003), according to data reported here at the European Society of Cardiology (ESC) Congress 2018.

The finding should be interpreted with caution because the trial was not powered for this secondary end point and the absolute difference between groups was small, lead author Holger Thiele, MD, Heart Center Leipzig-University Hospital, Germany, told theheart.org | Medscape Cardiology.

"It is possible that this finding could be related to the higher rate of complete revascularization in the multivessel PCI group, leading to subsequent improved ventricular function and a lower subsequent incidence of heart failure. However, this interpretation is only speculative as no randomized trials have addressed this issue," Thiele said. "This finding could also be a consequence of competing risks, as patients with cardiogenic shock at extreme risk will die early and will therefore not survive to develop heart failure."

"Accordingly, culprit-lesion-only PCI with its early survival benefit might select a cohort with subsequent higher risk for heart failure within the first year."

Stefan James, MD, Uppsala University, Sweden, who was not involved in the study, told theheart.org | Medscape Cardiology that "The finding is not concerning but it is very interesting and indirectly suggests that we should maybe consider staged revascularization in a stable phase in more patients after the index PCI," he said. "We should also consider physiologic evaluation with FFR in lesions not intervened upon acutely."

US guidelines do not have a specific recommendation for PCI in cardiogenic shock, but the 2016 appropriate-use criteria for coronary revascularization in patients with acute coronary syndrome give immediate multivessel revascularization its highest rating (9A) for patients with cardiogenic shock, Thiele noted.

The ESC ST-elevation MI (STEMI) 2017 guidelines also encourage immediate multivessel PCI in patients with cardiogenic shock, he said, but the 30-day results of CULPRIT-SHOCK prompted the class IIa C recommendation to be downgraded to IIIB in the new ESC 2018 revascularization guidelines, also released today at the Congress.

"The 1-year results of CULPRIT-SHOCK support the recent change in ESC guideline recommendations," Thiele said during the late-breaking interventional cardiology session.

The results, which were published simultaneously in the New England Journal of Medicine, are based on 12-month follow-up available for 343 patients randomly assigned to culprit-lesion-only PCI and 341 to immediate multivessel PCI. Of the 708 patients initially randomly assigned, 6.7% and 5.3% of patients, respectively, died between 30 days and 1 year.

At 1 year, the original primary composite endpoint occurred in 52.0% of patients in the culprit-lesion PCI group and in 59.5% of patients in the multivessel PCI group.

All-cause mortality did not differ significantly between the two groups (50.0% vs 56.9%). There also was no difference in 1-year all-cause mortality in a landmark analysis (RR, 1.08; 95% confidence interval, 1.08; P = .86), nor in any subgroup evaluated, including patients with a chronic total occlusion (CTO), Thiele noted.

The inclusion of patients with CTO in the trial was a point of contention when the 30-day results were released, with observers arguing that CTOs are usually beyond what most operators do with multivessel PCI in this setting and that treating them could potentially prolong the procedure, increase contrast doses, and raise the risk for renal failure.

Of note, events leading to renal replacement therapy occurred only within the first 30 days, with no further events observed during 1-year follow-up.

At 1 year, the composite of all-cause mortality or reinfarction was lower with culprit-only PCI vs multivessel PCI (50.9% vs 58.4%).

Culprit-lesion-only PCI, however, was associated with more frequent repeat revascularization at 1 year (32.3% vs 9.4%), but this was expected, Thiele said.

 

Table. One-Year Outcomes: Culprit-Lesion-Only vs Multivessel PCI

Endpoints RR (95% CI) P Value
Death from any cause or renal replacement therapya 0.87 (0.76 - 0.99) .048
Death from any cause 0.88 (0.76 - 1.01) .07
Death from any cause or reinfarction 0.87 (0.76-1.00) .048
Renal replacement therapy 0.71 (0.49 - 1.03) .07
Repeat revascularization 3.44 (2.39 - 4.95) <.001
Rehospitalization for congestive heart failure 4.46 (1.53 - 13.04) .003
aPrimary endpoint.

 

During a discussion of the results, session co-chair Robert Byrne, MD, German Heart Center, Munich, said this was an excellently conducted trial, the primary endpoint was relevant, and the follow-up excellent in excess of 99%.

"The unmet need for this trial was shown by the immediate change in the guidelines that you alluded to," he said, addressing Thiele.

Byrne described the HF hospitalization and repeat revascularization findings as "intriguing" and asked if data are available on whether repeat revascularizations were planned or unplanned.

Thiele replied that approximately one third of patients underwent urgent revascularization and two thirds planned revascularization within the first 30 days but that details are not available for the 1-year follow-up. Nevertheless, he said, the overall revascularization rate was much higher than in other trials, such as COMPARE ACUTE, reflecting the severity of coronary artery disease in the CULPRIT-SHOCK patients.

"I am not surprised by the results," but the lack of difference in 1-year outcome of these patients "is not good for either arm," Roxana Mehran, MD, Mount Sinai Medical Center, New York City, told theheart.org | Medscape Cardiology.

Given the strong 30-day outcomes from the trial, she said interventionalists will go with culprit-only PCI to reduce 30-day major adverse cardiac events but that we "need to work hard on what to do for these patients to improve long-term follow-up."

Nevertheless, Mehran said, the combined results should influence the next US revascularization guidelines. "Culprit-only should be the way to go, as there is no benefit in multivessel revascularization in shock."

"This is an extremely important trial because it helps us in clinical practice," panelist Julinda Mehilli, MD, Ludwig-Maximilians-University of Munich, said in an interview. "Doing complete revascularization in the middle of the night is really difficult and having this data in the background — that we don't need to do this [multivessel PCI] because we don't have a benefit in mortality — will help us.

"The take-home message is that you do the intervention acutely only of the culprit lesion and after the patient goes home, you can decide if you need another planned intervention," she said, noting that this has been the standard practice at her institution for some time.

Mehilli said multivessel PCI should be restricted to the small subset of patients with two acute occluded arteries or in those with a second lesion with reduced TIMI flow.

James said immediate multivessel PCI may be justified if the culprit lesion is difficult to identify or incorrectly defined initially, when multiple culprit lesions are identified, or in select cases where there is a flow-limiting nonculprit infarct with very severe stenosis irrigating a large myocardial area.

For his part, Thiele said when interviewed: "If you ask me, there is no role at all nowadays."

CULPRIT-SHOCK was funded by the European Union 7th Framework Program, the German Heart Research Foundation, and the German Cardiac Society. Thiele reports receiving grants from the European Union, German Cardiac Society, and German Heart Research Foundation during conduct of the study. James reports no relevant financial conflicts of interest.

European Society of Cardiology (ESC) Congress 2018. Presented August 25, 2018.

N Engl J Med. Published online August 25, 2018. Full text

Follow Patrice Wendling on Twitter: @pwendl. For more from theheart.org | Medscape Cardiology, follow us on Twitter and Facebook.

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