Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock - CULPRIT-SHOCK

Nov 01, 2018
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Presenter/Author:
Holger Thiele, MD
Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
European Union 7th Framework Program, German Heart Research Foundation, German Cardiac Society.
Date Presented:
08/25/2018
Date Published:
11/01/2018
Date Updated:
11/01/2018
Original Posted Date:
10/30/2017
References

Contribution To Literature:

The CULPRIT-SHOCK trial showed that culprit-lesion-only PCI is superior to multivessel PCI among patients with AMI and cardiogenic shock and evidence of MVD on angiography.

Description:

The goal of this trial was to assess safety and efficacy of culprit-lesion-only percutaneous coronary intervention (PCI) versus multivessel PCI among patients presenting with acute myocardial infarction (AMI) and cardiogenic shock in the setting of multivessel disease (MVD).

Study Design

Patients with AMI and cardiogenic shock and evidence of MVD on angiography were randomized in a 1:1 fashion to either culprit-lesion-only PCI (n = 344) or multivessel PCI (n = 341). In the former group, only the culprit lesion was revascularized at the time of the initial procedure; subsequent staged revascularization (almost all PCI) was performed in a further 18% of patients, based on either symptoms, clinical status, or objective evidence of ischemia (either noninvasively or via fractional flow reserve). In the latter group, all lesions >70% were revascularized, including chronic total occlusions (CTOs), with a maximum recommended dose of 300 cc of contrast.

Inclusion criteria:

  • AMI and cardiogenic shock
  • Evidence of MVD (≥2 vessels of 2 mm or larger with ≥70% stenosis)
  • Planned early revascularization by means of PCI
  • Identifiable culprit lesion
  • Total number screened: 1,075
  • Total number of enrollees: 685
  • Duration of follow-up: 30 days
  • Mean patient age: 70 years
  • Percentage female: 23%
  • Percentage with diabetes: 32%
  • Percentage with previous MI: 17%

Exclusion criteria:

  • Resuscitation of >30 minutes
  • No intrinsic cardiac activity
  • Assumed neurological devastation
  • Indication for primary urgent coronary artery bypass grafting (CABG)
  • Mechanical cause of cardiogenic shock, or noncardiogenic shock
  • Onset of shock >12 hours before randomization
  • Age >90 years
  • Massive pulmonary embolism
  • Known severe chronic kidney disease
  • Life expectancy <6 months

Other salient features:

  • Resuscitation prior to randomization: 53%, ST-segment elevation MI (STEMI): 62%, anterior STEMI: 54%; ≥1 CTO: 23%
  • Number of affected vessels, 2: 36%, 3: 63%
  • Median left ventricular ejection fraction: 32%
  • Any mechanical circulatory support: 28%, intra-aortic balloon pump: 26%, extracorporeal membrane oxygenation: 23%

Principal Findings:

The primary outcome, all-cause mortality or need for renal replacement therapy (RRT), for culprit-lesion-only vs. multivessel PCI at 30 days, was 45.9% vs. 55.4%, hazard ratio (HR) 0.83, 95% confidence interval (CI) 0.71-0.96, p = 0.01

  • All-cause mortality: 43.3% vs. 51.6%, p = 0.03
  • Need for RRT: 11.6% vs. 16.4%, p = 0.07

Secondary endpoints for culprit-lesion-only vs. multivessel PCI:

  • Recurrent MI: 1.2% vs. 0.9%, p = 1.0
  • Any bleeding: 16.6% vs. 22.0%, p = 0.07
  • Stroke: 3.5% vs. 2.9%, p = 0.68
  • Total contrast use: 190 vs. 250 cc, p < 0.001

1-year outcomes: Primary outcome for culprit-lesion-only vs. multivessel PCI: 52.0% vs. 59.5% (HR 0.87, 95% CI 0.76-0.99). All-cause mortality: 50% vs. 56.9% (HR 0.88, 95% CI 0.76-1.01). Landmark analysis at 30 days: HR 1.08, 95% CI 0.60-1.93. Recurrent MI: 1.7% vs. 2.1% (HR 0.85, 95% CI 0.29-2.5), death or MI: 50.9% vs. 58.4% (HR 0.87, 95% CI 0.76-1.00), rehospitalization for 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).

Interpretation:

The results of this trial indicate that culprit-lesion-only PCI is superior to multivessel PCI among patients with AMI and cardiogenic shock and evidence of MVD on angiography. These results were sustained up to 1 year of follow-up. The highest risk of mortality was within the first 30 days, after which rates were similar between the two arms. On the other hand, rehospitalization for heart failure and revascularization rates were higher among patients undergoing culprit-lesion only PCI. Cross-over rates were low, with only 18% of patients in the culprit-lesion PCI arm needing subsequent PCI/CABG. This landmark trial will likely change the guidelines on this topic.

The field of revascularization among patients with AMI has evolved considerably over the past few years. Earlier guideline documents listed revascularization of nonculprit vessels at the time of primary PCI for STEMI as a Class III indication (unhelpful or potentially harmful) in the absence of cardiogenic shock. However, trials such as PRAMI, DANAMI3-PRIMULTI, and CvLPRIT showed a possible benefit with nonculprit-vessel PCI in this setting. Accordingly, the 2015 ACC/AHA/SCAI STEMI guidelines changed this to a Class IIb recommendation (can be considered).

Similarly, for patients with cardiogenic shock and AMI, current guideline and appropriate use documents recommend multivessel revascularization if feasible. The current trial seems to suggest the exact opposite. The mechanisms of this dichotomy are somewhat unclear, but it seems that worsening renal dysfunction due to higher dye loads with multivessel PCI may be at least partially responsible. The current trial mandated CTO PCI when CTOs were present (nearly a quarter of patients), which is probably somewhat different from clinical practice, even in the presence of cardiogenic shock. CTO PCI has failed to show a beneficial effect among noncardiogenic shock STEMI patients as well.

For patients with cardiogenic shock, time to support is gaining increasing traction over time to revascularization. Although those data are not provided for the current trial, this hypothesis will need to be tested in future trials.

References:

Thiele H, Akin I, Sandri M, et al., on behalf of the CULPRIT-SHOCK Investigators. One-Year Outcomes After PCI Strategies in Cardiogenic Shock. N Engl J Med 2018;379:1699-1710.

Editorial: Adriaenssens T, Van de Werf F. Is Culprit-Lesion-Only PCI in Cardiogenic Shock Still Better at 1 Year? N Engl J Med 2018;379:1775-6.

Presented by Dr. Holger Thiele at the European Society of Cardiology Congress, Munich, Germany, August 25, 2018.

Thiele H, Akin I, Sandri M, et al., on behalf of the CULPRIT-SHOCK Investigators. PCI Strategies in Patients With Acute Myocardial Infarction and Cardiogenic Shock. N Engl J Med 2017;377:2419-32.

Editorial: Hochman JS, Katz S. Back to the Future in Cardiogenic Shock — Initial PCI of the Culprit Lesion Only. N Engl J Med 2017;377:2486-8.

Presented by Dr. Holger Thiele at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2017), Denver, CO, October 30, 2017.

Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery, Cardiac Surgery and Heart Failure, Acute Heart Failure, Interventions and ACS, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: ESC18, ESC Congress, Acute Coronary Syndrome, Angiography, Coronary Artery Bypass, Constriction, Pathologic, Coronary Occlusion, Extracorporeal Membrane Oxygenation, Heart Failure, Myocardial Infarction, Myocardial Revascularization, Percutaneous Coronary Intervention, Renal Replacement Therapy, Shock, Cardiogenic, Stroke, TCT17, Transcatheter Cardiovascular Therapeutics


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