The Third DANish Study of Optimal Acute Treatment of Patients With STEMI: PRImary PCI in MULTIvessel Disease - DANAMI-3—PRIMULTI

Description:

The goal of the trial was to compare the utility of infarct-related percutaneous coronary intervention (PCI) versus fractional flow reserve (FFR)-guided complete revascularization in patients presenting with ST-segment elevation myocardial infarction (STEMI) and evidence of multivessel disease.

Contribution to the Literature: The DANAMI-3—PRIMULTI study suggests that FFR-guided complete revascularization prior to hospital discharge is superior to culprit vessel only PCI in patients with multivessel disease presenting with STEMI and undergoing primary PCI.


Study Design

After successful primary PCI of the culprit infarct-related artery (IRA), patients were randomized in a 1:1 fashion to no further revascularization (n = 313) or FFR-guided complete revascularization prior to discharge (n = 314). Median time to staged PCI was 2 days.

Patient population:

  • Total number of enrollees: 627
  • Duration of follow-up: 27 months
  • Mean patient age: 64 years
  • Percentage female: 19%
  • Percentage diabetics: 10%

Other salient features/characteristics:

  • Infarct location, anterior: 35%, inferior: 60%
  • Three-vessel disease: 32%
  • Use of drug-eluting stents: 93%
  • Bivalirudin: 75%
  • Left ventricular ejection fraction: 50%
  • Prasugrel: 64%

Inclusion criteria:

  • STEMI presenting within 12 hours
  • Successful culprit IRA primary PCI
  • >50% stenosis in non-IRA >2 mm suitable for PCI

Exclusion criteria:

  • Hemodynamic instability or evidence of ischemia in nonculprit IRA at the time of primary PCI
  • Chronic total occlusion of nonculprit IRA

Principal Findings:

The primary outcome, major adverse cardiovascular events (MACE; all-cause mortality, MI, ischemia-driven revascularization of non-IRA lesions) for FFR-guided complete revascularization vs. IRA only PCI was 13% vs. 22%, hazard ratio (HR) = 0.56, p = 0.004. Benefit was driven by a significant reduction in ischemia-driven revascularization: 5% vs. 17%, p < 0.001; mortality: 5% vs. 4%, p = 0.43; and nonfatal MI: 5% vs. 5%, p = 0.87, was similar.

Secondary outcomes:

  • Periprocedural stroke: 1.3% vs. 0.3%, p = 0.2
  • Urgent PCI: 2% vs. 6%, p = 0.03
  • Nonurgent PCI: 3% vs. 9%, p = 0.002

Interpretation:

The results of this trial indicate that, in patients with multivessel disease presenting with STEMI and undergoing successful primary PCI, FFR-guided multivessel PCI with a goal towards complete revascularization prior to hospital discharge is superior to culprit IRA only PCI. This study adds to the literature on multivessel PCI in patients with STEMI.

The PRAMI trial assessed the impact of multivessel PCI in the same setting as primary PCI, and reported a benefit in clinical outcomes. The CvLPRIT trial assessed multivessel PCI in the same or subsequent (but prior to hospital discharge) setting for a similar subset of patients, and also observed a reduction in MACE endpoints. In this trial, nonculprit IRA was not performed at the same setting as primary PCI, but was staged (median 2 days). Further, an ischemia-guided strategy was adopted using FFR to identify truly significant lesions. The majority of benefit appears to be in the need for future revascularization procedures, including urgent PCI, a very similar observation to the FAME-2 trial. It is unclear if detection of ischemia by noninvasive means post-primary PCI (and subsequent revascularization if positive) would have the same benefit as an invasive FFR management.

References:

Engstrøm T, Kelbæk H, Helqvist S, et al., on behalf of the DANAMI-3—PRIMULTI Investigators. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3—PRIMULTI): an open-label, randomised controlled trial. Lancet 2015;386:665-71.

Presented by Dr. Thomas Engstrøm at ACC.15, San Diego, CA, March 16, 2015.

Clinical Topics: Acute Coronary Syndromes, Arrhythmias and Clinical EP, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, EP Basic Science, Aortic Surgery, Cardiac Surgery and Arrhythmias, Interventions and ACS

Keywords: ACC Annual Scientific Session, Acute Coronary Syndrome, Bundle-Branch Block, Constriction, Pathologic, Coronary Disease, Coronary Stenosis, Coronary Vessels, Fractional Flow Reserve, Myocardial, Myocardial Infarction, Percutaneous Coronary Intervention, Myocardial Revascularization


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