PCI does not reduce primary endpoint in patients with severe ischemic LV systolic dysfunction

ESC 2022 PCI is frequently performed in route clinical practice in patients with severe ischemic LV systolic dysfunction despite lack of randomized evidence. The REVIVED trial investigated whether this is justified.

Presented at the ESC congress 2022 by: Prof. Divaka Perera, MD- London, UK

Introduction and methods

Although there is no evidence from randomized trials that support percutaneous coronary intervention (PCI) in patients with severe left ventricular dysfunction, this procedure is frequently performed in route clinical practice. In the ESC guidelines the recommendation has a class 2a, with Level of Evidence C and the AHA do not offer recommendations for this procedure.

In the REVIVED trial, patients with severe ventricular dysfunction (ejection fraction ≤35% and extensive coronary disease [BCIS-JS≥6) were enrolled. Patients needed to have a minimum amount of viable myocardium (as shown by CMR, OSE, SPECT or PET) of ≥4 dysfunctional segments that were viable and could be revascularized by PCI. Patients were randomized to PCI and optimal medical therapy (OMT) or OMT alone. Echocardiography was performed at 6 months and 12 months, and clinical, ICD and biochemical follow up was done at 6, 12 and 24 months.

Median follow-up was 3.4 years.

Main results

• PCI plus OMT therapy did not reduce the event rate of the primary outcome of all-cause or hospitalization for HF compared to OMT therapy alone (37.2% vs. 38.0%, respectively - HR 0.99, 95%CI:0.78-1.27. P=0.96).
• The major secondary outcome of improvement in LVEF was not different between the two groups.
• QoL measured by KCCQ score appeared to be higher in the PCI group after 6 and 12 months compared to the OMT group, but after 24 months there was no statistically significant difference between the 2 groups.

Conclusion

The REVIVED trial – the first randomized trial in this arena – demonstrated that PCI did not reduce the incidence of all-cause death or hospitalization for HF.

Perera said the key take home message is that this definitive results should allow guidelines to be strengthened and clinical practice to be rationalized.

• Our reporting is based on the information provided at the ESC Congress -

The findings of this trial were simultaneously published in N Eng J Med