ISCHEMIA-EXTEND – Follow-Up Interim Report

Presented at the AHA Scientific Sessions 2022 by: Judith S. Hochman, MD - New York, NY, USA

Introduction and methods

The ISCHEMIA trial previously investigated the effects of an initial invasive vs. conservative strategy in patients with chronic coronary disease (CCD) on the primary outcome of major adverse clinical events (CV death, MI, hospitalization for UA, HF or resuscitated cardiac arrest) at an original follow-up of 3.2 years. Enrolled patients had moderate or severe ischemia. Patients with EF <35%, recent ACS, unacceptable angina, or left main ≥ 50% stenosis were excluded. After 3.2 years, there was no evidence that the initial invasive strategy reduced the primary endpoint, all cause death, or CV death compared with an initial conservative strategy. Non-CV death was significantly higher in the invasive strategy group, predominantly due to excess malignancy. The current extended study of ISCHEMIA compares survival between the two treatment strategies during a long-term follow-up of 5179 patients for ~10 years. The interim results of ISCHEMIA-EXTEND at a median follow-up of 5.7 years were presented at the AHA Scientific Sessions 2022.

Main results

• After 5.7 years follow-up, no difference in all-cause mortality (adjusted HR 1,00, 95% CI 0.85-1.18, P=0.741) was observed for the invasive vs. conservative strategy.
• The invasive strategy reduced CV death compared with the conservative strategy (adjusted HR= 0.78, 95%CI 0.63-0.96, P=0.008).
• The previously reported excess in non-CV death in the invasive strategy group persisted over time (adjusted HR 1.44, 95% CI 1.08-1.91, P=0.016).
• Subgroup analyses showed no interaction between initial strategy assignment and pre-specified subgroups for all-cause death, CV death, and non-CV death.
• Patients with multivessel (≥2 vessels) disease with stenosis ≥70% had higher rates of all-cause death compared with those without multivessel disease, but there was no interaction between presence or absence of multivessel disease and treatment assignment for all-cause mortality. HRs for the treatment effects also did not differ significantly by presence or absence of multivessel disease for the outcomes of CV death and non-CV death (Interaction P values >0.05).

Conclusion

The ISCHEMIA-EXTEND study showed that after a median follow-up of 5.7 years an initial invasive strategy compared with an initial conservative strategy in patients with CCD resulted in no difference in all-cause mortality, lower risk of CV mortality, and higher risk of non-CV mortality.

-Our reporting is based on the information provided at the AHA Scientific Sessions-