New analysis of the REVIVED-BCIS2 trial adds more evidence that PCI has limited impact in patients with left ventricular dysfunction, even when you include quality of life and overall health status.
The secondary analysis of the REVIVED-BCIS2 trial examined outcomes from 700 patients with severe ischemic left ventricular systolic dysfunction (median age: 70yrs; mean LVEF: 27) who were randomized to receive PCI and optimal medical therapy or only optimal medical therapy.
When looking at the primary outcome at 24 months – a hierarchical composite of all-cause death, HF hospitalization, and KCCQ–Overall Summary Score – the researchers found that adding PCI didn’t significantly improve overall health (PCI vs OMT win ratio: 1.05).
This insignificant showing was largely due to the PCI group’s challenges sustaining short-term improvements…
- The PCI group achieved KCCQ-OSS quality of life improvements (54.1% vs 40.7%) and fewer deteriorations (25.2% vs 31.4%) at six months, however those improvements weren’t evident at 12 or 24 months.
- PCI also didn’t improve all-cause death and HF hospitalizations when follow-up was limited to 24 months (win ratio: 1.04).
This trend persisted with the trial’s secondary quality of life outcome, as the PCI group showed improved KCCQ-CSS scores at six months (45.0% vs 35.3%), but not at 12 or 24 months (40.9% vs 38.1%; 36.6% vs 37.1%).
Many readers might remember that the original REVIVED BCIS2 trial results also highlighted PCI’s limited impact on this patient group, as all-cause mortality and HF hospitalization were similar for PCI and optimal therapy (37.2% vs. 38%).
However, there’s still some evidence supporting PCI’s LV impact.
- The STICH trial was the only other RCT that focused on revascularizing patients with ischemic LV dysfunction and extensive CAD, and it showed that CABG did drive KCCQ-OSS and mortality improvements through 36 months.
- The PCI group’s early quality of life improvements in REVIVED-BCIS2 were greater than those seen in other medication-focused HFrEF trials, and most HF trials focus on short-term QoL improvements.
- Lastly, patients in REVIVED-BCIS2 were older than in other trials, which makes them more representative of the HF population, but more likely to have other conditions that limited their PCI response.
The Takeaway
Although PCI supporters might push back at these results, the authors made their takeaway quite clear — “in patients with left ventricular dysfunction, PCI should not be recommended to improve health status beyond the short term.”
