REVIVED-BCIS2: no benefit of routine PCI in patients with reduced LVEF
Reported from ESC Congress 2022
Dejan Milasinovic provides his take on the REVIVED trial - percutaneous revascularisation for ischaemic ventricular dysfunction, which was presented during ESC Congress 2022 in Barcelona.
Revascularization decisions in patients with reduced left ventricular ejection fraction (LVEF) have so far been largely based on a single randomized trial, that showed a benefit of CABG over optimal medical therapy (OMT) alone, albeit emerging in the longer-term follow-up (the STICH trial).
The REVIVED-BCIS 2 trial randomized 700 patients with reduced LVEF (<35%) and signs of viable myocardium subtended by lesions amenable to percutaneous revascularization to either PCI or OMT. During the median follow-up of 3.4 years (98% of patients were followed up for a minimum of 2 years), the rate of the primary endpoint (all-cause death or hospitalization for heart failure) was comparable between the two groups. All-cause death was frequent and similar (close to 32% in both arms), whereas cardiovascular mortality was numerically lower in the PCI group (21.9% vs. 24.9%; HR 0.88, 95%CI 0.65–1.20). Documented LVEF improvement was small (2-3%) and similar in both groups, whereas PCI led to a better quality of life over the first 12 months with the OMT group closing this gap by 2 years.
Although the overall results lead to a conclusion of no added value of PCI over OMT in patients with coronary artery disease and reduced LVEF, there are at least 3 issues that may be taken into account when interpreting the REVIVED trial.
- First, in the STICH trial, surgical revascularization was associated with higher early mortality risk, while over time this trend was reversed leading to a reduction in cardiovascular death by 5 years and all-cause death by 10 years of follow-up. While the mechanisms of this long-term benefit are not entirely transparent, in the REVIVED trial, PCI tended to reduce the occurrence of VT/VF terminated by implantable cardioverter defibrillator (ICD). Given that less than a quarter of patients had ICD on baseline, extended follow-up may provide further clues on the long-term impact of percutaneous revascularization.
- Second, mirroring what we could see in the ISCHEMIA and FAME 2 trials, the rate of spontaneous MI seems to be decreasing over time in patients who underwent PCI as opposed to OMT alone. In addition, and as expected, the rate of unplanned revascularization was reduced in the PCI arm.
- Third, and as pointed out in the accompanying editorial simultaneously published in the New England Journal of Medicine, a degree of selection bias could not be entirely ruled out, as some patients potentially profiting from revascularization, may have been diverted towards surgery before being considered for trial enrolment.
In addition, two thirds of patients had no angina on baseline and the decision to revascularize was preconceived by the existence of myocardial viability, which in the STICH trial did not have any impact on the effect of surgical revascularization on mortality.
In summary, the REVIVED trial, together with the STICH trial, does seem to challenge the hypothesis of hibernating myocardium amenable to functional improvement following successful revascularization that would ultimately improve prognosis. On a more practical side, and as the results of PCI are increasingly recognized to be dependent on understanding the factors constituting proper indication and procedural optimization, any decisions regarding percutaneous revascularization in patients with coronary artery disease and heart failure may need to follow the same selective pattern, compounded by considerations related to LV impairment.
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