Initial Invasive Versus Conservative Management of Stable Ischemic Heart Disease in Patients With a History of Heart Failure or Left Ventricular Dysfunction

Abstract

Background: It is unknown whether an initial invasive strategy in patients with stable ischemic heart disease and at least moderate ischemia improves outcomes in patients with a history of heart failure (HF) or left ventricular dysfunction (LVD) when EF ≥35%, but <45%. Methods: Among 5179 participants randomized into the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA), all of whom had LVEF ≥35%, we compared cardiovascular outcomes by treatment strategy in those with a history of HF or LV dysfunction (HF/LVD) at baseline versus those without HF/LVD. Median followup was 3.2 years. Results: There were 398 (7.7%) participants with HF/LVD at baseline of whom 177 had HF/LVEF>45%, 28 had HF/LVEF 35-45% and 193 had LVEF 35-45% but no prior history of HF. HF/LVD was associated with more comorbidities at baseline, particularly prior myocardial infarction (MI), stroke and hypertension. Compared to those without HF/LVD, those with HF/LVD were more likely to experience a primary outcome composite of cardiovascular death, nonfatal MI, or hospitalization for unstable angina, HF, or resuscitated cardiac arrest; four-year cumulative incidence rate (22.7% vs. 13.8%), cardiovascular death or MI (19.7% vs. 12.3%), and all-cause death or HF (15.0% vs. 6.9%). Those with HF/LVD randomized to the invasive versus conservative strategy had a lower rate of the primary outcome (17.2% vs. 29.3%, difference in 4-year event rate -12.1%; 95% CI: -22.6, -1.6%), whereas those without HF/LVD did not (13.0% vs. 14.6%, difference in 4-year event rate -1.6%; 95% CI: -3.8%, 0.7%; p-interaction = 0.055). A similar differential effect was seen for the primary outcome, all-cause mortality, and CV mortality when invasive versus conservative strategy associated outcomes were analyzed with LVEF as a continuous variable for those with and without prior HF. Conclusions: ISCHEMIA trial participants with stable ischemic heart disease and at least moderate ischemia with a history of HF or LVD were at increased risk for the primary outcome. In the small, high-risk subgroup with HF and LVEF 35-45%, an initial invasive approach was associated with a better event-free survival. This result should be considered hypothesis generating. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT01471522

What Is the Clinical Impact of Stress CMR After the ISCHEMIA Trial?

“…Indeed, the large majority of patients had LVEF ≥ 50% (median [IQR] = 60 [55–65]%) ( 5 ). Interestingly, a recent ancillary study of ISCHEMIA assessing only the subgroup of patients with LVEF 35–45% suggested a better event-free survival rate after an initial invasive strategy ( 52 ) ( Figure 3 ). However, initial studies assessing the potential interest of coronary revascularization in patients with reduced LVEF did not suggest any benefit in terms of CV outcomes.…”

“… Cumulative incidence curves for the primary composite outcome according to randomized treatment and history of heart failure (HF) or left ventricular dysfunction (LVD), from ISCHEMIA trial ( 52 ). CON indicates conservative strategy; and INV, invasive strategy.…”

To the Future and Beyond: Recent Advances in the Application of Percutaneous Coronary Intervention

“…Recently, there has been increasing interest in the early revascularization of subgroups of patients with heart failure. In the small, high-risk subgroup in the ISCHEMIA trial with heart failure and LVEF of 35% to 45%, an initial invasive approach was associated with better event-free survival [ 6 ]. However, upon analysis of a pooled database of five nationwide prospective registries from 55 centers in Korea, Kang et al demonstrated that complete revascularization reduced three-year adverse events only in patients with preserved LVEF.…”

Koronarrevaskularisation: Interventionelle Therapie versus Bypassoperation

“…In dieser Subgruppenanalyse der ISCHEMIA-Studie fiel auf, dass bei Patienten mit relevanter myokardialer Ischämie (> 10 % des Myokards) und eingeschränkter linksventrikulärer Funktion eine frühe Revaskularisation im Vergleich zu einer alleinigen OMT zu einer Verbesserung der Prognose führte [25] In der bereits 2016 vorgestellten STICH-Studie wurde gezeigt, dass Patienten mit ischämischer Kardiomyopathie (HFrEF mit EF < 35 %) und relevanter KHK von einer Bypassoperation (ACB) im Vergleich zu einer alleinigen optimalen medikamentösen Therapie profitieren [26]. Während einer Nachbeobachtung von 9,8 Jahren wurde die Mortalität signifikant nach ACB reduziert (58,9 % vs. 66,1 % bei alleiniger medikamentöser Therapie; HR: 0,84; 95 %-KI 0,73-0,97; p = 0,02).…”