Early intervention in NSTEACS reduces ischemic events but not CV mortality
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Confirming previously presented findings, early intervention for patients who presented with non-ST-segment elevation ACS without pretreatment with P2Y12 inhibitors reduced recurrent ischemic events compared with delayed coronary angiography, but there were no differences in CV mortality.
The EARLY randomized controlled trial, recently published in JACC: Cardiovascular Interventions and presented at the American Heart Association Scientific Sessions in November 2018, assessed differences between outcomes of early intervention (interquartile range, 0-1 hour) and delayed intervention (mean delay, 18 hours) for patients with non-ST-segment elevation ACS (NSTEACS) who received no pretreatment loading dose of P2Y12 inhibitors.
Ischemic event reduction
Researchers observed lower prevalence of the composite endpoint of CV death or recurrent ischemic events at 1 month in the early intervention group than in the delayed group (4.4% vs. 21.3%; HR = 0.2; 95% CI, 0.11-0.34), which was primarily driven by a reduction in ischemic events (19.8% vs. 2.9%; P < .001).
However, researchers found no difference between delayed or early intervention for CV death during hospitalization (0.8% vs. 0.3%, respectively; P = .62) or at 1-month after randomization (1.1% vs. 0.6%, respectively; P = .69).
“The present study is the first to address the issue of the optimal timing of the invasive strategy in the absence of pretreatment with P2Y12-adenosine diphosphate receptor antagonists, and thus gives original data on how to best manage these patients in clinical practice,” Gilles Lemesle, MD, PhD, of the Centre Hospitalier Régional et Universitaire de Lille, France, and colleagues wrote.
In other findings, patients who underwent early intervention had lower rates of total culprit vessel occlusion at the initial angiogram (4.7% for delayed group vs. 0.6% for early group; P < .001), but similar rates of in-hospital major bleeding (0.3% in both groups; P = 1) and major bleeding 1 month after randomization (delayed group, 0.8%, early group, 0.3%; P = .62).
For this study, 709 intermediate- or high-risk patients were randomly assigned to early or delayed intervention for NSTEACS at a 1:1 ratio.
“The current guidelines on the timing of the invasive strategy were based on subgroup analysis of negative studies at a time when pretreatment with P2Y12-adenosine diphosphate receptor was common,” Laurent Bonello, MD, of the intensive care and interventional cardiology unit at Hospital Nord in Marseille, France, told Healio. “Our study demonstrates that in patients who did not receive pretreatment, which is consistent with the current guidelines, the invasive strategy should be performed early and not delayed as usual. To date, there was no study regarding these patients and the optimal timing was unknown.”
Interesting insight
“Although the added clinical value of the EARLY trial can be considered only modest, mainly because of its small sample size and the lack of impact on hard endpoints, it provides an interesting insight into the clinical benefit of a very early invasive strategy in patients with high-risk NSTEACS when a no-pretreatment approach is chosen,” José Luis Ferreiro, MD, PhD, of the department of cardiology at Bellvitge University Hospital in Barcelona, Spain, wrote in a related editorial.
“The debate on the issue of pretreatment with oral P2Y12 inhibitors in patients with NSTEACS is far from over,” Ferreiro wrote. “More important, available evidence suggests that a ‘one-size-fits-all’ strategy (ie, routine use of pretreatment or absolute avoidance of it) is most certainly inadequate. An individualized approach based on a careful evaluation of individual ischemic and bleeding risk and of local logistics and practice standards should be the way to go.” – by Scott Buzby
Disclosures: Lemesle reports he received lecture or consultant fees from Amgen, AstraZeneca, Bayer, Biopharma, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Sanofi, Servier and The Medicines Company. Ferreiro reports he received honoraria from Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, Eli Lilly, Pfizer and Roche Diagnostics; consultant fees from AstraZeneca, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Daiichi-Sankyo, Eli Lilly, Ferrer and Pfizer; and research grants from AstraZeneca. Please see the study for all other authors’ relevant financial disclosures.
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Ferreiro JL. JACC Cardiovasc Interv. 2020;doi:10.1016/j.jcin.2020.02.036.
Lemesle G, et al. JACC Cardiovasc Interv. 2020;doi:10.1016/j.jcin.2020.01.231.
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