REDUCE-IT: Cardiovascular risk reduction with icosapent ethyl in PAD

Icosapent ethyl was associated with cardiovascular risk reduction in patients with prior peripheral artery disease (PAD) in a post-hoc analysis of the REDUCE-IT trial. A significant 32% reduction in total ischaemic events was demonstrated over approximately 5 years in patients with PAD treated with icosapent ethyl. The results in this subpopulation are consistent with the overall trial results [1].

The randomised, phase 3 REDUCE-IT trial (NCT01492361) was conducted to investigate the safety and efficacy of icosapent ethyl in patients at high risk for cardiovascular events [2]. For the primary analysis, 8,179 patients who were treated with statins were randomised 1:1 to 4 g icosapent ethyl once daily or placebo. After approximately 5 years of follow-up, a relative risk reduction in cardiovascular events of 24.8% was observed in participants receiving icosapent ethyl compared with those receiving placebo. The current subgroup analysis, presented by Dr Deepak Bhatt (Brigham and Women’s Hospital, Boston, MA, USA), examined whether this benefit extends to patients with prior PAD (n=688).

The subpopulation of patients with prior PAD was demonstrated to be a very high-risk cohort in the REDUCE-IT study: 41.7% of the patients with PAD showed a first ischaemic cardiovascular event in the 5-year follow-up period versus 31.1% of the patients with atherosclerosis but without PAD (P=0.0004). The cumulative event rate was 98.2% in patients with PAD versus 61.4% in patients without prior PAD (P<0.0001).

The risk reduction of icosapent ethyl on total cardiovascular events in patients with prior PAD after approximately 5 years of follow-up was 32% (P=0.03) and displayed a non-significant 22% risk reduction in first cardiovascular events (P=0.08). A similar effect was observed in patients with atherosclerosis but without PAD.

The safety profile of icosapent ethyl in patients with PAD was consistent with the overall trial population. Tolerability and adverse events of placebo receivers and icosapent ethyl receivers were mostly comparable. Atrial fibrillation was reported numerically more frequently in the icosapent ethyl arm (5.2%) than in the placebo arm (2.6%; P=0.07). No differences in bleeding were found. However, Dr Bhatt added that this last finding could be related to the limited sample size of the PAD subpopulation.

In conclusion, icosapent ethyl provided significant risk reduction in cardiovascular events in the very high-risk subpopulation of patients with prior PAD of the REDUCE-IT trial. The effect sizes were similar to the overall trial results.

 

1. 
   
   1. Bhatt DL, et al. Benefits of Icosapent Ethyl in Patients with Prior Peripheral Artery Disease: REDUCE-IT PAD. VA.RFO.19, AHA 2021 Scientific Sessions, 13–15 November.
   2. Bhatt DL, et al. N Engl J Med 2019;380:11–22.

 

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Posted on 14 January 202227 March 2024