Treatment With Icosapent Ethyl to Reduce Ischemic Events in Patients With Prior Percutaneous Coronary Intervention: Insights From REDUCE‐IT PCI

Q: What are the key findings of this study?

Icosapent ethyl reduced the primary composite cardiovascular endpoint by 34% compared to placebo (20.8% vs 29.4%; HR 0.66, 95% CI 0.58–0.76, P<0.001; NNT=12) in statin-treated patients with prior PCI.

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Prior percutaneous coronary intervention (PCI) with elevated triglycerides on statin therapy (n=3408). Intervention: Icosapent ethyl vs. Matching placebo added to stable statin therapy. Primary outcome: Composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization (HR 0.66, 95% CI 0.58-0.76, p=<0.001).

Q: What does this research mean for the field?

Icosapent ethyl reduces the risk of primary composite cardiovascular events by 34% in statin-treated patients with elevated triglycerides and a history of prior percutaneous coronary intervention. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Q: What question did this study set out to answer?

To evaluate the efficacy and safety of icosapent ethyl in reducing recurrent ischemic events among statin-treated patients with elevated triglycerides and a history of percutaneous coronary intervention.

doi:10.1161/jaha.121.022937

March 9, 2022Journal of the American Heart AssociationOpen Access

Treatment With Icosapent Ethyl to Reduce Ischemic Events in Patients With Prior Percutaneous Coronary Intervention: Insights From REDUCE‐IT PCI

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Key result

Icosapent ethyl cuts major cardiovascular events ~34% vs. placebo in statin-treated prior-PCI patients.

HR 0.66
95% CI 0.58-0.76
P<0.001
NNT 12
n=3,408

Figures

Why the study?

Patients undergoing PCI remain at increased risk for recurrent cardiovascular events despite aggressive medical therapy.

Does icosapent ethyl 4 g/day reduce ischemic cardiovascular events compared to placebo in statin-treated patients with elevated triglycerides and a history of prior percutaneous coronary intervention?

Key Points

To evaluate the efficacy and safety of icosapent ethyl in reducing recurrent ischemic events among statin-treated patients with elevated triglycerides and a history of percutaneous coronary intervention.
Post hoc subgroup analysis of the multicenter, randomized, double-blind, placebo-controlled REDUCE-IT trial (NCT01492361) evaluating 3408 patients with prior percutaneous coronary intervention.
Patients with low-density lipoprotein cholesterol <100 mg/dL and fasting triglycerides 135–499 mg/dL on background statin therapy received icosapent ethyl (4 g daily) or placebo, with a median follow-up of 4.8 years.
Icosapent ethyl significantly reduced the primary composite end point compared with placebo (20.8% vs 29.4%; HR, 0.66; 95% CI, 0.58–0.76; P<0.001; NNT=12).
The key secondary composite end point occurred in 12.0% of the icosapent ethyl group versus 17.4% of the placebo group (HR, 0.66; 95% CI, 0.56–0.79; P<0.001; NNT=19), with a 39% reduction in total ischemic events (RR, 0.61; 95% CI, 0.52–0.72; P<0.001).
Documented atrial fibrillation or flutter requiring emergency treatment occurred more frequently with icosapent ethyl than placebo (6.6% vs 4.5%, P=0.007), whereas total bleeding and trial-related adverse events did not differ.

Study Design

Type

RCT (n=3,408)

Blinding

Double-blind, placebo-controlled

Randomization

Stratified according to cardiovascular risk (established cardiovascular disease versus diabetes plus risk), geographic region, and ezetimibe use

Multicenter

Yes

Structured PICO

Does icosapent ethyl 4 g/day reduce ischemic cardiovascular events compared to placebo in statin-treated patients with elevated triglycerides and a history of prior percutaneous coronary intervention?

P

Population

3,408 patients with a history of prior PCI (median age 63 years, 20.7% female) on stable statin therapy with LDL-C <100 mg/dL and fasting triglycerides 135–499 mg/dL, followed for a median of 4.8 years.

I

Intervention

Icosapent ethyl 4 g oral daily (2 g twice daily) added to stable background statin therapy over a median follow-up of 4.8 years.

C

Comparator

Matching placebo added to stable background statin therapy (both groups treated with statins, with 8.5% also receiving ezetimibe).

O

Outcome

Composite of first occurrence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization at a median follow-up of 4.8 years.composite

Main Result

Hazard Ratio: 0.66 (95% CI 0.58–0.76)

Absolute Event Rate: 20.8% vs 29.4%

Absolute Risk Reduction: 8.5%

Number Needed to Treat: 12

p-value: p=<0.001

In high-risk statin-treated patients with prior PCI and elevated triglycerides, icosapent ethyl 4 g/day yields a substantial 34% relative risk reduction in major adverse cardiovascular events (NNT=12) and a 40% reduction in repeat coronary revascularizations over 4.8 years.

Limitations

Post hoc subgroup analysis not specifically powered for this subgroup and lacking adjustment for multiple comparisons
Randomization was not stratified by history of PCI, introducing potential for confounding
Time from PCI to randomization was unknown in 24.9% of the subgroup
Prerandomization extent of coronary artery disease, completeness of revascularization, and vessel/lesion-specific data were unavailable
Exploratory post hoc subgroup analysis lacking adjustment for multiple comparisons; P values should be considered hypothesis-generating
Randomization was not stratified by history of prior PCI, leaving potential for confounding
Time elapsed from prior PCI to randomization was unknown in 24.9% of the prior PCI subset
Prerandomization extent of coronary artery disease, revascularization strategy (complete vs incomplete), and vessel- or lesion-specific data (in-stent restenosis vs de novo plaque events) were not available

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Answers are grounded in this paper and cite their sources.

Implication

Supports icosapent ethyl in statin-treated post-PCI patients; extends REDUCE-IT benefits to this high-risk subgroup.

Abstract

Background Patients who undergo percutaneous coronary intervention (PCI) are at increased risk for recurrent cardiovascular events despite aggressive medical therapy. Methods and Results This post hoc analysis focused on the subset of patients with prior PCI enrolled in REDUCE‐IT (Reduction of Cardiovascular Events With Icosapent Ethyl–Intervention Trial), a multicenter, randomized, double‐blind, placebo‐controlled trial of icosapent ethyl versus placebo. Icosapent ethyl was added to statins in patients with low‐density lipoprotein cholesterol <100 mg/dL and fasting triglycerides 135–499 mg/dL. The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization. There were 8179 patients randomized in REDUCE‐IT followed for a median of 4.9 years, and 3408 (41.7%) of them had a prior PCI with a median follow‐up of 4.8 years. These patients were randomized a median of 2.9 years (11 days to 30.7 years) after PCI. Among patients treated with icosapent ethyl versus placebo, there was a 34% reduction in the primary composite end point (hazard ratio [HR], 0.66; 95% CI, 0.58–0.76; P <0.001; number needed to treat 4.8 years =12) and a 34% reduction in the key secondary composite end point of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke (HR, 0.66; 95% CI, 0.56–0.79; P <0.001; NNT 4.8 years =19) versus placebo. Similarly, large reductions occurred in total coronary revascularizations and revascularization subtypes. There was also a 39% reduction in total events (rate ratio, 0.61; 95% CI, 0.52–0.72; P <0.001). Conclusions Among patients treated with statins with elevated triglycerides and a history of prior PCI, icosapent ethyl substantially reduced the risk of recurrent events during an average of ~5 years of follow‐up with a number needed to treat of only 12. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01492361.

Discussion

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Cite This Study

A 2022 study conducted an RCT in Prior percutaneous coronary intervention (PCI) with elevated triglycerides on statin therapy (n=3,408). Icosapent ethyl vs. Matching placebo added to stable statin therapy was evaluated on Composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization (HR 0.66, 95% CI 0.58-0.76, p=<0.001). Icosapent ethyl reduced the primary composite cardiovascular endpoint by 34% compared to placebo (20.8% vs 29.4%; HR 0.66, 95% CI 0.58–0.76, P<0.001; NNT=12) in statin-treated patients with prior PCI.

synapsesocial.com/papers/6a7f19b1c5b020b0b6d0b18e https://doi.org/10.1161/jaha.121.022937

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Treatment With Icosapent Ethyl to Reduce Ischemic Events in Patients With Prior Percutaneous Coronary Intervention: Insights From REDUCE‐IT PCI

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Treatment With Icosapent Ethyl to Reduce Ischemic Events in Patients With Prior Percutaneous Coronary Intervention: Insights From REDUCE‐IT PCI

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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