What is the clinical evidence from this study?

Study design: RCT. Population: Acute myocardial infarction (n=245). Intervention: Alirocumab vs. Placebo. Primary outcome: Lesion-level mean change in percent atheroma volume (PAV) (MD -2.02, 95% CI -3.00 to -1.05, p=<.001).

What does this research mean for the field?

Adding alirocumab to high-intensity statin therapy induces greater coronary lesion-level percent atheroma volume regression and favorable plaque phenotype stabilization in patients with acute myocardial infarction. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

To assess the effects of intensive lipid-lowering therapy with alirocumab on advanced, high-risk coronary atherosclerotic lesions in patients with acute myocardial infarction.

September 2, 2024JAMA CardiologyOpen Access

Lesion-Level Effects of LDL-C–Lowering Therapy in Patients With Acute Myocardial Infarction

Q: What are the key findings of this study?

Alirocumab added to high-intensity statin therapy induced greater lesion-level percent atheroma volume regression than placebo (difference -2.02%; 95% CI -3.00 to -1.05; P<.001).

Q: What does this research mean for the field?

Adding alirocumab to high-intensity statin therapy induces greater coronary lesion-level percent atheroma volume regression and favorable plaque phenotype stabilization in patients with acute myocardial infarction. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

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

To assess the effects of intensive lipid-lowering therapy with alirocumab on advanced, high-risk coronary atherosclerotic lesions in patients with acute myocardial infarction.

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Key result

Alirocumab added to statins increases coronary plaque regression by ~2% over placebo.

Why the study?

Does alirocumab added to high-intensity statin therapy improve lesion-level high-risk plaque characteristics in patients with acute myocardial infarction?

Key Points

To assess the effects of intensive lipid-lowering therapy with alirocumab on advanced, high-risk coronary atherosclerotic lesions in patients with acute myocardial infarction.
Post hoc lesion-level analysis of the PACMAN-AMI randomized clinical trial (NCT03067844) assessing nonculprit lesions with baseline plaque burden ≥40% defined by intravascular ultrasound (IVUS).
Patients received alirocumab (n=118; 287 lesions) or placebo (n=127; 304 lesions) added to high-intensity statin therapy, with serial IVUS, near-infrared spectroscopy, and optical coherence tomography matched at baseline and 52-week follow-up by blinded readers.
Mean change in percent atheroma volume (PAV) was -4.86% with alirocumab vs -2.78% with placebo (difference: -2.02; 95% CI, -3.00 to -1.05; P < .001), and -10.14% vs -6.70% at the minimum lumen area site (difference: -3.36; 95% CI, -4.98 to -1.75; P < .001).
Minimum lumen area increased by 0.15 mm² with alirocumab and decreased by 0.07 mm² with placebo (difference: 0.21 mm²; 95% CI, 0.01 to 0.41; P = .04).
Alirocumab transitioned more lipid-rich plaques to less lipid-rich phenotypes (61.8% vs 41.8%; P = .03) and converted more thin-cap fibroatheromas into stable fibrous/fibrocalcific phenotypes (30.8% vs 8.1%; P = .02).

Study Design

Type

RCT (n=245)

Blinding

Blinded to treatment allocation

Randomization

Randomized

Structured PICO

Does alirocumab added to high-intensity statin therapy improve lesion-level high-risk plaque characteristics in patients with acute myocardial infarction?

Population

245 patients with acute myocardial infarction and nonculprit lesions with ≥40% plaque burden, followed for 52 weeks.

Intervention

Alirocumab in addition to high-intensity statin therapy for 52 weeks

Comparator

Placebo in addition to high-intensity statin therapy for 52 weeks

Outcome

Lesion-level imaging outcome measures, including high-risk plaque characteristics and phenotypes (percent atheroma volume [PAV]) at 52-week follow-upsurrogate

Main Result

Mean Difference: -2.02 (95% CI -3–-1.05)

Absolute Event Rate: -4.86% vs -2.78%

p-value: p=<.001

Discussion

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Implication

In patients with acute myocardial infarction, adding alirocumab to high-intensity statin therapy induced greater regression of percent atheroma volume and stabilized high-risk plaque phenotypes compared to statin therapy alone.

Cite This Study

Biccirè et al. (2024) conducted an RCT in Acute myocardial infarction (n=245). Alirocumab vs. Placebo was evaluated on Lesion-level mean change in percent atheroma volume (PAV) (MD -2.02, 95% CI -3.00 to -1.05, p=<.001). Alirocumab added to high-intensity statin therapy induced greater lesion-level percent atheroma volume regression than placebo (difference -2.02%; 95% CI -3.00 to -1.05; P<.001).

synapsesocial.com/papers/6a7f3fd8da7edfc28fb3ae61 https://doi.org/10.1001/jamacardio.2024.3200

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Lesion-Level Effects of LDL-C–Lowering Therapy in Patients With Acute Myocardial Infarction

Key Points

Study Design

Structured PICO

Main Result

Discussion

Implication

Cite This Study

Lesion-Level Effects of LDL-C–Lowering Therapy in Patients With Acute Myocardial Infarction

Key Points

Study Design

Structured PICO

Main Result

Discussion

Implication

Cite This Study

Also Consider

Also Consider