Effect of Alirocumab Added to High-Intensity Statin Therapy on Coronary Atherosclerosis in Patients With Acute Myocardial Infarction: The PACMAN-AMI Randomized Clinical Trial

Coronary plaques that are prone to rupture and cause adverse cardiac events are characterized by large plaque burden, large lipid content, and thin fibrous caps. Statins can halt the progression of coronary atherosclerosis; however, the effect of the proprotein convertase subtilisin kexin type 9 inh...

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Published in:	JAMA : the journal of the American Medical Association Vol. 327; no. 18; p. 1771
Main Authors:	Räber, Lorenz, Ueki, Yasushi, Otsuka, Tatsuhiko, Losdat, Sylvain, Häner, Jonas D, Lonborg, Jacob, Fahrni, Gregor, Iglesias, Juan F, van Geuns, Robert-Jan, Ondracek, Anna S, Radu Juul Jensen, Maria D, Zanchin, Christian, Stortecky, Stefan, Spirk, David, Siontis, George C M, Saleh, Lanja, Matter, Christian M, Daemen, Joost, Mach, François, Heg, Dik, Windecker, Stephan, Engstrøm, Thomas, Lang, Irene M, Koskinas, Konstantinos C
Format:	Journal Article
Language:	English
Published:	United States 10.05.2022
Subjects:	Aged Antibodies, Monoclonal, Humanized - therapeutic use Cholesterol, LDL Coronary Artery Disease - complications Coronary Artery Disease - diagnostic imaging Coronary Artery Disease - drug therapy Double-Blind Method Female Humans Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use Male Middle Aged Myocardial Infarction - complications Myocardial Infarction - drug therapy PCSK9 Inhibitors - therapeutic use Plaque, Atherosclerotic - complications Plaque, Atherosclerotic - diagnostic imaging Plaque, Atherosclerotic - drug therapy Treatment Outcome
ISSN:	1538-3598, 1538-3598
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Abstract	Coronary plaques that are prone to rupture and cause adverse cardiac events are characterized by large plaque burden, large lipid content, and thin fibrous caps. Statins can halt the progression of coronary atherosclerosis; however, the effect of the proprotein convertase subtilisin kexin type 9 inhibitor alirocumab added to statin therapy on plaque burden and composition remains largely unknown. To determine the effects of alirocumab on coronary atherosclerosis using serial multimodality intracoronary imaging in patients with acute myocardial infarction. The PACMAN-AMI double-blind, placebo-controlled, randomized clinical trial (enrollment: May 9, 2017, through October 7, 2020; final follow-up: October 13, 2021) enrolled 300 patients undergoing percutaneous coronary intervention for acute myocardial infarction at 9 academic European hospitals. Patients were randomized to receive biweekly subcutaneous alirocumab (150 mg; n = 148) or placebo (n = 152), initiated less than 24 hours after urgent percutaneous coronary intervention of the culprit lesion, for 52 weeks in addition to high-intensity statin therapy (rosuvastatin, 20 mg). Intravascular ultrasonography (IVUS), near-infrared spectroscopy, and optical coherence tomography were serially performed in the 2 non-infarct-related coronary arteries at baseline and after 52 weeks. The primary efficacy end point was the change in IVUS-derived percent atheroma volume from baseline to week 52. Two powered secondary end points were changes in near-infrared spectroscopy-derived maximum lipid core burden index within 4 mm (higher values indicating greater lipid content) and optical coherence tomography-derived minimal fibrous cap thickness (smaller values indicating thin-capped, vulnerable plaques) from baseline to week 52. Among 300 randomized patients (mean [SD] age, 58.5 [9.7] years; 56 [18.7%] women; mean [SD] low-density lipoprotein cholesterol level, 152.4 [33.8] mg/dL), 265 (88.3%) underwent serial IVUS imaging in 537 arteries. At 52 weeks, mean change in percent atheroma volume was -2.13% with alirocumab vs -0.92% with placebo (difference, -1.21% [95% CI, -1.78% to -0.65%], P < .001). Mean change in maximum lipid core burden index within 4 mm was -79.42 with alirocumab vs -37.60 with placebo (difference, -41.24 [95% CI, -70.71 to -11.77]; P = .006). Mean change in minimal fibrous cap thickness was 62.67 μm with alirocumab vs 33.19 μm with placebo (difference, 29.65 μm [95% CI, 11.75-47.55]; P = .001). Adverse events occurred in 70.7% of patients treated with alirocumab vs 72.8% of patients receiving placebo. Among patients with acute myocardial infarction, the addition of subcutaneous biweekly alirocumab, compared with placebo, to high-intensity statin therapy resulted in significantly greater coronary plaque regression in non-infarct-related arteries after 52 weeks. Further research is needed to understand whether alirocumab improves clinical outcomes in this population. ClinicalTrials.gov Identifier: NCT03067844.
AbstractList	Coronary plaques that are prone to rupture and cause adverse cardiac events are characterized by large plaque burden, large lipid content, and thin fibrous caps. Statins can halt the progression of coronary atherosclerosis; however, the effect of the proprotein convertase subtilisin kexin type 9 inhibitor alirocumab added to statin therapy on plaque burden and composition remains largely unknown. To determine the effects of alirocumab on coronary atherosclerosis using serial multimodality intracoronary imaging in patients with acute myocardial infarction. The PACMAN-AMI double-blind, placebo-controlled, randomized clinical trial (enrollment: May 9, 2017, through October 7, 2020; final follow-up: October 13, 2021) enrolled 300 patients undergoing percutaneous coronary intervention for acute myocardial infarction at 9 academic European hospitals. Patients were randomized to receive biweekly subcutaneous alirocumab (150 mg; n = 148) or placebo (n = 152), initiated less than 24 hours after urgent percutaneous coronary intervention of the culprit lesion, for 52 weeks in addition to high-intensity statin therapy (rosuvastatin, 20 mg). Intravascular ultrasonography (IVUS), near-infrared spectroscopy, and optical coherence tomography were serially performed in the 2 non-infarct-related coronary arteries at baseline and after 52 weeks. The primary efficacy end point was the change in IVUS-derived percent atheroma volume from baseline to week 52. Two powered secondary end points were changes in near-infrared spectroscopy-derived maximum lipid core burden index within 4 mm (higher values indicating greater lipid content) and optical coherence tomography-derived minimal fibrous cap thickness (smaller values indicating thin-capped, vulnerable plaques) from baseline to week 52. Among 300 randomized patients (mean [SD] age, 58.5 [9.7] years; 56 [18.7%] women; mean [SD] low-density lipoprotein cholesterol level, 152.4 [33.8] mg/dL), 265 (88.3%) underwent serial IVUS imaging in 537 arteries. At 52 weeks, mean change in percent atheroma volume was -2.13% with alirocumab vs -0.92% with placebo (difference, -1.21% [95% CI, -1.78% to -0.65%], P < .001). Mean change in maximum lipid core burden index within 4 mm was -79.42 with alirocumab vs -37.60 with placebo (difference, -41.24 [95% CI, -70.71 to -11.77]; P = .006). Mean change in minimal fibrous cap thickness was 62.67 μm with alirocumab vs 33.19 μm with placebo (difference, 29.65 μm [95% CI, 11.75-47.55]; P = .001). Adverse events occurred in 70.7% of patients treated with alirocumab vs 72.8% of patients receiving placebo. Among patients with acute myocardial infarction, the addition of subcutaneous biweekly alirocumab, compared with placebo, to high-intensity statin therapy resulted in significantly greater coronary plaque regression in non-infarct-related arteries after 52 weeks. Further research is needed to understand whether alirocumab improves clinical outcomes in this population. ClinicalTrials.gov Identifier: NCT03067844. Coronary plaques that are prone to rupture and cause adverse cardiac events are characterized by large plaque burden, large lipid content, and thin fibrous caps. Statins can halt the progression of coronary atherosclerosis; however, the effect of the proprotein convertase subtilisin kexin type 9 inhibitor alirocumab added to statin therapy on plaque burden and composition remains largely unknown.ImportanceCoronary plaques that are prone to rupture and cause adverse cardiac events are characterized by large plaque burden, large lipid content, and thin fibrous caps. Statins can halt the progression of coronary atherosclerosis; however, the effect of the proprotein convertase subtilisin kexin type 9 inhibitor alirocumab added to statin therapy on plaque burden and composition remains largely unknown.To determine the effects of alirocumab on coronary atherosclerosis using serial multimodality intracoronary imaging in patients with acute myocardial infarction.ObjectiveTo determine the effects of alirocumab on coronary atherosclerosis using serial multimodality intracoronary imaging in patients with acute myocardial infarction.The PACMAN-AMI double-blind, placebo-controlled, randomized clinical trial (enrollment: May 9, 2017, through October 7, 2020; final follow-up: October 13, 2021) enrolled 300 patients undergoing percutaneous coronary intervention for acute myocardial infarction at 9 academic European hospitals.Design, Setting, and ParticipantsThe PACMAN-AMI double-blind, placebo-controlled, randomized clinical trial (enrollment: May 9, 2017, through October 7, 2020; final follow-up: October 13, 2021) enrolled 300 patients undergoing percutaneous coronary intervention for acute myocardial infarction at 9 academic European hospitals.Patients were randomized to receive biweekly subcutaneous alirocumab (150 mg; n = 148) or placebo (n = 152), initiated less than 24 hours after urgent percutaneous coronary intervention of the culprit lesion, for 52 weeks in addition to high-intensity statin therapy (rosuvastatin, 20 mg).InterventionsPatients were randomized to receive biweekly subcutaneous alirocumab (150 mg; n = 148) or placebo (n = 152), initiated less than 24 hours after urgent percutaneous coronary intervention of the culprit lesion, for 52 weeks in addition to high-intensity statin therapy (rosuvastatin, 20 mg).Intravascular ultrasonography (IVUS), near-infrared spectroscopy, and optical coherence tomography were serially performed in the 2 non-infarct-related coronary arteries at baseline and after 52 weeks. The primary efficacy end point was the change in IVUS-derived percent atheroma volume from baseline to week 52. Two powered secondary end points were changes in near-infrared spectroscopy-derived maximum lipid core burden index within 4 mm (higher values indicating greater lipid content) and optical coherence tomography-derived minimal fibrous cap thickness (smaller values indicating thin-capped, vulnerable plaques) from baseline to week 52.Main Outcomes and MeasuresIntravascular ultrasonography (IVUS), near-infrared spectroscopy, and optical coherence tomography were serially performed in the 2 non-infarct-related coronary arteries at baseline and after 52 weeks. The primary efficacy end point was the change in IVUS-derived percent atheroma volume from baseline to week 52. Two powered secondary end points were changes in near-infrared spectroscopy-derived maximum lipid core burden index within 4 mm (higher values indicating greater lipid content) and optical coherence tomography-derived minimal fibrous cap thickness (smaller values indicating thin-capped, vulnerable plaques) from baseline to week 52.Among 300 randomized patients (mean [SD] age, 58.5 [9.7] years; 56 [18.7%] women; mean [SD] low-density lipoprotein cholesterol level, 152.4 [33.8] mg/dL), 265 (88.3%) underwent serial IVUS imaging in 537 arteries. At 52 weeks, mean change in percent atheroma volume was -2.13% with alirocumab vs -0.92% with placebo (difference, -1.21% [95% CI, -1.78% to -0.65%], P < .001). Mean change in maximum lipid core burden index within 4 mm was -79.42 with alirocumab vs -37.60 with placebo (difference, -41.24 [95% CI, -70.71 to -11.77]; P = .006). Mean change in minimal fibrous cap thickness was 62.67 μm with alirocumab vs 33.19 μm with placebo (difference, 29.65 μm [95% CI, 11.75-47.55]; P = .001). Adverse events occurred in 70.7% of patients treated with alirocumab vs 72.8% of patients receiving placebo.ResultsAmong 300 randomized patients (mean [SD] age, 58.5 [9.7] years; 56 [18.7%] women; mean [SD] low-density lipoprotein cholesterol level, 152.4 [33.8] mg/dL), 265 (88.3%) underwent serial IVUS imaging in 537 arteries. At 52 weeks, mean change in percent atheroma volume was -2.13% with alirocumab vs -0.92% with placebo (difference, -1.21% [95% CI, -1.78% to -0.65%], P < .001). Mean change in maximum lipid core burden index within 4 mm was -79.42 with alirocumab vs -37.60 with placebo (difference, -41.24 [95% CI, -70.71 to -11.77]; P = .006). Mean change in minimal fibrous cap thickness was 62.67 μm with alirocumab vs 33.19 μm with placebo (difference, 29.65 μm [95% CI, 11.75-47.55]; P = .001). Adverse events occurred in 70.7% of patients treated with alirocumab vs 72.8% of patients receiving placebo.Among patients with acute myocardial infarction, the addition of subcutaneous biweekly alirocumab, compared with placebo, to high-intensity statin therapy resulted in significantly greater coronary plaque regression in non-infarct-related arteries after 52 weeks. Further research is needed to understand whether alirocumab improves clinical outcomes in this population.Conclusions and RelevanceAmong patients with acute myocardial infarction, the addition of subcutaneous biweekly alirocumab, compared with placebo, to high-intensity statin therapy resulted in significantly greater coronary plaque regression in non-infarct-related arteries after 52 weeks. Further research is needed to understand whether alirocumab improves clinical outcomes in this population.ClinicalTrials.gov Identifier: NCT03067844.Trial RegistrationClinicalTrials.gov Identifier: NCT03067844.
Author	Heg, Dik Fahrni, Gregor Windecker, Stephan Siontis, George C M Mach, François Radu Juul Jensen, Maria D van Geuns, Robert-Jan Otsuka, Tatsuhiko Zanchin, Christian Stortecky, Stefan Spirk, David Matter, Christian M Engstrøm, Thomas Losdat, Sylvain Räber, Lorenz Koskinas, Konstantinos C Ueki, Yasushi Saleh, Lanja Daemen, Joost Häner, Jonas D Iglesias, Juan F Lonborg, Jacob Ondracek, Anna S Lang, Irene M
Author_xml	– sequence: 1 givenname: Lorenz surname: Räber fullname: Räber, Lorenz organization: Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland – sequence: 2 givenname: Yasushi surname: Ueki fullname: Ueki, Yasushi organization: Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland – sequence: 3 givenname: Tatsuhiko surname: Otsuka fullname: Otsuka, Tatsuhiko organization: Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland – sequence: 4 givenname: Sylvain surname: Losdat fullname: Losdat, Sylvain organization: CTU Bern, University of Bern, Bern, Switzerland – sequence: 5 givenname: Jonas D surname: Häner fullname: Häner, Jonas D organization: Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland – sequence: 6 givenname: Jacob surname: Lonborg fullname: Lonborg, Jacob organization: Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark – sequence: 7 givenname: Gregor surname: Fahrni fullname: Fahrni, Gregor organization: Department of Cardiology, University Hospital Basel, Basel, Switzerland – sequence: 8 givenname: Juan F surname: Iglesias fullname: Iglesias, Juan F organization: Division of Cardiology, University Hospital Geneva, Geneva, Switzerland – sequence: 9 givenname: Robert-Jan surname: van Geuns fullname: van Geuns, Robert-Jan organization: Department of Cardiology, Radboud UMC, Nijmegen, the Netherlands – sequence: 10 givenname: Anna S surname: Ondracek fullname: Ondracek, Anna S organization: Department of Cardiology, Medical University of Vienna, Vienna, Austria – sequence: 11 givenname: Maria D surname: Radu Juul Jensen fullname: Radu Juul Jensen, Maria D organization: Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark – sequence: 12 givenname: Christian surname: Zanchin fullname: Zanchin, Christian organization: Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland – sequence: 13 givenname: Stefan surname: Stortecky fullname: Stortecky, Stefan organization: Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland – sequence: 14 givenname: David surname: Spirk fullname: Spirk, David organization: Department of Pharmacology, Bern University Hospital, Bern, Switzerland, and Sanofi, Switzerland – sequence: 15 givenname: George C M surname: Siontis fullname: Siontis, George C M organization: Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland – sequence: 16 givenname: Lanja surname: Saleh fullname: Saleh, Lanja organization: Institute of Clinical Chemistry, Zurich University Hospital, Zurich, Switzerland – sequence: 17 givenname: Christian M surname: Matter fullname: Matter, Christian M organization: Department of Cardiology, Zurich University Hospital, Zurich, Switzerland – sequence: 18 givenname: Joost surname: Daemen fullname: Daemen, Joost organization: Department of Cardiology, Erasmus University Medical Center, Rotterdam, the Netherlands – sequence: 19 givenname: François surname: Mach fullname: Mach, François organization: Division of Cardiology, University Hospital Geneva, Geneva, Switzerland – sequence: 20 givenname: Dik surname: Heg fullname: Heg, Dik organization: CTU Bern, University of Bern, Bern, Switzerland – sequence: 21 givenname: Stephan surname: Windecker fullname: Windecker, Stephan organization: Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland – sequence: 22 givenname: Thomas surname: Engstrøm fullname: Engstrøm, Thomas organization: Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark – sequence: 23 givenname: Irene M surname: Lang fullname: Lang, Irene M organization: Department of Cardiology, Medical University of Vienna, Vienna, Austria – sequence: 24 givenname: Konstantinos C surname: Koskinas fullname: Koskinas, Konstantinos C organization: Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland
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References	35422520 - Nat Rev Cardiol. 2022 Jun;19(6):350. doi: 10.1038/s41569-022-00706-9. 36066524 - JAMA. 2022 Sep 6;328(9):891. doi: 10.1001/jama.2022.11830. 36066523 - JAMA. 2022 Sep 6;328(9):890-891. doi: 10.1001/jama.2022.11833.
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SubjectTerms	Aged Antibodies, Monoclonal, Humanized - therapeutic use Cholesterol, LDL Coronary Artery Disease - complications Coronary Artery Disease - diagnostic imaging Coronary Artery Disease - drug therapy Double-Blind Method Female Humans Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use Male Middle Aged Myocardial Infarction - complications Myocardial Infarction - drug therapy PCSK9 Inhibitors - therapeutic use Plaque, Atherosclerotic - complications Plaque, Atherosclerotic - diagnostic imaging Plaque, Atherosclerotic - drug therapy Treatment Outcome
Title	Effect of Alirocumab Added to High-Intensity Statin Therapy on Coronary Atherosclerosis in Patients With Acute Myocardial Infarction: The PACMAN-AMI Randomized Clinical Trial
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