Evidence map›Paper›PMID 32223446›Full record

Trial reportCirculation2020

Peripheral Artery Disease and Venous Thromboembolic Events After Acute Coronary Syndrome: Role of Lipoprotein(a) and Modification by Alirocumab: Prespecified Analysis of the ODYSSEY OUTCOMES Randomized Clinical Trial.

Gregory G Schwartz, Philippe Gabriel Steg, Michael Szarek, Vera A Bittner, Rafael Diaz, Shaun G Goodman, Yong-Un Kim, J Wouter Jukema, Robert Pordy, Matthew T Roe and 3 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled TrialVideo-Audio Media
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Circulation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01663402. Cited by 92 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
92citing papers in PubMed, 6 pooled it
20.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01663402 phase3completed

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Alirocumab (SAR236553/REGN727) on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome

Ran2012Enrolled18,924Registered outcomes15Posted comparisons6ConditionsAtherosclerotic Cardiovascular DiseaseArmsAlirocumab, LMT, Placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

92 citing papers in PubMed, 6 syntheses or guidelines pooled it, 183 citations in OpenAlex.

  1. Guideline
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32 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 12 institutions in 7 countries.

Gregory G SchwartzDivision of Cardiology, University of Colorado School of Medicine, Aurora (G.G.S.).
Philippe Gabriel StegUniversité de Paris, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, France (P.G.S.).
Michael SzarekState University of New York, Downstate School of Public Health, Brooklyn (M.S.).
Vera A BittnerUniversity of Alabama at Birmingham (V.A.B.).
Rafael DiazEstudios Cardiológicos Latinoamérica, Instituto Cardiovascular de Rosario, Argentina (R.D.).
Shaun G GoodmanCanadian VIGOUR Centre, University of Alberta, Edmonton, Canada (S.G.G.).
Yong-Un KimSanofi, Paris, France (Y.-U.K.).
J Wouter JukemaLeiden University Medical Center, The Netherlands (J.W.J.).
Robert PordyRegeneron Pharmaceuticals, Tarrytown, NY (R.P.).
Matthew T RoeDuke Clinical Research Institute, Duke University Medical Center, Durham, NC (M.T.R.).
Harvey D WhiteGreen Lane Cardiovascular Services Auckland City Hospital, New Zealand (H.D.W.).
Deepak L BhattBrigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA (D.L.B.).
ODYSSEY OUTCOMES Committees and Investigators*
Auckland City Hospital · NZBrigham and Women's Hospital · USDuke Medical Center · USEstudios Clínicos Latinoamérica · ARInserm · FRLeiden University Medical Center · NLRegeneron (United States) · USSanofi (France) · FRSt. Michael's Hospital · CASUNY Downstate Health Sciences University · USUniversity of Alabama at Birmingham · USUniversity of Colorado Denver · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with acute coronary syndrome are at risk for peripheral artery disease (PAD) events and venous thromboembolism (VTE). PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors reduce lipoprotein(a) and low-density lipoprotein cholesterol (LDL-C) levels. Our objective was to ascertain whether PCSK9 inhibition reduces the risk of PAD events or VTE after acute coronary syndrome, and if such effects are related to levels of lipoprotein(a) or LDL-C.

methodsThis was a prespecified analysis of the ODYSSEY OUTCOMES randomized clinical trial (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome), which was conducted in 18 924 patients with recent acute coronary syndrome on intensive or maximum-tolerated statin treatment who were randomized to the PCSK9 inhibitor alirocumab or placebo. In a prespecified analysis, PAD events (critical limb ischemia, limb revascularization, or amputation for ischemia) and VTE (deep vein thrombosis or pulmonary embolism) were assessed. LDL-C was corrected (LDL-C

resultsAt baseline, median lipoprotein(a) and LDL-C

conclusionsIn statin-treated patients with recent acute coronary syndrome, risk of PAD events is related to lipoprotein(a) level and is reduced by alirocumab, particularly among those with high lipoprotein(a). Further study is required to confirm whether risk of VTE is related to lipoprotein(a) level and its reduction with alirocumab. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01663402.

Indexed as

PCSK9 InhibitorsAcute Coronary SyndromeAgedAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsBiomarkersCholesterol, LDLDouble-Blind MethodDyslipidemiasFemaleHumansLipoprotein(a)MaleMiddle AgedPeripheral Arterial DiseaseProprotein Convertase 9alirocumabAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsBiomarkersCholesterol, LDLLipoprotein(a)LPA protein, humanPCSK9 InhibitorsPCSK9 protein, humanProprotein Convertase 9Serine Proteinase Inhibitorsacute coronary syndromelipoprotein(a)low-density lipoproteinsperipheral artery diseaseproprotein convertase subtilisin/kexin type 9venous thromboembolism

Identifiers

PMID32223446
PMCPMC7242174
OpenAlexW3013898768

What OpenQuestion holds

Texttitle and abstract
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.