Trial reportJAMA2018

Effect of Loading Dose of Atorvastatin Prior to Planned Percutaneous Coronary Intervention on Major Adverse Cardiovascular Events in Acute Coronary Syndrome: The SECURE-PCI Randomized Clinical Trial.

Otavio Berwanger, Eliana Vieira Santucci, Pedro Gabriel Melo de Barros E Silva, Isabella de Andrade Jesuíno, Lucas Petri Damiani, Lilian Mazza Barbosa, Renato Hideo Nakagawa Santos, Ligia Nasi Laranjeira, Flávia de Mattos Egydio, Juliana Aparecida Borges de Oliveira and 25 more

Erratum issued Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in JAMA, 2018. The graph read 2 numbers from its abstract, feeding 1 cell of the map: it finds no clear difference in 1. An erratum has been issued. It reports registered trial NCT01448642. Cited by 65 papers, 5 of them syntheses that pooled it.

2numbers the graph read from it
1cell of the map it votes in
65citing papers in PubMed, 5 pooled it
20.1field-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.

Ratios

← favours the treatmentfavours the comparator →
1 · no effect
Cardiovascular eventsno clear difference · against placebo · ascvd, dyslipidemiafeeds one cell of the map
HR 0.880.69 to 1.11P = .27
At 30 days, 130 patients in the atorvastatin group (6.2%) and 149 in the placebo group (7.1%) had a MACE (absolute difference, 0.85% [95% CI, -0.70% to 2.41%]; hazard ratio, 0.88; 95% CI, 0.69-1.11; P = .27).

Differences

← favours the treatmentfavours the comparator →
-0.702.410 · no effect
Cardiovascular eventsno clear difference · against placebo · ascvd, dyslipidemiafeeds one cell of the map
Δ 0.85-0.70 to 2.41P = .27
At 30 days, 130 patients in the atorvastatin group (6.2%) and 149 in the placebo group (7.1%) had a MACE (absolute difference, 0.85% [95% CI, -0.70% to 2.41%]; hazard ratio, 0.88; 95% CI, 0.69-1.11; P = .27).

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

Statins×cardiovascular events

InconclusiveOpen on the map →What to test next →

30 readable studies in this cell: 16 favour the treatment, 12 find no difference, 2 favour the comparator.

Belief with this paper
0.86replicated · 12 families support, 2 contradict · against placebo
Without it
0.86This paper does not move the number.
← favours the treatmentfavours the comparator →
1 · no effect
This paper4,191 enrolled · 2012
HR 0.880.69 to 1.11
HR 0.720.57 to 0.89
NCT023442907,769 enrolled · 2015
HR 0.640.48 to 0.84
HR 1.781.00 to 3.17
NCT03944512102 enrolled · 2019
RR 0.670.37 to 1.19
4 · 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.

NCT01448642 phase4completed

A Randomized, Multicenter Clinical Trial to Assess the Effect of Atorvastatin in Patients With Acute Coronary Syndrome and Intended Percutaneous Coronary Intervention

Ran2012Enrolled4,191Registered outcomes11Posted comparisons0ConditionsAcute Coronary SyndromeArmsAtorvastatin, Placebo
Open the trial in the graph
5 · Its place in the literature

Who cites it

65 citing papers in PubMed, 5 syntheses or guidelines pooled it, 132 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Efficacy Evaluation of High-Dose Atorvastatin Pretreatment in Patients with Acute Coronary Syndrome: A Meta-Analysis of Randomized Controlled Trials.Medical science monitor : international medical journal of experimental and clinical research · 2018
    Pooled it
  6. Trial
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  8. Trial
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  11. Review
  12. Review
  13. Article
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5 more citing papers are in PubMed but not listed here.

6 · The record

Corrections and comments

7 · Who and what money

Authors and funding

35 authors at 14 institutions in 2 countries.

Otavio BerwangerResearch Institute-Heart Hospital, São Paulo, Brazil.
Eliana Vieira SantucciResearch Institute-Heart Hospital, São Paulo, Brazil.
Pedro Gabriel Melo de Barros E SilvaResearch Institute-Heart Hospital, São Paulo, Brazil.
Isabella de Andrade JesuínoResearch Institute-Heart Hospital, São Paulo, Brazil.
Lucas Petri DamianiResearch Institute-Heart Hospital, São Paulo, Brazil.
Lilian Mazza BarbosaBrazilian Clinical Research Institute, São Paulo, Brazil.
Renato Hideo Nakagawa SantosResearch Institute-Heart Hospital, São Paulo, Brazil.
Ligia Nasi LaranjeiraResearch Institute-Heart Hospital, São Paulo, Brazil.
Flávia de Mattos EgydioBrazilian Clinical Research Institute, São Paulo, Brazil.
Juliana Aparecida Borges de OliveiraResearch Institute-Heart Hospital, São Paulo, Brazil.
Frederico Toledo Campo Dall OrtoHospital do Coração de Poços de Caldas, Poços de Caldas, Brazil.
Pedro Beraldo de AndradeSanta Casa de Marília, Marília, Brazil.
Igor Ribeiro de Castro BienertHospital das Clínicas da Faculdade de Medicina de Marília, Marília, Brazil.
Carlos Eduardo BossoSanta Casa de Presidente Prudente/Instituto do Coração de Presidente Prudente, Presidente Prudente, Brazil.
José Armando MangioneHospital São Francisco de Assis, Bragança Paulista, Brazil.
Carisi Anne PolanczykHospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Amanda Guerra de Moraes Rego SousaInstituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
Renato Abdala Karam KalilInstituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brazil.
Luciano de Moura SantosInstituto de Cardiologia do Distrito Federal, Brasília, Brazil.
Andrei Carvalho SpositoFaculdade de Ciências Médicas da Universidade Estadual de Campinas, Campinas, Brazil.
Rafael Luiz RechHospital Universitário de Canoas, Canoas, Brazil.
Antônio Carlos Sobral SousaHospital São Lucas, Aracaju, Brazil.
Felipe BaldisseraInstituto de Pesquisa e Estudos Médicos de Itajaí, Itajaí, Brazil.
Bruno Ramos NascimentoHospital Universitário Ciências Médicas, Belo Horizonte, Brazil.
Roberto Rocha Corrêa Veiga GiraldezInstituto do Coração, São Paulo, Brazil.
Alexandre Biasi CavalcantiResearch Institute-Heart Hospital, São Paulo, Brazil.
Sabrina Bernardez PereiraResearch Institute-Heart Hospital, São Paulo, Brazil.
Luiz Alberto MattosRede D'Or São Luiz, São Paulo, Brazil.
Luciana Vidal ArmaganijanBrazilian Clinical Research Institute, São Paulo, Brazil.
Hélio Penna GuimarãesResearch Institute-Heart Hospital, São Paulo, Brazil.
José Eduardo Moraes Rego SousaResearch Institute-Heart Hospital, São Paulo, Brazil.
John Hunter AlexanderDuke University Medical Center, Duke Clinical Research Institute, Durham, North Carolina.
Christopher Bull GrangerDuke University Medical Center, Duke Clinical Research Institute, Durham, North Carolina.
Renato Delascio LopesBrazilian Clinical Research Institute, São Paulo, Brazil.
SECURE-PCI Investigators
Hospital São Paulo · BRClinical Research Institute · USHospital do Coração · BRD’Or Institute for Research and Education · BRFaculdade de Ciências Médicas de Minas Gerais · BRFaculdade de Medicina de Marília · BRFundação Universitária de Cardiologia · BRHospital de Clínicas de Porto Alegre · BRHospital Regional de Presidente Prudente · BRHospital São Lucas da PUCRS · BRInstituto Dante Pazzanese de Cardiologia · BRInstituto de Cardiologia do Distrito Federal · BRSanta Casa de Misericórdia de Marília · BRUniversidade Estadual de Campinas (UNICAMP) · BR

Funding

No grant is acknowledged in the PubMed record.

8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

Importance: The effects of loading doses of statins on clinical outcomes in patients with acute coronary syndrome (ACS) and planned invasive management remain uncertain. Objective: To determine if periprocedural loading doses of atorvastatin decrease 30-day major adverse cardiovascular events (MACE) in patients with ACS and planned invasive management. Design, Setting, and Participants: Multicenter, double-blind, placebo-controlled, randomized clinical trial conducted at 53 sites in Brazil among 4191 patients with ACS evaluated with coronary angiography to proceed with a percutaneous coronary intervention (PCI) if anatomically feasible. Enrollment occurred between April 18, 2012, and October 6, 2017. Final follow-up for 30-day outcomes was on November 6, 2017. Interventions: Patients were randomized to receive 2 loading doses of 80 mg of atorvastatin (n = 2087) or matching placebo (n = 2104) before and 24 hours after a planned PCI. All patients received 40 mg of atorvastatin for 30 days starting 24 hours after the second dose of study medication. Main Outcomes and Measures: The primary outcome was MACE, defined as a composite of all-cause mortality, myocardial infarction, stroke, and unplanned coronary revascularization through 30 days. Results: Among the 4191 patients (mean age, 61.8 [SD, 11.5] years; 1085 women [25.9%]) enrolled, 4163 (99.3%) completed 30-day follow-up. A total of 2710 (64.7%) underwent PCI, 333 (8%) underwent coronary artery bypass graft surgery, and 1144 (27.3%) had exclusively medical management. At 30 days, 130 patients in the atorvastatin group (6.2%) and 149 in the placebo group (7.1%) had a MACE (absolute difference, 0.85% [95% CI, -0.70% to 2.41%]; hazard ratio, 0.88; 95% CI, 0.69-1.11; P = .27). No cases of hepatic failure were reported; 3 cases of rhabdomyolysis were reported in the placebo group (0.1%) and 0 in the atorvastatin group. Conclusions and Relevance: Among patients with ACS and planned invasive management with PCI, periprocedural loading doses of atorvastatin did not reduce the rate of MACE at 30 days. These findings do not support the routine use of loading doses of atorvastatin among unselected patients with ACS and intended invasive management. Trial Registration: clinicaltrials.gov Identifier: NCT01448642.

Indexed as

Percutaneous Coronary InterventionAcute Coronary SyndromeAgedAtorvastatinCardiovascular DiseasesDouble-Blind MethodFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsMaleMiddle AgedPreoperative CareST Elevation Myocardial InfarctionAtorvastatinHydroxymethylglutaryl-CoA Reductase Inhibitors

Identifiers

PMID29525821
PMCPMC5876881
OpenAlexW2790531075

What Socratic holds

Texttitle and abstract
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 Socratic graph.