Evidence map›Paper›PMID 15451146›Full record

Trial reportEuropean heart journal2004

Enoxaparin versus unfractionated heparin in patients treated with tirofiban, aspirin and an early conservative initial management strategy: results from the A phase of the A-to-Z trial.

James A de Lemos, Michael A Blazing, Stephen D Wiviott, William E Brady, Harvey D White, Keith A A Fox, Joanne Palmisano, Karen E Ramsey, David W Bilheimer, Eldrin F Lewis and 4 more

Registry-linked trialOpen access · bronzeAbstract readClinical TrialComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European heart journal, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00251576. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
4.7field-weighted citation impact, top 5% 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.

NCT00251576 phase3completed

A Multicenter, Randomized, Controlled, Double-Blind Trial to Investigate the Clinical Efficacy and Tolerability of Early Treatment With Simvastatin 40 mg Daily for 30 Days, Followed by Simvastatin 80 mg Daily Thereafter in Tirofiban-Treated Acute Coronary Syndrome Patients Who Have Been Randomized to Receive Enoxaparin or Unfractionated Heparin in Conjunction With Aspirin

Ran1999Enrolled4,497Registered outcomes2Posted comparisons0ConditionsAcute Coronary SyndromeArmsA-Phase: tirofiban; Z-Phase simvastatin, Comparator: A-Phase: low molecular weight heparin, unfractionated heparin, Duration of Treatment: A-Phase: low molecular weight heparin, 2 to 8 days; unfractionated heparin, minium suggested 48 hours, maximum 108 hours, Duration of Treatment: A-Phase: minimum suggested 48 hours, maximum suggested 108 hours. Z-Phase: 2 years, Duration of Treatment: Z-Phase, 2 years.
Open the trial in the graph
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 61 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Anticoagulant Therapy for Acute Coronary Syndromes.Interventional cardiology (London, England) · 2018
    Review
  4. Article
  5. Review
  6. Review
  7. Review
  8. Article
  9. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 7 institutions in 3 countries.

James A de LemosDonald W. Reynolds Cardiovascular Clinical Research Center, 5323 Harry Hines Blvd, Rm HA 9.133, UT Southwestern Medical Center, Dallas, TX 75390-9047, USA. james.delemos@utsouthwestern.edu
Michael A Blazing
Stephen D Wiviott
William E Brady
Harvey D White
Keith A A Fox
Joanne Palmisano
Karen E Ramsey
David W Bilheimer
Eldrin F Lewis
M Pfeffer
Robert M Califf
Eugene Braunwald
Investigators
Merck & Co., Inc., Rahway, NJ, USA (United States) · USBrigham and Women's Hospital · USDuke University · USGreenlane Clinical Centre · NZHarvard University Press · USThe University of Texas Southwestern Medical Center · USUniversity of Edinburgh · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsIn high risk patients with non-ST elevation acute coronary syndromes (ACS), enoxaparin is generally preferred to unfractionated heparin (UFH). However, less is known about the relative merits of these two forms of heparin in patients receiving concomitant glycoprotein IIb/IIIa inhibitors. METHODS AND

resultsThe A phase of the A-to-Z trial was an open label non-inferiority trial in which 3987 patients with non-ST elevation ACS were randomised to receive either enoxaparin or UFH in combination with aspirin and tirofiban. Inclusion required either ST depression or cardiac biomarker elevation. While the selection of an early management strategy (invasive or conservative) was at the discretion of the local investigator, investigators were asked to designate their plans for an invasive or conservative strategy on the case record form. An early conservative strategy was specified for 1778 patients (45%); this subgroup forms the population for the present analyses. Among patients with a planned conservative strategy, baseline characteristics were similar between those randomised to UFH (n = 872) and those randomised to enoxaparin (n = 906). The primary endpoint of death, new MI, or documented refractory ischaemia within 7 days of randomisation occurred in 10.6% of patients randomised to UFH and 7.7% of patients randomised to enoxaparin (HR 0.72; 95% CI 0.53-0.99; p = 0.04). The combined rate of TIMI major, minor, or loss no-site bleeding was 1.3% in patients treated with UFH and 1.8% in those treated with enoxaparin (p = ns).

conclusionsWhen a conservative approach to catheterisation and PCI was planned for ACS patients receiving tirofiban and aspirin, enoxaparin was associated with superior efficacy and similar bleeding vs UFH.

Indexed as

AspirinCoronary DiseaseDrug Therapy, CombinationEnoxaparinFemaleFibrinolytic AgentsHeparinHumansMaleMiddle AgedTirofibanTreatment OutcomeTyrosineAspirinEnoxaparinFibrinolytic AgentsHeparinTirofibanTyrosine

Identifiers

PMID15451146
OpenAlexW1984012923

What OpenQuestion holds

Textmetadata
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.