Anti-thrombotic and Glucose Lowering Therapy in Diabetic Patients Undergoing PCI (ARTHEMIS)

Anti-thrombotic and Glucose loweRing THerapy in diabEtics With CAD Undergoing PCI: a Prospective Multicenter observatIonal Study on Their Use and Implications for Clinical Outcomes - The ARTHEMIS Registry

Diabetes mellitus (DM) is one of the main risk factors for ischemic events in patients with coronary artery disease (CAD) and diabetes is a factor in several post-PCI (Percutaneous Coronary Intervention) risk scores. However, until recently, there were almost no studies performed specifically in the diabetic population of patients undergoing PCI. This study aims to describe the anti-thrombotic regimens, clinical outcomes and current diabetes medical treatment in an unselected consecutive population of patients with DM undergoing PCI.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Heart Disease; Type2 Diabetes Mellitus
• Intervention / Treatment: Other: Exposure to Anti-thrombotic treatment agents and glucose lowering therapy

Detailed Description

Diabetes is one of the main risk factors for ischemic events in patients with coronary artery disease and diabetes is a factor in several post-PCI risk scores (including the commonly used DAPT score). However, until recently, there were almost no studies performed specifically in the diabetic population of patients undergoing PCI. At large, results from randomized trials assessing the duration of DAPT have produced conflicting results and there is uncertainty about the best anti-thrombotic strategy in patients with diabetes. Further assessment of the patterns of use and their clinical effects, including those related to prolonged DAPT is needed, in diabetic patients, especially in less selected "real world" populations.

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• Portugal
  • Braga, Portugal, 4710-243
    • Hospital de Braga, EPE
  • Coimbra, Portugal, 3000-075
    • Centro Hospitalar e Universitário de Coimbra - Hospital Geral & Hospital Universitário de Coimbra
  • Faro, Portugal, 8000-386
    • Centro Hospitalar Universitário do Algarve - Hospital de Faro
  • Porto, Portugal, 4099-001
    • Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio
  • Setúbal, Portugal, 2910-549
    • Centro Hospitalar de Setubal
  • Évora, Portugal, 7000-811
    • Hospital do Espírito Santo de Évora, EPE
  • Lisbon
    • Amadora, Lisbon, Portugal, 2720-276
      • Hospital Prof. Doutor Fernando Fonseca
    • Carnaxide, Lisbon, Portugal, 2790-134
      • Centro Hospitalar Lisboa Ocidental - Hospital de Santa Cruz
    • Lisboa, Lisbon, Portugal, 1159-064
      • Centro Hospitalar Lisboa Central - Hospital de Santa Marta
    • Lisboa, Lisbon, Portugal, 1649-035
      • Centro Hospitalar Universitário Lisboa Norte - Hospital De Santa Maria
  • Porto
    • Vila Nova De Gaia, Porto, Portugal, 4434-502
      • Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE
  • Setúbal
    • Almada, Setúbal, Portugal, 2805-267
      • Hospital Garcia de Orta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

1000 Type 2 Diabetes mellitus consecutive patients submitted to PCI in 12 interventional Cardiology Portuguese centers

Description

Inclusion Criteria:

• PCI with stent implantation, performed in at least one major coronary artery in the context of stable coronary artery disease or acute coronary syndrome
• Type 2 Diabetes mellitus (previously diagnosed or diagnosed at the index admission)
• Informed consent signed
• Patient not simultaneously participating in any interventional study

Exclusion Criteria:

• Patients with Type 1 Diabetes mellitus
• Patients whose survival is expected to be lower than 1 year at hospital discharge
• Patients not whiling to participate

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diabetic patients with CAD submitted to PCI; Individuals with type 2 Diabetes mellitus (previously diagnosed or diagnosed at index admission) submitted to PCI	Other: Exposure to Anti-thrombotic treatment agents and glucose lowering therapy; Exposure to Anti-thrombotic treatment agents and glucose lowering therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enumeration of the anti-thrombotic agents prescribed to patients		Baseline to 24 months follow-up
Planned duration of dual anti-platelet treatment (DAPT) after the PCI.		From index admission to 24 months follow-up
Adherence to anti-thrombotic regimen	Classified qualitatively according to the assessment of the attending physician.	6 to 24 months follow-up
Actual duration of DAPT (if different from the planned duration)		6 to 24 months follow-up
Reasons for interrupting DAPT at a time different from the planned duration		6 to 24 months follow-up
Reasons for prolonging DAPT over 1 year		12 to 24 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Coronary Events (MACE)	Major Adverse Coronary Events (MACE) (death from any cause, new spontaneous acute myocardial infarction, stroke).	6 to 24 months follow-up
Death rate from any cause		6 to 24 months follow-up
Rate of cardiovascular death		6 to 24 months follow-up
Rate of new spontaneous acute myocardial infarction		6 to 24 months follow-up
Rate of hospital admissions for acute coronary infarction		6 to 24 months follow-up
Rate of unplanned coronary revascularization		6 to 24 months follow-up
Rate of stroke/transient ischemic attack		6 to 24 months follow-up
Death rate from heart failure		6 to 24 months follow-up
Rate of hospital admission due to heart failure		6 to 24 months follow-up
Rate of bleeding events of type 3-5 of BARC (Bleeding Academic Research Consortium) scale	The BARC (Bleeding Academic Research Consortium) scale will be used. The minimum and maximum scores of the scale are, respectively, type 0 (no bleeding) and type 5 (fatal). There will only be collected the events corresponding to type 3-5 of BARC scale.	6 to 24 months follow-up
Rate of bleeding events of type 1-5 of BARC (Bleeding Academic Research Consortium) scale	The BARC (Bleeding Academic Research Consortium) scale will be used. The minimum and maximum scores of the scale are, respectively, type 0 (no bleeding) and type 5 (fatal). There will be collected the events corresponding to type 1-5 of BARC scale.	6 to 24 months follow-up
Percentage of patients treated with different glucose-lowering drugs.		Before index admission to 24 months follow-up.
Diabetes control (HbA1c values)		At baseline to 24 months follow-up

Collaborators and Investigators

• Sponsor: Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA
• Collaborators: AstraZeneca; Cardiovascular Centre of the University of Lisbon (CCUL)
• Investigators: Principal Investigator: Sérgio B Baptista, PhD, Cardiovascular Centre of the University of Lisbon (CCUL); Principal Investigator: Luís Raposo, MD, Hospital de Santa Cruz, CHLO, EPE, Lisbon, Portugal

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: June 26, 2020
• First Submitted That Met QC Criteria: July 20, 2020
• First Posted (Actual): July 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Dual Antiplatelet Therapy; PCI-Percutaneous Coronary Intervention; Anti-diabetic drugs
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CET.NIS2020.01; ESR-19-20188 (Other Grant/Funding Number: AstraZeneca)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No