AβYSS: Beta Blocker Interruption After Uncomplicated Myocardial Infarction
Study Details
Study Description
Brief Summary
ABYSS is a national, multicenter, randomised, open label trial using the PROBE study design, that will evaluate the non-inferiority of the interruption of ΒB therapy after an uncomplicated MI after six months or more of follow-up compared to the continuation of βB evaluated by the primary endpoint or death, MI, Stroke and rehospitalization for others cardiovascular reasons.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Despite the outstanding progress made in cardiac care over the last few years, cardiovascular diseases remain the leading cause of morbidity and mortality in developed countries.
After the initial clinical event, patients are considered to have a chronic disease which combined with the increasing actual life expectancy patients with CAD are a major source of expenses due to their life-long treatment and follow-up.
ΒB are prescribed during the initial hospitalisation for MI and in the post-MI phase. European (European Society of Cardiology, ESC) and American (ACC/AHA) guidelines initially gave βB therapy a class I recommendation for MI or acute coronary syndrome (ACS) for the first year of treatment and extended such recommendation without solid data up to 3 years after MI , . However, there has been no recent clinical trial to evaluate safety and efficacy of long term ΒB therapy in the contemporary therapeutic era. Taking such lack of evidence in account and acknowledging that clinical practice has changed, the latest ESC STEMI (2014) and NSTEMI (2015) Guidelines degraded the recommendation for the use of ΒB in post MI patients (Class IIa B) during the hospitalization period and they question the validity of its use after the initial stabilization phase. This was confirmed in the 2017 STEMI Guidelines.
The primary objective of the ABYSS trial is to demonstrate the non-inferiority of the interruption of ΒB therapy after an uncomplicated MI after six months or more of follow-up compared to the continuation of βB evaluated by the primary endpoint.
The primary endpoint of the study will be evaluated, with one-year minimum follow-up, and will be the composite of Major Adverse Cardiovascular Events (MACE) measured at the longest follow-up including:
-
All-cause death
-
Stroke
-
Myocardial infarction Hospitalisation for other cardiovascular (CV) reason.
It is expected that the interruption of βB therapy will not alter the prognosis of patients and improve safety and quality of life of patients and considerably reduce healthcare direct or indirect costs.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Discontinuation of the Betablockers (βB) 1850 post-MI patients treated with chronic βB treatment will undergo withdrawal of their βB treatment.. |
Drug: Beta-blockers withdrawal
withdrawal of all type of betablockers
|
| Active Comparator: Continuation of the Betablockers (βB) 1850 post-MI patients treated with chronic βB treatment will be continued under their usual βB treatment without modification. |
Drug: Continuation of the Betablockers (βB) treatment
Use Betablockers treatment
|
Outcome Measures
Primary Outcome Measures
- The composite of Major Adverse Cardiovascular Events (MACE) [up to 48 months]
including: All-cause death Stroke Myocardial infarction Hospitalisation for other cardiovascular (CV) reason
Secondary Outcome Measures
- All individual parameters of MACE [up to 48 months]
All cause death Heart Failure Arrythmia = Ventricular or Supra-Ventricular Tachycardia Syncope, Conduction disorders or PaceMaker Implantation High Blood Pressure
- Stroke [up to 48 months]
Stroke
- Myocardial Infarction (MI) (Classified by type of MI, including Stent Thrombosis) [up to 48 months]
Myocardial Infarction (MI) (Classified by type of MI, including Stent Thrombosis)
- Hospitalisation for other CV reason [up to 48 months]
Angina, Recurrent ischemia, Coronary Angiography or Coronary; Revascularisation outside of the scope of an MI; Heart Failure; Arrythmia = Ventricular or Supra-Ventricular Tachycardia; Syncope, Conduction disorders or PaceMaker Implantation; High Blood Pressure;
Other Outcome Measures
- Cardiovascular death [up to 48 months]
Cardiovascular death
- Syncope/dizziness requiring a consultation or a hospitalisation. [up to 48 months]
Syncope/dizziness requiring a consultation or a hospitalisation.
- Invasive procedures (catheterisation, percutaneous coronary intervention (PCI), pace-maker or automatic defibrillator implantation, endoscopy…) [up to 48 months]
Invasive procedures (catheterisation, percutaneous coronary intervention
- Angina control [up to 48 months]
Angina control measured by the CCS grading scale
- Heart Rate Control [first year only]
Heart Rate Control by Cardiac Frequency during visit
- Blood Pressure Control [first year only]
Blood Pressure Control by Blood pressure during visit)
- An Episode of Heart failure [up to 48 months]
An Episode of Heart failure (consultation or Hospitalisation)
- The quality of life (QoL) [up to 12 months]
will be evaluated in every patient by using the questionnaire EQ5D-5L(range 0-1, higher=better health).
- The composite of: [up to 48 months]
Any Death and MI CV death, MI, and stroke. CV death, MI, and urgent coronary revascularisation. CV death, MI, and recurrent ischemia requiring hospitalisation (with or without revascularisation).
- Anxiety [up to12 months]
by using the HADS questionnaire to detect the presence of depression and anxiety ( there is no score; this will be determined by the response selected by the patient with "no" = no discomfort to "a lot" = significant discomfort
- Erection Dysfunction [up to 12 months]
by using the questionnaire IIEF (International Index of Erectile Function) with 5 questions whose answer is graded from 0 to 5 per question
- Exercise Capacity [up to 12 months]
by the volume of weekly physical activity
- Exercise Capacity [up to 12 months]
by the sport practiced
- Exercise Capacity [up to 12 months]
by the participation in competitions or not
- Exercise Capacity [up to 12 months]
by the results of stress tests when available
- Libido [up to 12 months]
by the degree of sex drive (self evaluation)
- Libido [up to 12 months]
by the frequency of sex drive (self evaluation)
- Side effects [up to 12 months]
by the presence of Blury Vision
- Side effects [up to 12 months]
by the presence of sensation of cold hands and feets
- Side effects [up to 12 months]
by presence of Insomnia
- Side effects [up to 12 months]
by presence of palpitations
Eligibility Criteria
Criteria
Inclusion criteria
Subjects meeting all of the following criteria will be considered for enrolment into the study:
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Male or female +/=18 years of age
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Current treatment with βB whatever the drug or the dose used
-
Prior acute myocardial infarction 6 months or more before randomisation defined either by:
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-
An episode of ST elevation MI with ST segment elevation (STEMI) and/or the presence of Q wave (Type I MI)
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an episode of Non ST Elevation MI (NSTEMI) with preferably at least one of the followings:
-
- a documented hypokinetic or akinetic segment on echo or any other imaging technique
-
- segmental hypoperfusion Thallium or any other imaging technique
-
- segmental aspect of necrosis on MRI
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An episode of silent MI discovered on ECG or Cardiac Imaging. Importantly = The mention of an MI on a report is enough to be considered as a prior MI and it is not necessary to retrieve the source document and/or documentation of this prior MI .
-
Patient affiliated to Social Security
-
Informed consent obtained in writing at enrolment into the study
Exclusion Criteria:
- Subjects presenting with any of the following will not be included in the study:
-
Uncontrolled arterial hypertension according to investigator decision
-
Prior episode of heart failure in the past two years of follow-up and/or low left ventricular ejection fraction <40% requiring the use of βB;
-
New ACS (in the past 6 months) including UA/NSTEMI and STEMI;
-
Persistent angina or ischemia (>10% viable myocardium) requiring the use of βB;
-
Prior episode of ventricular or supraventricular arrhythmia in the past year of follow-up requiring the use of ΒB;
-
Treatment with other investigational agents or devices within the previous 30 days, or previous enrolment in this trial.
-
Pregnant Women or breast feeding women
-
Patient under legal protection (protection of the court, or in curatorship or guardianship).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institut de Cardiologie - USIC - Hôpital Pitié-Salpêtrière | Paris | France | 75013 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
- Groupe Hospitalier Pitie-Salpetriere
Investigators
- Study Chair: Johanne SILVAIN, MD-PhD, APHP / Institut de Cardiologie, Pitié-Salpêtrière Hospital, Paris (APHP) / ACTION Study Group / Sorbonne Université Paris-France
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P150946J