CRAGS (Coronary aRtery diseAse in younG adultS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Finnish Foundation for Cardiovascular Research
Information provided by (Responsible Party):
Fausto Biancari, MD, University of Turku
ClinicalTrials.gov Identifier:
NCT01838746
First received: April 16, 2013
Last updated: April 20, 2013
Last verified: April 2013
  Purpose

Young patients requiring myocardial revascularization are generally considered at low operative risk, but data on their immediate and late outcome are scarce. The decision-making process in these young patients is complicated by the potentially aggressive nature of premature coronary artery disease and their likely long expectancy of life, which expose them to a significantly higher risk of recurrent coronary events as well as the need of repeat revascularization. The lack of data on long-term outcome as well as on operative details (in particular, on the use of arterial grafts) and peri- and postoperative medication prevent any conclusive results on the durability either of coronary artery bypass grafting (CABG) or of percutaneous coronary intervention (PCI) in these young patients. Furthermore, recent advances in stents technology as well in peri- and postoperative medical treatment indicate the need a comparative study to define the baseline characteristics of patients aged < 50 years undergoing either PCI or CABG and to evaluate their current immediate and late outcome.


Condition
Coronary Artery Disease
Acute Coronary Syndromes
Young Patient
Percutaneous Coronary Intervention
Coronary Artery Bypass Grafting

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Patients Aged < 50 Years: a Multicenter Study

Resource links provided by NLM:


Further study details as provided by University of Turku:

Primary Outcome Measures:
  • Repeat revascularization [ Time Frame: Three years ] [ Designated as safety issue: Yes ]
    Any percutaneous coronary intervention or coronary artery bypass grafting after primary revascularization


Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: Three years ] [ Designated as safety issue: Yes ]
  • Major cardiovascular and cerebral events (MACCE) [ Time Frame: Three years ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: Three years ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: Three years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2000
Study Start Date: April 2013
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
PCI
Patients undergoing PCI
CABG
Patients undergoing CABG

Detailed Description:

Age is, without any doubt, one of the most important risk factors for adverse events after any cardiovascular procedure and because of this it is incorporated in all major risk scoring methods. There is abundant literature dealing with the outcome of elderly patients undergoing cardiovascular procedures as their operative risk is significantly increased and preoperative risk assessment is of great importance in the decision-making process of these fragile patients (1). In the very elderly patients percutaneous coronary intervention (PCI) is an attractive treatment method, particularly in those with multiple comorbidities (2). On the other hand, coronary artery bypass grafting (CABG) has been shown to be a durable procedure also among octogenarians (2).

Young patients requiring myocardial revascularization are generally considered at low operative risk, but data on their immediate and late outcome are scarce. However, the decision-making process in these young patients is complicated by the potentially aggressive nature of premature coronary artery disease and their likely long expectancy of life, which expose them to a significantly higher risk of recurrent coronary events as well as the need of repeat revascularization. CABG seems to more durable compared with percutaneous coronary intervention (3), particularly because of excellent late results with the use arterial grafts (4). Therefore, young patients with diffuse coronary artery diffuse may likely benefit of surgical revascularization. However, no formal comparative analysis of these two treatment methods has been previously performed in this young patient population. Since CABG is a major procedure with a potential risk of operative mortality and major morbidity, this is an argument against surgical revascularization, even if recent pooled data showed that it can be performed with an exceedingly low mortality risk (0.9%) (Biancari et al. submitted, Fig. 1).

Such a low postoperative mortality rate is similar to that reported by Khawaja et al. (5) in patients aged ≤ 50 years treated by PCI (0.86%). However, PCI was performed in 41% of these patients with single vessel coronary artery disease. This is likely to significantly differ from surgical series (6).

Only two studies evaluated the outcome after CABG in patients aged < 40 years (7) and < 50 years (8) and estimated a survival rate at 10 years of about 75%. A study by Ellis (9) addressed survival after PCI in 86 patients aged < 40 years and showed a 10-year survival rate of about 91%, but a significant number of patients underwent repeat PCI (37%) and/or CABG (22%). These findings should be viewed in the light of the fact that most of patients did not have diffuse coronary artery disease (3-vessel disease was present in 11% of patients) and they were treated about two decades ago. Khawaja et al. (6) reported on 2922 patients aged ≤ 50 years who underwent percutaneous coronary intervention since 1979 and having a 5-year survival of about 95%. They reported repeat target revascularization rates ranging from 19% to 27% according to different study periods.

The lack of data on long-term outcome as well as on operative details (in particular, on the use of arterial grafts) and peri- and postoperative medication prevent any conclusive results on the durability either of CABG of PCI in these young patients. Furthermore, recent advances in stents technology as well in peri- and postoperative medical treatment indicate the need a comparative study to define the baseline characteristics of patients aged < 50 years undergoing either PCI or CABG and to evaluate their current immediate and late outcome.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients aged < 50 years who underwent CABG or PCI from 2005 to 2012 will be collected from multiple institutions.

Criteria

Inclusion Criteria:

- age < 50

Exclusion Criteria:

  • age > 50
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01838746

Locations
Finland
Oulu University Hospital
Oulu, Finland
Satakunta Central Hospital
Pori, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
Vaasa Central Hospital
Vaasa, Finland
Iceland
University of Iceland
Reykjavik, Iceland
Italy
University of Catania
Catania, Italy
University of Verona Medical School
Verona, Italy
Sweden
Sahlgrenska Hospital
Göteborg, Sweden
Sponsors and Collaborators
University of Turku
Finnish Foundation for Cardiovascular Research
Investigators
Principal Investigator: Fausto Biancari, MD, PhD Oulu University Hospital
Study Chair: Juhani Airaksinen, MD, PhD Turku University Hospital
  More Information

Publications:

Responsible Party: Fausto Biancari, MD, MD, PhD, University of Turku
ClinicalTrials.gov Identifier: NCT01838746     History of Changes
Other Study ID Numbers: CRAGS-1
Study First Received: April 16, 2013
Last Updated: April 20, 2013
Health Authority: Finland: Valvira - National Supervisory Authority for Welfare and Health

Keywords provided by University of Turku:
Percutaneous coronary intervention
Coronary artery bypass grafting
Coronary artery bypass surgery
Survival
Acute coronary syndrome
ST segment elevation myocardial infarction
Non-ST segment elevation myocardial infarction
Younge patient

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014