CRAGS (Coronary aRtery diseAse in younG adultS)

Sponsor

University of Turku (Other)

Overall Status

Unknown status

CT.gov ID

NCT01838746

Collaborator

Finnish Foundation for Cardiovascular Research (Other)

2,000

Enrollment

Locations

Duration (Months)

222.2

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Acute Coronary Syndromes Young Patient Percutaneous Coronary Intervention Coronary Artery Bypass Grafting

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Patients Aged < 50 Years: a Multicenter Study

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Dec 1, 2014

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
PCI Patients undergoing PCI
CABG Patients undergoing CABG

Outcome Measures

Primary Outcome Measures

Repeat revascularization [Three years]
Any percutaneous coronary intervention or coronary artery bypass grafting after primary revascularization

Secondary Outcome Measures

All-cause mortality [Three years]
Major cardiovascular and cerebral events (MACCE) [Three years]
Stroke [Three years]
Myocardial infarction [Three years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age < 50

Exclusion Criteria:

age > 50

Contacts and Locations

Locations

	Site	City	Country
1	Oulu University Hospital	Oulu	Finland
2	Satakunta Central Hospital	Pori	Finland
3	Tampere University Hospital	Tampere	Finland
4	Turku University Hospital	Turku	Finland
5	Vaasa Central Hospital	Vaasa	Finland
6	University of Iceland	Reykjavik	Iceland
7	University of Catania	Catania	Italy
8	University of Verona Medical School	Verona	Italy
9	Sahlgrenska Hospital	Göteborg	Sweden