CRAGS (Coronary aRtery diseAse in younG adultS)

Coronary Artery Disease Clinical Trial

— CRAGS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01838746
• Other study ID #: CRAGS-1
• Status: Active, not recruiting
• Phase: N/A
• First received: April 16, 2013
• Last updated: May 27, 2015
• Start date: April 2013
• Est. completion date: December 2016

Study information

• Verified date: May 2015
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Valvira - National Supervisory Authority for Welfare and Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: December 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• age < 50

Exclusion Criteria:

• age > 50

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Coronary Artery Bypass Grafting
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Percutaneous Coronary Intervention
• Young Patient

Locations

Country	Name	City	State
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
Iceland	University of Iceland	Reykjavik
Italy	University of Catania	Catania
Italy	University of Verona Medical School	Verona
Sweden	Sahlgrenska Hospital	Göteborg

Sponsors (2)

Lead Sponsor	Collaborator
University of Turku	Finnish Foundation for Cardiovascular Research

Countries where clinical trial is conducted

Finland,  Iceland,  Italy,  Sweden, 

References & Publications (7)

Canver CC, Nichols RD, Cooler SD, Heisey DM, Murray EL, Kroncke GM. Influence of increasing age on long-term survival after coronary artery bypass grafting. Ann Thorac Surg. 1996 Oct;62(4):1123-7. — View Citation

Cole JH, Miller JI 3rd, Sperling LS, Weintraub WS. Long-term follow-up of coronary artery disease presenting in young adults. J Am Coll Cardiol. 2003 Feb 19;41(4):521-8. — View Citation

Ellis CJ, French JK, White HD, Ormiston JA, Whitlock RM, Webster MW. Results of percutaneous coronary angioplasty in patients <40 years of age. Am J Cardiol. 1998 Jul 15;82(2):135-9. — View Citation

Gunn J, Kuttila K, Vasques F, Virtanen R, Lahti A, Airaksinen J, Biancari F. Comparison of results of coronary artery bypass grafting versus percutaneous coronary intervention in octogenarians. Am J Cardiol. 2012 Oct 15;110(8):1125-9. doi: 10.1016/j.amjcard.2012.05.055. Epub 2012 Jul 3. — View Citation

Kappetein AP, Feldman TE, Mack MJ, Morice MC, Holmes DR, Ståhle E, Dawkins KD, Mohr FW, Serruys PW, Colombo A. Comparison of coronary bypass surgery with drug-eluting stenting for the treatment of left main and/or three-vessel disease: 3-year follow-up of the SYNTAX trial. Eur Heart J. 2011 Sep;32(17):2125-34. doi: 10.1093/eurheartj/ehr213. Epub 2011 Jun 22. — View Citation

Locker C, Schaff HV, Dearani JA, Joyce LD, Park SJ, Burkhart HM, Suri RM, Greason KL, Stulak JM, Li Z, Daly RC. Multiple arterial grafts improve late survival of patients undergoing coronary artery bypass graft surgery: analysis of 8622 patients with multivessel disease. Circulation. 2012 Aug 28;126(9):1023-30. doi: 10.1161/CIRCULATIONAHA.111.084624. Epub 2012 Jul 18. Review. — View Citation

Nissinen J, Wistbacka JO, Loponen P, Korpilahti K, Teittinen K, Virkkilä M, Tarkka M, Biancari F. Coronary artery bypass surgery in octogenarians: long-term outcome can be better than expected. Ann Thorac Surg. 2010 Apr;89(4):1119-24. doi: 10.1016/j.athoracsur.2009.12.063. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repeat revascularization	Any percutaneous coronary intervention or coronary artery bypass grafting after primary revascularization	Three years	Yes
Secondary	All-cause mortality		Three years	Yes
Secondary	Major cardiovascular and cerebral events (MACCE)		Three years	Yes
Secondary	Stroke		Three years	Yes
Secondary	Myocardial infarction		Three years	Yes