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CRAGS (Coronary aRtery diseAse in younG adultS) (CRAGS)

27. mai 2015 oppdatert av: Fausto Biancari, MD, University of Turku

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

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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Forventet)

2000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Oulu, Finland
        • Oulu University Hospital
      • Pori, Finland
        • Satakunta Central Hospital
      • Tampere, Finland
        • Tampere University Hospital
      • Turku, Finland
        • Turku University Hospital
      • Vaasa, Finland
        • Vaasa Central Hospital
      • Reykjavik, Island
        • University of Iceland
      • Catania, Italia
        • University of Catania
      • Verona, Italia
        • University of Verona Medical School
      • Göteborg, Sverige
        • Sahlgrenska Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 50 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

Inclusion Criteria:

- age < 50

Exclusion Criteria:

  • age > 50

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
PCI
Patients undergoing PCI
CABG
Patients undergoing CABG

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Repeat revascularization
Tidsramme: Three years
Any percutaneous coronary intervention or coronary artery bypass grafting after primary revascularization
Three years

Sekundære resultatmål

Resultatmål
Tidsramme
Dødelighet av alle årsaker
Tidsramme: Tre år
Tre år
Major cardiovascular and cerebral events (MACCE)
Tidsramme: Three years
Three years
Stroke
Tidsramme: Three years
Three years
Myocardial infarction
Tidsramme: Three years
Three years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Fausto Biancari, MD, PhD, Oulu University Hospital
  • Studiestol: Juhani Airaksinen, MD, PhD, Turku University Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2013

Primær fullføring (Faktiske)

1. desember 2014

Studiet fullført (Forventet)

1. desember 2016

Datoer for studieregistrering

Først innsendt

16. april 2013

Først innsendt som oppfylte QC-kriteriene

20. april 2013

Først lagt ut (Anslag)

24. april 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

28. mai 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. mai 2015

Sist bekreftet

1. mai 2015

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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