Long-Term Safety of Drug Eluting Stents in the "Real World" (FReIburger STent Registry)

NCT00905008 | Unknown DMC

• 1 other identifier: FRIST_GH0102
• Study Type: observational
• Target: 1,502
• Locations: 0 countries
• Sites: N/A

Brief Summary

The FReIburger STent Registry (FRIST) is designed to determine the long term safety and efficacy of Drug Eluting Stents (DES) in a "real-world" patient population requiring stent implantation. FRIST included patients treated with DES and bare-metal stents (BMS) in the University Hospital of Freiburg, Germany, according to a non-restrictive inclusion criterion, in which virtually all consecutive patient subsets were considered eligible.

Conditions

Stent Thrombosis

Keywords

drug-eluting stent; bare-metal stent; long-term safety; mortality; stent thrombosis; Angioplasty; Transluminal; Percutaneous Coronary

Outcome Measures

Primary Outcomes (1)

• All cause mortality (cardiac- and non-cardiac death).

  5 years

Secondary Outcomes (2)

• The composite of death and MI and stent thrombosis.

  5 years

• The occurrence of TVR, stroke, major bleeding, sepsis and tumor were also assessed.

  5 years

Study Arms (2)

DES

Patients underwent percutaneous coronary intervention and received at least one drug-eluting stent during their index hospitalisation.

Procedure: transluminal percutaneous coronary intervention; Device: Drug-Eluting and Bare-Metal stents

BMS

Patients underwent percutaneous coronary intervention and received at least one uncoated stent during their index hospitalisation.

Procedure: transluminal percutaneous coronary intervention; Device: Drug-Eluting and Bare-Metal stents

Interventions

transluminal percutaneous coronary intervention PROCEDURE

All interventions were done according to current practice guidelines. The operator was responsible for the decision to choose a specific treatment strategy. Angiographic success was defined as residual stenosis \<30% by visual analysis in the presence of TIMI 3 flow grade. The patients were prescribed aspirin plus clopidogrel 75 mg per day, after a loading dose of 300 mg or 600 mg, before or during the index coronary intervention. After procedure, all patients were advised to maintain lifelong use of aspirin. The use of clopidogrel (75 mg per day) was always adapted according to guideline recommendations. Heparin was infused throughout the procedure to maintain an activated clotting time of at least 250 sec. The administration of platelet glycoprotein IIb/IIIa receptor blocker was encouraged, unless in existing contraindications.

BMS; DES

Drug-Eluting and Bare-Metal stents DEVICE

Sirolimus-eluting stents (Cypher®), Paclitaxel-eluting stents (Taxus®) Zotarolimus-eluting stents (Endeavor®) and uncoated (bare-metal) stents

BMS; DES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

FRIST (FReIburger STent) is a single-centre, long-term stent registry in a high volume tertiary referral cardiovascular centre. FRIST included patients treated with drug-eluting stents and uncoated stents at the University Hospital of Freiburg, Germany, according to non-restrictive inclusion criterions, in which virtually all consecutive patient subsets were considered eligible.

You may qualify if:

• Consecutive patients undergoing percutaneous coronary intervention

You may not qualify if:

• Patient refusal or inability to provide written informed consent

Sponsors & Collaborators

• University Hospital Freiburg: lead

Related Publications (1)

• Kersting S, Grumann T, Hummel J, Hauschke D, Bode C, Hehrlein C. Impact of chronic kidney disease on long-term clinical outcomes after percutaneous coronary intervention with drug-eluting or bare-metal stents. Crit Pathw Cardiol. 2012 Sep;11(3):152-9. doi: 10.1097/HPC.0b013e31825d267a.

  PMID: 22825536 DERIVED

Study Officials

• Thorsten Grumann, MD

  University of Freiburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 15, 2009
• First Posted: May 20, 2009
• Study Start: October 1, 2006
• Primary Completion: May 1, 2009
• Last Updated: May 20, 2009

Record last verified: 2009-05