Trial of Drug Eluting Stent Versus Bare Metal Stent to Treat Coronary Artery Stenosis

NCT00811772 | Completed DMC

• 3 other identifiers: 184916/V50 Res. council NorwayNSD19480PREKNORD40/2008
• Study Type: interventional
• Target: 9,013
• Locations: 1 country
• Sites: 8

Brief Summary

Stenosis of the coronary arteries may be treated by balloon dilatation followed by the implantation of a metal stent. However, restenosis occurs in 10-20% of patients treated with bare metal stents (BMS). Restenosis and treatment of restenosis is associated with risk of myocardial infarction (MI) and death. Drug eluting stents (DES)release drugs to the vessel wall that delay or inhibit the process of restenosis. Some reports have found that DES are associated with risk of acute stent thrombosis, MI and death. The precise magnitude of this risk is not known. Current evidence is therefore insufficient to balance the long-term risk and benefit of BMS vs DES. The purpose of this trial is to compare the long-term effects on MI and total mortality of BMS vs DES. The trial will recruit 8000 patients from 8 Norwegian hospitals. The patients will be randomized to treatment with BMS or DES. Clinical events will be registered for 5 years after treatment. The study hypothesis is that there is no difference in the risk of death or myocardial infarction after treatment with BMS vs DES. The trial is initiated and run by university researchers and is sponsored by not-for-profit organizations.

Conditions

Coronary Atherosclerosis; Angina Pectoris; Myocardial Infarction

Keywords

Randomized controlled trial; Bare metal stent; Drug eluting stent

Outcome Measures

Primary Outcomes (1)

• First occurrence of all-cause mortality and non-fatal myocardial infarction (composite)

  After five years of follow-up

Secondary Outcomes (2)

• Major cardiovascular events

  After five years of follow-up

• Health related quality of life

  After 6 months and then yearly for 5 years

Study Arms (2)

Bare metal stent

ACTIVE COMPARATOR

Implantation of one or more bare metal stent(s) to to treat coronary artery stenosis

Device: Percutaneous coronary intervention (PCI)

Drug eluting stent

EXPERIMENTAL

Implantation of one or more drug eluting stent(s) to treat coronary artery stenosis

Device: Percutaneous coronary intervention (PCI)

Interventions

Percutaneous coronary intervention (PCI) DEVICE

Implantation of one or more bare metal stent(s)

Bare metal stent

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women \>18 years with stable angina pectoris or acute coronary syndrome
• The patient has consented to participate and has signed the patient informed consent form
• All lesions requiring intervention in one or more native coronary artery/coronary artery by-pass graft are amendable for implantation of drug-eluting stents only, or bare-metal stents only.
• The patient has a unique 11-digit Norwegian person number, is able to communicate in Norwegian, and is expected not to emigrate during study follow-up.

You may not qualify if:

• Previous implantation of a coronary bare metal stent or coronary drug eluting stent
• Planned intervention of a bifurcation lesion with overlapping 2-stent technique
• The patient has a serious medical condition (other than coronary artery disease) with a life expectancy less than 5 years
• The patient is currently participating in another randomized trial that clinically interferes with the present trial, or requires coronary angiography or other coronary artery imaging procedures
• Hypersensitivity or allergies to drugs or components in use with percutaneous coronary intervention
• Contraindications for treatment with clopidogrel/ticlid for 9-12 months
• Patient is receiving chronic anticoagulation therapy (e.g., warfarin, heparin)

Sponsors & Collaborators

• University of Tromso: lead
• The Research Council of Norway: collaborator
• The Royal Norwegian Ministry of Health: collaborator
• Norwegian Council on Cardiovascular diseases: collaborator

Study Sites (8)

Department of Medicine, Sørlandet sykehus Arendal

Arendal, N-4838, Norway

Location

Department of Heart Disease, Haukeland University Hospital

Bergen, N-5053 Bergen, Norway

Location

Department of Heart Disease, Feiringklinikken AS

Feiring, N-2093, Norway

Location

Department of Heart Disease, Rikshospitalet HF

Oslo, N-0027, Norway

Location

Department of Heart and Vascular Radiology and Department of Heart Disease, Ullevål University Hospital

Oslo, N-0450, Norway

Location

Department of Heart Disease, Stavanger University Hospital

Stavanger, N-4068, Norway

Location

Department of Heart Disease, University Hospital of Northern Norway

Tromsø, N-9038, Norway

Location

Department of Heart Disease, St.Olav University Hospital

Trondheim, N-7006, Norway

Location

Related Publications (3)

• Nordrehaug JE, Wiseth R, Bonaa KH. Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease. N Engl J Med. 2016 Dec 29;375(26):2604-2605. doi: 10.1056/NEJMc1613866. No abstract available.

  PMID: 28029911 BACKGROUND

• Bonaa KH, Mannsverk J, Wiseth R, Aaberge L, Myreng Y, Nygard O, Nilsen DW, Klow NE, Uchto M, Trovik T, Bendz B, Stavnes S, Bjornerheim R, Larsen AI, Slette M, Steigen T, Jakobsen OJ, Bleie O, Fossum E, Hanssen TA, Dahl-Eriksen O, Njolstad I, Rasmussen K, Wilsgaard T, Nordrehaug JE; NORSTENT Investigators. Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease. N Engl J Med. 2016 Sep 29;375(13):1242-52. doi: 10.1056/NEJMoa1607991. Epub 2016 Aug 29.

  PMID: 27572953 RESULT

• Samuelsen PJ, Eggen AE, Steigen T, Wilsgaard T, Kristensen A, Skogsholm A, Holme E, van den Heuvel C, Nordrehaug JE, Bendz B, Nilsen DWT, Bonaa KH. Incidence and risk factors for major bleeding among patients undergoing percutaneous coronary intervention: Findings from the Norwegian Coronary Stent Trial (NORSTENT). PLoS One. 2021 Mar 4;16(3):e0247358. doi: 10.1371/journal.pone.0247358. eCollection 2021.

  PMID: 33661918 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Myocardial Infarction

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Kaare H Bønaa, MD, PhD

  Dept of Heart Disease, St.Olavs University Hospital, Trondheim, Norway; Norwegian University of Science and Technology, Trondheim, Norway; University of Tromsø, Tromsø, Norway

  PRINCIPAL INVESTIGATOR

• Jan E Nordrehaug, MD, PhD

  Department of Heart Disease, Haukeland University Hospital, Bergen, and University of Bergen, Bergen, Norway

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 19, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: December 24, 2018

Record last verified: 2018-12

Locations

NO (8)