Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Comparison of the Long-term Effects on Mortality and Cardiovascular Morbidity of Percutaneous Coronary Intervention With Drug-eluting Stent Versus Bare-metal Stent. Randomized, Five-year Prospective, Multicenter Clinical Trial
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.


Options:
A: Arm Label: Drug Eluting Absorbable Metal Scaffold; Type: EXPERIMENTAL; Interventions: Device: Percutaneous Coronary Intervention (DREAMS) stenting | Intervention Type: DEVICE; Name: Percutaneous Coronary Intervention (DREAMS) stenting; Assigned to Arm(s): Drug Eluting Absorbable Metal Scaffold
B: Arm Label: Bare metal stent; Type: ACTIVE_COMPARATOR; Interventions: Device: Percutaneous coronary intervention (PCI) | Arm Label: Drug eluting stent; Type: EXPERIMENTAL; Interventions: Device: Percutaneous coronary intervention (PCI) | Intervention Type: DEVICE; Name: Percutaneous coronary intervention (PCI); Assigned to Arm(s): Bare metal stent | Intervention Type: DEVICE; Name: Percutaneous coronary intervention (PCI); Assigned to Arm(s): Drug eluting stent
C: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Device: Biolimus eluted from an erodable stent coating (Biomatrix) | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Device: bare-metal stent (Gazelle) | Intervention Type: DEVICE; Name: Biolimus eluted from an erodable stent coating (Biomatrix); Assigned to Arm(s): 1 | Intervention Type: DEVICE; Name: bare-metal stent (Gazelle); Assigned to Arm(s): 2
D: Arm Label: Everolimus-eluting stent; Type: ACTIVE_COMPARATOR; Interventions: Device: Everolimus-eluting stent | Arm Label: Bare-metal stent; Type: ACTIVE_COMPARATOR; Interventions: Device: Bare-metal stent | Arm Label: Biodegradable Polymer-DES; Type: EXPERIMENTAL; Interventions: Device: Biodegradable Polymer-DES | Intervention Type: DEVICE; Name: Everolimus-eluting stent; Assigned to Arm(s): Everolimus-eluting stent | Intervention Type: DEVICE; Name: Bare-metal stent; Assigned to Arm(s): Bare-metal stent | Intervention Type: DEVICE; Name: Biodegradable Polymer-DES; Assigned to Arm(s): Biodegradable Polymer-DES

Answer: B