BACKGROUND

- Limited efficacy data on contemporary drug-eluting stents (DES) vs new bare-

metal stents (BMS)
- This study sets to compare effects of DES vs BMS
METHODS
- Multicentre, randomised trial conducted at all eight centres in Norway performing PCI
all patients undergoing PCI between September 15, 2008 and February 14, 2011
evaluated
- Inclusion:
- >18 y.o.
- P/w stable angina or an ACS
- Lesions in native coronary arteries or coronary-artery grafts (amenable for
implantation of either DES or BMS)
- Exclusion:
- Previously treated w/ a coronary stent
- Bifurcation lesion requiring treatment w/ a two-stent technique
- Serious medical condition other than CAD w/ life expectancy <5 years
- Participating in other randomised trial
- Intolerable SEs to any drug in use/CIs to long-term DAPT/prescribed warfarin
METHODS
- Randomly assigned 9013 patients with stable or unstable CAD to undergo PCI
with the implantation of either contemporary DES or BMS
- 1:1 ratio
- Assignment schedule based on computer-generated random numbers
- Patients, operators, and clinicians providing clinical care were aware of the type
of stent being placed
- DES group: 96% of patients received either everolimus- or zotarolimus-eluting
stents
- All patients prescribed aspirin 75mg OD indefinitely and clopidogrel 75mg for
9/12 after procedure regardless of assignment or indication for PCI
OUTCOMES
- Primary outcome composite of death from any cause and nonfatal spontaneous
myocardial infarction at median follow-up of 5 years
- Secondary outcomes:
- Subcategories of death
- Fatal and nonfatal spontaneous and periprocedural myocardial infarction and
stroke
- Hospitalisation for unstable angina pectoris
- Revascularisation of a target lesion, target vessel, or nontarget vessel w/ PCI or
coronary artery bypass grafting
- Definite stent thrombosis
- Major bleeding episodes
- Health-related quality of life
DISCUSSION
- Overall:
- Significantly lower rate of restenosis w/ DES compared w/ BMS min lumen diameter
2.37 +/- 0.63mm vs 1.84 +/- 0.62mm, p<0.001)
- Lower rates of binary restenosis 1.9% vs 16.7% (p=0.01)
- Significant reduction in target vessel revascularisation w/ DES at 2 years (4% vs
10.4%, p=0.009)
- Stable across subgroups by clinical presentation
- Size and length trial has statistical power to consider clinical outcomes
- Good evidence supporting the current preference for DES
- However:
- No overall difference in rates of mortality or myocardial infarction
- Open to all presentations not specific to any population
- Stringent exclusion criteria - ?representative of a relatively less complex or less
comorbid population who might be expected to have a better outcome
- Largest reduction of eligible patients due to previous stent (approx. 49% of all)
DISCUSSION
- Current generation of DES does not appear to have an increased risk of stent
thrombosis compared to BMS where the aim is for 9/12-1 year of DAPT following
PCI
- Pts w/ clear risk of life-threatening bleeding - ?BMS (as more clinical experience
in stopping the second antiplatelet agent early)
- Number needed to benefit = 30, in DES vs BMS to prevent one additional target
vessel revascularisation in 6 years
- Number needed to benefit = 250, for DES vs BMS to prevent one additional
definite re-stenosis
- May need to be taken in consideration in public health policy - ?costs vs benefits
DISCUSSION
- Unfortunately no subgroup analysis between angina vs myocardial infarction in
survival
DISCUSSION
- Also, no significant difference in QOL
- However questionnaires are not perfect/may
CONCLUSION
- NORSTAT suggests NO significant difference in mortality between BMS vs DES
- BUT, decrease in revascularisation and stent stenosis events with DES arm
- Supports use of DES, due to prevention of further re-vascularisations
- Generally, most cases will continue to use DES