- 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