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Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial.

BACKGROUND: Everolimus-eluting and paclitaxel-eluting stents, compared with bare metal stents, reduced the risk of restenosis in clinical trials with strict inclusion and exclusion criteria. We compared the safety and efficacy of the second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice. METHODS: We randomly assigned 1800 consecutive patients (aged 18-85 years) undergoing percutaneous coronary intervention at one centre to treatment with everolimus-eluting or paclitaxel-eluting stents. The primary endpoint was a composite of safety and efficacy (all-cause mortality, myocardial infarction, and target vessel revascularisation) within 12 months. Patients were not told which stent they had been allocated. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT01016041. FINDINGS: Follow-up was completed in 1797 patients. The primary endpoint occurred in 56 (6%) of 897 patients in the everolimus-eluting stent group versus 82 (9%) of 903 in the paclitaxel-eluting stent group (relative risk 0.69 [95% CI 0.50-0.95], p value for superiority=0.02). The difference was attributable to a lower rate of stent thrombosis (6 [<1%] vs 23 [3%], 0.26 [0.11-0-64], p=0.002), myocardial infarction (25 [3%] vs 48 [5%], 0.52 [0.33-0.84], p=0.007), and target vessel revascularisation (21 [2%] vs 54 [6%], 0.39 [0.24-0.64], p=0.0001). Cardiac death, non-fatal myocardial infarction, or target lesion revascularisation occurred in 44 [5%] patients in the everolimus-eluting stent group versus 74 [8%] patients in the paclitaxel-eluting stent group, p value for superiority was 0.005. INTERPRETATION: The everolimus-eluting stent is better than the second generation paclitaxel-eluting stent in unselected patients in terms of safety and efficacy. On the basis of our results, we suggest that paclitaxel-eluting stents should no longer be used in everyday clinical practice. FUNDING: Unrestricted grants from Abbott Vascular and Boston Scientific.

Trial
Journal Ref. Kedhi E, Joesoef KS, McFadden E, Wassing J, van Mieghem C, Goedhart D, Smits PC: Lancet 2010, 375:201-209.
Intervention Drug - paclitaxel-eluting stents
Number of sites 1
Countries involved The Netherlands
Sample size 1800
Type of statistical analyses ITT
Risk of bias Overall: Low Risk details
Participant characteristics Age: 63.6 (55.7-72.9) Paclitaxel: 62.9 (55.4-71.1) Everolimus
Condition: coronary artery disease
Baseline severity: referral for emergent of elective PCI
Duration of trial 18 months: February 2007 to September 2008
Primary outcome All cause mortality - within 12 months
Effect Measures
Events Intervention Total Events Control Total Risk Diff.
74 903 44 897 3.29 %
Primary outcome: 56 (6%) of 897 patients in everolumus stent group vs 82 (9%) of 903 in the paclitaxel stent group Relative risk 0.69 p value for superiority=0.02. 2ndry outcome used in risk difference calculation is MACE
Show Score Ranges

Scores:

(shows median if more than one score was entered)

Elig. Recr. Setting Org. Int. Flex. Del. Flex. Adherence Follow-Up Prim. Out. Prim. An.
3 5 3 5 4 -1 2 4 5