A meta-analysis of first generation drug eluting stents - including both first generation drug eluting stent extent of both mortality and Q-wave Myocardial Infarction in comparison to bare metal stents. Here the presenter Edoardo Camenzind (Geneva, Switzerland) and the discussant Alain Nordmann (Basel, Switzerland) provide an overview of the results.
Introduction
First generation drug eluting stents (1stg-DES: sirolimus eluting stent [SES] have been widely accepted and are used for a large spectrum of clinical indications.
Recently case reports and autopsy reports have been published on single cases as well as on series of cases which experienced stent thrombosis more than 30 days after stent deployment, so called late stent thrombosis. Delayed healing and diminished antiplatelet therapy could be demonstrated as relevant precipitating factor.
The global incidence of ‘in-1st g-DES’ thrombosis according to the literature remains uncertain. According to some single center registries and post-marketing surveyance registries as well as meta-analysis the incidence of late angiographic stent thrombosis does not seem to be higher in 1st g-DES as compared to bare metal stents (BMS). However according to the recently presented BASKET-Late trial, a small randomized trial designed to evaluate cost effectiveness of 1st g-DES versus BMS, severe cardio-vascular events were significantly higher in patients with 1st g-DES as compared to BMS in the year following the interruption of dual antiplatelet therapy.
Methods
The current analysis embraced both 1st g-DES clinical programs (SES and PES) and included all available data concerning company supported randomized double-blind clinical trials comparing 1st g-DES to the respective BMS control. Of the SES program the following trials were included: RAVEL, SIRIUS, E-SIRIUS and C-SIRIUS and for the PES program: TAXUS II, IV, V and VI accounting for a total of n=878 SES vs n=870 BMS and n=1685 PES vs n=1675 BMS. Available randomized trials’ data within a specific study program (SES or PES) were stratified by trials and data of the same time-periods of follow-up were pooled as well as data of the latest available follow-up.
randomized trials’ data within a specific study program (SES or PES) were stratified by trials and data of the same time-periods of follow-up were pooled as well as data of the latest available follow-up.
The clinically oriented analysis focuses on death, Q-wave MI and death and Q-wave MI combined thought to reflect the incidence of stent thrombosis best instead of using restrictive thrombosis definitions (e.g. late angiographic stent thrombosis).
Results
The incidence - up to the latest available follow-up - of total mortality and Q-wave MI combined were 38% (SES) and 16% (PES) higher in 1st g-DES as compared to control BMS (p-value: SES vs BMS: 0.03 ; PES vs BMS. 0.68).
SAFETY OF DRUG-ELUTING STENTS: INSIGHTS FROM A META-ANALYSIS
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Conclusion
Death and Q-wave myocardial infarction have a higher incidence in 1st generation drug eluting stents as compared to the bare metal control stents.
Thus the indiscriminated use of 1st g-DES should be avoided and the use of bare metal stent may still be maintained awaiting for safer 2nd g-DES.