Prof. Antoine Lafont,
In 2006, the issue of safety of DES was deeply questioned, with reports on over-mortality and very late DES thrombosis. This has led to a huge work in order to find common definitions of DES thrombosis in order to compare stents, and evaluate clinical trials and registries.
Virmani showed the occurrence of thrombosis in arteries in which healing did not occur (struts in the lumen) more than one year after deployment. She insisted on the thrombosis protection by neointimal hyperplasia, advocating for some late loss. Basically less than 50% of the DES were reendothelialised after more than 40 months whereas BMS were endothelialised at 6 months. She showed occurrence of atherogenesis within DES. She underlined the DES thrombosis when used during STEMI. Pocock defined the rules of methodology regarding safety, efficacy, and use of meta analysis. Clinical endpoints must not be replaced by surrogate end points and major adverse events must distinguish hard (acute MI, death) from soft (revascularisation, restenosis) endpoints. Lefevre showed several trials about to be published without confirmation regarding overmortality with DES. In particular the SCAAR trial did not confirm the overmortality with any DES. Late thrombosis occurs, but the amplitude of the threat is not confirmed at this stage. Simoons gives strong recommendations on behalf of the ESC in order to avoid misunderstanding of the delivered message. Basically, he blames errors in misinterpretation, misuse of the raw data, leading to contradictory metaanalysis even published by prestigious journals which increases the lack of guidance. All data should be available for an independent academic analysis.
Safety of Drug-eluting-stents: 1 year after Barcelona
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