Sechs versus zwölf Monate einer Clopidogrel-Therapie nach Drug-Eluting-Stentimplantation bei Patienten mit akutem Koronarsyndrom: Eine Subgruppenanalyse der ISAR-SAFE-Studie

by Annabelle Bohling née Wolk
Doctoral thesis
Date of Examination:2023-08-02
Date of issue:2023-07-31
Advisor:Prof. Dr. Claudius Jacobshagen
Referee:Prof. Dr. Claudius Jacobshagen
Referee:Prof. Dr. Claudia Dellas
Persistent Address: http://dx.doi.org/10.53846/goediss-10025

 

 

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Abstract

English

The use of a dual antiplatelet therapy after coronary stenting to prevent a stent thrombosis is undisputable. Because of the higher bleeding risk, DAPT should only be used as long as lowering the ischemic complications outweighs the bleeding complications. The european and american guidelines empirically recommend a DAPT duration of 12 months after implantation of drug-elutig stents in patients presenting with an acute coronary syndrome. However, as for the lack of data, the optimal duration of DAPT remains unclear. This subgroup analysis of the ISAR-SAFE-trial aimed to show a non-inferiority of a 6 months DAPT (ASS plus Clopidogrel) versus 12 months. The comparison was made randomised, placebo-controlled, double-blind and multicentered based on a combined primary endpoint (death, myocardial infarction, stent thrombosis, stroke and major bleeding) within an observation period of 9 months. Between September 2006 and April 2014, a total of 1601 patients were randomised into two study groups (6 months (n=794) vs. 12 months (n=807)), which showed no significant differences in clinical or angiographic characteristics. The primary endpoint occured in 1,8% of patients within the 6-months group vs. 2,2% within the 12-months group. This result was statistically non-significant (p=0.60, hazard ratio 0.83, 95% confidence interval 0.41-1.68) and showed the non-inferiority of a shorter DAPT-duration. Both ischaemic and bleeding events were low beyond 6 months following intervention. In conclusion, the results of the ISAR-SAFE-ACS trial suggest, that a 6 months dual antiplatelet therapy can be a safe and efficient treatment strategy for patients with acute coronary syndrome after drug-eluting stenting.
Keywords: DAPT; Clopidogrel; cardiology; acute coronary syndrome
 
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