PCI Clinical Trial
Official title:
Assessment of Coagulation and Thrombocyte Function After Termination of Ticagrelor in Patients Who Have Previously Undergone PCI Procedures and Insertion of Coronary Stents
When ticagrelor should be discontinued prior to elective surgery is unclear. The risks of bleeding when it is continued peri-operatively have to be weighed against the risk of coronary artery thrombosis when stopped. This study aims to assess coagulation and thrombocyte function every other day in patients who are taking ticagrelor after coronary artery stents and discontinue therapy at the end of one year.
Patients who have an acute coronary syndrome are today often treated by percutaneous
coronary intervention (PCI) and insertion of one or several coronary stents. Subsequently,
these patients are treated with oral anti-platelet (OAP) drugs, usually a combination of
acetyl salicylic acid (aspirin) and clopidogrel/ticagrelor. Although aspirin is continued
for a life-long period, clopidogrel/ticagrelor are used for a variable period of time, often
from 3 months - 1 year after PCI, depending on the type of stent. Interventional elective
non-cardiac surgery during the time of clopidogrel/ticagrelor therapy is not recommended
except for life-threatening (acute surgery) or life-prolonging (cancer surgery) procedures.
Specifically for life-prolonging procedures, surgery can be planned, and therefore the
question often arises as to when OAPs should be terminated prior to planned surgery. This
decision rests on balancing the risks of bleeding (when continued) or coronary stent
thrombosis (when stopped). Certainly, because of the small risk of severe bleeding when
using aspirin, this drug should be continued throughout the perioperative period in patients
with coronary stents. However, continuing clopidogrel/ticagrelor is more controversial since
severe perioperative bleeding is difficult to reverse in these patients. Therefore, surgeons
would normally discontinue clopidogrel/ticagrelor prior to surgery, specifically when the
potential for bleeding is high, and the consequences major. The exact duration for which
these drugs should be discontinued remains unclear and, depending on the drug used, a period
of 3 - 5 days is generally recommended, based on the pharmacokinetics and dynamics of
clopidogrel/ticagrelor in otherwise healthy patients.
This study was done to better understand coagulation and thrombocyte function immediately
before discontinuation of ticagrelor and at regular intervals after termination, in patients
who have previously undergone PCI, have coronary stents, are taking ticagrelor but
discontinue it after one-year of therapy in accordance with hospital routines. No surgical
intervention was planned in these patients after termination of ticagrelor.
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Observational Model: Case-Only, Time Perspective: Prospective
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