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Dr. Stefan Agewall,
View the Slides from this session in ESC Congress 365
The objective of this session was to understand some of the controversies surrounding clinical trials and to gain a better understanding of the issues.
Dr O. Frobert (Orebro,SE) discussed the results from the TASTE trial and why was it a negative study. The study was received with some skepticism. Because we can often see the result of a thrombus aspiration during a PCI procedure in STEMI patients and many cardiologists believe or have believed that it is obvious that this is a good treatment. Was the 30 day follow-up period too short? Was the number of patients to small? The study is the largest of its kind, with more than 7000 participants. But the death rate figures were quite low, which requires a very large number of patients to identify a small beneficial effect of thrombus aspiration. It is possible that a larger study with a longer follow-up period might have shown a beneficial effect of thrombus suction, but evidently thrombus aspiration in the short term period does not reduce mortality. The long-term results of the study will be presented on a hotline session later on during this congress.
Prof. Jean-Pierre Bassand ( Besançon France) reviewed the ATLAS II TIMI 51 study, which demonstrated a reduced mortality rate with the addition of rivaroxaban 2.5 mg BID to antiplatelet treatment, with an increased bleeding rate but not increased rate fatal bleedings after myocardial infarction. Others have shown increased thrombin generation after a myocardial infarction which makes the results reasonable, according to Prof. Bassand. The relative dose of rivaroxaban was considerable lower than the dose of apixaban in the negative Appraise study, which may explain the different outcomes between these studies.
Prof. Leonardo Bolognese (IT) discussed the ACCOAST trial and questioned the evidence for pretreatment with antiplatelet drug versus a loading dose at the time of PCI. Treatment times in NSTEMI populations have gradually become shorter and Professor Bolognese meant that reappraisal of routine pretreatment strategies in NSTEMI patients is needed. He concluded that prasugrel is a cath lab drug in NSTEMI patients.
Prof. Robert Califf ( Duke University, US) discussed if open trials have any value, focusing on the PRAMI study, which was an open study. In the rather small PRAMI study, preventive revacularization with PCI in STEMI patients reduced combined end-points compared to the only treating the culprit lesion. In an open study soft events like refractory angina pectoris may be difficult to interpret due to bias. A good example of the placebo effect was the old NIH cold study published in 1975. In the open study, C vitamin treatment dramatically decreased the cold period, whereas it had no effect at all in a similar double-blind study. Prof. Califf pointed out that open studies are important but the results should be evaluated carefully keeping bias and study design in mind.
Controversies in recent trials in acute coronary syndromes
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