January 27, 2023

CARDIOLOGY LANDMARK TRIALS AUGUSTUS PCI AFIB APIXABAN NIK NIKAM MD

Hello ladies and gentlemen welcome to triple in media i am dr. nick nickim a cardiologist from houston texas welcome to cardiology landmark trials in this presentation we are going to be looking at the augustus trial this trial was based on antithrombotic therapy in patients who are undergoing percutaneous interventions in the setting of an acute coronary syndrome

And atrial fibrillation as you’re very well aware of atrial fibrillation poses a great challenge in terms of managing antithrombotic therapy in patients with ischemic heart disease who have undergone coronary interventions who also need to be on antiplatelet agents the antithrombotic agents that we use for preventing blood clot formation and employ in patients

With atrial fibrillation doesn’t work that well in preventing thrombosis on the arterial side while at the same time the agents that we use like p2y 12 or aspirin in patients with pci does not very well protect people from getting deep venous thrombosis or or intravascular thrombosis leading to embolization in order to address this there are several studies

That have been done in the past first one looked at warfarin and antiplatelet agents in the host study wo est trial there was another study looking at the rivaroxaban with antiplatelet agents in pioneer a fib pci triumph the third study involved dagobert wrong with antiplatelet agents in re do pci trial and in all these patients there was a challenge of atrial

Fibrillation in the presence of ischemic heart disease where these patients had undergone pci this trial looked at a pack seban and its effectiveness in treating patients with atrial fibrillation in the presence of coronary intervention where they require antiplatelet agents this was a multicenter 2×2 factorial randomized controlled trial involving more than 33

Countries they were divided they actually into two main groups namely the population receiving a pac seban and the population receiving vitamin k antagonists and all these patients received it p2y twelve inhibitors in 92 percent of these patients they received clopidogrel the blinded medications included aspirin and placebo there was a total of four thousand six

Hundred and fourteen patients the study duration was a 180 days or six months the mean age of this population was seventy eight point seven years with 29 percent of them being female 36 percent of these patients had diabetes and all these patients had undergone recent coronary intervention and all these patients all these patients were on p2y two inhibitors and as

I said 92 percent of the time they were receiving critical 75 milligrams daily there were several main objectives in the study the first one was to see that maximum was non inferior to warfarin in terms of treating patients with atrial fibrillation in the presence of coronary artery disease the second point was to see if there was any p reality of packs bam whoa

Whoa vitamin k inhibitors in patients with pci with atrial fibrillation the groups were divided into two main groups namely pax bam and vitamin k there were twenty three hundred and six patients in the packs of m group twenty three hundred and eight patients in the vitamin k antagonist group this has to be assigned since patients receiving vitamin k antagonists

Had to have blood tests and to maintain an inr between two and three they were further blindly divided into two groups this is after the fact they received aspirin or placebo this group received aspirin or placebo which was blinded during the study now let’s look at some of the exclusion criteria those patients who had mechanical heart valves those people who are on

Anticoagulation for deep venous thrombosis or mitral stenosis with those patients who had intracranial hemorrhage patients with renal insufficiency patient who had been planned to undergo a coronary artery bypass surgery those patients who had coagulopathy or there were contraindications to the study medications 92% of them were white the creatinine level was 1.5

In about eight percent of the patients of course chad s vast score was 4.0 stroke transient ischemic attacks and thromboembolic events were noted in 14% of the patients as i said 92 percent of these patients received a clopidogrel acute coronary syndrome as a qualifying event was noted in two-thirds of the patients and the pro time in the therapeutic range in the

Patients who were receiving the vitamin k antagonists was in the range of 59% 59% had an inr reputed range between two and three and here are the results primary outcomes vitamin k antagonists and packs of em a packs been clearly showed there was a significant decrease in major bleeding compared to white amin k antagonists with a p-value of 0.01 for non-inferiority

And a p-value of 0.001 for superiority obviously hexa ban was superior to vitamin k in this patient population in terms of reducing major bleeding complications and here looking at aspen versus a placebo in terms of breeding obviously placebo had a significantly lower incidence of major bleeding compared to the aspirin group and the p-value of 0.001 and when you

Look at all these four different groups vitamin k and aspirin had the highest rate of complications namely bleeding hospitalizations and death compared to a pac seban with placebo which had the lowest incidence of complications so there is a clear dichotomy between these two groups the pac seban along with a p2 whitewell inhibitor and placebo had a much better

Outcome compared to those patients who were treated with the p2 whitewell inhibitor along with the vitamin k antagonists and aspirin this is where the risk was now let’s look at death and hospitalizations there was a modest decrease in the number of deaths and hospitalizations among the packs of m compared to the vitamin k antagonist group similarly in the aspen

And placebo group their death and hospitalizations there was a modest reduction in the placebo group compared to the aspen group so in terms of bleeding in terms of mortality and hospitalizations aspen proved to be more risky than the placebo and when death and hospitalizations were looked at again a pac seban and placebo had the lowest incidence compared to

Vitamin k antagonists and aspirin strength thrombosis was noted in 1.6 percent of the group 80% of them happening within the 30-day duration in conclusion aspirin in the first 30 days in the aspirin treated group in the first 30 days there was increased bleeding with a slight reduction in severe ischemic events whereas beyond 30 days there was more incidence of

Bleeding with aspirin compared with placebo and the incidence of ischemic events was not much different as far as a pac seban is concerned in patients undergoing pci the packs ban along with the p2y 2 inhibitor resulted in lower bleeding compared to those patients receiving p 2 y 2 with vitamin k and aspirin and it also reduced death and hospitalizations so ladies

And gentlemen thank you so much for watching this presentation and please stay tuned for other cardiology landmark trials on our youtube channel and please do subscribe to our youtube channel and we will see you next time thank you

Transcribed from video
CARDIOLOGY LANDMARK TRIALS AUGUSTUS PCI AFIB APIXABAN NIK NIKAM MD By Dr. Nik Nikam