Amid the controversy over the bleeding complications of anti-thrombotic drugs taken to treat acute myocardial infarction, local researchers have released a study that recommends adjusting the dose when treating Koreans.

Professor Park Seung-jung

Acute myocardial infarction is a disease in which the coronary artery surrounding the heart is completely blocked and causes necrosis in the heart muscles. Hospitals treat the illness with coronary artery bypass and provide anti-thrombotic drugs after the surgery to prevent the blood vessels from clogging again.

Recently developed anti-thrombotic drugs have proved to be effective and stable in large scale clinical studies in many countries, including the U.S. and Europe. However, there has been controversy in Korea as bleeding complications arose after using the same dose as Western countries.

To resolve the complications, the research team, led by Professor Park Seung-jung at Asan Medical Center, compared a year-long complication of 800 patients who received both conventional and new anti-thrombotic drugs after suffering from acute myocardial infarction at 10 cardiac centers in Korea from July 2014 to June 2017. Professor Kwon Oh-sung at Eunpyeong St. Mary’s Hospital also participated in the study.

The result showed the complication incidence rate was two times higher for patients who received new thrombotic drugs. The trial also revealed that the use of new anti-thrombotic drug doses in line with international standards results in a higher chance of bleeding-related complications in domestic patients.

New anti-thrombotic new drugs have proved their effectiveness and stability over existing drugs through a large-scale study of about 20,000 people in the U.S. and Europe after they were launched in 2009.

Such results led to the Korean ministry granting reimbursement benefits for the drugs since early 2013. However, the government has seen various cases of bleeding from clinical sites since then.

To evaluate the safety of anti-thrombotic drugs, the team followed 400 patients who had taken clopidogrel, a conventional anti-thrombotic drug, and 400 patients who took ticagrelor, a new anti-thrombotic medicine, for a year at 10 heart centers in Korea.

According to standard treatment guidelines, patients taking conventional anti-thrombotic tablets took 75 mg once daily, while patients taking new anti-thrombotic drugs took 90 mg daily twice daily (180 mg daily).

As a result, 11.7 percent of patients taking new anti-thrombotic drugs had bleeding-related complications, compared to the 5.3 percent of patients taking conventional anti-thrombotic tablets. Also, the incidence of the bleeding directly affecting the life of the patient, such as heart or cerebral hemorrhage was 7.5 percent in the new drug group and 4.1 percent in the conventional treatment group.

The incidence of mortality due to cardiovascular disease, myocardial infarction or stroke was 9.2 percent in the new drug and 5.8 percent in the conventional treatment. There was no statistically significant difference in the incidence of other complications.

“Unlike a pharmaceutical company-led clinical study, the team’s clinical trial was conducted as a public interest clinical study to reaffirm the safety of the drug in Koreans and find the best treatment dosage,” Professor Park said.

The journal Circulation published the results of the study.

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