Evaluating the effectiveness and safety of indobufen plus clopidogrel versus aspirin plus clopidogrel in patients with negative cardiac troponin undergoing percutaneous coronary intervention with drug-eluting stent.

This study evaluated the effectiveness and safety of indobufen (Ibustrin) plus clopidogrel (Plavix) versus aspirin plus clopidogrel in patients with negative cardiac troponin undergoing percutaneous coronary intervention (PCI) with drug-eluting stent (DES). The data showed that indobufen plus clopidogrel significantly reduced the risk of bleeding events without increasing the risk of heart attacks, stroke, or death events compared with aspirin plus clopidogrel in these patients.

Coronary artery disease (CAD) is a condition in which the blood vessels in the heart become blocked. CAD can lead to acute myocardial infarction (MI), also known as a heart attack. Percutaneous coronary intervention (PCI) is a minimally invasive procedure to improve blood flow. During PCI the blockage in the artery is removed. In some cases, a stent may be inserted to keep a blood vessel open.

One risk with PCI using DES is that blood clots can form on the stent and cause a blockage. Platelets are cells in the blood involved in blood clotting. Dual antiplatelet therapy (DAPT) is used to reduce this risk. DAPT reduces the risk of clotting and further blockages after PCI. Acetylsalicylic acid (Aspirin) and ticagrelor (Brilique) are antiplatelet medications commonly used in DAPT.

DAPT for at least 6-12 months is commonly prescribed after PCI with DES. However, DAPT with aspirin commonly increases the risk of bleeding in patients with CAD. Previous studies have suggested that indobufen is effective and could reduce the risk of side effects associated with aspirin. However, the effectiveness and safety of indobufen plus clopidogrel versus aspirin plus clopidogrel in patients with negative cardiac troponin undergoing PCI with DES are still unknown.

This study involved 4551 patients with negative cardiac troponin undergoing PCI with DES. Patients were randomly assigned into 2 groups. Group 1 included 2258 patients who received indobufen plus clopidogrel. Group 2 included 2293 patients who received aspirin plus clopidogrel. The patients were followed up for 12 months.

After 12 months, heart attacks, stroke, death, and bleeding events occurred significantly lower (by 27%) in patients in group 1 (4.47% patients) compared to group 2 (6.11%). This difference was statistically significant.

There was no significant difference in heart attacks, stroke, or death events between group 1 (1.51%) and group 2 (1.4%).

Bleeding events occurred in 2.97% of the patients in group 1 compared to 4.71% of the patients in group 2. This difference was significant. Indobufen plus clopidogrel reduced the risk of bleeding events by 37% compared to aspirin plus clopidogrel.

This study concluded that indobufen plus clopidogrel significantly reduced the risk of bleeding events without increasing the risk of heart attacks, stroke, or death events compared with aspirin plus clopidogrel in patients with negative cardiac troponin undergoing PCI with DES.

This study was funded by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd, the manufacturer of indobufen. This study only included patients from China. The patients knew which treatment they were getting. This might have influenced the results.