关键词: 药物洗脱支架, 冠心病, 冠状血管造影术, 血管成形术, 经腔, 经皮冠状动脉, 支架血栓

Abstract: Abstract: Objective To investigate the long-term safety and efficacy of the domestic biodegradable drug-eluting cor⁃ onary stents (BuMA) in treating coronary heart disease (CHD). Methods Patients (n=440) who received BUMA stents were designated as observation group while patients (n=460) received Resolutestents were designated as control group. The base⁃ line clinical characteristics, extend of pathological change shown by Coronary Arteriography (CAG），the procedure of percu⁃ taneous coronary intervention were similar between these two groups. The patients were followed up for a mean of 24±4 months; the primary endpoint was the occurrence of definite or probable stent thrombosis; secondary endpoint was major ad⁃ verse cardiac events (MACEs) including complex end such as recurrent angina, acute non-fatal myocardial infarction, death, target vessel revascularization (TVR); other endpoints include all- cause mortality, cardiac death, myocardial infarc⁃ tion (MI), target lesion revascularization (TLR), non-target vessel revascularization and stroke. Some patients were lost dur⁃ ing follow up, which include 5 in observation group and 26 in control group. Results Patients in observation groups were in⁃ serted with 615 stents while patients in control group were implanted with 614 stents, both groups with average of implanting 1.41 stent / case. There are no statistical significance differences in the primary endpoint [1.4%(6/435) vs 1.8%(8/434), χ2= 0.087], secondary endpoint [12.3% (54/435) vs 10.8%(47/434), χ2=0.524] and other endpoints between the two groups. Con⁃ clusion These data suggest that domestic biodegradable drug-eluting coronary stents (BuMA) are with good long-term safe⁃ ty and efficacy.

Key words: drug-eluting stents, coronary disease, coronary angiography, angioplasty, transluminal, percutaneous coro? nary, stent thrombosis