| Objective: To evaluated the efficacy and safety of domestic Firebird rapamyscin-eluting stent on prevention coronary in-stent restenosis,by comparing the early and 6 months follow-up coronary angiography results and the frequency of major adverse cardiac events among the Firebird, Cypher and Driver stent on trans-radial approach treatment coronary artery de novo lesions.Methods: From February 2005 to September 2006, a total of 190 in-hospital patients(159 men,31 women, mean age 58.39±10.42 years) on trans-radial approach PCI for de novo coronary artery lesions that stenosis from 80-100%, were divided into 3 groups: Firebird group(n=76,64 men,12 women, mean age 57.86±10.94 years),Cypher group(n=72,62 men,10 women, mean age 57.72±10.16 years) and Driver group(n=42,33men,9 women, mean age 60.50±9.86 years) according to the stent used . The MLD, DS, restenosis rates and MACE of 3 groups in instant and 6 months follow-up were compared. The patients in 3 groups were similar with age, gender, lesion vessel and length. All patients received 300 mg of aspirin, 300 mg of clopidogrel at the first time three days before PCI, then after 300 mg continue used for one month ,aspirin were take 100 mg/d infinitely, clopidogrel were used 75 mg/d post PCI at least 9 months . All the patients were performed Allen's test of both sides. patients with positive result were accepted. Left and right coronary angiography were performed by using 4 french angiography catheter. Guiding catheter and guilding wire were determined according to the coronary angiography result. The size of balloon and stent was based on the length and diameter of reference vessel,the ratio of stent to artery diameter is 1.0～1.1:1.0. the length of stent must be enough to cover the whole lesion and longer than the balloon. The pressure of dilation was 9~16 atm and the time of dilation was 10～30 seconds and insure the stent completely contacted with the artery wall, the stent were further dilated until the residual stenosis less than 20%. A successful procedure was defined as residual stenosis lower than 20% and TIMI grade 3. Every patients were recorded cardiac events and same projection positions were used at 6 months follow-up. The following parameters were assessed: reference vessel diameter, length of lesion, MLD, diameter stenosis. Angiograms were analyzed with QCA by experienced personnel blinded to treatment allocation and procedure results.All data analyzed with SPSS12 statistic software, continuous variables were presented as mean±standard deviation,categorical variables were presented as values or percentages, A P value <0.05 was considered statistically significant. Results: All patient were performed by median or clinic follow-up ,78 patients of them were performed re-angiography (71 men,7 women, mean age 58.06±9.72 years). Firebird group(n=30, 29 males, 1 woman,mean age 57.50±9.23years), Cypher group(n=28, 24 men, 4 women, mean age 57.18±9.81years) and Driver group(n=20, 18 men, 2 women, mean age 60.15±10.49years). the average interval of follow-up was 185.37±7.90 days in Firebird group,187.43±8.63 days in Cypher group and 195.65±13.01 days in Driver group. No patient died in Firebird group. one patient died in Cypher group was due to cerebrovascular accident and one patient died in Driver group was due to heart failure and serious arrhythmia. AMI occurred on two patients on day 3 post-PCI and rechecked angiography and proved the sub-acute thrombosis in Cypher group. It relieved by strengthened anti-thrombosis treatment. Angina occurred on two patients in Firebird group, one was due to non-stent vessel lesion and another was suffered from the in-stent restenosis. Angina occurred on three patients in Cypher group, two of them were due to non-stent vessel lesion, the other was suffered from in-stent restenosis. Angina occurred on eight patients in Driver group, one was due to non-stent vessel lesion and the others were suffered from in-stent restenosis. All patients of in-stent restenosis were implanted drug-eluting stent. Instant coronary angiographic result after the procedure: MLD increased from 0.33±0.14mm to 2.83±0.35 mm in Firebird group , 0.32±0.12 mm to 2.80±0.34mm in Cypher group and 0.39±0.14 mm to 2.95±0.38 mm in Driver group. there was no significant difference in Early Gain among three groups(2.50±0.35 vs. 2.49±0.30 vs. 2.56±0.34,P>0.05). DS decreased from 88.96±4.45% to 6.03±1.41% in Firebird group, P<0.05,89.38±3.65% to 5.08±1.66% in Cypher group, P<0.05 , 87.78±3.87% to 7.48±1.23% in Driver group, P<0.05, there were no significant difference in three groups, P>0.05. There were no difference in maximal dilation pressure among three groups(13.76±1.62 atm vs 13.78±1.65 atm vs 13.79±1.75 atm,P>0.05). Angiography result of 6 month follow-up showed that there were no difference in MLD between the Firebird and Cypher group(2.70±0.35mm vs. 2.67±0.34mm,P>0.05, while Firebird group and Cypher group compared with Driver group(2.70±0.35mm,2.67±0.34mm vs. 2.11±0.80mm, P<0.05) had significant difference. Firebird group compared with Cypher group in DS no difference(10.62±1.81% vs 9.78±2.09%,P>0.05), while Firebird group and Cypher group were obvious lower than Driver group (10.62±1.81%, 9.78±2.09% vs 35.13±20.28%, P<0.05). Late loss in Firebird group was no difference with Cypher group (0.14±0.04mm vs 0.13±0.05,P>0.05),however, Firebird group and Cypher group were less than Driver group (0.14±0.03mm,0.14±0.03mm vs 0.84±0.53mm,P<0.01). Restenosis rate in Firebird (1.32%) and in Cypher group(1.39%) were significantly lower than Driver group(16.67%),P<0.05. There were no difference between Firebird group(1.32%) and Cypher group(5.56%) in MACE, P>0.05. However, Firebird group and Cypher group were obvious lower than Driver group(19.05%) in MACE,P<0.05.Conclusion : There was no difference in instant effect for treatment of coronary de novo lesion among three types of stent. There was no difference between the Firebird and Cypher stent in restenosis rate and MACE. thrombosis event occurred in Firebird stent lower than Cypher stent , but no significant difference. Firebird stent and Cypher stent were significantly lower than Driver stent in restenosis rate and MACE. Neither acute and sub-acute thrombosis in-stent nor edge restenosis occurred. It proved that Firebird stent was safe and efficient in preventing in-stent restenosis.
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