| Objective: To evaluated the safety and efficacy of Endeavor TMZotarolimus Drug-eluting Stent in patients with coronary heart disease and diabetes who were performed percutaneous coronary intervention (PCI) via trans-radial artery approach treatment coronary artery de novo lesions by comparing the results early and 6 months follow-up coronary angiography(CAG) and the incidence of major adverse cardiac events between the EndeavorTMZotarolimus Drug-eluting stent and Cypher rapamycin Drug-eluting stent.Methods: From September 2007 to june 2008, a total of 96 in-hospital patients with coronary heart disease and diabetes(male,78,female,18 average age 58.81±10.60 years) Who performed PCI via trans-radial approach for de novo coronary artery lesions were randomly divided into 2 groups: Endeavor group(n=52, male, 41, female,11, average age 58.89±10.84 years), Cypher group(n=44, male, 37, female,7, average age 58.72±10.36 years).The minimal luminal diameter(MLD), diameter stenosis (DS), restenosis incidence and major adverse cardiac event (MACE) of 2 groups instant and 6 months follow-up after PCI were compared.The patients in 2 groups were similar in baseline characteristics such as age,gender,lesion vessel , lesion length and so on.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 12 months. Acute myocardial infarction(AMI) patients begin to take 300mg aspirin and 300mg Clopidogrel immediately after admission Whether GPⅡb/Ⅲa receptor blocker were used or not according to the patient condition, amount of heparin during an operation should be 100 U/kg, it will be reduced to 50 U/kg if using GPⅡb/Ⅲa receptor blocker.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 guide wire were used according to the coronary angiography result.The size of balloon and stent was based on the length and diameter of reference vessel and the ratio of stent to artery diameter is 1.0~1.1:1.0. Before implanting the stent, predilation by balloon should be performed. A stent can be directly implanted in suitable lesions. The length of stent must be enough to cover the whole lesion and longer than the length of balloon.The pressure of dilation was 9~16 atm and the time of dilation was 10~30 seconds to insure the stent completely contacting with the wall of the artery.If the residual stenosis were less than 20%, the stent were further dilated with post dilation balloon.A successful PCI was defined as residual stenosis was lower than 20%, TIMI grade reached grade 3 and the patient no serious complication. Clinical follow-up were porformed after PCI for 6 months by telephone interview, clinical interview and readmission.One month after PCI ECG and UCG were rechecked. Every patient was used the same projection positions at 6 months follow-up.The following parameters were assessed: reference vessel diameter (RD), length of lesion, MLD and DS.Angiograms were analyzed with quantitative coronary analysis (QCA) by two experienced interventional cardiologists who were blinded to treatment allocation and procedure results. The main incidence of adverse cardiac events (MACE), rate of intra-stent thrombosis, target lesion revascularization(TLR) during six-months′follow up, and Late Loss (LL) were recorded.All data analyzed with SASV8.0 statistic software, continuous variables were represented as mean±standard deviation, and analyzed by t-test, categorical variables were represented as values or percentages, and analyzed by chi-square test. A P value<0.05 was considered statistically significant.Results: 1.162 drug-eluting stent have been implant in 96 patients with coronary heart disease and diabetes, among them 89 Endeavor stents were implanted in 94 lesions of 52 patients in Endeavor group, 73 Cypher stent were implanted in 79 lesions of 44 patients in Cypher group, There are no significant differences between the two groups in baseline characteristics (average age, male percentage, hypertension, hyperlipidemia, smoking, using of GPIIb/IIIa receptor blocker and LVEF before PCI).2. There was no significant differences between the two groups in target-vessel distribution and ACC / AHA classification. Majority lesions treated were consisted of Type B2/C (62.95%) and 57.26% lesions were in left anterior descending artery (LAD). The average length of lesion was 27.19±6.45mm, (Eneaor group27.78±6.35mm, Cypher group 26.59±6.54mm,P>0.05).Average diameter of reference vessel was 2.72±0.63mm, (Eneaor group 2.71±0.64mm, Cypher group 2.72±0.62mm,P>0.05). 28(63.64%) cases in Cypher group was multivessel lesions, 33 (63.46%) cases in Endeavor group was multivessel lesions. P>0.05 41(25.31%) stents were directly implanted (Eneaor group, 23, Cypher group, 18, P>0.05) while the rest 121 (74.69%) stents. (Eneaor group 66, Cypher group, 55, P>0.05) were implanted after perdilation with balloon .The average release pressure was 13.77±2.64 atm, (Eneaor group, 13.76±2.62 atm, Cypher group, 13.78±2.65 atm, P>0.05). High pressure post dilation were performed in 11 stent (6.79%), (Eneaor group, 6, Cypher group, 5). Success rate of PCI was 100% in both of the two groups.3. All of the 96 patients were finished clinical follow up, among them CAG were reperformed in 52 patients (male, 43, female, 9, average age 58.34±9.57years) and there were 28 cases in Endeavor group (male, 23, female, 5, average age 58.50±9.43years), Cypher group 24 cases (male, 20, female, 4, average age 58.18±9.71years). The average follow-up period in Endeavor group was 186.47±7.70 days, and 184.53±8.83 days in Cypher group. There was no patient died during in hospital. One patient happened AMI, which was caused by subacute thrombosis intra-stent on the third day post-PCI that identified by CAG in Cypher group. In Endeavor group, one patient happened AMI four months after PCI whose CAG showed that infarction relation artery (IRA) was not the vessel with stent implant in, and successful emergent PCI was performed. Angina occurred in three patients in Endeavor group, one was due to a new lesion of another vessel while others were suffered from the intra-stent restenosis.Angina occurred in four patients in Cypher group, two of which were due to new lesions of vessel without stent implanting, others were suffered from intra-stent restenosis.All patients of intra-stent restenosis were implanted the same drug-eluting stent. There was no significant difference between the two groups. MLD: increased from 0.33±0.15mm before PCI to 2.93±0.34 mm post PCI, in Endeavor group while 0.34±0.12mm before PCI to 2.91±0.33mm post PCI in Cypher group; early gain (EG): (Endeavor group,2.60±0.31mm vs.Cypher group, 2.58±0.32mm,P>0.05); DS:decreased from 89.76±4.55% before PCI to 5.09±1.42% post PCI in Endeavor group,P<0.05,while 89.38±3.65% before PCI to 5.03±1.37% post PCI in Cypher group,P<0.05.Results of CAG at 6 months after PCI showed that there was no significant difference in MLD: (2.58±0.35mm vs.2.58±0.34mm, P>0.05); DS: (9.27±1.53% vs 9.45±1.68%,P>0.05); LL: (0.35±0.04 mm vs 0.34±0.03 mm, P>0.05); Restenosis rate: (3.85% vs 4.55%, P>0.05); MACE (5.77% vs6.82%, P>0.05) between the two groups.Conclusion: There was no significant difference between Endeavor group and Cypher group in instant effects and restenosis rate and MACE at 6-months for treatment of coronary de novo lesions. Incidence of intra-stent thrombsis in Endeavor group was lower than that in Cypher group, but no statistical significance, which proved that EndeavorTMZotarolimus-eluting Stent was as safe and efficient as Cypher stent in patients with coronary heart disease and diabetes.
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