| Objective: To contrast the effectiveness and safety of the clinical application of three different stents including Lepu stent, the EXCEL stent and the Xience V stent, 306 patients with unstable angina pectoris of the coronary heart disease in treating their small vascular and long lesions were studied.Methods: In our study, we chosed 306 patients with unstable angina pectoris of the coronary heart disease from our department during from September 2012 to September 2014 period, in accordance with the criteria of long lesions of small vascular under the perfect coronary angiography examination and percutaneous coronary intervention(PCI). Those 306 cases were randomly divided into three groups. One group of 102 patients(Lepu group) were fixed with home-made Lepu stents, another group of 104 patients(EXCEL group) with home-made EXCEL stents, and the other group of 100 patients(Xience V group) with imported Xience V stents. The chosen conditions of the patients are: ① The patient must comply with following standard, the consensus and guidance of interventional therapy of coronary cardiopathy as well as the probability of drug coating stent. ② The patient’s age must be no more than 75 years of age and no less than 18, and the patient must have full civil capacity and sign the Informed Consent. ③ The diagnostic standard of small vessel disease(SVD) is that the diameter of each end of the targeted pathological changes of the coronary artery must be no more than 2.75 mm, and the standard of long pathological changes is that the length of the targeted pathological change must be no less than 30 mm. The exclusive conditions are: ① Acute myocardial infarction(ST elevation myocardial infarction and non-ST elevation myocardial infarction). ②planned step-by-step revascularization graded revascularization treatment as scheduled. ③ the combination of a coronary artery is not the condition of the long lesion of pathological changes in small vascular and is in need of interventional therapy. ④ severe renal insufficiency. ⑤the subject’s expected life span is under one year.⑥the simple root diseased blood vessel is transplanted stents of different brands.⑦left main stem diseases. In accordance with the coronarography, relevant spots of pathological changes are pre-dilated with sacculuses suitable in size. When Thrombolysis In Myocardial Infarction(TIMI) of the targeted vessels reaches up to grade Ⅱ, the arterial stenting for the above-mentioned three groups are performed. The following indexes are closed observed during operation and post-operation: ① basic interventional procedure indexes:the number and location of the vessels affected by diseased coronary artery, the narrowness of target vessel, the number and length of stents transplanted, and the success rate, etc. ② operation success rate indexes: after the operation, observe the multi-position angiography and measure the narrowness of the target lesion local remainders, make sure it is less than 20%(including complementary vertical positions), observe the blood flow classification of target blood vessel TIMI, check the frame number of TIMI. ③ post-operation safety indexes: follow up and pay close attention to the occurrence of MACE. During the process of following up, if there is a terminal point of observation, the observation will be ended. ④ the effectiveness indexes after operation: including the target lesion reconstruction(TLR), the target vessels reconstruction(TVR), the late lumen loss(LLL) within the stent, LLL within the segment(5mm from each end of the stent), the minimal lumen diameter(MLD) within the stent, and MLD as a substitute for the effectiveness index within the segment, etc. ⑤ complex indexes: target lesion failure(TLF)rate, including the reconstruction of the blood supply of the target lesion, myocardial infarction resulted from target blood vessel and cardiac death, etc. All the data should be statistically calculated, analyzed using SPSS17.0 statistical software, all the indicators were proceed normality distribution tests. Non-normal distribution data were transformed into natural logarithm to approximate normal distribution before statistical analysis.(To make the result simply, the original data were used). The measurement data should be shown by means and ±standard deviations and be tested by F, and taking P<0.05 difference as statistical meaningfulness. Enumeration data is shown by percentage, and checked by X2. When the three data needed to have a pairwise comparison, X2 partition method should be used, and the P value should be revised as 0.0125, taking P<0.0125 as difference, so that it has statistical meaning.Results: The sexes, ages, etc. of the three groups usually have no statistical differences; neither smoking history, nor hypertension, nor diabetes,etc. has statistical difference in number; the blood vessel number ac- cumulated by the coronary artery disease as well as the accumulated parts has no statistical meaning(P>0.05); the level of the blood vessel stenosis has no statistical difference(P=0.40); the length and number of the stent have no statistical differences(P>0.05); the success stenting rate has no statistical difference(P>0.05).After PCI operation, the ratios of the patients of the three groups with the TIMI grade Ⅲ are similar(96.08%, 98.08% and 94.00% respectively)(P>0.05); the frame numbers have no statistical difference(20.92±2.70, 21.02±4.00and20.96±3.08 respectively)(P=0.64),;the comparisons of MACE of the three groups during hospital stay have no significant difference(0.00%、0.96%and 0.00% respectively P>0.05). Six months after operation, the minimum interior lumen diameter of each stent(2.62±0.04 、 2.63±0.04 、2.64±0.04 respectively P>0.05), the minimum interior lumen diameter of each segment(2.62±0.04、2.62±0.04、2.63±0.05 respectively P>0.05), the late lumen losses within the stent(0.02±0.01、0.02±0.01、0.02±0.01 respectively P>0.05), the late lumen losses within the segment(0.02±0.01、0.03±0.01、0.03±0.01 respectively P>0.05), and the failure rates of target lesion of all the three groups(0.98% 、 0.00%and0.00% respectively P>0.05) have no significant differences during the follow-up six months after the operation, the MACE occurrences of the three groups have no difference, including the hospitalized patients with angina pectoris((0.98%、1.92%、1.00% P>0.05); non fatal myocardial infarction(0.00%、0.00%、0.00% P>0.05);TLR(0.98%、0.00%、0.00% P>0.05); TVR(0.00%、0.00%、0.00% P>0.05); cardiac death(0.00%、0.00%、0.00% P>0.05).Conclusion: The three medicine stents of Lepu, Excel and Xience V are safe for patients with unstable angina pectoris of the coronary heart disease in treating their small angina pectoris and long lesions, and the three stents can remarkably improve the coronary blood supply and they have no obvious differences in success operation indexes, postoperation safety indexes, postoperation validity indexes and complex indexes. |
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