| Objective: Long coronary artery lesion that characterized of length more than 20mm, is type C lesion defined by AHA/ACC. Because of complication of long lesion, the method of dilatation by long balloon, long BMS implantation or overlapped BMSs implantation previously did not induce satisfactory clinical efficacy. With the utilization of DES more and more widespreadly, much evidence revealed that utilization of DES for treatment CAD could decrease the incidence of stent restenosis and TVR or TLR for long-term after PCI. Because of that, overlapped DES implantation has became one of the most important methods in treatment of long coronary artery lesion. But the DES overlapping brought about some new problems, such as delayed endothelialization, incomplete stent apposition, stents fracture, increasing incidence of late stent thrombosis or very late stent thrombosis, and stent restenosis, which induced more and more attention on it. Excel stent adopted new technology of single-sided biodegradable polymer-coated faced on the side of vessel wall which was different from other SES, and could avoid both SR or LST theoretically. More research were focused on clinical effects of single Excel stent previously, few literature concerning on clinical efficacy of overlapped Excel stents for treatment long coronary artery lesion. This study aims at evaluation on efficacy and safety of overlapped Excel stents implantation for treatment long coronary artery lesion by comparison the incidence of MACE, ST and SR after overlapped Excel or Cypher stents implantation during hospitalization and 12-month clinical follow-up, and observes the differences of angiographic results between overlapped site and non-overlapped site of these 2 kinds of SES.Method: Consecutive patients with SAP or ACS who got long de-novo lesion of coronary artery and performed 2 overlapped Excel stents or Cypher stents implantation in cardiac and vascular department of General Hospital Of Chinese Army Police Force during 2006.8 to 2009.3 were enrolled in this study retrospectively; target lesion of which performed PCI with use of stents which diameter varied from 2.5mm to 3.5mm, and the diameter stenosis was more than 75%, or less than 75% but the patient ill with severe angina, were cured. Patients died but not caused by operation, patients with AMI which induced severe complication, patients who accepted unsuccessful PCI, patients who were cured with stent that diameter less than 2.5mm or more than 3.5mm, patients who were performed PCI or CABG on target lesion or target vessel previously, patients performed more than 2 stents, neither overlapped Excel stents nor Cypher stents, heterogeneous DES implantation or performed overlapped stents implantation for non-target lesion during hospitalization were excluded. Patients were divided into 2 groups by the type of stents implanted: the overlapped Excel stents group and the overlapped Cypher stents group. Information about hospitalization and 12-month clinical follow-up outside hospital after PCI and results of repeat CAG during the term of follow-up were collected and analyzed, the incidence of composite MACE and acute/subacute stent thrombosis during hospitalization, incidence of composite MACE and late stent thrombosis during 12-month clinical follow-up after PCI, and incidence of SR and LLL in repeat CAG during the term of follow-up between 2 groups were compared. Result of CAG before or after PCI and repeated CAG during the term of follow-up were performed QCA analysis by QAngio XA (Version 7.2, Medis) software.Statistic analysis: Continuous variables are presented as Mean±SD, Categorical variables are presented as percentages. Normal distribution of all continuous variables was tested by Kolmogorov-Smirnov test first. Differences of continuous variables among 2 groups were analyzed by 2-samples t-test or nonparametric Mann-Whitney U test, differences of continuous variables among multi-groups were analyzed by One-Way ANOVA test or nonparametric Kruskal-Wallis H test; categorical variables were compared with Pearson chi-square test or Fisher's exact test as appropriate between 2 groups. Differences with P value less than 0.05 (2-sided) were considered as statistical significance. All data were performed statistical analyses with use of SPSS software (Version 13.0 , SPSS).Results: 657 consecutive patients performed overlapped DES were collected during 2006.8 to 2009.3, but 66 patients performed more than 2 stents implantation, 113 patients who were implanted neither overlapped Excel or Cypher stents, 52 patients who were performed heterogeneous DES implantation, 12 patients who were performed Excel stents implantation which diameter more than 4.0mm, 37 patients who were performed overlapped stents implantation in non-target lesion during hospitalization and 3 patients with AMI which induced severe complication (of 2 died during precedual) were excluded. 374 patients were enrolled in this study in all.211 patients accepted 2 overlapped Excel implantation, and 163 patients accepted 2 overlapped Cypher implantation. The characteristics of baseline and target lesion, clinical characteristics between 2 groups are similar, information of PCI procedure reveal non-significant differences between 2 groups except the percentage of pre-dilatation (94.8% vs. 98.8%, P=0.046), the QCA data pre-procedure and post-procedure also reveal non-significant differences between 2 groups.During hospitalization, between 2 groups, the incidence of composite MACE (5.7% vs. 6.1%, P=0.855) reveal non-significant differences: the incidence of death (2.4% vs. 2.5%, P=1.000), including cardiac death (1.9% vs. 2.5%, P=0.733), MI (4.3% vs. 4.3%, P=0.989), including immortal MI (3.3% vs. 3.7%, P=0.849), TVR (0.9% vs. 1.8%, P=0.657) and TLR (0.9% vs. 1.8%, P=0.657) reveal non-significant differences; the incidence of acute/subacute stent thrombosis defined by ARC (2.8% vs. 2.5%, P=1.000) also reveal non-significant differences.331 patients (183 patients of Excel group and 146 patients of Cypher group) were followed-up during 12 months outside hospital after PCI. During this period, between 2 groups, the incidence of composite MACE (6.6% vs. 8.8%, P=0.446) reveal non-significant differences: the incidence of death (2.2% vs. 2.0%, P=1.000), cardiac death (1.6% vs. 1.4%, P=1.000), MI (2.2% vs. 2.0%, P=1.000), immortal MI (1.6% vs. 2.0%, P=1.000), TVR (4.9% vs. 6.1%, P=0.643) and TLR (3.8% vs. 5.4%, P=0.492) reveal non-significant differences; the reoccurrence of angina (31.1% vs. 32.4%, P=0.803) and admittion to hospital caused by angina (23.0% vs. 25.0%, P=0.664) are similar between 2 groups; the incidence of late stent thrombosis defined by ARC (2.7% vs. 2.7%, P=1.000) also reveal non-significant differences.167 patients were performed repeat CAG (84 patients of Excel group and 83 patients of Cypher group) during 6~12 months after PCI. The results of CAG revealed that in-stent LLL (0.09±0.05 vs. 0.10±0.05, P=0.037), proximal edge LLL (0.08±0.03 vs. 0.13±0.02, P < 0.001), proximal stent LLL (0.11±0.03 vs. 0.14±0.02, P<0.001), overlapping site LLL (0.16±0.02 vs. 0.20±0.02, P<0.001), distal edge LLL (0.06±0.02 vs. 0.08±0.02, P<0.001) were different significantly, but the occurrence of in-stent restenosis (6.0% in Excel group and 9.6% in Cypher group, P=0.374) and in-segment restenosis (9.5% in Excel group and 12.0% in Cypher group, P=0.599) revealed non-significant differences between 2 groups. Aneurysm was observed in 2 patients during follow-up of angiography, the one was in proximal stent in Excel group, the other was in distal stent in Cypher group. No late stent thrombosis was observed in angiography of follow-up.The LLL measurements of proximal edge, proximal stent, overlapping site, distal stent and distal edge either in Excel group or Cypher group revealed significant differences between each other (except difference between LLL of proximal edge and distal stent in Excel group). The incidence of restenosis of proximal edge, proximal stent, overlapping site, distal stent and distal edge in either Excel group or Cypher group revealed non-significant differences between each other.Conclusions: 1. The safty and efficacy of overlapped Excel stents implantation to treat long coronary lesion is similar to Cypher stents. 2. The degree of late lumen loss in-stent caused by stents implantation could be relieved by using overlapped Excel stent than Cypher stents for the technology that single-sided biodegradable polymer-coated faced on the side of vessel wall of Excel stent, so application of overlapped Excel stents may reduce the possibility of SR for long time than Cypher stents. 3. The LLL of overlapped site is more severe than other regions, whatever overlapped Excel stents or Cypher stents implantation, but the incidence of restenosis in overlapped site are not higher than other regions significantly. |
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