Firebird and Cypher sirolimus-eluting stents and bare metal stents in treatment of very long coronary lesions

Background As a kind of sirolimus-eluting stent （SES） made in China, Firebird SES is more effective than bare metal stent （BMS） and not inferior to Cypher SES for short coronary lesions in terms of reduction of restenosis and revascularization. However, Firebird SES does not show any benefits in patients with a very long coronary lesion （VLCL）. The present study was undertaken to evaluate the safety and efficacy of Firebird SES for VLCL by comparison of Cypher SES and BMS. Methods In this prospective, nonrandomized and comparative study, eligible patients with de novo coronary lesion （≥ 30 mm） between January 2005 and June 2006 were allocated into Firebird SES group, Cypher SES group or BMS group. They were subjected to an angiographic follow-up of 6 months and a clinical follow-up of 12 months. The primary endpoints constitute the in-stent and in-segment restenosis rates at 6 months. The secondary endpoint was defined as a major adverse cardiovascular event （MACE） that was a 12-month combined endpoint of all-cause deaths, reinfarction or in-stent thrombosis, and target-lesion revascularization. The 12-month in-stent thrombosis was also evaluated to address the safety of Firebird SES implantation exceptionally. Results A total of 468 patients were assessed for eligibility. Of 113 patients who were finally included according to the prior inclusion and exclusion criteria, 39 （41 lesions） were treated with Firebird SES, 37 （39 lesions） with Cypher SES, and 37 （37 lesions） with BMS. There were no significant differences in the baseline characteristics between the three groups; but there were longer lesions, more frequent use of overlapping stent in the Firebird SES group and the Cypher SES group. Angiographic follow-up showed that the rates of binary stenosis were similar between the Firebird SES group and the Cypher SES group （in-segment： 14.6% vs 12.8%, relative risk （RR）1.14, P=0.81; in-stent： 9.8% vs 10.3%, RR 0.95, P=0.94）, and significantly lower than those in the B     

Quantitative assessment of late lumen loss after biodegradable polymer and permanent polymer sirolimus-eluting stents implantation

Background Sirolimus-eluting stents (SES) are reported to be associated with reduced late lumen loss (LLL),resulting in less frequent restenosis when compared to bare-metal stent.The current study aime...     

Short-term safety and efficacy of the biodegradable iron stent in mini-swine coronary arteries

Background To overcome the drawbacks of permanent years. The bioabsorbable polymer vascular scaffold （BVS） stents, biodegradable stents have been studied in recent was the first bioabsorbable stent to undergo clinical trials, demonstrating safety and feasibility in the ABSORB studies. Iron can potentially serve as the biomatedal for biodegradable stents. This study aimed to assess the short4erm safety and efficacy of a biodegradable iron stent in mini-swine coronary arteries. Methods Eight iron stents and eight cobalt chromium alloy （VISION） control stents were randomly implanted into the LAD and RCA of eight healthy mini-swine, respectively. Two stents of the same metal base were implanted into one animal. At 28 days the animals were sacrificed after coronary angiography, and histopathological examinations were performed. Results Histomorphometric measurements showed that mean neointimal thickness （（0.46±0.17） mm vs. （0.45±0.18） mm, P=0.878）, neointimal area （（2.55±0.91） mm2 vs. （3.04±1.15） mm2, P=0.360） and percentage of area stenosis （（44.50±11.40）% vs. （46.00±17.95）%, P=0.845） were not significantly different between the iron stents and VISION stents. There was no inflammation, thrombosis or necrosis in either group. The scanning electron microscopy （SEM） intimal injury scores （0.75±1.04 vs. 0.88±0.99, P=0.809） and number of proliferating cell nuclear antigen （PCNA） positive staining cells were not significantly different between the two groups. The percentage of neointimal coverage by SEM examination was numerically higher in iron stents than in VISION stents （（84.38±14.50）% vs. （65.00±22.04）%, P=0.057）, but the difference was not statistically significant. Iron staining in the tissue surrounding the iron stents at 28 days was positive and the vascular wall adjacent to the iron stent had a brownish tinge, consistent with iron degradation. No abnormal histopathological changes were detected in coronary arteries or major organs. Conclusions The biodegradable iron stent has good biocompatibility and short-term safety and efficacy in the mini- swine coronary artery. Corrosion of iron stents is observed at four weeks and no signs of organ toxicity related to iron degradation were noted.     

Novel side branch ostial stent （BIGUARD^TM）： first-in-man study

Background Stenting a bifurcation lesion is technically challenging. No study has reported the clinical outcome of a dedicated bifurcation stent in China. We aimed to analyze the safety and clinical outcome of a novel side branch ostial stent （BIGUARDTM） stent in treating coronary bifurcation lesions. Methods Forty-seven patients were enrolled in this first-in-man study, with 61.7% true bifurcation lesions （0,1,1 and 1,1,1） and 26.7% diabetes. A two-stent technique was used in 27.6% of the patients, and 64.7% of patients crossed from the one-stent technique to the two-stent arm. Clinical and angiographic follow-up data at 12 months were available in all the 47 patients and in 43 patients （91.9%）, respectively. The study endpoint was the occurrence of major adverse cardiac events （MACE） at 12 months. Results Only one patient had a non-ST segment elevation myocardial infarction, which led to 2% of the in-hospital composite MACE. Notably, the target lesion revascularization at 12 months was 8.6%, with a 10.6% composite MACE at 12 months. Neither cardiac death nor stent thrombosis was seen during the follow-up. By quantitative coronary analysis, the restenosis rate at the main vessel and ostium of the side branch was 9.4% and 2.1%, respectively. Four of 12 patients （33.3%） treated with one-stent and kissing balloon inflation had restenosis in the main vessel. Conclusion BIGUARDTM stent was safe and feasible in treatment of bifurcation lesions.     

Age-based clinical and angiographic outcomes after sirolimus-eluting stent implantation in patients with coronary artery disease

Background Advanced age independently predicts early and late mortality and major adverse cardiac events （MACE） after percutaneous coronary intervention （PCI）. Randomized clinical trials indicate that siroUmus-eluting stent （SES） implantation reduces target lesion revascularization （TLR）, but there are limited data on the impact of age on outcomes following SES implantation in patients with coronary artery disease （CAD） in real-world practice. Methods A total of 333 CAD patients with 453 lesions were enrolled in this study. Subjects were divided into two groups according to age： a young group （〈65 years old, 244 patients with 369 lesions） and elderly group （≥65 years old, 89 patients with 113 lesions）. Clinical follow-up and quantitative coronary angiography （QCA） were performed seven months after PCh Results Baseline clinical, demographic, angiographic, and procedural chararcteristics were similar in both groups, except that there were more female patients in the elderly group （21.3% vs 9.8%, P=-0.006）. Primary success rate was similar in both groups （96.5% in young group vs 95.7% in elderly group, P〉0.05）. During angiographic follow-up at 7 months, binary in-stent restenosis and in-segment restenosis rates were not significantly different between the two groups （4.7% vs 1.8%; 9.7% vs 8.8%, P〉0.05 respectively）. Both sub-acute and late thrombosis rates were similar in the two groups （0.3% vs 0.9% and 1.2% vs 0.9%, P〉0.05 respectively. TLFI was not significantly different between the two groups （6.5% vs 3.5%;P=-0.246）. The rates of bleeding, stroke, angina rehospitalization during the, follow-up period were also similar in both groups （P〉0.05 respectively）. Conclusion Despite a high-risk clinical profile, coronary SES implantation can be safely and effectively performed in elderly patients with a similar procedural success rate, a low complication rate, and excellent 7-month outcomes.     

Investigation of long-term implantation of BuMA stent in a porcine coronary model

Background  Stent-based delivery of sirolimus has been shown to reduce neointimal hyperplasia significantly. However, the long-term effect of the polymer is thought to initiate and sustain an inflammatory response and contribute to the occurrence of late complications. Our study aimed to evaluate the efficacy and safety of the BuMA biodegradable drug-coated sirolimus-eluting stent (BSES) for inhibiting neointimal hyperplasia in a porcine coronary model.

Methods  Four types of stents were implanted at random in different coronary arteries of the same pig: BSES (n=24), bare metal stent (BMS) (n=24), biodegradable polymer coated stent without drug (PCS) (n=24) and only poly (n-butyl methacrylate) base layer coated stent (EGS) (n=23). In total, 26 animals underwent successful random placement of 95 oversized stents in the coronary arteries. Coronary angiography was performed after 28 days, 90 days and 240 days of stent implantation. After 14 days, 28 days, 90 days and 240 days, 6 animals at each timepoint were sacrificed for histomorphologic analysis.

Results  The 28-day, 90-day and 240-day results of quantitative coronary angiography (QCA) showed reduction in luminal loss (LL) in the BSES group when compared with the BMS group;  (0.20±0.35) mm vs. (0.82±0.51) mm (P=0.035), (0.20±0.30) mm vs. (0.93±0.51) mm (P=0.013), and (0.18±0.16) mm vs. (0.19±0.24) mm (P=0.889), respectively. By 28-day, 90-day and 240-day histomorphomeric analysis results, there was also a corresponding significant reduction in neointimal tissue proliferation with similar injury scores of BSES compared with the BMS control; average neointimal area (0.90±0.49) mm² vs. (2.16±1.29) mm² (P=0.049), (1.53±0.84) mm² vs. (3.41±1.55) mm² (P=0.026), and (2.43±0.95) mm² vs. (3.12±1.16) mm² (P=0.228), respectively. High magnification histomorphologic examination revealed similar inflammation scores and endothelialization scores in both the BSES and BMS groups.

Conclusions  The BuMA biodegradable drug-coated sirolimus-eluting stents can significantly reduce neointimal hyperplasia and in-stent restenosis. Re-endothelialization of the BuMA stent is as good as that of the BMS in the porcine coronary model due to the reduced inflammation response to the BuMA stent.

     

A prospective multicenter parallel-controlled trial of TIVOLI biodegradable-polymer-based sirolimus-eluting stent compared to ENDEAVOR zotarolimus-eluting stent for the treatment of coronary artery disease: 8-month angiographic and 2-year clinical follow-up results

Background  Available drug-eluting stents (DES) have achieved great success in reducing restenosis rates. Recently, investigators have demonstrated that the durable polymer carrier plays a significant role in DES-related hypersensitive reaction and delays vessel healing. TIVOLI stent is a novel sirolimus-eluting coronary stent with biodegradable coating containing sirolimus and polylactic-co-glycolic acid (PLGA) polymer. The present study sought to evaluate the effectiveness and safety of the TIVOLI biodegradable-polymer-based sirolimus-eluting stent in treating patients with coronary artery disease. 

Methods  A prospective, multicenter clinical trial comparing TIVOLI biodegradable coated sirolimus-eluting stent with ENDEAVOR zotarolimus-eluting stent was conducted in 324 patients (TIVOLI group: 168 patients; ENDEAVOR group: 156 patients) at 12 centers in China to demonstrate the non-inferiority of in-stent late loss with TIVOLI stent compared to ENDEAVOR stent in subjects with a maximum of two de novo native coronary artery lesions (lesion length ≤40 mm, reference vessel diameter 2.25–4.00 mm). The primary end point was angiographic in-stent late loss at 8-month. The secondary end points were clinical outcomes at 2 years, including major adverse cardiac events (cardiac death, myocardial infarction, or target-lesion revascularization) and stent thrombosis.

Results  Angiographic late lumen loss at 8 months in the TIVOLI group was superior to the ENDEAVOR group (in-stent (0.25±0.33) mm vs. (0.57±0.55) mm, diff (95% CI) –0.23 (–0.32, –0.14), P <0.0001; in-segment (0.25±0.33) mm vs. (0.42±0.55) mm, diff (95% CI) –0.13 (–0.23, –0.02), P=0.0083). The rate of in-stent binary restenosis at 8 months was reduced from 8.6% in the ENDEAVOR group to 2.9% in the TIVOLI group (P=0.0229). Compared to ENDEAVOR stent, TIVOLI stent resulted in a significant reduction in target-lesion revascularization (4.2% vs. 9.6%, P=0.0495) at 2 years. The two-year major adverse cardiac events (MACE) rate was lower for the TIVOLI group, but not significantly different (6.6% vs. 10.9%, P=0.1630).

Conclusions  TIVOLI was superior to ENDEAVOR stent with respect to late lumen loss at 8 months, and it yielded both lower rates of angiographic binary restenosis at 8 months and target lesion revascularization (TLR) at 2 years. The MACE rate at 2 years was comparable in both groups.

     

Acute coronary syndrome is an independent risk factor for late incomplete stent apposition after sirolimus-eluting stent implantation

Background Late incomplete stent apposition （ISA） may occur after drug-eluting stent implantation, affecting long-term clinical outcomes. This study aimed to evaluate the impact of clinical presentations of coronary artery disease on late ISA after percutaneous coronary intervention （PCI） with sirolimus-eluting stents （SES） by means of three-dimensional volumetric intravascular ultrasound （IVUS） analyses. Methods One hundred and thirty-seven patients with coronary artery disease received SES implantation during PCI and had repeat angiography with IVUS examination. All patients were followed up one year after the procedure. Results In overall 219 treated lesions （137 patients）, late ISA was identified in 25 lesions （16 patients）. Clinical diagnosis of acute coronary syndrome （ACS） and use of long stents were more common in patients with than in those without late ISA. Patients with late ISA had greater external elastic membrane （EEM） area in stented segment （（15.34±5.44） vs （13.83±4.51） mm^2, P=0.026）, stented-to-reference segment EEM area ratio （1.13±0.22 vs 1.02±0.18, P 〈0.001）, and plaque and media area （（8.43±3.93） vs （7.01±2.93） mm^2, P =0.002） than in those without late ISA. Multivariate Logistic regression analysis showed that clinical diagnosis of ACS and use of long stents were independent risk factors for late ISA （OR 6.477, 95%CI 2.297-18.263, P 〈0.001; OR 3.680, 95%Cl 1.181-11.469, P =0.025; respectively）. During one-year follow-up after IVUS examination, the rate of very late stent thrombosis tended to be higher in patients with than in those without late ISA （18.7% vs 3.3%, P =0.051）. Conclusions The occurrence of late ISA after SES implantation may be related to clinical status, use of long stents, and marked positive vessel remodeling. Late ISA tended to increase the rate of very late stent thrombosis during follow-up, highlighting the importance of long-term dual antiplatelet therapy for these patients.     

Drug-eluting stent for the treatment of small coronary lesion: comparison between sirolimus- and paclitaxel-eluting stent

Background  Patients with small coronary lesions are at increased risk for repeat interventions after coronary angioplasty and stenting. The efficacy of drug-eluting stents (DES) has been demonstrated to improve the outcomes of these patients and is a focus of interest. Currently, two platforms of DES are available (sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES)). However, it has less been known that DES, SES vs PES, is superior for the treatment of small coronary lesions.
Methods  In this retrospective study, 87 consecutive patients with 151 lesions underwent implantation of coronary SES (n=68) and PES (n=83). Quantitative coronary angiography (QCA) was performed at the time of stent implantation and subsequently at 8 months post-stenting. Small vessel disease was defined as lesions in vessels with diameter 2.5 mm measured by QCA. Major adverse cardiac events (MACE) including death, thrombosis, nonfatal myocardial infarction and target lesion revascularization (TLR) were compared between the two groups.
Results  Baseline clinical characteristics and angiographic parameters were similar between the two groups. At clinical and angiographic follow-up, overall thrombosis rates were similar in both groups (0 vs 1.2%, P>0.05). The TLR and in-segment restenosis were not significantly different (19.1% vs 25.3%; 10.3% vs 10.8%, P=0.365 and P=0.913 respectively) between the two groups. The in-stent restenosis rate, however, was significantly higher in the PES group (4.4% vs 21.7%; P=0.002). Similarly, the late loss was significantly higher in the PES group ((0.140.38) mm vs (0.490.61) mm; P<0.001).
Conclusions  In this small sample-size, non-randomized study, the data indicated that implantation of SES for the treatment of patients with small coronary lesion showed more favorable results in respect of restenosis compared with PES implantation.

     

雷帕霉素洗脱支架治疗冠心病的近期疗效研究

目的评价冠心病患者接受雷帕霉素洗脱支架(SES)的近斯安全性及有效性。方法对160例接受雷帕霉素洗脱支架植入术患者实施即刻疗效和临床随访。结果160例中共处理病变210处,植入支架216枚。其中B2型以上复杂病变145处(69.0%),小管径支架(2.5mm~2.75mm)44例(27.5%),长支架58例(36.3%),术中无严重并发症发生,手术成功率100%。130例(81.3%)随访1~17个月,6例患者类似胸痛发作,其中3例复查了冠状动脉造影,无支架及节段内再狭窄,未发生心肌梗死及死亡。结论雷帕霉素洗脱支架治疗冠心病患者近期疗效安全有效。     

Safety and efficacy of polymer-free paclitaxel-eluting microporous stent in real-world practice: 1-year follow-up of the SERY-I registry

BackgroundPolymer coating on coronary stents induces vascular inflammatory response,reduces re-endothelialization,and affects long-term outcome after percutaneous coronary intervention (PCI).The SERY-1 registry aimed to determine whether a novel polymer-free paclitaxel-eluting microporous Yinyi stent could improve 1-year outcome after index procedure in real-world clinical practice.Methods Clinical and angiographic data and follow-up outcome were collected in 1045 patients who underwent PCI with implantation of ≥1 Yinyi stents between June 2008 and August 2009 at 27 medical centers.The primary endpoint was the cumulative rate of composite major adverse cardiac events (MACE) and the secondary endpoint was the incidence of stent thrombosis at 1 year.Results Overall,1376 lesions were treated successfully with 1713 Yinyi stents,and 1019 (98.7％) patients received dual antiplatelet therapy for at least 12 months.During 1-year follow-up,8 patients (0.78％) had cardiac death,6 (0.58％)suffered non-fatal myocardial infarction,and 46 (4.46％) underwent repeat PCI due to recurrence of angina,resulting in 1-year MACE-free survival of 94.09％.Stent thrombosis occurred in 10 (0.97％) patients,and the rate of Academic Research Consortium (ARC) definite or probable stent thrombosis was 0.78％.Conclusions Polymer-free paclitaxel-eluting microporous Yinyi stent is effective and safe for interventional treatment of coronary artery disease in real-world clinical practice,without recourse to carrier polymer.Potential long-term clinical advantages of this stent deserve further investigation.     

Loss of bifurcation patency after cross-over stenting of ostial lesions in superficial femoral artery: possible causes, prevention and reintervention

Background Crossover stenting across the origin of the profunda femoral artery （PFA） and occasionally into the common femoral artery （CFA） is commonly used after suboptimal balloon angioplasty of ostial occlusive lesions of the superficial femoral artery （SFA） involving the bifurcation. Late stent occlusion at the bifurcation is not rare and results in severe lower extremity ischemia. Therefore, we tried to assess its possible causes, prevention and reintervention. Methods Using a prospectively maintained single-center database, 12-month femoral bifurcation patency was retrospectively compared and lesion and procedural predictors of stent occlusion were determined among 63 patients （64 lesions） who between July 2011 and February 2013 underwent crossover （36 non-jailed and 15 jailed SFA, and 12 distal and 1 complete CFA） stenting of de novo ostial SFA lesions. Results Twelve-month overall patency rate at the femoral bifurcation was 88%, with no significant difference between jailed-ostial SFA （80%） and distal CFA （67%） stenting （P=0.731）, and significant differences between either and non-jailed ostial stenting （100%,P=0.035 and 0.002）. When PFA ostium was jailed by the stent, patients with preexisting CFA or PFA lesions had a 12-month bifurcation patency rate of 20%, significantly lower than those with simple ostial SFA lesions （83%, P=0.015）. Stent induced intimal hyperplasia caused bifurcation occlusion in 6 surgical reintervention cases. Conclusions In crossover stenting of ostial lesions in SFA, bifurcation patency loss was significantly higher in distal CFA and jailed ostial SFA stenting than non-jailed ostial SFA stenting. Preexisting CFA or PFA lesion is a significant risk factor for bifurcation patency loss when PFA ostium is jailed by crossover stenting.     

Clinical outcomes and cost-utility after sirolimus-eluting versus bare metal stent implantation

Background Randomized studies have shown beneficial effects of drug-eluting stent （DES） in reducing the risk of repeated revascularization. Other studies have shown higher proportion of death, myocardial infarction （MI） and increased cost concerning DES. However the long term safety and effectiveness of DES have been questioned recently.Methods To compare long term clinical outcomes, health-related quality of life （HRQOL） and cost-utility after sirolimus-eluting stent （SES） and bare metal stent （BMS） implantation in angina patients in China, 1241 patients undergoing percutaneous coronary revascularization （PCl） with either SES （n=632） or BMS （n=609） were enrolled continuously in this prospective, nonrandomized, multi-center registry study.Results Totally 1570 stents were implanted for 1334 lesions. Follow-up was completed in 1205 （97.1%） patients at 12 months. Rates of MI, all causes of death were similar between the two groups. Significant differences were found at rate of cardiovascular re-hospitalization （136 （22.4%） in BMS group vs. 68 （10.8%） in SES group, P=0.001） and recurrent angina （149 （24.5%） vs. 71 （11.3%）, P=0.001）. Dramatic difference was observed when compared the baseline and 9-month HRQOL scores intra-group （P 〈0.001）. However no significant difference was found inter-group either in baseline or follow-up HRQOL. Compared with SES, the total cost in BMS was significantly lower on discharge （62 546.0 vs. 78 245.0 Yuan, P=0.001）. And follow-up expenditure was remarkably higher in the BMS group than that in the SES group （13 412.0 vs. 8 812.0 Yuan, P=0.0001）.Conclusions There were no significant differences on death, in-stent thrombosis, MI irrespective of stent type. SES was superior to BMS on improvement of life quality. SES was with higher cost-utility compared to BMS.     

Changes of the colonic physiologic functions after colonic anastomosis with a degradable stent in a porcine model

Background A new procedure of colonic anastomosis with a degradable stent has already been proven to be simple, feasible, and safe in our porcine model. In this study, we evaluated its impact on the colonic physiologic functions. Methods A total of 20 pigs were assigned randomly to either a stent anastomosis group （SA, n=10） or a conventional anastomosis group （CA, n=10）. Colonic anastomosis with a degradable stent was performed in the SA group, and conventional hand-sewn anastomosis was performed in the CA group. Body weight, fecal weight, total colonic transit time, immunohistochemistry staining of interstitial cells of Cajal （ICC）, plasma diamine oxidases （DAO） levels, and Western blotting analysis of occludin were evaluated before and after anastomosis. Results No obvious diarrhea or constipation was observed in all pigs. No significant difference in body weight between the groups was detected at any time. Yet, the fecal weight was less in the CA group compared with the SA group on postoperative day （POD） 7. No observable colonic paralysis or retention occurred. For total colonic transit time, there was no significant difference between the two groups at any time or among different time points in the same group. The integrated optical density of ICC showed no significant difference on either POD 14 or 30. The plasma DAO levels were remarkably elevated after surgery, and began to decrease since POD 3. However, there was no significant difference between both two groups in plasma DAO levels at any time either. For both groups, the expression of occludin was not significantly different from their pre-surgery level on either POD 14 or 30. Conclusions According to these results, this procedure with a degradable stent was supposed to be the same as the conventional hand-sewn procedure in their impact on the colonic physiologic functions.     

Platelet function monitoring guided antiplatelet therapy in patients receiving high-risk coronary interventions

Background Large-scale clinical trials have shown that routine monitoring of the platelet function in patients after percutanous coronary intervention （PCI） is not necessary. However, it is still unclear whether patients received high-risk PCI would benefit from a therapy which is guided by a selective platelet function monitoring. This explanatory study sought to assess the benefit of a therapy guided by platelet function monitoring for these patients. Methods Acute coronary syndrome （ACS） patients （n=384） who received high-risk, complex PCI were randomized into two groups. PCI in the two types of lesions described below was defined as high-risk, complex PCI： lesions that could result in severe clinical outcomes if stent thrombosis occurred or lesions at high risk for stent thrombosis. The patients in the conventionally treated group received standard dual antiplatelet therapy. The patients in the platelet function monitoring guided group received an antiplated therapy guided by a modified thromboelastography （TEG） platelet mapping： If inhibition of platelet aggregation （IPA） induced by arachidonic acid （AA） was less than 50% the aspirin dosage was raised to 200 mg/d; if IPA induced by adenosine diphosphate （ADP） was less than 30% the clopidogrel dosage was raised to 150 mg/d, for three months. The primary efficacy endpoint was a composite of myocardial infarction, emergency target vessel revascularization （eTVR）, stent thrombosis, and death in six months. Results This study included 384 patients; 191 and 193 in the conventionally treated group and platelet function monitoring guided group, respectively. No significant differences were observed in the baseline clinical characteristics and interventional data between the two groups. In the platelet function monitoring guided group, the mean IPA induced by AA and ADP were （69.2＋24.5）% （range, 4.8% to 100.0%） and （51.4＋29.8）% （range, 0.2% to 100.0%）, respectively. The AA- induced IPA of forty-three （22.2%）     

Routine use of a transanastomotic stent is unnecessary for hepatojejunostomy in liver transplantation

Background  The use of transanastomotic stents for Roux-en-Y hepatojejunostomy (RYHJ) in liver transplantation (LT) remains controversial. The aim of this retrospective study was to assess the role of transanastomotic stent for RYHJ in LT.

Methods  RYHJ for biliary reconstruction in LT was performed in 52 patients. Twenty-five patients had bile duct reconstruction by RYHJ with transanastomotic stents (S group), while 27 patients underwent the same procedure without transanastomotic stents (non-S group). The two groups were compared in terms of post-LT biliary complications and survival.

Results  The incidences of bile leakage, anastomotic stricture, non-anastomotic stricture, biliary sludge/lithiasis and biliary infection were 12% (3/25), 9.5% (2/21), 23.5% (4/17), 11.8% (2/17), and 24% (6/25), respectively in the S group, and 0, 0, 20.0% (5/25), 10.0% (2/20), and 16.7% (4/24), respectively in the non-S group. One and three year survival rates were 48.0% (12/25) and 34.0% (8/23), respectively, in the S group and 57.7% (15/26) and 38.9% (7/18), respectively, in the non-S group. There was no significant difference between the two groups in terms of the incidence of various biliary complications and survival (P >0.05).

Conclusion  The routine use of transanastomotic stents is not necessary for RYHJ for biliary reconstruction in LT

     

Firebird sirolimus eluting stent versus bare mental stent in patients with ST-segment elevation myocardial infarction

Background There are few evidences about the value of drug eluting stent in patients with ST-segment elevation myocardial infarction （STEMI）. We prospectively designed a randomized controlled trial to compare the safety and efficacy of Firebird sirolimus eluting stent （Firebird stent） and bare metal stent （BMS）. Methods Patients with STEMI enrolled during one year period were randomized to undergo implantation of Firebird stent or BMS, and clinical and angiographic follow-up. The primary endpoint of the present study was in-lesion late lumen loss （LLL） at 6 months, and secondary endpoint includes stent thrombosis and major adverse cardiac events （MACE） at 6 months. Results During one year period, 156 patients were randomized into the Firebird stent group （101 patients with an average age of 57.8 years） or the BMS group （55 patients with 59.7 years on average）. Six-month angiographic follow-up was available in 66.3% and 63.7% of patients assigned to Firebird stent and BMS, respectively. At 6-month follow-up, mortality, target vessel revascularization （TVR） and MACE were 2.0%, 6.9% and 9.9% in the Firebird stent group, while 3.6%, 30.9% and 36.4% in the BMS group （P〈0.05）. Subacute thrombosis occurred in 1 patient in both groups, respectively. The mean LLL was 0.18 mm in the Firebird stent group versus 0.72 mm in the BMS group. Conclusion Implantation of Firebird sirolimus eluting stent for STEMI may greatly reduce TVR and MACE at 6 months with low incidence of acute/subacute stent thrombosis compared with BMS.     

小血管支架点状置入与雷帕霉素洗脱支架治疗小血管长病变的对照研究

目的 评价小血管支架点状置人与雷帕霉素洗脱支架治疗小血管长病变的近期以及远期疗效。方法 2002年12月至2005年8月接受经皮穿刺冠状动脉介入治疗的小血管、长病变（血管直径〈3．0mm,病变长度〉20mm）患者。根据其治疗策略分为小血管支架点状置入组（SVS组）及雷帕霉素洗脱支架组（SES组）。观察两组术后6个月时支架内再狭窄、靶病变再次血运重建（TLR）以及主要不良心脏事件（MACE）发生率。结果 共有206例患者人选,其中SVS组113例,SES组93例。两组之间基础临床及病变血管特征均无显著差异。SES组有2例病变血管迂曲、钙化,CYPHER支架不能通过,换用DRIVER支架后顺利完成手术。在随访期间SES组支架内再狭窄发生率（4．0％vs26．5％,P〈0．05）,TLR发生率（2．2％vs10．6％,P〈0．05）以及MACE发生率（3．2％vs13．3％,P〈0．05）均明显低于SVS组。结论 对于SES通过困难的小血管、长病变,可选用SVS点状置入。     

Nine-month Angiographic and Two-year Clinical Follow-up of Novel Biodegradable-polymer Arsenic Trioxide-eluting Stent Versus Durable-polymer Sirolimus-eluting Stent For Coronary Artery Disease

Background:

Despite great reduction of in-stent restenosis, first-generation drug-eluting stents (DESs) have increased the risk of late stent thrombosis due to delayed endothelialization. Arsenic trioxide, a natural substance that could inhibit cell proliferation and induce cell apoptosis, seems to be a promising surrogate of sirolimus to improve DES performance. This randomized controlled trial was to evaluate the efficacy and safety of a novel arsenic trioxide-eluting stent (AES), compared with traditional sirolimus-eluting stent (SES).

Methods:

Patients with symptoms of angina pectoris were enrolled and randomized to AES or SES group. The primary endpoint was target vessel failure (TVF), and the second endpoint includes rates of all-cause death, cardiac death or myocardial infarction, target lesion revascularization (TLR) by telephone visit and late luminal loss (LLL) at 9-month by angiographic follow-up.

Results:

From July 2007 to 2009, 212 patients were enrolled and randomized 1:1 to receive either AES or SES. At 2 years of follow-up, TVF rate was similar between AES and SES group (6.67% vs. 5.83%, P = 0.980). Frequency of all-cause death was significantly lower in AES group (0 vs. 4.85%, P = 0.028). There was no significant difference between AES and SES in frequency of TLR and in-stent restenosis, but greater in-stent LLL was observed for AES group (0.29 ± 0.52 mm vs. 0.10 ± 0.25 mm, P = 0.008).

Conclusions:

After 2 years of follow-up, AES demonstrated comparable efficacy and safety to SES for the treatment of de novo coronary artery lesions.     

药物洗脱支架与金属裸支架置入术后对糖尿病患者远期死亡、心肌梗死和支架血栓发生情况的影响

目的本研究通过比较糖尿病患者置入金属裸支架(bare metal stents,BMS)vs药物洗脱支架(drug eluting stents,DES)后发生死亡、心肌梗死(myocardial infarction,MI)、再次血运重建和支架血栓的情况,以评价糖尿病患者置入DES后的远期安全性和有效性。方法本研究于2003年7月～2005年12月连续入选了834例因冠心病合并糖尿病在首都医科大学附属北京安贞医院心内科行经皮冠状动脉介入治疗(percutaneous coronary intervention,PCI)的患者,按置入支架类型将患者分为DES组(n=583)和BMS组(n=251)。主要终点事件为24个月时全因病死率;次要终点事件为24个月时非致死性MI、再次血运重建以及主要不良心血管事件(major adverse cardiac events,MACE)的发生率。结果本研究结果经多因素回归分析显示,DES组明显降低了24个月时死亡[3.2%vs 5.1%,危险比(hazard ratio,HR)0.34,95%可信区间(confidential interval,CI)0.12～0.94,P=0.038]和心性死亡的风险(2.2%vs 4.4%,HR=0.29,95%CI:0.13～0.87,P=0.027),非致死性MI和心性死亡与非致死性MI复合终点发生风险比较差异无统计学意义;明确和可能的支架血栓的发生风险比较差异也没有统计学意义(1.9%vs 2.0%,HR=0.96,95%CI:0.51～2.17,P=0.351)。DES明显降低了再次血运重建的风险(10.5%vs 20.7%,HR=0.24,95%CI:0.11～0.78,P<0.001)和靶血管再次血运重建的风险(8.9%vs 17.1%,HR=0.33,95%CI:0.16～0.87,P<0.001);与BMS组比较DES组的MACE的风险也明显降低,差异有统计学意义(15.8%vs 27.9%,HR=0.19,95%CI:0.09～0.85,P<0.001);其主要与DES组患者的死亡和靶血管再次血运重建的风险降低有关。结论与BMS相比,DES可显著降低糖尿病患者的24个月时死亡、再次血运重建和MACE的风险,而未增加非致死性MI和支架血栓的风险。置入DES后死亡风险的降低原因,主要与DES降低再狭窄后的死亡和MI风险,获得更高的完全血运重建率以及未增加支架血栓的风险相关。