A randomized, prospective, two-center comparison of sirolimus-eluting stent and zotarolimus-eluting stent in acute ST-elevation myocardial infarction: The SEZE trial

Background  The zotarolimus-eluting stent has shown larger in-stent late lumen loss compared to sirolimus-eluting stents in previous studies. However, this has not been thoroughly evaluated in ST elevation myocardial infarction.

Methods  This was a prospective, randomized, controlled trial evaluating angiographic outcomes in patients presenting with ST elevation myocardial infarction, treated with zotarolimus-eluting stents or sirolimus-eluting stents. From March 2007 to February 2009, 122 patients were randomized to zotarolimus-eluting stents or sirolimus-eluting stents in a 1:1 fashion. The primary endpoint was 9-month in-stent late lumen loss confirmed by coronary angiography, and secondary endpoints were percent diameter stenosis, binary restenosis rate, major adverse cardiac events (a composite of cardiac death, non-fatal myocardial infarction, and target vessel revascularization), and late-acquired incomplete stent apposition.

Results  Angiographic in-stent late lumen loss was significantly higher in the zotarolimus-eluting stent group compared to the sirolimus-eluting stent group ((0.49±0.65) mm vs. (0.10±0.46) mm, P=0.001). Percent diameter stenosis at 9-month follow-up was also larger in the zotarolimus-eluting stent group ((30.0±17.9)% vs. (17.6±14.0)%, P <0.001). In-segment analysis showed similar findings. There were no significant differences in binary restenosis rate, major adverse cardiac events, and late-acquired incomplete stent apposition.

Conclusions  Compared to sirolimus-eluting stents, the zotarolimus-eluting stent is associated with significantly higher in-stent late lumen loss at 9-month angiographic follow-up in the treatment of ST elevation myocardial infarction. Although there was no significant difference in 1-year clinical outcomes, the clinical implication of increased late lumen loss should be further studied.

     

Sirolimus-eluting cobalt alloyed stents in treating patients with coronary artery disease: six-month angiographic and one-year clinical follow-up result A prospective, historically controlled, multi-center clinical study

Background  The emergence of drug-eluting stents (DES) has dramatically reduced the incidence of in-stent restenosis. This study was conducted to evaluate the safety and efficacy of sirolimus-eluting cobalt-chrome stents (Firebird 2) for treating patients with coronary artery disease.
Methods  Sixty-seven patients with de novo or non-stented restenostic coronary lesions were chosen to receive the Firebird 2 stent as the final treatment (Firebird 2 group). Another 49 consecutive patients were implanted with bare cobalt alloyed stents (Driver, Medtronic) within the previous six months and served as historical controls (control group). Baseline clinical characteristics, angiographic features, procedural results, 30-day, 6-month and 12-month clinical follow-up regarding the occurrence of major adverse cardiac events (MACE), as well as the primary endpoint of late lumen loss at 6-month angiographic follow-up were compared between the two groups.
Results  The demographic characteristics were similar between the two groups despite more patients in the Firebird 2 group who underwent previous percutaneous coronary intervention (22.4% vs 8.2%, P=0.0418) and who had diabetes mellitus (29.9% vs 12.2%, P=0.0253). In the Firebird 2 group, the mean diameter of the reference vessel was smaller ((2.79±0.46) mm vs (2.98±0.49) mm, P=0.0175) and more stents were implanted for each lesion (1.28±0.52 vs 1.10±0.30, P=0.0060). Other angiographic, procedural results and the device success rate were similar between the two groups. The MACE rate at 30-day and 3-month was the same, but significantly fewer MACE occurred in the Firebird 2 group at 6- and 12-month follow-up (1.5% vs 12.2% at 6 month, P=0.0168; 1.5% vs 26.5% at 12 month, P<0.0001). The primary endpoint of late lumen loss at 6-month angiographic follow-up was significantly reduced in the Firebird 2 group (in-stent: (0.05±0.09) mm vs (0.98±0.61) mm; in-segment: (0.05±0.18) mm vs (0.72±0.59) mm; P<0.0001) than the control group. One patient in the Firebird 2 group had in-segment restenosis (1.3%) while the rate in the control group (38.1%) was significantly higher, P<0.0001. Intravascular ultrasound examination was performed in 70.1% of patients in the Firebird 2 group and revealed that the percentage of volumetric obstruction was (1.26±1.05) %. No stent thrombosis was observed in either group at 12-month follow-up.
Conclusion  The Firebird 2 sirolimus-eluting cobalt alloyed stent is safe and feasible in treating patients with coronary artery disease.

     

First report of a novel abluminal groove filled biodegradable polymer rapamycin-eluting stent in de novo coronary artery disease: results of the first in man FIREHAWK trial

Background  Durable polymers used for first-generation drug-eluting stents (DES) potentially contribute to persistent inflammation and late DES thrombosis. We report the first in human experience with the rapamycin-eluting biodegradable polymer coated cobalt-chromium FIREHAWK stent with abluminal groove.

Methods  A total of 21 patients with stable or unstable angina, or prior myocardial infarction, with single de novo native coronary stenoses <30 mm in length in vessel sizes ranging from 2.25 to 4.0 mm were enrolled. The primary endpoint was major adverse cardiac events (MACE) at 30 days defined as the composite of cardiac death, myocardial infarction (Q and non-Q), or ischemia-driven target lesion revascularization. Secondary endpoints include device, lesion, and clinical success rates, 4-month in-stent late lumen loss by quantitative coronary angiography (QCA), proportion of uncovered or malapposed stent struts by optical coherence tomograpphy (OCT) at 4 months, and MACE at 4, 12, 24 and 36-month follow-up.

Results  Device success was 95.7%, lesion and clinical success was 100.0%. There were no MACE events at 30 days. One patient died of non-cardiac hemorrhagic stroke 5 days after index procedure. At 4 months, in-stent late loss was (0.13±0.18) mm, and complete strut coverage was 96.2% by OCT with 0.1% strut malapposition. At 4-month follow-up there was no additional MACE events, and a single target vessel (non-target lesion) revascularization.

Conclusions  The FIREHAWK abluminal groove biodegradable polymer rapamycin-eluting stent demonstrated feasibility, safety and efficacy in this first in human experience. OCT findings indicated excellent stent strut coverage 4 months after implantation. Larger studies are required to confirm whether the early FIREHAWK stent results translate into longer term restenosis and thrombosis benefits.

     

Smoking control hindered by realities in China

Background Calcified coronary lesions carry the risk of suboptimal stent expansion, subsequently leading to restenosis. The effectiveness of sirolimus-eluting stents （SES） for the treatment of calcified lesion has not been fully investigated. In the present study, therefore, we evaluated the effectiveness of SES implantation for the treatment of calcified coronary lesions.Mothods A total of 333 consecutive patients with 453 lesions were enrolled in this study. They were divided into two groups according to whether the lesion treated with SES was calcified or not; no calcification group （n=-264） and calcification group （n=-189）. Lesions treated with SES were subjected to quantitative coronary angiography （QCA） immediately and 8 months following stenting. Results Baseline clinical, demographic or angiographic characteristics were well balanced in both groups. Angiographic follow-up at 8 months, the in-stent restenosis and in-segment restenosis rates were not significantly different between the two groups; instent restenosis： 3.8% vs 4.2%; P=0.081; in-segment restenosis： 8.7% vs 10.6%, P=0.503. The target lesion revascularization （TLR） was also not significantly different between the two groups; 4.9% vs 6.9%, P=0.378. In addition, the in-stent late loss was similar in both groups; （0.16±0.40） mm vs （0.17±0.33） mm, P〉0.05. Meantime, overall thrombosis rates were also similar in both groups; 1.6% vs 1.6%, P〉0.05. Conclusion Although calcified coronary lesion was hard to stent, successful percutaneous coronary intervention with SES stenting for calcified lesions was conferred by the similar favorable results that were seen when comparing non-calcified and calcified coronary lesions.     

Modified culotte stenting for treatment of complex coronary bifurcation lesions: immediate and 9-month outcomes in a pilot studyand 9-month outcomes in a pilot study

Background  The optimal stenting strategy for the treatment of coronary bifurcation lesions (CBLs) remains uncertain. The present study observed technical feasibility and reliability, 9-month clinical and angiographic outcomes of the modified culotte stenting (MCS) in the treatment of CBLs with drug-eluting stents.

Methods  A total of 34 consecutive patients with CBLs that required stenting the parent vessel (PV), the main branch (MB) and the side branch (SB) were included. All patients were first assigned to receive MCS for CBL interventions (per MCS), and might be switched to receive the double-kissing-crush stenting (DKS) in case of temporally acute branch occlusion (per protocol).

Results  The immediate angiographic or procedural success was achieved in 33/34 (97%) lesions (patients) per MCS, 34/34 (100%) lesions (patients) per protocol with 100% successful final balloon kissing. The long-term clinical success at 9 months was 94% per MCS and 94% per protocol, only 2 patients had reoccurrence of angina but none of them needed target lesion revascularization. There were no procedure-related biomarker elevation, no in-stent thrombosis peri-procedurally and at 9-month follow-up. Quantitative coronary angiography data at 9 months showed that in-stent (6%) or in-segment (6%) binary stenosis was infrequent, and minimal lumen diameter was significantly reduced but late lumen loss was acceptable with only (0.10±0.14) mm for PV, (0.21±0.23) mm for MB and (0.27±0.32) mm for SB.

Conclusions  MCS for treatment of CBLs that required dual-stent implantation was technically easier and safer, readily to complete final balloon kissing, and was associated with high immediate success and optimal 9-month outcomes.

     

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     

Nine-month angiographic and two-year clinical follow-up of polymer-free sirolimus-eluting stent versus durable-polymer sirolimus-eluting stent for coronary artery disease: the Nano randomized trial

Background First generation drug-eluting stents （DES） were associated with a high incidence of late stent thrombosis （ST）,mainly due to delayed healing and re-endothelization by the durable polymer coating.This study sought to assess the safety and efficacy of the Nano polymer-free sirolimus-eluting stent （SES） in the treatment of patients with de novo coronary artery lesions.Methods The Nano trial is the first randomized trial designed to compare the safety and efficacy of the Nano polymer-free SES and Partner durable-polymer SES （Lepu Medical Technology,Beijing,China） in the treatment of patients with de novo native coronary lesions.The primary endpoint was in-stent late lumen loss （LLL） at 9-month follow-up.The secondary endpoint was major adverse cardiac events （MACE）,a composite of cardiac death,myocardial infarction or target lesion revascularization.Results A total of 291 patients （Nano group：n=143,Partner group：n=148） were enrolled in this trial from 19 Chinese centers.The Nano polymer-free SES was non-inferior to the Partner durable-polymer DES at the primary endpoint of 9 months （P 〈0.001）.The 9-month in-segment LLL of the polymer-free Nano SES was comparable to the Partner SES （0.34±0.42） mm vs.（0.30±0.48） mm,P=0.21）.The incidence of MACE in the Nano group were 7.6% compared to the Partner group of 5.9% （P=0.75） at 2 years follow-up.The frequency of cardiac death and stent thrombosis was low for both Nano and Partner SES （0.8% vs.0.7%,0.8% vs.1.5%,both P=1.00）.Conclusions In this multicenter randomized Nano trial,the Nano polymer-free SES showed similar safety and efficacy compared with the Partner SES in the treatment of patients with de novo coronary artery lesions.Trials in patients with complex lesions and longer term follow-up are necessary to confirm the clinical performance of this novel Nano polymer-free SES.     

Efficacy and safety of Firebird sirolimus-eluting stent in treatment of complex coronary lesions in Chinese patients: one-year clinical and eight-month angiographic outcomes from the FIREMAN registry

Background  Off-label application of drug-eluting stents (DES) during percutaneous coronary intervention (PCI) was not uncommon in daily practice, however DES in treating Chinese patients with complex lesion subset was under-investigated. The primary objective of the FIREMAN registry was to evaluate the long term efficacy and safety of the Firebird sirolimus-eluting stent (SES) in treating patients with complex coronary lesions. Here we report the mid-term of one-year clinical outcomes and eight-month angiographic follow-up results of FIREMAN registry. 

Methods  The FIREMAN registry was a prospective multi-center registry, which included 1029 consecutive patients undergoing PCI with Firebird SES implantation between September 2006 and July 2007 in 45 centers in China. The clinical follow-up was designed to be performed at 1, 6, 12, 18, 24, 30 and 36 months post index procedure, and non-mandatory angiographic follow-up at 8 months was planned. One hundred percent site monitoring was conducted.

Results  Long lesions (59.2%), multi-vessel disease (50.4%), and small vessel disease (31.6%) were mostly found in angiography. Major adverse cardiac events (MACE) occurred in 51 (5.1%) patients at 1 year clinical follow-up, including cardiac mortality in 6 (0.6%), non-fatal myocardial infarction in 11 (1.1%), and target lesion revascularization in 36 (3.5%) of the patients. Definite and probable stent thrombosis (ST) by Academic Research Consortium (ARC) definition occurred in 12 (1.36%) patients at one-year clinical follow-up. The 8-month binary restenosis rate was 5.7% in-segment and 4.3% in-stent, respectively. Late lumen loss was (0.21±0.40) mm in-segment and (0.23±0.36) mm in-stent, respectively. Furthermore, Cox regression analysis revealed that diabetes, small vessel diameter, and chronic total occlusion were independent predictors of ST.

Conclusions  The results showed that the Firebird SES was effective and safe in treating Chinese patients with complex coronary lesions and occurrence of ST rate at one-year clinical follow-up was acceptable, however further long-term follow-up was still necessary. (NCT00552656)

     

293例不同直径长支架术后3及6个月的冠脉造影随访

OBJECTIVE:To assess the acute and long-term angiographic outcome of placement of long stents with different diameters for treatment of long diffuse coronary lesions. METHODS: Acute and long-term (3-and 6-month follow-up) quantitative coronary angiographic (QCA) data were obtained from 293 consecutive patients (65.9-/+8.2 years old, including 232 male patients) with long stent placement. The patients were divided into 4 groups according to the diameter of the stent implanted: group A (diameter>/=4.0 mm, n=68), Group B (3.5 mm相似文献   

Safety and efficacy of cobalt chromium alloy based sirolimus-eluting stent with bioabsorbable polymer in porcine model

Background  First generation drug-eluting stents (DESs) were based on 316L stainless steel and coated with a permanent polymer. The vessel wall of these DESs was inflammatory and late in-stent thrombosis was reported. Hence, cobalt chromium based DES coated with a bioabsorbable polymer was an alternate choice.

Methods  Cobalt chromium based DES with bioabsorbable polymer (Simrex stent) as well as control stents (Polymer stent and EXCEL^TM stent) were implanted into porcine arteries. At a designated time, angiography, quantitative coronary angiography (QCA) analysis, histomorphometry, and electron-microscopical follow-up were performed.

Results  A total of 98 stents of all the three groups were harvested. At week 24, percent diameter stenosis (%DS), late loss (LL), and percent area stenosis (%AS) of Simrex was (12.9±0.4)%, (0.35±0.02) mm, and (24.5±4.2)%, respectively, without significant difference in comparison to commercialized EXCEL^TM stent. Slight inflammatory reaction was seen around the stent strut of Simrex, just as in the other two groups. Electron-microscopical follow-up suggested that it might take 4–12 weeks for Simrex to complete its re-endothelialization process.

Conclusions  Cobalt chromium based, bioabsorbable polymer coated sirolimus-eluting stent showed excellent biocompatibility. During 24 weeks observation in porcine model, it was proved that this novel DES system successfully inhibited neointima hyperplasia and decreased in-stent stenosis. It is feasible to launch a clinical evaluation to improve the current prognosis of DES implantation.

     

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。     

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.

     

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.

     

Is adjunctive balloon postdilatation necessary with drug-eluting stents? One center experience in Chinese patients

Background With the advent of drug-eluting stents （DES） and much lower rates of target vessel revascularization （TVR）, whether adjunctive balloon postdilatation can further optimize outcome is still unknown. The present study was to compare the outcomes of postdilatation with un-postdilatation following deployment of DES. Methods From April 2004 to September 2006, 6479 consecutive Chinese patients who underwent DES implantation, including 1769 with postdilatation （1454 male, （57.9 ± 10.8） years old） and 4710 without postdilatation （3819 male, （57.9 ± 10.6） years old） were analyzed. Clinical and angiographic follow-up was performed at 7 months. Results Compared with the un-postdilatation group, the postdilatation group had more complex lesions and larger relevant vessel diameter （RVD）. In the postdilatation group, in-stent residual restenosis was significantly improved right after the procedure （（16.80±5.88）% vs （19.60±6.07）%; P=0.000）. There was no statistical difference in the major adverse cardiac events （MACE） rate between the groups （2.9% vs 3.3%; P=0.420）, and there were also no statistical differences in death, acute myocardial infarction （AMI） and target lesion revascularization （TLR） rates in the two groups （0.1% vs 0.4%, P=0.127; 1.7% vs 1.3%, P=0.229; and 1.5% vs 2.0%, P=0.206, respectively）. The in-stent thrombosis rate was almost the same in both groups （0.5% vs 0.5%; P=1.000）. Seven months angiographic follow-up results showed that both in-stent and in-segment restenosis rates were lower in the postdilatation group （8.8% vs 15.6%, P=0.000; and 10.5% vs 17.3%, P=0.000）, and so were instent and in-segment late loss （（0.32±0.12） mm vs （0.49±0.13） mm, P=0.000; and （0.24±0.08） mm vs （0.36±0.09） mm, P=0.001 ）. Conclusion Postdilatation after DES deployment was safe and could reduce the restenosis rate, especially for more complex lesions.     

A single center investigation of bare-metal or drug-eluting stent restenosis from 1633 consecutive Chinese Han ethnic patients

Background Stents are widely used in China but the clinical impression is somehow that restenosis is less common because of the lower prevalence of coronary artery disease (CAD) and associated risk factors in Chinese populations. However, no large-sample published studies are available on angiographic stent restenosis including those of bare-metal stent (BMS) or drug-eluting stent (DES) in Chinese Han ethnic population.Mothods A total of 1633 consecutive patients with CAD who had undergone coronary stenting, quantitative coronary angiography (QCA) were retrospectively studied. At the time of stent implantation and at 7 months post-stenting 675 patients had a follow-up angiography. Statistical analysis was made with the chi-square test for categorical variables, unpaired t test for continuous variables, univariate or multivariate regression for baseline and angiographic characteristics and the Kaplan-Meier method for rate of target lesion revascularization (TLR).Results Stent restenosis was defined as ≥50% diameter stenosis in the dilated segment. A total of 675 patients with 1074 lesions were subjected to angiographic follow-up for 7 months on average. Of these lesions, 448 were implanted with BMS whereas 626 lesions with DES. At 7 months, bare-metal in-stent restenosis occured in 148 lesions (33.0%), and bare metal in-segment restenosis in 155 lesions (34.6%) in contrast to drug-eluting in-stent restenosis in 48 lesions (7.7%) and drug-eluting in-segment restenosis in 73 lesions (11.7%) (P&lt;0.001 compared with BMS respectively). Late loss in both in-stent and in segment was higher in BMS than in DES groups [(1.00±0.69) vs (0.28±0.52); (0.78±0.71) vs (0.21±0.52), P&lt;0.001 respectively]. Angulated lesion, lesion length, pre-procedural minimal luminal diameter (MLD), and BMS were independent predictors for TLR, (P&lt;0.01 respectively), whereas current smoker, ostial lesion, and stent overlapping, post-procedure in-stent MLD, lesion length, and stent types were independent predictors for in-segment restenosis (P&lt;0.01 respectively). Standard coronary risk factors such as hypertension, hyperlipidemia, diabetes, and history of CAD were not associated with a higher rate of restenosis caused by BMS or DES implantation in our Chinese Han ethnic population.Conclusions Coronary stenting including BMS or DES implantation in Chinese Han ethnic patients is associated with a restenosis rate comparable to that demonstrated in previous studies from the western countries, and predictors of stent restenosis are somehow different from those in the western population.     

Comparison of immediate and followup results between transradial and transfemoral approach for percutaneous coronary intervention in true bifurcational lesions

Background  A comparison of efficacy and safety between transradial and transfemoral approach for percutaneous coronary intervention (PCI) in bifurcations has not been done. This study evaluated feasibility of transradial PCI (TRI) and compared the immediate and followup results with transfemoral PCI (TFI) in bifurcations.
Methods  One hundred and thirty-four consecutive patients with bifurcations were treated with PCI in our hospital from April 2004 to October 2005. Of these, there were 60 patients (88 lesions) in TRI group and 74 patients (101 lesions) in TFI group. Bifurcations type was classified according to the Institut Cardiovasculaire Paris Sud Classification.
Results  TRI group had smaller stent diameter ((3.06±0.37) mm vs (3.18±0.35) mm, P=0.023) and postprocedural in-stent minimum lumen diameter ((2.62±0.37) mm vs (2.74±0.41) mm, P=0.029) than TFI, but there were not significant differences in in-stent subacute thrombosis rate (0% vs 1.0%, P=0.349),  target lesion revascularization (TLR) (0% vs 1.0%, P=0.349) following procedure and thrombosis (2.3% vs 1.0%, P=0.482), in-stent restenosis (12.5% vs  10.9%, P=0.731), in-segment restenosis (17.0% vs 14.9%, P=0.681), TLR (10.2% vs 13.9%, P=0.446) and TLR-free cumulative survival rate (89.8% vs 86.1%, P=0.787) at seven months followup. No death was reported in the two groups.
Conclusion  Transradial intervention is feasible and appears to be as effective and safe as transfemoral PCI in treatment of true bifurcational lesions.

     

Cutting balloon angioplasty for treatment of coronary in-stent restenosis: immediate results and 6-month outcomes

目的　研究切割球囊对支架内再狭窄的即刻和 6个月内随访效果。方法　 6 9例支架内再狭窄患者随机分配到切割球囊和普通球囊治疗组。切割球囊组 38例。球囊扩张前及扩张后即刻在定量冠状动脉造影和冠状动脉内超声下 ,测定相关参数。随访 6个月内临床改善及冠状动脉造影结果。研究终点包括出现心肌梗塞 ,需要冠状动脉搭桥或再介入治疗。结果　两组的手术成功率为 10 0 %。切割球囊组 1例患者扩张后在支架的远端出现夹层。平均随访 6 7± 2 3月。切割球囊组于术后 3和 6个月时的再狭窄率显著低于普通球囊组 (15 %VS 38%及 18%VS 4 3%,P均小于0 0 0 1)。扩张后即刻血管直径获得值在切割球囊组和普通球囊组分别为 1 72± 0 5 2mm和 1 15± 0 5 4mm ,而随访终点时切割球囊组的血管直径晚期丢失为 0 2 6± 0 0 5mm(3个月 )及 0 38± 0 0 6mm ,同时的普通球囊组丢失值为 0 78± 0 19mm(3个月 )及 0 89± 0 16mm。对于支架体部狭窄 ,普通球囊难以固定 ,扩张时移动明显 ,而切割球囊较易于固定 ,扩张时罕见移动。结论　切割球囊治疗支架内再狭窄效果可靠 ,安全 ,容易操作。再狭窄率低 ,手术费用相对易于患者接受 ,是一个较有前途的治疗手段。     

A comparison of clinical and angiographic outcomes after Excel bioabsorbable polymer versus Firebird durable polymer rapamycin-eluting stent for the treatment of coronary artery disease in a “real world” setting: six-month follow-up results

Background Several clinical trials have shown that rapamycin-eluting stents significantly reduce the risk of restenosis after percutaneous coronary intervention (PCI). The Firebird stent and the Excel stent (coated with bioabsorbable polymer) are two different types of rapamycin-eluting stents made in China, both have been recently approved for clinical use in China by State Food and Drug Administration. However, it is unclear whether there are differences in safety and efficacy between the two types of stents in daily practice. Methods In the month of June 2006, a total of 190 consecutive patients were treated exclusively with Firebird stents (n=93, Firebird group) or Excel stents (n=97, Excel group) in our center and were included in this study. The frequency of major adverse cardiac events (MACE, a composite of death, myocardial infarction or target lesion revascularization), binary restenosis, and late lumen loss and stent thrombosis during a six-month follow-up period were compared between the two groups.Results Patient and lesion characteristics were comparable between the groups. Major adverse cardiac event rates were low in hospital and at 6 months (2.1% in the Excel group and 0% in the Firebird group, P﹥0.05). The 6-month angiographic in-stent restenosis rate was 0% in both groups, with an associated late loss of (0.15 ± 0.21) mm versus (0.14 ± 0.20) mm (P=0.858) and the in-segment restenosis rate was also 0% for the Excel group and the Firebird group. There was no definite stent thrombosis identified in either group during the six-month follow-up period and only one patient in the Excel group had probable stent thrombosis in hospital. Conclusions Results from this mid-term, single-center study showed that both of the Firebird and the Excel rapamycin eluting stent had similar effects on reducing the incidence of MACE and the risk of restenosis (both in-stent and in-segment binary restenosis) after PCI in daily practice.     

冠状动脉弥漫性长病变的介入治疗

目的:评价冠心病患者应用长支架及多个支架序贯置入进行经皮冠状动脉介入治疗(PCI)的临床疗效。方法:对164例冠心病患者的284支靶病变血管进行了PCI,其中194支(68.3%)为弥漫性长病变,平均靶病变狭窄93.8%±8.7%。A组59例:1支靶病变血管置入单个长支架20~36mm;B组105例:至少1支靶病变血管为多个支架相连接(2~5个)。结果:A、B二组长病变置入支架的平均总长度分别为23.1±10.1mm,28.8±10.5mm(P<0.05);A、B组的PCI手术成功率均为100%,恢复TIMI 3级血流分别为93.6%、96.1%,手术即刻残余狭窄率分别为1.7%、2.1%,住院期间心血管病事件(MACE)发生率分别为3.4%、2.9%,二组间上述各项数值统计学无显著差异(P>0.05)。平均随访11.8个月,A组随访58例,MACE发生率为8.6%,无事件生存率为93.1%(54/58);B组随访101例,MACE发生率为11.9%,无事件生存率为83.8%(88/105),二组间比较,统计学无显著差异(P>0.05)。结论:冠心病患者的弥漫性长病变,应用长支架或多个支架序贯置入进行PC I,临床疗效均较好。     

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.