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.     

无保护左主干病变应用药物洗脱支架介入治疗的预后及影响因素分析

目的评价无保护左主干病变应用药物洗脱支架介入治疗的预后及影响因素。方法 45例无保护左主干病变患者接受经皮冠状动脉介入治疗（PCI）,根据病变是否累及左主干远端分叉分组,开口或体部病变为非分叉组（26例）,累及左主干远端或前降支、回旋支开口者为分叉组（19例）。15例患者术中应用血管内超声指导,13例在术后（9.5±6.3）个月进行了冠状动脉造影复查。结果 45例患者经治疗后均达到操作成功标准。术后42例患者获得随访,随访时间13～48个月。分叉组随访期间再发心绞痛率明显高于非分叉组（P〈0.05）,但两组主要心脏不良事件（MACE）发生率比较差异无统计学意义（P〉0.05）。对MACE单因素分析发现,术中血管内超声指导患者MACE发生率明显低于未应用血管内超声指导患者（P〈0.05）。13例术后复查患者4例发生支架内再狭窄,均发生在分叉组,且双支架术再狭窄率明显高于单支架（P〈0.01）。结论经选择的无保护左主干病变药物洗脱支架治疗是可行和安全的,可取得较好的近远期效果,术中应用血管内超声指导可明显减少MACE的发生。     

Clinical outcomes after recanalization of a chronic total occluded vessel with bifurcation lesions: results from single-center, prospective, chronic total occlusion registry study

Background  Stenting strategies and clinical outcomes of bifurcation lesions in a chronic total occlusion (CTO) vessel after successful recanalization remain to be unknown.

Methods  Between January 2001 and December 2009, 195 (41.1%) patients with 254 (47.0%) bifurcation lesions in CTO vessels from a pool of 564 patients with 659 CTO lesions were included and divided into proximal (n=134) and distal (n=120) groups, according to the location of the bifurcation lesions. The primary endpoint was the occurrence of major adverse cardiac events (MACE) at the end of clinical follow-up, including cardiac death, myocardial infarction, or target vessel revascularization (TVR).

Results  Collaterals with Rentrop class 3 were seen more in distal group (100% and 68.3%), compared to proximal group (76.9% and 45.6%). Two-stent technique for proximal bifurcation lesions was used in 24.6%, significantly different from the distal group (6.7%, P <0.001), without significant difference in composite MACE between proximal and distal groups, or between one- and two-stent subgroups in proximal group. The composite MACE after 1-year in complete revascularization subgroup was 17.9% relative to 29.6% in the incomplete revascularization group (P=0.044). Stents in long false lumen in main vessel were mainly attributive to decreased TIMI grade flow, with resultant increased in-stent restenosis, total occlusion, TVR and coronary aneurysms. Imcomplete revasculzarization (HR 2.028, P=0.049, 95% CI 1.002–4.105) and post-stenting TIMI flow (HR 6.122, P=0.020, 95% CI 1.334–28.092) were two independent predictors of composite MACE at the 1-year follow-up.

Conclusions  Two-stent was more used for proximal bifurcation lesions. No significant difference was observed in MACE between proximal and distal, or between one- and two-stent subgroups in the proximal group. Placement of a safety wire was critical for proximal bifurcation lesions. Complete revascularization was mandatory to improve clinical outcomes.

     

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.

     

Comparison of drug eluting stents with bare metal stents in daily practice for bifurcation lesions in Chinese patients

Background Recently, numerous randomized and controlled trials have demonstrated great advantages of drug eluting stents (DES) with respect to significant reduction of restenosis and recurrence of symptoms and improvement of clinical outcomes after percutaneous coronary intervention (PCI). Little is known about the comparative effects between DES and bare metal stents (BMS) for bifurcation angioplasty in the Chinese population. We compared the inpatient and 7-month follow-up outcomes between DES and BMS for the treatment of bifurcation lesions. Methods From April 2004 to October 2005, 291 Chinese patients [85.9% male, mean age (57.8±10.4) years] underwent DES (387 lesions) and/or BMS (297 lesions) implantation for bifurcation lesions. Clinical and angiographic follow-up was performed at 7 months. Results Compared with BMS group, patients in DES group had significantly lower rates of restenosis at main branch (9.5% vs 28.7%, P < 0.001) or side branch (14.5% vs 37.0%, P < 0.001) and major adverse cardiac events (MACE) (14.0% vs 26.3%, P = 0.000). The occurrence rate of late in-stent thrombosis did not differ between the two groups in both main (0.8% vs 0, P = 0.224) and side branches (1.4% vs 0, P = 0.198). Target lesion revascularization (TLR) was less frequent in DES group for main branch (8.3% vs 21.3%, P < 0.001) and for side branch (7.6% vs 23.5%, P < 0.001). Multivariate regression analysis revealed that total stent length (OR = 1.029, P = 0.01), postprocedural in-stent minimum lumen diameter (OR = 0.476, P = 0.03) and stent type (OR = 3.988, P = 0.0001) were independent predictors of TLR for main branch. Prior history of coronary intervention (OR = 2.424, P = 0.041), angulated lesion (OR = 2.337, P = 0.033), postdilation (OR = 0.267, P = 0.035) and stent type (DES vs BMS, OR = 5.459, P = 0.000) were independent predictors of TLR for side branch. Conclusion The implantation of DES may be associated with greater reduction of restenosis and TLR than BMS in bifurcations angioplasty.     

必要时T支架术边支开口优化治疗冠状动脉分叉病变的初步临床研究

目的 比较真性分叉病变患者主支支架植入后有无边支开口优化(OOT)的1年临床效果. 方法选取真性分叉病变介入治疗连续性患者45例,按主支支架植入后有无OOT分为OOT组(OOT,n=22)和无OOT组(non-OOT,n=23).比较2组术前、术后即刻及术后9~12月冠状动脉造影结果及1年内主要心血管不良事件(MACE)发生例数. 结果 2组基线特征可比(P>0.05).术后1年造影显示:non-OOT 组主支、边支支架内最小管腔直径小于OOT组[主支:(2.36 ± 0.35)mm vs(2.64 ± 0.42)mm,P= 0.024;边支:(1.66 ± 0.38)mm vs (2.23 ± 0.44)mm,P<0.01],主支、边支再狭窄率也高于OOT 组[主支:(22.69 ± 6.81)% vs(13.32 ± 3.61)%, P<0.01;边支:(32.35 ± 13.99)% vs(13.71 ± 3.69)%,P<0.01].1年随访期间,non-OOT 组和OOT 组分别发生3例和1例M ACE(P>0.05). 结论 在冠状动脉真性分叉病变的介入治疗中,以必要时T支架术为起始治疗策略者,OOT技术可降低主支和边支血管再狭窄.     

Comparison of short- and mid-term outcomes between CYPHER and TAXUS stents in patients with complex lesions of the coronary arteries

Background Drug-eluting stent （DES） could obviously reduce in-stent restenosis, which has been proved by international multi-center clinical trials. However, the types of the lesions for stenting were highly selected in these trials. Up to now, there has been no large scale study on the effect of DES in treating complex lesions in real world. Although REALITY trial was just reported during American College of Cardiology Congress 2005, the entry criteria for lesions were limited to one or two de novo lesions. This study was conducted to compare the short- and mid-term clinical outcomes between sirolimus-eluting stent （CYPHER stent） and paclitaxel-eluting stent （TAXUS stent） in patients with complex lesion. Methods This is a retrospective study. From April 2002 to June 2004, a total of 1061 patients were treated with DES in Fu Wai Hospital, of which, 611 patients （642 lesions with 698 CYPHER stents） were in CYPHER group, and 450 patients （534 lesions with 600 TAXUS stents） were in TAXUS group. There was no significant difference in clinical data and lesion types between CYPHER group and TAXUS group. Results Success rates of stent implantation were 99.2% and 98.8% in CYPHER and TAXUS stent groups respectively. The major adverse cardiac events （MACE） during in-hospital and 6-8-month follow-up were 0.7% and 2.3% in CYPHER stent group versus 1.3% and 3.2% in TAXUS stent group. There was no significant difference in MACE rate between these two groups. Restenosis rate was a little higher in TAXUS stent group than that in CYPHER stent group （14.0% vs 7.3%）, but there was no significant difference. The incidence of acute occlusion of side branch after implanting DES in main vessel was 6.9% in CYPHER group and 11.9% in TAXUS group （P〈0.05） . Conclusions CYPHER and TAXUS DES were safe and effective in patients with complex lesion. Clinical outcomes of CYPHER stent were better than TAXUS stent in bifurcation lesions. There was an increasing tendency in restenosis rate and late thrombosis in TAXUS group as compared with that of CYPHER group.     

冠状动脉支架术治疗416例择期无保护左冠状动脉主干病变的2年随访

目的探讨冠状动脉支架术治疗择期无保护左冠状动脉主干（ULMCA）病变的安全性和术后平均2年的临床效果。方法回顾分析1997年9月至2007年1月在沈阳军区总医院接受冠状动脉支架植入术的416例ULMCA的病例资料。结果治疗对象中病变位于远端分叉处291例（70．0％）。ULMCA靶病变共植入支架503枚,人均植入支架（1．2±0．7）枚。支架植入成功率99．5％,住院期间无死亡病例,靶病变重建2例,主要不良心脏事件（MACE）发生率0．5％（2／416）。随访期内共死亡16例（3．9％）,其中心源性死亡12例（2．9％）。造影随访136例（33．1％）,靶病变发生再狭窄20例（再狭窄率14．7％,20／136）,其中14例行冠状动脉搭桥术,6例植入药物洗脱支架。ULMCA病变择期行PCI后总的MACE发生率为8．3％（34／411）。结论冠状动脉支架术治疗择期无保护ULMCA病变的技术成功率、围术期安全性均较高,平均随访2年疗效较好。降低PCI术后再狭窄和MACE发生率的有效策略（如药物洗脱支架的选择和植入方法等）值得进一步探讨。     

简单和复杂支架技术治疗主要冠状动脉分叉病变的临床疗效

目的：比较简单支架技术与复杂支架技术治疗主要冠状动脉分叉病变的临床疗效。方法：自1998年1月至2002年6月间我院共完成38例主要冠状动脉分叉病变，其中28例采用对吻球囊技术对主支和边支预扩张，仅主支内植入支架为简单支架术A组；10例采用“T型”或“Y型”支架技术，分别在边支和主支均植入支架为复杂支架术B组，随访6个月以上，记录主要不良心脏病事件（心绞痛、急性心肌梗死，急诊搭桥，心源性死亡）。结果：两组患之间基础临床情况及造影血管特征无显著差异，A组主支成功率为100％，边支成功率为89．3％（25／28例）3例边支因残余狭窄＞50％，随即植入支架获得成功：B组支架成功率为100％，3例因边支在球囊扩张后残后余狭窄轻，主支植入支架后边支残余狭窄＜50％，未植入支架，随访期间A组再发心绞痛5例（5／28，17．85），B组再发绞痛2例（2／7，28．6％），两组均无其他不良心脏事件发生，结论：复杂支架技术在治疗主要冠状动脉分叉病变的疗效方面并不优于简单支架技术。     

植入金属裸支架治疗急性冠脉综合征患者的长期疗效与安全性随访研究

目的　探讨植入金属裸支架（BMS）治疗急性冠脉综合征（ACS）患者的长期疗效和安全性。方法　选择2000—2005年北华大学附属医院住院植入BMS随访资料完整的ACS患者491例为研究对象,均行经皮冠状动脉介入治疗植入BMS。经住院冠状动脉造影随访、门诊随访或电话随访,记录主要终点事件。结果　平均随访（95±39）个月,随访期间累积171例发生主要心脏不良事件（MACE）,MACE发生率为34.83%,年均MACE发生率为4.38%。死亡68例（13.85%）,靶病变血管重建71例（14.46%）,靶血管重建28例（5.70%）,晚期支架内血栓（LST）和极晚期支架内血栓（VLST）0例,心力衰竭2例（0.41%）,冠状动脉旁路移植2例（0.41%）。发生支架内再狭窄106例（21.59%）,支架节段内再狭窄60例（12.22%）,支架内再狭窄合并支架节段内再狭窄127例（25.87%）。结论　植入BMS治疗ACS患者,远期MACE、LST、VLST发生率较低,安全性较好。     

国产药物洗脱支架对冠心病小血管病变介入治疗近中期疗效研究

目的 探讨国产药物洗脱支架（Firebird）对冠心病小血管病变介入治疗的安全性和近中期临床效果。方法 对2005年10月～2006年10月于我院进行药物支架介入治疗的114例（Firebird支架56例,Gypher支架58例）冠心病小血管病变患者进行随访观察6～10个月,并重复造影评价再狭窄及血管重建情况。结果 支架置入成功率为100%,术中无急性血栓形成、急性血管闭塞及死亡。临床随访及复查造影显示,Firebird组支架内再狭窄患者5例（8.9%）,3例（5.4%）再次血管重建治疗,其中1例（1.8%）患者进行了外科血管重建治疗。Cypher组支架内再狭窄患者5例（8.6%）,2例（3.4%）再次血管重建治疗。结论 应用国产药物洗脱支架（Firebird）对小血管病变进行介入治疗,具有良好的安全性和满意的近、中期疗效。     

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.

     

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)

     

COMPARISON OF SHORT- AND LONG-TERM OUTCOMES BETWEEN CYPHER AND TAXUS DRUG-ELUTING STENTS FOR IN-STENT RESTENOSIS

IN-STENT restenosis (ISR) is the overriding factorthat influences therapeutic effect of interventionaltherapy.Although balloon dilation, especially for thecutting balloon, showed some effects on ISR lesions, therestenosis rate after balloon dilation remai…     

Hemodynamic change in wall shear stress in patients with coronary bifurcation lesions treated by double kissing crush or single-stent technique

Background  Fluid dynamic mechanisms attributed to coronary bifurcation lesions remain a subject of study. The present study aimed at investigating the hemodynamic change of wall shear stress (WSS) in patients with coronary bifurcation lesions treated by double kissing (DK) crush or one-stent with final kissing balloon inflation (FKBI).

Methods  Eighty-one patients with bifurcation lesions treated by stenting who had 3-D model reconstruction were studied. The bifurcation vessels were divided into main vessel (MV), main branch (MB), side branch (SB), and polygon of confluence (POC). MB and SB were classified by internal- and lateral-subsegments, respectively.

Results  The baseline magnitude of WSS in proximal MV, POC-MV, POC-MB, POC-SB and MB-internal segments increased significantly, compared to MB-lateral, SB-internal and SB-lateral. DK crush had the potential of uniformly reducing WSS, turbulent index and the WSS gradient. The WSS value at the POC-SB and SB in the one-stent group remained higher. The turbulent index and WSS gradient between the POC-SB minus the SB-lateral had equal predictive values for in-stent restenosis (ISR).

Conclusion  Fluid dynamic results favor the use of DK crush over the one-stent technique.

     

Crush stenting in treating coronary bifurcate lesions: paclitaxel eluting stents versus sirolimus eluting stents

Background Because no data regarding the comparison of crush stenting with paclitaxel （PES） or sirolimus eluting stents （SES） for coronary bifurcate lesions have been reported, we compared the clinical outcomes of these two types of stents. Methods Two hundred and thirty patients with 242 bifurcate lesions were enrolled in a prospective, nonrandomized trial Primary endpoints included myocardial infarction, cardiac death and target vessel revascularization at 8 months. Results All patients were followed up clinically and 82% angiographically at 8 months. Final kissing balloon inflation was performed in 72% in the PES and 75% in the SES groups （P〉0.05）. Compared to the SES group, PES group had a higher late loss and incidence of restenosis （P=0.04） in the prebifurcation vessel segment. The postbifurcation vessel segment in the PES group had a greater late loss （（0.7±0.6） mm vs （0.3±0.4） mm, P〈0.001） and higher restenosis in the side branch （25.5% vs 15.6%, P=0.04） when compared to the SES group. There was significant difference of insegment restenosis in the entire main vessel between PES and SES groups （P=0.004）. Target lesion revascularization was more frequently seen in the PES group as compared to the SES group （P=0.01）. There was significant difference in the accumulative MACE between these two groups （P=-0.01）. The survival rate free from target lesion revascularization was significantly higher in the SES group when compared to the PES group （P〈0.001）. Conclusion SES is superior to PES in reducing restenosis and target lesion revascularization by 8-month follow-up after crush stenting for bifurcate lesions.     

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.

     

Comparison of paclitaxal vs. sirolimus eluting stents with bio-degradable polymer for the treatment of coronary bifurcation lesions: subgroup analysis from DKCRUSH-I and DKCRUSH-II studies

Background  The difference in clinical outcome between paclitaxal-eluting stents (PES) and sirolimus-eluting stents with bio-degradable polymer (SES-BDP) for bifurcation lesions remains unclear. The present study aimed to investigate the one-year clinical outcome after DK crush stenting using PES (Taxus^TM) vs. SES-BDP (Excel^TM) from our database.

Methods  A total of 275 patients (90 from the DKCRUSH-I and 185 from the DKCRUSH-II study) were studied. The primary endpoint was the occurrence of major adverse cardiac events (MACE) at 12 months; including cardiac death, myocardial infarction (MI), or target vessel revascularization (TVR). The rate of binary restenosis and stent thrombosis served as secondary endpoints.

Results  At follow-up, minimal luminal diameter (MLD) in the Taxus group was (2.11±0.66) mm, with resultant increased target lesion revascularization (TLR) 12.2% and TVR 14.4%, significantly different from the Excel group; (2.47±0.56) mm, P <0.001, 3.2%, P=0.006, 4.9%, P=0.019, respectively. As a result there was a significant difference in MACE between the Taxus (20.0%) and Excel (10.3%, P=0.038) groups. Overall stent thrombosis was monitored in 11 patients (4.0%), with five in the Excel group (2.7%) and six in the Taxus group (6.7%). All stent thrombosis in the Excel group was classified as early, and all were defined as late in the Taxus group.

Conclusion  The Excel stent had lower rate of stent thrombosis, TLR, TVR, and composite MACE at 12-month after an indexed stenting procedure, compared to the Taxus stent.

     

球囊支架对吻术治疗冠状动脉分叉病变的疗效观察

目的 观察球囊支架对吻术治疗冠状动脉分叉病变的临床疗效。方法 连续入选2015年5月至2016年4月45例于同济大学附属东方医院心内科行球囊支架对吻术的冠状动脉分叉病变的患者,观察患者的临床特点、术中病变特点及术后影像学及短期临床事件情况的发生。结果 45例患者共有48处分叉病变处成功进行了球囊支架对吻治疗。其中大多数病变为(70.8%)为Medina1,1,1型。术后即刻TIMI3级血流,主支为100%,分支为96%。2例患者边支置入支架。术中边支内被拘禁的导丝及球囊均能顺利撤出。住院期间及出院1月内无明显的主要心脏不良事件发生。结论 在单支架方法(必要时分支置入支架)治疗分叉病变时,球囊支架对吻术是一种可行、有效的技术,能有效降低边支闭塞的风险,降低住院期间的主要心脏不良事件的发生率。     

Short and long-term outcomes of two drug eluting stents in bifurcation lesions

Background Because no large prospective studies are available, this study evaluated the clinical outcomes of two drug eluting stents in bifurcation lesions. Methods Lesions with diameter of side branch ≥2.5 mm were selected. From October 2003 to June 2005, 112 patients with 113 bifurcation lesions were treated by two drug eluting stents （DESs）, technique. The location of bifurcation lesions were left anterior descending coronary artery/diagonal in 62 patients, left main distal bifurcation in 32, left circumflex coronary artery/obtute marginal branch in 18 and right coronary artery distal bifurcation in 1. Procedures for bifurcation lesions were crush or modified crush technique in 64, ＂T＂ stenting technique in 27, modified ＂Y＂ stenting, kiss stenting, ＂V＂ stenting as well as culotte stenting technique in 11, 5, 3 and 3, respectively. Among 226 lesions, 91 Cypher or Cypher select stents, 74 TAXUS and 67 Firebird were used. Final kiss balloon dilation was performed in 60 （93.7%） with crush technique after stenting. Results Success rate of percutaneous coronary intervention for the bifurcation lesions was 100%. One patient, who developed inhospital acute myocardial infarction due to subacute thrombosis, was successfully treated by a second intervention. Major adverse cardiac events rate in-hospital was 0.89% （1/112） and during followup was 7.14% （8/112）, No death occurred during the followup of all patients. Angiographic followup was effected for 46 patients, restenosis for eight, coronary artery bypass grafting for 1 and a repeat intervention for 5. Restenosis involving TAXUS, Cypher and Firebird was 5 （5/18, 27.8%）, 2 （2/17, 11.8%） and 1 （1/11, 9.1%）, respectively （P〉0.05）. Total restenotic rate was 17.4% （8/46）. Conclusions When ostium of side branch has severe stenosis and 〉12.5 mm in diameter, two-stent strategy in this bifurcation lesion is safe and effective, and the outcomes are satisfactory. Restenotic rates were not different between TAXUS, Cypher and Firebird DESs.