Evaluation of neointimal coverage in patients with coronary artery aneurysm formation after drug-eluting stent implantation by optical coherence tomography

Background The vessel healing in patients with coronary artery aneurysms (CAA) that form after drug-eluting stent (DES) implantation is not clear.This study aims to assess the vessel healing in patients with CAA formation after DES implanation.Methods From June 2008 to August 2011,follow-up coronary angiography was conducted on 1160 patients who underwent percutaneous coronary intervention (PCI).The average period of follow-up was about (18.95+13.05) months.A total of 175 patients who underwent DES implantation into de novo lesions and who underwent coronary angiography and optical coherence tomography (OCT) examination during follow-up were identified.Patients were divided into the CAA group (n=31) and non-CAA group (n=144) based on the results of the coronary angiography.The cardiac events including angina and acute myocardial infarction were noted; in addition,the neointimal thickness and the frequency of strut malapposition and strut uncoverage were also noted.Results A greater proportion of incomplete neointimal coverage (17.17％ vs.1.90％,P ＜0.001) and strut malapposition (18.20％ vs.1.38％,P ＜0.001) were observed in the CAA group.The neointimal thickness in the CAA group was significantly thinner than that in the non-CAA group ((146.6+94.8) μm vs.(192.5+97.1) μm,P ＜0.001),as detected via OCT.Patients with CAA formation had a higher frequency of cardiac events including angina pectoris (25.81％ vs.6.25％,P=0.001) and acute myocardial infarction (9.68％ vs.0.13％,P=0.002) and thrombosis (16.13％ vs.0.69％,P ＜0.001).The longitudinal length of the CAA in the cardiac event group was significantly longer than in the no cardiac event group ((20.0+9.07) mm vs.(12.05+5.38) mm,P=-0.005).Conclusion CAA formation after DES implantation is frequently associated with cardiac events as a result of stent malapposition and incomplete neointimal coverage.     

光学相干断层成像技术分析犬冠状动脉支架术后内膜增殖情况

目的通过和组织学分析进行对比,评价在活体应用光学相干断层成像分析犬冠状动脉支架术后内膜增殖程度的精确性。方法选取15只杂种犬为研究对象,每只犬冠状动脉植入一枚金属裸支架,3个月后复查冠状动脉造影、光学相干断层成像(OCT)、组织学分析,分别应用OCT和高倍电子显微镜定量分析内膜增殖情况,测量两组靶血管支架内膜增殖最严重处的平均内膜厚度(mm)、直径狭窄程度(%)、血管残腔面积(mm2)、新生内膜面积(mm2)、支架面积(mm2)、面积狭窄程度(%)。最终将OCT和组织学测量结果进行统计学分析。结果 15只动物均完成实验,OCT及组织学两种方法测量支架面积(mm2)差异无显著性(5.01±0.79 vs 4.99±0.81,P>0.05),OCT测量新生内膜厚度(mm)和面积(mm2)明显小于组织学测量(0.19±0.08 vs 0.22±0.10,1.52±0.49 vs 1.85±0.78,P<0.05),OCT测量残余管腔面积明显大于组织学测量(3.50±0.66 vs 3.15±0.43,P<0.05)。OCT测量新生内膜厚度(R2=0.767)、新生内膜面积(R2=0.537)和支架面积(R2=0.528)时和组织学测量有良好的直线相关性,测量残余管腔面积(R2=0.307)时直线相关性较低。所有支架金属丝均完全内皮化,无血栓、夹层及血管正性重构形成。结论在活体上,OCT能够精确并反复分析支架内膜增殖情况,而测量残腔管腔面积时,OCT和组织学分析直线相关性较低。     

Coronary plaque response after drug eluting stent implantation assessed by serial optical coherence tomography analysis

Background  In general, percutaneous coronary intervention (PCI) relieves vessel stenosis by implantation of a stent, however, the relationship between plaque characteristics and response after stenting is not clear.

Methods  We enrolled 68 patients (68 vessels) with diagnosed unstable angina pectoris that prospectively underwent PCI and an optical coherence tomography (OCT) examination was done before and after stenting. Coronary plaques were classified as fibrous, lipid-rich and calcified plaque according to OCT examination, and fibrous cap thickness, lumen eccentricity, stent expansion, stent malapposition, tissue prolapse, thrombosis, dissection and stent symmetry were noted.

Results  The frequency of prolapse was higher in lipid-rich plaques than fibrous plaques (85% vs. 40%, P <0.001). Dissection most often occurred in fibrous plaque compared with lipid-rich and calcified plaques (60% vs. 32% vs. 29%, P <0.001). The frequency of stent strut malapposition in calcified plaques was higher than firous and lipid-rich plaques (71% vs. 40% vs. 5%, P <0.001). In-stent micro-thrombosis was detected only in lipid-rich plaques, with a frequency of 37% (15/41). The risk factors of micro-thrombosis after PCI were cap thickness (OR 0.903, 95% CI 0.829–0.985), lumen eccentricity (OR 1.147, 95% CI 1.012–1.30), and stent length (OR 1.495, 95% CI 1.032–2.166).

Conclusion  Plaque response after PCI is associated with its characteristics, and of those, micro-thrombosis after stenting in lipid-rich plaques was the most significant finding and can be predicted.

     

Morphologic characteristics of late stent malapposition after drug-eluting stents implantation by optical coherence tomography follow-up

Background Late stent malapposition was frequently observed after DES implantation, which has been associated with the occurrence of late stent thrombosis due to poor neointimal coverage. This study was designed to evaluate the frequency of late stent malapposition at least 1 year after different DESs implantation by optical coherence tomography （OCT）. Methods Angiographic and OCT examinations were given to 68 patients who had received total 126 various DESs implantation for at least 1 year to detect late stent malapposition. Malapposed strut distance （MSD）, malapposed strut area （MSA）, reference lumen area （RLA） and reference stent area （RSA） were checked with off-line OCT analysis. Results Totally 26 Cypher Select stents, 15 Taxus Liberte stents, 51 Partner stents and 34 Firebird I stents were examined. Among 68 patients who underwent DES implantation, 7 patients （10.3%） had late malapposition. Average RSA, MSA and MSD were （7.9=6？..8） mm2,（2.0＋1.6） mm2 and （590_＋_270） pm respectively. According to the MSA/RSA ratio 4 patients had slight malapposition, 2 patients had moderate malapposition and 1 patient had severe malapposition. Conclusions Late stent malapposition is detected frequently after implantation of DES, but if this predisposes to late stent thrombosis and requires any specific therapy needs to be further elucidated.     

首次和重复经桡动脉冠状动脉介入术后桡动脉无鞘区急慢性损伤的光学相干断层成像比较

目的 利用光学相干断层成像（optical coherence tomography,OCT）对经皮桡动脉冠状动脉介入（transradial intervention,TRI）术后桡动脉无鞘区（non-sheathed radial artery,NSRA）急慢性损伤进行评估。方法 2016年2月至2017年9月有162例患者在OCT指导下完成TRI后对NSRA进行OCT检查,根据患者有无TRI史分为重复TRI组（n=31）和首次TRI组（n=131）,对比两组急性损伤（内膜撕裂、夹层、穿孔、血栓和痉挛）发生率和慢性损伤指标差异,包括内膜面积、管腔狭窄率（percentage of lumen narrowing,% LN）、血管内膜与中膜厚度比值（intima-media ratio,IMR）和内膜厚度指数（intimal thickness index,ITI）。结果 NSRA急性损伤发生率为31.5%,重复TRI组患者NSRA总体急性损伤发生率明显高于首次TRI组（48.4% vs 27.5%,P=0.032）,内膜撕裂（6.5% vs 5.3%,P=1.000）、夹层（9.7% vs 1.5%,P=0.075）、穿孔（3.2% vs 1.5%,P=1.000）、血栓（12.9% vs 6.9%,P=0.457）及痉挛（29.0% vs 16.0%,P=0.094）的发生率两组差异无统计学意义。重复TRI组患者内膜面积（0.59 mm² vs 0.46 mm²,P=0.011）、IMR（0.40 vs 0.28,P=0.001）和ITI（0.27 vs 0.22,P=0.012）明显大于首次TRI组,而% LN差异无统计学意义（31.70% vs 30.81%,P=0.244）。多因素Logistic回归分析显示,重复TRI是NSRA急性损伤发生的独立危险因素（OR=2.772,95%CI：1.053~7.301,P=0.039）。结论 TRI术后NSRA急性损伤发生率为31.5%,与首次TRI组相比,重复TRI组NSRA急性损伤发生率更高且慢性内膜增生显著,重复TRI是NSRA急性损伤发生的独立危险因素。     

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     

光学相干断层扫描在Vogt-小柳-原田病诊疗中的应用

目的 观察和分析Vogt-小柳-原田病的光学相干断层扫描（optical coherence tomography,OCT）的典型图像特征.方法 对23例（46眼）Vogt-小柳-原田病急性期患者进行OCT和荧光素眼底血管造影（fundus fluorescein angiography,FFA）检查,并对所得到的图像进行分析.结果 治疗前,23例患者OCT均表现为后极部程度不等的神经上皮脱离,呈“拱桥样”高度隆起,通常被薄的间隔分成几部分,呈囊样或多囊样,黄斑中心凹视网膜平均厚度为（914.64±391.30） μm.口服糖皮质激素治疗后,视网膜下液逐渐吸收,神经上皮脱离范围和高度逐渐恢复正常,最终完全吸收,浆液性视网膜脱离消失,OCT恢复正常,黄斑中心凹视网膜平均厚度为（160.88±29.49） μm,与治疗前相比,差异有统计学意义（t=8.609,P＜O.01）.结论 Vogt-小柳-原田病OCT图像的特征性表现对于该病的早期诊断很有帮助,并能够直观地呈现其视网膜组织微细结构的改变,同时为疾病的病情追踪、疗效评价及视力预后判断提供了客观定量的评价标准。     

Optical coherence tomography assessment of edge dissections after drug-eluting stent implantation in coronary artery

Background  Edge dissections after coronary stent implantation are associated with increased short-term risk of major adverse cardiovascular events. The incidence and outcome of edge dissections after coronary stent implantation were reportedly different using different imaging techniques. We used optical coherence tomography (OCT) to assess the incidence, morphological findings and related factors of edge dissections after drug-eluting stent (DES) implantation.

Methods  Totally 42 patients with 43 de novo lesions in 43 native arteries undergoing DES implantation with OCT imaging were enrolled in this study.

Results  Nine edge dissections were detected in 43 arteries after DES implantation. There were four morphological patterns of stent edge dissections indentified in this study: (1) superficial intimal tears (n=3), (2) subintimal dissections (n=4), (3) split of media (n=1), (4) disruption of the fibrotic cap of plaque (n=1). Stent edge expansion and stent expansion were both higher in the group with dissections than those in the group without dissections (1.682±0.425 vs. 1.229±0.285, P=0.0290; 1.507±0.445 vs. 1.174±0.265, P=0.0072).

Conclusions  The incidence of stent edge dissections detected by OCT was 21%. Stent edge dissection is related with stent edge expansion and stent expansion.

     

应用光学相干层析成像对大鼠舌的在体显微检测研究

目的应用自行装置的光学相干层析成像(OCT)设备对大鼠舌苔与舌苔下浅表组织进行在体的显微成像研究,为光学相干层析成像技术在中医舌诊的应用可能性与其价值进行初步的探讨。方法应用OCT,以Lab VIEW编写软件操作平台,将大鼠舌上表面进行显微成像检测,并对舌苔的某些观测内容进行量化处理;同时,与大鼠舌的常规组织切片结果进行对比性分析。结果大鼠舌表面显微成像显示:分辨率为10~20μm,深度约2 mm,能够清楚地分辨出舌苔层、舌苔舌体连接层与舌体层结构,在舌苔苔质的某些观察内容可以实现量化;OCT与组织学检测大鼠舌显微结构结果显示具有一定的相似性。结论光学相干层析成像技术在大鼠舌诊中能实现成像研究,能实现一定的量化研究,具有一定的实用性价值。     

Effects of age on ocular anterior segment dimensions measured by optical coherence tomography

Background  Older subjects tend to have smaller ocular anterior segment. The present study aimed to measure anterior segment dimensions with optical coherence tomography (OCT) and quantitatively assess the effect of age and other factors.

Methods  Anterior segment OCT images were obtained in normal subjects residing in the greater Los Angeles area. Four line scans were acquired at the 90˚, 45˚, 0˚ and 135˚ meridians of each eye. Computer calipers acquired anterior segment dimensions of corneal diameter, anterior chamber width, corneal vault and anterior chamber depth on OCT images. Measurements from 4 meridians were averaged. Axial length and corneal power were measured by partial coherence interferometry. Univariate and multivariate analyses were performed to assess correlations.

Results  Sixty-six eyes of 33 normal subjects (aged 22–65 years, 19 Asians, 14 Caucasians) were enrolled. For every 1 year of age, corneal diameter was 0.033 mm narrower (P <0.01), anterior chamber width was 0.031 mm narrower (P <0.01), corneal vault was 0.016 mm lower (P <0.01), and anterior chamber depth was 0.025 mm lower (P <0.01). Asian eyes had smaller corneal diameter (P=0.035) and anterior chamber width (P=0.015) compared with those of Caucasian eyes. Body height showed positive correlation with corneal diameter (0.039 mm per centimeter of height, P <0.01) and corneal vault (0.024 mm per centimetre of height, P <0.01). Gender did not have an independent effect on anterior segment dimensions.

Conclusions  Anterior segment dimensions were smaller in older subjects. Age-related changes may affect the tolerability of long-term implants such as phakic intraocular lens.

     

Thrombosis and morphology of plaque rupture using optical coherence tomography

Background Thrombosis following plaque rupture is the main cause of acute coronary syndrome,but not all plaque ruptures lead to thrombosis.There are limited in vivo data on the relationship between the...     

生物可降解与非可降解涂层支架临床应用的meta分析

目的对生物可降解聚合物涂层药物支架与非可降解药物洗脱支架应用于我国冠心病人群的安全有效性进行meta分析。方法通过计算机搜索国内外电子数据库,并结合文献追溯方式,收集已公开发表与生物可降解聚合物涂层药物支架（biodegradable polymer drug eluting stent,BPS）与永久聚合物涂层支架（permanent polymerdrug eluting stent,PPS）相关的临床对照研究资料,对随访末期主要不良心血管事件（major adverse cardiac events,MACE）、支架内血栓事件（stent thrombosis,ST）及支架内晚期管腔丢失（late lumen loss,LLL）情况进行meta分析,探讨BPS在我国冠心病人群中晚期应用的安全性及有效性。结果共纳入国内公开发表的研究共7篇文献,共有2 533名患者分别植入BPS及PPS。BPS与PPS两组之间,1年随访末期MACE发生差异无统计学意义（OR=0.94,95%CI：0.68～1.32,Z=0.34,P=0.74〉0.05）,1年支架内血栓事件发生差异无统计学意义（OR=1.73,95%CI：0.59～5.04,Z=1.00,P=0.32〉0.05）,随访末期血管造影支架内LLL发生无统计学差异（WMD=-0.02,95%CI：-0.24～0.19,Z=0.22,P=0.83〉0.05）。结论根据目前研究结果,BPS应用于中国人群其安全性并不劣于PPS,而以支架内LLL作为评价标准,BPS早期也并未表现出预期降低管腔丢失的优势。BPS的理论优越性尚需要随访时间更长、规模更大的临床研究来证实。     

Using optical coherence tomography to detect peripheral pulmonary thrombi

Background  Optical coherence tomography (OCT) is a new imaging technique capable of obtaining high-resolution intravascular images of small vessels and has been widely used in interventional cardiology. However, application of OCT in peripheral pulmonary arteries in patients has been seldom documented.

Methods  Three patients who were highly suspected peripheral pulmonary arteries thrombi and had undergone CT pulmonary angiography but tested negative for thrombi in peripheral pulmonary arteries were enrolled. Subsequently, OCT imaging was performed in peripheral pulmonary arteries. The patients received more than three-month anticoagulative treatment if thrombi were detected by OCT. Thereafter, OCT re-evaluation of the thrombolized blood vessels detected earlier was performed. The changes of thrombi before and after anticoagulative treatment were compared.

Results  Three patients underwent OCT imaging of peripheral pulmonary arteries. Thrombi were found in most of imaged vessels in these patients. Red and white thrombi can be differentiated, according to features of the thrombus on OCT images. After anticoagulation treatment, these patients’ symptoms and hypoxemia improved. Repeated OCT imaging showed that most thrombi disappeared or became smaller.

Conclusion  OCT may be used as a potential tool for detecting peripheral pulmonary artery thrombi and differentiating red thrombi from white ones.

     

涂层可降解与不可降解药物洗脱支架在冠状动脉疾病治疗中的对比研究

目的：比较涂层可降解药物洗脱支架（Excel）与涂层不可降解药物洗脱支架（Partner）在冠状动脉疾病治疗中的近期疗效及安全性。方法：将1315例接受药物洗脱支架治疗的冠心病患者纳入此回顾性对照研究,其中Excel组498例,Partner组817例．观察术后1年内两组患者主要不良心脏事件（MACE）及支架内血栓事件发生情况。结果：两组患者在基线资料、冠脉病变特征等方面均无统计学差异（P〉0．05）;两组患者平均置入支架直径[（2．97±0．39）mm vs（3．03±0．46）mm]及置入支架长度[（25．37±7．39）mm vs（24．57±7．11）mm]比较,差异均有统计学意义（P〈0．05）。尽管Excel组患者平均置入支架直径较小且支架长度偏长,但随访结果显示两组患者1年内主要不良心脏事件及支架内血栓事件发生情况差异均无统计学意义（2．41％vs2．69％,P〉0．05;0．60％vs0．86％,P〉0．05）。结论：涂层可降解与不可降解药物洗脱支架在冠状动脉疾病治疗中的近期疗效及安全性相似。     

视网膜脱离术前和术后黄斑区改变的光学相干断层扫描评估

目的:观察黄斑区受累及的孔源性视网膜脱离行巩膜扣带术后黄斑区的结构,并分析其与术后视力的关系.方法:术前视网膜脱离已累及黄斑区的41人纳入本次研究,均经间接眼底镜下巩膜外加压术联合或不联合环扎术视网膜成功复位,分别于术后1周、1、3、6、12个月行最佳矫正视力、眼底检查和光学相干断层扫描(OCT)检查,并进行统计学分析.结果:术后1周时,最佳矫正视力在0.05～0.50(P=0.019),OCT显示黄斑区视网膜下液完全吸收者占9.7%,好转者占41.5%,与术前相比差异有显著性(P=0.008);术后1个月时,与术后1周相比从视力恢复(P=0.084)和OCT检查视网膜下液的吸收情况上均无显著差异(P=0.053);术后3个月时,最佳矫正视力在0.1～0.6,提高2行以上者占75.6%;术后12个月时,最佳矫正视力在0.15～1.00,提高2行以上者占92.7%,与术后3月时相比,差异有显著性(P=0.025),与术后6月时相比差异无显著性(P=0.21),黄斑区网膜下液完全吸收者占95.1%,另2例也有显著好转,与术后6个月时相比差异有显著性(P=0.0019).结论:OCT的检查能够揭示临床眼底检查不能发现"亚临床型黄斑区视网膜脱离"的存在,进而为预测术前视网膜脱离已累及黄斑区的患者术后视力恢复进程以及病情解释提供帮助.     

Comparative study of optic disc measurement by Copernicus optical coherence tomography and Heidelberg retinal tomography

Background  Copernicus optical coherence tomography (SOCT) is a new, ultra high-speed and high-resolution instrument available for clinical evaluation of optic nerve. The purpose of the study was to compare the agreements between SOCT and Heidelberg retinal tomography (HRT).

Methods  A total of 44 healthy normal volunteers were recruited in this study. One eye in each subject was selected randomly. Agreement between SOCT and HRT-3 in measuring optic disc area was assessed using Bland-Altman plots. Relationships between measurements of optic nerve head parameter obtained by SOCT and HRT-3 were assessed by Pearson correlation.

Results  There was no significant difference in the average cup area (0.306 vs. 0.355 mm, P=0.766), cup volume (0.158  vs. 0.130 mm, P=0.106) and cup/disc ration (0.394 vs. 0.349 mm, P=0.576) measured by the two instruments. However, other optic disc parameters from SOCT were significantly lower compared with HRT-3. The Bland-Altman plot revealed good agreement of cup area and cup volume measured by SOCT and HRT-3. Bad agreement of disc area, rim area, rim volume and cup/disc ratio were found between SOCT and HRT-3. The highest correlations between the two instruments were observed for cup area (r²=0.783, P=0.000) and cup/disc ratio (r²=0.669, P=0.000), whereas the lowest correlation was observed for disc area (r²=0.100, P=0.037), rim area (r²=0.275, P=0.000), cup volume (r²=0.005, P=0.391) and rim volume (r²=0.021, P=0.346).

Conclusions  There were poor agreements between SOCT and HRT-3 for measurement of optic nerve parameters except cup area and cup volume. Measurement results of the two instruments are not interchangeable.

     

Local aneurysmal dilatation mimicking stent malapposition and concurrent vulnerable plaque within neointima of normal lumen after drug-eluting stent implantation: primary new findings from optical coherence tomography

Very late stent thrombosis is a life-threatening complication of implantation of drug-eluting stent (DES). The mechanisms are still unidentified. Stent malapposition is supposed to be one debated reason. Here we report a case of 33 months after DES implanted. Observed by optical coherence tomography, we detected a lipid-rich plaque with defective fibrous cap within the neointima and many local aneurysmal dilatations between stent struts, which mimic “malapposition” on the angiogram. These indicated that vulnerable plaque hidden in the neointima at the stent segment might be a potential mechanism of very late stent thrombosis after DES implantation.

     

白内障超声乳化术后黄斑区光学相干断层扫描观察

正常对照组黄斑区厚度(144.5±15.3)μm,白内障患者术前黄斑区厚度(143.9±16.8)μm,术后1周厚度(156.8±35.6)μm,术后1个月厚度(150.5±34.1)μm,超声高能量组术后1周厚度(171.6±31.5)μm,术后1个月厚度(169.8±30.5)μm,低能量组术后1周厚度(155.5±19.2)μm,术后1个月厚度(153.6±18.8)μm。13只眼出现房水中度闪光,术前厚度(142.8±10.5)μm,术后1周(196.4±35.7)μm。超声乳化白内障吸除术可导致术眼黄斑中心凹视网膜厚度增加及黄斑水肿;术中高超声能量可明显影响术后黄斑中心凹视网膜的厚度;术后黄斑中心凹视网膜厚度是预测术后视功能恢复的有效指标。     

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.