地塞米松涂层支架治疗小直径冠状动脉病变的初步研究

目的　评价以磷酸胆碱为载体的地塞米松涂层支架 (PC MATRIX)治疗小直径冠状动脉病变的临床效果。方法　前瞻性分析了 82例患者 10 6枚小直径支架置入的临床成功率、心脏事件(MACE)及远期疗效。PC MATRIX支架组 4 1例 (支架 5 4枚 ) ,PC支架组 4 1例 (支架 5 2枚 )。结果　两组患者手术成功率均为 10 0 % ,PC MATRIX支架组的MACE率为 9 8% ,PC支架组为 2 2 0 % ;临床再狭窄率分别为 4 9%和 2 3 0 % ;造影再狭窄率分别为 6 2 %和 2 9 7% ,两组间统计学差异有显著性。结论　PC MATRIX支架治疗小直径冠状动脉病变的手术成功率高 ,术中、术后严重的心脏事件发生率低 ,并可能降低冠状动脉小血管病变支架再狭窄发生率。     

Initial and follow-up results of the BiodivYsio phosphorylcholine coated stent for treatment of coronary artery disease.

BACKGROUND: The BiodivYsio stent is coated with a phosphorylcholine containing copolymer to confer biocompatibility. The present study was designed to assess the safety and efficacy of this coronary stent for the treatment of native coronary artery lesions in patients with coronary artery disease. METHODS AND RESULTS: From August 2001 to April 2003, 130 patients with lesions were treated with this stent. Elective stenting (ES) was performed in 90 patients and bailout stenting (BS) was performed in 40 patients with small vessels. Pre-interventional reference diameter, minimal lumen diameter (MLD), and lesion length were 2.68+/-0.51, 1.00+/-0.30, 12.78+/-4.32, respectively, and post-interventional MLD was 2.24+/-0.45 mm. The initial success rate was 100%. However, 2 non-Q-wave myocardial infarctions (non-QMI) occurred post-procedurally due to branch occlusion. A 6-month follow-up was performed. No subacute thrombosis occurred. In the ES group, 1 non-QMI occurred after the interventional procedure in another vessel. There was no death or coronary artery bypass grafting (CABG). The angiographic restenosis rate was 15.6%. In the BS group, there was no death, myocardial infarction or CABG. The angiographic restenosis rate was 17.5%. CONCLUSION: The BiodivYsio stent is safe and effective as a primary device for the treatment of native coronary artery lesions, especially in small vessels.     

A prospective multicentre registry of the procedural and long-term clinical and angiographic results of stent implantation using a Dylyn coated coronary stent system

OBJECTIVES: A prospective registry was performed to evaluate the safety and efficacy of a Dylyn coated coronary stent.BACKGROUND: Diamond-like nanocomposite (Dylyn) stent coating is thought to be biocompatible, resulting in decreased thrombogenicity and decreased neointimal hyperplasia.METHODS: In a multicentre, open, prospective, clinical and angiographical registry, the Dylyn-coated stent system was evaluated in patients requiring percutaneous coronary intervention. The primary procedural and angiographical endpoint of the study was the sustained success of stent-implantation using a follow-up catheterisation at six months. The primary clinical endpoint of the study was the composite incidence of death, non-fatal myocardial infarction and revascularisation at six months after stent implantation. RESULTS: 127 Dylyn coated coronary stents were implanted in 121 patients. Procedural success was obtained in 100% of the cases. No episodes of acute stent thrombosis occurred. The number of patients with instent restenosis at six months was 29 (24%). The primary procedural, angiographical endpoint was achieved in 91 (70%) patients. The clinical results at six-month follow-up were favourable with a MACE-rate of 7.4%. CONCLUSIONS: A Dylyn coated coronary stent system is well tolerated and has excellent short-term results. The amount of angiographic restenosis at 6 months, however, is considerable, but comparable to other non-drug-eluting stent systems. (Int J Cardiovasc Intervent 2004; 6: 137-141)     

Italian BiodivYsio open registry (BiodivYsio PC-coated stent): study of clinical outcomes of the implant of a PC-coated coronary stent

Rapid technological developments have made new materials available for percutaneous coronary intervention procedures. The coronary stent in particular has undergone progressive structural improvements leading to the recent availability of a third generation of stents, namely, coated stents. The rapid evolution of the stent has often made its evaluation problematical, since trials are frequently confined to small groups of patients in single centers. The purpose of this registry was to verify the safety and efficacy of the BiodivYsio stent (a stent coated with phosphorylcholine polymer) in a broad population of patients who reflect the daily reality of coronary intervention in a cardiac catheterization laboratory. METHODS AND RESULTS: The registry was designed to collect the principal angiographic and clinical data of a consecutive series of Oreal worldO patients. Patients were treated with a BiodivYsio stent (Biocompatibles, Galway, United Kingdom) in 12 centers (11 Italian and 1 Swiss) between January 1998 and January 1999. Procedural, in-hospital, 30-day and six-month follow-up data were collected. The monitoring, data entry and statistical analyses were carried out by an independent center. During the study, 218 patients were enrolled; 165 (76%) male and 53 (24%) female, with an average age of 61.6 +/- 9.4 years (range, 36Eth 84 years). A total of 258 stents were implanted in 233 lesions (1.1 stents per lesion), of which 233 (90%) were the BiodivYsio PC coated stent, the remaining 25 implants were of other stent types. The percutaneous transluminal coronary angioplasty and stenting procedure were carried out in 109 (50%) patients with unstable angina, 65 (30%) with stable angina, 29 (13%) with acute myocardial infarction, and 15 (7%) patients with silent ischemia. Procedural success was achieved in 217/218 (99.5%) patients. Optimal results were achieved in 212 (97.7%) patients. In 34 (15.6%) cases, patients were treated with periprocedural abciximab. During the hospitalization period, one (0.4%) death occurred on day 7 due to subacute occlusion of the stent, and 3 (1.4%) myocardial infarctions were reported. At 30-day follow-up, 211 (97.2%) patients were asymptomatic, as were 189 (87%) patients at clinical follow-up at 6 months. CONCLUSIONS: This study evaluated the safety and efficacy of a third-generation stent. The results demonstrate a high procedural success rate and a low incidence of major adverse cardiac events at short- and medium-term follow-up. It appears that the BiodivYsio stent should be considered safe in clinical and/or anatomical situations with a high risk of complications, confirming the hypothesis that PC may have non-thrombogenic properties. To corroborate these results, an appropriately designed study would be required to measure the stentOs efficacy in the most suitable clinical context, i.e., clinical situations that are at the highest risk of ischemic relapse.     

Clinical and angiographic outcome after angiography-guided stent placement in small coronary vessels

BACKGROUND: Although it is widely accepted that stenting confers favorable angiographic and clinical results in coronary arteries >/=3.0 mm in diameter, the outcome of stent placement in smaller vessels remains largely unclear. METHODS AND RESULTS: We sought to specifically determine the early and long-term clinical outcomes in a large series of 197 consecutive patients who underwent stent placement in 207 vessels <3.0 mm in diameter. Procedural success, accomplished in 97.3%, was accompanied by a significant reduction in lesion severity from 85% +/- 9% before to 3% +/- 7% diameter stenosis after the procedure (P =.0001) and a 0.5% incidence of subacute stent thrombosis. At 1 and 2 years of follow-up, survival rate without major target lesion-driven events was observed in 77.3% and 73.9% of patients, respectively. Repeat revascularization procedures accounted for most of these events; cardiac deaths (including those related to subacute stent thrombosis) and late (>30 days) myocardial infarctions were infrequent (2.4% and 1.0%, respectively). The 6-month angiographic binary instent restenosis rate was 30.1%. On multivariate analysis, diabetes mellitus (P =. 0275), small baseline reference vessel size (P =.0300), and stent size 相似文献   

小血管支架术290例临床疗效观察

目的　观察小血管支架术手术成功率、术后即刻效果、术后主要临床不良事件发生情况及远期再狭窄率。方法　观察我院 1997年 4月至 2 0 0 2年 3月所纳入的 2 90例小血管支架患者的 2 99支血管 30 4处病变共 316个小血管支架 (支架直径 <3 0mm)术后的手术成功率 ,术后即刻效果 ,主要临床不良事件发生情况及远期再狭窄率。随访 1个月至 4年 ,其中 12 2例行冠状动脉造影术复查。结果　手术成功率 10 0 % ,支架全部顺利置入。血管狭窄率由 89%± 12 %改善至术后的 5 %± 5 % (直径法 ) ,术后 1个月随访 2 0 2例( 6 9 7% ) ,存活 197例 ,5例于术后 3h～ 7d死亡。 2例死于术后持续低血压 ,1例死于急性左心衰 ,2例猝死。 180例随访 5个月至 4年 ,无事件存活率 (NES) 73 3% ( 132 / 180 )。其中 12 2例行冠状动脉造影复查 ,39例发生支架内再狭窄( 30 3% ) ,37例二次行PCI,2例行CABG ,再狭窄患者中 2例二次PCI后再次发作心绞痛 ,经冠脉造影证实再次再狭窄1例行第 3次PTCA ,1例行CABG。 1例患者术后 2年死于心衰 ,1例术后 3年再发急性心肌梗死 (为支架术相关动脉 )。结论　小血管支架术手术成功率高 ,术后即刻效果好 ,术后主要不良事件率 (死亡、AMI及TLR)未增高 ,术后远期无事件存活率较高 ,再狭窄率较大血管支架     

西罗莫司洗脱支架和Pixel支架治疗冠状动脉小血管病变的比较

目的对比研究西罗莫司洗脱支架(CypherTM支架)和Pixel支架治疗冠状动脉小血管病变的安全性及疗效。方法将2003年3月至2005年1月在我院住院的67例小血管病变患者随机分成A、B两组,A组34例接受CypherTM支架治疗,B组33例接受Pixel支架治疗。比较分析两组的手术成功率、并发症发生率、心脏不良事件发生率、再狭窄率及晚期管腔丢失等指标。结果两组支架置入术的成功率均为100%,无残余狭窄或残余狭窄<10%,无任何并发症。A组有30例、B组有29例患者在术后约9个月复查了定量冠状动脉造影。随访期间,A组中有2例出现支架内再狭窄导致临床心绞痛复发;B组有7例复发心绞痛,其中6例经冠状动脉造影证实为支架内再狭窄所致;两组均无一例死亡。A组的造影再狭窄率为6.7%,B组为20.7%(P<0.05);A组的晚期管腔丢失为0.19±0.58mm,B组为0.63±0.61mm(P<0.01);A组的靶血管再次血运重建率为6.7%,B组为20.7%(P<0.05)。结论CypherTM支架和Pixel支架治疗小血管病变均安全、有效,但CypherTM支架的远期疗效明显优于Pixel支架。     

小冠脉支架的临床应用经验

目的在直径小于3 mm的冠状动脉分别进行PTCA和支架术,观察其急性并发症和近期疗效.方法 42例患者,52支血管,血管直径小于3 mm,随机选择单纯PTCA或支架术.测量术前和术后参考血管直径、直径狭窄程度和最小管腔直径,并观察术后30天内急性闭塞、亚急性血栓形成、Q波或非Q波心肌梗塞、急诊冠脉搭桥和死亡发生情况.结果支架组选用更大的球囊和更高的充盈压力,术后获得较大的管腔直径,残余狭窄程度显著低于PTCA组.支架组出现1例亚急性血栓形成,PTCA组出现1例急性闭塞.两组均无Q波或非Q波心肌梗塞、冠脉搭桥和死亡发生.结论对于直径小于3 mm的冠状动脉应该在PTCA基础上,选择性地植入支架,以避免急性并发症和减少再狭窄.     

药物涂层球囊在冠状动脉小血管原发病变的临床效果评价

目的:评价药物涂层球囊对冠状动脉小血管原发病变(SVD)的临床效果。方法:前瞻性选取2017年1月至2017年12月,我院收治的SVD患者166例作为研究对象,分为药物洗脱支架(DES)组78例和药物涂层球囊(DCB)组88例,观察两组治疗效果、血管再狭窄(ISR)和不良事件。结果:DCB组治疗后最窄直径、病变长度和直径狭窄率均较治疗前明显改善(DCB组:t=32.963、3.420、28.346;DES组:t=17.613、2.089、9.862,P0.05);DCB组治疗后最窄直径、病变长度和直径狭窄率改善情况均优于DES组(t=7.672、2.593、8.619,P0.05)。至随访结束时,两组均有部分病例出现病变血管ISR,其中DES组进展比例高于DCB组(χ~2=34.901,P0.05),而维持、好转比例低于DCB组(χ~2=18.769、8.448,P0.05);DES组不良事件发生率(25.6%)高于DCB组(14.8%),但组间比较差异无统计学意义(χ~2=3.067,P0.05)。结论:DCB治疗冠状动脉SVD的临床疗效优于DES,同时降低远期ISR,不良事件无显著增加。     

冠状动脉小血管支架植入的临床研究

目的：观察冠状动脉小血管病变患者的临床特点、支架植入情况及预后效果。方法：回顾分析冠状动脉小血管严重狭窄患者的临床及支架植入资料，并与同期进行的冠脉大血管支架患者进行比较，比较二者的临床特点、手术方法及预后的异同。结果：冠脉小血管支架组植入成功率97．14％，大血管支架组植入成功率98．95％（P〉0．05）；两组在年龄、性别及高血压患病率方面组间比较差异无统计学意义（P〉0．05），2型糖尿病患病率在小血管支架组高于大血管支架组（P〈0．05）；植入方法上，使用球囊预扩的比例两组比较差异无统计学意义（P〉0．05）；支架释放后球囊后扩张比例小血管支架组低于大血管支架组（P〈0．05）；术中并发症及随访期预后差异元统计学意义（P〉0．05）。结论：冠状动脉小血管支架植入的成功率、预后与大血管支架组无显著差异，可安全地用于冠脉小血管病变的治疗。     

Vessel caliber and restenosis: a prospective clinical and angiographic study of NIR stent deployment in small and large coronary arteries in the same patient.

Retrospective analyses of patient cohorts undergoing stent deployment have shown that small vessel diameter and long lesion length are two angiographic predictors of increased restenosis. We determined the effects of these factors in patients with lesions treated in both small- and large-diameter coronary arteries. This multicenter prospective quantitative angiographic study evaluated patients with de novo coronary disease undergoing intervention who had at least two lesions < or = 16 mm length, one in a vessel < or = 2.75 mm diameter (9 or 16 mm length seven-cell NIR stent) and the other in a vessel > or = 3.0 mm diameter (9 or 16 mm nine-cell NIR stent). Of 94 patients enrolled, 76% were male, mean age was 62 years (range, 40-85), 41% were hypertensive, 18% had diabetes, 15% were current smokers, and 64% had hypercholesterolemia. Additional lesions were treated in 23% of patients. The procedural success rate was 99%. Six months postprocedure, there were no deaths or late stent occlusions. One patient suffered a Q-wave myocardial infarction, one a non-Q-wave infarction, eight underwent percutaneous reintervention, two coronary artery bypass graft surgery operations, and five stenting of other nonstudy lesions. The mean reference diameter for the small vessel was 2.35 mm and the large vessel 3.22 mm. Six-month angiography was performed in 87 patients (92% of those eligible). The overall restenosis rate was 24% in the small vessel (9 mm length stent, 17%; 16 mm length stent, 30%) and 15% in the large vessel (9 mm length stent, 3%; 16 mm length stent, 22%), respectively. Multivessel stenting including treatment of lesions in small-caliber vessels can be performed with a good clinical and angiographic outcome. When the patient, operator, technique, and stent type are the same, vessel caliber and stent length both appear to influence the restenosis rate.     

一种新型可降解聚合物涂层-雷帕霉素洗脱支架对猪冠状动脉新生内膜增生的影响

目的:评价可降解高分子材料聚丙交酯-乙交酯(PLGA)作为支架药物载体的可行性及携带雷帕霉素的PLGA涂层支架的抗内膜增生作用。方法:在14头微型猪的3支冠状动脉分别植入钴铬合金裸支架(CoCr-BMS)、不载药的PLGA涂层支架(PCOS)和PLGA涂层雷帕霉素洗脱支架(PLGA-SES)。分别在支架植入后1个月和3个月时,复查冠状动脉造影,然后分离支架段血管行组织病理学分析。结果:共有12头动物存活,其余2头动物可能因麻醉剂相关的呼吸抑制而死亡。支架植入后1个月和3个月,不载药的PLGA涂层支架新生内膜面积和晚期管腔丢失与CoCr-BMS组相近,而PLGA-SES组则明显低于CoCr-BMS组。组织形态学示3组支架段血管损伤积分、炎症积分及再内皮化积分差异无统计学意义。结论:在猪冠状动脉支架模型中,PLGA涂层的支架设计具有良好的生物相容性和安全性;携带雷帕霉素的这种支架可抑制新生内膜形成,预防支架再狭窄的发生。     

PC支架治疗小直径冠脉病变3年随访研究

目的　评价PC支架治疗小直径冠状动脉血管病变的手术成功率、术后主要临床不良事件发生情况及远期再狭窄率。方法　观察我院 1998年 4月至 2 0 0 1年 5月 4 5例小血管 (血管直径 <2 8mm)患者冠心病患者植入PC支架的手术成功率、主要临床不良事件发生情况及远期再狭窄率。随访 1个月至 3年 ,其中 2 8例行冠状动脉造影术复查。结果　手术成功率 10 0 % ,支架全部顺利置入。血管狭窄率由 (82± 10 ) %改善至术后的 (0± 5 ) % (直径法 )。术后 30d随访 ,1例支架内 5 0 %狭窄。 1例术后第 2 2天因急性左心衰死亡。术后 6个月随访 38例。 1例支架完全闭塞 ,1例原支架内及近远端多发性狭窄 ,考虑合并其他血管病变 ,给予搭桥术。 35例随访时间 3年。完全无症状 2 6例。 2例随访过程中支架内狭窄 ,1例术后第 2年因心血管事件死亡。术后第 3年 ,有 2 8例在行冠脉造影复查 ,PC支架植入的 30处 ,6处发生支架内再狭窄 (狭窄 >5 0 % ) ,2例出现支架近端狭窄。冠脉造影再狭窄率为 2 6 6 7% ,总再狭窄率为 2 5 5 %。结论　小血管PC支架术手术成功率高 ,术后即刻效果好 ,术后远期生存率较高 ,再狭窄率接近大血管 >3 0mm普通裸支架     

Multicenter evaluation of the XT modular coronary stent: clinical and angiographic results

BACKGROUND: In the past few years, the indications for stent implantation have broadened, along with a larger number of available designs. The Bard XT stent is a new modular stent with an original structure and design. METHODS: To evaluate the new Bard XT stent, we studied its use in a multicenter experience in 163 patients, with a total of 168 lesions and 180 implanted units. RESULTS: Despite the predominance of complex lesions, the procedural success rate was 98%, with only a 2% failure of stent implantation. There was only one death (no-reflow phenomenon in a rescue primary PTCA in a patient in cardiogenic shock) without other major periprocedural complications. Centralized QCA showed a statistically significant increase of MLD (from 0.73 +/- 0.43 mm to 2.71 +/- 0.40 mm, p < 0.0001) and DS reduction (from 73.8 +/- 15.1% pre-treatment to 7.8 +/- 0.4% after stent implantation; p < 0.0001). Aspirin and ticlopidine were routinely administered after the procedure. Thirty-day follow-up reported only one case of subacute stent thrombosis (in the first day), treated with re-PTCA. CONCLUSIONS: In a group of patients with complex lesions, we obtained a high rate of success with a low incidence of complications. The Bard XT stent had a high-performance profile with normalization of vessel diameter and angiographic results similar to the ones obtained with the "slotted tube" stents.     

冠脉小血管支架在急性冠脉综合征中的临床应用

目的　探讨冠脉小血管最佳支架置入术的安全性和有效性。方法　对急性冠脉综合征 (ACS) 6 6处冠脉直径 <3mm的患者行支架置入术 ,测量术前和术后参考血管直径、最小管腔直径、直径狭窄程度、病变长度 ,并观察术后和住院期间心绞痛复发、急性闭塞、亚急性血栓形成、Q波或非 Q波心肌梗死、急诊冠脉搭桥和死亡发生情况。结果　所有病例血管造影和操作成功率均为 10 0 % ,获得近期临床成功 ,术后和住院期间无心绞痛复发、无主要心血管事件发生。结论　在 ACS中小血管支架的置入是安全、有效的。术前的合理用药、最佳支架置入技术及肝素涂层支架的应用可以降低支架内血栓形成并发症     

The XIENCE nano™ everolimus eluting coronary stent system for the treatment of small coronary arteries: The SPIRIT small vessel trial

Objectives : The SPIRIT Small Vessel (SV) was designed to evaluate the safety and effectiveness of the 2.25‐mm XIENCE V everolimus eluting coronary stent system (EECSS), known as the XIENCE nano EECSS, in subjects with SVs and ischemic heart disease. Background : The core sizes of XIENCE V EECSS are associated with low rates of restenosis and thrombosis in the general population, but the XIENCE nano EECSS has not been tested in the United States. Methods : This prospective, single‐arm, open‐label study was conducted at 33 centers and in 150 patients in the United States. The primary endpoint was the target lesion failure (TLF) rate at 1 year, required to meet the prespecified performance goal (PG) of 20.4%, derived from historical data. Results : The mean patient age was 63 years, 38% were women, 39.2% were diabetic, 49.3% had multivessel disease, and the reference vessel diameter was 2.13 ± 0.23 mm. The 1‐year TLF rate was 8.1% in with an upper limit of the one‐sided 95% confidence interval of 13.0%, which met the PG of 20.4% (P < 0.0001). At 1 year, the rate of cardiac death was 1.5%, the target vessel myocardial infarction rate was 1.5%, and clinically indicated target lesion revascularization rate was 5.1%. The 8‐month angiographic in‐stent late loss was 0.2 ± 0.4 mm, respectively. The 1‐year academic research consortium defined definite/probable stent thrombosis rate was 1.5%. Conclusions : Based on the 1‐year clinical and 8‐month angiographic SPIRIT SV data, the XIENCE nano EECSS is considered safe and effective in the treatment of SVs. © 2011 Wiley Periodicals, Inc.     

Clinical and angiographic outcome of NIR stent implantation in small vessels with unfavorable lesion morphology

BACKGROUND: Coronary artery stents are used for the treatment of acute or threatened vessel occlusion complicating coronary angioplasty or for the prevention of restenosis after angioplasty. Improvements in stent design made the stenting of complex and small vessels feasible. We prospectively evaluated the safety, efficacy and long-term patency of NIR stent (Boston Scientific, Maple Grove, Minnesota) implantation in small vessels with complex lesion morphology. METHODS: The study population consisted of patients with complex (type OCO) lesions under 3 mm vessel diameter who were undergoing coronary angioplasty for symptomatic coronary artery disease followed by high-pressure NIR stent implantation and antiplatelet therapy only. Follow-up angiography was performed six months after the initial procedure. RESULTS: Of 143 patients fulfilling the angiographic criteria and undergoing stent implantation between October 1995 and November 1997, 67 patients (46.9%) received NIR stents. In 58 patients (86.6%), angiographic 6-month follow-up was available. In one patient (1.7%), stent implantation was unsuccessful. Procedural success of the NIR stent implantation was 98.2%. Implantation of other stents failed in 12 cases. NIR stent implantation was successful in all of them. No patient required urgent bypass surgery. No patient died. Restenosis occurred 5.8 +/- 1.3 months after the initial procedure in 21 patients (36.2%). CONCLUSIONS: Coronary high-pressure stenting of small (< 3 mm) type OCO (AHA/ACC) lesions in patients with symptomatic coronary heart disease is a feasible treatment option with a high procedural success rate and low complication rate. The new flexible NIR stent showed an acceptable restenosis rate. The implantation was successful even in vessels in which previous attempts of Palmaz-Schatz stent placement had failed.