血管内超声对复杂冠状动脉左主干病变患者介入治疗的指导价值

目的研究血管内超声(IVUS)对复杂冠状动脉左主干病变患者PCI的指导价值。方法收集2014年1月～2017年1月我科收治的复杂冠状动脉左主干病变并且行PCI的患者110例,分为对照组55例和观察组55例(PCI术中采用IVUS技术进行指导)。比较2组患者基本资料、最小管腔直径(MLD)、最小管腔面积(MLA)、面积狭窄率(AS)、支架直径及长度、支架释放压力、后扩张球囊压力及直径等指标;随访1年,观察2组靶病变血运重建和主要不良心脏事件(MACE)情况。结果观察组MLD[(2.17±0.36)mmvs (1.62±0.59)mm,P=0.000]、MLA[(4.94±1.61)mm~2 vs (2.51±1.77)mm~2,P=0.000]、支架直径[(3.54±0.24)mmvs (3.34±0.31)mm,P=0.002]、支架长度[(14.41±5.25)mmvs (12.11±4.21)mm,P=0.038]、后扩张球囊直径[(3.98±0.51)mmvs (3.77±0.38)mm,P=0.040]、后扩张球囊压力明显大于对照组(P=0.000),AS明显低于对照组[(63.23±8.17)%vs (77.31±7.42)%,P=0.000)];随访期观察组总MACE发生率虽低于对照组,但无统计学差异(9.09%vs 12.73%,P=0.540)。结论 IVUS能有效指导左主干病变PCI支架定位,辅助判断支架扩张和贴壁情况。     

血管内超声在无保护左主干病变介入治疗中的应用

目的:评价血管内超声(IVUS)指导下的无保护左主干病变介入治疗的临床疗效。方法:纳入2012年1月至2015年12月入住我院的368例经冠状动脉(冠脉)造影证实无保护左主干狭窄超过50%的冠心病患者为研究对象,除外急性ST段抬高的急性心肌梗死患者,按倾向匹配得分法,1∶2分为IVUS组和常规造影介入(CAG)组,最终36例患者入选IVUS组,72例患者入选CAG组,比较2组患者的临床特征、住院期间和1年随访期间的主要心脏不良事件(MACE)(包括死亡、心绞痛复发及因缺血所致的再次血运重建等)。结果:2组患者年龄、性别构成、吸烟、高血压、糖尿病、高血脂、脑卒中、陈旧性心肌梗死、既往经皮冠脉介入术(PCI)史和外周血管疾病史无明显差异(均P0.05)。2组患者在最小管腔直径[(1.06±0.42)mm比(1.01±0.39)mm,P=0.697]、管腔直径狭窄百分比(83.9%±10.4%比87.6%±9.0%,P=0.064)、死亡率(0%比2.8%,P=0.551)、心绞痛复发率(8.3%比25%,P=0.071)、再次靶血管血运重建率(5.6%比13.9%,P=0.330)也无明显差异,但与CAG组相比,IVUS组的参考血管直径[(3.53±0.52)mm比(3.29±0.47)mm,P=0.018]、植入支架直径[(3.72±0.34)mm比(3.44±0.41)mm,P=0.001]、高压后扩球囊直径[(3.99±0.43)mm比(3.54±0.47)mm,P=0.000]及术后最小管腔直径[(3.88±0.40)mm比(3.49±0.42)mm,P=0.000]均明显大,MACE的发生率(8.3%比27.8%,P=0.038)明显降低。结论:IVUS指导下的无保护左主干病变介入治疗安全、有效,可明显改善此类患者的临床预后。     

血管内超声与单纯冠状动脉造影指导下无保护左主干病变介入治疗的疗效对比研究

目的:比较血管内超声(IVUS)和单纯冠状动脉造影指导的无保护左主干冠状动脉疾病(ULMCAD)介入治疗的疗效。方法:回顾性纳入本院2004年1月至2015年12月行ULMCAD介入治疗的患者3 960例,其中1 568例(39.6%)在IVUS指导下完成左主干支架置入术(IVUS组),其余2 392例(60.4%)仅在冠状动脉造影指导下行介入治疗(对照组)。比较两组3年随访时的主要不良心脏事件(MACE,包括全因死亡、心肌梗死和再次血运重建)及其各组分的发生率。结果:与对照组相比,IVUS组除男性比例较高(77.7%vs. 80.5%,P=0.03)外,其他基线临床资料相似。IVUS组的最终球囊对吻扩张率、后扩张率、双支架术应用率和操作成功率较对照组更高,置入支架的平均直径更大[(3.6±0.5) mm vs.(3.4±0.5)mm,P0.01]。IVUS组的MACE(12.2%vs. 15.9%,P0.01)、全因死亡(2.8%vs. 4.3%,P=0.02)、心肌梗死(3.2%vs. 5.3%,P0.01)、再次血运重建(7.8%vs. 9.7%,P=0.04)和确定或可能的支架内血栓形成(1.0%vs. 1.9%,P=0.02)发生率较对照组更低,而两组的靶血管血运重建率(3.5%vs. 4.3%,P=0.21)和靶病变血运重建率(2.7%vs. 3.5%,P=0.20)差异均无统计学意义。结论:与单纯冠状动脉造影指导相比,IVUS指导下的ULMCAD介入治疗疗效更佳、更安全。     

尿酸水平对冠状动脉支架内再狭窄的影响

目的探讨尿酸水平对稳定性心绞痛患者支架置入后发生支架内再狭窄的影响。方法 136例稳定性心绞痛成功行支架置入治疗患者,根据术后12~18个月冠状动脉造影结果分为再狭窄组62例及对照组74例;对冠状动脉造影结果用计算机辅助的定量分析法评价。结果对照组尿酸水平明显低于再狭窄组[(364.21±42.47)μmol/L vs(440.66±69.05)μmol/L,P=0.000];对照组术后12~18个月的最小管腔直径明显大于再狭窄组[(2.12±0.38)mmvs(0.76±0.37)mm,P=0.013];狭窄程度术后12~18个月对照组明显低于再狭窄组[(35.84±12.34)%vs(84.53±14.26)%,P=0.000];对照组晚期管腔丢失明显小于再狭窄组[(0.27±0.14)mmvs(1.66±0.57)mm,P=0.000]。尿酸与支架术后再狭窄有关(OR=0.680,95%CI:0.564~0.937,P<0.05)。结论尿酸水平增高可能是稳定性心绞痛患者支架置入后发生支架内再狭窄的原因之一。     

血管内超声成像在冠脉左主干复杂病变介入治疗中的作用

目的:研究血管内超声成像(IVUS)在冠脉左主干复杂病变介入治疗中的作用。方法:我院的102例需行经皮冠状动脉介入治疗(PCI)的冠脉左主干复杂病变患者被随机均分为常规造影组(PCI术中行常规冠脉造影)与IVUS组(PCI术中行IVUS)。观察比较两组PCI治疗指标、冠脉左主干最小管腔面积(MLA)、最小管腔直径(MLD)、面积狭窄率(AS)、置入支架参数及随访12个月主要不良心血管事件(MACE)发生率。结果:与常规造影组比较,IVUS组冠脉左主干MLD[(1.63±0.75)mm比(2.18±0.61)mm], MLA[(2.50±0.96)mm~2比(4.95±1.21)mm~2],置入支架直径[(3.35±0.29)mm比(3.55±0.28)mm]、长度[(12.10±4.21)mm比(14.43±5.03)mm],治疗后扩张球囊直径[(3.78±0.39)mm比(3.98±0.51)mm]、压力[(14.45±2.48)atm比(17.05±2.81)atm]均显著升高,AS[(77.34±7.41)%比(63.25±8.16)%]显著降低,P0.05或0.01。随访12个月,IVUS组MACE发生率显著低于常规造影组(13.73%比37.25%,P=0.006)。结论:IVUS能显著提高冠脉左主干复杂病变介入治疗的精准性及疗效。     

血管内超声指导冠状动脉中重度钙化病变介入治疗的效果

目的:评价血管内超声(IVUS)对冠状动脉中-重度钙化病变介入治疗的指导作用及对预后的影响。方法:2009年1月~2013年1月冠状动脉中-重度钙化病变患者219例接受冠状动脉介入治疗,其中95例患者术中应用血管内超声指导,124例患者在单纯冠状动脉造影(CAG)指导下完成介入治疗。结果:两组患者的临床基线特征、靶血管部位、病变类型、置入支架数目、长度、直径;冠状动脉旋磨和切割球囊应用等方面,差异均无统计学意义。两组患者住院期间及术后30 d临床终点事件,包括主要不良心血管事件(MACE)事件、支架内血栓发生率的差异均无统计学意义。随访12个月时,IVUS组MACE事件发生率显著低于CAG组(8.4%vs.17.7%,P0.05),IVUS组靶血管重建发生率显著低于CAG组(3.2%vs.10.5%,P0.05)。IVUS组与CAG组在支架内血栓发生率方面差异无统计学意义(3.2%vs.3.2%)。结论:IVUS指导中-重度冠状动脉钙化病变术后即刻和短期临床效果并不优于CAG,但应用IVUS指导能够显著降低术后1年靶血管重建发生率。     

药物洗脱支架治疗支架内再狭窄的对照研究

目的 比较3种药物洗脱支架(DES)治疗支架内再狭窄的长期临床效果.方法 回顾性分析阜外医院对支架内再狭窄病例用DES行经皮冠状动脉介入治疗(PCI)的390例患者,其中雷帕霉素药物洗脱支架(Cypher)组187例(C组),紫杉醇药物涂层支架(Taxus)组89例(T组),国产雷帕霉素涂层支架(Firebird)组114例(F组).结果 T组不稳定性心绞痛比率高于另2组,F组左主干病变比率低于另2组,而3支病变比率高于另2组.3组平均临床随访时间为864、848和719 d,主要不良心脏事件发生率差异无统计学意义(P=0.081),3组总的支架内血栓发生率差异无统计学意义(P=0.605).7个月造影随访支架内和血管段再狭窄率T组有增高的趋势(17.9%比29.4%比13.6%.P=0.214和21.8%比35.3%比15.9%,P=0.132).支架内和血管段的晚期丢失T组均明显大于另外2组[(0.31±0.12)mm比(0.75±0.24)mm比(0.31±0.13)mm,P=0.000和(0.33±0.18)mm比(0.61±0.23)mm比(0.31±0.14)mm,P=0.001].结论 3种DES治疗支架内再狭窄病变的长期疗效相似,Cypher和Firebird抑制内膜增生的作用更强.     

血流储备分数指导下功能性血运重建对STEMI多支血管病变患者预后的影响

目的观察血流储备分数(FFR)指导下经皮冠状动脉介入治疗(PCI)功能性血运重建对急性ST段抬高型心肌梗死(STEMI)多支血管病变患者短期预后的影响。方法回顾性分析陕西省第四人民医院心血管内科2016年1月～2017年1月住院治疗STEMI多支血管病变患者的病历资料,根据干预非梗死相关血管(Non-IRA)时是否行FFR检查将患者分为:FFR组68例(FFR指导下功能性血运重建组)和CAG组92例(冠状动脉造影指导下血运重建组)。比较两组支架置入数量、平均支架总长度和围手术期主要并发症,患者术后随访12个月,比较两组术后1个月和术后12个月主要不良心血管事件(MACE)发生率。结果 FFR组支架置入数量[(1.5±1.0)枚vs.(2.6±0.5)枚,P=0.02]和平均支架总长度[(51.4±30.0)mm vs.(67.2±20.5)mm,P=0.03]显著低于CAG组(P0.05);术后1个月两组MACE发生率(1.5%vs. 3.3%,P=0.64)无统计学差异(P0.05),继续随访至术后12个月,FFR组MACE发生率(5.9%vs. 16.3%,P=0.04)较CAG组显著降低。结论 STEMI多支血管病变患者,FFR指导下分期PCI功能性血运重建减少支架置入数量和患者术后12个月发生MACE的风险。     

药物洗脱支架与金属裸支架对冠状动脉临界病变的远期疗效

目的:评估药物洗脱支架与金属裸支架对于治疗冠状动脉临界病变的远期疗效。方法:自身冠状动脉首次介入治疗病变(在线定量冠状动脉造影分析50%≤管腔狭窄直径≤70%)的患者入选本研究,共计151例患者分为药物洗脱支架组(n=102)和金属裸支架组(n=49),两组的基本临床特征和冠状动脉造影结果差异无统计学意义。术前、术后和随访6～12个月时进行定量冠状动脉造影分析,并在住院期间、30天和6～12个月时观察严重不良心脏事件的发生。结果:151例患者支架置入成功率均为100%。住院期间严重不良心脏事件发生率,在药物洗脱支架组和金属裸支架组差异无统计学意义(0%和2.0%,P=0.15)。在随访30天时,两组均无死亡和支架内血栓形成。6～12个月随访期间,药物洗脱支架组和金属裸支架组比较①严重不良心脏事件发生率(3.9%vs8.1%,P=0.97),②靶病变重复血管重建率(2.9%vs6.1%,P=0.39),③急性心肌梗死发生率(1.96%vs2.04%,P=0.95),差异均无统计学意义。12个月时药物洗脱支架组和金属裸支架组比较,支架内血栓发生率和病死率差异也无统计学意义(1.96%vs0%,P=0.34;0%vs4.08%,P0.05)。定量冠状动脉造影分析显示:远期管腔丢失药物洗脱支架组明显低于金属裸支架组[(0.23±0.73)mmvs(0.95±0.94)mm,P=0.01],两组比较差异有统计学意义;而支架内再狭窄率两组比较差异无统计学意义(12.9%vs25.0%,P=0.34)。结论:药物洗脱支架和金属裸支架对于治疗自身冠状动脉临界病变安全有效,两组远期严重不良心脏事件发生率差异无统计学意义。     

生物可降解涂层雷帕霉素洗脱支架治疗冠脉小血管病变的长期临床安全性与有效性:CREATE研究亚组分析

目的评估国产生物可降解涂层雷帕霉素洗脱支架(ExcelTM,山东吉威医疗制品有限公司)治疗冠状动脉小血管病变的长期临床安全性与有效性。方法 2006年6月至11月在4个国家的59个中心共有2077例接受单一Excel支架治疗的患者连续入选CREATE研究。以靶病变两端参考血管直径≤2.75 mm为小血管标准(有一支靶血管直径≤2.75 mm即为小血管病变患者),将患者分为小血管病变组(886例,42.7%)和非小血管病变组(1 191例,57.3%)。术后接受双联抗血小板药物(氯吡格雷和阿司匹林)治疗6个月,比较两组术后9个月定量冠状动脉造影(QCA)复查结果及18个月临床随访主要心脏不良事件(MACE)、心性死亡和血栓事件的发生率。结果与非小血管组相比,小血管组女性(29.0%vs 24.5%,P=0.022)、高血压(59.9%vs 52.6%,P=0.001)、既往有心肌梗死(14.0%vs.9.2%,P=0.001)的患者较多,平均年龄大[(61.9±10.6)岁vs.(59.6±11.4)岁,P<0.001],氯吡格雷用药时间两组无明显差别[(200.1±55.0)d vs(197.4±55.0)d,P=0.262]。小血管组患者病变较长[(23.23±14.14)mm vs(21.43±11.79)mm,P=0.039],人均支架植入数多[(2.23±1.33)枚vs(1.49±0.82)枚,P<0.001]。术后9个月QCA结果显示,小血管组和非小血管组支架内晚期管腔丢失[(0.20±0.38)mm vs(0.21±0.42)mm,P=0.654]和再狭窄率(3.9%vs3.4%,P=0.856)无显著差别。18个月临床随访结果表明,小血管组靶病变血运重建率(2.8%vs 1.2%,P=0.006)显著高于非小血管组,但两组MACE(3.9%vs 2.5%,P=0.086)、心性死亡(0.9%vs 1.3%,P=0.441)和支架内血栓(1.0%vs 0.8%,P=0.528)发生率均无显著差异。多因素Cox回归分析结果表明,小血管病变并非MACE的独立危险预测因素(OR 0.848,95%CI 0.482-1.491,P=0.567)。结论 Excel支架治疗冠状动脉小血管病变的长期疗效及安全性与非小血管病变相近,但还需随机对照临床研究证实。     

血管内超声指导冠脉临界病变介入治疗的应用价值

目的：探讨血管内超声（IVUS）检查在冠状动脉临界病变介入治疗中的应用价值。方法：选择我院130例经冠状动脉造影（CAG）证实为临界病变的患者进行前瞻性研究,随机分为CAG组（95例,接受CAG检查）和IVUS组（35例,先后接受CAG和IVUS检查）。应用量化冠状动脉造影（QCA）分析法和血管内超声定量分析法测量两组最小管腔直径、参考血管直径、直径狭窄率及面积狭窄率的差异,并比较住院期间及随访期间的主要心血管事件（MACE）的发生情况。结果：与CAG组相比,IVUS组的冠脉内膜钙化率[8．4％（8／95）比28．6％（10／35）],直径狭窄率[（43．97±6．53）%比（55．25±7．41）％]及面积狭窄率[（56．48±10．38）％比（69．87±9．97）％]显著升高（P〈0．05）,而最小管腔直径及参考血管直径无显著差异（P〉0．05）。住院期间两组的MACE发生率无差异（P〉0．05）,但自随访1月起IVUS组的MACE发生率显著低于CAG组（2．86％比6．32％,P〈0．05）。结论：血管内超声检查能显著提高冠脉临界病变的检出率,更好地指导冠脉介入治疗,防止并发症,改善预后．     

国产西罗莫司洗脱支架与裸支架治疗急性心肌梗死临床疗效的比较

目的探讨国产西罗莫司洗脱支架与裸支架治疗急性心肌梗死（AMI）临床疗效的差异。方法173例连续行直接PCI的AMI患者随机分为西罗莫司洗脱支架组（87例）和裸支架组（86例）,分析住院期间和支架置入后6个月的支架内血栓、主要心血管事件（包括再次心肌梗死、缺血性靶血管重建和死亡）发生率及6个月再狭窄率。结果两组患者在术后血管通畅、肌酸激酶峰值、心功能和住院期间心脏事件方面差异均无统计学意义（P〉0．05）。两组各有2例支架内血栓（2．4％比2．3％,P〉0．05）。6个月时,国产西罗莫司洗脱支架组的支架内再狭窄率（4．5％比40．0％,P〈0．01）、节段内再狭窄率（6．8％比44．9％,P〈0．01）和主要不良心脏事件发生率（8．0％比24．4％,P〈0．01）显著低于裸支架组。国产西罗莫司洗脱支架组主要心脏事件的减少主要是因为缺血性靶血管重建减少所致（3．4％比11．6％,P〈0．05）。结论与裸支架相比,国产西罗莫司洗脱支架治疗AMI患者并未增加6个月内支架内血栓的发生,而显著降低6个月的再狭窄率和主要心脏事件发生率。     

120例无保护左主干冠状动脉病变药物洗脱支架术的临床疗效和随访研究

目的探讨药物洗脱支架(DES)在无保护左主干冠状动脉(LMCA)病变的疗效。方法回顾性分析符合条件连续的120例无保护LMCA病变患者行DES的疗效,将其分为分叉病变组(80例)和非分叉病变组(40例)两组,根据病变特点行单支架术或双支架术,分析其支架术的操作特点,住院期间及出院后随访其主要心脏不良事件(MACE,包括死亡、非致死性心肌梗死及靶病变重建)及支架内血栓形成(ST)的情况。结果两组间的临床基线情况差异无统计学意义,共106(88.3%)例患者完成随访,分叉病变组更多使用血管内超声(IVUS)指导治疗(但P>0.05),分叉病变组33例行双支架术,非分叉病变组5例行双支架术(P=0.001),住院期间无MACE及支架内血栓(ST)发生,出院随访平均(26.3±14.5)个月,MACE11例(9.2%),总共死亡3例(2.8%),都是SYNTAX积分及EuroSCORE均属高危的患者,非致死性心肌梗死2例(1.9%),靶病变重建(TLR)6例(5.7%),造影再狭窄6例(占造影随访患者的15.8%),两组ST各1例,两组间MACE差异无统计学意义(7.5%比12.5%,χ2=0.801,P=0.503)。结论在选择性患者行DES治疗无保护LMCA病变不论是否分叉病变近远期的安全性和有效性可以接受。     

Optimal final lumen area and predictors of target lesion revascularization after stent implantation in small coronary arteries

Despite similar early clinical events, patients who undergo treatment of small vessels are at an increased risk for target lesion revascularization (TLR) after coronary artery stenting. We sought to determine predictors of TLR after stent implantation in small coronary arteries. We identified 423 consecutive patients who underwent intravascular ultrasound (IVUS)-guided small vessel stenting procedures in 465 coronary lesions with an angiographic reference vessel diameter of <2.75 mm. Patients were divided into 2 groups based on a final IVUS lumen area of < or =6.0 mm2 (n=345 lesions, group I) and >6.0 mm2 (n=115, group II). Baseline patient characteristics and in-hospital outcomes were similar between the 2 groups, except for a higher rate of restenotic lesions in group I and bifurcation lesions in group II. Group I had higher TLR rates at 1 year compared with group II patients (39% vs 26%, p = 0.02). The TLR rate appeared to decrease with greater stent expansion, especially at >90% of the reference vessel area, as assessed by IVUS. By multivariate analysis, an IVUS final stent area of < or =6 mm2, diabetes, absence of prior myocardial infarction, and history of intervention were independent predictors of 1-year TLR in this population. Final stent area of >6.0 mm2 and greater stent expansion were associated with a decrease in TLR. Therefore, there does not appear to be any "downside" to aggressive stent implantation strategies in small vessels. In contrast, IVUS allows maximization of final lumen dimensions to minimize clinical restenosis.     

Intravascular ultrasound-guided percutaneous transluminal coronary angioplasty with provisional spot stenting for treatment of long coronary lesions.

OBJECTIVES: The purpose of this study was to evaluate the approach of intravascular ultrasound (IVUS)-guided percutaneous transluminal coronary angioplasty (PTCA) with spot stenting (SS) for the treatment of long coronary lesions. BACKGROUND: Treating long coronary lesions with balloon angioplasty results in suboptimal short- and long-term outcomes. Full lesion coverage with traditional stenting (TS) has been associated with a high restenosis rate. METHODS: We prospectively evaluated a consecutive series of 130 long lesions (>15 mm) in 101 patients treated with IVUS-guided PTCA and SS. The results were compared with those of TS in a matched group of patients. Coronary angioplasty was performed with a balloon to vessel ratio of 1:1, according to the IVUS media-to-media diameter of the vessel at the lesion site, to achieve prespecified IVUS criteria: lumen cross-sectional area (CSA) > or =5.5 mm(2) or > or =50% of the vessel CSA at the lesion site. The stents were implanted only in the vessel segment where the criteria were not met. RESULTS: In the SS group, stents were implanted in 67 of 130 lesions, and the mean stent length was shorter than that of lesions in the matched TS group (10.4 +/- 13 mm vs. 32.4 +/- 13 mm, p < 0.005). The 30-day major adverse cardiac event (MACE) rate was similar (5%) for both groups. Angiographic restenosis was 25% with IVUS-guided SS, as compared with 39% in the TS group (p < 0.05). Follow-up MACE and target lesion revascularization rates were lower in the SS group than in the TS group (22% vs. 38% [p < 0.05] and 19% vs. 34% [p < 0.05], respectively). CONCLUSIONS: Intravascular ultrasound-guided SS for the treatment of long coronary lesions is associated with good acute outcome. Angiographic restenosis and follow-up MACE rates were significantly lower than those with TS.     

冠心病合并2型糖尿病患者冠状动脉内支架术后的远期随访

目的 探讨冠心病合并2型糖尿病(DM)患者冠状动脉异常程度和冠状动脉内支架术后远期疗效.方法 将行冠状动脉内支架术的1172例冠心病患者分为DM组(249例)和非DM组(923例).对两组的冠状动脉病变情况及远期临床疗效进行比较.结果 与非DM组比较,DM组病变数较多(P=0.046),2支(P=0.029)和3支(P=0.013)病变比例较高,弥漫病变(P=0.001)、慢性闭塞性病变(P=0.044)及重度病变(P=0.012)多见.两组临床随访率差异无统计学意义.与非DM组相比,DM组支架内再狭窄(55.96/万比35.51/万)、再次血运重建(76.18/万比51.55/万)和主要不良心血管事件(85.50/万比61.47/万)的人月发病率均明显增高(均P=0.000).COX多因素回归分析显示,2型DM与支架内再狭窄(P=0.000)、再次血管重建(P=0.001)、主要不良心血管事件(P=0.003)密切相关,但与死亡无明显相关.结论 合并2型DM的冠心病患者冠状动脉病变较重.2型DM是支架内再狭窄、再次血管重建和主要不良心血管事件的独立预测因子.     

First human experience with local delivery of novel antisense AVI-4126 with Infiltrator catheter in de novo native and restenotic coronary arteries: 6-month clinical and angiographic follow-up from AVAIL study

BACKGROUND: A novel antisense phosphorodiamidate morpholino oligomer, AVI-4126, was shown to be effective in reducing neointimal formation in different animal models following delivery by pluronic gels, porous balloon catheters, and coated stents. The purpose of the AVAIL study was to investigate both the safety and the efficacy of AVI-4126 delivered locally via Infiltrator catheter after percutaneous coronary intervention in humans. METHODS: The AVAIL trial is a prospective, evaluator-blinded, randomized study including clinical follow-up at 30 days and 6 months after intervention and 6-month angiographic and intravascular ultrasound (IVUS) follow-up. An Infiltrator catheter was advanced to target lesion and either drug was delivered (Groups A and B) or catheter was advanced (Group C) after stent implantation in de novo lesions or percutaneous transluminal coronary angioplasty in restenotic lesions. Primary end points include major adverse cardiovascular events (MACE), target vessel revascularization (TVR), angiographic restenosis, and IVUS at 6 months. RESULTS: Forty-four patients with either de novo lesions or restenosis were randomized into three groups: (A) low dose, 3 mg (19 patients); (B) high dose, 10 mg (15 patients), and (C) control (10 patients). Baseline angiographic characteristics did not differ between the groups (reference vessel diameter, 2.5-4 mm; lesion length, <16 mm). Procedural success was 81. 82% (unable to advance Infiltrator catheter to target lesion in 8 patients, 5 from Group B and 3 from Group C). There was no in-hospital or 30-day MACE recorded in any group. Clinical follow-up was available in 25 patients. At 6 months, four patients (50%) from the control group (Group C, n=8) and 7 (100%) patients from the low-dose group (Group A, n=7) required TVR. In contrast, in the high-dose group (Group B, n=10) only 1 patient (10%) needed TVR. Angiographic follow-up in 25 patients (Group A, 8 patients; Group B, 7 patients; and Group C, 10 patients) demonstrated late loss of 1.4+ to 0.54, 0.8+ to 0.55, and 1.5+ to 0.65, respectively (P=.025). Binary restenosis was 38% in Group C (control), 29% in Group A (low dose), and 0% in Group B (high dose). CONCLUSION: Local delivery of antisense is feasible. These preliminary findings from the small cohort of patients require confirmation in a larger trial utilizing more sophisticated drug-eluting technologies.     

Two-year clinical follow-up results of intracoronary radiation therapy with rhenium-188-diethylene triamine penta-acetic acid-filled balloon.

We investigated the 2-year clinical follow-up results as well as 6-month angiographic and clinical follow-up results of intracoronary radiation therapy using a rhenium-188-diethylene triamine penta-acetic acid ((188)Re-DTPA)-filled balloon system. The study comprised of 161 patients with significant de novo (83%) or in-stent restenosis (17%) lesions. Irradiation to deliver 17.6 Gy at a depth of 1.0 mm into the vessel wall was carried out after successful intervention. At 6-month follow-up, binary restenosis developed with significantly lower frequency in the radiation group than in the control group (24.3% vs. 46.3%; P = 0.009), although target lesion revascularization rate did not show significant benefit. At 2-year follow-up, cumulative target lesion revascularization rate was not significantly different between radiation group (n = 86) and control group (n = 75; 20.0% vs. 26.0%; P = 0.368). The rate of major adverse cardiac events including death, myocardial infarction, and target lesion revascularization did not show significant difference between two groups either (22.3% vs. 30.1%; P = 0.266). In conclusion, although significant reduction in restenosis rate was noted at 6-month angiographic follow-up, intracoronary radiation therapy mostly in patients with de novo lesion did not show significant clinical benefit in 6-month and 2-year follow-up results. The benefit was noted only in a small subgroup of patients with in-stent restenosis.     

药物洗脱支架治疗冠状动脉小血管病变的疗效分析

目的通过分析比较裸金属支架(BMS)与药物洗脱支架[DES,包括雷帕霉素(Cypher)支架和紫杉醇(TAXUS)支架]治疗冠状动脉小血管病变疗效的差异,为DES治疗多支及单支小血管病变冠心病提供依据。方法连续入选2002年12月至2005年5月沈阳军区总医院首次接受经皮冠状动脉介入治疗(PCI)、靶血管为小血管病变且达到完全血运重建的486例患者,其中多支小血管病变(多支)150例。分为BMS组214例(多支63例)、Cypher组140例(多支46例)和TAXUS组132例(多支41例),对比分析各组患者住院期间及随访6个月的临床情况。结果3组患者冠脉病变特点、PCI成功率及住院期间主要不良心脏事件(MACE)发生率等指标差异均无显著性(P>0·05)。冠脉造影随访显示,两个DES组再狭窄率均明显低于BMS(Cypher组4·9%,TAXUS组7·5%对BMS组29·2%,P<0·05),随访期间MACE发生率亦明显低于BMS(Cypher组2·9%,TAXUS组3·9%对BMS组12·0%,P<0·01)。进一步分析多支小血管病例,发现两个DES组的再狭窄率及随访期间MACE发生率仍然明显低于BMS组(再狭窄率Cypher组6·7%,TAXUS组7·1%对BMS组37·5%,P<0·05;MACE发生率Cypher组4·1%,TAXUS组4·8%对BMS组21·0%,P<0·05)。结论Cypher和TAXUS支架治疗小血管病变安全可行,疗效显著,治疗多支小血管病变可得到相同的疗效。     

Impact of renal insufficiency on clinical and angiographic outcomes following percutaneous coronary intervention with sirolimus-eluting stents.

BACKGROUND: Sirolimus-eluting stents (SES) have been demonstrated to reduce restenosis. However, there have been few studies evaluating the impact of renal insufficiency on the angiographic as well as clinical outcomes after SES implantation. METHODS: This study was composed of 304 consecutive patients having 361 lesions who underwent percutaneous coronary intervention with SES. The patients were divided into 3 groups according to renal function (group 1 [n = 204]; creatinine clearance (Ccr) > or = 60 ml/min, group 2 [n = 69]; Ccr < 60 ml/min, group 3 [n = 31]; hemodialysis). Clinical and angiographic follow-up were evaluated at 8 months. RESULTS: Clinical follow-up was obtained in all patients and angiographic follow-up was obtained in 283 patients (93.1%). Patients in group 3 showed a higher incidence of previous coronary artery bypass graft surgery, and there were more female gender, hypertensive, and less hyperlipidemia in this group. Late lumen loss at 8 months was significantly different among the 3 groups (group 1; 0.16 +/- 0.46 mm, group 2; 0.44 +/- 0.62 mm, group 3; 0.81 +/- 0.88 mm, P < 0.0001). Major adverse cardiac events (MACE) were documented in 22 patients (10.8%) in group 1, 13 patients (18.8%) in group 2, and 12 patients (38.7%) in group 3, respectively (P = 0.0002). CONCLUSION: Neointimal growth following SES implantation is more pronounced in patients with renal insufficiency, especially those undergoing dialysis, compared with patients with normal renal function. Regardless of the beneficial effect of SES, the increased risk of MACE mainly due to high incidence of target vessel revascularization in the subgroup of patients with renal insufficiency should be taken into account.