雷帕霉素洗脱支架治疗急性冠状动脉综合征临床观察

目的:评价在非选择的急性冠状动脉综合征(ACS)患者中置入雷帕霉素洗脱支架(SES)的安全性和临床疗效。方法:选择224例接受冠状动脉内支架术治疗的ACS患者,其中103例接受普通支架治疗(普通支架组),121例接受SES治疗(SES组)。记录一般临床情况、手术成功率和术后随访心脏事件发生率,包括:心原性死亡、再梗死、心绞痛复发等。结果:两组支架术的手术成功率相似。与普通支架组比较,SES组30天内心脏事件发生率无显著差异(0%比1.94%,P=0.210)。平均随访(9.1±3.6)个月,SES组心肌缺血症状复发率较普通支架组明显减低(4.96%比20.39%,P=0.001)。两组9个月无心脏事件生存率SES组与对照组分别为95.04%和77.67%(P=0.001)。结论:ACS患者中SES支架术安全有效,且远期临床疗效明显改善。     

冠状动脉带膜支架的疗效

目的:观察冠状动脉带膜支架的疗效.方法:冠状动脉带膜支架术13例,包括冠状动脉穿孔11例及冠状动脉瘤2例,观察即刻临床效果.术后双联抗血小板治疗至少1年,随访急性心肌梗死、死亡等主要心血管事件,并复查冠状动脉造影,分析支架内再狭窄及支架内血栓形成发生率.结果:11例冠状动脉穿孔的患者行带膜支架术后,10例即刻造影显示无明显造影剂外渗,临床症状缓解;1例造影仍提示造影剂大量外渗,紧急外科手术,最终死亡.2例冠状动脉瘤的患者行带膜支架术后,造影显示瘤体基本不显影.术后随访1年,未出现急性心肌梗死、死亡等主要心血管事件,6～12个月复查冠状动脉造影,发现1例支架内再狭窄,6例支架处内膜增生,未见支架内血栓形成.结论:带膜支架能有效地处理冠状动脉严重穿孔及部分冠状动脉瘤病变,即刻及近期效果良好.     

直接冠状动脉内置入支架的应用

目的　探讨直接冠状动脉内置入支架的可行性、安全性和近期疗效。方法　回顾性分析 3 4例冠心病患者行直接冠状动脉内置入支架的临床资料和支架植入的影像学资料 ,并且进行随访。结果　 3 4例冠心病患者共检出病变部位 44处 ,置入支架 3 8个 ,其中 3 4处病变直接置入支架 ,残余狭窄 <15 % ,无急性并发症。置入成功率 10 0 %。随访 6～ 12个月 ,心绞痛明显减轻 ,无 AMI、需CABG手术或 PTCA术、死亡等严重心脏事件的发生。结论　直接冠状动脉内置入支架在部分冠心病患者中的应用是可行和安全的 ,近期疗效令人满意     

肾动脉支架术在需行冠状动脉旁路术合并肾动脉狭窄患者的应用

目的研究需行冠状动脉旁路术患者合并肾动脉狭窄的肾动脉支架治疗,以防止冠状动脉旁路术术后发生急性肾功能不全.方法自2001年4月至2005年1月,我院对拟行冠状动脉旁路术的892例患者中的874例(98%)在冠状动脉造影同时行肾动脉造影,共检出肾动脉狭窄行支架术治疗患者82例(占9%),狭窄肾动脉104支,狭窄＞70%或跨狭窄压差＞20 mm Hg(1 mm Hg=0.133kPa).82例中男56例,女26例,平均年龄66.6±5.1(56～77)岁,合并高血压者77例,肾功能减退者21例.肾动脉支架术前不用抗血小板药物及低分子量肝素,术前抗凝用肝素.支架内径4～7mm,长度14～22mm.肾动脉支架术均先行球囊扩张,再置入支架.每例患者造影剂一次用量35ml～200mi.80例肾动脉支架术后5天内行冠状动脉旁路术,2例肾动脉支架术后第13、15天内行冠状动脉旁路术.结果104处病变肾动脉支架成功率100%,无并发症.术前肾功能减退者中9例于出院时血肌酐下降,3例支架术后一过性血肌酐升高;术前肾功能正常者中4例支架术后一过性血肌酐升高,P＞0.05.所有支架术后一过性血肌酐升高均为双侧肾动脉重度狭窄.892例接受冠状动脉旁路术者术后未发生急性肾功能不全;2001年4月之前我院共行冠状动脉旁路术106例,术前均未行肾动脉造影,其中2例术后发生急性肾功能不全.结论肾动脉狭窄可致冠状动脉旁路术术后急性肾衰的发生,本组冠状动脉旁路术前行肾动脉支架术者占9%.需冠状动脉旁路术者肾动脉狭窄病变多符合动脉硬化病变特点,由于术前成功置入肾动脉支架,冠状动脉旁路术后无一例发生急性肾功能衰竭.肾动脉支架术是治疗肾动脉狭窄的安全有效且简便易行的方法.为防止冠状动脉旁路术术中及术后出血并发症,肾动脉支架术者于冠状动脉旁路术术前应停用抗血小板药及低分子量肝素,因此,尽量缩短肾动脉支架术与冠状动脉旁路术的时间间隔,既可以减少肾动脉支架术后血栓并发症,亦可以减少患者持续卧床的时间.肾动脉支架术对冠心病行冠状动脉旁路术合并肾动脉狭窄并肾功能减退患者的术后肾功能改善有益.     

老年急性心肌梗死患者急诊冠状动脉支架术的临床评价

目的　探讨老年急性心肌梗死 (AMI)患者急诊冠状动脉支架术的临床疗效和安全性。方法　共对 95例住院老年AMI患者的 10 4支靶血管、114处靶病变急诊植入冠状动脉支架 110枚。患者术前合并心源性休克 2 9例 ,心肺复苏 3例 ,急诊冠状动脉造影示多支病变 5 8例 ,梗死相关动脉 (IRA)狭窄 99%～ 10 0 % ,心肌梗死溶栓试验 (TIMI)血流 0级 72例 ,1～ 2级 2 3例。结果　IRA开通率 10 0 % ,110枚支架均植入成功 ,术后平均残余狭窄 (0 .4± 3.5 1) % ,全部恢复TIMI 3级血流 ,无操作并发症 ,即刻成功率 10 0 %。从入导管室至IRA开通时间平均 (17.6± 1.87)min。术后共 6例死亡 ,住院期间总病死率 6 .3% ,其中 4例死于不可逆心源性休克 (休克病死率 13.8% )。对出院的 89例随访 1～ 5 2个月 ,平均 (2 5 .1± 12 .3)个月 ,87例存活 ,存活率 97.8%。 2 8例造影随访者中 5例支架内再狭窄 (再狭窄率17.8% )。结论　急诊支架术对老年AMI患者具有理想的即刻和长期疗效。合理选择器械、操作技术熟练和围术期并发症处理经验是保证老年AMI急诊冠状动脉支架术获得高成功率的 3个关键。     

急性冠状动脉综合征支架置入术临床分析

目的探讨急性冠状动脉综合征(ACS)患者置入冠状动脉内支架的临床疗效。方法选择2003年5月~2006年5月入院的90例ACS患者,均行多体位多角度选择性冠状动脉造影(CAG),确定靶血管后,经皮腔内冠状动脉成形术(PTCA)预扩张再置入支架76例,直接置入支架14例,观察置入不同大小、类型支架手术成功率,住院和随访期间的临床心脏事件、心功能情况。结果90例患者置入支架115枚。支架直径2.5~4.0mm,长度8~32mm;支架类型为Evolution5枚,MedtronicS660 7枚,Vismed 10枚,B/BRAUN 27枚,Biodiv Ysiooc 47枚,Firebird 19枚。全部随访3至12个月,2例不稳定型心绞痛(UAP)患者手术即刻出现急性心肌梗死(AMI);1例1个月后行冠状动脉旁路移植术;2例术后未规律抗凝,半年后出现支架内再狭窄,重新置入支架;1例多支病变置入3枚支架,1年后死于心肌梗死;1例多发冠状动脉瘤半年后心脏性猝死。手术即刻成功率97.78%,心脏事件发生率6.67%,心功能改善62.50%。结论ACS行支架置入术安全有效,随访心脏事件发生少,心功能得到改善。但多支病变置入多枚支架再狭窄发生率高,易出现心脏事件。     

老年急性冠状动脉综合征的急诊介入治疗

目的　观察 70岁以上老年人急性冠状动脉综合征 (acutecoronarysyndromes ,ACS)急诊介入治疗的安全性及临床效果。方法　同期行急诊介入治疗的 183例大于 70岁ACS患者 (≥ 70岁组 )与 76例小于 70岁但大于 6 0岁的ACS患者 (对照组 ) ,两组均在心绞痛发作时行冠状动脉造影证实病变 ,根据造影结果选择适宜的介入方式对“罪犯”病变予干预。结果　≥ 70岁组经皮冠状动脉腔内成形术 (PTCA)后置入支架 173枚 ,直接置入支架 2 2枚 ;手术成功率 97.8%;术后 15 1例 (82 .5 %)患者心绞痛消失 ,18例有胸闷感 ,次日自行消失 ,14例患者仍有心绞痛症状 ;对照组PTCA后置入支架 71枚 ,直接置入支架 10枚 ;手术成功率 98.7%;术后 6 5例 (85 .5 %)患者心绞痛消失 ,3例仍有心绞痛症状。两组手术成功率及术后心绞痛改善情况差异无显著性意义 (P >0 .0 5 ) ;置入支架后两组均无急性闭塞和死亡病例 ;随访期内 ,两组心绞痛复发率及复发后接受再次血运重建术情况比较差异无显著性意义 (P >0 .0 5 )。结论　在有条件的心脏介入中心 ,对老年ACS患者行急诊介入治疗是积极有效的 ,与对照组比较 ,手术的成功率、安全性及近、远期临床效果无明显差异。     

急性心肌梗死行冠状动脉内支架术初步探讨

目的评价急诊冠状动脉内支架术治疗急性心肌梗死的疗效及安全性.方法 48例急性心肌梗死患者入院6 h内接受急诊介入治疗,共置入支架58枚,术后行即刻血管造影评价,观察住院及近期临床事件.结果 44例(92%)患者梗死相关动脉(IRA)重建后TIMI-3级血流,全部病例IRA残余狭窄<30%.住院期间1例死亡,无急性再闭塞,急诊搭桥及严重出血发生.随访6个月,无再次心肌梗死、需外科血运重建术、卒中、脏器出血和死亡等重大临床事件.结论急诊支架置入术治疗急性心肌梗死成功率高,住院及近期临床效果好,是抢救急性心肌梗死的安全可靠方法.     

冠状动脉内旋磨术联合支架术治疗严重钙化病变的疗效及随访研究

目的评价冠状动脉(冠脉)内旋磨术联合支架术治疗严重钙化病变的疗效及中期随访结果。方法对21例冠心病患者的严重钙化病变行冠脉内旋磨术及支架术治疗,6例患者在血管内超声的引导下进行,观察其治疗的即刻成功率及6个月的随访结果。结果行冠脉内旋磨术的21例患者,冠脉造影结果均为В2、C型严重钙化病变。旋磨头均成功通过了病变,15例(71.4%)病例仅选择1.25mm的旋磨头,3例(14.3%)病例仅选择1.5mm旋磨头,3例(14.3%)病例使用了2个旋磨头。全部病例均联合应用经皮冠脉血管成形术(PTCA),19例(90.5%)在旋磨术后置入支架。2例(9.5%)在术中发生冠脉痉挛;1例(4.8%)发生无血流现象;无冠脉穿孔、死亡、急性心肌梗死及急诊冠脉旁路移植术(CABG)。对15例患者进行了术后6个月的冠脉造影随访,有2例(13.3%)发生支架内再狭窄。结论冠脉内旋磨术联合支架术治疗严重钙化病变,去除钙化斑块增大管腔,提高了严重钙化病变的经皮冠脉介入治疗(PCI)成功率。     

冠状动脉支架置入术后并发冠状动脉瘤的临床分析

目的:通过分析药物洗脱支架置入术后发生冠状动脉瘤病例的临床情况,探讨药物支架后发生冠状动脉瘤的机制及远期预后。方法:支架置入后5~12个月复查冠状动脉造影的患者,对比药物支架与普通支架术后冠状动脉瘤发生情况;并对发生动脉瘤的患者进行长期临床随访。结果:457例患者于支架术后5~12个月复查了冠状动脉造影,有5例随访时发现了支架部位冠状动脉瘤(4例药物支架,1例裸支架);Cypher支架、Taxus支架和裸支架后发生冠状动脉瘤的比例分别为2.13%(3/141)、0.90%(1/111)和0.49%(1/205),P>0.05;药物支架术后左前降支、左回旋支和右冠状动脉发生动脉瘤分别有2.05%(3/146)、2.08%(1/48)和0%(0/48),P>0.05。这些患者平均19个月的临床随访中没有发生任何不良事件。结论:药物支架和裸支架在不同部位发生动脉瘤情况差异无统计学意义,远期预后良好。     

Mini-invasive strategy in acute coronary syndromes: direct coronary stenting using 5 Fr guiding catheters and transradial approach.

The purpose of this study was to assess the feasibility and safety of direct coronary stenting in acute coronary syndromes using 5 Fr guiding catheters by transradial approach. A series of 119 patients with an acute coronary syndrome (unstable angina, n = 55; acute myocardial infarction, n = 45; recent acute myocardial infarction, n = 19) explored by transradial approach and eligible for direct stenting were included. A large proportion of patients (52%) was treated during the procedure by platelet IIb/IIIa receptor blockade. Only Medtronic 5 Fr guiding catheters were used in this study. Direct coronary stenting was attempted in all 119 highly selected patients. Failure of direct stenting was observed in only five cases (3.9%) and the stent successfully retrieved in each case in the 5 Fr guiding catheter. In these five cases, balloon predilation was performed and then the stent implanted successfully. Different stents were used: ACS stent (54%), AVE stent (33%), Velocity stent (10%), Nir stent (3%), with diameter ranging from 2.5 to 4 mm. In four cases, the dilation was finally performed using 6 Fr guiding catheters because the backup of the 5 Fr catheter was considered to be too low (3%). No vascular access site complications occurred in this series of patients. We conclude that direct coronary stenting using transradial approach and 5 Fr guiding catheters yields excellent procedural success rate. In the setting of acute coronary syndromes requiring platelet IIb/IIIa receptor blockade or after failure of thrombolysis, this mini-invasive strategy is very attractive because of the low risk of access site complications.     

急性冠状动脉综合征合并肾功能不全的支架术治疗

目的　评估急性冠状动脉 (冠脉 )综合征合并肾功能不全患者经皮腔内支架术的预后。方法　 6 3例急性冠脉综合征合并肾功能不全行冠脉内和或肾动脉支架植入术患者 (肾功能不全组 ) ,随机选取同期 6 3例一般情况匹配 ,肾功能正常行介入治疗患者 (对照组 )。比较两组临床特征、血管造影、支架术及随访情况。结果　肾功能不全组患者血清肌酐水平显著增高 [(177± 31) μmol/L比(98± 2 1) μmol/L ,P <0 0 0 1]、左室射血分数减低 (0 4 5± 0 10比 0 5 0± 0 0 9,P <0 0 5 ) ,冠脉多支病变增多 (84 %比 6 5 % ,P <0 0 5 )且肾动脉狭窄发生率显著增高 (2 7%和 8% ,P <0 0 5 ) ,13例患者在冠脉支架术同时行肾动脉支架术 (比较对照组 2例 ,P <0 0 5 ) ;两组冠脉支架术手术成功率和术中并发症相似 ;随访表明 ,肾功能不全组严重心脏不良事件发生率较高 (13%和 8% ,P =0 38) ,平均血清肌酐水平较术前降低 (177± 31μmol/L和 14 7± 11μmol/L ,P <0 0 5 ) ,9例 (6 9% )肾动脉狭窄患者肾动脉支架术后血清肌酐恢复正常。结论　急性冠脉综合征合并肾功能不全患者冠脉支架术安全、有效 ,2 / 3接受肾动脉支架术患者术后血清肌酐恢复正常。     

冠状动脉内直接支架置入治疗急性冠状动脉综合征--与传统支架置入方法的随机对比研究

目的 :采用与传统支架置入术 (CS)随机对比研究的方法 ,评价冠状动脉 (冠脉 )内直接支架置入术 (DS)治疗急性冠脉综合征相关病变的可行性和安全性。　　方法 :将 15 0例急性冠脉综合征患者随机分为DS组和CS组 ,两组的基本临床特征和造影特征及术前治疗无显著差异。实验第一终点是影像学的成功 :支架置入后靶病变残余狭窄 <2 0 % ,心肌梗死溶栓治疗临床试验 (TIMI) 3级血流 ,“无再流或慢血流现象”的减少 ;第二终点为严重并发症发生率和手术操作时间及花费的评价。　　结果 :DS组和CS组组间手术成功率无差异 (DS组为 94 7% ,CS组为 96 0 % )。无再流或慢血流现象发生率DS组为 5例 (6 7% ) ,CS组为 4例 (5 3 % ) ,两组间亦无差异 (P =NS)。手术时间、球囊导管及造影剂用量DS组均低于CS组 ,两组比较有极显著差异 (P <0 0 1)。住院期间效果及严重并发症两组间无差异 ;6个月随访结果两组比较亦无显著性差异。　　结论 :本随机研究证实了一些回顾性研究的结果 ,DS治疗急性冠脉综合征的相关病变具有可行性和安全性 ,与CS相比较 ,这一策略的突出优点是显著增加效益费用比 ,而对急性并发症特别是“无再流或慢血流”现象的发生无影响。     

冠状动脉内支架置入术的临床疗效及影响因素

目的探讨影响冠状动脉内支架置入术疗效的相关因素。方法对1995年3月～1998年5月间75例冠脉内支架患者进行回顾性分析,评价手术疗效及并发症,观察终点为心肌梗死或死 亡。结果75例患者共置入支架95个,成功率为97．9％,术中支架脱落2例(占2．1％),术后6h急性血栓性闭塞1例。随访(24．4±13．6)个月,再发心绞痛7例,冠脉造影证实5例再狭窄,2例支架部 位闭塞,其中1例死于不可逆性心原性休克。结论冠脉内支架手术成功率高、再狭窄率低,冠脉病变的特点及是否进行了有效的抗凝、降脂治疗,是影响临床疗效的重要因素。     

Rheolytic thrombectomy with AngioJet catheter during transluminal coronary revascularization in patients with acute myocardial infarction

BACKGROUND: Although balloon angioplasty and stenting are effective in the treatment of acute myocardial infarction (M1), reduced coronary flow and distal embolization frequently complicate interventions when thrombus is present. Adjunctive treatment with mechanical thrombectomy devices was suggested to reduce these complications. METHODS: We evaluated immediate angiographic, in-hospital and 30-day follow-up clinical outcomes of 185 patients with acute MI and angiographically evident thrombus who were treated with AngioJet rheolytic thrombectomy followed by immediate definitive treatment. RESULTS: Procedural success (residual diameter stenosis <50% and thrombolysis in myocardial infarction [TIMI] flow >2 after final treatment) was 97%. Rheolytic thrombectomy success was achieved in 7% of patients. Subsequent definitive treatment included stenting in 67% and balloon angioplasty alone in 26% of patients. Final TIMI 3 flow was achieved in 89%. AngioJet treatment resulted in mean thrombus area reduction from 69.6 mm(2) at baseline to 17.3 mm(2) post-thrombectomy (p<0.001). Procedural complications included distal embolization (7.6%) and perforation (1.1%). Clinical success (procedure success without major in-hospital cardiac events) rate was 88%, in-hospital mortality - 7.0%. There were no further major adverse events during 30-day follow-up. CONCLUSION: Rheolytic thrombectomy can be performed safely and effectively in patients with acute MI, allowing for immediate definitive treatment of thrombus-containing lesions.     

Direct Stenting Application in Acute Coronary Syndromes

Although published reports about direct stenting in treating stable coronary artery disease have been increasing, the number of studies regarding direct stenting for acute coronary syndrome is limited. In this study, we report immediate and mid-term results of patients who underwent direct stenting for treating acute coronary syndrome. The average lesion length was 12.1 ± 3.3 mm. The preprocedure average minimum luminal diameter (MLD) was 0.67 ± 0.33 mm. Post-procedure average MLD was 3.19 ± 0.42 mm. In 35 of the 36 cases (97%), the stent delivery system crossed the lesion and was implanted successfully. In one case, an acute occlusion, which was treated by percutaneous transluminal coronary angioplasty (PTCA), occurred. The rate of procedure success was 94%. The amount of contrast media used was 88 ± 16 ml and duration of radiation exposure was 9 ± 2 min. Control angiography was performed in 28 out of 35 cases (80%). Seven patients who did not consent to coronary angiography were asymptomatic and had negative exercise tests. MLD was 2.66 ± 0.53 mm after a six month follow-up. The clinical and angiographic restenosis rates were 14% (5/35) and 18% (5/28), respectively. Three of the five cases of restenosis were treated by excimer laser coronary angioplasty (ELCA) and PTCA and the other two were treated with PTCA only. Target lesion revascularization rate was 14% (5/35). The rate of major adverse cardiac events (MACE) was 17% (6/35) after the six month follow-up period. Based on these results, we conclude that direct stenting for acute coronary syndrome is safe if the lesion is determined to be suitable.     

The Application of Dual-wire Balloon in The Treatment of Coronary Bifurcation Lesions

Objectives To assess the efficiency and safety of dual-wire balloon angioplasty side branch combined stenting the main branch in the treatment of coronary bifurcation lesions. Methods This study included thirty-six patients with 41 coronary bifurcation lesions. Selective dual-wire balloon angioplasty was performed in side branch and/or in main branch, and implantation of stents was performed in main branch only. Clinical outcome and major adverse cardiac events were observed in-hospital and follow-up. Results Success rate of side branch dilatation before main branch stenting was 100%; main branch direct stenting performed in 4 cases; success main branch dilatation performed in the other 37 cases; kissing technique was performed successfully in 5 cases, which side branch was jailed after main branch stenting with TIMI grade 0-2 flow. No Q-wave myocardial infarction, acute revascularization and death occurred during in-hospital. Clinical follow-up was available in all patients. No Q-wave myocardial infarction, revascularization and death occurred, angina pectoris recurred in three patients, released by strengthen drug treatment. Conclusions Dual-wire balloon angioplasty side branch combined stenting the main branch is simple, safe and effective for the treatment of coronary bifurcation lesions.     

Direct coronary stenting: effect on coronary blood flow, immediate and late clinical results.

Direct stenting (DS) was attempted in 99 coronary lesions in 94 patients while standard stenting (SS) was attempted in 113 lesions in 103 patients matched for clinical characteristics, stenosis type, and location and stent type. The angiographic result was also evaluated according to TIMI frame count method (TFC) before and after procedure. A clinical follow-up was performed 1 year after the procedure. Before the procedure, TIMI grade 3 flow was detected in 42 cases (42.4%), grade 2 in 40 cases (40.4%), grade 1 in 5 cases (5.1%), and grade 0 in 12 cases (12.1%) in the DS group; these data were similar in SS group. After the procedure, TIMI grade flow was 3 in 90 cases (92.8%) in DS group and in 87 (77.0%) in SS group (P < 0.005); grade 2 was observed in 7 case (7.2%) in DS group and in 25 (22.1%) in SS group (P < 0.005). Major adverse cardiac events during hospitalization and at follow-up were similar in two groups. Radiation exposure time and procedure costs per lesion were significantly reduced in DS group compared to SS group (10.1 +/- 8 min vs. 13.9 +/- 4.7 min, P < 0.001; and 1901 +/- 687 Euro vs. 2352 +/- 743 Euro, P < 0.001, respectively). This study confirms that, in selected patients, direct stenting is a safe and successful procedure, allowing a significant reduction in radiation exposure time and procedural costs compared to standard stenting technique. The angiographic success is confirmed by the improvement in TFC in all cases.     

Direct stenting with the Bx VELOCITY™ balloon-expandable stent mounted on the Raptor ® rapid exchange delivery system versus predilatation in a European randomized Trial: the VELVET trial

AIMS: This study examined the six-month angiographic results of direct coronary stenting, and compared the nine-month safety, efficacy and cost of this strategy versus stenting after balloon predilatation. METHODS: In phase I of VELVET, 122 patients (mean age = 62.3 &#45 10.1 years, 77% male, 11% with diabetes) with angina pectoris or myocardial ischemia resulting from a single de novo 51% to 95% coronary stenosis underwent direct stenting. The endpoints of phase I included angiographic findings and rates of major adverse cardiac events up to six months of follow-up. In phase II, 401 patients (mean age = 61.3 &#45 10.8 years, 79% male, 16% with diabetes) with angina pectoris or documented myocardial ischemia resulting from single or multiple, de novo or restenotic, coronary lesions were randomized between direct stenting and stenting after predilatation. The immediate angiographic results, and clinical outcomes and costs associated with the two treatment strategies up to nine months of follow-up were compared. RESULTS: In phase I the mean diameter stenosis immediately before and after the procedure, and at six months was 61.7 &#45 9.4%, 13.5 &#45 6.3%, and 33.6 &#45 16.2%, respectively. The six-month binary restenosis rate was 11%. The overall rate of major adverse cardiac events, including two non-cardiac deaths, was 9.8%. In phase II, the success rates of the intended delivery strategies were 87.9% and 97.9% for direct stenting and predilatation, respectively (p < 0.001), while the procedural success rates were similar (93.9% vs 96.5%). Over a follow-up period of nine months, major adverse cardiac events rates were 12.0% and 10.9% in patients randomized to direct stenting and predilatation, respectively (non-significant). Analyses of the costs incurred up to nine months in each treatment group revealed a mean saving of e362 per patient in favor of the direct stenting strategy (non-significant). CONCLUSIONS: Compared with a strategy of stenting preceded by balloon dilatation, direct stenting was associated with an equivalent procedural success rate, equivalent clinical results up to nine months of follow-up, and a reduction in procedural and in-hospital costs (p < 0.0001 and p < 0.001, respectively), that was no longer significant after nine months.     

A safe and effective regimen without heparin therapy after successful primary coronary stenting in patients with acute myocardial infarction

Short-term heparin therapy has been administered routinely after primary coronary stenting. However. heparin therapy results in a significantly higher incidence of bleeding and vascular complications. A new therapeutic regimen of ticlopidine and aspirin without further heparin after coronary stenting in patients without AMI has been shown to be safe and reduce the incidence of stent thrombosis. The aim of this study was to evaluate whether a new therapeutic regimen of aspirin and ticlopidine without heparin is safe and effective in patients with acute myocardial infarction (AMI) who have undergone primary coronary stenting and have Thrombolysis in Myocardial Infarction (TIMI) grade 3 flow in the infarct-related artery. Between January 1997 and September 1999, one hundred and fifty two consecutive patients with AMI on Killip score 1 or 2 who underwent primary coronary stenting resulting in TIMI grade 3 flow were enrolled and divided into two groups: Group 1 (n = 95 patients) received aspirin, ticlopidine and further intravenous heparin infusion for 48 hours following primary coronary stenting; Group 2 (n = 57 patients) received only aspirin and ticlopidine without further heparin therapy following primary coronary stenting. No in-hospital major cardiac events were observed in either group. However, the combined incidence of bleeding and vascular complications (27.4% vs 12.3%, p = 0.029) and the need for blood transfusions (9.5% vs 0%, p = 0.013) were significantly higher in Group I patients. Furthermore, hospital stay was also longer in Group I patients (5.8+/-2.4 vs 4.7+/-1.7 days, p = 0.0003). At the 30-day follow-up, there were no differences (1.05% vs 0%, p = 0.63) in the combined incidence of vascular complications and the major cardiac events were similar (1.05% vs 1.75%, p = 0.71) between the groups. The results suggest that further heparin therapy following primary coronary stenting increases the combined incidence of bleeding and vascular complications as well as the need for blood transfusions and prolongs the length of hospital stay without further benefit to those patients with coronary flow restored to TIMI 3 grade flow.