无预扩张直接冠状动脉内支架置入术

目的　探讨无预扩张直接冠状动脉内支架置入术的可行性及临床效果。方法　参照国外直接冠状动脉内支架置入术标准 ,对 2 7例冠心病患者进行无预扩张直接冠状动脉内支架置入术。结果　 2 7例患者共 2 8处病变 ,置入 2 8个支架 ,其中 A型病变 14例 ,B1 型病变 10例 ,B2 型病变 4例。置入支架前管腔狭窄程度为 78.2 %± 5 .6% ,支架置入后血管残存狭窄程度为 0 .9%± 1.4% ,支架置入成功率为 10 0 % ,无并发症发生。术后随访 1年 ,2例患者出现心绞痛 ,冠状动脉造影证实 1例患者出现支架内再狭窄。结论　正确选择适应证的情况下 ,无预扩张直接冠状动脉内支架置入术是一种安全有效的治疗方法 ,可获得较好的近、远期临床效果     

预扩张支架术和直接支架术治疗老年冠心病患者比较观察

目的 比较采用充分预扩张支架术、有限预扩张支架术和直接支架术治疗老年冠心病患者的优缺点及远期疗效。方法 选择具有如下特点的病例进入观察:①临床诊断不稳定型心绞痛(UAP)或非ST段抬高性心肌梗死(NSTEMI)。②年龄≥65岁。③无糖尿病史。④冠状动脉(冠脉)病变狭窄程度≥75％但≤95％,长度≤30mm,参考直径≥3.0mm,成角≤45°。⑤透视下病变钙化程度中度以下。对人选病例的病变随机分为3组:①充分预扩张支架组,采用与病变参考血管直径1:1的球囊充分预扩张后置入支架。②有限预扩张支架组,采用比病变参考血管直径小30％左右的球囊作有限预扩张后置入支架。③直接支架组,不经过预扩张直接置入支架。全组病例术后常规服用噻氯匹定4周,联合应用β-阻滞剂、钙拮抗剂、血管紧张素转换酶抑制剂和他汀类降脂药物。每半年随访症状和心电图,对有胸痛症状和缺血检查结果者复查冠脉造影。结果 共入选198例患者(263个病变),男/女为122/76,年龄(72±11)岁。3组病变分组情况及介入治疗结果:①充分预扩张支架组,87个病变(63例),支架全部放置成功,支架直径(3.3±0.7)mm,长度(2.68±0.7)mm,预扩张后33个病变(37.9％)出现夹层,其中11个(33.3％)需采用长支架或补放支架处理。②有限预扩张支架组88个病变(69例),支架全部放     

未预扩张直接冠状动脉内支架置入术的临床疗效观察

目的 观察未预扩张直接冠状动脉内支架置入术的可行性和安全性。方法 选择23例冠心病患者不作冠状动脉预扩张直接行支架置入，分析其疗效和成功率。结果 未行球囊预扩张的23例患者25枚冠状动脉支架均顺利推送至病变处，均成功扩张，手术成功率为100％，术中无撕裂、痉挛及其他并发症发生。随诊40d所有患者无不良反应。结论 在恰当选择的冠心病患者中。行直接冠状动脉支架置入术是安全可行的。其优点是降低病人费用，减少造影剂用量，支架定位准确，缩短手术时间及X线曝光时间。血管损伤轻，减少了术后发生支架内再狭窄的机会。     

直接冠状动脉支架置入术的临床应用

目的评价冠状动脉直接支架置入术的可行性,临床效果及安全性. 方法选择17例冠心病患者不作预扩张直接进行支架置入,观察临床效果及手术成功率.     

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     

直接冠状动脉支架置入术的临床应用

冠状动脉内支架置入术在冠心病介入治疗中应用最为广泛 ,冠状动脉内支架置入一般先对靶病变部位用球囊进行预扩张 ,然后再置入支架。近年来 ,由于支架置入技术和球囊预装支架设计的改进 ,临床医师对一些选择的病变开始试用直接支架置入术 ,在支架置入前不用球囊预先扩张冠状动脉狭窄部位〔1 ,2〕。我们对 42例患者进行了直接冠状动脉支架置入术 ,现总结报告如下。1　对象与方法选自 1 998年 7月～ 2 0 0 1年 5月在我院住院治疗的 42例冠心病患者 ,入选标准为〔1～ 3〕:①病变无钙化或轻度钙化 ;②病变长度 <2 5ｍｍ ;③血管直径≥ 2 .5ｍｍ …     

冠状动脉内支架置入术治疗老年患者复杂冠状动脉病变

目的　探讨经皮冠状动脉腔内支架置入术治疗老年患者复杂性冠状动脉病变的疗效及安全性。方法对 4 5例冠心病患者施行冠状动脉内支架置入术 ,病变血管共 5 8支 ,B型病变 4 9处 ,C型病变 1 3处 ,慢性完全闭塞病变 4处 ,共置入支架 64只。置入左前降支 2 7只 ,左回旋支 1 3只 ,右冠状动脉 2 4只。De Novo支架置入 4 4只 ,Suboptimal支架置入 1 5只 ,Bail-out支架置入 3只 ,再狭窄病变支架置入 2只。结果　术后经冠状动脉造影证实疗效满意 ,支架置入成功率为 98.4 %。术前病变平均直径狭窄 (86.5± 7.8) % ,术后残余直径狭窄 (5 .1± 1 0 .3 ) %。住院期间无亚急性支架血栓形成。 1例出现假性动脉瘤 ,1例在术中及术后出现三次心室颤动 ,4例患者术后心绞痛复发 ,复查冠状动脉造影发现了 3个支架节段血管有再狭窄。结论　对于老年冠心病患者复杂冠状动脉病变 ,经皮冠状动脉内支架置入术是一种安全有效的介入性治疗技术 ,其成功率高 ,并发症发生率低     

直接冠状动脉支架置入术的前瞻性临床研究

目的　前瞻性探讨无预扩张直接冠状动脉支架置入术的即刻和长期效果。方法　 1 997年 5月～ 2 0 0 0年 1 2月共 4 6 5例冠心病患者入选该研究 ,选择性冠状动脉造影示 4 6 5处靶病变狭窄程度 6 0 %～ 99%,平均 (79± 1 0 8) %,均为单支、单处病变 ,随机分至无预扩直接支架组 (A组 )、预扩后置入支架组 (B组 )及单行经皮冠状动脉腔内成形术 (PTCA)组 (C组 )。结果　A组与B组支架置入成功率差异无显著性。PTCA组术后即刻残余狭窄明显大于两个支架组 (P <0 0 1 )。A组X线暴光时间、手术时间、造影剂及球囊导管用量均明显少于其他两组。术后所有患者心绞痛消失。随访 8～ 5 1(2 7 9± 1 5 9)个月 ,A、B、C组心绞痛复发率分别为 4 3 %、1 8 6 %及 2 9 5 %(P <0 0 5 ) ;共有 1 87例患者复查冠状动脉造影 ,示A、B、C组再狭窄率分别为 8 6 %、1 3 3 %及 2 8 6 %,无症状存活率分别为95 2 %、80 3 %及 6 8 2 %(P <0 0 1 )。结论　对选择恰当的冠状动脉病变 ,直接冠状动脉支架置入术具有较高的即刻成功率、安全性和较理想的长期效果     

直接冠状动脉内支架置入术治疗急性心肌梗死

目的观察急性心肌梗死(AMI)时行无球囊预扩张直接置入冠状动脉内支架治疗的临床效果.方法对22例AMI患者在发病12小时内,未经球囊预扩张而直接置入冠状动脉内支架.梗死相关血管(IRA)(共22支血管),左前降支12例(54.5%),左回旋支5例(22.7%),右冠状动脉5例(22.7%).心肌梗死溶栓试验(TIMI)血流1级5例(22.7%),2级13例(59.1%),3级4例(18.2%).结果 22例患者共置入22个支架,支架置入后 TIMI血流3级21例(95.5%),2级1例(4.5%),残余狭窄为3.2±2.9%,支架置入成功率100%.住院期间无一例死亡、再次心肌梗死及再次靶病变需重复再通治疗.结论急性心血肌梗死(AMI)时行无球囊预扩张直接置入冠状动脉内支架治疗,成功率高、并发症少,TIMI血流3级达到率高.     

低压力球囊预扩张及高压力冠状动脉内支架置入临床疗效观察

目的 :评估低压力球囊预扩张、高压力冠状动脉 (冠脉 )内支架置入的可行性和效果。方法 :10 6例选择性支架置入的冠心病患者 ,低压力 (40 5 .3～ 6 0 7.9kPa)球囊预扩张后 ,冠脉内置入支架 ,高压力 12 15 .9～ 16 2 1.2kPa)释放。结果 :共 12 7处病变置入支架 135只 ,球囊预扩张平均压力为 4 86 .4kPa ,平均支架释放压力为 136 7.9kPa ,即刻支架置入和释放的成功率为 10 0 %。低压力预扩张冠脉内膜撕裂发生率为 3.9%(5 / 12 7处 )。结论 :选择性冠脉内支架置入 ,低压力球囊预扩张、高压力支架置入是一种安全、有效和可行的方法 ,可能减少冠脉内膜撕裂的发生率。     

Direct coronary stenting without predilation

OBJECTIVES

Coronary stenting is the primary therapeutic option for percutaneous treatment of many coronary lesions, after the risk of subacute stent thrombosis and bleeding complications has been reduced by improved antithrombotic regimens and high pressure stent expansion.

BACKGROUND

Direct stent implantation (without predilation) has been considered a promising new technique that may reduce the procedure time, radiation exposure time and cost.

METHODS

After having reviewed all cases of stent implantation from February to June 1998 (n = 585), 185 (32%) of these patients were retrospectively considered candidates for direct stent implantation without predilation, according to prespecified criteria (i.e., absence of severe coronary calcifications and/or tortuosity of the lesion or the segment proximal to the lesion). By operator preference, direct coronary stent implantation was actually attempted in 123 (21%) of the 585 patients (100 men, 60 ± 10 years old) on 123 lesions. The impact of direct stenting in terms of cost, procedure time, radiation exposure time and amount of contrast dye used was assessed by comparing the two groups of patients who underwent single-vessel stenting without (n = 69) and with (n = 46) predilation.

RESULTS

Direct stenting was successful in 118 patients (96%). No acute or subacute complications occurred in these patients. Procedure time, radiation exposure time and cost were significantly lower in the group of patients who had single-vessel direct versus conventional stenting (45 ± 31 vs. 64 ± 46 min, 12 ± 9 vs. 16 ± 10 min and 1,305 ± 363 vs. 2,210 ± 803 Euro, respectively; p < 0.05 for all).

CONCLUSIONS

Direct stenting without predilation in selected lesions seems to be a safe and successful procedure that provides a way to contain cost and to shorten radiation exposure time.     

Nonselected use of direct coronary stenting. The DISCO 2 trial

INTRODUCTION AND OBJECTIVES: Direct coronary stenting yields immediate long-term clinical results similar to those obtained with balloon predilation, with the advantage of lower costs and procedural times. Until now, direct stenting has been attempted only for selected lesions, so that the potential scope of its use in everyday practice remains unknown. The DISCO 2 trial was designed to identify the number and type of lesions that could be safely treated by direct stenting. Patients and method. 1,269 lesions (886 patients) were treated consecutively in 7 different hospitals. Direct stenting was attempted in all cases, except for total chronic occlusions, severe tortuosity or calcification of the vessel, lesions in the sinus ostium, or bifurcated lesions and vessel diameter < 2.4 mm. If the procedure failed, the stent was recovered and the lesion dilated with a balloon before a second attempt at stenting. RESULTS: Direct stenting was attempted in 585 lesions (54.9% of all electively implanted stents and 46.1% of all angioplasties). This was successful in 553 (94.6%) and failed in 32 (5.4%). In 30 of these latter patients a stent was implanted after predilation. Predictors of failure were tortuosity, location in the nonproximal right coronary artery, age > 65 years and type B2 or C lesion. After 6 months of follow-up the total incidence of major adverse cardiovascular events in patients treated with direct stenting was 6.2%, with a target lesion revascularization rate of 4.45%. CONCLUSIONS: In a mostly nonselected sample of coronary lesions, direct stenting was as safe as stenting with predilation. More than half of all elective stenting procedures can be attempted safely without balloon predilation. Greater need for predilation was associated with tortuosity, nonproximal right coronary artery location, older age and lesion complexity (B2, C). The 6-month clinical outcome was excellent, with a low rate of repeat revascularization.     

Comparison of direct stenting versus stenting with predilation for the treatment of selected coronary narrowings.

Direct stenting may reduce costs, procedure times, and injury to the vessel wall, positively influencing acute and late results. This study was designed to demonstrate 6-month clinical outcome equivalence between direct and standard stenting techniques. Four hundred eleven patients (425 lesions) were randomized in 7 sites to undergo direct (210 patients, 216 lesions) or conventional (201 patients, 209 lesions) stent implantation. Lesions with severe calcification were excluded. Angiographic success rate was 100% in the direct stent group (2.8% requiring balloon predilation) and 98.6% in the predilation group (p = 0.12). Direct stenting was associated with decreased use of balloons (0.15 vs 1.09 balloons/lesion treated) and with a trend toward a reduction of procedure time (22.7 +/- 15.0 vs 25.6 +/- 18.2 minutes; p = 0.073). Fluoroscopy time and contrast volume were not different between groups. At 6-month follow-up, the incidences of death (direct [1.4%] vs predilation [2.5%]), myocardial infarction (5.3% vs 5.0%), and target vessel revascularization (8.2% vs 10.5%) were similar in both groups. Major adverse cardiac event-free survival rate was 87.5% for those who underwent the direct stent technique and 85.5% for patients who underwent predilation (p = 0.0002 for equivalence). In conclusion, direct stenting is at least equivalent to the standard technique in terms of 6-month clinical outcomes when performed on selected coronary lesions without significant calcification. This strategy is associated with decreased use of balloons, but, in general, does not significantly reduce procedure times.     

Could direct stenting reduce no-reflow in acute coronary syndromes? A randomized pilot study

Objectives Recently, direct stenting has been shown in retrospective and randomized studies to be feasible and safe in highly selected patients, with a potential interest to reduce the cost of the procedure and the rate of no-reflow. This randomized pilot study was designed to compare the incidence of no-reflow after direct stenting or conventional stenting after balloon predilation in acute coronary syndrome-related lesions. Methods and Results Between December 1998 and October 1999, 130 patients in our center with acute coronary syndromes were included in this study and randomized in 2 groups. In group A (n = 65), direct stent implantation was performed without balloon predilation. In group B (n = 65), conventional balloon predilation was carried out before stent implantation. Baseline clinical and angiographic characteristics before the procedure were similar in the 2 groups of patients. No-reflow was observed in 7.7% after direct stenting and in 6.1% after conventional stent implantation (P = not significant). The immediate clinical success rate was similar in the 2 groups. Among the procedural data, only duration of the procedure (shorter in the direct stenting group), the number of balloons used, and the quantity of contrast agent (lower in the direct stenting group) were significantly different between the 2 groups (P < .05). The 6-month clinical outcome was similar in the 2 groups. Conclusion This randomized study confirms the promising results of previous studies that show the feasibility and the safety of direct coronary stenting in highly selected acute coronary syndrome-related lesions. The major impact of this strategy is the improvement of the cost-benefit ratio, with no major influence on the acute complications and especially on the occurrence of no-reflow in this high-risk population. (Am Heart J 2002;143:1027-32.)     

Direct stenting with sirolimus-eluting stents

The sirolimus-eluting stent has been studied extensively in randomized controlled trials of patients with native de novo coronary lesions. Lesion predilation before stent placement has been the predominant implantation strategy in these trials. Direct implantation of the sirolimus-eluting stent without lesion predilation has been undertaken at the investigators' discretion in certain trials as well as in patients enrolled in a post-marketing surveillance registry, and was the intended implantation strategy in the DIRECT trial. Comparisons with patients receiving sirolimus-eluting stents after lesion predilation in the trials and the registry were all confounded by imbalances in patient, lesion, and/or procedural characteristics and point to the highly selective nature of the direct-stenting strategy. At present, direct implantation of the sirolimus-eluting stent appears to be safe and as effective as conventional (predilated) stenting, provided that the targeted coronary lesion is amenable to the direct approach. Since a randomized trial of implantation strategies is lacking, there is no conclusive evidence as to the hypothesized superiority of direct over predilated stenting in suitable coronary lesions.     

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.     

Efficacy and safety of direct stenting in coronary angioplasty

BACKGROUND: Direct stenting is the deployment of an intracoronary stent without lesion predilation. Potential advantages include shorter procedural time, lower contrast dose and reduced spiral dissections. There is also the potential financial benefit of less balloon and/or stent usage. Concern still exists among some operators, however, regarding failure of stent deployment and local complications. METHODS: Of 467 consecutive angioplasty cases at the Alfred Hospital between August 1, 1997 and May 22, 1998, direct stenting was attempted in 93 patients (20%). Interventionalist preference determined whether direct stenting was attempted. Vessels with excessive calcification, severe proximal tortuosity or small caliber were typically considered unsuitable for direct stenting. RESULTS: A total of 102 lesions (38 type A, 60 type B, and 4 type C) were treated with direct stenting. Initial deployment was successful in 98 of 102 lesions, with a further 3 lesions successfully stented following predilation. A stent was unable to be deployed in only 1 case; however, the lesion was treated with balloon angioplasty alone. The majority of lesions required only 1 stent (an average of 1.1 stents were used per lesion). Distal complications occurred in 5 patients. In 3 patients, a small distal dissection was successfully stented, and in 1 case embolization of debris occurred down the distal vessel, resulting in a small procedural myocardial infarction. Only 1 patient out of 93 (1%) developed a large distal dissection requiring the deployment of multiple stents, compared with 22 of the remaining 374 patients (5.9%) who underwent conventional angioplasty. This was a significant difference in favor of direct stenting (Chi-square, p < 0.05). When compared with a cohort of patients matched by lesion grade treated with conventional stenting, direct stenting used significantly less contrast per case (154 +/- 7.6 ml compared with 202 +/- 9.5 ml for conventional stenting; p = 0.0001). CONCLUSION: Direct stenting is a safe and effective method for treating coronary artery disease. In appropriately selected cases, it has a low rate of procedural failure and results in less contrast usage and fewer distal complications than conventional angioplasty and stenting.     

冠脉内支架直接置入术治疗急性冠脉综合征58例

目的:探讨未预扩张直接置入冠脉内支架术治疗急性冠脉综合征的临床疗效及安全性。方法:对58例急性冠脉综合征患者采用未预扩张直接置入冠脉内支架术进行治疗。结果:本法成功率为95％,未发生支架脱落及偏位现象,3例支架扩张后残余狭窄<30％。结论:应用未预扩张直接置入冠脉内支架术治疗冠脉中等严重狭窄(<85％)的急性冠脉综合征患者,操作简便,近期疗效确切,并发症少,安全、经济。     

Effect of direct stent implantation on QTc dispersion

The aim of this study was to evaluate whether direct stenting is superior to conventional stent implantation technique with respect to QTc dispersion in prospectively selected patients with simple lesion morphology and class II stable angina undergoing elective coronary stenting. One hundred thirty-four consecutive patients were divided into 2 groups based on the stenting technique used: the direct stenting without predilation group, group I (n = 64), and the stenting with predilation group, group II (n = 70). All patients had single-vessel disease. The primary end point of the study was the QTc dispersion at the 24th hour and at the first month after the procedure and the secondary end point of the study was the major clinical events (MCEs) rate in the hospital period and up to 1 month. Baseline maximum QTc, minimum QTc, and QTc dispersion were not different between the 2 groups. QTc dispersion decreased from 47+/-8 msec before stent implantation to 41+/-11 msec at 24 hours and 37+/-7 msec 1 month after angioplasty in group I (p < 0.006 and p < 0.01, respectively), whereas QTc dispersion decreased from 49+/-9 msec before stent implantation to 46+/-8 msec at 24 hours and 42+/-10 msec 1 month after angioplasty in group II (p < 0.03 and p < 0.01, respectively). Compared with group II, the decrease in QTc dispersion was significantly greater at the 24th hour and at the first month after the procedure in group I (p < 0.003 and p < 0.001, respectively). There was a decreased trend toward MCE rate in group I in relation to that of group II, but the statistical difference was not significant. Direct stenting is a feasible and safe technique. It is superior to conventional stenting technique in decreasing the QTc dispersion at the 24th hour and at the first month after the procedure, whereas it is equivalent to single-vessel conventional stent implantation technique with respect to MCEs rate in the short-term period.