药物洗脱支架在冠心病无保护左主干病变中的应用

目的评价药物洗脱支架治疗经选择冠心病无保护左主干病变的安全性和有效性。方法2003年1月~2005年6月间,共有48例经选择的冠心病患者,年龄39~81岁,经冠状动脉造影证实为无保护左主干病变(左主干狭窄均≥75%)行介入治疗置入药物洗脱支架。结果48例患者介入治疗均获得成功,共置入药物洗脱支架75枚(51 Cypher,18 Taxus,6 Firebird)。其中左主干开口部狭窄5例(10.4%,5/48),体部狭窄6例(12.5%,6/48),远端分叉部位狭窄37例(77.1%,37/48)。37例远端分叉部位狭窄患者中,主支支架加边支经皮冠状动脉介入治疗(PCI)10例,双支架术27例,最后成功对吻球囊扩张30例(81.1%,30/37)。所有患者治疗后临床症状明显缓解或消失,住院及6个月随访期间无严重心血管事件发生,43例患者术后6个月行冠状动脉造影随访,2例患者再狭窄(均为分叉病变)行冠状动脉旁路移植术(CABG),冠状动脉造影随访率89.6%,再狭窄率4.7%。结论药物洗脱支架介入治疗冠心病无保护左主干病变安全有效,近中期效果良好。     

Sirolimus-eluting stent fractures leading to restenosis in cardiac allograft vasculopathy

Cardiac allograft vasculopathy (CAV) is the most common cause of long-term graft failure after heart transplantation. In the absence of a specific treatment for this condition, percutaneous coronary revascularization (PCI) has been the main palliative treatment. Although long-term results are unknown, use of drug-eluting stents (DES) has been shown to have favorable outcome when used in heart transplant patients for treatment of focal lesions in CAV. We report the case of a 77-year-old male who presented with restenosis secondary to DES stent fracture (SF) after treatment of CAV with sirolimus-eluting stents (SES).     

可生物降解涂层药物洗脱支架介入治疗的近期疗效

目的 评估国产新型西罗莫司可生物降解涂层支架在急性心肌梗死患者介入治疗(percutaneous coronary intervention,PCI)中的疗效及安全性.方法 急性心肌梗死患者56例,其中ST段抬高性心肌梗死48例,非ST段抬高性心肌梗死8例,均置人西罗莫司可生物降解涂层洗脱支架,观察手术成功率、支架内血栓等并发症及主要不良心脏事件(main adverse coronary events,MACE)发生率,术后随访1～14个月,6～9个月行冠状动脉造影复查.结果 成功行PCI 55例,手术即刻成功率98%.82处病变共置入西罗莫司支架98枚,其中17枚(17.3%)为直接支架术.4例出现无复流现象,1例使用主动脉气囊反搏.1例术后6 h猝死,考虑急性支架内血栓.术中及住院期间无其他严重并发症发生.50例(89.3%)随访1～14个月,无晚期支架内血栓发生,无MACE;复查冠状动脉造影19例,1例发生支架内再狭窄,无需血运重建.结论 国产西罗莫司可生物降解涂层支架在急性心肌梗死患者行PCI治疗有较好疗效及安全性.     

EXCEL支架在慢性闭塞病变介入治疗中的应用及疗效观察

目的总结冠状动脉性心脏病(冠心病)慢性完全闭塞(chronic total occlusion,CTO)病变经皮冠状动脉介入(percutaneous coronary intervention,PCI)治疗中EXCEL生物降解药物涂层支架的应用及3年随访结果,评价其在CTO病变的疗效及安全性。方法2006年1月至2009年3月入住成都军区昆明总医院,冠状动脉造影确诊CTO病变并行PCI治疗患者185例,靶病变均植入EXCEL支架,常规二联抗血小板治疗至少6个月。术后6个月、1年、2年、3年临床及冠状动脉造影随访,以主要心血管事件(major adverse cardiac events,MACE)发生率、再狭窄率(in-stent restenosis,ISR)、血运重建率为研究终点,同时了解亚急性及晚期支架内血栓发生率。结果共147例CTO病变血管开通,即刻血管开通率为79.5%(147/185);共201处闭塞病变中,26处导丝无法通过,8处导丝通过闭塞病变后球囊无法跨越病变部位,靶血管开通率83.1%;闭塞时间12个月以内及超过12个月的靶血管开通率分别为87.5%、62.4%,有桥侧支存在者PCI治疗成功率低于无桥侧支者,断端呈刀切状的成功率低于鼠尾状(P0.05)。术中无死亡病例;术后6个月、1年、2年、3年冠状动脉造影复查率分别为30.8%、19.5%、15.1%、10.3%,MASE发生率分别为3.2%、2.3%、1.95、4.0%,再狭窄率分别为8.8%、8.3%、7.1%、5.3%;发生亚急性、晚期支架内血栓各1例,发生率分别为0.6%、0.1%,无急性支架内血栓事件。结论EXCEL支架应用于CTO病变PCI治疗中安全有效,没有增加MACE发生率及支架内血栓事件。     

药物洗脱支架与裸支架介入治疗冠心病的对比研究

目的比较冠心病患者应用药物洗脱支架与应用裸支架的安全性和有效性。方法回顾我院2006—2011年行冠脉支架置入术患者的随访结果,比较应用药物洗脱支架与裸支架的再狭窄率。结果应用药物洗脱支架患者的再狭窄率为8％,应用裸支架患者的再狭窄率为25％,两者相比差异有统计学意义。结论药物洗脱支架较裸支架具有更低的支架内再狭窄发生率。     

雷帕霉素药物洗脱支架治疗急性心肌梗死六个月随访结果

目的探讨雷帕霉素药物洗脱支架（Cypher）在急性ST段抬高心肌梗死急诊经皮冠状动脉介入治疗（PCI）中应用的安全性和有效性.方法选择2002年11月至2004年12月间的急性ST段抬高心肌梗死患者168例,于发病12 h内行急诊PCI治疗,于梗死相关血管的靶病变置入Cypher支架.记录1个月和6个月随访终点时的主要心脏不良事件（包括死亡、再发心肌梗死、靶血管再成形等）发生率、支架内血栓发生率、支架内再狭窄发生率.结果 168例患者急诊PCI治疗均获得成功.168支梗死相关血管的171处罪犯病变共置入175枚Cypher支架,未发生与介入治疗有关的并发症.1个月随访终点时死亡3例（死亡率1.8%）;支架内亚急性血栓1例;主要心脏不良事件发生率2.4%.6个月随访终点时死亡4例（死亡率2.4%）;主要心脏不良事件发生率4.2%;支架内血栓发生率1.2%;支架内再狭窄发生率1.8%.结论药物洗脱支架（Cypher）在急性ST段抬高心肌梗死急诊PCI中应用与普通支架一样有较强的安全性和有效性,并可以明显降低再狭窄率.     

Role of adjunct pharmacologic therapy in the era of drug-eluting stents

The success of percutaneous coronary intervention (PCI) has historically been limited by a relatively high rate of restenosis, a response of the coronary artery to trauma induced during PCI. Bare-metal stents, by providing a supportive intravascular scaffolding, have significantly reduced the incidence of restenosis compared with traditional balloon PCI. However, significant loss of lumen within the bare-metal device (in-stent restenosis) occurs in 10-30% of patients within 6 months of the procedure. The recent introduction of drug-eluting stents, permitting local delivery of high concentrations of immunosuppressive or anti-proliferative agents, promises to prevent the processes underlying restenosis. Although these devices have been successful in providing an incremental reduction in rates of restenosis, they are expensive. To date, clinical trials of pharmacologic treatment have failed to demonstrate a clinically significant impact on restenosis. Recently, results of the Cilostazol for Restenosis (CREST) trial, a randomized, double-blind study, show that cilostazol reduces the risk of restenosis in patients who receive bare-metal stents, including high-risk patients. Effective adjunct pharmacologic therapy to prevent in-stent restenosis, therefore, remains desirable, particularly in patients receiving bare-metal stents, and potentially in patients receiving drug-eluting stents who are at high risk for restenosis (i.e., those with diabetes, long lesions, and small vessels).     

An angiographic evaluation of restenosis rate at a six-month follow-up of patients with ST-elevation myocardial infarction submitted to primary percutaneous coronary intervention

BACKGROUND: Percutaneous coronary intervention (PCI) is considered to be the optimal type of revascularization in patients with ST-segment elevation myocardial infarction (STEMI). However, the long-term effectiveness of this procedure can be reduced by restenosis. This investigation was aimed at a prospective evaluation, in a group of STEMI patients of "the real world" (not involved in randomised trials), of the angiographic restenosis rate at a 6-month follow-up, and at identifying the relationship between restenosis and the patients' characteristics. MATERIALS AND METHODS: Our study population consisted of 123 patients with STEMI submitted to primary PCI to then undergo stress echocardiography 3 months after PCI and an angiographic evaluation at a 6-month follow-up. RESULTS: a) In real life the restenosis rate is quite high (42.3%); b) no correlation was found between patients' clinical characteristics and restenosis; c) restenosis rate was higher in patients with bare metal stents than in those with drug-eluting stents (55.8% vs. 11.1%; p<0.001); in patients with longer stents (21.6+/-8.62 vs 18.1+/-6.34 mm, p=0.015) and when more than one stent was implanted. Moreover, a consistent number of patients showed restenosis though asymptomatic. CONCLUSIONS: Our data suggest that primary PCI is associated with a high incidence of angiographic restenosis. No correlation was found between patients' clinical characteristics and restenosis. The length and the number of implanted stents seem to be associated with a more probable restenosis at six-month angiographic evaluation. Drug-eluting stent implantation seems to be associated with a lower incidence of restenosis even in STEMI patients.     

Drug-eluting stents in patients with left main coronary lesions who are not candidates for surgical revascularization

INTRODUCTION AND OBJECTIVES: Surgical revascularization is the treatment of choice in patients with left main coronary artery stenosis. Conventional stents are not a valid alternative because of the rate of restenosis and sudden cardiac death. Drug-eluting stents, which reduce the rate of restenosis, may represent an alternative to cardiac surgery. The objective of this study was to describe the results with drug-eluting stents in patients with left main coronary artery stenosis who were poor candidates for surgical revascularization. PATIENTS AND METHOD: We prospectively followed a consecutive series of patients who were poor candidates for surgical revascularization and were treated with implantation of a drug-eluting stent in the left main coronary artery between May 2002 and April 2004. In-hospital and long-term results were analyzed. Follow-up included angiographic and intravascular ultrasound (IVUS) studies. RESULTS: Forty-two patients (25 men, 59.5%) with a mean age of 70.1 (10.5) years were studied. Fourteen (33%) had diabetes, and 7 (16.7%) had a protected left main coronary artery. The reasons for ruling out surgery were poor distal vessels in 19 (45.2%), previous surgery in 9 (21.4%), age in 6 (14.3%), primary angioplasty in 5 (11.4%), and other reasons in 3 (7.2%). Four patients (9.5%) died before discharge, three of them after primary angioplasty. No in-hospital revascularization procedures were needed. Median follow-up time was 288 days; mean follow-up time was 315 (241) days. Another four patients died after discharge (9.5%) on days 5, 24, 34 and 115. Angioplasty was repeated in one patient, and another was referred for heart transplantation. CONCLUSIONS: Drug-eluting stents represent a valid alternative in patients with left main coronary artery stenosis who are poor candidates for surgical revascularization. Randomized studies with a longer follow-up should be performed to evaluate their benefits in patients eligible for surgery.     

国产药物洗脱支架治疗冠心病九个月随访结果

目的：观察国产药物洗脱支架择期治疗冠心病的临床近、远期疗效。方法：2004年8月至2006年2月择期接受Firebird支架（雷帕霉素洗脱支架）治疗的265例冠心病患者，368支病变血管的401处相关病变置入421枚Firebird支架，随访9个月以上。结果：支架植入成功率100％，30天、6个月、9个月的严重心脏不良事件（包括死亡、再发心肌梗死、靶血管再成形等）分别为1．13％、1．51％、3．77％，血栓形成发生率为0，造影随访率32．01％，9个月的支架内再狭窄率为3．53％。结论：国产药物洗脱支架有良好的临床近、远期疗效。     

Predictors of long-term major adverse cardiac events and clinical restenosis following elective percutaneous coronary stenting

Limited data exist regarding the predictors of long-term clinical outcomes following elective percutaneous coronary intervention (PCI) in the current era of stenting. The authors investigated the predictors of major adverse cardiac events (MACE) and clinical restenosis in 740 consecutive patients who underwent successful elective PCI with bare metal stents (BMSs) or drug-eluting stents (DESs). At 30-month follow-up, compared with BMS recipients, DES recipients had a significantly lower rate of MACE, which was mainly driven by a decreased repeat target vessel PCI. The rate of 30-month clinical restenosis was significantly lower in DES recipients. The authors conclude that baseline clinical, angiographic, and procedural characteristics determine long-term MACE and clinical restenosis after elective PCI, with DES being the independent predictor for both.     

国产雷帕霉素洗脱支架在老年冠心病病人中的早期临床应用

目的评价国产雷帕霉素药物洗脱支架（FirebirdTM）,在老年冠心病病人介入治疗中的早期临床应用疗效及其安全性.方法 2004年11月-2005年9月共有52例老年冠心病病人接受FirebirdTM支架治疗,对这些病人进行6个月的临床随访.结果 52例老年冠心病病人共置入72枚Firebird^TM药物涂层支架,其中干预的病例：长病变血管（病变长度≥20 mm）25例、病变血管参考直径≤2.75 mm 23例,原普通裸支架内再狭窄4例.手术成功率100%.46例病人完成6个月的随访,随访期间靶病变血管重建术、心肌梗死及心源性死亡均为0,复发心绞痛2例,有9例病人在术后6个月复查冠状动脉造影,未发现支架内再狭窄.结论 FirebirdTM支架治疗老年冠心病是安全、有效的,对冠状动脉长病变、小血管病变也有较好的疗效.     

药物涂层支架的研究进展

冠状动脉支架的应用极大地降低了再狭窄率,使经皮冠状动脉介入治疗有了质的飞越.冠状动脉支架发展至今已多种多样,其中药物涂层支架应用最为广泛,但药物涂层支架在降低支架内再狭窄的同时存在增加支架内血栓的风险.因此,不断改进药物支架是目前的研究热点,且药物支架向可降解支架逐渐发展.现就主要的药物涂层支架进行综述,介绍药物涂层支架的发展过程并大胆预测其发展趋势.     

标签内与标签外应用药物洗脱支架对冠心病预后的影响

目的探讨标签内与标签外使用药物支架的患者术后心脏事件的影响。方法选择上海市胸科医院2004年1月至2007年12月1004例接受药物洗脱支架的冠心病患者进行回顾性研究,按照美国食品和药物管理局(FDA)推荐的药物洗脱支架适应证分为标签内和标签外两个组,观察术后主要心脏不良事件(MACE事件)及支架内血栓发生率的统计学意义,比较这两组患者的预后情况。结果标签外组各项临床基线特征中,合并心功能不全和高脂血症明显高于标签内组;冠脉特点上,标签外组目标血管狭窄程度和支架总长度大于标签内组,其他基线水平相似。在心脏事件平均36个月的随访中,标签外组MACE事件206例(28.3%),标签内组MACE事件43例(15.6%);标签外组心源性死亡率7.7%,术后心梗6.9%和靶血管血运重建(TVR)18.4%均高于标签内组的3.9%,3.6%和7.6%;标签外组中慢性阻塞性病变、桥血管病变和无保护左主干病变等一些复杂病变与心脏事件相关性较大。随访中5例支架内血栓均出现在标签外组。结论标签外组患者有更高的心脏病事件发生率,提示药物支架标签外应用带来更大事件风险。     

Coronary Artery Bypass Graft Versus Drug-Eluting Stent for High-Risk Proximal Left Anterior Descending Stenosis

Determining how to treat a patient with symptomatic isolated proximal left anterior descending coronary artery disease may present a challenge. Previous randomized trials comparing percutaneous coronary intervention (PCI) with bare metal stents with minimally invasive direct coronary artery bypass surgery demonstrated significantly higher reintervention rates for stenting, with similar mortality and reinfarction rates. However, current evidence suggests that the use of drug-eluting stents may reduce the need for repeat revascularization. Also, in recent studies there were fewer periprocedural complications in patients undergoing PCI, with similar death and reinfarction rates. Moreover, the quality of life for patients who have received drug-eluting stents is similar to that of patients who have undergone minimally invasive direct coronary artery bypass surgery. Therefore, PCI with drug-eluting stents is the current treatment of choice for patients with isolated proximal left anterior descending coronary artery disease, unless they have complex lesions or repeated in-stent restenosis. In this article, the current treatment options are reviewed and outlined.     

Long-term outcomes after percutaneous coronary intervention of left main coronary artery for treatment of cardiac allograft vasculopathy after orthotopic heart transplantation

The present study evaluated the safety and efficacy of percutaneous coronary intervention (PCI) of the unprotected left main coronary artery (ULMCA) for the treatment of cardiac allograft vasculopathy (CAV) in consecutive unselected patients with orthotopic heart transplantation (OHT). PCI in patients with OHT and develop CAV has been associated with greater restenosis rates compared to PCI in patients with native coronary artery disease. A paucity of short- and long-term data is available from patients with OHT who have undergone PCI for ULMCA disease. The present retrospective, multicenter, international registry included 21 patients with OHT and CAV who underwent ULMCA PCI from 1997 to 2009. Angiographic success was achieved in all patients. Drug-eluting stents were used in 14 of the 21 patients. No major adverse cardiac events or repeat OHT occurred within the first 30 days. At a mean follow-up of 4.9 ± 3.2 years, 3 patients (14%) had died, myocardial infarction had occurred in 1 patient (5%), and target lesion revascularization had been required in 4 patients (19%). Follow-up angiography was performed in 16 patients (76%), and restenosis was observed in 4 (19%). No stent thrombosis of the ULMCA was observed. One patient (5%) underwent coronary artery bypass grafting, and 5 patients (24%) underwent repeat OHT. In conclusion, the results of our study have shown ULMCA PCI to be safe and reasonably effective in patients with OHT and represents a viable treatment strategy for CAV in these patients.     

Coronary angioplasty and stenting in orthotopic heart transplants: a fruitful act or a futile attempt?

Accelerated allograft coronary artery disease remains the major cause of mortality after the first year of transplantation. Despite the extensive use of stents and angioplasty in coronary artery disease, there is a paucity of data about the efficacy of such interventions in orthotopic heart transplants. The authors herein report the outcome of those patients in their institution who had undergone percutaneous coronary artery angioplasty and stenting at a late stage of their transplantation. Within a 12-year period, 106 adult patients underwent orthotopic heart transplantation at their institution. Eight of these patients with 17 lesions underwent deployment of nine stents and eight angioplasties 8.1 +/- 3.2 years posttransplantation. There were 15 denovo and two restenotic lesions. The indications for intervention were presence of symptoms in five patients and severity of lesions in three asymptomatic patients detected on their follow-up angiogram. All patients had angiographic worsening of lesions at their follow-up angiogram. The initial procedural success for both stented and angioplastied lesions was 100%. Within a mean angiographic follow-up of 261 days, all balloon angioplastied lesions had developed restenosis, whereas within a mean period of 67 days, 50% of stented lesions had developed restenosis. On the follow-up angiogram, deterioration of the nontreated segments were noted throughout the coronary arterial tree; however, the immediate proximal and distal parts of the target segments demonstrated an exaggerated hyperproliferative response as compared to other sites. The overall median time to the detection of restenosis for both stented and angioplastied lesions was 5.2 months (inner quartile 2.5-6.2 months). The authors conclude that angioplasty and stenting late in the course of transplantation is associated with a significant restenosis rate and in such patients earlier or alternative catheter-based interventions must be considered.     

Long-term outcome after implantation of bare metal stents for the treatment of coronary artery disease: rationale for the clinical use of antiproliferative stent coatings

BACKGROUND: The widespread use of drug-eluting stents in patients with coronary artery disease (CAD) is hampered by unequal regulations for reimbursement. Identification of patients with maximal benefit from this technology may be achieved by assessing long-term clinical outcome after implantation of uncoated bare metal stents. PATIENTS AND METHODS: A consecutive series of 1,000 patients with CAD treated with bare metal coronary stents of various designs from January 1995 to December 1995 was retrospectively followed over 4 years. The primary end points of the study were major adverse cardiac events. RESULTS: The mean age of patients was 62 +/- 10.3 years, 77.5% were male, and 18% were diabetic. Clinical follow-up was obtained in 821 patients (82.1%) after 4.6 +/- 1.1 years. During this period of time, 31.8% were admitted for repeat PCI, 15.1% underwent CABG operation, 3.5% had myocardial infarctions, and 3.7% died. At 4 years, 46.3% of diabetic patients survived without event versus 57.6% of nondiabetic patients (P < 0.05). Patients with CAD I survived without event in 65.3% versus 54.0% of patients with CAD II and 48.5% of patients with CAD III (P < 0.02). CONCLUSION: Implantation of uncoated stents provides the worst long-term clinical outcome in patients with diabetes and those with multivessel CAD. Both groups of patients appear to be primary candidates for the use of drug-eluting stents.     

Revascularization for coronary artery disease in diabetes mellitus: Angioplasty,stents and coronary artery bypass grafting

Patients with diabetes mellitus (DM) are prone to a diffuse and rapidly progressive form of atherosclerosis, which increases their likelihood of requiring revascularization. However, the unique pathophysiology of atherosclerosis in patients with DM modifies the response to arterial injury, with profound clinical consequences for patients undergoing percutaneous coronary intervention (PCI). Multiple studies have shown that DM is a strong risk factor for restenosis following successful balloon angioplasty or coronary stenting, with greater need for repeat revascularization and inferior clinical outcomes. Early data suggest that drug eluting stents reduce restenosis rates and the need for repeat revascularization irrespective of the diabetic state and with no significant reduction in hard clinical endpoints such as myocardial infarction and mortality. For many patients with 1- or 2-vessel coronary artery disease, there is little prognostic benefit from any intervention over optimal medical therapy. PCI with drug-eluting or bare metal stents is appropriate for patients who remain symptomatic with medical therapy. However, selection of the optimal myocardial revascularization strategy for patients with DM and multivessel coronary artery disease is crucial. Randomized trials comparing multivessel PCI with balloon angioplasty or bare metal stents to coronary artery bypass grafting (CABG) consistently demonstrated the superiority of CABG in patients with treated DM. In the setting of diabetes CABG had greater survival, fewer recurrent infarctions or need for re-intervention. Limited data suggests that CABG is superior to multivessel PCI even when drug-eluting stents are used. Several ongoing randomized trials are evaluating the long-term comparative efficacy of PCI with drug-eluting stents and CABG in patients with DM. Only further study will continue to unravel the mechanisms at play and optimal therapy in the face of the profoundly virulent atherosclerotic potential that accompanies diabetes mellitus.