Percutaneous left main coronary artery stent for acute myocardial ischemia after repaired ALCAPA

Percutaneous coronary artery stent angioplasty is rare in the pediatric population but can be a life‐saving by rapidly reestablishing flow to an obstructed coronary artery. It is a technically challenging and high‐risk procedure in infants and further limited by the need for future surgical intervention. We report of an infant with anomalous left coronary artery from the pulmonary artery who underwent acutely successful surgical reimplantation of the left coronary artery onto the ascending aorta. One month later, she developed acute myocardial ischemia and emergent catheterization diagnosed near‐total occlusion of the left coronary artery. We implanted a 2.5 mm coronary stent in the left main coronary artery with reestablishment of flow. The patient's left ventricular systolic function recovered within 4 weeks and repeat angiography 3 months later showed complete normalization of the entire left coronary artery system. The patient weighed 3 kg and was < 6 weeks of age at the time of stent implantation which to our knowledge is the smallest and youngest reported patient to undergo coronary stent angioplasty. This case supports the feasibility of this procedure in infants as a temporizing solution to hemodynamic instability from myocardial ischemia due to coronary artery stenosis. The left ventricular systolic function remained normal at 7 months after stent placement and the patient was clinically well from a cardiac perspective. © 2014 Wiley Periodicals, Inc.     

Long-term clinical and angiographic follow-up of patients treated with the self-expanding coronary stent for acute occlusion during balloon angioplasty of the right coronary artery.

A self-expanding coronary stent was implanted in 17 patients to treat acute occlusion of the right coronary artery after percutaneous transluminal angioplasty. There were 2 women and 15 men, with a mean age of 59 +/- 8 years. All patients underwent at least one follow-up angiographic examination 4 to 6 months after implantation and six patients had additional follow-up angiography. During a mean follow-up interval of 32 +/- 10 months no patient died or had a myocardial infarction. Restenosis within the stent did not occur. Two patients had a new stenosis adjacent to the stent. Stent occlusion was found on follow-up angiography in one patient who had not been treated with an antiplatelet agent. The mean intraluminal diameter was 2.77 +/- 0.5 mm after implantation and 2.67 +/- 0.5 mm on follow-up angiography. It is concluded that coronary stenting is effective in treating right coronary artery occlusion after balloon angioplasty. Immediate and long-term outcome suggest that the right coronary artery may be a particularly favorable site for stent implantation.     

Provisional stenting for multivessel PCI

Background: Bare stents reduce acute complications and repeat revascularization following percutaneous coronary intervention (PCI), but are costly and may lead to in‐stent restenosis. It remains unclear whether stents should be universally implanted or whether provisional stenting mainly to suboptimal balloon dilatation results is an acceptable approach for multivessel PCI. Objective: To compare the long‐term clinical restenosis and target lesion revascularization (TLR) of stented and non‐stented coronary artery lesions in patients who had multivessel PCI. Methods: We performed retrospective analysis of matched data from 129 consecutive patients who underwent multivessel PCI (at least optimal balloon angioplasty to one coronary artery segment and balloon angioplasty plus stenting to another coronary artery in the same patient, all lesions are de novo native coronary artery lesions with vessel diameter ?2.5?mm). The study endpoint was restenosis and repeat revascularization at one‐year follow‐up. Results: Baseline characteristics were similar in both groups. Low in‐hospital MACE (3.1%). Acute myocardial infarction, emergency revascularization via either PCI or CABG was detected and angiographic success was achieved in 99.3% of lesions in both groups. The rate of clinically driven angiographic restenosis and TLR at one‐year (follow‐up?100%) was similar (17.1% versus 18.6%, P?=?0.871, and 13.9% versus 16.3%, P?=?0.728, for optimal balloon angioplasty versus provisional stenting. Conclusions: The main findings from this study are that long‐term angiographic restenosis and TLR was comparable for optimal balloon angioplasty and provisional stenting, suggesting that provisional stenting is an acceptable approach for multivessel PCI.     

Long-term (> 3 years) clinical and angiographic outcomes of coronary multilink stent implantations: a single center experience

The ACS Multilink (ML) stent is a novel second-generation stent. The largest amount of information available on the long-term outcome of coronary stenting is based on the use of Palmaz-Schatz stents. Fewer data exist on long-term follow-up results of ML coronary stents implantations. The authors present the long-term (> 3 years) clinical and angiographic follow-up results of the ACS Multilink coronary stents implanted in their institution. From May 1996 to December 1997, 125 patients underwent 133 coronary ML stent implantations. Stented vessels were as follows: 49% left anterior descending artery, 31% right coronary artery, and 20% left circumflex coronary artery. Indications for stent implantations were elective in 64%, because of suboptimal result from percutaneous transluminal coronary angioplasty (PTCA) in 26%, and bailout from PTCA in 10% of patients. The mean reference diameter of stented vessels was 3.2 +/- 0.2 mm. The mean percentage stenosis was 80 +/- 11% and 3 +/- 5% before and after stent implantation, respectively. Long-term clinical follow-up was completed in 75% (80 men, mean age 53 +/- 10 years) of the patients (either by interview or phone), and angiographic follow-up (37 +/- 12 months) was completed in 58% of the patients. There were no baseline clinical or angiographic differences between those angiographically followed up and the remaining patients. Angiographic restenosis (> 50% diameter stenosis) was detected in 22% of stents. Target lesion revascularization was 12%, nontarget lesion revascularization was 14% in angiographically followed up patients. During the follow-up period death and new myocardial infarction occurred in 12% and 6% of patients, respectively, and survival rate was 88%. This study provides long-term follow-up results of intracoronary Multilink stent implantations for native coronary artery lesions. These data show that clinical and angiographic benefits of ML stents are comparable to those of the first-generation stents, especially to the Palmaz-Schatz stents, of which results have been reported previously. A considerable rate of nontarget lesion revascularization occurs during the follow-up period.     

经皮桡动脉冠状动脉造影及冠状动脉成形术的临床应用

目的 :评价经皮桡动脉冠状动脉造影术与冠状动脉腔内成形术 (PTCA)的临床应用价值。方法 :有选择性的对 37例患者行经皮桡动脉途径冠状动脉造影及冠状动脉成形术 ,观察其疗效和血管并发症。结果 :1 桡动脉穿刺成功率为 93 8% (有 2例失败 )。 2 14例冠状动脉造影正常 ,17例冠状动脉造影显示 2 6处存在≥ 70 %的狭窄病变 ,适合行冠状动脉介入手术。 2 6处病变有 4处PTCA疗效满意 ,2 2处行PTCA +支架术 ,植入支架 31只。狭窄从 (81± 12 ) %降低至 (10 6± 7 4 ) % ,最小血管直径由 (0 86± 0 12 )mm增加至 (3 0 8± 0 32 )mm。 6例病人行冠状动脉旁路移植术。 3 所有患者术后即拔导管鞘 ,局部压迫 4h。术后并发症的发生率为 3 3% (1例术后的桡动脉闭塞 )。结论 :经桡动脉途径行冠状动脉造影及冠状动脉成形术安全可行 ,其具有穿刺部位出血少、住院时间短的特点 ,可选择性的应用于某些冠心病患者。     

Endovascular stent implantation in the pulmonary arteries of infants and children without the use of a long vascular sheath.

Endovascular stent implantation for pulmonary artery stenosis requires the use of a long, large-bore vascular sheath to insure precise implantation without embolization or malposition. A long vascular sheath may be difficult to position and usage may be associated with vascular compromise and/or hemodynamic embarrassment, especially in infants and small children. We report a new technique for pulmonary artery endovascular stent implantation without the use of a long sheath. From December 2000 to May 2001, 10 patients underwent implantation of 13 Palmaz Corinthian premounted biliary transhepatic stents for pulmonary artery stenosis. Median age was 0.8 years (range, 0.5-18.5) and median weight was 11.8 kg (range, 4.6-65). Patient diagnoses were tetralogy of Fallot (five), double outlet right ventricle (three), branch peripheral pulmonary artery stenosis (two), single ventricle s/p cavopulmonary shunt (one), and truncus arteriosus (one). All Palmaz Corinthian stents were delivered uncovered on Cordis Opta LP balloon catheters via short sheaths (6-7 Fr); super-stiff guidewires were not always necessary. These stents, with a maximal expanded diameter of 12 mm, were placed for peripheral pulmonary artery stenosis as a definitive procedure or at the pulmonary artery bifurcation in patients who were expected to undergo future open heart surgery. The stents were initially implanted on 4, 6, or 8 mm balloon catheters and further expanded if needed. Stents were placed in the right pulmonary artery alone in three patients, left pulmonary artery alone in four patients, and side-by-side stents were implanted simultaneously in three patients. All thirteen stents were implanted successfully in the desired location without stent malposition or embolization. Mean angiographic diameter increased from 2.5 +/- 1.5 to 5.7 +/- 1.4 mm (P < 0.01) and peak systolic ejection gradients decreased from 44 +/- 22 to 14 +/- 11.6 mm Hg (P < 0.01). The uncovered delivery of the premounted Palmaz Corinthian stent allowed for precise and safe endovascular stent implantation without the hemodynamic and technical problems associated with long vascular sheath usage. This technique is useful for the palliation of proximal pulmonary artery stenosis and is effective definitive treatment for peripheral pulmonary artery stenosis in small infants and children.     

Percutaneous interventional treatment of vertebral artery stenosis with coronary stents: two case reports

Two patients underwent percutaneous interventional treatment for vertebral artery stenosis using coronary stents. Vertebral angiography of Case 1 (78-year-old male) showed right ostial 100% obstruction and left ostial 99% stenosis. Balloon angioplasty and stent placement (Multilink 4.0 x 18 mm) were performed for the left vertebral artery. Vertebral angiography of Case 2 (64-year-old male) showed bilateral ostial severe stenoses (right 90%, left 99% + alpha). Balloon angioplasty and stent placement(Multilink 3.5 x 18 mm) were performed for the right vertebral artery. These two patients showed excellent angiographic results with no complication associated with stent placement. Vertebral artery angioplasty can be performed safely using coronary interventional equipment and techniques.     

Improved hemodynamic, angiographic and functional results after renal artery stenting

Eighteen patients with severe renal artery atherosclerosis underwent conventional percutaneous transluminal renal angioplasty (PTRA) followed immediately by implantation of an endovascular stent. Hemodynamic measurements showed a baseline trans-stenotic pressure gradient of 78.3 mmHg that was reduced to 14.8 mmHg after PTRA. The post PTRA trans-stenotic pressure gradient was further reduced to 0.86 mmHg after stent placement. The average baseline diameter stenosis of 81.3% was reduced to 43.7% after PTRA and 6.1% after stent placement. Six month angiographic follow-up revealed restenosis in 6/16 patients. In patients treated for chronic renal insufficiency without restenosis the 6 month creatinine was 1.46 mg/dl compared to a pre-procedure creatinine of 2.4 mg/dl. Therefore those patients with renal insufficiency and renal artery stenosis who had long term patency after successful stent implantation showed significant improvement in renal function at six months. Stent implantation also significantly improved acute hemodynamic results and acute angiographic results compared to conventional renal artery angioplasty.     

Deteriorative effect of smoking on target lesion revascularization after implantation of coronary stents with diameter of 3.0 mm or less.

BACKGROUND: Although smoking cessation is widely encouraged because of the associated risk of cardiovascular events, the impact of smoking on target lesion revascularization (TLR) after percutaneous coronary intervention (PCI) is controversial. Therefore, the present study retrospectively investigated the effect of smoking on TLR after plain-old balloon angioplasty (POBA; n=376) and stenting (STENT; n=434) in patients undergoing secondary coronary angiography at a single center. METHODS AND RESULTS: A smoker was defined as current smoking or quitting within 2 years of the first PCI. In the POBA group, the predictors for TLR, as calculated by multiple logistic regression analysis, were a complex type of lesion (p<0.0001) and the left anterior descending artery (LAD) as affected vessel (p<0.05). In the STENT group, the predictors were the final % diameter of stenosis after stenting, measured by quantitative coronary arteriography (p<0.0005), LAD (p<0.01), and smoking (p=0.049). When the STENT group was divided into 2 groups according to the diameter of the implanted stent, smoking was a predictive factors for TLR in the group that received relatively small stents (diameter < or =3.0 mm) (p<0.02), but not in the group that received larger stents (diameter > or =3.5 mm). CONCLUSION: Smoking has a deteriorative effect on TLR after implantation of relatively small coronary stents with a diameter of 3.0 mm or less.     

Stent angioplasty to relieve left pulmonary artery obstruction caused by patent ductus arteriosus device occlusion

A 7‐month‐old patient in congestive heart failure due to a moderate sized patent ductus arteriosus (PDA) underwent uncomplicated implantation of an Amplatzer Ductal Occluder (ADO1). Two months after percutaneous device PDA closure, left pulmonary artery (LPA) stenosis was discovered. Rather than spontaneous improvement as reported in previous cases, our patient's LPA stenosis progressed in severity 7 months after ADO1 placement. A catheterization demonstrated a 32 mm Hg peak gradient from her main pulmonary artery to her LPA. She underwent successful stent angioplasty of her LPA with an excellent result and preserved PDA closure. This case demonstrates that stent angioplasty is a feasible an effective method of relieving LPA obstruction caused by a PDA occluder device. Additionally, despite slight deflection by the stent, the ADO1 device continued to provide complete ductal closure. Stent angioplasty should be considered in patients who have LPA stenosis caused by ADO1 occluder device that does not improve over time. © 2013 Wiley Periodicals, Inc.     

Pressure wire guide provisional coronary stent implantation

OBJECTIVES: Whether coronary artery lesion successfully dilated by balloon angioplasty should be stented or not is unclear. The purpose of this study is to evaluate the provisional stent implantation method assessing residual ischemia by pressure wire. METHODS: Thirty-one patients with de-novo lesions suitable for stenting were enrolled in a pressure wire guided provisional stent study. The pressure wire was used to assess the fractional flow reserve(FFR) before and after balloon angioplasty. When the FFR after angioplasty was less than 0.75, stent implantation was planned. Patients with lesions consisting of an intermediate stenosis proximal to the target lesion, chronic total occlusion, bypass graft and left main lesion were excluded from the study. Stent implantation was permitted even if the FFR was more than 0.75 when the operator thought stenting was necessary. Medical treatment was given with aspirin 162 mg/day, cilostazol 200 mg/day for 6 months and additional ticlopidine 200 mg/day for a month after stenting the lesion. RESULTS: Target vessel was the left anterior descending coronary artery in 19 lesions, the right coronary artery in 3, and the circumflex coronary artery in 9. Stent implantation was performed in seven (23%) of 31 lesions and the other 24(77%) lesions were treated with only balloon angioplasty. The FFR before intervention was 0.58 +/- 0.16, and improved to 0.87 +/- 0.07 (p < 0.0001). Percentage diameter stenosis before intervention was 70.7 +/- 12.6% and improved to 20.1 +/- 13.3% (p < 0.0001) after intervention. There was no major cardiac event (death, coronary artery bypass grafting, myocardial infarction, stent thrombosis). Six months follow-up angiography was performed in 27 patients (87%). Angiographic restenosis (percentage diameter stenosis > or = 50%) was found in four patients (15%). A new lesion was found in two patients. Target vessel revascularization was performed in six patients (21%). CONCLUSIONS: Lesions successfully dilated by balloon angioplasty with FFR > or = 0.75 do not require stenting.     

Effect of cutting balloon angioplasty on resistant pulmonary artery stenosis

The effectiveness of cutting balloon (CB) therapy was evaluated in severe pulmonary artery (PA) stenosis resistant to high-pressure balloon angioplasty in children with tetralogy of Fallot and pulmonary atresia. Thirty-eight pulmonary vessels (initial diameter 0.4 to 4.0 mm) resistant to high-pressure balloon angioplasty, as evidenced by a persistent waist, were treated with CB angioplasty in 12 patients. Thirty-two vessels underwent standard CB angioplasty and 6 vessels were treated with a CB catheter augmenting technique. Of the vessels treated with standard CB angioplasty, 17 vessels underwent subsequent high-pressure balloon angioplasty, 8 vessels had additional high-pressure balloon angioplasty and stent placement, and 7 vessels underwent CB dilation alone. The diameter of these vessels increased from 1.3 +/- 0.7 to 2.8 +/- 0.9 mm (p <0.001). Six of the 38 vessels were treated with a CB catheter augmenting technique; these vessels were larger with an initial diameter of 2.6 +/- 0.8 mm and increased to 4.4 +/- 1.7 mm (p <0.001). Of the 38 vessels, 35 increased by >50%, for a procedural success rate of 92%. Intimal damage was angiographically evident in 17 of 38 vessels (45%) after CB angioplasty; 1 procedure was complicated by an unconfined tear requiring coil occlusion of the distal vessel and another resulted in a confined tear, successfully managed with stent implantation. This study supports prior reports of successful angioplasty with CB therapy for resistant PA stenosis, identifies potential complications, and expands the experience to infants, larger vessels, and sublobar locations.     

Predictors of restenosis after implantation of 2.5 mm stents in small coronary arteries.

BACKGROUND: The results of stent implantation for small coronary disease have been inconclusive. The purpose of the present study was to evaluate the factors in predicting the risk of angiographic restenosis after 2.5-mm stent implantation for small coronary arteries. METHODS AND RESULTS: The study group comprised 134 consecutive patients who had a reference small coronary artery with diameter from 1.8 mm to 2.5 mm on quantitative coronary angiography and who had been successfully treated by stent implantation with a 2.5-mm stent. Of the 134 patients, 55 had angiographic restenosis (41%). The rate of target lesion revascularization was 32%. Diabetes mellitus, acute coronary syndrome, lesion length, bifurcation lesion, lower left ventricular ejection fraction (LVEF), stent strut, stent/artery ratio, and stent length were identified as predictors of restenosis by univariate analysis. Subsequent multivariate analysis revealed that lower LVEF (odds ratio (OR) 3.37, p=0.01), bifurcation lesion (OR 2.47, p=0.04), thicker stent strut (OR 2.30, p=0.04), and longer stent length (OR 1.05, p=0.02) were significant predictors of restenosis. CONCLUSIONS: Two pre-interventional factors (reduced left ventricular function and bifurcated lesion) and 2 procedure-related factors (thickness of stent strut and total stent length) were identified as predictors of restenosis. These factors should be taken into account when deciding on the percutaneous coronary intervention strategy for small coronary artery disease.     

Clinical outcomes following predilation with a novel 1.25‐mm diameter angioplasty catheter

Objective: An unmet need is represented in angioplasty catheters that permit the predilation stage of treating complex coronary anatomy oftentimes not amenable to conventional device therapies. Background: Lesion preparation with balloon angioplasty prior to stent placement remains the most common method of percutaneous coronary revascularization. Methods: Clinical and angiographic outcomes were evaluated following a treatment strategy of coronary artery disease that included predilation with a low‐profile, 1.25‐mm angioplasty catheter prior to stent placement. The study primary end point of procedural success was defined as successful device delivery and lesion treatment, including the absence of clinically significant perforation, arrhythmia, flow‐limiting dissection, or reduction in baseline Thrombolysis In Myocardial Infarction (TIMI) grade with final achievement of TIMI 3 flow. Results: Among 51 patients (54 lesions), predilation using a 1.25 mm angioplasty catheter was associated with procedural and device‐related success rates of 100%. In‐hospital target lesion failure occurred in one patient (2.0%) related to postprocedural myocardial infarction. Patient and angiographic characteristics included diabetes, 43.1%; lesion length ≥20 mm, 20.4%; bifurcation lesion, 31.5%; lesion classification B2/C, 74.1%; and baseline TIMI 0/1 flow, 13.0%. No subsequent in‐hospital adverse events occurred. Conclusions: Percutaneous coronary revascularization involving a predilation strategy with a low profile, 1.25‐mm angioplasty catheter is associated with favorable procedural safety and efficacy and may represent an effective initial treatment for complex coronary anatomy. © 2010 Wiley‐Liss, Inc.     

First human trial of KW39 slotted-tube stents: for percutaneous coronary intervention

The KW39 stent is a balloon-expandable, stainless-steel, slotted-tube stent, newly designed to adjust to the shape of the coronary arteries. We evaluated the clinical efficacy and safety of KW39 stent-based percutaneous coronary interventions in human native coronary arteries. A total of 105 patients (110 lesions), with a diagnosis of stable angina, acute coronary syndrome, or asymptomatic myocardial ischemia, were included in this prospective study. The primary endpoint was the target-lesion revascularization rate at the conclusion of a 6-month follow-up period. The secondary endpoints were the rates of technical and procedural success and the rate of major adverse cardiac events (defined as cardiac death, myocardial infarction, and target-lesion revascularization) in the course of the 6 months after stent placement. The 6-month target-lesion revascularization rate was 8.6%. The KW39 stent was highly satisfactory in regard to all secondary endpoint comparisons. Binary (>50%) in-stent restenosis was observed in 22 of 110 lesions (20%). The mean diameter stenosis at 6 months after percutaneous coronary intervention was 35.1% ± 14.4%, and the mean late lumen loss was 1.06 ± 0.48 mm. Stepwise multivariate analysis showed probable causal associations between adverse local environments for stent implantation and the subsequent need for target-lesion revascularization. We conclude that KW39 stent implantation was technically feasible and clinically safe in the patient population that we studied. The results of the safety endpoints, including cardiac death and acute myocardial infarction, were acceptable.     

Multiple percutaneous coronary stent implantation due to myocardial bridging--a case report

We present a case of a woman who had acute coronary syndrome caused by myocardial bridge. She was treated with percutaneous coronary intervention and stent implantation. Two months after the procedure the patient had myocardial infarction because of subacute thrombosis and during the second intervention another stent was implanted. After a few months another acute coronary syndrome occurred because of restenosis and balloon angioplasty with stent implantation was performed. Despite this the artery occluded and sufficient collateral circulation was developed. Current opinions concerning percutaneous coronary interventions of myocardial bridges are presented.     

Intravascular stent prosthesis for right ventricular outflow obstruction.

OBJECTIVES. This study was designed to assess the impact of implantation of balloon-expandable stents on right ventricular outflow obstruction in children with congenital heart disease. BACKGROUND. Intravascular stenting has been established as a useful treatment in adults with coronary and peripheral vascular disease. Its application in the treatment of infants and children with pulmonary, systemic and right ventricular conduit obstruction resistant to balloon angioplasty is limited. METHODS. A total of 24 stainless steel stents were implanted in 17 patients. Five stents were placed within right ventricular to pulmonary artery conduits, 17 in branch pulmonary arteries and 1 in an aortopulmonary collateral vessel. Follow-up time has ranged from 1 to 14 months, with 6 patients having hemodynamic and angiographic studies greater than 1 year after stent placement. The mean age at implantation was 7.4 +/- 5.6 years and the mean weight 33 +/- 16 kg. RESULTS. Optimal stent position was obtained in 22 of 24 implantations. In one patient the stent slipped from the delivery balloon and was left positioned in the inferior vena cava. No embolization or thrombotic event has been documented. Among patients with right ventricular to pulmonary artery conduit obstruction, the gradient was immediately reduced from 85 +/- 30 mm Hg to 35 +/- 20 mm Hg after stent implantation; however, three patients required conduit replacement because of persistent obstruction with elevated right ventricular pressures (82 +/- 16 mm Hg). In 10 of 11 patients with pulmonary artery stenosis, clinical improvement was noted in association with enlargement of vessel diameter by 92% +/- 90% (range 17% to 355%) and the gradient reduction of 22 +/- 24 mm Hg to 3 +/- 4 mm Hg. CONCLUSIONS. These data support the view that intravascular stenting will become an important adjunct in the management of children with congenital heart disease.     

Transradial coronary angioplasty and stent implantation in acute myocardial infarction: initial experience

Transradial coronary angioplasty and stent implantation in have been associated with reduced complications, length of stay and hospital costs when compared to the transfemoral approach. Fourteen high-risk patients with acute myocardial infarction underwent transradial coronary angioplasty and stent placement. All diagnostic and interventional procedures were successfully completed using 6 French guide catheters and ACS Tristar stents (Guidant Corporation, Santa Clara, California) up to 4 mm in diameter. Thirteen patients received glycoprotein IIb/IIIa inhibitors. There were no procedural or access site complications. The mean length of stay was 3.5 days and the mean time interval from initial radial cannulation compared favorably with 14 acute myocardial infarction patients undergoing transfemoral angioplasty and stent placement. Transradial angioplasty in acute myocardial infarction appears to be a safe and feasible option. The procedure time is not increased in experienced hands, and the combination of rare access site complications and early ambulation may lead to decreased morbidity and lower costs. Transradial angioplasty in acute myocardial infarction may be an attractive option in thrombolytic therapy patients (facilitated percutaneous coronary intervention) or those who require aggressive anticoagulation or antiplatelet therapy.     

Aktuelle Indikationsstellung und Sicherheit beim Einsatz des koronaren Sirolimus-Stents im klinischen Alltag in Deutschland

BACKGROUND: Although randomized, controlled clinical trials (RCTs) showed a reduced target vessel revascularization rate and a good safety profile for the sirolimus-eluting coronary Cypher stent, at least the safety data need to be confirmed by larger data in clinical practice. Under the circumstances of frozen medical budgets in Germany, there may also be a shift toward implantation of a drug-eluting stent (DES) for indications not yet evaluated by RCTs. METHODS: The authors analyzed the data of the German Cypher Registry a nationwide registry which was initiated in parallel to the launch of the first DES, the Cypher stent, in April 2002. RESULTS: From April 2002 until December 2003, 3,579 interventions using a Cypher stent at 102 centers were included in the German Cypher Registry. This reflects a proportion of this DES compared to all stents implanted at the participating centers of < 10%. Patients' median age was 63.4 years (quartiles: 55-70 years) with 75% men. Renal insufficiency was seen in 10.1%, previous myocardial infarction in 37%, prior percutaneous coronary intervention (PCI) in 54.6%, and prior coronary artery bypass grafting (CABG) in 18.7%. In a large proportion of interventions, Cypher stents were implanted in lesions or in clinical situations not yet evaluated by RCTs: 10.1% ST elevation myocardial infarction, 1.8% cardiogenic shock, 2.1% left main stenoses, 5.5% CABG lesions, 23.2% in-stent stenosis, and 6% chronic total occlusions. PCI before DES implantation was performed in 65.5% of cases, a mean of 1.02 +/- 0.43 Cypher stents per lesion were implanted with a median sum length of all Cypher stents per lesion of 18 mm (quartiles: 13-21 mm). Maximum median balloon diameter during stent implantation was 3.00 mm (quartiles: 2.75-3.00 mm). Acute complication rate was low, with 0.2% deaths, 0.3% subacute stent thromboses, 1.3% myocardial infarctions, 2.1% urgent PCIs, and 0.2% CABGs. CONCLUSION: In about one half of the patients included into the German Cypher Registry, the DES were implanted in lesions that were excluded from RCTs. The use of this sirolimus-eluting coronary stent in "real life" conditions was found to be safe concerning acute complications.     

Coronary intervention in the diabetic patient: improved outcome following stent implantation compared with balloon angioplasty

BACKGROUND: Diabetic patients undergoing coronary interventional procedures are at increased risk of restenosis and adverse clinical events. The relative impact of stents compared with balloon angioplasty on the outcome of percutaneous intervention in diabetics remains controversial. HYPOTHESIS: The goal of this study was to determine whether stent placement was superior to balloon angioplasty in reducing restenosis of diabetic patients undergoing coronary intervention. METHODS: The STRESS Trial was a prospective randomized comparison of stent placement and balloon angioplasty in the treatment of new native coronary lesions. Of 594 randomized patients. 92 (16%) were diabetic. In this substudy analysis of the STRESS Trial, the outcomes after stenting and balloon angioplasty in diabetic patients were compared. The primary endpoint was restenosis as determined by angiography at 6 months. Clinical outcomes at 1 year were assessed. RESULTS: Procedural success was achieved in 82% of diabetic patients assigned to angioplasty and in 100% assigned to stenting (p < 0.01). Compared with angioplasty, stenting resulted in a larger postprocedural lumen diameter (2.34 +/- 0.44 vs. 1.87 +/- 0.52 mm, p < 0.001) and greater acute luminal gain (1.61 +/- 0.47 vs. 1.06 +/- 0.46 mm, p < 0.001). At 6 months, stenting conferred a larger lumen (1.69 +/- 0.57 vs. 1.38 +/- 0.60 mm, p = 0.03) and greater net luminal gain (0.97 +/- 0.55 vs. 0.52 +/- 0.52 mm, p < 0.001). Restenosis occurred in 60% of the angioplasty group and in 24% of the stent group (p < 0.01). This was accompanied by a lower need for repeat target vessel revascularization after stenting (31 vs. 13%, p < 0.03). CONCLUSIONS: Compared with balloon angioplasty, stent placement in diabetic patients with focal de novo lesions resulted in superior procedural results, reduced restenosis, and improved clinical outcome with fewer repeat revascularization procedures.