Early and late clinical and angiographic outcomes following terumo coronary stent implantation

The Terumo stent is a new, balloon-expandable, stainless-steel device with a unique multicellular design to provide robust radial force and end-stoppers to prevent dislodgement. We evaluated the early and late clinical and angiographic outcomes of Terumo coronary stent implantation in native coronary arteries using an open, nonrandomized 3-center registry. From July 1998 to June 1999, a total of 118 Terumo stents were implanted in 105 patients (mean age, 58 +/- 10 years). A significant proportion of patients suffered from diabetes (34%), prior myocardial infarction (MI; 43%) and unstable angina (31%). Most target lesions (48%) had unfavorable morphological characteristics (type B2 or C); mean reference luminal diameter was 2.76 +/- 0.41 mm and lesion length was 11.4 +/- 5.3 mm. Primary success in stent deployment was achieved in 103 patients (98%). There was 1 patient with acute stent thrombosis in whom 2 overlapping stents were deployed. Following stenting, the minimal luminal diameter increased from 1.04 +/- 0.48 mm to 2.39 +/- 0.33 mm. Six-month angiography was performed in 97 patients (92%), and the binary angiographic restenosis (> or = 50% narrowing) rate was 16%. Late loss index was 0.50 +/- 0.43. By 6 months, two patients (1.9%) died, two patients (1.9%) had Q-wave MI and 9 patients (8.4%) required repeat coronary interventions. Therefore, our study shows that the Terumo stent is potentially safe and efficacious in the treatment of coronary narrowings, even in the presence of unfavorable clinical conditions and complex lesion morphological characteristics.     

Micro stent I,initial results,and six months follow-up by quantitative coronary angiography

The Micro stent^TM (MS) is a balloon expandable stent that allows the treatment of stenoses in distal and tortuous coronary arteries. This prospective study was performed to evaluate initial and late results of MS implantations. A total of 127 MS (101 in native coronary arteries and 26 in saphenous vein grafts) were implanted in 85 patients (1.5 stents/pt, 65 male, and 20 female, age 62, ±10 yr) with angina pectoris class II-III: 21 (25%), angina pectoris class IV: 41(48%), and acute myocardial infarction: 23 (27%). Indications per segment treated (n=93): elective: 49 (53%); suboptimal balloon angioplasty (PTCA) result: 33(35%); bailout: 11 (12%). The patients were discharged with 100 mg of aspirin daily unless other indications for oral anticoagulants were present. Procedural success (diameter stenosis of 30% without the occurrence of clinical events within 3 wk) was 85%. Early clinical events (<3 wk included: death:1%; subacute closure: 5%; coronary artery bypass surgery (CABG): 1%; vascular complications: 4%. Late clinical events (3 wk-6 mo) included: acute myocardial infarction:3%, PTCA 5%, CABG 3%, angina class III-IV: 4%. Quantitative angiographic results were: the minimum lumen diameter increased from 0.90 ± 0.72 before to 3.05 ± 0.48 mm (<P0.001) after stent implantation. At follow-up, which was 5.5 mo ± 1.1 mo, 61/79 pts (77%), the loss in diameter was 0.90 ± 0.68 mm. The net gain was 1.26 ± 0.90 mm. The restenosis rate (diameter stenosis > 50% at FU) was 13%. This study demonstrates high procedural and late success rates of Micro stent implantations. Cathet. Cardiovasc. Diagn. 43:19-27, 1998. © 1998 Wiley-Liss, Inc.     

Micro stent,™ quantitative coronary angiography,and procedural results

Micro stent™ (MS) is a radiopaque stainless steel balloon expandable intracoronary stent. The stent is mounted on a rapid-exchange delivery system. From August 1994–March 1995, 127 MS were implanted in 85 patients (pts, 1.5 stents/pt, 85 in native vessels and 42 in bypass vein grafts, 61 male and 24 female, age 33–77 yr, mean age 61 ± 10 yr). Pts studied were scheduled for either elective PTCA (n = 62, 73%) or PTCA for acute myocardial infarction (n = 23, 27%). Elective stent implantation was performed in 45 pts (53%). An MS was implanted because of a suboptimal balloon angioplasty result in 26 pts (31%). The stent was implanted because of threatened or acute vessel closure after balloon angioplasty in 14 pts (16%). During the procedure, 500 mg aspirin and 2 × 7,500 units of heparin were administered intravenously, followed by systemic heparinization for 48 hr. Pts were discharged with 100 mg aspirin daily (n = 50, 59%), or anticoagulant drugs and 100 mg aspirin daily (n = 19, 22%), or anticoagulant drugs only (n = 16, 19%). Angiographic results were analyzed with computer-assisted quantitative coronary arteriography. Angiographic success (defined as a residual stenosis of <30%) was achieved in 124 of 127 attempts (98%). The mean minimal luminal diameter of the target lesions increased from 0.88 ± 0.79 mm before stent implantation to 3.08 ± 0.56 mm (P < 0.001). The percentage of diameter stenosis was reduced from 77.9 ± 20.9% before to 13.3 ± 10.5% (P < 0.001) after stent implantation. The average initial gain was 2.53 ± 1.37 mm. The procedural success rate (defined as a residual stenosis of <30% without occurrence of major clinical events within 3 wk after procedure) was 84%. Major clinical events included: death 1 pt (1%); cerebrovascular accident, 1 pt (1%); subacute stent closure, 5 pts (6%); coronary artery bypass grafting, 3 pts (4%); false femoral aneurysm, 2 pts (2%). The initial results of Micro stent implantations are promising. No anticoagulant therapy was given to most of the patients (59%). Few vascular and bleeding complications were observed. However, at this stage, no data about the restenosis rate after implantation of a Micro stent are available. © 1996 Wiley-Liss, Inc.     

The value of intravascular ultrasound-facilitated internal carotid artery stenting in a patient with heavily calcified and ambiguous common carotid artery stenosis

Percutaneous transluminal carotid artery stenting (CAS) is a promising new treatment option for carotid artery stenosis. These procedures are currently performed in high-risk patients and have demonstrated favorable outcomes. We described the use of intravascular ultrasound (IVUS) to facilitate internal carotid artery stenting in a patient with heavily calcified and ambiguous common carotid artery stenosis. The common carotid artery angiogram revealed 50% stenosis, but IVUS of the common carotid demonstrated a 90% stenosis with complex superficial calcification. Protrusion of the superficial calcification inside the common carotid artery which was demonstrated by IVUS has not only created a difficulty to deliver the stent to the internal carotid artery, but also left the common carotid artery lesion untreated, which is not likely to achieve clinical the benefit of internal carotid stenting. IVUS was an indispensable tool for a procedural success in this case.     

One-year outcome of cardioversion of atrial fibrillation in patients with mitral stenosis after percutaneous balloon mitral valvuloplasty

Our objectives were to study the success rate of electrical cardioversion after percutaneous balloon mitral valvuloplasty (PBMV) in patients with symptomatic moderate-to-severe mitral stenosis and atrial fibrillation (AF) and the maintenance rate of sinus rhythm for < or =1 year. We studied patients with mitral stenosis and AF who were scheduled for PBMV. Electrical cardioversion was performed 1 month after PBMV. Amiodarone 200 mg/day was started the day after PBMV. The primary outcomes studied were the rate of successful cardioversion and the maintenance rate of sinus rhythm at 12 months. Of 272 patients scheduled for PBMV, 70 were enrolled. The average age was 45 +/- 10 years. The average mitral valve area was 0.82 +/- 0.22 cm(2). Cardioversion was successful in 50 patients (71%). Logistic regression analysis revealed that left atrial size and associated aortic valvular disease were predictors of successful cardioversion. Of the 50 patients with successful cardioversion, AF recurred in 24 (48%). An increased left atrial diameter was the only factor associated with AF recurrence at 12 months. In conclusion, good candidates for cardioversion after PBMV were those with a left atrial diameter of <60 mm and no associated aortic valvular disease -- approximately 43% of patients with AF scheduled for PBMV. In this group, about 2/3 were in sinus rhythm at 12 months after cardioversion.     

Impact of sirolimus-eluting stent on the outcome of patients with chronic total occlusions

Several randomized trials have demonstrated that stent implantation after successful recanalization of long-term total occlusions decreases restenosis and reocclusion rates. The sirolimus-eluting stent (SES) has recently proved its efficacy to decrease restenosis in selected patients. However, the efficacy of SES implantation in patients who have chronic total occlusions is currently unknown. Therefore, we investigated procedural and 6- and 12-month angiographic outcomes (analyzed by quantitative coronary angiography) and left ventricular function in 60 patients who received SESs and 120 patients who received bare metal stents (BMSs). Minimum luminal diameter did not differ immediately after recanalization (SES group 3.04 +/- 0.50 mm vs BMS group 3.12 +/- 0.48 mm). After 6 months, the SES group still had significantly larger luminal diameters (3.04 +/- 0.44 mm vs 1.94 +/- 0.98 mm) and significantly lower restenosis and reocclusion rates (2% and 0%, respectively) than did the BMS group (32% and 6%, respectively). Late loss was significantly smaller in the SES group than in the BMS group. At follow-up, the SES group had fewer cardiac events, including target lesion revascularization (p <0.001), than did the BMS group. In conclusion, SES implantation after recanalization of chronic total occlusion provides a better clinical outcome with less restenosis and target lesion revascularization after 6 months than does BMSs.     

Stent implantation in very small coronary arteries: the Tsunami SV International Registry

The aim of this multicenter registry was to examine the in-hospital and long-term clinical outcomes of patients who underwent Tsunami SV stent implantation for the treatment of lesions involving coronary arteries with a reference diameter of <2.5 mm. The angiographic success rate was 97.5%. No in-hospital or 30-day major adverse cardiac events occurred. During the 6-month follow-up, there was 1 cardiac death (1%), and 5 subjects (4.8%) underwent repeat target lesion revascularization.     

DK Crush技术治疗真性冠状动脉分叉病变:与经典Crush技术的对比

目的 检验作者改良的DK Crush技术能否确保最终对吻扩张的成功.方法 本研究属于连续、非随机和开放式研究,共入选了88例真性分叉病变(分支血管直径＞2.0 mm)的患者.其中2004年10月至2005年1月间入选的44例患者接受经典Crush技术治疗,2005年1月至2005年6月间入选的44例患者接受DK Crush技术治疗.比较两组患者术前、术中和术后30 d内的诸项参数.结果 DK Crush组与经典Crush组比较,患者分支血管病变长度长(13.5±3.4 mm比7.8±3.1 mm,P＜0.05)、经皮冠状动脉介入术需时短(44±12 min 比68±17 min,P＜0.05)、最终对吻扩张成功率高(100%比70%,P＜0.01)、使用球囊数鼍少(1.6±0.4个比2.7±0.7个,P＜0.05)及造影剂使用量小(102±38 mL比176±46 mL,P＜0.05).DK Crush组与经典Crush组患者的主干与分支血管之间的夹角[(57±18).比(47±15).],主干血管病变长度(24.3±8.6 mm比21.1±7.3 mm)差异均无统计学意义(P均＞0.05).经典Crush组有两例(4.3%)最终对吻失败的患者出现亚急性血栓栓塞.DK Crush组术后即刻分支血管开口部位最小血管直径显著大于经典Crush组(3.01±0.13 mm比2,74±0.12 mm,P＜0.01),而残余狭窄却显著小于后者(7.3%±8.6%比17.4%±11.2%,P＜0.05).经典Crush组有5例患者术后即刻分支血管开口残余狭窄＞30%(对吻失败).结论 经典Crush技术存在的技术缺陷是导致预后不良的主要原因.改良的DK Crush技术能显著提高对吻扩张的成功率.进一步的随机研究可以明确后者的有效性.     

The ‘all comer’ Coroflex Please drug-eluting stent registry in Europe and Asia – An overall and transcontinental assessment of the 10-month major adverse cardiac events

BackgroundRandomized trials assess the potential of a medical device in well defined indications while “all comer studies” reveal the device performance in the real clinical environment.AimsThis ‘all comers’ registry assessed the 10-month outcome of the Coroflex^® Please drug-eluting stent in Europe and Asia by clinically driven major adverse cardiac events.MethodsThe Coroflex^® Please Registry was an international, prospective, multicenter registry enrolling patients with symptomatic ischemic heart disease. The primary endpoint was clinically driven target lesion revascularization (TLR) at 9 months. Secondary endpoints were technical success, in-hospital outcomes, definite stent thrombosis and major adverse cardiac events (death, myocardial infarction, or TLR) for subgroup analyses.ResultsOf the enrolled 1230 patients (63.6 ± 11.2 years, 33.9% diabetics), 339 (27.6%) had an acute coronary syndrome, 148 (12.1%) STEMI and 191 (15.6%) NSTEMI. After 10.5 ± 3.8 months (follow-up rate 92.8%), the target lesion revascularization rate (TLR) was 7.8% overall, 8.3% in STEMI, and 11.3% in NSTEMI patients. Total MACE was 11.1% and significantly higher in ACS with either diabetes mellitus (22.9%, p = 0.017) or age ≥75 years (25.4%, p = 0.026). In European and Asian patients MI rates (5.2% vs 3.1%, p = 0.135) and cardiac death rates (1.6% vs 0.9%, p = 0.414) were similar. The MACE rate was higher in Europe (13.6% vs 4.7%, p < 0.001) driven by a six times higher TLR rate.ConclusionsTLR and MACE occurred within the range of previously published data. The incidence of MI and cardiac death were not different between Europe and Asia. MACE were higher in Europe driven by target lesion revascularization.     

Clinical safety and efficacy of a novel thin‐strut cobalt–chromium coronary stent system: Results of the real world Coroflex Blue Registry

Objectives : The aim of this registry was to evaluate the clinical efficacy and safety of the Coroflex Blue cobalt–chromium stent in real‐world practice. Background: The development of cobalt–chromium bare‐metal stents (BMS) with thinner struts has lead to better deliverability and lower target‐lesion revascularization rates compared with stainless steel BMS. Methods: The Coroflex Blue Registry was an international, prospective, multicenter registry enrolling patients with symptomatic ischemic heart disease attributable to single de novo or restenotic nonstented lesions of a single vessel amenable for percutaneous stenting. The primary end point was clinically driven target‐lesion revascularisation (TLR) 6 months after enrolment, secondary endpoints were technical/procedural success, in‐hospital outcome, definite stent thrombosis and major adverse cardiac events (death, myocardial infarction, or TLR) after 6 months. Results: The registry included 2,315 patients (mean age 64.3 ± 11.1 years, 19.8% diabetes, 37.3% acute myocardial infarction). Although a complex lesion cohort with 60.3% Typ B₂/C‐lesions, the technical success rate was 99.1% and the procedural success rate 98.5%. The incidence of TLR after 6 months was 5.5% and the cumulative 6‐month acute/subacute stent thrombosis rate was 1.6%. After 6 months cumulative event‐free survival was 90.8% in all patients and 87% in patients with acute PCI for acute myocardial infarction. Conclusions: This registry demonstrates the safety and efficacy of the Coroflex Blue cobalt–chromium stent platform in real‐world practice. In the era of drug‐eluting stents (DES), these results raise the serious question if the use of DES for primary prevention of restenosis and TLR is really justified.