Stenting very small coronary narrowings (< 2 mm) using the biocompatible phosphorylcholine-coated coronary stent.

Published data regarding stenting very small arteries are still limited. The BiodivYsio stent is a new stent coated with phosphorylcholine, a biocompatible molecule designed to reduce the formation of thrombus and potentially the risk of restenosis. The feasibility, safety, and efficacy of implantation of the 2.0 mm coated coronary stent were prospectively studied. We studied 97 patients from three centers who underwent elective, urgent, or bailout implantation of 106 BiodivYsio mini-stents (2.0 mm) in 101 lesions. Forty percent of lesions had unfavorable characteristics (type B2 or C) and 16% had thrombus and/or chronic total occlusion. Successful stent deployment was achieved in 100/101 lesions (99%). MLD increased from 0.49 +/- 0.31 mm to 1.89 +/- 0.41 mm and diameter stenosis decreased from 89% +/- 7% to 5.6% +/- 6%. Small vessel stenting was the only procedure in 71% patients. There was one acute stent thrombosis case. During 6-month follow-up, none died, one had MI, and one was referred to CABG due to nontarget lesion progression. Angiographic restenosis that required target lesion revascularization was performed in 8/18 that had catheterization due to chest pain or significant ischemia. Most patients improved in their clinical symptoms. The rate of major adverse cardiac events was 4.1% at 30-day and 10.3% at 6-month follow-up. This initial clinical experience indicates that the implantation of 2.0 mm stents coated with phosphorylcholine appears to be safe and efficacious in the treatment of complex coronary lesions and is associated with low target vessel revascularization rate in spite of the very small vessel diameter.     

Initial and follow-up results of the BiodivYsio phosphorylcholine coated stent for treatment of coronary artery disease.

BACKGROUND: The BiodivYsio stent is coated with a phosphorylcholine containing copolymer to confer biocompatibility. The present study was designed to assess the safety and efficacy of this coronary stent for the treatment of native coronary artery lesions in patients with coronary artery disease. METHODS AND RESULTS: From August 2001 to April 2003, 130 patients with lesions were treated with this stent. Elective stenting (ES) was performed in 90 patients and bailout stenting (BS) was performed in 40 patients with small vessels. Pre-interventional reference diameter, minimal lumen diameter (MLD), and lesion length were 2.68+/-0.51, 1.00+/-0.30, 12.78+/-4.32, respectively, and post-interventional MLD was 2.24+/-0.45 mm. The initial success rate was 100%. However, 2 non-Q-wave myocardial infarctions (non-QMI) occurred post-procedurally due to branch occlusion. A 6-month follow-up was performed. No subacute thrombosis occurred. In the ES group, 1 non-QMI occurred after the interventional procedure in another vessel. There was no death or coronary artery bypass grafting (CABG). The angiographic restenosis rate was 15.6%. In the BS group, there was no death, myocardial infarction or CABG. The angiographic restenosis rate was 17.5%. CONCLUSION: The BiodivYsio stent is safe and effective as a primary device for the treatment of native coronary artery lesions, especially in small vessels.     

Use of stents for small coronary arteries. Results of the Multi-Link 2.5 Portuguese Registry.

INTRODUCTION: Stents are being used with increasing frequency in percutaneous transluminal coronary angioplasty (PTCA) but their use in small vessels is still controversial, due to the possibility of excessively high rates of adverse events and restenosis. OBJECTIVE: To assess the safety and clinical efficacy of ACS RX Multi-Link (ML) 2.5 mm stents, in "de novo" coronary stenosis. DESIGN: Prospective Registry, with 6 months clinical follow-up, involving all Portuguese centers of Interventional Cardiology. POPULATION: Between April 7 and November 20 1998, 102 patients were enrolled, 82 male and with ages ranging from 30 to 86 years (average 58 +/- 11). Clinical presentation for PTCA was stable angina in 53%, unstable angina in 36% and silent ischemia in 11%. There was a history of previous myocardial infarction in 29% of patients. The main risk factors were hypertension (58%), hyperlipidemia (57%), smoking (25%) and diabetes (20%). Multivessel coronary artery disease was present in 46% of patients and left ventricular function was normal in 89%. Of the 217 existing lesions, 188 (87%) were treated: 35 with balloon angioplasty and 153 with stent implantation, 114 of which were ML 2.5 mm: 79 of 15 mm in length and 35 of 25 mm. METHODS: Angiographic success with ML stent implantation and major adverse cardiac events (MACE)--myocardial infarction (MI), coronary artery bypass graft (CABG), new target vessel revascularizations and death--were evaluated during hospital stay, and at 1 and 6 months clinical follow-up. RESULTS: Angiographic success was 97.4%. In one patient it was not possible to cross the lesion, in another there was stent migration and in a third distal coronary flow after stenting was TIMI grade 1. Clinical success was 96.1% and there were no cases of death, Q-wave MI or urgent CABG. Two patients had non-Q wave MI and two required urgent repeat angioplasty. Subacute stent thrombosis occurred in 1 patient. There were no additional MACE at 1 month follow-up. At 6-month follow-up (in 97% of patients) MACE had occurred in 14.1%: 2 deaths (one non-cardiac), 3 MI (one non-Q) and 14 new PTCA (one in a non-ML stent). There was no need for CABG in any patient. Six-month survival rate was 97.9%, 94.9% were free of infarction and 84.8% were free of infarction and new revascularization. CONCLUSIONS: Multi-Link 2.5 mm stent implantation appears to be safe and efficient with a low incidence of immediate and 6-month adverse events in the range of centers and operators of the Registry.     

Clinical experience with a new biocompatible phosphorylcholine-coated coronary stent

AIMS: The BiodivYsio stent is a new stent coated with phosphorylcholine, a biocompatible molecule designed to reduce the formation of thrombus and potentially the risk of restenosis. The feasibility, safety, and efficacy of elective and urgent implantation of this coated coronary stent were prospectively studied. METHODS AND RESULTS: We studied 224 patients who underwent elective (67%) or bail-out implantation of 303 BiodivYsio stents in 286 lesions. Most lesions (62%) had unfavorable characteristics (type B2 or C) and half of them (50%) had thrombus and/or chronic total occlusion. Clinical follow-up was obtained in all patients at one month and in the first 132 patients at six months. Repeat angiography was undertaken in all patients with recurrent ischemia. Successful stent deployment was achieved in 284 lesions (99.3%). One emergency coronary artery bypass graft (CABG) was required. Angiographic success rate was 98.3% (281/286). There was 1 (0.4%) subacute stent thrombosis associated with Q-wave myocardial infarction and two (0.9%) in-hospital deaths. Reference vessel diameter was 2.82 +/- 0.32 mm. Minimum luminal diameter (MLD) increased from 0.38 +/- 0.25 mm to 2.97 +/- 0.35 mm and diameter stenosis decreased from 83.8 +/- 12.1% to 5.8 +/- 9.7%. Clinical restenosis rate was 6.1% (8/132 patients) at 6-month follow-up. Target vessel revascularization rate at 6-month follow-up was 5.4%. CONCLUSIONS: This initial clinical experience indicates that the implantation of stents coated with phosphorylcholine appears to be safe and efficacious in the treatment of complex coronary lesions and is associated with an extremely low target vessel revascularization rate.     

Coronary stenting or balloon angioplasty for chronic total coronary occlusions: the Taiwan experience (a single-center report)

The authors conducted this study to compare the restenosis and reocclusion rates of primary balloon angioplasty alone versus angioplasty followed by stenting in Taiwanese patients with chronic total occlusions. They also evaluated whether stenting reduced the incidence of restenosis and improved left ventricular function in these patients. From October 1998 to April 2000, a total of 294 patients with chronic total occlusion (Thrombolysis in Myocardial Infarction grade 0 flow) underwent recanalization using balloon angioplasty alone or followed by stent implantation. Of these, only 129 patients were included after procedural failure and patients lost to follow-up; 62 patients were placed in the stent group, while 67 patients were assigned to the percutaneous transluminal coronary angioplasty (PTCA) group. Coronary angiography was performed at baseline and at 6 months follow-up or earlier if angina or objective evidence of ischemia involving the target vessel or other vessels was present. Procedural success was 60%. Minimal lumen diameter increased significantly after stenting: 2.97 +/-0.41 vs 2.24 +/-0.41 (p < 0.001); 60% of patients in the stent group were free of restenosis, whereas only 33% in the PTCA group were free of restenosis at follow-up. Only 1 patient in the stent group had reocclusion, as opposed to 17 (25%) patients in the PTCA group (p < 0.001). The follow-up minimal lumen diameter (MLD) at 6 months was significantly larger in the stent group: 1.80 +/-0.85 mm vs 1.08 +/-0.82 mm (p < 0.001). Left ventricular function improved in the stent group, but not in the PTCA group (58.44 +/-16.58% to 63.60 +/-14.59% [p < 0.001] vs 54.13 +/-15.66% to 54.31 +/-15.60% [p = 0.885]). More patients had angina in the PTCA group than in the stented group 43 vs 29 (p = 0.053). The postprocedural MLD and reference vessel diameter (RVD) were the strong predictors of restenosis and follow-up MLD (p < 0.001). Stenting of chronically occluded arteries significantly reduced the incidence of reocclusion and restenosis, at the same time improving left ventricular function in these patients. This should be the procedure of choice after successful angioplasty of chronically occluded vessels.     

载雷帕霉素可降解聚合物涂层支架治疗冠心病的临床观察

目的以Cypher支架为标准,评价载雷帕霉素可降解聚合物涂层支架(EXCEL支架)治疗冠心病(CAD)的安全性和临床效果。方法采用前瞻性、非随机对比研究方法,根据入选和剔除标准入选60例CAD患者,根据所置入支架分为EXCEL组(n=32)和Cypher组(n=28);相同方法进行冠状动脉造影(CAG)和支架置入;以6个月主要不良心脏事件(MACE)、再狭窄率、直径狭窄程度和晚期管腔丢失(LLL)为研究终点评价EXCEL支架治疗CAD的安全性和临床效果。结果平均随访(6.04±2.12)个月,两组MACE发生率均为0;EXCEL组27例(84.38%)和Cypher组10例(35.71%)于术后平均(6.04±2.12)个月接受了定量冠状动脉造影随访。各组再狭窄率均为0;直径再狭窄率分别为(5.98±5.52)%和(5.21±6.3)%,LLL分别为-(0.02±0.09)mm和-(0.01±0.07)mm,上述各项指标差异均无统计学意义(P>0.05)。两组均未发现与雷帕霉素及其聚合物相关的不良反应。结论EXCEL支架治疗CAD安全有效。在降低主要心脏不良事件、预防再狭窄和LLL方面可获得与Cypher支架同样满意的临床效果。     

Comparative trial of stent-like balloon angioplasty versus coronary stenting for acute myocardial infarction.

Primary PTCA has been shown to be superior to any thrombolytic regimen and offers higher reperfusion rates and better coronary flow grades. Its limitations include recurrent ischemia (10%-15%), infarct-related artery reocclusion (5%-10%), angiographic restenosis (35%-50%), and need to perform repeat PTCA or CABG at 6-month follow-up (20%). Thus, the current role of coronary stenting for acute myocardial infarction (AMI) is very promising. From December 1995 through January 1997, 335 patients underwent primary angioplasty during the first 12 hr from symptom onset at our institution. We performed a retrospective study comparing the in-hospital and 6-month follow-up outcome of 61 patients who underwent coronary stenting (stent group) against 61 patients with optimal (residual lesion stenosis < 30%) balloon-only primary angioplasty (stent-like group). Patients were routinely treated with aspirin, and ticlopidine was given only to the stent group. In-hospital major adverse cardiac events (MACE) rate was 11.5% without statistical differences between the groups. Cardiac death rate was similar in both groups (4.9 vs. 6.6%; P = 1.0) and only two (3.3%) patients from the stent group and none from the PTCA group had nonfatal myocardial reinfarction. At 6-month follow-up, the rate of recurrent angina was higher in the stent-like group (30.9 vs. 7.1%; P < 0.001). Multivariate analysis showed that only stenting of the infarct-related artery was a borderline independent predictor for MACE (OR = 0; 95% CI = 0-1; P = 0.057). Primary stenting for AMI reduces the rate of recurrent angina or symptoms and MACE at 6-month follow-up.     

Latin American randomized trial of balloon angioplasty vs coronary stenting for small vessels (LASMAL): immediate and long-term results

PURPOSE: To assess the potential role of coronary stent to improved acute success and reduce late restenosis in lesions with reference diameter <2.9 mm using a bare metal stent specifically designed for small coronary vessels. There is controversy on the results among previous studies comparing bare metal stent implantation with conventional balloon percutaneous transluminal coronary angioplasty (PTCA). Differences in baseline characteristics, inclusion and exclusion criteria, and stent design may account for these discrepancies. METHODS: The population of this multicenter, multinational randomized study (LASMAL) consisted of 246 patients undergoing percutaneous coronary intervention of small vessel reference diameter. They were randomized into 2 strategies of percutaneous revascularization: elective primary stent (n = 124) or conventional balloon PTCA with provisional stenting (n = 122) in the presence of acute, threatened closure or flow-limiting dissections. RESULTS: The clinical success rate was significantly better for the stent group (98.3% vs 91.8%; P = 0.038). At 30 days follow-up, requirements of target vessel revascularization (TVR) (6.6% vs 0.8%; P = 0.018) and incidence of major adverse cardiac and cerebrovascular events (MACCE) (9.8% vs 2.4%; P = 0.01) was significantly lower in the stent strategy. Postpercutaneous coronary intervention minimal luminal diameter (MLD) was significantly larger in the stent group (2.3 +/- 0.2 mm vs 2.2 +/- 0.2 mm; P = 0.003). At follow-up, MLD in the stent group was larger than with PTCA (1.7 +/- 0.7 mm vs 1.5 +/- 0.7 mm, respectively; P = 0.035). Net gain was also significantly better with stent strategy (1.1 +/- 0.7 mm vs 0.8 +/- 0.7 mm, respectively; P = 0.002). Stenting resulted in a significant lower angiographic binary restenosis (20% vs 31%; P = 0.02) than PTCA. Furthermore, patients treated with stent were more frequently free from MACCE at 9-month follow-up (death, acute myocardial infarction [AMI], stroke, repeat revascularization procedures) than those treated initially with PTCA (82.2% vs 72% of PTCA, P = 0.046). CONCLUSIONS: The use of a specifically designed bare metal coronary phosphoril choline-coated stent as primary device during percutaneous interventions in small coronary arteries was associated with high procedural success and low in-hospital and 30-day follow-up complications. At long-term follow-up, patients initially treated with stents had lower angiographic restenosis rate and were more frequently free from major adverse cardiac events.     

The SV stent study: a prospective, multicentre, angiographic evaluation of the BiodivYsio phosphorylcholine coated small vessel stent in small coronary vessels

OBJECTIVE: To evaluate the use of the phosphorylcholine (PC) coated BiodivYsio small vessel (SV) stent in native coronary vessels of small calibre. DESIGN AND SETTING: Prospective, multi-centre, multi-national registry with 6-month clinical and core-lab angiographic follow-up. Adverse events were adjudicated by a Clinical Events Committee (CEC) and included peri-procedural analysis of cardiac enzymes. PATIENTS: Patients with signs or symptoms of ischaemia with an identified target lesion in an epicardial vessel with reference diameter 2.0-2.75 mm were enrolled. Intervention in other epicardial territories in the same patient was permitted. RESULTS: Recruitment of 150 consecutive lesions (in 143 patients) was completed in 19 centres in Europe and Israel. The stent was deployed successfully in all but one lesion. At 6 months, 1 patient (1%) had experienced sudden cardiac death, 4 further patients (3%) had a non-Q wave MI, and a further 24 patients (17%) had repeat revascularisation of a study target vessel. The mean reference vessel diameter prior to stenting was 2.2 mm (S.D. 0.4). Mean minimal luminal diameters at pre-procedure, post procedure and follow-up were 0.6 mm (S.D. 0.3), 2.0 mm (S.D. 0.4) and 1.2 mm (S.D. 0.6), respectively. The late lumen loss index was 0.55 (S.D. 0.53) with a binary restenosis rate of 32%. CONCLUSIONS: In stenting of selected lesions in small vessels, the BiodivYsio SV stent demonstrated high rates of implant success. The rates of major adverse cardiac events (MACE), angiographic restenosis and repeat revascularisation are similar to those reported in other small vessel bare metal stent studies.     

Treatment of focal in-stent restenosis with balloon angioplasty alone versus stenting: Short- and long-term results

BACKGROUND: Although both percutaneous transluminal coronary angioplasty (PTCA) and additional stenting can be used for the treatment for focal in-stent restenosis (ISR), no large-scale comparative data on the clinical outcomes after these interventional procedures have been reported. METHODS: In the current study we compared the in-hospital and long-term clinical results of PTCA alone (n = 266 patients, n = 364 lesions) versus stenting (n = 135 patients, n = 161 lesions) for the treatment of focal ISR, defined as a lesion length less than or equal to 10 mm. RESULTS: There were significantly more diabetic patients in the PTCA group than in the stent group (36% vs 26%, P =.04), but other baseline characteristics were similar. Lesion length and preprocedure minimal lumen diameter (MLD) were also similar in the two groups, but the stent group had a larger reference vessel diameter (3.40 +/- 0.73 mm vs 2.99 +/- 0.68 mm, P <.001). Stenting achieved a larger postprocedure MLD than PTCA did (2.95 +/- 0.95 mm vs 2.23 +/- 0.60 mm, P <.001) and a smaller residual diameter stenosis (11% +/- 15% vs 23% +/- 16%, P =.04). Angiographic success was achieved in all cases. The rate of death/Q-wave infarction of urgent revascularization was higher with PTCA than with stent (5.6% vs 0.7%, P =.02). Postprocedure creatine kinase myocardial band enzyme elevation >5 times normal was more frequent with stent (18.5% vs 9.7%, P =.05). At 1 year the two interventional strategies had similar cumulative mortality (4.6% PTCA vs 5.1% stent, P not significant) and target lesion revascularization rate (24.6% PTCA vs 26.5% stent, P not significant). By multivariate analysis, the sole predictor of target lesion revascularization was diabetes (odds ratio 2.4, 95% confidence intervals 1.2-4.7, P =.01). CONCLUSION: Repeat stenting for the treatment of focal ISR had a higher postprocedure creatine kinase myocardial band elevation rate and similar long-term clinical results compared with PTCA alone.     

Stenting of bifurcation lesions: classification, treatments, and results.

Percutaneous transluminal balloon coronary angioplasty (PTCA) of coronary bifurcations is associated with a low success rate, high rate of complications, and high incidence of target vessel revascularization (TVR). The strategy of systematic coronary stenting in bifurcation lesions involving a side branch >/= 2.2 mm in diameter was prospectively evaluated in a single-center observational study during a 35-month inclusion period. All patients meeting these criteria were consecutively included. Bifurcation lesions and treatment were predefined in the study. The study included 366 patients (12.1% of PTCA) with 373 bifurcation lesions, mean age 63.7 +/- 11.6 years, 79.2% male, 46.7% with unstable angina, and 8.3% acute MI. The left anterior descending/diagonal bifurcation was involved in 55.2% of cases, circumflex/marginal 22. 2%, PDA/PLA 10.4%, left main bifurcation in 6.8%, and others 5.4%. The main branch (2.78 +/- 0.42 mm reference diameter) was stented in 96.3% of cases and the side branch (2.44 +/- 0.43 mm) in 63.2% (the two branches were stented in 59.5% of cases). Procedural success was obtained in 96.3% in both branches and 99.4% in the main branch. At1-month follow-up, The major cardiac event rate (MACE) was 4.8% (death 1.1%, emergency CABG 0.6%, Q-wave MI 0.9%, acute or subacute closure 1.4%, repeat PTCA 1.1%, and non-Q-wave MI 2.3%). At 7-month follow-up, the total MACCE rate was 21.6%, including a TVR rate of 17.2%. Analysis of the 7-month outcome according to two study periods (period I, 1 January 1996 to 31 August 1997, 182 patients; period II, 1 September 1997 to 30 June 1998, 127 patients) showed that the TVR rate decreased from 20.6% to 13.8% (P = 0.04) and the MACE rate from 29.2% to 17.1% (P < 0.01) in period I and II, respectively. This was associated by univariate analysis with an increasing use of tubular stents deployed in the main branch (94.2% vs. 59.1%, P < 0.001) and kissing balloon inflation after coronary stenting (75.4% vs. 18.1%, P < 0.001). Bifurcation lesions are frequent. Procedural success of coronary stenting is high with a low rate of in-hospital MACE. TVR rate at follow-up is relatively low. In-hospital and follow-up results are influenced not only by the learning curve but also by the use of tubular stents in the main branch and final kissing balloon inflation.     

Elective coronary stent implantation in cardiogenic shock complicating acute myocardial infarction: in-hospital and six-month clinical and angiographic results.

Effective treatment of patients with acute myocardial infarction and cardiogenic shock depends on restoring persistent patency of the infarct-related artery. Coronary stenting, reducing abrupt or delayed closure related to dissection and suboptimal result, may improve PTCA results in cardiogenic shock. Eighteen patients (14 males and 4 females, mean age 59 +/- 7 years), referred to catheterization laboratory for acute myocardial infarction and shock, had elective stent implantation during 14 primary and 4 rescue PTCA. Time delay between shock onset and PTCA was 4.1 +/- 3 hr (range, 30 min to 12 hr). The IRA was LAD in seven patients (38%), LCx in two (11%), and RCA in eight (45%). One patient (5.%) had distal LMCA occlusion. Stent deployment was successful in 100% of patients and resulted in TIMI 3 flow in 13 (72%) patients. In 13 (72%) cases, cardiogenic shock gradually resolved and the patients were discharged alive. Five patients (28%) died because of irreversible hemodynamic deterioration without evidence of reinfarction. At 6-month follow-up, all the discharged patients were alive and no patient had reinfarction or recurrent angina. Heart transplant was required in one patient 5 months after stenting because of refractory congestive heart failure. Angiography demonstrated patency of all the coronary arteries treated, with TIMI 3 flow in all patients. Stent restenosis rate was 30%, and target lesion revascularization with CABG or re-PTCA was not required in any case. LV function improved from 39% +/- 15% to 51% +/- 15% (P < 0.01). Elective coronary stenting is an effective treatment for acute myocardial infarction complicated by cardiogenic shock and may improve acute and long-term survival.     

Effect of anti-oxidant (carvedilol and probucol) loaded stents in a porcine coronary restenosis model.

BACKGROUND: The long-term clinical efficacy of intracoronary stenting is limited by restenosis and delivery by the stent of agents inhibiting cell cycle progression should prevent in-stent neointimal hyperplasia. Carvedilol is an antioxidant that inhibits smooth muscle cell proliferation and migration, whereas probucol is a vascular protectant and reduces stent restenosis by improving the lumen dimension at the stent placement site. METHODS AND RESULTS: BiodivYsio phosphorylcholine-coated stents were dip-coated with carvedilol (5 mg/ml) or probucol (50 mg/ml) by immersion in respective methanol solutions. Twenty-four stents (carvedilol=8, probucol=8, control=8) were placed in 12 pigs and histopathologic analysis was done 4 weeks later. Histomorphometry of the carvedilol-coated stent group compared with the control groups showed that the neointimal area decreased by 42% (1.12+/-0.55 mm2 in the carvedilol group vs 1.92+/-0.52 mm2 in the control, p=0.004) and the lumen area increased by 20% (5.15+/-0.90 mm2 vs 4.17+/-0.87 mm2, p=0.008), resulting in a 43% reduction of the percent area stenosis (18.22+/-9.6% vs 31.9+/-9.2%, p=0.002). In the probucol-coated stent group, the lumen area, neointimal area, and %area stenosis did not different significantly from the control group. There were 7.7+/-2.97% proliferating nuclear cell antigen-positive cells in the carvedilol-coated stent group compared with 17.8+/-1.45% in the control group (p=0.0001) and 15.9+/-1.91% in the probucol group (vs control, p=NS). CONCLUSIONS: The carvedilol-coated stent, but not the probucol-coated one, inhibited neointimal hyperplasia in a porcine stent restenosis model.     

Percutaneous and surgical interventions for in-stent restenosis: long-term outcomes and effect of diabetes mellitus

OBJECTIVE: We examined long-term outcomes of patients with in-stent restenosis (ISR) who underwent different percutaneous interventions at the discretion of individual operators: balloon angioplasty (BA), repeat stent or rotational atherectomy (RA). We also examined long-term outcomes of patients with ISR who underwent coronary artery bypass surgery (CABG). BACKGROUND: In-stent restenosis remains a challenging problem, and its optimal management is still unknown. METHODS: Symptomatic patients (n = 510) with ISR were identified using cardiac catheterization laboratory data. Management for ISR included BA (169 patients), repeat stenting (117 patients), RA (107 patients) or CABG (117 patients). Clinical outcome events of interest included death, myocardial infarction, target vessel revascularization (TVR) and a combined end point of these major adverse cardiovascular events (MACE). Mean follow-up was 19+/-12 months (range = 6 to 61 months). RESULTS: Patients with ISR treated with repeat stent had significantly larger average post-procedure minimal lumen diameter compared with BA or RA (3.3+/-0.4 mm vs. 3.0+/-0.4 vs. 2.9+/-0.5, respectively, p < 0.05). Incidence of TVR and MACE were similar in the BA, stent and RA groups (39%, 40%, 33% for TVR and 43%, 40%, 33% for MACE, p = NS). Patients with diabetes who underwent RA had similar outcomes as patients without diabetes, while patients with diabetes who underwent BA or stent had worse outcomes than patients without diabetes. Patients who underwent CABG for ISR, mainly because of the presence of multivessel disease, had significantly better outcomes than any percutaneous treatment (8% for TVR and 23% for MACE). CONCLUSIONS: In this large cohort of patients with ISR and in the subset of patients without diabetes, long-term outcomes were similar in the BA, repeat stent and RA groups. Tissue debulking with RA yielded better results only in diabetic patients. Bypass surgery for patients with multivessel disease and ISR provided the best outcomes.     

Early experience with coronary stenting.

From April 1988 to December 1991, we implanted 75 coronary stents (29 self-expanding and 46 balloon expandable) in 62 patients. All had New York Heart Association class II to IV angina, and 11 (18%) had prior coronary artery bypass grafting (CABG). Thirty nine patients (63%) had 1 vessel disease, and 23 (37%) had multivessel disease. The mean left ventricular ejection fraction was 63 +/- 11%. The indications for coronary stenting were acute post percutaneous transluminal coronary angioplasty (PTCA) occlusion in 45 (73%) (bail out stenting) and restenosis in 17 (24%) (elective stenting). There were 52 single stent (84%), 7 double stent (11%), and 3 triple stent procedures (5%). The mean stent diameter was 3.8 +/- 0.5 mm, and the mean stent length 21 +/- 7 mm. The attempted vessels were the left main coronary artery in 2(3%), left anterior descending coronary artery in 27 (44%), left circumflex coronary artery in 8 (13%), right coronary artery in 17 (27%), and a saphenous vein graft in 8 (13%). Technical success was achieved in 74 stent implantations (98%). Technical failure occurred in 1 case with a self expanding stent because of inability to reach the lesion. In hospital complications (mean hospital stay 10 +/- 10, range 2-60 days) included temporary stent occlusion in 2 patients (3%) treated by balloon dilatation and thrombolysis with intravenous urokinase, permanent stent occlusion in 5 patients (8%), Q-wave infarction in 5 patients (8%), CABG in 4 patients (11%), and death in 3 patients (5%). At least 1 major complication (Q wave infarction, CABG, or death) occurred in 8 patients (13%).(ABSTRACT TRUNCATED AT 250 WORDS)     

Study of antirestenosis with the BiodivYsio dexamethasone-eluting stent (STRIDE): a first-in-human multicenter pilot trial.

The aim of this multicenter pilot study was to evaluate the acute safety and efficacy of the dexamethasone-eluting stent (0.5 microg/mm(2) of stent) implanted in patients with de novo single-vessel disease. This study included 71 patients, 42% of whom had unstable angina pectoris. An appropriately sized BiodivYsio Matrix Lo stent loaded with a total dexamethasone dose of 0.5 microg/mm(2) of stent was used. Technical device success rate was 95%. Six-month MACE occurred in two patients (3.3%). Binary restenosis rate was 13.3%. Late loss was 0.45. Late loss and percent diameter stenosis were lower in the unstable angina pectoris patients compared to the stable patients (0.32 +/- 0.39 vs. 0.60 +/- 0.55 mm, P < 0.07, and 26.86 +/- 14 vs. 38.40 +/- 16%, P < 0.02). This study demonstrated the feasibility and safety of the implantation of a dexamethasone-eluting stent and its effect on in-stent neointimal hyperplasia.     

High-energy eccentric excimer laser angioplasty for debulking diffuse iIn-stent restenosis leads to better acute- and 6-month follow-up results

BACKGROUND: Restenosis of diffuse in-stent stenosis (> 10 mm) treated with percutaneous transluminal coronary angioplasty (PTCA) is as high as 80%. The excessive tissue-hyperplasia led to debulking before PTCA. Because debulking is limited by the intensity and applicability of its use, the large debulking trials were criticized and showed no major benefit. Considering that a significantly greater diameter than its own diameter can be ablated by the Eccentric Excimer Laser (eccELCA), we evaluated its effectiveness and safety in a prospective study. METHODS: Thirty-nine patients with diffuse in-stent restenosis (3.4 +/- 0.6 mm diameter; 14 +/- 9 mm in length) were treated by EccELCA followed by PTCA. In addition to clinical/angiographic target lesion revascularization (TLR) and major adverse cardiac events (MACE), the study endpoints were diameter stenosis (DS) and minimal lumen diameter (MLD), which were calculated before EccELCA, after EccELCA, after adjunctive PTCA and at 6-month follow-up. RESULTS: Procedural success was 99.8%. Delivered laser energy was 2,134 +/- 856 Joules. DS decreased from 84 +/- 14% to 23 +/- 11% after eccELCA (p = 0.0018) to 9 +/- 5% after PTCA (p = 0.001) and was 31 +/- 12% at follow-up (p = 0.0041). MLD increased from 0.7 +/- 0.2 mm to 2.2 +/- 0.4 mm after EccELCA (p = 0.0017), to 2.7 +/- 0.4 mm after PTCA (p = 0.001) to 1.7 +/- 0.3 mm at follow-up (p = 0.0049). Maximal balloon inflation pressure was 9.4 +/- 4.0 atmospheres. At follow-up angiography, TLR = 23.1%, clinical TLR = 12.8%, and MACE = 0%. CONCLUSION: Due to a greater debulking effect, additional lumen gain can be achieved immediately and at follow-up through the high-energy use of EccELCA for debulking and through the use of lower balloon inflation pressures for adjunctive PTCA. Clinical and angiographic TLR is significantly lower than other debulking techniques or PTCA alone and comparable with local irradiation therapy.     

Intravascular ultrasound-guided percutaneous transluminal coronary angioplasty with provisional spot stenting for treatment of long coronary lesions.

OBJECTIVES: The purpose of this study was to evaluate the approach of intravascular ultrasound (IVUS)-guided percutaneous transluminal coronary angioplasty (PTCA) with spot stenting (SS) for the treatment of long coronary lesions. BACKGROUND: Treating long coronary lesions with balloon angioplasty results in suboptimal short- and long-term outcomes. Full lesion coverage with traditional stenting (TS) has been associated with a high restenosis rate. METHODS: We prospectively evaluated a consecutive series of 130 long lesions (>15 mm) in 101 patients treated with IVUS-guided PTCA and SS. The results were compared with those of TS in a matched group of patients. Coronary angioplasty was performed with a balloon to vessel ratio of 1:1, according to the IVUS media-to-media diameter of the vessel at the lesion site, to achieve prespecified IVUS criteria: lumen cross-sectional area (CSA) > or =5.5 mm(2) or > or =50% of the vessel CSA at the lesion site. The stents were implanted only in the vessel segment where the criteria were not met. RESULTS: In the SS group, stents were implanted in 67 of 130 lesions, and the mean stent length was shorter than that of lesions in the matched TS group (10.4 +/- 13 mm vs. 32.4 +/- 13 mm, p < 0.005). The 30-day major adverse cardiac event (MACE) rate was similar (5%) for both groups. Angiographic restenosis was 25% with IVUS-guided SS, as compared with 39% in the TS group (p < 0.05). Follow-up MACE and target lesion revascularization rates were lower in the SS group than in the TS group (22% vs. 38% [p < 0.05] and 19% vs. 34% [p < 0.05], respectively). CONCLUSIONS: Intravascular ultrasound-guided SS for the treatment of long coronary lesions is associated with good acute outcome. Angiographic restenosis and follow-up MACE rates were significantly lower than those with TS.     

Intracoronary stenting for acute and threatened closure complicating percutaneous transluminal coronary angioplasty.

BACKGROUND. Acute closure remains a significant limitation of percutaneous transluminal coronary angioplasty (PTCA) and underlies the majority of ischemic complications. This study details the clinical and angiographic characteristics of a series of patients receiving an intracoronary stent device to manage acute and threatened closure and presents the early clinical results. METHODS AND RESULTS. From October 1989 through June 1991, 115 patients undergoing PTCA received intracoronary stents to treat acute or threatened closure in 119 vessels. Sixty-three percent had multivessel coronary disease, 33 (29%) had undergone prior coronary artery bypass grafting (CABG), and 52 (45%) had had previous PTCA. Using the American College of Cardiology/American Heart Association (ACC/AHA) classification, 15% of lesions were class A, 55% were class B, and 30% were class C. Eight patients were referred with severe coronary dissection and unstable angina after PTCA at other institutions. Acute closure was defined as occlusion of the vessel with TIMI (Thrombolysis in Myocardial Infarction) 0 or 1 flow immediately before stent placement. Threatened closure required two or more of the following criteria: 1) a residual stenosis greater than 50%, 2) TIMI grade 2 flow, 3) angiographic dissection comprising extraluminal dye extravasation and/or a length of greater than 15 mm, 4) evidence of clinical ischemia (either typical angina or ECG changes). Twelve vessels (10%) met the criteria for acute closure, and 87 vessels (73%) satisfied the criteria for threatened closure. Twenty vessels (17%) failed to meet two criteria. Stenting produced optimal angiographic results in 111 vessels (93%), with mean diameter stenosis (+/- 1 SD) reduced from 83 +/- 12% before to 18 +/- 29% after stenting. Overall, in-hospital mortality was 1.7% and CABG was required in 4.2%; Q wave myocardial infarction (MI) occurred in 7% and non-Q wave MI in 9%. Stent thrombosis occurred in nine patients (7.6%). For the 108 patients who presented to the catheterization laboratory without evolving MI, Q wave MI occurred in 4% and non-Q wave MI occurred in 7%. Angiographic follow-up has been performed in 81 eligible patients (76%), and 34 patients (41%) had a lesion of greater than or equal to 50%. CONCLUSIONS. This stent may be a useful adjunct to balloon dilatation in acute or threatened closure. Randomized studies comparing this stent with alternative technologies are required.     

Safety and feasibility of coronary stenting during rescue PTCA: in-hospital outcome.

BACKGROUND: Rescue PTCA is still a debatable procedure and the results published in the literature may not justify routine application of this strategy. AIM: To evaluate the hospital outcome of patients undergoing rescue PTCA with the aim of achieving a complete recanalization of the infarct-related artery (IRA)--residual stenosis assessed with QCA < 30% and TIMI 3 forward flow--obtained with adjuvant coronary stenting when needed. METHOD: From April 1993 to December 1997, 59 consecutive patients underwent rescue PTCA after thrombolysis failure (SK or front-loaded r-tPA, UK) within 6 hours of chest pain onset. All patients had a pre-procedure TIMI 0-1 flow. IRA was the right coronary artery in 23 cases (39%), the left anterior descending in 26 (44%), the left circumflex in 9 (15.3%) and a saphenous vein graft in 1 case (1.7%). In 2 (3.3%) patients, PTCA was not performed (impossibility of crossing the stenosis with the guide-wire). Fifteen patients (26.3%) had a successful procedure (TIMI 3 flow, residual stenosis < 30%) with lone PTCA. Forty-two patients (73.6%) had an intracoronary stent placed (Palmaz-Schatz, Micro-Stent, Multilink, IRIS III): 24 patients (57.1%) for suboptimal angiographic result (TIMI 2 flow, residual stenosis > 30%), 11 patients (26.2%) for dissection, 7 patients (16.7%) for intracoronary thrombosis. All 57 patients had a TIMI 3 flow and a residual stenosis < 30% at the end of the procedure. Mean vessel diameter was 3.22 +/- 0.4 mm, mean balloon size 3.3 +/- 0.4 mm, mean inflation pressure 12 +/- 4 atm, mean residual stenosis 8 +/- 9%. RESULTS: The overall procedure success rate was 96.6%. During hospitalization, three patients (5.1%) suffered subacute reocclusion managed conservatively in one case, with CAGB in another and with re-PTCA in the last one. Three patients (5.1%) had minor vascular complications (groin hematoma) not requiring surgical correction or blood transfusion. No patients died, suffered reinfarction or stroke. All patients were discharged alive and free of angina or clinical heart failure. CONCLUSIONS: Coronary stenting performed in the setting of rescue PTCA leads to a good procedural success rate allowing TIMI 3 flow and low residual stenosis (< 30%). Therefore, when conventional balloon angioplasty is unable to achieve an optimal angiographic result, stenting can be accomplished safely, thereby improving the procedural success rate and allowing a bright event-free survival rate.