Intravascular Red Light Therapy after Coronary Stenting Ñ Angiographic and Clinical Follow-up Study in Humans

In animal models of coronary restenosis, intravascular red light therapy (IRLT) using a diode laser source has been shown to reduce neointimal hyperplasia following balloon-induced injury and coronary stenting. We studied the safety and efficacy of catheter-based IRLT for preventing restenosis after coronary stenting in 22 patients with angina pectoris. IRLT was performed using a diode laser (650 nm) at an energy level of 10 megawatts delivered through a rapid exchange balloon system containing the fiberoptics. The procedure was successful in all patients, with no procedural or in-hospital complications. Two patients with recurrence of symptoms had angiography at 3 and 4.1 months respectively. Angiographic follow-up was also done after 6 months in the 20 remaining asymptomatic patients. The mean minimal lumen diameter (MLD) for the whole group at 6 months follow-up was 2.57 +/- 0.62 mm. The calculated late lumen loss was 0.49 +/- 1.12 mm with a late loss index of 0.21 +/- 0.54. Four patients (2 symptomatic and 2 asymptomatic) in the series developed angiographic restenosis. Clinical events at follow-up of 10.9 +/- 3.5 months were repeat angioplasty in 2 patients for symptomatic restenosis with a 91% event free survival. These preliminary results demonstrate that IRLT after coronary artery stenting is safe and feasible; it is associated with low rates of angiographic indices of restenosis.     

A randomized comparison of repeat stenting with balloon angioplasty in patients with in-stent restenosis

OBJECTIVES: This randomized trial compared repeat stenting with balloon angioplasty (BA) in patients with in-stent restenosis (ISR). BACKGROUND: Stent restenosis constitutes a therapeutic challenge. Repeat coronary interventions are currently used in this setting, but the recurrence risk remains high. METHODS: We randomly assigned 450 patients with ISR to elective stent implantation (224 patients) or conventional BA (226 patients). Primary end point was recurrent restenosis rate at six months. Secondary end points included minimal lumen diameter (MLD), prespecified subgroup analyses, and a composite of major adverse events. RESULTS: Procedural success was similar in both groups, but in-hospital complications were more frequent in the balloon group. After the procedure MLD was larger in the stent group (2.77 +/- 0.4 vs. 2.25 +/- 0.5 mm, p < 0.001). At follow-up, MLD was larger after stenting when the in-lesion site was considered (1.69 +/- 0.8 vs. 1.54 +/- 0.7 mm, p = 0.046). However, the binary restenosis rate (38% stent group, 39% balloon group) was similar with the two strategies. One-year event-free survival (follow-up 100%) was also similar in both groups (77% stent vs. 71% balloon, p = 0.19). Nevertheless, in the prespecified subgroup of patients with large vessels (> or =3 mm) the restenosis rate (27% vs. 49%, p = 0.007) and the event-free survival (84% vs. 62%, p = 0.002) were better after repeat stenting. CONCLUSIONS: In patients with ISR, repeat coronary stenting provided better initial angiographic results but failed to improve restenosis rate and clinical outcome when compared with BA. However, in patients with large vessels coronary stenting improved the long-term clinical and angiographic outcome.     

Stent restenosis in a Chinese population

BACKGROUND: Stents are now widely used in Hong Kong and China and there is a clinical impression that restenosis is less common because of the lower prevalence of coronary artery disease and associated risk factors in the Chinese. However, there are no published data on angiographic stent restenosis rates in Chinese patients. METHOD: In a prospective study of 114 consecutive Chinese patients who underwent coronary stenting, quantitative coronary analyses were made at the time of stent implantation and subsequently at 6 months post-stenting (n = 97). RESULTS: At 6 months, restenosis (> or = 50% diameter stenosis in the dilated segment) was present in 42 (43.3%) of the 97 patients and 54 (33.5%) of the total 161 lesions stented. Vessel reference diameter (VRD) of < 3 mm and stented length of > or = 18 mm were associated with higher restenosis rates (36% and 38%). Compared to those without, those with restenosis had a greater residual stenosis of 16.53+/-11.54% and smaller final minimal luminal diameter (MLD) of 2.41+/-0.49 mm, (p < 0.01 and p < 0.008 respectively). Standard coronary risk factors were not associated with a higher rate of restenosis. Lesion morphology was significantly associated with restenosis. CONCLUSION: Coronary stenting in Hong Kong Chinese patients is associated with a restenosis rate comparable to that demonstrated in previously published trials from populations in the West.     

Long-term follow-up of primary stenting with coil stent in acute myocardial infarction

The authors evaluated clinical and angiographic outcomes for 1 year after primary stenting using coil stent for acute myocardial infarction. Twenty-eight patients underwent primary stenting with coil stent. Follow-up coronary arteriography at 3 months and 1 year was planned in all patients. Procedural success was achieved in 96%. There was no acute or subacute thrombosis. Minimal lumen diameter (MLD) was increased from 0.08 +/- 0.19 to 2.73 +/- 0.49 mm after stenting. MLD had decreased significantly for 3 months (MLD at 3 months: 2.03 +/- 0.86 mm, p = 0.001). On the other hand, MLD did not differ between 3-month; and 1-year follow-up (MLD at 1 year: 2.26 +/- 0.73 mm, p = NS). Only one patient manifested reocclusion at 3-month follow-up. The cumulative restenosis rate and target lesion revascularization rate at 1-year follow-up were 25.9% (7/27) and 11.1% (3/27). Primary stenting using coil stent is safe and feasible in patients with acute myocardial infarction and may improve clinical outcome and decrease restenosis and target lesion revascularization rate.     

Optimal treatment of nonaorto ostial coronary lesions in large vessels: acute and long-term results.

Percutaneous interventions of nonaorto ostial coronary lesions are usually complex, often requiring a combined approach of debulking and stenting, insertion of multiple guidewires and long procedure duration. Debulking with atherectomy device preserves side-branch patency by reducing plaque shift while coronary stenting minimizes vessel recoil and restenosis. We retrospectively evaluated the acute and long-term results of rotational atherectomy (group R, n = 94), coronary stenting (group S, n = 39), and combination of rotational atherectomy and stenting (group R-S, n = 59) in a total of 192 patients with nonaorto ostial lesions. The number of patients with diabetes mellitus and rest angina was significantly higher in groups S and R-S. Clinical success rates were high and procedural complication rates were low and comparable in all three groups. Despite the similar reference vessel size and preprocedure minimal lumen diameter (MLD), postprocedure MLD showed a trend toward larger lumen in groups S (3.15 +/- 0.18 mm) and R-S (3.21 +/- 0.16 mm). Group S had significantly higher incidence of side-branch narrowing (30.7%), requiring intervention (15.4%). At long-term follow-up (mean of 9 +/- 4 months), target lesion revascularization rate was significantly lower in groups R-S (11.9%) and S (15.4%) compared to group R (28.9%; P = 0.02). Our nonrandomized data suggest that stenting with or without rotational atherectomy provides the best long-term approach for the interventional treatment of nonaorto ostial coronary lesions. The clinical benefit and cost effectiveness of performing rotational atherectomy before stent implantation to reduce the incidence of side-branch closure requires further study.     

Previous cytomegalovirus infection and restenosis after aggressive angioplasty with provisional stenting

The aim of this study was to determine the impact of previous with cytomegalovirus (CMV) on restenosis after aggressive angioplasty with provisional stenting. DESIGN: We prospectively studied 78 consecutive patients scheduled for 6-month follow-up coronary angiography as part of the SIPS study. Anti-CMV IgG and IgM antibodies were measured on admission. RESULTS: Anti-CMV IgG positive and anti-CMV IgG negative patients had similar minimal lumen diameter (MLD) in the target vessel before (0.68 +/- 0.49 mm vs 0.71 +/- 0.52 mm, P = 0.84) and directly after the intervention (2.50 +/- 0.60 mm vs 2.57 +/- 0.52 mm, P = 0.58). After 6 months, however, the MLD was significantly smaller in CMV-positive as compared to CMV-negative patients (1.57 +/- 0.82 mm vs 2.00 +/- 0.83 mm, P < 0.03). Net lumen gain at 6 months was significantly lower in CMV-positive patients (0.89 +/- 0.79 mm vs 1.30 +/- 0.87 mm, P < 0.04) and the rate of clinically relevant restenosis was significantly higher (31% vs 7%, P < 0.02). In a multivariate logistic regression model, CMV seropositivity was an independent predictor of restenosis (odds ratio 5.7 (95% CI 1.2-30.3, P = 0.04). CONCLUSIONS: Six months after aggressive coronary angioplasty with provisional stenting, patients with prior CMV infection had a smaller MLD and a higher restenosis rate. CMV seropositivity was a strong independent predictor of restenosis.     

The French Randomized Optimal Stenting Trial: a prospective evaluation of provisional stenting guided by coronary velocity reserve and quantitative coronary angiography. F.R.O.S.T. Study Group

OBJECTIVES: We sought to make a prospective comparison of systematic stenting with provisional stenting guided by Doppler measurements of coronary velocity reserve and quantitative coronary angiography. BACKGROUND: Despite the increasing use of stents during percutaneous transluminal coronary angioplasty, it is unclear whether systematic stenting is superior to a strategy of provisional stenting in which stents are placed only in patients with unsatisfactory results or as a bail-out procedure. METHODS: Two hundred fifty-one patients undergoing elective coronary angioplasty were randomly assigned either to provisional stenting (group 1, in which stenting was performed if postangioplasty coronary velocity reserve was <2.2 and/or residual stenosis > or =35% or as bail-out) or to systematic stenting (group 2). The primary end point was the six-month angiographic minimal lumen diameter (MLD). Major adverse cardiac events were secondary end points (death, acute myocardial infarction and target lesion revascularization). RESULTS: Stenting was performed in 48.4% of patients in group 1 and 100% of patients in group 2 (p<0.01). Six months after angioplasty, the MLD did not differ between groups (1.90+/-0.79 mm vs. 1.99+/-0.70 mm, p = 0.39), as was the rate of binary restenosis (27.1% vs. 21.4%, p = 0.37). Among patients with restenosis, 13/32 (40.6%) in group 1 but 100% (25/25) in group 2 had in-stent restenosis (p<0.01). Target lesion revascularization (15.1% vs. 14.4% in groups 1 and 2 respectively, p = 0.89) and major adverse cardiac events (15.1% vs. 16.0%, p = 0.85) were not significantly different. CONCLUSIONS: Systematic stenting does not provide superior angiographic results at six months as compared with provisional stenting.     

Angiographic, intravascular ultrasound, and fractional flow reserve evaluation of direct stenting vs. conventional stenting using BeStent2 in a multicentre randomized trial.

AIMS: Direct stenting (DS) may not be as safe and effective as conventional stenting. The objective was to demonstrate equivalence of post-procedural mean luminal diameter (MLD) by angiography after BeStent2 placement between DS and pre-dilatation (PD) strategy. METHODS AND RESULTS: Two hundred and two patients with a single de novo lesion (diameter >/=3.0 mm and length 相似文献   

Stented segment length as an independent predictor of restenosis.

OBJECTIVES: We sought to evaluate the relation between stented segment length and restenosis. BACKGROUND: Multiple or long coronary stents are now being implanted in long lesions or in tandem lesions. A longer stented segment might result in a higher probability of restenosis. However, there is little information available on the relation between stented segment length and restenosis. METHODS: Between April 1995 and December 1996, 725 patients with 1,090 lesions underwent stenting. Lesions were divided into three groups according to the length of the stented segment: 1) group I (n = 565): stented segment length < or =20 mm; 2) group II (n = 278): stented segment length >20 but < or =35 mm; and 3) group III (n = 247): stented segment length >35 mm. RESULTS: There was no significant difference in the incidence of subacute stent thrombosis among the three groups (0.4% in group I, 0.4% in group II, 1.2% in group III; p = NS). The minimal lumen diameter (MLD) after stenting was greater in group I than in group III (3.04 +/- 0.60 mm in group I, 3.01 +/- 0.54 mm in group II, 2.91 +/- 0.58 mm in group III; p < 0.05). At follow up, a smaller MLD was observed in group III as compared with group I and group II (2.04 +/- 0.93 mm in group I, 1.92 +/- 1.00 mm in group II, 1.47 +/- 0.97 mm in group III; p < 0.01). The restenosis rates were 23.9% in group I, 34.6% in group II and 47.2% in group III (p < 0.01). Using multivariate analysis, the longer stented segment, the angiographic reference vessel diameter and the percent diameter stenosis after stenting were independent predictors of restenosis. CONCLUSIONS: The present study shows that a longer stented segment is an independent predictor of restenosis without an influence on the risk of subacute thrombosis.     

Results of the quantitative coronary angiographic analysis in the angiographic subgroup of the Multi-Link 2.5 Portuguese Registry.

INTRODUCTION: The restenosis rate of stents implanted into small coronary arteries is considered higher than that of stents in arteries > or = 3 mm, but could be influenced by clinical parameters and by the type and length of the stents. OBJECTIVE: To assess the incidence of angiographic restenosis at 6 months after implantation of 2.5 mm ACS RX Multi-Link (ML) stents, 15 and 25 mm length, in de novo coronary stenosis. DESIGN: Angiographic substudy of the Portuguese Multi-Link 2.5 Registry, which included Interventional Cardiology centers with facilities for coronary angiographic recordings allowing quantitative analysis. POPULATION: Between April 7 and November 20 1998 and in the 5 hospitals that agreed to participate, 61 patients were enrolled and 40 selected as having procedural and 6-month angiographies of sufficient quality for quantitative analysis. The only significant differences in the demographic, clinical and angiographic characteristics of the patients relative to those of the Registry were the lower prevalence of unstable angina and smoking in the angiographic substudy. There were 43 lesions and 46 ML stents were implanted. In 37% the lesions were located in the LAD, in 37% in the LCx and 26% in the RCA. 29 stents of 15 mm length and 17 stents of 25 mm were used. METHODS: The morphologic characteristics of the lesions were analyzed subjectively using the AHA/ACC classification. Quantitative coronary analysis (QCA) was performed, in an independent laboratory using the CAAS 2 system, for reference vessel diameter, lesion length, percentage of stenosis, minimum lumen diameter (MLD) and related parameters. Restenosis was defined as > or = 50% lumen obstruction at 6-month angiography. RESULTS: In the subjective analysis, 2 lesions were type B1, 27 type B2 and 14 type C. The overall restenosis rate was 32.6%. Restenosis was 27.7% for 15 mm stents and 36% for 25 mm stents (p = 0.4). For the QCA parameters analyzed, only MLD at the end of stent implantation was a predictor of 6-month restenosis (2.19 +/- 0.30 without vs. 2.03 +/- 0.18 with restenosis, p = 0.048). CONCLUSIONS: The restenosis rate of the Multi-Link 2.5 mm stents, of 15 and 25 mm length, was similar to that described with other types of stents in small coronary arteries. Minimum lumen diameter after stenting was found to be the best predictor of 6-month restenosis.     

Valsartan for prevention of restenosis after stenting of type B2/C lesions: the VAL-PREST trial

The following study was performed to evaluate the effects of chronic 6-month administration of the angiotensin I receptor antagonist valsartan on restenosis rate after stenting of type B2/C lesions in comparison to placebo. Despite encouraging results of the BENESTENT and STRESS trials, stenting of complex coronary lesions leads to an in-stent restenosis rate of up to 40%. Several attempts at systematic medical therapy (e.g., ACE inhibitors) have not improved these results. Because of the important role of angiotensin in endothelial function, the hypothesis that angiotensin I receptor antagonists after stent implantation lead to a reduction of the in-stent restenosis rate should be tested in a single-center trial. Two hundred and fifty patients with type B2/C coronary lesions were randomized in an open-label study with respect to age, gender, lesion type and indication of percutaneous coronary intervention to a chronic administration of 80 mg valsartan or placebo (beta-blocking agents and/or ACE inhibitors). In-stent restenosis rate according to quantitative coronary angiography (QCA) and need for reintervention as primary and secondary endpoints were analyzed after a repeat angiogram at 6 months in 99 patients with 80 mg valsartan and 101 patients with placebo. Chronic administration of 80 mg valsartan reduced the in-stent restenosis rate to 19.2% (n = 19/99) in comparison to placebo with an in-stent restenosis rate of 38.6% (n = 39/101) (p < 0.005). Reintervention rate was 28.7% (n = 29/101) in the placebo group and only 12.1% (n = 12) in the valsartan group (p < 0.005). QCA analysis of stented coronary segments disclosed no differences in reference vessel diameter (2.68 +/- 0.26 mm in the valsartan group versus 2.71 +/- 0.24 mm in the placebo group) but significant differences in stented vessel diameter (2.17 +/- 0.27 mm in the valsartan group and 1.60 +/- 0.20 mm in the placebo group) (p < 0.000001).     

Is Direct Stent Implantation Without Predilatation Safe? Acute and Long‐Term Outcome

Direct stenting could potentially lead to a reduction in dissections, time, and restenosis at 6-month follow-up. Using the premounted Palmaz-Schatz Crown stent elective stenting was performed without predilatation in 61 consecutive patients who were compared with a control group of provisional stenting. All patients underwent clinical and angiographic follow-up at 6 months. Direct stenting was successful in 81% of patients. In 16% of the patients predilatation was needed. In 3% the stent could not be implanted despite predilatation. Stent dislodgment occurred in 2% of patients, without embolization. Six-month angiographic follow-up was performed in 51 (84%) of 61 patients. In the direct stenting group the mean preprocedural minimal luminal diameter (MLD) increased from 0.96 +/- 0.47 to 3.09 +/- 0.54 mm directly after the procedure. At 6-month follow-up the MLD measured 2.32 +/- 0.79 mm. In the provisional stenting group the mean MLD increased from 0.92 +/- 0.51 to 2.44 +/- 0.58 mm and was 1.84 +/- 0.70 mm at 6-month follow-up. Restenosis, defined as a diameter stenosis > 50%, occurred in 8% of the direct stenting group compared with 28% in the provisional stenting group (P < 0.001). Direct coronary stent implantation can be attempted safely and efficaciously. The risk of stent loss is low. The initial and long-term angiographic results are significantly better as compared with provisional stenting. The risk of restenosis is significantly lower.     

Acute and long-term outcomes of stenting in coronary vessel > 3.0 mm, 3.0-2.5 mm, and < 2.5 mm.

We compared the acute and long-term outcomes of stentings in coronary vessels > 3.0 mm, 3.0-2.5 mm, and < 2.5 mm. A total of 1,152 patients underwent coronary stenting was divided into three groups based on the reference vessel size. Group A consisted of 598 patients (667 lesions) with a reference vessel diameter > 3.0 mm, group B 485 patients (544 lesions) with a reference vessel diameter of 3.0-2.5 mm, and group C 114 patients (119 lesions) with a reference vessel diameter < 2.5 mm. The procedural success, stent thrombosis, and in-hospital cardiac event rate were similar in the three groups. At 6-month angiographic follow-up, the lesion restenotic rate was significantly higher in the small-vessel group (14%, 22%, and 26% in groups A, B, and C, respectively; P = 0.011). These differences appeared to result from a lesser acute gain and a lesser net gain in small-vessel group; the late luminal loss was similar in the three groups. During a follow-up duration of 28 +/- 3 months, group C patients had a significantly lower rate of event-free survival than the group A and B patients (71% vs. 85% and 82%; P = 0.002). Stepwise regression analysis demonstrated that complex lesion (P = 0.032) and long lesion (P = 0.046) are independent predictors of restenosis in very-small-vessel (< 2.5 mm) stenting. In conclusion, the acute results of stenting in small coronary arteries appear safe and feasible with a high procedural success rate and a low incidence of stent thrombosis. Stenting in patients with a small coronary artery appears to have a similar in-hospital cardiac event rate, but a higher angiographic restenosis rate and a lower event-free survival rate, compared to stenting in patients with a larger coronary artery. The predictors of restenosis in very-small-vessel stenting are complex lesions and long lesions. Cathet Cardiovasc Intervent 2001;53:314-322. Copyright Wiley-Liss, Inc.     

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.     

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.     

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。     

Six-month outcome after excimer laser coronary angioplasty for diffuse in-stent restenosis in native coronary arteries

This study evaluated the intermediate-term follow-up after excimer laser coronary angioplasty (ELCA) and adjunctive percutaneous transluminal coronary angioplasty (PTCA) in patients with diffuse in-stent restenosis (lesion length >10 mm). Clinical and angiographic follow-up were performed at 6 months. Quantitative coronary angiography performed at 3 stages-during stent implantation, before and after ELCA + PTCA, and at follow-up-included measurements of the minimum lumen diameter (MLD) and percent diameter stenosis (DS). Sixteen consecutive patients were included. The (median + range) stent length was 36 mm (range 15 to 105), with a restenotic lesion length of 32 mm (range 10 to 90). After ELCA + PTCA, the MLD increased from 0.60 +/- 0.41 to 2.28 +/- 0.50 mm, whereas the DS decreased from 76 +/- 16% to 22 +/- 8%. Despite adjunctive high-pressure PTCA, the MLD after ELCA + PTCA remained smaller than the MLD after initial stent implantation, (2.28 +/- 0. 50 mm vs 2.67 +/- 0.32 mm, p = 0.014). Adverse events included ELCA-related acute coronary occlusion in 4 patients and a per-procedural intracerebral hematoma in 1. At 6 months, there was recurrence of angina in all patients. Angiographic follow-up was completed in 13 patients (87%), showing a reocclusion in 6 (46%), a >50% DS in 6 (MLD 1.03 +/- 0.87 mm, DS 68 +/- 24%), and a distal de novo lesion in 1. Despite satisfactory acute angiographic results, the recurrence of significant restenosis in all patients suggests that ELCA + PTCA is not a suitable stand-alone therapy for diffuse in-stent restenosis of long stented segments.     

Comparison of cutting balloon vs stenting alone in small branch ostial lesions of native coronary arteries.

Angioplasty of small vessels is associated with a higher rate of restenosis, even in the ostium. The present study compared the acute, late results of cutting balloon vs those of stenting alone in small branch ostial lesions of native coronary arteries and the effect on the parent vessel. The study group comprised 61 patients with successful angioplasty of smaller branch ostial lesions in native coronary arteries. The reference vessel diameter was between 2.5 and 3.0 mm. Patients were divided into 2 groups: group I (cutting balloon, n=30) and group II (stenting alone, n=31). After intervention, patients in group II achieved significant acute lumen gain, larger minimal lumen diameter (MLD) and less diameter stenosis. At 3-month follow-up, the MLD and diameter stenosis of the 2 groups were almost identical; however, late loss was lower in group I. At the 6-month follow up, the cumulative restenosis rate was 41% (11/27) in group I compared with 63% (19/31) in group II (p=0.05), and the target lesion revascularization was also lower in the cutting balloon group [29% (8/27) vs 53% (16/30) p=0.05]. In group 1, the MLD of the parent vessel did not change before, after cutting balloon or at follow-up. In contrast, there were significant reductions in parent vessel MLD following stenting alone and at follow-up. Plaque shift did not occur in the cutting balloon group. Cutting balloon angioplasty is a feasible approach for the treatment of small branch ostial lesions and does not cause significant narrowing of the parent vessel.     

Intracoronary β-irradiation prevents excessive in-stent neointimal proliferation in de novo lesions of patients with high plasma ACE levels. The BetAce randomized trial

BACKGROUND: This study evaluated vascular brachytherapy (VBT) as a potent antiproliferative treatment to prevent in-stent restenosis (ISR) after coronary angioplasty of de novo lesions in patients carrying the D allele of the I/D polymorphism of the ACE gene and high ACE plasma levels (>34 U/l). METHODS AND MATERIALS: A prospective randomized trial was designed to detect a 30% improvement in the minimal lumen diameter (MLD) of the stenotic artery, as measured by quantitative coronary analysis (QCA), 6 months following VBT at the time of stented angioplasty. All patients were carriers of the D allele of the ACE gene, with plasma ACE levels >34 U/l. RESULTS: Thirty-one patients (33 stenoses) were allocated to stent implantation (control group) and 30 patients (31 stenoses) to VBT and stented angioplasty. After angioplasty, in-stent MLD was similar in the two groups. At 6 months in the control group, in-stent MLD had decreased to 1.74+/-0.8 versus 2.25+/-1.05 mm in the VBT group (P=.04). The mean in-stent diameter was 2.3+/-0.8 mm in the control group versus 2.9+/-1.05 mm after VBT (P=.02), and the restenosis rate was 37.5% versus 17.9%, respectively (P=.08). At 6 months, a higher need for target vessel revascularization (TVR) was observed in the control group: 35.5% versus 13.3% (P=.04). CONCLUSIONS: This randomized study confirms that patients with high plasma ACE concentrations are exposed to an increased risk for ISR after coronary stenting. The preventive use of VBT in these patients reduced neointimal formation by 65% such that the MLD at follow-up was increased by 29% compared with the control group.     

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.