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.     

Clinical and angiographic outcome after angiography-guided stent placement in small coronary vessels

BACKGROUND: Although it is widely accepted that stenting confers favorable angiographic and clinical results in coronary arteries >/=3.0 mm in diameter, the outcome of stent placement in smaller vessels remains largely unclear. METHODS AND RESULTS: We sought to specifically determine the early and long-term clinical outcomes in a large series of 197 consecutive patients who underwent stent placement in 207 vessels <3.0 mm in diameter. Procedural success, accomplished in 97.3%, was accompanied by a significant reduction in lesion severity from 85% +/- 9% before to 3% +/- 7% diameter stenosis after the procedure (P =.0001) and a 0.5% incidence of subacute stent thrombosis. At 1 and 2 years of follow-up, survival rate without major target lesion-driven events was observed in 77.3% and 73.9% of patients, respectively. Repeat revascularization procedures accounted for most of these events; cardiac deaths (including those related to subacute stent thrombosis) and late (>30 days) myocardial infarctions were infrequent (2.4% and 1.0%, respectively). The 6-month angiographic binary instent restenosis rate was 30.1%. On multivariate analysis, diabetes mellitus (P =. 0275), small baseline reference vessel size (P =.0300), and stent size 相似文献   

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.     

Intracoronary Stenting for Restenosis: Long-Term Follow-up: A Single Center Experience

One-hundred thirteen stents (78 Wallstents, 29 Palmaz-Schatz and 6 Wiktor) were implanted in 106 patients aged 63 +/- 5 years to treat a restenosis following previous angioplasty in a native coronary artery (86 cases) and in a venous graft (20 cases). Implantation was technically possible in all cases. The native vessels had a mean reference diameter of 3.3 +/- 0.3 mm and their mean minimal lumen diameter increased from 1.2 +/- 0.3 mm before angioplasty to 2.8 +/- 0.8 after stent implantation. The venous grafts mean reference diameter was 4.4 +/- 0.7 mm and their mean minimal lumen diameter increased from 1.3 +/- 0.4 mm before angioplasty to 4.0 +/- 0.7 mm after implantation. Percentage stenosis in the native arteries and in the venous grafts were respectively 78 +/- 13% and 69 +/- 14% before angioplasty and 24 +/- 8% and 22 +/- 8% after stent implantation. Complications at 6 months, presented as a ranking scale with 100% follow-up rate were, overall, of 20% clinical events (4% deaths, 6% myocardial infractions, 2% coronary artery bypass grafting and 8% re-angioplasty). Angiographic complications were of 8% subacute thrombosis and 19% restenosis and chronic occlusions. Long-term, at 65 +/- 9 months, clinical (86% follow-up) and angiographic (74% follow-up) showed that only a further 9% clinical events and 14% restenosis (12% of them between 6 and 12 months) occurred after 6 months. At an estimated follow-up time of 104 months, 70% patients remain event-free and the survival rate is 95%. In conclusion, stent implantation in the treatment of restenosis following conventional balloon angioplasty is a valid strategy with good long-term results.     

Randomized comparison of coronary stenting with optimal balloon angioplasty for treatment of lesions in small coronary arteries.

AIMS: Angioplasty of lesions in small coronary arteries remains a significant problem because of the increased risk of restenosis. The aim of this study was to compare the efficacy of elective coronary stent placement and optimal balloon angioplasty in small vessel disease. METHODS: One hundred and twenty patients with lesions in small coronary arteries (de novo, non-ostial lesion and reference diameter <3 mm) were randomly assigned to either balloon angioplasty or elective stent placement (7-cell NIR stent). The primary end-point was restenosis at 6 months follow-up. Optimal balloon angioplasty was defined as diameter stenosis less than or = 30% and the absence of major dissection after the angioplasty, and crossover to stenting was allowed. RESULTS: Baseline clinical and angiographic characteristics were similar in the two groups. Procedure was successful in all patients, and in-hospital events did not occur in any patient. However, 12 patients in the angioplasty group were stented because of suboptimal results or major dissection. Postprocedural lumen diameter was significantly larger in the stent group than in the angioplasty group (2.44 +/- 0.36 mm vs 2.14 +/- 0.36, P<0.05, respectively), but late loss was greater in the stent group (1.12 +/- 0.67 mm vs 0.63 +/- 0.48, P<0.01, respectively). The angiographic restenosis rate was 30.9% in the angioplasty group, and 35.7% in the stent group (P = ns). Clinical follow-up was available in all patients (15.9 +/- 5.7 months) and clinical events during the follow-up were similar in both groups. CONCLUSIONS: These results suggest that optimal balloon angioplasty with provisional stenting may be a reasonable approach for treatment of lesions in small coronary arteries.     

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.     

Effectiveness of rotational atherectomy of right coronary artery ostial stenosis

Balloon angioplasty and stenting of right coronary ostial stenosis may frequently be impeded by lesion calcification, whereas rotational atherectomy, which ablates calcified plaque, should treat these lesions effectively. Accordingly, we evaluated procedural success and longterm clinical outcome of rotational atherectomy of right coronary ostial stenosis. Procedural data were obtained from a comprehensive interventional registry and follow-up information was obtained by chart review and patient enquiry. All patients who developed recurrent angina underwent angiographic restudy. During a 5-year interval, 119 patients underwent rotational atherectomy of right coronary ostial stenosis. Multilesion interventions were performed in 55% of patients. Ostial lesions were 3.73+/-3.69 mm in length (mean +/- SD), and 57.1% were significantly calcified. Reference vessel diameter was 3.42+/-0.56 mm. Maximum burr:artery ratio was 0.64+/-0.1 with adjunct balloon angioplasty in 89.1% and adjunct stenting in 9.2%. Procedural success (<50% residual stenosis without major complication) was 97.5%, with 1.7% uncomplicated failure and 0.8% Q-wave infarction. Maximum residual stenosis was 15+/-17%. During 6-month follow-up, available in 94% of patients, 82.7% remained angina-free, 10.9% developed recurrent angina due to right coronary ostial restenosis, and 6.4% developed recurrent angina due to another lesion. Two years after intervention, target lesion revascularization rate was 16%. Predictors of symptomatic angiographic restenosis were dissection >10 mm, final minimal luminal diameter <2.5 mm, lesion length >10 mm, restenotic lesion, and diabetes. We conclude that rotational atherectomy of right coronary ostial stenosis results in excellent acute procedural success and in low incidence of clinical recurrence, with a high proportion of patients remaining angina-free 2 years after intervention.     

Is Palmaz-Schatz stenting effective for second restenosis?

The long-term outcome after coronary stent placement in restenotic lesions after balloon angioplasty (percutaneous transluminal coronary angioplasty: PTCA)may be less favorable compared to stent treatment of de novo lesions, but the role of stents in restenotic lesions after 2 prior PTCA procedures is unknown. Elective Palmaz-Schatz stent placement was performed in 124 consecutive patients. Stents were placed in 70 patients(56%) in the native coronary arteries for de novo lesions(de novo group), in 33 patients (27%)for restenotic lesions after one prior PTCA(restenosis group), and 21 patients(17%)for restenotic lesions after 2 prior PTCA(second restenosis group). The 3 groups were well matched with respect to lesion type, lesion length, and reference diameter. Stent size was similar in the 3 groups. Follow-up angiograms taken about 6 months after stenting were available for all patients. The restenosis rate after stenting was similar for the de novo group and restenosis group(19% vs 27%, NS). The second restenosis group tended to have a higher restenosis rate after stenting than the de novo group(38% vs 19%, p = 0.06). The frequency of diffuse type in-stent restenosis of the second restenosis group tended to be higher than that of the de novo group(63% vs 13%, p = 0.08). Our results suggest that the restenosis rate after stenting was higher in patients with repeated restenosis. Therefore, other therapeutic methods should be considered.     

A randomized comparison of the value of additional stenting after optimal balloon angioplasty for long coronary lesions: final results of the additional value of NIR stents for treatment of long coronary lesions (ADVANCE) study

OBJECTIVES: We sought to investigate the clinical benefit of additional stent implantation after achieving an optimal result of balloon angioplasty (BA) in long coronary lesions (>20 mm). BACKGROUND: Long coronary lesions are associated with increased early complications and late restenosis after BA. Stenting improves the early outcome, but stent restenosis is also related to both lesion length and stent length. METHODS: A total of 437 patients with a single native lesion 20 to 50 mm in length were included and underwent BA, using long balloons matched to lesion length and vessel diameter (balloon/artery ratio 1.1) to achieve a diameter stenosis (DS) <30% by on-line quantitative coronary angiography (QCA). "Bail-out stenting" was performed for flow-limiting dissections or >50% DS. Patients in whom an optimal BA result was achieved were randomized to additional stenting (using NIR stents) or no stenting. The primary end point was freedom from major adverse cardiac events (MACE) at nine months, and core laboratory QCA was performed on serial angiograms. RESULTS: Bailout stenting was necessary in 149 patients (34%) and was associated with a significantly increased risk of peri-procedural infarction (p < 0.02). Among the 288 randomized patients, the mean lesion length was 27+/-9 mm, and the vessel diameter was 2.78+/-0.52 mm. The procedural success rate was 90% for the 143 patients assigned to BA alone (control group), as compared with 93% in the 145 patients assigned to additional stenting (stent group), which resulted in a superior early minimal lumen diameter (0.54 mm, p < 0.001) and led to reduced angiographic restenosis (27% vs. 42%, p = 0.022). Freedom from MACE at nine months was 77% in both groups. CONCLUSIONS: A strategy of provisional stenting for long coronary lesions led to bailout stenting in one-third of patients, with a threefold increase in peri-procedural infarction. Additional stenting yielded a lower angiographic restenosis rate, but no reduction in MACE at nine months.     

Clinical outcome of stent implantation in small coronary arteries using different types of coronary stents

PURPOSE: We evaluated the results of stent placement in small coronary arteries. SUBJECTS: The subjects were divided into 2 groups: the first contained 911 lesions treated with stenting in the coronary arteries (stent group), and the second contained 1,203 background- and patient-matched lesions treated with balloon angioplasty (POBA group). There was no significant difference in the background of patients or lesions between the groups. A "small coronary artery" was defined as a coronary artery with a reference vessel diameter < 3.0 mm. RESULTS: There was no significant difference in incidence of acute myocardial infarction (AMI), coronary artery bypass grafting, or death between the groups. In the stent group, acute occlusion (0.8%) and subacute thrombosis (2.1%) occurred. The restenosis rate of 29.8% in the stent group was significantly lower than in the POBA group (38.2%; p < 0.01). The restenosis rate of 19.4% in stented vessels 3.0 mm diameter was significantly lower than in vessels < 3.0 mm diameter (29.8%; p < 0.01). The rate of restenosis was 22.9% for the Multi-Link stent, 24.4% for the NIR stent, 34.1% for the GFX stent, and 35.3% for the PS stent. The restenosis rate of 23.8% in stented vessels > 2.5 mm diameter and < or = 20 mm length was significantly lower than in vessels , < or = 2.5 mm diameter and > 20 mm length (32.7%; p < 0.01). Factors associated with restenosis, analyzed using a stepwise multivariate logistic regression model, included ostial lesions and post-procedural minimum lumen diameter. CONCLUSIONS: Stent implantation in vessels < 3.0 mm diameter using a newly designed coronary stent yielded favorable clinical results, while there was a high prevalence of restenosis, leading to diffused stenotic lesions, in vessels < 2.5 mm diameter.     

Results (>6 months) of stenting of >1 major coronary artery in multivessel coronary artery disease.

Multivessel percutaneous transluminal coronary angioplasty (PTCA) is associated with a high requirement for further revascularization procedures. Although stenting can reduce restenosis and clinical events after 1-vessel intervention, little information is available after multivessel coronary stenting. We followed up 136 patients (9% of 1,481 undergoing stenting in our center) who had had stent implantation in at least 2 different major native coronary arteries and were followed-up for >6 months. Each patient had received a mean of 2.3 +/- 0.6 stents (1.13 +/- 0.4 stents per lesion) and procedural success was 95%. In-hospital complications included 1 death, 1 Q-wave infarction, 5 non-Q-wave myocardial infarctions, and 1 repeat PTCA. After a mean of 18 +/- 13 months, 7 patients died (3 of heart failure, 4 of noncardiac causes), 2 required coronary bypass surgery, 1 had a myocardial infarction, 13 target vessel repeat PTCA, and 4 non-target vessel PTCA. Survival free of major cardiac events was 75% at 3 years. A history of heart failure, dilation of a restenotic lesion, and 3-vessel dilation were independent negative predictors of event-free survival. Angiographic follow-up was available in 86 patients: 56 (65%) were restenosis free, 23 (27%) had 1-vessel restenosis, and 6 (7%) had 2-vessel and 1 patient 3-vessel restenosis. Restenosis per vessel was 23% (41 of 177). Reference diameter, past-PTCA minimal luminal diameter, and length of the stent were independent predictors of restenosis. We conclude that multivessel stenting provides good midterm results in selected patients with multivessel coronary artery disease. Midterm events are less frequent than previously reported after balloon PTCA.     

Intravascular ultrasonic predictors of angiographic restenosis after long coronary stenting

The intravascular ultrasound (IVUS) criteria for stent optimization have not been determined in stenting long lesions. We evaluated the predictors of angiographic restenosis and compared it with stent lumen cross-sectional area (CSA) and stent length between short (stent length <20 mm) and long (> or =20 mm) coronary stenting. IVUS-guided coronary stenting was successfully performed in 285 consecutive patients with 304 native coronary lesions. Six-month follow-up angiogram was performed in 236 patients (82.8%) with 246 lesions (80.9%). Results were evaluated using conventional (clinical, angiographic, and IVUS) methods. The overall angiographic restenosis rate was 22.8% (56 of 246 lesions) (short stent 17.6% vs. long stent 32.2%, p = 0.009). Using multivariate logistic regression analysis, the independent predictors of angiographic restenosis were the IVUS stent lumen CSA (odds ratio 1.51, 95% confidence intervals 1.18 to 1.92, p = 0.001) and stent length (odds ratio 0.95, 95% confidence intervals 0.91 to 1.00, p = 0.039). The angiographic restenosis rate was 54.8% for stent lumen CSA of <5.0 mm2 (short stent 37.5% vs. long stent 73.3%, p = 0.049), 27.4% for CSA between 5.0 and 7.0 mm2 (short stent 24.1% vs. long stent 31.7%, p = 0.409), 10.5% for CSA between 7.0 and 9.0 mm2 (short stent 10.0% vs. long stent 12.5%, p = 0.772), and 11.4% for stent lumen CSA of > or =9.0 mm2 (short stent 10.4% vs. long stent 13.3%, p = 0.767) (p = 0.001). Compared with short coronary stenting, long coronary stenting is effective treatment modality to cover long lesions with comparable long-term clinical outcomes in cases of stent lumen CSA of > or =7.0 mm2. Regardless of the stent length, the most important factor determining angiographic restenosis was the IVUS stent lumen CSA in relatively large coronary artery lesions.     

Effects of stent length and lesion length on coronary restenosis

The choice of drug-eluting versus bare metal stents is based on costs and expectations of restenosis and thrombosis risk. Approaches to stent placement vary from covering just the zone of maximal obstruction to stenting well beyond the lesion boundaries (normal-to-normal vessel). The independent effects of stented lesion length, nonstented lesion length, and excess stent length, on coronary restenosis have not been evaluated for bare metal or drug-eluting stents. We analyzed the angiographic follow-up cohort (1,181 patients) from 6 recent bare metal stent trials of de novo lesions in native coronary arteries. Stent length exceeded lesion length in 87% of lesions (mean lesion length 12.4 +/- 6.3 mm, mean stent length 20.0 +/- 7.9 mm, mean difference 7.6 +/- 7.9 mm). At 6- to 9-month follow-up, the mean percent diameter stenosis was 39.1 +/- 20.1%. In an adjusted multivariable model of percent diameter stenosis, each 10 mm of stented lesion length was associated with an absolute increase in percent diameter stenosis of 7.7% (p <0.0001), whereas each 10 mm of excess stent length independently increased percent diameter stenosis by 4.0% (p <0.0001) and increased target lesion revascularization at 9 months (odds ratio 1.12, 95% confidence interval 1.02 to 1.24). Significant nonstented lesion length was uncommon (12.5% of cases). In summary, stent length exceeded lesion length in most stented lesions, and the amount of excess stent length increased the risk of restenosis independent of the stented lesion length. This analysis supports a conservative approach of matching stent length to lesion length to reduce the risk of restenosis with bare metal stents.     

Intracoronary stents in small vessels: short- and long-term clinical results

OBJECTIVE: To assess the clinical outcome of coronary stenting in small vessels (< 3 mm), using high pressure balloon inflation and antithrombotic therapy. PATIENTS AND METHODS: Vessel size was evaluated as < or >= 3 mm at the time of procedure and measured at a level of maximum diameter. We studied 234 consecutive patients with placement of 300 stents in 279 lesions, comprising 84 stents implanted in 79 lesions located at small vessels (< 3 mm). The standard technique included high pressure balloon inflation (15.8 +/- 2.2 atm) and post-stenting therapy with ticlopidine and aspirin for one month. Mean clinical follow-up was 17.6 +/- 10 months. RESULTS: Procedural success without in-hospital major events was similar between small and large vessels (93.7 in vessels of < 3 mm vs 93.5% in vessels of >= 3 mm; p = NS). Three small vessels presented subacute stent thrombosis, whereas no thrombotic occlusion occurred in large vessels (3.8 vs 0%; p = 0.006). At two years, small vessels had a lower target lesion revascularization free survival (73.6 vs 90.3%; p < 0.001). After adjustment for variables previously described as predictors of stent restenosis, in multivariate analysis, a small vessel of < 3 mm was an independent predictor of target lesion revascularization (p = 0.001). Although patients with stenting in small vessels did not differ significantly in terms of any cause death (4.6 vs 3.8%; p = 0.7) nor acute myocardial infarction (2.9 vs 1.1%; p = 0.3), event-free survival was significantly lower after two years (69.1 vs 86.6%; p < 0.001). CONCLUSIONS: As compared to large vessels, coronary stenting in small vessels was performed with similar rates of initial success, however they had a significantly worse clinical long-term outcome in terms of subacute stent thrombosis and target lesion revascularization at follow-up.     

Latin American randomized trial of balloon angioplasty versus coronary stenting in diabetic patients with small vessel reference size (Latin American Small Vessel [LASMAL II] Trial): immediate and long-term results

Percutaneous coronary interventions (PCIs) in diabetic patients with small reference diameter vessels remain an important challenge in interventional cardiology because it is associated with increased complications and restenosis rates. Plain old balloon angioplasty (POBA) has limited efficacy in patients with lesions in small vessels. Although coronary stenting (stent) has been demonstrated to improve both immediate and long-term results after coronary intervention, small reference diameter is a strong predictor of restenosis after stent implantation. Thus, the question of how to best treat diabetic patients with lesions in small reference diameter remains unanswered. The purpose of this international and multicenter study was to compare the incidence of angiographic restenosis between percutaneous transluminal coronary angioplasty (PTCA) and stent in diabetic patients undergoing PCI of small reference diameter vessels using a specially designed phosphoryl choline (PC)-coated stent for small vessels. The patient population comprised of 220 diabetic patients with lesions in small reference diameter (< 2.9 mm but > 2.0 mm) that were randomized into two different PCI strategies: PTCA with provisional stenting (n = 109) versus stent (n = 111). In the PTCA arm, 26 patients (24%) crossed over to stent during the initial procedure; glycoproteins IIb to IIIa was used in 40.5% of patients in both groups. During initial procedure and at 30 days, both strategies of revascularitation had similar clinical success and acute complications. During long-term follow-up, even though requirements of target vessel revascularization and incidence of major adverse cardiovascular event were similar with both techniques, angiographic binary restenosis (45% with PTCA and 28% with stents, P = .047), net gain (0.74 mm with POBA and 0.94 mm with stents, P = .008), and freedom from target vessel failure (66% with POBA and 81.2% with stents, P = .013) were significantly improved when diabetic patients were initially treated with stent therapy. In summary, in diabetic patients with small coronary arteries, the use of a coronary PC coated stent as a primary device during percutaneous interventions was associated with better angiographic and long-term outcome.     

Long-term outcome of simultaneous kissing stenting technique with sirolimus-eluting stent for large bifurcation coronary lesions.

OBJECTIVES: This study was conducted to evaluate the outcomes of simultaneous kissing stenting with sirolimus-eluting stent (SES). BACKGROUND: Percutaneous intervention for bifurcation coronary lesions is still challenging. METHODS: This study was designed to evaluate the long-term outcomes of 36 consecutive patients with large bifurcation coronary lesions who underwent simultaneous kissing stenting with SES. RESULTS: Lesion location was unprotected left main in 29 patients (81%) and anterior descending artery in 7 (19%). The patients received a combination of aspirin and clopidogrel for 6 months and cilostazol for 1 month. Mean proximal reference diameter was 4.05 +/- 0.68 mm. Compared with the side branch (SB), the main vessel (MV) involved longer lesions (25.8 +/- 17.0 mm vs. 10.2 +/- 10.8 mm, P < 0.001) and smaller preprocedural minimal lumen diameters (1.02 +/- 0.53 mm vs. 1.46 +/- 0.78 mm, P = 0.006) and was treated with larger stents (3.1 +/- 0.3 mm vs. 3.0 +/- 0.3 mm, P = 0.006). Angiographic success rate was 100%. Over the follow-up of 26.7 +/- 8.6 months, no deaths, myocardial infarctions or stent thromboses occurred. Target lesion revascularization was performed in five patients (14%). Overall angiographic restenosis occurred in 5/30 patients (17%), consisting of 4 (13%) at MV and 3 (10%) at SB. At follow-up angiography, a membranous diaphragm at the carina was identified in 14 patients (47%), but only one of whom was associated with angiographic restenosis. CONCLUSION: Simultaneous kissing stenting with SES appears a feasible stenting technique in large bifurcation coronary lesions. However, a new angiographic structure of carinal membrane developed in a half of patients at follow-up and its influence needs to be further investigated.     

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.     

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.     

Acute and long-term outcomes of intracoronary stenting in aorto-ostial, left anterior descending artery-ostial and nonostial stenoses

Percutaneous transluminal coronary angioplasty in ostial lesions is technically difficult and is associated with a lower procedural success rate, higher complication rate and restenosis rate as compared to nonostial lesions. The safety, feasibility, immediate and 6-month angiographic, and long-term clinical outcomes of stenting in aorto-ostial, left anterior descending artery (LAD)-ostial and nonostial stenoses, were retrospectively compared in 19 patients with 20 aorto-ostial lesions (group A), 97 with 97 LAD-ostial lesions (group B) and 1778 with 2242 nonostial lesions (group C). The major adverse cardiac events during hospitalization were similar among the three groups (p = 0.816). Twelve patients with 12 lesions in group A, 75 with 75 lesions in group B and 1384 with 1749 lesions in group C underwent a 6-month follow-up coronary angiography. There were no differences in acute gain (2.04 +/- 0.46 vs. 2.34 +/- 0.50 vs. 2.39 +/- 0.54 mm, respectively, p = 0.057) and net gain (0.89 +/- 1.02 vs. 1.26 +/- 1.08 vs. 1.34 +/- 0.76 mm, respectively, p = 0.105) among the three groups. Group B had a larger late loss than group A and C (1.15 +/- 1.01 vs. 1.22 +/- 0.76 vs. 1.04 +/- 0.65 mm, respectively, p = 0.048) and group A had a larger loss index than group B and C (0.59 +/- 0.50 vs. 0.52 +/- 0.31 vs. 0.48 +/- 0.29, respectively, p = 0.027). The binary restenosis rate among the three groups was 33%, 29% and 20%, respectively, (p = 0.072). Group B had higher restenotic rate as compared to group C (p = 0.036). During a long-term follow-up period of 42+/-21 months, major adverse cardiac events were similar among the three groups (15.8% vs. 25.8% vs. 20.1%, respectively, p = 0.362), but group B had a higher incidence of recurrent angina as compared to group C (17.5% vs. 10.9%, p = 0.039). The cardiac event-free survival rate, as determined by Kaplan-Meier analysis, was similar among the three groups (56% vs. 57% vs. 67%, respectively, p = 0.149); a borderline significance was noted as compared group B to group C (p = 0.051). In conclusion, stenting in aorto-ostial or LAD-ostial lesions is safe, feasible and has a similar acute result as compared to stenting in nonostial lesions; however, it still has a higher 6-month angiographic restenosis rate. LAD-ostial stenoses may have a less favorable long-term clinical outcome than nonostial stenoses.     

Clinical and angiographic outcomes following elective implantation of the Carbostent in patients at high risk of restenosis and target vessel failure.

The Carbostent is a new balloon-expandable, stainless steel, tubular stent with innovative multicellular design and unique turbostratic carbon coating. The aim of this study was to assess clinical and angiographic outcomes after Carbostent implantation in 112 patients poorly suitable for an effective treatment with stenting because of the high risk of thrombosis, late restenosis, and clinical target vessel failure. The inclusion criteria were age > 75 years, diabetes mellitus, a lesion length > 10 mm, a reference vessel diameter < 3.0 mm, an ostial location of the target lesion, and chronic total occlusion. Overall, a total of 175 stents ranging from 9 to 25 mm in length were placed in 147 lesions. There were no stenting attempt failures. The acute gain after stent implantation was 2.46 +/- 0.51 mm, and the residual stenosis 0 +/- 4%. No stent thrombosis occurred, nor myocardial infarction. The 6-month event-free survival rate was 74% +/- 5%. The 6-month angiographic follow-up showed a late loss of 0.81 +/- 0.88 mm and a binary (> or = 50%) restenosis rate of 25%. The results of this study suggest that the Carbostent may be highly effective in patients at high risk of restenosis and target vessel failure.