Long-term angiographic follow-up after successful repeat balloon angioplasty for in-stent restenosis

BACKGROUND: Coronary stent implantation is associated with improved angiographic short-term and mid-term clinical outcome. However, restenosis rate still remains between 20 and 30%. HYPOTHESIS: The purpose of the study, performed as a prospective angiographic follow-up to detect restenosis, was to evaluate the immediate and the 6-month angiographic results of repeat balloon angioplasty for in-stent restenosis. METHODS: From April 1996 to September 1997, 335 stenting procedures performed in 327 patients underwent prospectively 6-month control angiography. Of the 96 lesions that showed in-stent restenosis (> 50% diameter stenosis) (29%), 72 underwent balloon angioplasty. RESULTS: The primary success rate was 100%. Follow-up angiogram at a mean of 6.9 +/- 2.4 months was obtained in 54 patients. Recurrent restenosis was observed in 24 of the 55 stents (44%). Repeat intervention for diffuse and body location in-stent restenosis before repeat intervention was associated with significantly higher rates of recurrent restenosis (p < 0.001 and p < 0.05, respectively). Of the 19 patients who underwent further balloon angioplasty (100% success rate), coronary angiography was performed in 18 (95%) at a mean of 8.2 +/- 2.0 months and showed recurrent restenosis in 12 patients (67%). Further repeat intervention for diffuse and severe in-stent restenosis before the second repeat intervention was associated with significantly higher rates of further recurrent restenosis (p < 0.05 and p < 0.005, respectively). CONCLUSIONS: Although balloon angioplasty can be safely, successfully, and repeatedly performed after stent restenosis, it carries a progressively high recurrence of angiographic restenosis rate during repeat 6-month follow-ups. The subgroup of patients with diffuse, severe, and/or body location in-stent restenosis proved to be at higher risk of recurrent restenosis.     

Sirolimus-eluting stents for treatment of in-stent restenosis: immediate and late results

We analyzed the clinical, angiographic, and late intravascular ultrasonographic findings from 140 patients whose in-stent restenosis was treated with sirolimus-eluting stents. In-stent restenosis remains the main limitation to percutaneous coronary revascularization and has a high recurrence rate after bare stent implantation. From May 2002 through July 2003, we studied 140 patients with clinical restenosis after bare-stent treatment. In 107 patients, in-stent restenosis occurred de novo; in 28 patients, this was the 2nd restenosis; and in another 5, it was the 3rd occurrence. A sirolimus-eluting stent was implanted directly after angiographic evaluation of the in-stent restenosis in 79 patients and after pre-dilation in 61 patients. All patients were given the following antithrombotic regimen: low-molecular-weight heparin, ticlopidine, and aspirin for 1 month, followed by clopidogrel and aspirin for 1 year. Primary success was achieved in 137 patients. Three patients had a non-Q wave myocardial infarction. At the 1-month evaluation, 2 patients had died: 1 due to subacute stent thrombosis and another due to acute mesenteric ischemia. After a mean follow-up of 16 +/- 4 months, the major adverse cardiac events were acute myocardial infarction due to late stent thrombosis in 2 patients and the need for target lesion revascularization in 15 patients. Late angiographic evaluation was performed in 97 patients (69%), 16 of whom had new restenosis: 14 of the restenoses were intrastent, and 2 were at the edges of the stent. Our results suggest that sirolimus-eluting stents are effective in the prevention of in-stent restenosis and, therefore, may become the leading treatment alternative for patients with in-stent restenosis.     

Angiographic results of the first human experience with everolimus-eluting stents for the treatment of coronary lesions (the FUTURE I trial)

The purpose of this study was to report the angiographic findings of the first human evaluation of the everolimus-eluting stent (EES) for the treatment of noncomplex coronary lesions. Forty-two patients with de novo coronary lesions (2.75 to 4.00 mm vessels; lesion length, <18 mm) were prospectively randomized in a 2:1 ratio to receive either the EES (n = 27) or a metallic stent (n = 15). Baseline clinical and angiographic characteristics were similar among both groups. At 6-month follow-up, EES had a lower in-stent late lumen loss (0.10 +/- 0.22 vs 0.85 +/- 0.32 mm, p <0.0001) and in-segment diameter stenoses (20.7 +/- 12.3% vs 37.0 +/- 15.8%, p = 0.002). There was no in-stent restenosis with EES; however, 1 focal distal edge restenosis was present. There was 1 in-stent and 1 in-segment (proximal edge) restenosis in the metallic stent group. There was no stent thrombosis or aneurysm formation at follow-up in either group.     

Long-term clinical and angiographic follow-up after placement of Palmaz-Schatz coronary stent: a single center experience

The purpose of this study is to evaluate long-term clinical and angiographic follow-up results after placement of the Palmaz-Schatz stent and angiographic follow-up results of repeat interventions for stent restenosis. From June 1990 to September 1993, the Palmaz-Schatz stent was placed in 411 patients, 427 lesions. Follow-up angiography was performed in 307 lesions at 3-6 months and in 189 lesions at 1 year. Palmaz-Schatz stent implantation resulted in 97.2% procedure success and 94.6% clinical success. Stent thrombosis was observed in 2.2%. Angiographic restenosis rate was 16.3% at 3-6 months study. At 1 year study, "new" restenosis occurred only in 2.3%. Minimal lumen diameter did not change between 6 months and 1 year (2.32 +/- 0.51 mm vs 2.30 +/- 0.54 mm). With the mean follow-up interval of 22 +/- 9 months, cardiac event-free survival was achieved in 74.3%. Among 50 lesions with restenosis, stent restenosis occurred diffusely in 15 lesions (30%), focally inside the stent in 22 lesions (44%) and focally at the stent border in 13 lesions (26%). Repeat interventions were performed in 35 lesions. Restenosis at 3 months after repeat intervention was demonstrated in 9 (32.1%) out of 28 lesions restudied. Restenosis rate after repeat intervention for diffuse stent restenosis was significantly higher than that for focal in-stent restenosis (75% vs 7.7%). Palmaz-Schatz stent implantation was associated with a high initial success rate and a low late restenosis rate. Luminal renarrowing did not occur beyond 6 months up to 1 year.     

Balloon angioplasty for the treatment of coronary in-stent restenosis: immediate results and 6-month angiographic recurrent restenosis rate

Objectives. The purpose of this prospective study was to evaluate the immediate results and the 6-month angiographic recurrent restenosis rate after balloon angioplasty for in-stent restenosis.Background. Despite excellent immediate and mid-term results, 20% to 30% of patients with coronary stent implantation will present an angiographic restenosis and may require additional treatment. The optimal treatment for in-stent restenosis is still unclear.Methods. Quantitative coronary angiography (QCA) analyses were performed before and after stent implantation, before and after balloon angioplasty for in-stent restenosis and on a 6-month systematic coronary angiogram to assess the recurrent angiographic restenosis rate.Results. Balloon angioplasty was performed in 52 patients presenting in-stent restenosis. In-stent restenosis was either diffuse (≥ 10 mm) inside the stent (71%) or focal (29%). Mean stent length was 16 ± 7 mm. Balloon diameter of 2.98 ± 0.37 mm and maximal inflation pressure of 10 ± 3 atm were used for balloon angioplasty. Angiographic success rate was 100% without any complication. Acute gain was lower after balloon angioplasty for in-stent restenosis than after stent implantation: 1.19 ± 0.60 mm vs. 1.75 ± 0.68 mm (p = 0.0002). At 6-month follow-up, 60% of patients were asymptomatic and no patient died. Eighteen patients (35%) had repeat target vessel revascularization. Angiographic restenosis rate was 54%. Recurrent restenosis rate was higher when in-stent restenosis was diffuse: 63% vs. 31% when focal, p = 0.046.Conclusions. Although balloon angioplasty for in-stent restenosis can be safely and successfully performed, it leads to less immediate stenosis improvement than at time of stent implantation and carries a high recurrent angiographic restenosis rate at 6 months, in particular in diffuse in-stent restenosis lesions.     

Late stent thrombosis in brachytherapy: the role of long-term antiplatelet therapy

Advances in percutaneous coronary intervention (PCI) have emerged in the past decade. Stenting has improved upon the limitations of angioplasty, acute vessel closure and restenosis by providing mechanical vascular support, resulting in sustained clinical and angiographic benefit. This has led to greater utilization of the technique, although it is associated with a significant incidence of in-stent restenosis. Neointimal hyperplasia is the pathophysiologic process that leads to in-stent restenosis. Brachytherapy can be effective in reducing the occurrence of this process. Unfortunately, brachytherapy trials have identified the phenomenon of late stent thrombosis as a potentially serious complication of this procedure. Late stent thrombosis is thrombosis that occurs > 30 days after PCI. The risk of thrombosis is increased in patients receiving a new stent in addition to brachytherapy. It also appears to be increased when adjunctive antiplatelet therapy with ticlopidine or clopidogrel is discontinued early. Strategies to prevent late stent thrombosis include the prolonged use of combination antiplatelet therapy in addition to limited placement of new stents in patients treated with brachytherapy for in-stent restenosis.     

Sirolimus-eluting stent in chronic total occlusion: the SICTO study

Coronary stenting can significantly reduce the restenosis and reocclusion rates after successful balloon angioplasty for chronic total occlusions (CTO). Nevertheless, recanalization of CTO remains among the worst predictors for in-stent restenosis and reocclusion. This multicenter, nonrandomized study assessed the safety and effectiveness of the CYPHER sirolimus-eluting stent in reducing angiographic in-stent late loss in totally occluded native coronary arteries. A total of 25 eligible patients were treated with the CYPHER sirolimus-eluting stent. Baseline clinical and angiographic data were collected and 6-month follow-up angiography and intravascular ultrasound (IVUS) were performed. Clinical follow-up was required at 30 days, 6, 12, 18, and 24 months. Study stent implantation was successful in all patients, with a mean stent length of 28.4 +/- 11 mm. Six-month angiographic outcomes showed that mean lumen diameter stenosis did not change (2.22 +/- 0.56 mm postprocedure; 2.26 +/- 0.60 mm at 6 months follow-up; P = NS). Similarly, mean percent diameter stenosis did not change significantly (15.7 +/- 8.6% postprocedure, 19.3 +/- 11% at follow-up; P = NS). The absolute late lumen loss was -0.03 +/- 0.28 mm with a 6-month in-stent restenosis rate of 0%. IVUS follow-up revealed in-stent obstruction volume of only 4.9 +/- 6.8%. Long-term clinical follow-up showed target lesion revascularization at 12 months was only 4%, with target vessel revascularization of only 12%. The CYPHER sirolimus-eluting stent was safe and effective in the treatment of CTO compared to historical data with bare metal stents.     

Stenting for in-stent restenosis.

Intravascular ultrasound studies have shown that additional stent implantation is the only percutaneous technique that allows for recovery of all the lumen area of the original implantation procedure. Despite this theoretical advantage, information on systematic additional stent implantation is still forthcoming, especially concerning the impact of new stent designs. This prospective study evaluated the efficacy of routine additional stent implantation for treatment of in-stent restenosis in 68 consecutive patients. Repeat stenting was successful in all cases, and second-generation tubular stents were used in 84% of patients. The mean additional stent length was 19.2 +/- 9.4 mm, and 15% of patients had multiple stent implantation. The postprocedure minimum lumen diameter was 3.11 +/- 0.41 mm, and the percentage residual stenosis was 2% +/- 7%. At a mean clinical follow-up of 10 +/- 8 months (follow-up rate 100%), the incidence of major adverse events was 21% (1 death, 13 target vessel revascularizations). Overall, angiographic restenosis rate was 32% (angiographic follow-up rate 79%). By multivariate analysis, the only predictors of recurrence after additional stenting were unstable angina at the second procedure (OR 8.70, 95% CI 1.50-50.33, P = 0.019), and early clinical recurrence after the first stent procedure (OR 4.83, 95% CI 1.13-20.71, P = 0.038). Additional stenting is a safe and effective treatment modality for the majority of patients with in-stent restenosis. Alternative treatments should be considered only for patients with in-stent restenosis presenting as unstable angina or early recurrence after a first stent procedure.     

Use of Taxus polymer-coated paclitaxel-eluting stents for treatment of in-stent restenosis in real world patients: results of clinical and angiographic follow-up at six months in a single-center registry.

OBJECTIVE: To evaluate the safety and efficacy of Taxus paclitaxel-eluting stents in a real world group of unselected patients with coronary in-stent restenosis (ISR) lesions. METHODS: This is a prospective single-center registry of a consecutive series of 94 patients with 104 ISR lesions, without previous brachytherapy, over a period of 1 year. Quantitative coronary angiographic analyses were performed at baseline and at 6-month angiographic follow-up. Clinical follow-up were obtained at 6 months. RESULTS: Pre-intervention mean reference vessel diameter was 2.62 +/- 0.50 mm and mean lesion length was 13.95 +/- 6.78 mm. Baseline ISR patterns were mostly either Type I focal (32.7%) or Type II diffuse intrastent (48.1%). At 6-month angiographic follow-up, the in-stent and in-segment binary restenosis was 3.8% (4/105) and 7.6% (8/105) respectively, and the in-stent and in-segment late loss was 0.30 +/- 0.50 mm and 0.57 +/- 0.54 mm, respectively. Seven of these eight restenosed lesions had a diffuse or proliferative ISR pattern prior to intervention. Lesions that restenosed had longer mean stent length per lesion (37.3 mm vs. 22.5 mm in nonrestenosed group; P = 0.001) and more likely to have had a pattern of total occlusion pre-intervention (25.0% vs. 3.1% in nonrestenosed group; P = 0.046). At 6-month clinical follow-up, the MACE rate was 8.5% and target lesion revascularization rate was 7.4%. There was no death but subacute stent thrombosis occurred in 1 patient (1.1%) at 3 days after intervention. CONCLUSIONS: Paclitaxel-eluting Taxus stent for the treatment of ISR effectively suppresses recurrent neointimal proliferation, and was safe and efficacious at 6-month follow-up.     

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.     

Short- and long-term clinical outcome after various stent implantation: overview of the results of uni- and multicenter stent registries.

The present study reports the results of the short- and long-term outcomes of prospective uni- and multicenter stent registries: Palmaz-Schatz (n = 140 patients), Ave-Micro and GFX (n = 280), Multilink Duet (n = 340), Multilink Tetra (n = 192), and Carbo (n = 140) Stent Registries, as well as the predictors and angiographic cutoff points predicting major adverse cardiac events (MACE) after different stent implantations. Significant decrease in subacute stent thrombosis (from 2.9% to 0) and MACE (from 35% to 8.3%) occurred as the improved stents, optimized stent implantation technique, and new postintervention drug therapy were introduced. The changes of angiographic cutoff values (postintervention minimal lumen diameter and preintervention reference diameter: from 2.9 and 3.1 mm for Palmaz-Schatz to 2.5 and 2.8 mm for Multilink Duet, Multilink Tetra, and Carbo stents) and clinical and angiographic factors predicting MACE indicated the change of traditional restenosis paradigm and that progress in clinical practice might be able to counterbalance unfavorable lesion and intervention-related characteristics.     

Sirolimus-eluting stents for the prevention of restenosis in a worst-case scenario of diffuse and recurrent in-stent restenosis.

For recurrent in-stent restenosis (ISR), surgical revascularization or brachytherapy is still the principal therapeutic options. The present investigation explores the efficacy of a sirolimus-eluting stent to prevent restenosis in these lesions with a high risk of recurrence. In 22 consecutive patients with a recurrent and diffuse ISR, a sirolimus-eluting stent was implanted to cover the restenotic lesion. All patients were followed clinically for at least 1 year and underwent a repeat angiography after 7 months. A quantitative coronary angiographic analysis was done. The target vessel failure was 14% in the sirolimus-eluting stent group, with an angiographic late loss of only 0.39 +/- 0.54. No subacute stent thrombosis was observed, and the 1-year event-free survival was 86%. The three cases with restenosis were all focal and could be successfully treated by additional drug-eluting stent implantation. This study showed the efficacy of a sirolimus-eluting stent for the prevention of restenosis in a worst-case scenario of recurrent and diffuse ISR. The observed restenosis rate is lower than that reported after brachytherapy and suggests that sirolimus-eluting stents are a promising treatment option for ISR.     

冠心病合并2型糖尿病患者置入药物洗脱支架的疗效评价

目的 评价冠心病合并2型糖尿病患者冠状动脉病变置入药物洗脱支架后的疗效。方法 选择我院2004年4月至2005年8月连续接受置入药物洗脱支架（DES）或金属裸支架（BMS）治疗并且进行了冠状动脉造影随访的139例的冠心病合并2型糖尿病患者。所有患者在支架术后6个月后接受冠状动脉造影随访。结果共139例患者（男性114例,女性25例）221处病变完成随访。其中C型病变94处（42．5％）,完全闭塞病变42处（19．0％）,平均每个病变支架长度（26．53±14．72）mm,平均参考血管直径（2．80±0．43）mm。两组患者在性别比例和年龄方面差异无统计学意义。两组在冠心病的危险因素如：高血压病、高脂血症、吸烟等方面差异无统计学意义。两组病变的复杂程度基本相当。DES组的参考血管直径比BMS组小[（2．71±0．41）mm比（2．98±0．53）mm,P〈0．001]。6个月后随访,DES组的支架内再狭窄率（10．6％比38．6％,P〈0．001）和病变内晚期腔径丢失[（0．24±0．56）mm比（0．91±0．77）mm,P〈0．001]明显低于BMS组。DES组的靶病变血管重建率显著低于BMS组（8．6％比30．0％,P〈0．001）。DES组有4例晚期支架内血栓。结论 本研究显示药物洗脱支架对于冠心病合并2型糖尿病患者冠状动脉病变的介入治疗有着良好的治疗效果,明显优于金属裸支架。     

Procedural and long-term results of sirolimus-eluting stent in patients at high risk for restenosis

AIM: In-stent restenosis still affects 10-50% of long-term outcome after percutaneous coronary intervention (PCI). Large clinical trials have shown that sirolimus-eluting stents (SES) have reduced restenosis rate to 0-9% in lesions at low-moderate risk. The aim of this study was to evaluate long-term clinical and angiographic outcome of SES in a real world population, at very high risk of restenosis. METHODS: Ninety lesions at high risk of restenosis (lesion length >20 mm, target vessel diameter <2.5 mm, in-stent diffuse restenosis, total occlusions and complex lesions on bypass grafts and bifurcations) were treated in 75 patients. A follow-up was scheduled at 6 months. RESULTS: Restenosis rate was 16.6% with a focal pattern of presentation in most cases. Subacute in-stent thrombosis occurred in 2.2%. Resteno-sis occurred mainly in small vessels, diabetic patients and in vessels previously treated with brachytherapy. CONCLUSION: The treatment of lesions at high risk of restenosis with SES is safe with a low restenosis rate at follow-up. An aggressive and prolonged antiplatelet regimen is mandatory because of high subacute in-stent thrombosis rates.     

Intracoronary radiotherapy with a (188)rhenium liquid-filled PTCA balloon system in in-stent restenosis: acute and long-term angiographic results, as well as 1-year clinical follow-up

BACKGROUND: Intracoronary radiotherapy with beta- and gamma-emitters has been shown to reduce the risk of restenosis after balloon angioplasty and after coronary stenting. The present study addresses the question whether intracoronary radiotherapy using the (188)rhenium liquid-filled PTCA balloon system is feasible, safe and effective in cases of in-stent restenosis. Acute and long-term angiographic results as well as clinical events within 1 year after the procedure were evaluated. METHODS AND RESULTS: From September 1999 to April 2000, 41 patients (mean age 60+/-10 years, 33 male, 8 female) with symptomatic in-stent restenosis underwent repeat PTCA and immediate intracoronary brachytherapy. After successful repeat PTCA (residual stenosis less than 30% in diameter), a second standard PTCA catheter was inflated with liquid (188)rhenium in the redilated in-stent restenosis for 315-880, mean 540+/-155 s with low pressure (3 atm) in order to reach 30 Gy at 0.5 mm depth of the vessel wall. In all patients with successful reintervention, intracoronary radiotherapy was unproblematically performed; in 16 patients, 21 new stents were implanted during the procedure-either immediately before or after radiation therapy. During follow-up, four episodes of stent thrombosis with subsequent myocardial infarction occurred in three patients (8 days, 37 days, 5 months and 6 months after the procedure, respectively). This complication was seen exclusively in patients with newly implanted stents. One patient of the stent group died suddenly 46 days after the procedure. All 40 surviving patients underwent repeat angiography in cases of repeat angina or routinely 6 months after brachytherapy, respectively. In the redilated target vessels without new stenting, restenosis (stenosis >50% in diameter) or reocclusion was observed in only 5 of 25 (=20%) cases, but in the restented target lesions, in 10 of 15 (=67%). Event-free survival (death, myocardial infarction, TVR) at 1 year after repeat dilatation and subsequent brachytherapy was 80% for patients not newly stented, but only 44% for patients with new stents. CONCLUSIONS: Intracoronary radiation therapy with the liquid-filled beta-emitting (188)rhenium balloon is a safe and effective therapy in cases of in-stent restenosis. The positive effect of irradiation, however, is abolished if a new stent is needed. In the not newly stented patients, 1-year follow-up is encouraging.     

Comparison between sirolimus-eluting stents and intracoronary catheter-based beta radiation for the treatment of in-stent restenosis

We report the outcomes of patients who had in-stent restenosis (IRS) that was treated with intravascular brachytherapy (IVBT) or sirolimus-eluting stent (SES) implantation. The benefit of IVBT for treating ISR is well documented. SES implantation decreases first-time ISR and, in preliminary reports, has been used to treat ISR. Fifty consecutive patients who had ISR were treated; the first 25 patients underwent SES implantation and the next 25 patients were treated with IVBT using a beta-Cath System (a 40-mm strontium-90/yttrium-90 source). Quantitative angiographic and intravascular ultrasound follow-up were performed at 5.2 +/- 1.1 and 12.1 +/- 1.2 months; clinical follow-up was performed at 15 months. SES deployment and IVBT were successful in all patients. At 12-month follow-up, 8 patients who underwent IVBT had angiographic recurrence (4 in the stent and 4 at the stent edge); only 1 patient who underwent SES implantation developed recurrent ISR. At 12 months, in-stent late luminal loss was similar between the SES and IVBT groups (0.35 +/- 0.45 vs 0.34 +/- 0.46 mm, p = 0.9); however, in-stent net luminal gain was higher in the SES group than in the IVBT group (1.32 +/- 0.13 vs 0.57 +/- 0.19 mm, p <0.0001), and in-lesion late luminal loss was higher in the IVBT group (0.48 +/- 0.32 vs 0.16 +/- 0.42 mm, p = 0.004). At 12 months, intravascular ultrasound stent volume obstruction was higher after IVBT versus than after SES implantation (38.7% vs 6.7%, p <0.0001). At 15-month clinical follow-up, 64% and 96% (p <0.01) of patients who underwent IVBT and SES implantation, respectively, were free of major adverse cardiac events. In conclusion SES implantation for the treatment of ISR was effective and superior to catheter-based IVBT in preventing recurrent neointimal proliferation and angiographic restenosis at 1-year follow-up.     

Mechanisms of acute lumen gain and recurrent restenosis after rotational atherectomy of diffuse in-stent restenosis: a quantitative angiographic and intravascular ultrasound study.

OBJECTIVES: This quantitative angiographic and intravascular ultrasound study determined the mechanisms of acute lumen enlargement and recurrent restenosis after rotational atherectomy (RA) with adjunct percutaneous transluminal coronary angioplasty in the treatment of diffuse in-stent restenosis (ISR). BACKGROUND: In-stent restenosis remains a significant clinical problem for which optimal treatment is under debate. Rotational atherectomy has become an alternative therapeutic approach for the treatment of diffuse ISR based on the concept of "tissue-debulking." METHODS: Rotational atherectomy with adjunct angioplasty of ISR was used in 45 patients with diffuse lesions. Quantitative coronary angiographic (QCA) analysis and sequential intravascular ultrasound (IVUS) measurements were performed in all patients. Forty patients (89%) underwent angiographic six-month follow-up. RESULTS: Rotational atherectomy lead to a decrease in maximal area of stenosis from 80+/-32% before intervention to 54+/-21% after RA (p < 0.0001) as a result of a significant decrease in intimal hyperplasia cross-sectional area (CSA). The minimal lumen diameter after RA remained 15+/-4% smaller than the burr diameter used, indicating acute neointimal recoil. Additional angioplasty led to a further decrease in area of stenosis to 38+/-12% due to a significant increase in stent CSA. At six-month angiographic follow-up, recurrent restenosis rate was 45%. Lesion and stent length, preinterventional diameter stenosis and amount of acute neointimal recoil were associated with a higher rate of recurrent restenosis. CONCLUSIONS: Rotational atherectomy of ISR leads to acute lumen gain by effective plaque removal. Adjunct angioplasty results in additional lumen gain by further stent expansion and tissue extrusion. Stent and lesion length, severity of ISR and acute neointimal recoil are predictors of recurrent restenosis.     

Polymer-based paclitaxel-eluting stent for treatment of chronic total occlusions of native coronaries: results of a Taxus CTO registry.

The purpose of this prospective nonrandomized study was to evaluate both safety and efficacy of the polymer-based paclitaxel-eluting Taxus stent for treatment of chronic total coronary occlusions. Drug-eluting stents have been proven safe and efficacious in suppressing neointimal proliferation when used in simple native de novo coronary lesions. However, there are only limited data on safety and efficacy of these stents for treatment of more difficult lesion subsets, especially chronic total occlusions. Forty-five consecutive symptomatic patients with chronic total coronary occlusions were included in this observational single-arm study. Only patients with successfully crossed occlusions were enrolled. Primary endpoints were binary restenosis and late lumen loss at 6-month angiographic follow-up. Secondary endpoints were MACE at 30-day and 6-month follow-up. The 30-day MACE rate was 0%. At 6 months, the cumulative MACE-free survival was 84.4%. There were no deaths, myocardial infarctions, or stent thrombosis up to 6 months poststenting. At angiographic follow-up, the in-stent restenosis rate was 13.2% (5/38). There was a total of five in-stent restenoses, with three focal and two diffuse restenosis patterns. The in-segment late lumen loss was 0.13 +/- 0.58 mm. The stent edge analyses revealed a late loss of 0.21 +/- 0.66 proximally and a negative late loss of -0.10 +/- 0.67 at the distal edge segment. This study shows safety and indicators of efficacy of implantation of the paclitaxel-eluting Taxus stent for treatment of chronic total coronary occlusions. The quantitative angiographic analysis revealed beneficial results with respect to the efficacy surrogates binary restenosis rate and late loss.     

Procedural results and distal embolization after saphenous vein graft stenting and angioplasty for in-stent restenosis of grafts

Saphenous vein graft (SVG) angioplasty is associated with frequent periprocedural complications due to distal embolization and a high risk of restenosis. The purpose of this single-center, retrospective study was to determine the distal embolization incidences and outcomes of stenting for SVG lesions and percutaneous angioplasty for in-stent restenosis of these SVGs. We studied 48 consecutive patients (mean age, 62 +/- 7 years, 92% men) who had prior CABG and underwent stent deployment to SVG lesions detected at our institution over a period of 4 years. Mean lesion length was 12.4 +/- 3.2 mm. The minimal lumen diameter increased from 0.7 +/- 0.3 mm to 3.2 +/- 0.4 mm after stenting. Distal embolization as no reflow/slow flow phenomenon occurred in 5 (10%) patients. Angiographic success was achieved in 98% of the patients. Procedural success was achieved in 96% of the patients. No reflow/slow flow phenomenon was observed, particularly in patients with acute coronary syndrome. During the follow-up, 11 patients (23%) had angiographic evidence of restenosis. Lesions were treated with balloon angioplasty and the minimal lumen diameter increased from 2.6 +/- 1.1 mm to 3.1 +/- 0.3 mm. The angiographic and procedural success rates were both 100%. There were no cases of "no" reflow/slow flow. Restenosis was particularly frequent in patients with diabetes mellitus, hypercholesterolemia, and acute coronary syndrome. Stent implantation in patients with de novo SVG lesions can be achieved with a high rate of angiographic and procedural success. The distal embolization risk is lower during angioplasty of in-stent restenosis lesions of SVGs compared to de novo SVG lesions.     

西罗莫司和紫杉醇洗脱支架治疗支架内再狭窄的临床近期及10个月疗效

目的比较西罗莫司洗脱支架（Cypher或Cypher select）和紫杉醇洗脱支架（TAXUS）治疗支架内再狭窄的临床近期及10个月疗效。方法自2002年12月至2005年3月,对253例支架内再狭窄的患者采用了药物洗脱支架（DES）治疗并完成了10个月的临床随访和冠状动脉造影复查。253例中男性218例,女性35例,年龄30～80岁,平均年龄57．2岁。结果253例（262处病变）中152例使用Cypher支架176个,101例使用TAXUS支架132个。使用的Cypher和TAXUS支架的平均直径分别为（2．96±0．27）mm和（3．05±0,35）mm,P=0．04,平均长度分别为（23.31±6．68）mm和（23．56±6．54）mm,P=0．745。支架内再狭窄表现为100％闭塞29处,≥90％狭窄143处,〈90％狭窄90处。病变类型为A、B1、B2和C型各为9处、45处、73处和135处。PCI的成功率两组均为100％,住院期间无死亡,Cypher组主要心脏不良事件（MACE）发生率为2．63％,TAXUS组为2．97％,P=0．872。10个月临床造影显示在Cypher支架和TAXUS支架组中造影再狭窄率分别为14．0％和29．4％,P=0．075,MACE发生率分别为6．7％和16．0％,P=0．031。结论应用Cypher和TAXUS支架治疗支架内再狭窄有良好的近期临床疗效,10个月疗效Cypher支架优于TAXUS支架。