Usefulness of intracoronary brachytherapy for in-stent restenosis with a 188Re liquid-filled balloon

The objective of this randomized pilot trial with 21 patients was to evaluate the effectiveness of a rhenium-188 liquid-filled balloon system to prevent recurrent restenosis after percutaneous transluminal coronary angioplasty for in-stent restenosis. A significant benefit from brachytherapy was seen at 6-month repeat angiography, as well as during the clinical follow-up of 12 months.     

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.     

经皮腔内β-射线放射疗法与切割球囊成形术联合治疗冠状动脉支架内再狭窄

目的　旨在研究经皮冠状动脉 (冠脉 )内 β 射线放射疗法 (β 放疗 ,Novoste)与切割球囊成形术 (CBA)联合治疗支架内再狭窄 (ISR)的疗效及其安全性。方法　冠脉内支架置入术后ISR >70 %的病人 2 95例 [男性 2 0 5例 ,女性 90例 ,年龄 (5 9 76± 10 83)岁 ],其中 112例均行CBA联合 β 放疗为 β 放疗组 (n =112 ) ,183例单独采用CBA(89例 )或普通球囊扩张成形术 (94例 )为对照组 (n =183)。弥漫性长病变ISR者β 放疗先照射病变远段 ,再回撤导管照射病变近段。所有病例术前、术后即刻及术后随访期行冠脉造影 ,分析病变长度、最小管腔直径 (MLD)、参照管腔直径 (RLD)和管腔直径狭窄百分比 (DS)。随访靶血管再次成形率 (TVR)和主要不良心血管事件 (MACE)发生率。结果　术前及术后即刻两组病人的冠脉造影结果差异无显著性。随访期 (6 3± 1 6月 ) β 放疗组的MLD大于对照组 ,DS小于对照组 ,P <0 0 5。β 放疗组与对照组的心绞痛、心肌梗死及死亡率相似 ,差异无显著性(心绞痛为 10 %vs17% ,心肌梗死为 1%vs 2 % ,死亡率为 0 %vs2 % ) ,但β 放疗组的TVR和MACE明显低于对照组 (TVR为 5 %vs 16 % ,MACE为 10 %vs 2 5 % ,P <0 0 5 )。β 放疗组 2 8例 (2 6 % ,2 8 10 6 )弥漫性长病变ISR ,回撤 β 放疗导管分     

切割球囊成形术与经皮腔内β-射线放射疗法联合治疗冠状动脉支架内再狭窄

目的观察切割球囊成形术(CBA)与经皮冠状动脉(冠脉)内β-射线放射疗法(β-放疗)联合治疗支架内再狭窄(ISR)的疗效及其安全性.方法冠脉内支架置入术后ISR>70%的患者295例,男性205例,女性90例,平均年龄(59.76±10.83)岁,其中112例均行CBA联合β-放疗作为β-放疗组(n=112),183例单独采用CBA(89例)或普通球囊扩张成形术(94例)为对照组(n=183).弥漫性长病变ISR者回撤β-放疗导管分段照射.所有患者术前、术后即刻及术后随访期行冠脉造影,随访靶血管血运重建(TVR)和主要不良心血管事件(MACE)发生率.结果两组患者的术前及术后即刻冠脉造影结果差异无显著性.随访期(6.3±1.6) 月β-放疗组的最小管腔直径大于对照组,管腔直径狭窄百分比小于对照组,P<0.05.β-放疗组与对照组的心绞痛、心肌梗死及病死率相似(心绞痛为10%比17%,心肌梗死为1%比2%,病死率为0%比2%), 但β-放疗组的TVR和MACE明显低于对照组(TVR为5%比16%,MACE为11%比21%,P<0.05).β-放疗组28例(25%)弥漫性长病变ISR,分段照射后随访TVR和MACE无增加.结论冠脉内β-放疗和CBA相结合治疗ISR安全、有效,TVR和MACE明显降低.采用回撤β-放疗导管技术可以有效地治疗弥漫性长病变ISR.     

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.     

Efficacy of cutting balloon angioplasty for in-stent restenosis: an intravascular ultrasound evaluation

BACKGROUND: The increase in the use of stents has seen the increasing emergence of in-stent restenosis (ISR). Reports suggest that the Cutting Balloon (Interventional Technologies, San Diego, California) may be a useful treatment modality for this new clinical entity. METHODS: In this study, we compared the efficacy of Cutting Balloon angioplasty (CBA) with conventional balloon angioplasty (PTCA) for ISR in 47 patients (47 lesions). Results were evaluated with intravascular ultrasound (IVUS). The CBA group included 25 patients (mean age, 65 +/- 78 years; 7 females) and the PTCA group included 22 patients (mean age, 69 +/- 51 years; 6 females). RESULTS: The procedural success rate was 100% in both groups. IVUS showed that luminal area acute gain was larger in the CBA group (2.5 +/- 0.8 mm2) compared to the PTCA group (1.8 +/- 1.0 mm2), while late loss was smaller in the CBA group (0.5 +/- 0.4 mm2) compared to the PTCA group (1.3 +/- 0.5 mm2). The change in total area was similar in both groups. The increase in area at the stented portion was 0.4 +/- 0.8 mm2 in the CBA group and 1.2 +/- 0.5 mm2 in the PTCA group. The restenosis rate at follow-up (mean follow-up, 5.4 months) was higher in PTCA patients (59%) than in the CBA patients (24%). CONCLUSION: CBA may result in no increase in total vessel area, a constant stent area, a decrease in plaque area, and an increase in lumen area (induced by the decrease in plaque area). Our IVUS findings suggest that compared to PTCA, the dilatation mechanism of CBA may be associated with reduced dilatation of both the total vessel area and the stent area for ISR. The mechanism of this modality may minimize injury to the intimal membrane and may potentially be a primary device for in-stent restenosis in the future.     

Intracoronary beta-irradiation with liquid rhenium-188: results of the Taiwan radiation in prevention of post-pure balloon angioplasty restenosis study

STUDY OBJECTIVE: To assess the feasibility and short-term outcome of intracoronary irradiation after pure balloon angioplasty (POBA) of de novo and post-POBA restenotic lesions with a liquid beta-emitter (188)Re-filled balloon. DESIGN AND SETTING: Nonrandomized prospective study with contemporaneous control group in a single medical center. PATIENTS AND METHODS: In the Taiwan Radiation in Prevention of Post-Pure Balloon Angioplasty Restenosis study, 40 patients underwent 14-Gy irradiation and 15 patients underwent 20-Gy irradiation at a tissue depth of 0.5 mm after POBA. Thirty control patients received a 5-min inflation with a perfusion balloon catheter after POBA. RESULTS: No procedural or in-hospital complications, or 30-day major adverse cardiac events were noted. Six-month angiographic restenosis rates were 49% in the 14-Gy group, 20% in the 20-Gy group, and 57% in the control group (p = 0.05, 20-Gy group vs control group). In the lesions with an arc of calcification of < 180 degrees, restenosis occurred in 15 of the 34 lesions (44%) in the 14-Gy group and in none of the 11 lesions (0%) in the 20-Gy group (p = 0.007). In a vessel with a reference diameter < 3.0 mm, restenosis occurred in 1 of the 8 lesions (13%) in the 20-Gy group, and in 8 of the 11 lesions (73%) in the control group (p = 0.02). In the post-POBA restenotic lesions, restenosis occurred in none of the six lesions (0%) in the 20-Gy group, and in five of the six lesions (83%) in the control group (p = 0.008). CONCLUSIONS: Post-POBA, catheter-based brachytherapy in nonstented native coronary artery with a (188)Re-filled balloon can effectively reduce target lesion restenosis with 20-Gy irradiation at a tissue depth of 0.5 mm and seems to be more effective in the treatment of lesions with an arc of calcification < 180 degrees, in a vessel with a reference diameter of < 3.0 mm, and in post-POBA restenotic lesions.     

Intracoronary irradiation markedly reduces restenosis after balloon angioplasty in a porcine model

Objectives. This study examined the effects of intracoronary Irradiation on neointimal proliferation after overstretch balloon angioplasty in a normolipemic swine model of restenosis.Background. Restenosis after percutaneous transluminal coronary angioplasty represents, in part, a proliferative response of vascular smooth muscle at the site of injury. We have previously shown that ionizing radiation, delivered by means of an intracoronary source, causes focal medial fibrosis. We therefore hypothesized that ntracoronary irradiation delivered at the time of balloon angtoplasty might impair the restenosis process.Methods. Nineteen juvenile swine underwent coronary angiography; a segment of the coronary artery was chosen as a target for balloon injury. In 10 swine, a ribbon of iridiun-192 was positioned at the target segment, and 2,000 cGy was delivered at the vessel wall. Subsequently, overdilation balloon angioplasty was perfromed at the irradiated segment. In nine control swine, overdilation balloon angioplasty was performed without previous irradiation. Eighteen animals survived and were killed at 30 days. Histopathologic analysis was performed by a pathologist in blinded manner. The area of maximal lumen compromise within the target segment was analyzed by computer-assisted planimetry.Results. In the control group, mean (± SD) neointimal area was 0.84 ± 0.60 mm²compared with that in the irradiated group, 0.24 ± 0.13 mm²(p = 0.01). In the control group, mean percent area stenosis was 47.6 ± 20.7%, whereas that in the irradiated group was 17.6 ± 10.5% (p = 0.001). This represents a 71.4% reduction in neointimal area and a 63.0% reduction in percent area stenosis in the irradiated group. Adjacent coronary segments and surrounding myocardium were unaffected.Conclusions. Intracoronary irradiation (2,000 cGy) delivered to a target porcine coronary segment before balloon overdilation markedly reduces neointima formation at 30 days and thus significantly impairs the restenosis process.     

Drug-coated balloon angioplasty versus balloon angioplasty for treating patients with in-stent restenosis in the femoropopliteal artery: A meta-analysis

Background:The introduction of endovascular surgery has led to frequent stent use, although in-stent restenosis (ISR) remains a challenging issue. Drug-coated balloon (DCB) and conventional balloon angioplasty (BA) are common endovascular procedures for addressing ISR in the femoropopliteal artery. However, there is controversy regarding which procedure provides the greatest benefit to patients.Methods:The PubMed, EMBASE, and Cochrane Central Register of Controlled Trials databases were searched for prospective controlled trials that compared DCB and BA for patients with ISR in the femoropopliteal artery. The study has been approved by Ethics Committee of Wuhan Central Hospital.Results:The meta-analysis included 6 prospective trials with 541 patients. We found that DCB use was associated with significant reductions in binary restenosis at 6 months (relative risk [RR]: 0.45, 95% confidence interval [CI]: 0.33–0.63; P < .00001), binary restenosis at 1 year (RR: 0.44, 95% CI: 0.34–0.57; P < .00001), target lesion revascularization (TLR) at 6 months (RR: 0.36, 95% CI: 0.20–0.65; P = .0006), and TLR at 1 year (RR: 0.38, 95% CI: 0.27–0.54; P < .00001). The DCB group also had significantly better clinical improvement (RR: 1.39, 95% CI: 1.13–1.71; P = .002), although we did not detect inter-group differences in terms of death, target vessel thrombosis, or ipsilateral amputation. The brand of DCB may a cause of heterogeneity.Conclusion:Relative to BA, DCB use increases the durability of treatment for ISR in the femoropopliteal artery, based on significant reductions in binary restenosis and TLR at 6–12 months after the procedure. Furthermore, DCB use was associated with better clinical improvement. However, additional randomized controlled trials are needed to validate these findings.     

Cutting balloon angioplasty for the treatment of in-stent restenosis: a matched comparison with rotational atherectomy, additional stent implantation and balloon angioplasty

OBJECTIVES: The purpose of the study was to determine whether cutting balloon angioplasty (CBA) has advantages over other modalities in treatment of in-stent restenosis (ISR). BACKGROUND: Controversies exist regarding optimal treatment for ISR. Recently, CBA emerged as a tool in management of ISR. METHODS: A total of 648 lesions treated for ISR were divided into four groups according to the treatment strategy: CBA, rotational atherectomy (ROTA), additional stenting (STENT), and percutaneous transluminal coronary angioplasty (PTCA). Following the matching process, 258 lesions were entered into the analysis. RESULTS: Baseline clinical and angiographic characteristics were similar among the groups (p = NS). Acute lumen gain was significantly higher in the STENT group (2.12 +/- 0.7 mm), whereas in the CBA group the gain was similar to one achieved following ROTA and following PTCA (1.70 +/- 0.6 vs. 1.79 +/- 0.5 mm and 1.56 +/- 0.7 mm, respectively; p = NS). The lumen loss at follow-up was lower for the CBA versus ROTA and versus STENT (0.63 +/- 0.6 vs. 1.30 +/- 0.8 mm and 1.36 +/- 0.8 mm, respectively; p < 0.0001), yielding a lower recurrent restenosis rate (20% vs. 35.9% and 41.4%, respectively; p < 0.05). By multivariate analysis, CBA (odds ratio [OR] = 0.17; confidence interval [CI], 0.06 to 0.51; p = 0.001) and diffuse restenosis type at baseline (OR = 2.07; CI, 1.15 to 3.71; p = 0.02) were identified as predictors of target lesion revascularization. CONCLUSIONS: We conclude that CBA is a safe and efficient technique for treatment of ISR, with immediate results similar to atheroablation and better clinical and angiographic outcomes at follow-up. This approach might be implemented as a viable option in management of focal ISR and to prepare diffuse ISR for brachytherapy treatment.     

Cutting balloon versus conventional balloon angioplasty for the treatment of in-stent restenosis: results of the restenosis cutting balloon evaluation trial (RESCUT)

OBJECTIVES: The aim of this trial was to compare cutting balloon angioplasty (CBA) with conventional balloon angioplasty (i.e., percutaneous transluminal coronary angioplasty [PTCA]) for the treatment of patients with coronary in-stent restenosis (ISR). BACKGROUND: Retrospective studies suggest CBA might be superior to conventional PTCA in the treatment of ISR. METHODS: The Restenosis Cutting Balloon Evaluation Trial (RESCUT) is a multicenter, randomized, prospective European trial including 428 patients with all types of ISR (e.g., focal, multifocal, diffuse, proliferative). RESULTS: In both groups, the majority of ISR lesions were shorter than 20 mm. The length of restenotic stents was similar (CBA: 18.6 +/- 9.7 mm; PTCA: 18.3 +/- 8.7 mm). The number of balloons used to treat ISR was lower in the CBA group: only one balloon was used in 82.3% of CBA cases, compared with 75% of PTCA procedures (p = 0.03). Balloon slippage was less frequent in the CBA group (CBA 6.5%, PTCA 25%; p < 0.01). There was a trend toward a lower need for additional stenting in the CBA group (CBA 3.9%, PTCA 8.0%; p = 0.07). At seven-month angiographic follow-up, the binary restenosis rate was not different between the groups (CBA 29.8%, PTCA 31.4%; p = 0.82), with a similar pattern of recurrent restenosis. Clinical events at seven months were also similar. CONCLUSIONS: Cutting balloon angioplasty did not reduce recurrent ISR and major adverse cardiac events, as compared with conventional PTCA. However, CBA was associated with some procedural advantages, such as use of fewer balloons, less requirement for additional stenting, and a lower incidence of balloon slippage.     

Cutting balloon angioplasty for the treatment of in-stent restenosis in diabetics: A matched comparison of 6 months' outcome with conventional balloon angioplasty

Ranging from 24% to 55%, angiographic in-stent restenosis (ISR) rates in diabetics are higher than the 17% to 28% rates observed in nondiabetics. There are controversies regarding optimal treatment for ISR. Recently, cutting balloon angioplasty (CBA) emerged as a tool in management. The authors assessed the hypothesis that CBA has advantages over conventional percutaneous transluminal balloon angioplasty (PTCA) in treatment of ISR in diabetics. CBA or PTCA was applied to 165 diabetics (267 ISR lesions) in their institution. With a computer algorithm, an attempt was made to match each lesion in the CBA group with a corresponding lesion in the PTCA group. The lesion pairs should match with respect to the patients' age and gender, type of target vessel and stent, reference vessel diameter, and baseline minimal lumen diameter (MLD). Following the matching process, 55 ISR lesion pairs were identified. Baseline patient characteristics were similar among the groups (p = NS). There was no difference in the in-hospital major adverse cardiac events (MACE) between the groups, whereas MACE at follow up was significantly lower in the CBA group compared to the PTCA group (CBA, 20.0% vs PTCA, 43.6%, p<0.05). The recurrent ISR rate was significantly lower in the CBA group compared to the PTCA group (CBA, 27.3% vs PTCA, 49.1%; p < 0.05). Also, a diffuse pattern of recurrence was more common in lesions treated with PTCA, whereas a focal pattern of recurrence was more common in the CBA group. The minimal luminal diameter at follow-up, the acute gain, and net gain were significantly higher in the group of lesions treated with CBA than in the PTCA group. In addition, a significantly higher late loss and loss index at follow-up were observed in the PTCA group compared to the CBA group. CBA has advantages over PTCA in treatment of diabetic patients with ISR, with better immediate and follow-up angiographic outcomes, and better follow-up clinical outcome.     

Treatment of diffuse in-stent restenosis with rotational atherectomy followed by radiation therapy with a rhenium-188-mercaptoacetyltriglycine-filled balloon

OBJECTIVES: This study was done to evaluate the feasibility and efficacy of beta-radiation therapy with a rhenium-188-mercaptoacetyltriglycine ((188)Re-MAG(3))-filled balloon after rotational atherectomy for diffuse in-stent restenosis (ISR). BACKGROUND: Rotational atherectomy has been shown to be safe and efficient for the treatment of ISR, but the recurrence rate is still high. Intracoronary beta-irradiation after rotational atherectomy may be a reasonable approach to prevent recurrent ISR. METHODS: Fifty consecutive patients with diffuse ISR (length >10 mm) in native coronary arteries underwent rotational atherectomy and adjunctive balloon angioplasty, followed by beta-irradiation using a (188)Re-MAG(3)-filled balloon catheter. The radiation dose was 15 Gy at a depth of 1.0 mm into the vessel wall. RESULTS: The mean lengths of the lesion and irradiated segment were 25.6 +/- 12.7 mm and 37.6 +/- 11.2 mm, respectively. Radiation was delivered successfully to all patients, with a mean irradiation time of 201.8 +/- 61.7 s. No adverse event, including myocardial infarction, death or stent thrombosis, occurred during the follow-up period (mean 10.3 +/- 3.7 months), and nontarget vessel revascularization was needed in one patient. The six-month binary angiographic restenosis rate was 10.4%, and the loss index was 0.17 +/- 0.31. CONCLUSIONS: Beta-irradiation using a (188)Re-MAG(3)-filled balloon after rotational atherectomy is safe and feasible in patients with diffuse ISR, and it may improve their clinical and angiographic outcomes. Further prospective, randomized trials are warranted to evaluate the synergistic effect of debulking and irradiation in patients with diffuse ISR.     

Comparison of angiographic and clinical outcomes between rotational atherectomy versus balloon angioplasty followed by radiation therapy with a rhenium-188-mercaptoacetyltriglycine-filled balloon in the treatment of diffuse in-stent restenosis

BACKGROUND: The purpose of this study was to compare the efficacy of rotational atherectomy (RA) with simple balloon angioplasty, prior to beta-radiation therapy with a rhenium-188-mercaptoacetyltriglycine (188Re-MAG3)-filled balloon for diffuse in-stent restenosis (ISR). METHODS: After completing 50 cases with RA prior to beta-radiation (Group I), we performed optimal balloon angioplasty followed by beta-radiation in the next 53 consecutive patients (Group II) for the treatment of diffuse ISR. The radiation dose was 15 Gy at a depth of 1.0 mm into the vessel wall. RESULTS: The baseline clinical and angiographic characteristics were similar between the two groups. The mean length of the lesion was 25.6+/-12.7 mm in Group I and 22.9+/-8.6 mm in Group II (p=0.26). Radiation was successfully delivered to all patients, with a mean irradiation time of 179+/-55 s. The 6-month angiographic restenosis rate was 10% (5/50) in Group I versus 33% (17/51) in Group II (p=0.007). No adverse event including myocardial infarction, death, or stent thrombosis occurred during the 1-year follow-up period. The risk of a target lesion revascularization or a major adverse cardiac event was significantly lower in Group I than in Group II (two patients in Group I vs. nine patients in Group II; OR, 0.20; 95% CI, 0.04-0.96; p=0.04). CONCLUSION: Concomitant treatment with rotational atherectomy and beta-irradiation using a 188Re-MAG3-filled balloon for diffuse ISR has a synergistic effect, in terms of 6-month angiographic restenosis and 1-year cardiac event-free survival.     

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.     

Sirolimus- and paclitaxel-eluting stents in comparison with balloon angioplasty for treatment of in-stent restenosis.

This study evaluated the acute and follow-up effectiveness of sirolimus-eluting stents (SESs) and nonpolymer-based paclitaxel-eluting stents (PESs) in comparison will balloon angioplasty for treatment of complex in-stent restenosis (ISR) lesions. Drug-eluting stents have been demonstrated to be highly effective for treatment of de novo lesions. The use of drug-eluting stents for treatment of complex ISR is less well defined. Eighty one lesions with in-stent restenosis (lesion length < 30 mm in a native coronary artery) were treated with either PTCA alone (n = 26 lesions in 25 patients), PES (n = 27 lesions in 24 patients; Achieve, Cook; 3,1 mug paclitaxel/mm(2) nonpolymer-based coating), SES (n = 28 lesions in 28 patients; Cypher, Cordis; 140 mug sirolimus/cm(2) metal surface area). Nine-month MACE rates were 32%, 8%, and 14% (all due to repeated revascularization procedures, except one death in the SES group) in the PTCA, PES, and SES group, respectively. Postintervention minimal lumen diameter in stent was significantly greater in the SES and the PES group in comparison with the PTCA group (2.37 +/- 0.26, 2.54 +/- 0.42, 1.78 +/- 0.23 mm; P < 0.001). At 6-month angiographic follow-up, late loss in stent was 0.77 +/- 0.45, 0.43 +/- 0.53, and 0.29 +/- 0.52 mm for the PTCA, PES, and SES group, respectively (P = 0.005). In-lesion restenosis rate was 61% for the PTCA group, 20% for the PES group, and 13% for the SES group (P = 0.042). The implantation of SES as well as nonpolymer PES proved to be effective for treatment of ISR. The combination of improved acute gain and reduced late loss results in a significantly improved angiographic follow-up result in comparison with PTCA.