Primary and mid-term outcome of sirolimus-eluting stent implantation with angiographic guidance alone

BACKGROUND: Usefulness and efficacy of intravascular ultrasound (IVUS) for the implantation of sirolimus-eluting stent (SES) is controversial. We investigated the primary and mid-term results of SES deployment with angiographic guidance comparing with IVUS guidance, retrospectively. METHODS AND RESULTS: SESs were deployed in 480 de novo lesions of 459 patients (341 lesions treated without IVUS and 139 lesions treated using IVUS); 368 lesions underwent follow-up coronary angiography. Late luminal loss, in-stent restenosis (ISR) rate and target lesion revascularization (TLR) rate were not significantly different between the non-IVUS group and the IVUS group. There was no acute thrombosis or other major adverse cardiac events except for TLR in both groups. Multivariate logistic regression analysis showed that SES implantation without IVUS was not an independent risk factor for restenosis. On the other hand, in one case, target-vessel revascularization was difficult because of the mal-apposition of the SES previously implanted without IVUS. CONCLUSIONS: For lesions for which stent size and endpoint are decided from angiographic information alone, angio-guided SES implantation is safe and provides a good mid-term outcome that is comparable to the IVUS-guided SES stent deployment., while IVUS may be helpful to decide stent size for complex lesions and reduce possible complications.     

雷帕霉素洗脱支架治疗支架内再狭窄的临床及冠状动脉造影随访观察

目的评价雷帕霉素洗脱支架(商品名Cypher支架,强生公司产品)治疗支架内再狭窄的疗效及安全性。方法27例支架内再狭窄且有临床缺血症状的患者接受了Cypher支架治疗,其中23例患者的支架内再狭窄为弥漫、复杂病变,有5例同时置入了2个Cypher支架。术后对所有患者进行临床随访及冠状动脉造影复查。结果所有支架均成功置入,无残余狭窄或残余狭窄<10%,未见任何并发症。平均随访时间8.9±2.1(5～14)年,临床随访率96.3%,造影随访率92.6%。随访期间,无一例患者死亡。有1例支架近端边缘节段血管发生了再狭窄导致临床心绞痛复发,2例支架近端边缘节段有轻微的新生内膜增殖,但狭窄程度<25%,其余24例均无明显的晚期管腔丢失。本组支架内平均晚期管腔丢失(0.09±0.02)mm、支架远端边缘节段(0.10±0.03)mm、支架近端边缘节段(0.20±0.06)mm。靶血管血运重建率3.8%。结论Cypher支架治疗支架内再狭窄安全、可行,它能有效防止这类病变的新生内膜增殖和再次再狭窄。     

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.     

A randomized comparison of sirolimus-eluting stent with balloon angioplasty in patients with in-stent restenosis: results of the Restenosis Intrastent: Balloon Angioplasty Versus Elective Sirolimus-Eluting Stenting (RIBS-II) trial.

OBJECTIVES: We sought to assess the effectiveness of sirolimus-eluting stents (SES) in patients with in-stent restenosis (ISR). BACKGROUND: Treatment of patients with ISR remains a challenge. METHODS: The Restenosis Intrastent: Balloon Angioplasty Versus Elective Sirolimus-Eluting Stenting (RIBS-II) study is a multicenter randomized trial conducted in 150 patients with ISR (76 allocated to SES and 74 to balloon angioplasty [BA]). The primary end point was recurrent restenosis rate at nine months. Secondary end points included prespecified subgroup analysis, lumen volume on intravascular ultrasound (IVUS), and a composite of major clinical events at one year. RESULTS: Angiographic success was obtained in all patients. At 9-month angiographic follow-up (96% of eligible patients) minimal lumen diameter was larger (2.52 mm [interquartile range (IQR) 2.09 to 2.81] vs. 1.54 mm [IQR 0.91 to 2.05]; p < 0.001) and recurrent restenosis rate was lower (11% vs. 39%; p < 0.001) in the SES group. Prespecified subgroup analyses were consistent with the main outcome measure. Lumen volume on IVUS at 9 months was also larger (279 mm3 [IQR 227 to 300] vs. 197 mm3 [IQR 177 to 230]; p < 0.001) in the SES group. At one-year clinical follow-up (100% of patients), the event-free survival (freedom from death, myocardial infarction, and target vessel revascularization) was significantly improved in the SES group (88% vs. 69%; p < 0.004) as the result of a lower requirement for target vessel revascularization (11% vs. 30%; p < 0.003). CONCLUSIONS: In patients with ISR, the use of SES provides superior long-term clinical, angiographic, and IVUS outcome than BA treatment.     

Intravascular ultrasound predictors of angiographic restenosis after sirolimus-eluting stent implantation.

AIMS: In many countries, drug-eluting stent implantation is the dominant interventional strategy. We evaluated the clinical, angiographic, procedural, and intravascular ultrasound (IVUS) predictors of angiographic restenosis after sirolimus-eluting stent (SES) implantation. METHODS AND RESULTS: SES implantation was successfully performed in 550 patients with 670 native coronary lesions. Six-month follow-up angiography was performed in 449 patients (81.6%) with 543 lesions (81.1%). Clinical, angiographic, procedural, and IVUS predictors of restenosis were determined. Using multivariable logistic regression analysis, the only independent predictors of angiographic restenosis were post-procedural final minimum stent area by IVUS [odds ratio (OR)=0.586, 95% confidence interval (CI) 0.387-0.888, P=0.012] and IVUS-measured stent length (OR=1.029, 95% CI 1.002-1.056, P=0.035). Final minimum stent area by IVUS and IVUS-measured stent length that best separated restenosis from non-restenosis were 5.5 mm2 and 40 mm, respectively. Lesions with final minimum stent area<5.5 mm2 and stent length>40 mm had the highest rate of angiographic restenosis [17.7% (11/62)], P<0.001 compared with other groups. CONCLUSION: Independent predictors of angiographic restenosis after SES implantation were post-procedural final minimum stent area by IVUS and IVUS-measured stent length. The angiographic restenosis rate was highest in lesions with stent area<5.5 mm2 and stent length>40 mm.     

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.     

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.     

Use of everolimus-eluting stent with a bioresorbable polymer coating for treatment of recurrent in-stent restenosis

Recently, an everolimus-eluting stent utilizing a bioresorbabale PLA polymer coating to release the agent everolimus has proven safe and effective in preventing restenosis for up to six months in de novo coronary arteries. But the use of a bioresorbable polymer-coated everolimus-eluting stent for in-stent restenosis lesions has not been previously investigated. This is a case report of one-year angiographic follow-up results after the implantation of a bioresorbable PLA polymer-coated everolimus-eluting stent for the treatment of recurrent in-stent restenosis. The case involved a 63-year-old female who had repeatedly presented with recurrent in-stent restenosis in the LCX. We successfully treated this recurrent ISR lesion by using a bioresorbable PLA polymer-coated everolimus-eluting stent; the one-year follow-up angiography revealed prevention of ISR after the implantation of this device.     

药物洗脱支架治疗后冠状动脉再狭窄相关因素的分析

目的探讨药物洗脱支架治疗后冠状动脉再狭窄与临床和造影的相关因素。方法入选416例冠状动脉造影(CAG)资料完整的冠心病患者,男性328例,女性88例,共置入支架470枚,按照CAG结果分为再狭窄组59例和无再狭窄组357例,平均造影随访时间(7．91±2．37)个月。结果再狭窄组CAG示61枚支架发生再狭窄(13．0％),女性、既往冠状动脉旁路移植术(CABG)病史、慢性闭塞(CTO)病变病史、最大球囊释放压力、置入支架长度与术后再狭窄相关(P<0．05);置入支架血管直径与再狭窄高度相关(OR=0．61,95％CI:0．43～0．82,P< 0．01)。结论女性、既往CABG病史、CTO病变、血管直径、置入支架长度是支架术后再狭窄的危险因素,而糖尿病史等与再狭窄无关。     

Late target lesion revascularization after implantation of sirolimus‐eluting stent

Objectives : We evaluated the incidence, clinical presentation, and angiographic in‐stent restenosis (ISR) pattern of late target lesion revascularization (TLR) after sirolimus‐eluting stent (SES) implantation. Background : Late TLR is an unusual finding beyond 6–9 months after bare‐metal stent implantation. However, late TLR after SES implantation has not been sufficiently evaluated. Methods : The study population consisted of 804 patients with 1,020 native lesions that were patent at 6‐month follow‐up angiogram after SES implantation. Results : Late TLR was performed in 18 patients with 18 lesions (1.8%) at 24.1 ± 2.6 months (range; 18–30 months) after SES implantation. Clinical presentation of late TLR patients was silent ischemia in eight patients and recurrent angina in 10 patients, but none had an acute coronary syndrome. Angiographic ISR pattern of late TLR lesions were focal ISR in 12 lesions (67%) and diffuse ISR in six lesions (33%). Serial quantitative coronary angiographic analysis of these lesions showed a minimal lumen diameter of 2.6 ± 0.5 mm immediately after SES implantation, 2.4 ± 0.4 mm at 6‐month follow‐up and 0.7 ± 0.6 mm at 24‐month follow‐up (ANOVA P < 0.001). By stepwise multiple logistic regression analysis, the only independent predictor of late TLR was stent length (P < 0.001, OR = 1.040, 95% CI = 1.019–1.061). Conclusions : Late TLR was performed in 1.8% of 1,020 native lesions that were patent at 6‐month follow‐up angiogram. Clinical presentations of late TLR was either silent ischemia or recurrent angina, but not acute coronary syndrome. Two‐thirds of late TLR lesions had a focal angiographic ISR pattern. © 2007 Wiley‐Liss, Inc.     

Frequency of stent fracture as a cause of coronary restenosis after sirolimus-eluting stent implantation

Stent fracture (SF) was suggested as a cause of restenosis after sirolimus-eluting stent (SES) implantation. This study was performed to evaluate the incidence and characteristics of SF to determine its contribution to restenosis in patients with in-stent restenosis (ISR) after SES implantation. From May 2003 to February 2006, SESs were used for percutaneous coronary intervention in 868 patients with 1,109 coronary narrowings. Follow-up coronary angiography was performed in 366 patients (42%), and 26 ISR lesions were observed. These patients were enrolled in this study. SF was divided into 3 types as avulsion, collapse, and partial based on the findings of fluoroscopy, coronary angiography, and intravascular ultrasound study. Of 26 patients with ISR lesions, SF was identified in 10. SF types were avulsion (5 patients), collapse (2 patients), and partial (3 patients). SF was identified at the midshaft (7 patients) and overlap sites (3 patients) of stents. SF was not observed in the 30 patients with ISR after bare-metal Bx Velocity stent implantation. Four patients with SF were treated with paclitaxel-eluting stents. In conclusion, SF is 1 of the leading causes of ISR after SES implantation. Careful fluoroscopic examination is necessary at the time of follow-up angiography to identify this problem.     

Angiographic and intravascular ultrasound findings of the late catch-up phenomenon after intracoronary beta-radiation for the treatment of in-stent restenosis

We report one-year angiographic and intravascular ultrasound (IVUS) outcomes of in-stent restenosis (ISR) patients treated with intravascular brachytherapy (IVBT). The benefit of IVBT for treating ISR is well documented. However, few data exist on significant angiographic and intravascular ultrasonic in-stent lumen deterioration beyond the habitual 6-month analysis after the index radiation procedure or so-called late catch-up process in the treatment of ISR. Twenty-five consecutive patients with ISR were treated with IVBT using the Beta-Cath System (a 40 mm 90 Sr per 90 gamma source). Quantitative angiographic and IVUS analysis was performed in all of them at 6 and 12 months. IVBT was successful in all patients. Four patients (16%) developed recurrent angiographic binary restenosis at 6-month follow-up, all located within the adjacent reference segments, with 2 being associated with geographical miss. An additional 4 patients (16%) presented with recurrent ISR at 12-month follow-up, all within the stented segment. Significant in-stent lumen loss (0.16 +/- 0.42 mm to 0.34 +/- 0.46 mm; p = 0.008) and in-stent intimal hyperplasia growth (+11.2 +/- 0.48 mm3; p = 0.03) was observed between 6 and 12 months. Intracoronary beta-radiation for the treatment of ISR was associated with significant luminal deterioration (late catch-up) within the stents between 6 and 12 months due to an important late progression of in-stent intimal hyperplasia.     

Intravascular ultrasound evaluation after sirolimus eluting stent implantation for de novo and in-stent restenosis lesions.

AIMS: The aim of this study is to compare the efficacy of sirolimus-eluting stents (SES) on neointimal growth and vessel remodelling for in-stent restenosis versus de novo coronary artery lesions using serial intravascular ultrasound (IVUS). METHODS AND RESULTS: The study population consisted of 86 patients with in-stent restenosis (ISR) (n=41) or de novo lesions (n=45) treated with SES and evaluated by IVUS post-procedure and at follow-up. One 18-mm SES was used for de novo lesions while 16 patients with ISR received >1SES (total stented length 17.9 mm vs 22.0 mm respectively; P=0.004). At follow-up, no differences were observed between the ISR and de novo groups with respect to changes in the mean external elastic membrane (1.7% vs 1.3%; P=0.53), plaque behind the stent (1.2% vs 3.4%; P=0.49), and lumen areas (0.7% vs 1.9%; P=0.58). No positive remodelling or edge effect was observed. A gap between stents was observed in two patients with ISR, where more prominent, though non-obstructive, neointimal proliferation was noted. CONCLUSION: Sirolimus-eluting stenting is equally effective at inhibiting neointimal proliferation in de novo and ISR lesions without inducing edge restenosis or positive vascular remodelling.     

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.     

Cypher~(TM)支架治疗冠心病的疗效观察

目的评价雷帕霉素洗脱冠状动脉支架(CypherTM)应用于冠心病的临床疗效及再狭窄情况。方法选择接受CypherTM支架治疗的348例冠心病患者,观察术后即刻效果、术后6个月心脏性死亡、心肌梗死、再次血管重建及冠状动脉造影复查情况。病例中包括ST段抬高的急性心肌梗死86例,非ST段抬高的急性心肌梗死21例,不稳定型心绞痛149例,稳定型心绞痛92例。结果支架植入成功率99.3%,住院期间无死亡,术后出现急性和亚急性血栓各1例,1例晚期血栓致心肌梗死,1例心衰死亡,另有5例随访中进行了血管重建术,术后6个月主要心脏不良事件发生率2.9%。术后6个月56例冠状动脉造影复查的再狭窄率为7.1%(支架内为1.8%),支架内平均晚期管腔丢失为0.16mm(病变段内为0.20mm),靶病变重建率为5.4%。结论应用CypherTM支架治疗冠心病是安全和有效的,主要心脏不良事件发生率低,支架内再狭窄率和靶病变重建率明显低于普通金属支架。     

雷帕霉素洗脱支架冠状动脉造影随访结果分析

目的通过对接受雷帕霉素洗脱支架(sirolimus-eluting stent,SES)治疗的冠心病患者冠状动脉造影随访,观察其临床实际应用的效果。方法339例患者接受治疗,所有患者均接受了临床随访,165例患者于置入术后6~12个月行冠状动脉造影复查。结果冠状动脉造影随访时,支架近端边缘晚期管腔丢失显著高于支架内及支架远端边缘(0.17 mmvs0.08 mmvs0.09 mm),再狭窄率为9.7%,再血管化率4.84%,再狭窄以局限性狭窄为主。在339例患者中,有4例患者于支架置入后5天~4个月发生猝死。猝死发生率为1.18%。1例于支架置入后14天发生支架内亚急性血栓形成,发生率0.50%。晚期血栓形成1例(术后12个月),主要心血管不良事件为1.70%。结论对复杂的冠状动脉病变SES有较好的疗效,能显著降低支架后再狭窄,减少靶血管的再血管化率。     

Preinterventional peak monocyte count and in-stent intimal hyperplasia after coronary stent implantation in human coronary arteries

BACKGROUND: The mechanism of restenosis after stent implantation principally is neointimal hyperplasia. There is evidence that monocytes play a important role in in-stent restenosis (ISR) after stent implantation. Hypothesis: This study assessed the relationship between preinterventional peak monocyte count and neointimal growth after successful stent implantation. METHODS: We performed coronary stent implantation in 85 patients (85 de novo lesions). Peripheral blood sample was obtained in all patients every 12 h before coronary angiography for measurement of peripheral monocytes. All patients received angiographic and intravascular ultrasound (IVUS) follow-up at 6 months after stenting. RESULTS: The preinterventional circulating monocyte count was significantly higher in the ISR group than that in the group without ISR (654 +/- 62/vs. 461 +/- 222/mm3, p < 0.001) and was significantly higher in the reintervention group than that in the no-reintervention group (660 +/- 72/ vs. 470 +/- 216/mm3, p< 0.001). The incidence of ISR and repeat intervention associated with preinterventional monocyte count was highest among the patients in the highest tertile, who were at a 2.64-fold increased risk of ISR and 3.22-fold increased risk of repeat intervention compared with the patients in the lowest tertile. A significant positive correlation was found between preinterventional peak monocyte count and preinterventional plaque and media cross-sectional area and follow-up neointima area (r = 0.311, p = 0.007, r = 0.465, p < 0.001, respectively). The neointima area associated with preinterventional monocyte count was largest among the patients in the highest tertile, that is, 2-fold larger than that of the patients in the lowest tertile (p < 0.001) and 1.44-fold larger than that of the patients in the middle tertile (p = 0.001). CONCLUSION: Our results suggest that circulating preinterventional monocytes play a principal role in the process of in-stent neointimal growth after successful stent implantation.     

Angiographic patterns of in-stent restenosis in men and women.

BACKGROUND: The angiographic classification of in-stent restenosis (ISR) has been described. However, no comparative analysis of the morphologic ISR patterns between sexes has been performed. We sought to assess the ISR rate and the morphology of the different ISR patterns in the two genders. METHODS: The study population comprised 487 patients (231 male, 256 female) who underwent systematic angiographic follow-up 6 months after coronary stent implantation. RESULTS: The angiographic patterns of ISR were defined as: a) focal (length < or = 10 mm), b) diffuse (length > 10 mm and within the stent margins), c) proliferative (length > 10 mm extending beyond the stent margins), and d) totally occlusive. Angiographic ISR had a significantly higher incidence in women as compared to men (35.9 vs 29.4%, p = 0.04). In addition, angiographic analysis showed that, although all ISR patterns were present in both sexes, more males had focal ISR (59.7 vs 28.2%, p < 0.001). Conversely, females showed a higher incidence of diffuse ISR (71.8 vs 40.3%, p < 0.001), including intrastent, proliferative and occlusive patterns. The only predictors of a specific ISR pattern were diabetes mellitus and hypertension for diffuse ISR in both sexes. CONCLUSIONS: Females seem to be at higher risk of angiographic restenosis and higher levels of ISR class after coronary stent implantation. These findings may be prognostically important and should be considered for the appropriate use of newer revascularization strategies.     

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.     

Drug-eluting stents versus repeat vascular brachytherapy for patients with recurrent in-stent restenosis after failed intracoronary radiation

Recurrent in-stent restenosis (ISR) following intracoronary radiation therapy (IRT) continues to be a therapeutic challenge. The present study aims to evaluate the clinical outcomes of patients who were treated with drug-eluting stent (DES) implantation versus repeat IRT for recurrent ISR after brachytherapy failure. A cohort of 88 patients who were previously treated with brachytherapy for ISR and presented with angina and recurrence of angiographic restenosis were evaluated for treatment with either DES [sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES); n = 34] or percutaneous coronary intervention (PCI) and repeat radiation (gamma or beta radiation; n = 54). The two groups had similar baseline clinical and angiographic characteristics. The in-hospital outcomes were similar between both groups. At long-term follow-up of 9.7 +/- 4.1 months for the DES group and 10.3 +/- 3.5 months for the repeat IRT group, there were no deaths or myocardial infarctions (MI). There was a trend toward more target vessel revascularization-major adverse cardiac events (TVR-MACE) in the DES group (p = 0.09). In addition, the patients in the DES group had a significantly lower survival rate compared to those in the repeat IRT group (p = 0.018). For patients who had recurrent ISR following IRT, either DES implantation or repeat radiation is safe and is associated with excellent immediate outcomes. Yet, at long-term follow-up, repeat IRT was associated with less recurrences and need for repeat revascularization when compared to DES implantation. Therefore, repeat IRT should be considered as an option for this difficult patient subset.