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Background: Treatment of in-stent restenosis (ISR) remains a significant challenge. Current options include repeat stenting or drug-coated balloons. However, there is a paucity of data regarding vascular healing after these strategies. We, aimed to compare optical coherence tomography (OCT)-based vessel healing after treatment with paclitaxel-coated balloons (PCB) or everolimus-eluting stents (EES)., Methods: An OCT substudy (baseline and 6-9 months) of patients from RIBS IV and RIBS V, two prospective multicenter, randomized controlled clinical trials comparing PCB vs. EES in patients with ISR was performed., Results: Sixty-four patients were included (30 PCB and 34 EES). There were no differences in the baseline or angiographic characteristics between groups. Both groups had the same proportion of drug-eluting and bare-metal stent (BMS) ISR. Baseline OCT analysis did not show differences in the qualitative characteristics of the ISR nor the restenotic tissue burden. Follow-up OCT showed a larger mean lumen area in the EES group (6.03 ± 1.5 vs. 5.24 ± 1.3 mm 2 ; P  = 0.043) but no difference in angiographic restenosis ( P  = 0.66). Percentage tissue coverage was higher with PCB vs. EES (26 ± 13 vs. 19 ± 11%; P  = 0.031). EES-treated ISR more frequently had uncovered struts at follow-up [21 (72%) vs. 12 (44%); P  = 0.034]. Tissue covering struts more frequently had a high backscatter structure after PCB [21 (78%) vs. 16 (55%); P  = 0.07]., Conclusions: Compared with EES, ISR treated with PCB demonstrated more strut coverage with mainly high backscattering tissue. Larger OCT-defined neointimal proliferation in PCB-treated ISR did not translate into higher angiographic restenosis rates., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: To investigate the outcomes of deferred coronary revascularization in patients with non-significant in-stent restenosis (ISR) by physiological assessment., Background: The pathophysiology and natural history of ISR is markedly different from de-novo stenoses. There is a paucity of data on the safety of deferral of revascularization of ISR using physiological assessment., Methods: In this single centre study, using a propensity-score matched analysis, we compared the long-term clinical outcomes of patients with ISR and de-novo disease deferred based on intracoronary physiology. Matching was on a 1:2 basis of ISR to de-novo stenosis. The primary end point was major adverse cardiovascular events (MACE) a composite of all-cause mortality, target lesion revascularization or target vessel myocardial infarction at 36 months., Results: Matched cohorts of 56 ISR and 112 de-novo stenoses were analyzed. The median percentage stenosis was 50% in both groups (p = 0.403). Deferral was based on fractional flow reserve (FFR). The mean FFR was 0.86 across both groups (p = 0.942). At 36-months, freedom from MACE was similar between groups; 86.2% versus 92.8% log rank p=0.180 for ISR and de-novo lesions, respectively. Neither were there differences in the individual components of MACE., Conclusions: Deferral of coronary revascularization in patients with ISR based on its functional impact is associated to similar long-term safety as in de-novo coronary stenosis., (© 2021 Wiley Periodicals LLC.)

Introduction and Objectives: Neoatherosclerosis is one of the causes of in-stent restenosis (ISR). Our objective was to evaluate the influence of neoatherosclerosis on prognosis and treatment response in patients with ISR., Methods: This is a pooled analysis of the optical coherence tomography (OCT)-substudies of 2 multicenter, randomized clinical trials, RIBS IV and V, comparing treatment with paclitaxel-coated balloon vs everolimus-eluting stent in patients with ISR. OCT evaluation was performed at baseline and at 6 to 9 months. Neoatherosclerosis was defined in baseline OCT as neointima with calcified or lipid content. We evaluated the angiographic and OCT results at 6 to 9 months and the occurrence of major adverse cardiovascular events at 3 years of follow-up in patients with and without neoatherosclerosis treated with paclitaxel-coated balloon or everolimus-eluting stents., Results: Sixty-four patients underwent OCT at the time of the index procedure. Neoatherosclerosis was documented in 23 (36%) lesions. Angiographic follow-up at 6 to 9 months showed no differences in restenosis [5 (24%) vs 6 (15%) P=.49], minimum lumen diameter (1.79±0.7 vs 1.94±0.6mm; P=.41) or late loss (0.33±0.7 vs 0.15±0.5; P=.34) in patients with and without neoatherosclerosis, respectively. Follow-up OCT confirmed the absence of differences in quantitative parameters and the characteristics of tissue coverage between the 2 groups. At 3 years of follow-up, the major adverse cardiovascular events rate was 3 (13%) vs 5 (12%) in the neoatherosclerosis and nonneoatherosclerosis groups (HR, 0.94; 95%CI, 0.22-3.93; P=.93)., Conclusions: In this limited study population, OCT-defined neoatherosclerosis did not seem to influence acute and long-term outcomes in patients randomized to paclitaxel-coated balloon or everolimus-eluting stents for ISR., (Copyright © 2021 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Objective: Data on long-term outcomes after internal mammary artery (IMA) coronary graft failure are scarce. Our objective was to describe the clinical characteristics, management, and prognosis after angiographically confirmed IMA graft failure following coronary revascularization., Methods: A three-hospital retrospective registry, observational and descriptive, with prospective follow-up of all consecutive cases of IMA graft failure between 2004 and 2014 was conducted. After treatment, clinical and procedural features were compared between those with and without cardiovascular events., Results: Fifty-seven patients were included (89% male, mean age: 62 years, at surgery) in the registry. Most patients underwent an IMA angioplasty (percutaneous coronary intervention [PCI], 74%). In nine cases, the PCI failed at the graft level, and seven underwent a native vessel revascularization. Native vessel treatment was performed in 20% of the study subjects, all with stents. Finally, medical management was decided in three cases. Events after treatment for IMA graft failure were frequent (50.8%), during a median follow-up of 7.5 years. Acute presentation (hazard ratio MACE  = 1.35; 95% confidence interval (CI): 1.12-3.00, p < 0.01), age of the patient (hazard ratio MACE  = 1.85, 95% CI: 1.17-2.11, p < 0.01), presence of diabetes mellitus (hazard ratio MACE  = 2.75, 95% CI: 1.13-6.69, p = 0.02), and the management modality used (IMA-simple angioplasty VS IMA-stenting: hazard ratio MACE  = 5.5, 95% CI: 1.40-21.15, p = 0.01) displayed prognostic relevance on multivariate analysis. All-cause mortality occurred in 21.1% and presentation as infarction (hazard ratio DEATH  = 1.05, 95% CI: 1.01-2.17, p = 0.01), age (hazard ratio DEATH  = 9.08, 95% CI: 2.52-32.69, p < 0.01), and left ventricular ejection fraction (hazard ratio DEATH  = 3.68, 95% CI: 1.65-8.18, p < 0.01) were independent predictors of the same., Conclusions: In this long-term registry, most patients presented with an acute condition (myocardial infarction, progressive angina) within 12 months after surgery. Acute presentation, age, diabetes mellitus, reduced left ventricular ejection fraction, IMA graft failure segment affected, and the management strategy were related with long-term prognosis., (Copyright © 2018 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.)

Background: Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) remains a major challenge., Objectives: This study evaluated the comparative efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients presenting with DES-ISR., Methods: The study design of this multicenter randomized clinical trial assumed superiority of EES for the primary endpoint, in-segment minimal lumen diameter at the 6- to 9-month angiographic follow-up., Results: A total of 309 patients with DES-ISR from 23 Spanish university hospitals were randomly allocated to DEB (n = 154) or EES (n = 155). At late angiography (median 247 days; 90% of eligible patients), patients in the EES arm had a significantly larger minimal lumen diameter (2.03 ± 0.7 mm vs. 1.80 ± 0.6 mm; p < 0.01) (absolute mean difference: 0.23 mm; 95% CI: 0.07 to 0.38) [corrected], net lumen gain (1.28 ± 0.7 mm vs. 1.01 ± 0.7 mm; p < 0.01), and lower percent diameter stenosis (23 ± 22% vs. 30 ± 22%; p < 0.01) and binary restenosis rate (11% vs. 19%; p = 0.06), compared with patients in the DEB arm. Consistent results were observed in the in-lesion analysis. At the 1-year clinical follow-up (100% of patients), the main clinical outcome measure (composite of cardiac death, myocardial infarction, and target vessel revascularization) was significantly reduced in the EES arm (10% vs. 18%; p = 0.04; hazard ratio: 0.58; 95% CI: 0.35 to 0.98), mainly driven by a lower need for target vessel revascularization (8% vs. 16%; p = 0.035)., Conclusions: In patients with DES-ISR, EES provided superior long-term clinical and angiographic results compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent [RIBS IV]; NCT01239940)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: This study will compare the efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients with drug-eluting stent (DES) in-stent restenosis (ISR)., Methods and Results: This is a prospective, multicentre, randomised clinical trial comparing DEB and EES in patients with DES-ISR. The study is an investigator-driven initiative generated within the RIBS study programme. A total of 310 patients with DES-ISR will be included and randomised (1:1) to DEB or EES. Angiographic follow-up has been scheduled at six to nine months. Quantitative coronary analyses will be performed in a centralised core lab by blinded personnel. The primary endpoint of the study is minimal lumen diameter at angiographic follow-up. Other secondary angiographic endpoints include % diameter stenosis, late loss, net gain and binary restenosis rate. An independent clinical events committee will adjudicate clinical events after reviewing source documents. The main clinical outcome measure is a combined endpoint of cardiac death, myocardial infarction and target vessel revascularisation at one year. Individual components of the combined clinical endpoint and rates of target lesion revascularisation and stent thrombosis will also be compared., Conclusions: This randomised clinical trial will determine the relative efficacy of EES versus DEB in patients presenting with DES-ISR. (ClinicalTrials.gov Identifier: NCT01239940).

Background: Mechanisms of lumen gain during reinterventions in patients with drug-eluting stent (DES) in-stent restenosis (ISR) remain unsettled., Methods: We sought to assess the mechanisms of acute lumen gain after balloon angioplasty (BA) and repeat drug-eluting stent (DES) implantation in patients with DES-ISR. Following a prospective protocol 29 consecutive patients with DES-ISR were sequentially treated with BA and new DES implantation under a multimodality intracoronary imaging assessment including intravascular ultrasound (IVUS) and optical coherence tomography (OCT). Imaging studies were systematically obtained, at baseline, after BA, and after DES. Results of interventions were compared using volumetric and morphometric (ISR pattern and injury score) analyses., Results: IVUS and OCT demonstrated that acute lumen gain after BA and DES equally results from a reduction in intra-stent neointimal volume and further DES expansion. As compared with BA, repeat DES implantation not only increased final lumen (baseline 39.6±18.5mm(3), post-BA 58.6±26.6mm(3), post-DES 84.2±30.8mm(3), all p<0.001) but also provided a smoother lumen (injury score 1.57±0.86 vs 0.22±0.26, p<0.001). At the 9th month of angiographic follow-up (86% patients) in-stent late loss was 0.44±0.5mm and 4 patients (16%) developed ISR. The ISR pattern on OCT was not associated with the injury score after interventions or late angiographic findings. Likewise, the injury score did not predict late angiographic outcome., Conclusions: In patients with DES ISR, lumen gain equally results from a reduction in intra-stent neointimal volume and further DES expansion. As compared with BA, repeat DES implantation provides a larger and smoother coronary lumen., (Published by Elsevier Ireland Ltd.)

Objectives: This study sought to compare the efficacy of drug-eluting balloons (DEB) with that of everolimus-eluting stents (EES) in patients with bare-metal stents (BMS) in-stent restenosis (ISR)., Background: Treatment of patients with ISR remains a challenge., Methods: This was a prospective, multicenter, randomized trial comparing DEB with EES in patients with bare-metal stents (BMS) in-stent restenosis (ISR). The primary endpoint was the minimal lumen diameter at 9 months' follow-up., Results: A total of 189 patients with BMS-ISR from 25 Spanish sites were included (95 were allocated to DEB and 94 to EES). Procedural success was achieved in all patients. At late angiography (median 249 days; 92% of eligible patients), patients in the EES arm had a significantly larger minimal lumen diameter (2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm, p < 0.001; absolute mean difference: 0.35 mm; 95% confidence interval [CI]: 0.16 to 0.53) and a lower percent of diameter stenosis (13 ± 17% vs. 25 ± 20%, p < 0.001). However, late loss (0.04 ± 0.5 mm vs. 0.14 ± 0.5 mm, p = 0.14) and binary restenosis rate (4.7% vs. 9.5%, p = 0.22) were very low and similar in both groups. Clinical follow-up (median 365 days) was obtained in all (100%) patients. Occurrences of the combined clinical outcome measure (cardiac death, myocardial infarction, and target vessel revascularization; 6% vs. 8%; hazard ratio [HR]: 0.76; 95% CI: 0.26 to 2.18, p = 0.6) and the need for target vessel revascularization (2% vs. 6%; HR: 0.32: 95% CI: 0.07 to 1.59, p = 0.17) were similar in the 2 groups., Conclusions: In patients with BMS-ISR, both DEB and EES provided excellent clinical results with a very low rate of clinical and angiographic recurrences. However, compared with DEB, EES provide superior late angiographic findings. (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs. Everolimus-eluting Stent [RIBS V]; NCT01239953)., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Inadequate stent expansion and apposition during percutaneous coronary intervention increases the risk of subsequent restenosis and thrombosis. In repeat and complex percutaneous interventions, such as treatment of stent restenosis or bifurcation techniques, these aspects present a renewed importance. Intravascular ultrasound (IVUS) constitutes the standard technique to assess stent expansion, but its use in clinical practice is far from being universal. Although most current stent designs are radiolucent, new radiological imaging modalities, specifically tailored to coronary stent imaging, can render images with enough quality to visualise stent sub-expansion. While this approach might be complementary to IVUS in clinical practice, few in vivo studies comparing both techniques are available. In this article we review the principles of digital enhancement of stent images and the available validation studies. Furthermore, we report on a comparison between IVUS and digital enhancement stent images performed after coronary stenting.

Objectives: We sought to assess the long-term effectiveness and safety of sirolimus-eluting stents (SES) in patients with in-stent restenosis (ISR)., Background: Treatment of patients with ISR remains a challenge. The long-term outcome of patients with ISR treated with SES remains unknown., Methods: The RIBS-II (Restenosis Intra-stent: Balloon angioplasty vs. elective sirolimus-eluting Stenting) study was a randomized trial conducted in 150 patients with ISR (76 SES, 74 balloon angioplasty [BA]). The long-term (>1 year) clinical outcome and pre-specified subgroup analyses were pre-defined secondary study end points., Results: At 1 year, the event-free survival (death, myocardial infarction, target vessel revascularization [TVR]) was better in the SES group (88% vs. 69%, p < 0.005). Additional long-term (>3 years) clinical follow-up was obtained in 97% of patients (median 3.3 years). After the first year, 3 patients died (1 SES, 2 BA), 5 suffered myocardial infarction (4 SES, 1 BA), and 7 required TVR (4 SES, 3 BA). At last follow-up, definitive/probable/possible stent thrombosis was similar in both groups (2/2/1 SES vs. 1/0/3 BA, p = NS). At 4 years, the event-free survival was 76% in the SES arm and 65% in the BA arm (p = 0.019). On multivariate analysis, SES implantation was an independent predictor of event-free survival. Subgroup analyses were consistent with the main outcome measure., Conclusions: In patients with ISR, SES implantation remains effective and safe at very long-term clinical follow-up.

Aims: Controversy exists about the clinical significance of in-stent late loss (ISLL) after drug-eluting stent (DES) implantation. We sought to clarify whether ISLL after DES implantation is related to a potential clinical impact., Methods and Results: We included in a meta-regression analysis 21 trials (8641 patients) that randomly compared DES with bare-metal stents (BMS). We evaluated the relationship between angiographic behaviour of DES and the clinical impact of using DES instead of BMS in each trial using meta-regression techniques, weighting by the number of patients included in each trial. Mean ISLL in patients allocated to DES and DeltaISLL (difference in ISLL in patients allocated to BMS and DES) were used as angiographic parameters of efficacy of DES. The number of patients needed to be treated (NNT) to prevent one target lesion revascularization (TLR) was used to quantify the clinical impact of using DES instead of BMS. There was a significant relationship between mean ISLL in patients allocated to DES and the clinical benefit of using DES instead of BMS, as measured with the NNT for TLR: NNT for TLR = 6.2 + 18.4 [ISLL-DES] (R = 0.62; P = 0.007). Therefore, a 0.1 mm increase in mean ISLL-DES was associated with a 1.8 increase in NNT for TLR. There was also a significant association between the degree of inhibition of neointimal hyperplasia of DES in comparison with BMS with the NNT for TLR: NNT for TLR = 17.1-11.8 [DeltaISLL] (R = 0.61; P = 0.008). Therefore, a 0.1 mm reduction in ISLL by using DES instead of BMS was associated with a 1.2 decrease in mean NNT for TLR., Conclusion: There is a strong and significant association between the degree of inhibition of neointimal formation with the use of DES and the clinical impact of using DES instead of BMS.

Late loss (LL) has been a fundamental angiographic end-point in drug-eluting stents (DES) clinical trials. However, calculation of LL may be affected by a mismatch between post-procedure (PO) and follow-up (FU) sites of the minimal lumen diameter (MLD). Our aims were to investigate the incidence and methodological implications of the relocation of MLD after bare metal (BMS), sirolimus-eluting (SES), and paclitaxel-eluting (PES) stent implantation. Data from DIABETES I and II trials, which involved diabetic patients treated with BMS, SES, and PES, were analyzed. Angiographic data with matched projections between PO and 9-month angiographic FU were included. In-stent, in-lesion, and in-segment analyses included conventional and customized sub-segmental (5-mm/subsegment) methodology. MLD relocation was considered when the sites of MLD shifted a distance >> the intrinsic variability of the method. Conventional LL, site matched LL, maximal LL (MaxLL), and average LL (AvgLL) were calculated. Relationships between various LL and 1-year target lesion revascularization (TLR) were investigated. Post MLD was located distally, outside the stent, in > or =65% of the analyses. At FU, MLD relocation occurred in 70.5% (BMS), 40% (SES), and 35% (PES). MLD shifted > or =11 mm on average, mainly towards the stented segment. MLD relocation still occurred in 42.8% (BMS), 33.7% (SES), and 36.4% (PES), when analysis was restricted to in-stent segment. Among LL measurements, MaxLL showed the best association with TLR rates. Relocation of the MLD is a frequent phenomenon after both BMS and DES, and should be taken into account when calculating LL. Comprehensive LL analyses, including MaxLL and AvgLL, provides a better appraisal of the biological and clinical effectiveness of DES., ((c) 2006 Wiley-Liss, Inc.)

Introduction and Objectives: Diabetic patients frequently have small-diameter vessels, which increases their risk of restenosis. The aim of this study was to determine the efficacy of sirolimus-eluting stent implantation in these high-risk patients following percutaneous coronary intervention., Methods: Our study population comprised a subset of 85 diabetic patients from the DIABETES (DIABETes and sirolimus Eluting Stent) trial who had very small vessels, defined as those with a reference diameter < or =2.25 mm. In the 100 lesions treated, 49 sirolimus-eluting stents and 51 bare-metal stents were used. Glycoprotein IIb/IIIa inhibitors were used as recommended by the protocol and dual antiplatelet therapy was administered for 1 year., Results: Baseline clinical and angiographic characteristics were comparable in the two groups. The patients' mean age was 66 (9) years, 42% were women, and 37% were insulin-dependent. On average, the lesion length was 15.0 (9.0) mm and the reference diameter was 1.9 (0.2) mm. At 9-month follow-up, both late lumen loss and the restenosis rate were significantly lower in the sirolimus-eluting stent group than in the bare-metal stent group, at -0.03 (0.3) mm vs 0.44 (0.5) mm (P< .001), and 9.1% vs 39.1% (P=.001), respectively. These differences were also observed in the subgroup of insulin-dependent patients. At 1-year follow-up, the stent thrombosis rate was 0% in the sirolimus-eluting stent group, whereas two patients in the bare-metal stent group presented with stent thrombosis., Conclusions: Sirolimus-eluting stent implantation in diabetics with very small vessels is safe and effective, even in insulin-dependent patients.

Unlabelled: In-stent restenosis (ISR) has an incidence between 20% and 30% using bare metal stents. ISR late regression phenomenon (ISRLR) has been previously described, but clinical variables related with this phenomenon remain unclear. The aim of the study was to identify the variables related with ISRLR., Methods: We identified from our data base 30 patients between November 1995 and September 2002 that fulfilled the following criteria: 1) Documented ISR at follow-up angiography (CA-1); 2) treated medically; and 3) Referred for a second follow-up angiography (CA-2). at least 3 months after CA-1. ISRLR was defined as a > 0.2 mm increase in MLD between CA-1 and CA-2, calculated as the 2-fold of our inter-observer variability. ISR late progression was defined as a > 0.2 mm decrease in minimum lumen diameter (MLD) between CA-1 and CA-2., Results: At the time of CA-2 only 2 patients (6.7%) had symptoms related with the previously stented vessel. We found a mean MLD of 1.03+/-0.34 mm and 1.54+/-0.48 mm at CA-1 and CA-2 respectively (AMLD = 0.51 +/-0.34 mm; p < 0.001). Twenty four patients (80.0%) had ISRLR. Two variables were related to the presence or absence ISRLR: Current smoking at the time of coronary stenting (70.8% vs 20.0% respectively, p = 0.026) and acute coronary syndrome as clinical indication for coronary stenting (and 83.5% vs 40.0% respectively, p = 0.029)., Conclusion: ISRLR is a frequent phenomenon in patients with ISR treated medically, probably contributing to the benign long-term clinical outcome that has been previously described in patients with asymptomatic or mildly symptomatic ISR. Current smoking at the time of coronary stenting and acute coronary syndrome as clinical indication for coronary stenting are associated with this phenomenon.

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.

Background: The implications of the American College of Cardiology/American Heart Association (ACC/AHA) lesion classification in patients with in-stent restenosis (ISR) are unknown., Methods: Four hundred fifty patients included in the RIBS randomized study were analyzed. A centralized core laboratory assessed ISR classifications including ACC/AHA, the classification of Mehran et al (Circulation 1999;100:1872-8), diffuse/focal, and a new quantitative ISR index (lesion length/stent length). Logistic regression models were constructed for prespecified outcome measures including (1) unsatisfactory acute results and (2) recurrent restenosis rate., Results: Complex (B2/C) lesions (78%) more frequently obtained unsatisfactory acute results (20% vs 8%, P = .007), smaller minimal lumen diameter after the procedure (2.45 +/- 0.5 vs 2.73 +/- 0.5 mm, P = .001) and at follow-up (1.48 +/- 0.8 vs 1.94 +/- 0.8 mm, P = .0001), and had a higher restenosis rate (43 vs 24%, P = .001) than simple (A/B1) lesions. On logistic regression analysis, all classification schemes were useful to predict unsatisfactory initial results (area under the curve: 0.63, 0.61, 0.59, and 0.62) and recurrent restenosis (area under the curve: 0.60, 0.64, 0.61, and 0.63). The predictive ability of these schemes persisted despite adjustment for potential confounders. Although the ACC/AHA classification was a better predictor of acute results, the classification of Mehran was superior to predict restenosis., Conclusions: The ACC/AHA classification provides a useful tool to determine acute procedural results and the long-term angiographic outcome of patients with ISR.

The occurrence of balloon slippage ("watermelon seeding"; WMS) during treatment of patients with in-stent restenosis (ISR) has been described, but predisposing factors and the potential implications of this phenomenon remain unknown. In the Restenosis Intrastent: Balloon Angioplasty vs. Elective Stenting (RIBS) randomized study, 450 patients with ISR were included. Of these, 42 patients (9%) presented WMS during the procedure. WMS was detected in 26 patients (12%) in the balloon arm and 16 (7%) in the stent arm (P=0.11). In the stent arm, WMS was only noticed during balloon predilation, never during stent implantation. As compared with 408 patients without WMS, patients with WMS had more severe (TIMI flow 1; 21% vs. 8%; P=0.01) and diffuse (length>15 mm: 45% vs. 28%; P=0.02) ISR lesions. Patients with WMS required more balloon inflations, longer total inflation time, had more frequent crossover to stenting or ended the procedure with residual dissections, and eventually obtained poorer acute results (minimal lumen diameter, 2.35+/-0.5 vs. 2.53+/-0.5 mm; P=0.03). In addition, at 6-month follow-up, patients with WMS had a smaller minimal lumen diameter (1.26+/-0.7 vs. 1.61+/-0.7 mm; P=0.007) and a higher restenosis rate (56% vs. 37%; P=0.017). On logistic regression analysis, the WMS phenomenon emerged as an independent predictor of recurrent restenosis (adjusted RR=2.1; 95% CI=1.1-4.1; P=0.04). The WMS phenomenon may complicate treatment of patients with ISR. Long and severe lesions appear to predispose to this technical problem that never occurs during stent deployment. In patients with ISR, WMS is associated with cumbersome procedures and poorer acute and long-term angiographic results., (Copyright (c) 2005 Wiley-Liss, Inc.)

Coronary stents are currently used in most percutaneous coronary interventions, since they have demonstrated to reduce restenosis and allow to solve threatened closure after balloon angioplasty. Despite these beneficial effects, restenosis remains as the main limitation of percutaneous coronary interventions even with the use of coronary stents. In the last 3 years, some coronary stents eluting anti-proliferative drugs have demonstrated to dramatically reduce the risk of restenosis. By November 2004, two different types of antiproliferative drugs eluted by coronary stents are commercially available: sirolimus (rapamycin) and paclitaxel. The mechanisms, clinical evidence, as well as the remaining limitations of these drug-eluting stents are reviewed. The current knowledge of other anti-proliferative drugs that are currently under investigation is also reviewed.

Patients with in-stent restenosis involving the proximal segment of the left anterior descending coronary artery are frequently sent for surgical revascularization. We studied the long-term (3.3 +/- 2.8 years) outcome of 123 patients with in-stent restenosis involving the proximal left anterior descending coronary artery who were treated with a second percutaneous procedure. Cumulative survival rate, probability of being alive and free from surgical revascularization, and probability of being alive and free from new revascularization procedures was 98.3 +/- 1.2%, 92.8 +/- 2.5%, and 82.2 +/- 3.6% at 1 year, and 95.2 +/- 2.5%, 88.5 +/- 3.4%, and 76.9 +/- 4.3% at 3 years, respectively. Thus, in patients with in-stent restenosis involving the proximal left anterior descending artery, a second percutaneous procedure is a feasible and safe long-term strategy, with few patients ultimately requiring surgical revascularization.

Background: Early lumen loss (ELL) may be detected in patients undergoing coronary interventions for in-stent restenosis. This phenomenon may contribute to recurrences. This prospective, randomized study was designed to determine if repeat stent implantation may prevent ELL in patients with in-stent restenosis., Methods: Forty patients were randomized: 20 were allocated to elective stent implantation and 20 to conventional balloon angioplasty. Quantitative coronary angiography and intravascular ultrasound (IVUS) volumetric studies were systematically performed (1) before the procedure, (2) immediately after intervention, and (3) 30 to 60 minutes later., Results: Baseline characteristics were similar in both groups. After the delay time interval (46 +/- 8 minutes), quantitative coronary angiography revealed a significant reduction in minimal lumen diameter (2.2 +/- 0.5 mm vs 1.7 +/- 0.5 mm, P < .001) in the balloon angioplasty arm. Likewise, in this group, IVUS demonstrated a reduction in mean lumen area (7.1 +/- 2 mm2 vs 6.2 +/- 2 mm2 , P < .001) and lumen volume (144 +/- 59 mm3 vs 126 +/- 54 mm3 , P < .001). In 4 of these patients, ELL was severe enough to require further intervention. In the stent arm, however, angiographic data and IVUS mean lumen area (7.7 +/- 3 mm2 vs 7.7 +/- 3 mm2) and lumen volume (161 +/- 72 mm3 vs 160 +/- 69 mm3) remained unchanged after the delay time interval. On multivariate analysis, stent implantation was an independent predictor of the absence of ELL by quantitative coronary angiography and by IVUS. In addition, patients with a larger ELL on IVUS had a lower event-free survival at 1 year (40% vs 79%, log rank P = .003)., Conclusions: This randomized study demonstrates that (1) ELL is frequently detected after treatment of in-stent restenosis with balloon angioplasty, that (2) ELL influences the long-term clinical outcome of these patients, and that (3) repeat stent implantation prevents ELL.

Objectives: We sought to assess the efficacy of vascular brachytherapy (VBT) combined with stenting for the primary prevention of restenosis., Background: Intravascular brachytherapy after stent implantation for de novo lesions has been abandoned for the present. We revisited this procedure by optimizing all procedural steps-the use of glycoprotein IIb/IIa blockers, direct stenting, adequate radiation coverage, avoidance of edge damage, source centering, intravascular ultrasound-guided dosimetry, and continuation of a dual anti-platelet regimen for one year., Methods: The Beta-Radiation Investigation with Direct stenting and Galileo in Europe (BRIDGE) study is a multicenter, randomized controlled trial evaluating the long-term efficacy of VBT with P-32 (20 Gy at 1 mm in the coronary wall) after direct stenting. The primary end point was angiographic intra-stent late loss; secondary end points were six months binary restenosis and neo-intimal hyperplasia. Patients (n = 112) with de novo lesions (2.5 to 4.0 mm in diameter up to 15 mm long) were randomized to either VBT or no-VBT., Results: At six months, intra-stent loss was 0.43 and 0.84 mm (p < 0.001) in the irradiated and control groups, respectively. Intra-stent neo-intimal volume was reduced from 36 mm3 to 10 mm3. However, in the irradiated group there were six late occlusions as well as eight restenoses outside the stented and peri-stented area at the fall-off dose edges of the irradiated area. Accordingly, the target vessel revascularization and major adverse cardiac and cerebrovascular events rates at one year in the VBT group (20.4% and 25.9%, respectively) were higher than in the control group (12.1% and 17.2%, respectively)., Conclusions: Despite the optimization of pre-, peri-, and post-procedural factors and despite the relative efficacy of the brachytherapy for the prevention of the intra-stent neo-intimal hyperplasia, the clinical outcome of the irradiated group was less favorable than that of the control group.

Encouraging results have been obtained with drug-eluting stents (DESs) to prevent restenosis following PCI. However, DESs are not immune from restenosis and we describe a case of "candy wrapper" effect, commonly observed with intracoronary brachytherapy (IBT). In this article, we review the common drawbacks of DES and IBT and their prevention., (Copyright 2004 Wiley-Liss, Inc.)

A polymorphic marker of the gene encoding the interleukin-1 (IL-1) receptor antagonist has been recently reported to be associated with risk of coronary artery disease. However, no prospective studies of the IL-1 gene cluster in relation to the occurrence of restenosis, a major complication of percutaneous transluminal coronary angioplasty (PTCA), have so far been conducted. We had the opportunity to investigate this question in a large, prospective cohort characterized by quantitative coronary angiography in all subjects. The IL1A A114S, IL1B -511C>T, IL1B 3953T>C, IL1RI exon1B T>C, and IL1RN VNTR (intron 2) polymorphisms were characterized in a cohort of 779 patients of whom 342 ("cases") had developed restenosis (as defined by >50% loss of lumen compared to immediate post-procedure results) at repeat angiography at 6 months post-PTCA. All observed genotype frequencies were in Hardy-Weinberg equilibrium. Frequencies for the rare alleles were: IL1A S, 0.29 (cases), 0.28 (controls); IL1B T, 0.31 (cases), and 0.33 (controls); IL1B C, 0.23 (cases), 0.24 (controls); IL1RI C, 0.34 (cases), 0.35 (controls); and IL1RN 2, 0.29 (cases), 0.29 (controls), respectively. There was no evidence for an association between genotype and restenosis or degree of lumen loss (adjusted for covariables). Our data indicate that the common variants in the IL-1 cluster genes are not associated with incidence of restenosis after PTCA., (Copyright 2003 Elsevier Ireland Ltd.)

Drug-eluting stents (DES) have significantly reduced the incidence of restenosis. Although the results obtained with these novel antiproliferative devices are encouraging, recent reports have shown that DES are not completely immune from restenosis. Therefore, the broad use of DES has inevitably led to a major issue: treatment of DES failure. Intracoronary brachytherapy (IBT) represents an important advancement for treatment of in-stent restenosis (ISR) and has led to important pathophysiological insight on the restenotic process. To date, IBT, when properly used, still represents the gold standard for treatment of ISR. However, experience with IBT is for treatment of ISR occurring with bare metal stents (BMS). Whether IBT may be used with the same safety and efficacy profile as an adjunctive treatment for ISR following DES implantation is still unknown. In this article, we report the outcome of a series of patients with DES failure treated with IBT. IBT for treatment of DES failure was shown to be both safe and efficient and, therefore, until ISR exists, IBT still remains an important player in this growing and even more challenging setting.

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.

Objectives To evaluate the safety and effectiveness of the Kaname™ cobalt-chromium (Co-Cr), thin strut, bare metal stent (BMS) system for the treatment of coronary artery lesions. Background Despite widespread use of drug-eluting stents, a certain percentage of patients with coronary artery disease are still treated with BMS. Therefore, it is essential to evaluate their clinical performance. Methods Two hundred eighty-two patients were enrolled in this prospective, single-arm study including a predefined subset of 79 patients with small vessels. The primary end-point was freedom from target vessel failure (TVF) at 6 months. Key angiographic and intravascular ultrasound (IVUS) end-points were late loss, diameter stenosis, binary restenosis, and neointimal hyperplasia volume. Results Freedom from TVF at 6 months was 93.3% and at 1 year 90.8% in total population, and 92.4% and 87.3% in small vessels, respectively. Clinically driven target lesion revascularization (TLR) rates at 6 and 12 months were 4.3% and 6.4% in total population, and 3.8% and 7.6% in small vessels, respectively. At 6 months in-stent late loss was 0.75 ± 0.43 mm and binary restenosis rate was 16.9% in total population, and 0.64 ± 0.40 mm and 26.1% in small vessels, while IVUS assessed neointimal hyperplasia volume at 6 months was 128.9 ± 42.6 mm 3 for total population. There were no definite and probable stent thromboses up to 12 months. Conclusions Results indicate good safety and effectiveness of the Kaname™ stent with clinically equivalent results in small and larger vessels, as such providing useful treatment option for patients with ischemic heart disease considered for BMS implantation. (J Interven Cardiol 2014;27:491-499) [ABSTRACT FROM AUTHOR]

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AIMS: This study examined the six-month angiographic results of direct coronary stenting, and compared the nine-month safety, efficacy and cost of this strategy versus stenting after balloon predilatation. METHODS: In phase I of VELVET, 122 patients (mean age = 62.3 ± 10.1 years, 77% male, 11% with diabetes) with angina pectoris or myocardial ischemia resulting from a single de novo 51% to 95% coronary stenosis underwent direct stenting. The endpoints of phase I included angiographic findings and rates of major adverse cardiac events up to six months of follow-up. In phase II, 401 patients (mean age = 61.3 ± 10.8 years, 79% male, 16% with diabetes) with angina pectoris or documented myocar-dial ischemia resulting from single or multiple, de novo or restenotic, coronary lesions were randomized between direct stenting and stenting after predilatation. The immediate angiographic results, and clinical outcomes and costs associated with the two treatment strategies up to nine months of follow-up were compared. RESULTS: In phase I the mean diameter stenosis immediately before and after the procedure, and at six months was 61.7±9.4%, 13.5±6.3%, and 33.6±16.2%, respectively. The six-month binary restenosis rate was 11%. The overall rate of major adverse cardiac events, including two non-cardiac deaths, was 9.8%. In phase II, the success rates of the intended delivery strategies were 87.9% and 97.9% for direct stenting and predi-latation, respectively (p < 0.001), while the procedural success rates were similar (93.9% vs 96.5%). Over a follow-up period of nine months, major adverse cardiac events rates were 12.0% and 10.9% in patients randomized to direct stenting and predilatation, respectively (non-significant). Analyses of the costs incurred up to nine months in each treatment group revealed a mean saving of &uro;362 per patient in favor of the direct stenting strategy (non-significant). CONCLUSIONS: Compared with a strategy of... [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to compare the efficacy and safety of drug-eluting stent (DES) and bare-metal stent (BMS) use in chronic total occlusion (CTO) recanalization. Background: The long-term effectiveness and safety of DES use in CTO recanalization are unclear, and performance of randomized clinical trials in the field is complex. Methods: Major electronic information sources were explored for articles comparing outcomes with DES and BMS use among patients with CTO. Assessed clinical outcomes were death, myocardial infarction, target vessel revascularization, major adverse cardiac events, and stent thrombosis; angiographic outcomes were stent restenosis and stent reocclusion. Results: Fourteen comparative studies were identified (a total of 4,394 patients). When compared with BMS, DES significantly reduced risk of major adverse cardiac events (relative risk [RR]: 0.45, 95% confidence interval [CI]: 0.34 to 0.60, p < 0.001) and TVR (RR: 0.40, 95% CI: 0.28 to 0.58, p < 0.001) without increasing death (RR: 0.87, 95% CI: 0.66 to 1.16, p = 0.88) or myocardial infarction (RR: 0.89, 95% CI: 0.54 to 1.46, p = 0.80). This benefit was sustained at ≥3 years of follow-up. Lower RRs for restenosis (RR: 0.25, 95% CI: 0.16 to 0.41, p < 0.001) and stent reocclusion (RR: 0.30, 95% CI: 0.18 to 0.49, p < 0.001) were also observed in the DES group. A strong trend toward a higher rate of stent thrombosis was documented in DES-treated patients (RR: 2.79, 95% CI: 0.98 to 7.97, p = 0.06). Conclusions: DES use in CTO recanalization is associated with significantly fewer major adverse cardiac events and fewer occurrences of target vessel revascularization, restenosis, and stent reocclusion than with BMS. Although a statistical trend toward a higher risk of stent thrombosis was observed, the use of DES in this context seems to be safe, with an overall benefit sustained in the long term. [Copyright &y& Elsevier]