Decreased risk of stent fracture‐related restenosis between paclitaxel‐eluting stents and sirolimus eluting stents: Results of long‐term follow‐up

Objective: To compare the outcomes between paclitaxel‐eluting stents (PES) and sirolimus‐eluting stents (SES) for the treatment of drug‐eluting stent (DES) fracture. Background: DES fracture is considered as an important predictor of in‐stent restenosis (ISR). However, little data are available evaluating the optimal treatment for this complication of coronary stenting. Methods: From January 1, 2004 to December 31, 2008, patients with DES ISR treated with a second DES were identified and evaluated for stent fracture. Stent fracture was defined by the presence of strut separation in multiple angiographic projections, assessed by two independent reviewers. Target lesion revascularization (TLR) at 6 and 12 months were the primary end points. Results: Of 131 lesions with DES ISR treated with a second DES, we found 24 patients (24 lesions, 18.2%) with angiographically confirmed stent fracture. Of these, 20 patients (20 lesions) treated with either PES (n = 11/55%) or SES (n = 9/45%) were included in the study. TLR at 6 months occurred in 9% of patients treated with PES and 22% of those treated with SES (P = 0.41). After 12 months, TLR was 9% and 55.5%, respectively (P = 0.024). Conclusions: This study demonstrates a high incidence of stent fracture in patients presenting with DES ISR in need of further treatment with another DES. The suggested association between treatment of stent fracture‐associated DES ISR with PES as compared with SES, and better long‐term outcomes, is in need of confirmation by larger prospective registries and randomized trials. © 2011 Wiley Periodicals, Inc.     

Comparison of sirolimus‐eluting stent,paclitaxel‐eluting stent,and bare metal stent in the treatment of long coronary lesions

Objective: This study compared the efficacy of the sirolimus‐eluting stent (SES), the paclitaxel‐eluting stent (PES), and the bare metal stent (BMS) for long coronary lesions. Background: The outcome of drug‐eluting stent (DES) implantation in long coronary lesions remains unclear. Methods: The study involved 527 patients with de novo long coronary lesions (≥24 mm), which were treated with long (≥28 mm) SESs (223 lesions), PESs (194 lesions), or BMSs (201 lesions). Results: Lesions in the SES (36.0 ± 14.9 mm, P < 0.001) and PES (36.3 ± 14.5 mm, P < 0.001) groups were longer than those in the BMS group (32.0 ± 12.3 mm), meaning the two DES groups had longer stented segments than did the BMS group. Six‐month angiographic follow‐up showed the SES (9.3%, P < 0.001) and PES (21.3%, P < 0.001) groups had lower in‐segment restenosis rates than that of the BMS group (42.5%). The rate of major adverse cardiac events (MACE) including death, myocardial infarction, and target lesion revascularization at 9 months was higher in the BMS group (26.6%) than that in the SES (13.0%, P < 0.001) and PES (15.7%, P < 0.001) groups. Posthoc analysis of the two DES groups showed that the in‐segment restenosis rate was lower for the SES than that for the PES group (P = 0.002), while the MACE rate was similar. Conclusions: The use of DESs for long coronary lesions appears to be safe and more effective than the use of BMSs in terms of restenosis and adverse clinical events. SES use was associated with lower late luminal loss and a lower angiographic restenosis rate compared with PES use. © 2006 Wiley‐Liss, Inc.     

Impact of a prolonged delivery inflation time for optimal drug‐eluting stent expansion

Purpose: We examined the importance of prolonged inflation time for optimal sirolimus‐eluting stent (SES) or paclitaxel‐eluting stent (PES) expansion. Methods: Eighty‐one de novo lesions deployed single SES or PES between April 2007 and March 2008 were divided into four groups; group 1: 21 SES deployed at 20 atm × 60 sec, group 2: 20 SES deployed with 2‐step inflation at 20 atm × 60 sec following 20 atm × 20 sec, group 3: 20 PES deployed same as group 1, group 4: 20 PES deployed same as group 2. The minimal lumen diameter (MLD) and stent expansion ratio (SER; stent cross‐ sectional area at lesion/balloon cross‐sectional area which was calculated according to the compliance chart at the same atmosphere as stent deployment) were compared between group 1 and group 2 in SES, between group 3 and group 4 in PES. Results: The MLD of post 60 sec was significantly higher than that of post 20sec (2.84 ± 0.28 mm in group 1, 2.76 ± 0.33 mm in group 2 vs. 2.54 ± 0.33 mm in group 2; P = 0.003, 0.045, respectively and 2.94 ± 0.28 mm in group 3, 3.00 ± 0.34 mm in group 4 vs. 2.69 ± 0.35 mm in group 4; P = 0.022, 0.007, respectively). The SER of post 60 sec was significantly higher than that of post 20 sec (79.3% ± 8.5% in group 1, 80.8% ± 7.8% in group 2 vs. 71.1% ± 10.2% in group 2; P = 0.014, 0.011, respectively and 81.1% ± 7.9% in group 3, 84.3% ± 9.9% in group 4 vs. 72.6% ± 10.5% in group 4, P = 0.011, 0.001, respectively). Conclusion: The prolonged delivery inflation for 60 sec may result in a more optimal stent expansion. It is therefore considered to be a useful method for deploying drug‐eluting stent. © 2008 Wiley‐Liss, Inc.     

One‐Year Results of the CRISTAL Trial,a Randomized Comparison of Cypher Sirolimus‐Eluting Coronary Stents versus Balloon Angioplasty for Restenosis of Drug‐Eluting Stents

Objectives: We compared the efficacy of the Cypher Select? (Cordis Corporation, Bridgewater, NJ, USA) sirolimus‐eluting stent (SES) versus balloon angioplasty (BA) in in‐stent restenosis (ISR) of Taxus? or Taxus Liberté? paclitaxel‐eluting stents (PES; Boston Scientific, Natick, MA, USA) or Cypher/Cypher Select SES. Background: Optimal treatment strategies have not been identified for drug‐eluting stent (DES) ISR. Methods: Patients with a native coronary artery SES or PES ISR were randomized to SES or BA. In addition, a control group included BMS ISR treated with SES. Angiographic control was performed at 12 months. Results: 281 patients were enrolled. Significant differences favoring SES over BA were noted in immediate and net gain (1.39 ± 0.51 vs. 0.97 ± 0.54 mm, P < 0.0001 and 1.07 ± 0.69 vs. 0.49 ± 0.67 mm, P < 0.0001), 12‐month mean luminal diameter (MLD; 2.14 ± 0.62 vs. 1.71 ± 0.55 mm, P < 0.0001) and percent diameter stenosis (%DS; 21 ± 19.24 vs. 29.82 ± 18.47, P = 0.001). There was no significant difference at 12 months between SES and BA in the primary end‐point late lumen loss (LLL; 0.37 ± 0.57 vs.0.41 ± 0.63, P = 0.73) and in in‐stent binary restenosis (11.1% vs. 14%, P = 0.59). Target‐lesion revascularization (TLR) was numerically lower in patients treated with SES (5.9% vs. 13.1%, P = 0.097). There was no difference according to the initial DES. In contrast, significantly higher immediate and net gains and MLD were noted in the BMS control group treated by SES. Conclusions: In this angiographic randomized trial comparing SES and BA in SES or PES restenosis, 12 month MLD, immediate and net gain, and %DS favored SES whereas no difference was noted in LLL. Condensed Abstract Optimal treatment strategies have not been identified for sirolimus‐ (SES) or paclitaxel‐eluting stent (PES) in‐stent restenosis (ISR). We randomized patients with a native coronary artery SES or PES ISR to SES or BA. In addition, a control group included BMS ISR treated with SES. There was no difference in the primary end‐point, late lumen loss (LLL) at 12 months between the SES and BA groups. However, follow‐up MLD and immediate and net gain favored SES. (J Interven Cardiol 2012;25:586–595)     

The incidence and predictors of postprocedural incomplete stent apposition after angiographically successful drug‐eluting stent implantation

Objectives: The aim of this study was to evaluate the incidence and predictors of postprocedural incomplete stent apposition (ISA) after angiographically successful drug‐eluting stent (DES) implantation. Background: The deployed stents are usually evaluated by angiography alone; however, there are possibilities of postprocedural ISA despite the angiographically successful implantation. Methods: A total of 339 lesions in which poststent intravascular ultrasound (IVUS) was performed after successful DES implantation was included. Paclitaxel‐eluting stents were implanted in 237 lesions and sirolimus‐eluting stents (SES) in 102 lesions. Clinical, angiographic and procedural characteristics and IVUS findings for all cases were analyzed. Results: The overall incidence of ISA was 13.9% (47/339). By multivariate analysis, male gender (OR: 2.36, 95% CI: 1.09–5.11), deployment of SES (OR: 2.90, 95% CI: 1.49–5.67), the presence of intracoronary thrombus (OR: 7.47, 95% CI: 1.67–33.47), and non‐ST elevation myocardial infarction (OR: 2.73, 95% CI: 1.09–6.83) were independent predictors for postprocedural ISA after angiographically successful DES implantation. Conclusions: The incidence of postprocedural ISA after angiographically successful implantation of DES was not infrequent. A DES deployment strategy incorporating IVUS guidance might be helpful to reduce the incidence of postprocedural ISA. © 2009 Wiley‐Liss, Inc.     

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.     

Difference of neointimal growth patterns in bifurcation lesions among four kinds of drug‐eluting stents

Aim: Neointimal proliferation of bifurcation lesions after implantation of drug‐eluting stents (DES) has not been well evaluated. Thus, we compared neointimal proliferation of bifurcation lesions among four DES using optical coherence tomography (OCT). Methods: 8‐month follow‐up OCT was performed in 68 bifurcation lesions treated by 15 sirolimus‐eluting stents (SES) and 17 paclitaxel‐eluting stents (PES) as first‐generation DES, and by 17 zotarolimus‐eluting stents (ZES) and 19 everolimus‐eluting stents (EES) as second‐generation DES. Cross‐sectional images of the bifurcation lesion using OCT were analyzed every 450 µm. All images were divided into three areas: inner wall of the bifurcation (IB), outer wall of the bifurcation (OB), and ostium of the side branch (SB). We compared the incidence of uncovered struts (IUS) among three areas and the averaged neointimal thickness (NIH) between IB and OB in each stent and also compared these OCT parameters among all DES. Results: There were no significant differences of IUS between IB and OB in second‐generation DES, while in first‐generation DES, IUS of IB and OB showed significant differences. The IUS of SES in both areas was significantly higher than in the other DES (all P < 0.001). PES had a significantly higher IUS in SB than the others (all P < 0.001). NIH of OB was significantly higher than that of IB in PES, ZES, and EES, but in SES the NIH was similar in the two areas. Conclusions: OCT revealed different neointimal growth patterns among SES, PES, ZES, and EES in bifurcation lesions. © 2014 Wiley Periodicals, Inc.     

Drug‐eluting stents versus bare‐metal stents for treatment of bare‐metal in‐stent restenosis

Objectives : We compared the long‐term outcomes of drug‐eluting stents (DES) versus bare‐metal stents (BMS) for treatment of bare‐metal in‐stent restenosis (ISR). Background : There are no randomized trials or observational studies directly comparing the safety and efficacy of DES versus BMS for treatment of bare‐metal ISR. Methods : We examined data on all patients who underwent percutaneous coronary intervention (PCI) for ISR at Cleveland Clinic between 05/1999 and 06/2007. We compared the efficacy and safety of DES to BMS for treating bare‐metal ISR. The primary end point was a composite of death, myocardial infarction (MI), or target lesion revascularization (TLR). The secondary endpoints were individual components of the primary endpoint. Results : Of the 931 patients identified over 8 years, 706 had bare‐metal ISR and met our study criteria. Of the 706 patients with bare‐metal ISR, 362 were treated with DES and 344 with BMS. There were 230 cumulative events for a median follow‐up of 3.2 years. After adjusting for 27 variables, DES were associated with lower primary endpoint compared to BMS for treatment of bare‐metal ISR (21% vs. 45%, adjusted hazard ratio [HR] 0.63; 95% confidence interval [CI], 0.42–0.95; P = 0.03). The individual secondary endpoint of death (8% vs. 24%, P = 0.005) favored DES, but MI (3% vs. 8%, P = 0.31), and TLR (13% vs. 20%, P = 0.23) failed to reach statistical significance. Conclusions : In our multivariate analysis of patients with bare‐metal ISR, DES use was associated with significantly lower death, MI, or TLR when compared to BMS. © 2010 Wiley‐Liss, Inc.     

Five‐year clinical outcomes of sirolimus‐eluting versus paclitaxel‐eluting stents in high‐risk patients

Objectives and Background : First generation drug‐eluting stents have shown differential efficacy in high‐risk patient subsets at one year. It is unclear whether these differences endure over the medium‐ to long‐term. We compared the five‐year clinical efficacy and safety of sirolimus‐eluting stents (SES) and paclitaxel‐eluting stents (PES) in a population of high‐risk patients. Methods : The patient cohorts of the ISAR‐DESIRE, ISAR‐DIABETES, and ISAR‐SMART‐3 randomized trials were followed up for five years and data were pooled. The primary efficacy endpoint of the analysis was the need for target lesion revascularization (TLR) during a five‐year follow‐up period. The primary safety endpoint was the combination of death or myocardial infarction (MI) after five years. Results : A total of 810 patients (405 patients in the SES group and 405 patients in the PES group) was included. Over five years TLR was reduced by 39% with SES compared with PES stent (hazard ratio [HR] 0.61; 95% confidence interval [CI] 0.44–0.85; P = 0.004). No difference was observed according to death or MI rates between the two groups (HR 1.10; 95% CI 0.80–1.50; P = 0.57). Definite stent thrombosis occurred in 0.2% (n = 1) in the SES group and in 1.6% (n = 6) in the PES group (HR 0.16; 95% CI 0.02–1.34; P = 0.12). Conclusions : In high‐risk patient subsets the lower rate of 12‐month TLR observed with SES in comparison PES is maintained out to five years. In terms of safety, although there was no difference in the overall incidence of death or MI, there was a trend towards more frequent stent thromboses with PES. © 2011 Wiley‐Liss, Inc.     

Comparison between sirolimus‐ and paclitaxel‐eluting stents in complex patient and lesions subsets

Background : Sirolimus‐eluting stents (SES) and paclitaxel‐eluting stents (PES) both significantly reduce the need for repeat intervention compared to bare metal stents. Studies comparing the clinical outcomes of these stents in noncomplex subsets of patients and lesions demonstrate a similar safety and efficacy profile. The data for more complex subsets of patients and lesions remains conflicting. This study aimed to compare SES with PES in a selected population with a broad range of complex features. Methods and Results : The patient population consisted of 1,591 consecutive patients with complex features undergoing drug‐eluting stent (DES) implantation. In the SES group there were 1,095 patients (1,653 lesions) and in the PES group 496 patients (802 lesions). In‐hospital, 30‐day, and 12‐month clinical outcomes were compared between groups. No discernable difference in major adverse cardiac events (MACE) between SES and PES was detected at intermediate and longer‐term follow‐up (SES 22.4% vs. PES 20.5% at 12 months; P = 0.407). A trend toward increased angiographically documented stent thrombosis was observed in the SES group at both 3 and 12 months (SES 2.2% vs. PES 0.8% at 12 months; P = 0.051). When adopting the more inclusive definition of probable stent thrombosis, this trend was no longer seen. After adjusting for baseline differences between the two groups, there still remained no difference in MACE between SES and PES (HR 1.051 [CI 0.826–1.339] P = 0.685). The trend toward increased angiographically documented stent thrombosis in the SES group remained after adjustment for baseline differences (HR 2.836 [CI 0.968–8.311] P = 0.057). Conclusions : In a selected population with complex disease the rate of MACE was comparable between SES and PES, with higher overall rates of thrombosis and MACE compared to a noncomplex population. Thus, the focus should be directed to prevent late complications in this complex subset regardless of stent type selection. © 2007 Wiley‐Liss, Inc.     

Comparison of 2‐year clinical outcomes between zotarolimus‐, sirolimus‐, and paclitaxel‐eluting stents in real life clinical practice

Background : There are few studies comparing the long‐term efficacy and safety of the zotarolimus‐eluting stent (ZES) with sirolimus‐ (SES) and paclitaxel‐eluting stents (PES) in the unselected cohorts that were subject to real life clinical practice. Methods : Total 2,769 patient who underwent successful percutaneous coronary intervention (PCI) with the three drug‐eluting stents (DES) between April 2006 and July 2008 were analyzed retrospectively. A total of 1,152 patients were treated with SES, 810 with PES, and 807 with ZES. The primary analysis endpoint was cumulative rate of target‐lesion failure (TLF) at 24 months, defined as the composite of cardiac death, target‐vessel‐related myocardial infarction (MI), and target‐lesion revascularization (TLR). Results : At 24 months, the incidence of TLF was significantly lower in the SES group compared with the ZES (7.6% vs. 11.3%, HR = 0.66, CI = 0.49–0.88, P = 0.005) or the PES group (7.6% vs. 10.2%, HR = 0.74, CI = 0.55–0.99, P = 0.048), while similar between the PES and the ZES groups (HR = 0.89, CI = 0.66–1.20, P = 0.443). The difference was mostly driven by higher rate of TLR in the ZES and PES groups compared with the SES group, mostly within the first year post‐PCI. However, the rate of hard endpoints (cardiac death or nonfatal MI) was similar among the three groups. These results were reproduced in the propensity score‐matched cohort.Conclusions : This observational study shows that the use of SES is superior to PES or ZES for the TLF in the overall and matched analysis. © 2011 Wiley Periodicals, Inc.     

Comparison of 2‐year clinical outcomes with sirolimus and paclitaxel‐eluting stents for patients with diabetes: Results of the Registro Regionale AngiopLastiche Emilia‐Romagna Registry

Background: Long‐term outcomes of percutaneous coronary interventions (PCI) with sirolimus‐eluting stents (SES) compared to paclitaxel‐eluting‐stents (PES) in unselected diabetics in routine practice is still debated. Objective: This study compared the 2‐year incidence of MACE (all‐cause mortality, nonfatal myocardial infarction and target vessel revascularization) of SES and PES in a real‐world setting of patients with diabetes. Design: Observational, multicenter, nonrandomized study. Setting: Prospective web‐based registry (REAL Registry; study period, 2002–2005) comprising all 13 hospitals performing PCI. Patients: Among the 945 eligible patients treated with either SES alone (n = 606) or PES alone (n = 339), 29% were insulin‐requiring, 72% had multivessel coronary disease, 26% had prior myocardial infarction and 10% had poor left ventricular function. Measurements: Unadjusted and propensity score‐adjusted 2‐year clinical outcome. Results: After propensity score adjustment, 2‐year MACE incidence in the SES and PES groups was equivalent (23.3% vs. 23.7%, HR 1.01, 95%CI 0.72–1.42, P = 0.96). Adjusted 2‐year angiographic stent thrombosis occurred in 1.1% of the SES patients versus 2.6% of the PES patients (P = 0.15). In this large, real‐world, diabetic population treated with DES, there was no difference in outcome between SES and PES. Further studies are needed to demonstrate the long‐term safety of different types of DES in patients with diabetes. © 2009 Wiley‐Liss, Inc.     

Effect of intravascular ultrasound-guided adjuvant high-pressure non-compliant balloon post-dilation after drug-eluting stent implantation

Drug-eluting stent (DES) expansion characteristics after aggressive high-pressure post-dilation using a non-compliant (NC) balloon have not been fully investigated. We evaluated 58 patients with native coronary lesions treated with DESs [24 paclitaxel eluting stents (PES) and 34 sirolimus-eluting stents (SES)]. After post-dilation (12–14 atm) using a stent-mounted semi-compliant balloon to reduce stent edge injury, adjuvant high-pressure post-dilation using NC balloon was performed within the stents. Stent size, stent length, and NC balloon size were selected based on preinterventional intravascular ultrasound (IVUS) assessment. Stent underexpansion was defined according to criteria of the Multicenter Ultrasound Stenting in Coronaries (MUSIC) study as a minimal stent cross-sectional area <90% of the average reference lumen area. Resultant endpoint was to obtain optimal stent expansion. Serial changes of stent expansion and stent symmetry were calculated in each group. After stent-mounted semi-compliant balloon post-dilation, both stents could not achieve adequate percent stent expansion (PES 73 ± 18% vs. SES 67 ± 9%, p = 0.38). After high-pressure post-dilation using an NC balloon, percent stent expansion was 97 ± 14% in PES and 91 ± 13% in SES, respectively (p = 0.25). Axial stent symmetry indices also significantly improved in both groups. Although radial stent symmetry indices improved significantly in PES group, those in the SES group had no significant changes. Finally, frequency of stent underexpansion significantly reduced, 87–20% in PES and 92–15% in SES, respectively (p = 0.01) without any significant stent edge injury. DES expansion improved safely after adjuvant high-pressure post-dilation using an NC balloon under IVUS guidance.     

Comparison of three‐year clinical outcomes between sirolimus‐versus paclitaxel‐eluting stents in diabetic patients: Prospective randomized multicenter trial

Background : Three‐year follow‐up of major adverse cardiovascular event (MACE) (death, nonfatal myocardial infarction, target lesion revascularization) and the predictors of MACEs in diabetic patients after sirolimus‐eluting stent (SES) or paclitaxel‐eluting stent (PES) implantation have not been reported. Methods : Diabetic patients with de novo coronary lesions (169 patients with 190 lesions) were randomly assigned prospectively to either SES or PES. Results : Baseline characteristics were similar between the two groups. The rates of MACEs [5.9% (n = 5) in the SES vs. 9.5% (n = 8) in the PES Group, P = 0.374] and definite stent thrombosis [1.2% (n = 1) in the SES vs. 3.6% (n = 3) in the PES Group, P = 0.368] were similar in the two groups during the three‐year follow‐up. Multivariate logistic analysis showed that insulin treatment was the only independent predictor of MACE [odds ratio (OR) 8.60, 95% confidence interval (CI) 3.25–22.76, P < 0.001] and target vessel revascularization (TVR) (OR 9.50, 95% CI 3.07–29.44, P < 0.001) during the three‐year follow‐up. Conclusions : The rates of MACEs, TVR, and stent thrombosis during the three‐year follow‐up were similar in the SES and PES Groups. Insulin treatment was a main predictor of MACEs and TVR during the three‐year follow‐up after either SES or PES implantation. © 2009 Wiley‐Liss, Inc.     

Real World,Long‐Term Outcomes Comparison Between Paclitaxel‐Eluting and Sirolimus‐Eluting Stent Platforms

We compare real‐world, extended target vessel revascularization (TVR)‐free survival following percutaneous coronary intervention (PCI) for patients receiving either sirolimus‐eluting stents (SES) or paclitaxel‐eluting stents (PES) following an index drug‐eluting stent (DES) supported procedure. We analyzed 2,363 consecutive patients having first DES‐supported PCI at receiving PES (n = 1,012) or SES (n = 1,332) from April 2004 to July 2006. Baseline clinical and procedural characteristics and in‐hospital outcomes were recorded during the time of the index procedure and extended clinical outcomes data were obtained thereafter. TVR and all cause mortality were identified during the study period. Adjusted Kaplan‐Meier and Cox's proportional hazard survival methods were performed. TVR‐free survival at 2.3 years was 91.3% for SES compared with 88.9% for PES (P = 0.06). Kaplan‐Meier survival curves did not significantly differ (adjusted hazard ratio ?1.39 [95% CI 0.99–1.97]) between the SES and PES patient cohorts. TVR was similar between the stent platforms at one (96.6% for SES [95% CI 95.3–97.6] vs. 95.7% for PES [95% CI 94.1–96.9]) and two (95.0%[95% CI 93.0–96.4] for SES vs. 93.7% for PES [95% CI 91.6–95.3]) years. Overall survival at 2 years was 96.2% for SES (95% CI 94.7–97.3) and 95.3% for PES (95% CI 93.7–96.5). SES and PES drug‐eluting stent platforms have good and similar extended outcomes in this real world registry of unselected patients having PCI. (J Interven Cardiol 2010;23:167‐175)     

Kissing drug eluting balloons for in‐stent restenosis complicating bifurcations treated with drug‐eluting stents

The management of in‐stent restenosis (ISR) complicating bifurcation lesions is technically challenging and implant of further stents may not be feasible. The use of drug‐eluting balloons provides an attractive option for treatment of such lesions allowing a technically simple procedure without the need for further complex stenting. The SeQuent Please paclitaxel‐eluting balloon (B. Braun, Berlin, Germany) has been shown to be superior to a paclitaxel eluting stent or balloon angioplasty for ISR complicating a bare‐metal stent. However, there is no data on the efficacy of the SeQuent Please in ISR complicating drug‐eluting stents or bifurcation lesions. We report two cases where the SeQuent Please was used in this setting with angiographic success and freedom from target vessel failure and angina at 24 months. In both cases the Sheathless Eau Cath guide (Asahi Intecc, Japan) was employed to perform a kissing‐balloon dilatation with the SeQuent Please, so allowing treatment via radial access. © 2012 Wiley Periodicals, Inc.     

Bioresorbable vascular scaffold to treat in‐stent restenosis: Single‐center experience

Aims

The management of patients with in‐stent restenosis (ISR) is still a major clinical challenge even in the era of drug‐eluting stents (DES). Recent studies have demonstrated acceptable clinical outcomes for the everolimus‐eluting bioresorbable vascular scaffold (BVS) ABSORB? in patients with stable coronary artery disease but data are scarce on its use in patients with ISR. We report the long‐term results of our preliminary experience with this novel approach at our institution.

Methods and Results

We investigated the safety and efficacy of BVS implantation to treat ISR. 34 consecutive patients (37 lesions) underwent PCI for ISR with BVS implantation between May 2013 and June 2015 at our institution and were included in the current analysis. Follow‐up was available in 91.9% of the patients. Mean follow‐up period was 801.9 ± 179 days. One patient had definite scaffold thrombosis (ScT) 2 months after stent implantation which was treated with DES. Five patients (six lesions) experienced target lesion revascularization (TLR). The composite endpoint rate of TLR, ScT, myocardial infarction, and death occured in 6/37 lesions at follow‐up (16.2%).

Conclusions

These real‐world data using BVS in patients with ISR demonstrates that ISR treatment with ABSORB? BVS is feasible but could have slightly higher target lesion failure rates as compared to DES. This proof of concept could be hypothesis‐generating for larger randomized controlled studies.

     

Clinical outcomes of drug‐eluting versus bare‐metal in‐stent restenosis

In‐stent restenosis (ISR) is a challenging syndrome that affects drug‐eluting stents and bare‐metal stents. However, data comparing the outcomes of drug‐eluting versus bare‐metal ISR are limited. Our objective was to evaluate the long‐term clinical outcomes of drug‐eluting versus bare‐metal ISR. Patients who underwent percutaneous coronary intervention at Cleveland Clinic for ISR from 05/1999 to 06/2007 were included. Unadjusted outcomes were tested using Kaplan‐Meier curves followed by multivariable adjusted Cox proportional hazards analyses. Twenty seven variables, including type of stent used to treat ISR and procedural date, were included. The primary end point was a composite of death, myocardial infarction (MI), or target lesion revascularization (TLR). The secondary endpoints were components of the primary endpoint. Of 931 patients identified, 225 had drug‐eluting ISR and 706 had bare‐metal ISR. There were 279 cumulative events for a median follow‐up of 3.2 years. The primary endpoint was not different between drug eluting and bare‐metal ISR (22% versus 33%, adjusted hazard ratio [HR] 1.14; 95% confidence interval [CI], 0.79–1.66; P = 0.49). The secondary endpoints of death (8% versus 16%, adjusted HR 1.05; 95% CI, 0.56–1.98; P = 0.88), MI (4% versus 5%, adjusted HR 1.48; 95% CI, 0.54–4.04; P = 0.45), and TLR (15% versus 16%, adjusted HR 1.30; 95% CI, 0.81–2.11; P = 0.28) were also not different. This study represents the largest analysis comparing drug‐eluting to bare‐metal ISR. On multivariable Cox proportional hazard analyses, drug‐eluting and bare‐metal ISR have similar long term outcomes. © 2009 Wiley‐Liss, Inc.     

Comparison of paclitaxel-eluting stent and sirolimus-eluting stent expansion at incremental delivery pressures

OBJECTIVES: We sought to compare the adequacy of paclitaxel-eluting stent (PES) and sirolimus-eluting stent (SES) expansion based on intravascular ultrasound (IVUS) imaging criteria at conventional delivery pressures. METHODS: Forty-six patients underwent SES implantation and 42 patients underwent PES implantation for de novo native coronary lesions<33 mm in length with reference lumen diameters of 2.5-3.5 mm. Stents were serially expanded with gradual balloon inflations at 14 and 20 atm. IVUS imaging was performed prior to intervention and after each balloon inflation. Stent expansion (minimal stent cross-sectional area/reference lumen cross-sectional area) was measured. Inadequate stent expansion was defined using the MUSIC criteria (all struts apposed, no tissue protrusion, and final lumen cross-sectional area>80% of the reference or >90% if minimal lumen cross-sectional area was <9 mm2). RESULTS: The baseline characteristics of the two groups were similar except for shorter lesion length, larger mean lumen cross-sectional area, larger lumen diameter, and lower plaque burden in the PES group. Stent expansion was inadequate in 80% of patients with SES versus 63% of patients with PES at 14 atm, although this was not statistically significant. After 20 atm, 48% of patients with SES remained underexpanded as compared with 35% of patients with PES. CONCLUSION: Drug-eluting stents showed significant underexpansion by MUSIC criteria at conventionally used inflation pressures. Higher balloon inflations are required especially during deployment of a SES. IVUS guidance is recommended to ensure optimal results and outcomes with both stents.