Search

Background: Treatment of patients with in-stent restenosis (ISR) remains challenging. In this setting the use of drug-coated balloons (DCB) represents an attractive approach to avoid adding another metal layer to the coronary wall., Aims: The Chansu Vascular Technologies (CVT)-ISR trial aimed to evaluate the safety and efficacy of a novel everolimus-DCB (CVT-DCB) using a new coating formulation and crystalline everolimus., Methods: The CVT-ISR trial was a prospective, multicenter, open, single-arm, first-in-man (FIM) study. A total of 51 patients (mean age 69.2 years, 74.5% male) with single ISR coronary lesions (≤24 mm in length) were enrolled at nine sites in Europe., Results: The primary safety endpoint, freedom from target lesion failure (TLF) at 180 days, was 92.2%, with the lower bound of the 95% confidence interval (81.1%), above the protocol-defined objective performance criterion (OPC) (65% for conventional balloon angioplasty, P  < 0.05). At 1 year freedom from TLF was 90.2%. The primary efficacy endpoint, in-stent late lumen loss at 180 days (evaluated in a predefined subgroup of 25 patients scheduled for late angiography), was 0.40 mm (median 0.30 mm), lower than the protocol-defined OPC of the plain balloon angioplasty historical control (0.80 mm, P  < 0.001)., Conclusion: This FIM study demonstrated the superior efficacy of the new everolimus CVT-DCB compared with conventional balloon angioplasty in the treatment of patients with ISR., Clinical Trials Registration: NCT05731700., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: Ultrathin bioresorbable polymer sirolimus-eluting stents (BP SES) have been proposed as an alternative to thin durable polymer drug-eluting stents (DP DES). Although BP SES show a significant decrease in target lesion failure rates, clear superiority with respect to efficacy and safety of BP SES in comparison to DP EES has not been consistently proven., Methods and Results: A comprehensive search of several electronic databases identified studies that assessed efficacy and safety of BP SES, compared with DP EES. Relative risks (RRs) were pooled across studies using a fixed-effects model and a random-effect model, respectively, calculating pooled RRs and associated 95% confidence intervals (CIs). The I statistic was used to assess heterogeneity. We retrieved six studies enrolling >7000 patients. BP SES significantly reduced the risk of target vessel myocardial infarction (RR, 0.79; 95% CI, 0.64-0.97; I = 0%; Test for overall effect: z = 2.24, P = 0.03) in comparison with DP EES using a random-effects model. Use of BP SES was associated with a significant reduction in any myocardial infarction (RR, 0.83; 95% CI, 0.70-0.98; I = 12%; Test for overall effect: z = 2.19, P = 0.03), using a fixed-effects model. The subgroup analyses demonstrated, following-up ≥2 years, a statistically significant 27% RR increase in the risk of all-case death for patients randomized to BP SES (RR, 1.27; 95% CI, 1.01-1.60; I = 0%; Test for overall effect: z = 2.08, P = 0.04). No differences in cardiac death, stent thrombosis events (STE), target lesion revascularization (TLR) and target vessel revascularization (TVR) between BP SES and DP EES were observed., Conclusion: BP SES significantly reduced the risk of any myocardial infarction and target vessel myocardial infarction in comparison with DP EES. There were no differences in cardiac death, STE, TLR, TVR and all-cause death with its follow-up time <2 year between BP SES and DP EES. Following-up ≥2 years, a statistically significant 27% RR increase in the risk of all-case death for patients randomized to BP SES was observed.

Objective: Approximately, 10-20% of patients with drug eluting stent (DES) in-stent restenosis (ISR) will develop recurrent ISR; yet, the optimal management of recurrent DES-ISR is unknown. We sought to compare the outcomes of recurrent DES-ISR treated with drug eluting balloons (DEB) to those with repeated implantation of new-generation DES., Methods: A total of 172 patients with recurrent DES-ISR were enrolled and stratified into two cohorts: the repeated DES implantation (Re-DES) group and the DEB group. The primary endpoint was the 1-year incidence of major adverse cardiovascular events (MACE)., Results: Ninety-three patients treated with DEB and 79 patients with Re-DES implantation were analyzed. Both groups had comparable baseline characteristics. Lesser residual stenosis was achieved in the Re-DES group (11.3 ± 3.2% vs. 22.4 ± 4.3%; P = 0.00) than in the DEB group. However, the incidence of MACE and target lesion revascularization (TLR) were less in the DEB group (17.2% vs. 32.9%; P = 0.02 and 15.1% vs. 27.8%; P = 0.04, respectively). For the ≥3 metal-layered DES-ISR subgroup, DEB drastically reduced the incidences of MACE and TLR compared with Re-DES (20.0% vs. 57.9%; P = 0.02 and 16.0% vs. 47.4%; P = 0.04, respectively). Survival analysis demonstrated that MACE-free survival was significantly higher in the DEB group compared with the Re-DES group, whether the metal layers were ≥3 or 2. Multivariate analysis revealed that the risk factors of MACE were diabetes mellitus, ≥3 metal-layered DES ISR, and repeat DES deployment., Conclusions: For recurrent DES-ISR, DEB may improve clinical outcomes compared with Re-DES implantation, especially for ≥3 metal-layered DES-ISR.

Background: Everolimus-eluting stent (EES) is effective for treating in-stent restenosis (ISR). However, the long-term incidence of target lesion revascularization (TLR) is unknown. Further, the role of post-intervention minimal stent area (MSA) measured by intravascular ultrasound (IVUS) in TLR is unknown in this setting., Patients and Methods: Overall, 223 ISR lesions (192 patients) that were treated with EES between 2010 and 2016 were analyzed retrospectively. Lesions were divided into two groups according to the post-intervention MSA [ ≤ 5.3 mm: 72 lesions (67 patients), and > 5.3 mm: 151 lesions (138 patients)]. The cut-off point was determined on the basis of receiver operating characteristic curve analysis., Results: The cumulative 5-year incidence of TLR was significantly higher in the group with MSA of 5.3 mm or less than in the group with MSA more than 5.3 mm (15.8 and 7.2%, P = 0.01). After adjusting for confounders, the excess risk of the group with MSA of 5.3 mm or less relative to the group with MSA more than 5.3 mm for TLR remained significant [hazard ratio: 3.07, 95% confidence interval (CI): 1.17-8.51, P = 0.02]. Using multivariate logistic regression analysis, we identified female sex (odds ratio: 2.39, 95% CI: 1.06-5.49, P = 0.04) and stent size of 3.0 mm or less (odds ratio: 13.43, 95% CI: 6.23-32.38, P < 0.0001) as independent predictors of MSA of 5.3 mm or less., Conclusion: EES implantation for ISR was associated with an acceptable rate of TLR through long-term follow-up. Postintervention MSA of 5.3 mm or less was associated independently with a higher risk for TLR.

Background: In patients with high bleeding risk, percutaneous coronary intervention is still debated. This study compared 9-month angiographic and physiologic results in patients with high bleeding risk and de novo coronary lesions treated with either paclitaxel-coated balloon (PCB) or bare-metal stent (BMS)., Patients and Methods: A total of 40 patients (40 lesions) with high bleeding risk who underwent successful balloon angioplasty with fractional flow reserve (FFR) after balloon angioplasty more than 0.80 were randomized 1: 1 to treatment with PCB versus BMS. Dual antiplatelet therapy was limited to 1 month after the procedure., Results: Baseline clinical and lesional characteristics were well balanced between the two groups. There was no significant difference in the postprocedural FFR (0.87 ± 0.06 in PCB vs. 0.89 ± 0.06 in BMS, P = 0.254). At 9 months, late luminal loss was significantly lower in the PCB group (0.2 ± 0.3 vs. 1.2 ± 0.8 mm, P < 0.001). Restenosis only occurred in the BMS group (0 vs. 25.0%, P = 0.049)., Conclusion: In patients with high bleeding risk, FFR-guided PCB treatment showed superior efficacy in terms of angiographic and physiologic patency compared with BMS at mid-term follow-up with only 1 month of dual antiplatelet therapy (Clinicaltrials.gov identifier, NCT02456402).

Background: The aim of this study was to investigate whether the underlying plaque type affects the neointimal coverage after drug-eluting stent implantation., Methods: A total of 1793 struts in 22 zotarolimus-eluting stents were assessed using optical coherence tomography imaging within 3 months of implantation. Neointimal coverage was evaluated within 5 mm from each stent edge on cross-sectional optical coherence tomography images at every 1-mm interval. The percentage of struts covered by neointima was compared among the normal segment group, the fibrous plaque group, and the lipid plaque group on the basis of the underlying plaque type., Results: The percentage of covered strut was significantly lower in the normal segment group than in the fibrous plaque group (35.9±30.2 vs. 57.1±31.0%, P<0.05) and the lipid plaque group (vs. 64.7±23.5%, P<0.01). The neointima was significantly thinner in the normal segment group than in the lipid plaque group (19.0±22.3 vs. 32.0±18.8 μm, P<0.01). The percentage of struts on the normal segment was significantly higher in cross-sections with a ratio of uncovered to total struts per section more than 0.3 than in cross-sections with a ratio up to 0.3 (32.4±31.7 vs. 19.5±33.8%, P<0.01)., Conclusion: Struts on the normal segment were less covered and had thinner neointima than struts on the lipid plaque at the stent edge within 3 months after zotarolimus-eluting stent implantation. Caution should be exercised when implanting longer drug-eluting stents to achieve uniform strut coverage in the early phase.

Background: Treatment of in-stent restenosis (ISR) is still a clinical challenge in interventional cardiology. Paclitaxel-coated balloons (PCBs) are an attractive therapeutic option for ISR. There are several different types of PCBs available for percutaneous coronary intervention, but to date, comparative data between different types of PCBs for the treatment of ISR are scarce., Patients and Methods: This single centre, nonrandomized, retrospective study under real-world condition included 194 patients with 194 ISR treated by repeat percutaneous coronary intervention with PCBs. The primary end point was major adverse cardiac events (MACEs), defined as cardiac death, myocardial infarction and need for target lesion revascularization (TLR) at 1 year. Secondary end points were MACE and TLR at long-term follow-up., Results: Baseline clinical and angiographic parameters were comparable between the two groups. Patients in the iopromide-based PCB and butyryl-tri-hexyl citrate (BTHC)-PCB groups were followed up for 32.2±20.5 and 24.2±13.3 months, respectively (P=0.001). MACEs at 1-year follow-up were 15.0 and 15.8% (P=0.879) for the BTHC-PCB and iopromide-based PCB groups, respectively. TLR, myocardial infarction and cardiac death for BTHC-PCB versus iopromide-based PCB at 1-year follow-up were 9.6 versus 11.8%, P=0.622; 5.3 versus 3.9%, P=0.640; and 5.3 versus 3.9%, P=0.640, respectively. If complete follow-up periods were included in the analysis, BTHC-PCB and iopromide-based PCB had comparable rates of MACE (P=0.835) and TLR (P=0.792)., Conclusion: BTHC-PCB and iopromide-based PCB had comparable rates of MACE and TLR for the treatment of ISR at 1-year and long-term follow-up.

Background: It remains controversial whether coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) should be optimized to treat coronary artery disease in patients on chronic hemodialysis (HD). Recently, further refinement of drug-eluting stents, such as the everolimus-eluting stent (EES), has led to marked development in this field. We compared long-term clinical outcomes after CABG versus PCI with EES implantation in patients on chronic HD., Patients and Methods: We compared 138 patients undergoing CABG and 187 patients treated with EES implantation. The endpoint was major adverse cardiac events (MACE) as a composite outcome, including any revascularization, nonfatal myocardial infarction, or mortality. To reduce the selection bias for the two procedures, propensity score-matching was performed., Results: During the follow-up period (43 months), 95 (29.2%) MACEs, including 43 (13.2%) revascularizations, 14 (4.3%) nonfatal myocardial infarctions, and 63 (19.4%) deaths, occurred. The freedom rate from MACE and mortality at 5 years were comparable between groups (69.7 vs. 66.7%, P=0.82 and 75.0 vs. 80.6%, P=0.10, respectively); however, those from revascularization at 5 years was higher in the CABG group than the EES group (89.4 vs. 81.0%, P=0.030). In propensity score-matched patients (n=92), the freedom rate from revascularization at 5 years was still higher in the CABG group than in the EES group (93.4 vs. 79.1%, P=0.013). Similarly, the freedom rates from MACE and mortality were comparable (70.0 vs. 66.3%, P=0.69 and 73.8 vs. 79.7%, P=0.30, respectively)., Conclusion: Even in the second-generation drug-eluting stent era, CABG is still superior for preventing revascularization in patients on chronic HD. However, PCI with EES implantation might not have disadvantages compared with CABG in terms of MACE.

Objectives: The introduction of the bioresorbable vascular scaffold (BVS) has led to new avenues of coronary intervention; however, there have been concerns raised regarding the mechanical properties of BVS and the resulting in-stent thrombosis. We aim to assess whether intracoronary imaging improves outcome in patients following BVS implantation., Patients and Methods: All patients undergoing percutaneous coronary intervention using BVS at a single centre between June 2013 and June 2016 were included in this study (n=79). Percutaneous coronary intervention with BVS was performed according to conventional practice: predilatation, postdilatation and intracoronary assessment with optical coherence tomography (OCT) according to operator's preferences. The primary endpoint was Major Adverse Cardiovascular Events (MACE), defined as all-cause mortality, myocardial infarction and revascularization, at 120 days., Results: Forty-three (54.4%) patients underwent OCT assessment and 36 (45.6%) patients underwent angiography alone post-BVS insertion. There were no significant differences at baseline between both groups; a total of 13 (30.2%) patients who had intracoronary OCT imaging performed underwent further postdilatation after malapposed struts were identified. Although no deaths were observed, there was a significant difference seen in MACE over the follow-up period between OCT and angiography cohorts (4.7 vs. 19.4% respectively; P=0.042). There was a greater number of MACE in low-experienced operators., Conclusion: As visual assessment with angiography has poor specificity for identifying strut malapposition, intracoronary OCT should be undertaken in all patients postinsertion of BVS stents in inexperienced operators to appropriately assess for stent malapposition, and reduce the subsequent risk of MACE.

Background: Paclitaxel-coated balloon (PCB) coronary angioplasty is an alternative treatment for de-novo coronary lesions in small vessels. This study with the new Essential PCB aimed to evaluate early and mid-term clinical outcomes following angioplasty with the Essential PCB in the treatment of de-novo lesions in small vessels., Patients and Methods: We included all patients who underwent PCB angioplasty for treating de-novo coronary lesions in small vessels (reference diameter <2.5 mm) between October 2015 and June 2016 in 2 centres. The primary endpoint was the 12-month target lesion failure (TLF) rate: a composite of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization. The secondary endpoints were rates of target vessel failure and global major adverse cardiac events (MACE)., Results: A total of 71 patients (comprising 71 lesions) were included, with a mean age of 66±11 years. A 56% were diabetic and 70% had an acute coronary syndrome as an indication for coronary revascularization. The mean vessel diameter and lesion length were 2.21±0.41 and 20.7±9.2 mm, respectively. Predilatation was performed in 85.9% of patients. The median diameter, length, and inflation pressure of the Essential balloon were 2.0 [interquartile range (IQR): 2.0-2.5] mm, 20 (IQR: 15-30) mm, and 12±2 atmospheres, respectively. Angiographic success was achieved in 97.2% of cases, and bail-out stenting was required in nine (12.7%) cases. The incidence of TLF at the 12-month follow-up was 4.2%, with a target lesion revascularization rate of 4.2%. Target vessel failure and global MACE rates were 4.2 and 9.9%, respectively., Conclusion: Use of the Essential PCB for treating de-novo coronary lesions in small vessels was safe, with low TLF and MACE rates at the 12-month follow-up.

Objectives: Periprocedural myocardial infarction (PMI) is reported to be associated with adverse long-term clinical outcomes. This study compared the rates of PMI following treatment of de novo coronary lesions using either a paclitaxel-coated balloon (PCB) or a newer-generation drug-eluting stent (DES)., Patients and Methods: We compared the incidence of PMI in propensity-matched patients with stable angina pectoris and single-vessel de novo coronary lesions who underwent treatment with a PCB or newer-generation DES. Propensity score matching was performed to adjust for differences in baseline clinical and angiographic characteristics., Results: After propensity matching, the study cohort included 108 patients (PCB: n=54 and DES: n=54). The peak mean values of creatine kinase-myocardial band (13.3±26.3 vs. 2.2±2.8 ng/ml, P=0.003) and high-sensitive troponin T (0.62±1.38 vs. 0.09±0.19 ng/ml, P=0.007) were significantly higher in the DES group compared with the PCB group. The incidence of PMI was significantly higher in the DES group [DES: 11 (20.4%) vs. PCB: one (1.9%); P=0.002]. Total occlusion of the side-branch occurred in two patients treated with DES, but no patients treated with PCB. Treatment with a newer-generation DES was found to be an independent predictor of PMI on multivariable analyses., Conclusion: In patients with stable angina using a PCB, compared with deployment of a newer-generation DES, is associated with a significant reduction in the risk of PMI.

Background: SYNERGY, a bioabsorbable polymer-based, everolimus-eluting stent (BP-DES), recently received regulatory approval in the USA for use in percutaneous coronary interventions. Yet, information on the safety of BP-DES in routine clinical practice is limited. Our aim was to compare the safety of the recently approved BP-DES with current durable polymer drug-eluting stents (DP-DES) by analyzing adverse events, namely, stent thrombosis (ST), reported to the Manufacturer and User Facility Device Experience (MAUDE) database., Materials and Methods: The MAUDE database requires nationwide mandatory notification for adverse events on devices approved for clinical use. This database was searched for adverse events reported between 1 October 2015 and 25 December 2016, encountered after the placement of either BP-DES or DP-DES. Only those adverse events were included where the exposure period to the stents was comparable after the index procedure. Of all the adverse events reported, the event of interest was ST., Results: A total of 951 adverse events were reported. ST occurred in 48/951 of all events, 31/309 and 17/642 when BP-DES or DP-DES were used, respectively (P=0.00001). Of the 31 ST events with BP-DES, 68% (21/31) occurred within less than or equal to 24 h of the index procedure and 52% (16/31) occurred within less than or equal to 2 h., Conclusion: Our results raise the possibility of an increased risk of ST, particularly early ST (within 24 h), with the recently approved BP-DES. However, because of the inherent limitations of reporting within the MAUDE database, these data merely highlight a potential need for additional surveillance and randomized trials to assess further the safety of the bioabsorbable platform.

Background: The Nobori biolimus-eluting stent (BES) is a biodegradable polymer drug-eluting stent (DES). Several studies have shown its noninferiority in comparison with durable polymer DES., Aim: We sought to investigate the efficacy and the safety of Nobori BES in an all-comer population undergoing a percutaneous coronary intervention., Patients and Methods: A total of 12 912 patients with 19 947 coronary lesions, undergoing percutaneous coronary intervention with Nobori BES implantation at 200 centres around the world between August 2010 and December 2015, were included in this prospective registry. Patients were stratified into four groups according to the total stent length, with cutoffs at 18, 24 and 28 mm. The primary endpoint was the occurrence of major adverse cardiac events defined as the composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularization at 1 year., Results: At 1 year, the major adverse cardiac events rate was the highest (4.6%) in the fourth quartile of stent length (>28 mm), whereas the overall rate of the primary endpoint in the all cohort was 3.5%. Both target lesion revascularization and target vessel revascularization rates were significantly higher in patients with longer stent length was implanted (all P<0.05). The incidence of definite and probable stent thrombosis at 1 year was 0.5% in all cohort and similar across the four groups (varying from 0.4 to 0.7%, all P=NS)., Conclusion: Our data confirmed the efficacy and the safety of the Nobori BES in routine clinical practice. Longer stent length is associated with a higher risk of adverse cardiac events, and yet, this risk is comparable with that of other DES.

Objective: The third generation drug eluting Orsiro stent had shown already promising results in non-complex lesions., Background: We evaluated angiographic and 24 month clinical results of the sirolimus eluting Orsiro stents (O-SES) after recanalization of coronary chronic total occlusions (CTO). Results were compared with the zotarolimus eluting Resolute Integrity (R-ZES)., Methods: In a prospective series 57 patients were treated with a R-ZES followed by 74 patients treated with a O-SES stent. Angiographic follow up after 9 months and clinical follow-up after 12 and 24 months was performed., Results: In-stent late lumen loss was 0.24±0.53 mm for the O-SES compared with 0.59±0.72 (P=0.01) for R-ZES. Rates for TLR were similar (O-SES 10.0% versus R-ZES 11.1%, P=0.84). There was no definite stent thrombosis., Conclusion: The O-SES resulted in a significant lower late lumen loss but with similar clinical results up to 24 month compared to the R-ZES after treatment of CTO lesions.

Objectives: Data on bioresorbable vascular scaffolds for recanalization of chronic total occlusions (CTOs) are limited. We compared the bioresorbable scaffold Absorb with everolimus-eluting stents for the treatment of true CTO., Methods: After recanalization of CTO, 15 lesions treated with the bioresorbable scaffold Absorb were matched with 15 lesions receiving everolimus-eluting stent (EES) (http://www.clinicaltrials.gov NCT02162082). Match criteria were presence of diabetes mellitus, total device length and maximal device diameter. Angiographic follow-up was scheduled after 9 months and clinical follow-up after 12 months. Dual antiplatelet therapy was administered for 12 months. Quantitative coronary analysis was carried out before and after implantation and at angiographic follow-up. All lesions were predilated. The Absorb scaffolds and drug-eluting stents were carefully placed and postdilatated with high-pressure balloons. Patients received dual antiplatelet therapy for 12 months. The baseline characteristics were similar between both the groups. The mean scaffold length was 81.7±29.1 versus 79.3±27.4 mm for the mean stent length (P=0.82). In-device late lumen loss at the 9-month follow-up was 0.38±0.47 versus 0.46±0.60 mm (P=0.69). The device-oriented composite endpoint was similar in both groups, with 6.7% in the Absorb-group versus 13.3% in the EES group because of target lesion revascularization (P=0.54)., Conclusion: In CTOs, the use of a bioresorbable scaffold Absorb after recanalization showed similar 9-month angiographic and 12-month clinical results compared with an EES with 12 months of dual antiplatelet therapy.

Aims: Bioresorbable polymer drug-eluting stent technologies have been considered to have the potential to enhance vascular healing by reducing polymer exposure to the vessel wall, potentially allowing the earlier discontinuation of dual antiplatelet therapy. At present, the early vascular healing response to this type of technologies is still unclear., Patients and Methods: The TIMELESS study is a multicenter, prospective, single-arm study that enrolled real-world patients undergoing percutaneous coronary intervention. All patients underwent Synergy stent implantation, which consists of a platinum-chromium platform coated with an ultra-thin abluminal bioabsorbable poly-D,L-lactide-co-glycolide polymer-eluting everolimus., Results: A total of 37 patients were included in the study. The majority of the patients underwent percutaneous coronary intervention because of acute coronary syndromes. At 3 months, angiographic follow-up showed a percentage diameter of stenosis of 8.1±7.5% and an angiographic late loss of 0.03±0.24 mm. In all analyzed struts, less than 1% of struts were definitely uncovered or covered with fibrin, 12.5% (5.0-18.5%) showed evidence of partial coverage, and the remaining (∼85%) were fully covered. No stent thrombosis was observed up to 12 months of clinical follow-up., Conclusion: In a real-world population, the implantation of a bioresorbable polymer drug-eluting stent resulted in almost complete strut coverage throughout the entire stent length at 3 months. The clinical implications for antiplatelet therapy and outcomes should be investigated further.

Objectives: Data on multiple bioresorbable vascular scaffolds (BVS) for the treatment of coronary lesions are limited. We compared clinical results after implantation of single or multiple BVS for the treatment of de-novo coronary artery disease., Methods: We enrolled 236 patients with 311 lesions treated with Absorb BVS. Quantitative coronary angiography before and after scaffold implantation was performed. All lesions were predilated. Absorb was implanted with slow inflation and 81% were postdilated with a high-pressure balloon. Patients received dual antiplatelet therapy for 6 months for stable angina pectoris and for 12 months for acute coronary syndrome. Patients were clinically followed for 12 months. Acute gain was 1.39±0.47 mm. Multiple scaffolds per lesion were implanted in 23.8% (N=74/311 lesions). The mean scaffold length was 21 mm for single and 48 mm (range 28-112 mm) for multiple BVS. Periprocedural myocardial infarction (13.5 vs. 4.6%, P<0.013) and target lesion revascularization (6.8 vs. 0.8%; P=0.003) were significantly higher in the multiple-scaffold group compared with the single-scaffold group. There was no definite scaffold thrombosis. (http://www.clinicaltrials.gov, NCT02162056)., Conclusion: Target lesion revascularization within 12 months and periprocedural myocardial infarction were higher for lesions treated with multiple scaffolds compared with lesions treated with single BVS.

Aim: The aim of this meta-analysis was to evaluate the efficacy of drug-eluting balloons (DEBs) plus bare-metal stents (BMS) for the treatment of de-novo coronary lesions., Methods and Results: Eleven trials involving 1279 patients were included in this study. The main endpoints were as follows: late lumen loss (LLL), binary restenosis, stent thrombosis (ST), and major adverse cardiovascular events (MACEs). The definition of MACEs was a composite of death, myocardial infarction (MI), and target lesion revascularization (TLR). Compared with BMS alone, DEB plus BMS showed a lower risk for LLL (P=0.007) and MACEs (P=0.010). There were no significant differences in binary restenosis (P=0.212), ST (P=0.199), death (P=0.141), MI (P=0.439), and TLR (P=0.340). Compared with drug-eluting stents (DES), DEB plus BMS could increase the risk of LLL (P=0.002) and MACEs (P=0.026). The risks of binary restenosis (P=0.113), ST (P=0.832), death (P=0.115), MI (P=0.831), and TLR (P=0.111) were similar between DEB plus BMS and DES., Conclusion: DEB plus BMS was better than BMS alone in reducing LLL and MACEs, especially when dilatation was performed after stenting for de-novo coronary lesions, but it was inferior to DES. Therefore, the treatment strategy with DEB plus BMS should not be recommended for de-novo coronary lesions, except for patients who have contraindications for DES.

Background: Besides its potent plasma cholesterol-lowering activity, statin treatment has several other important effects, including lowering high-sensitive C-reactive protein (hs-CRP), levels, and stabilizing risk factors of atherosclerosis, thereby reducing the risk of cardiovascular events. Our aim in this study was to identify how intensive statin therapy can affect plasma levels of inflammatory markers over the long term., Methods and Results: We used a prospective, randomized, open blinded-endpoint design. A total of 30 patients with stable coronary artery disease treated with everolimus-eluting stent implantation were randomized to receive rosuvastatin 2.5 (standard therapy group) or 10 mg (intensive therapy group) for 12 months. Plasma levels of hs-CRP, pentraxin-3, monocyte chemoattractant protein-1, and CXC chemokine ligand 4 were measured after a percutaneous coronary intervention, at 1, 3, 6, 9, and 12 months. Levels of LDL cholesterol (LDL-C) and HDL cholesterol were also measured. We investigated short-term and long-term clinical outcomes. After 12 months of therapy, the intensive therapy group had lower levels of LDL-C than the standard therapy group. Plasma levels of hs-CRP largely fluctuated in the standard therapy group, whereas they were stable in the intensive therapy group during the follow-up period. There were no significant differences in serum pentraxin-3, monocyte chemoattractant protein-1, and CXC chemokine ligand 4 levels, or in the incidence of any clinical adverse events, between the standard and the intensive therapy groups., Conclusion: Intensive rosuvastatin therapy stabilizes hs-CRP levels, but not chemokine levels, besides lowering LDL-C levels. Thus, this therapy may inhibit the progression of atherosclerosis by stably inhibiting the inflammatory cascade.

Objectives: The long-term clinical impact of polymer-free sirolimus-eluting stents (PF-SES) in unselected patients undergoing percutaneous coronary intervention (PCI) still remains poorly investigated. We studied the long-term clinical impact of PF-SES in a large cohort of unselected patients receiving PCI therapy at two tertiary care centers in India., Methods: A total of 3213 patients received PCI with drug-eluting stents during the period from December 2004 to September 2011. Among these, those receiving PF-SES implantation were retrospectively included in this registry. The primary endpoint in our study was the occurrence of major adverse cardiac events (MACE), defined as the composite of death/myocardial infarction (MI) and target lesion revascularization, whereas the main secondary endpoints were cardiac death/MI and definite/probable stent thrombosis., Results: A total of 1213 patients (83.8% men, 31.8% diabetics) with 1658 lesions (52.5% B2/C, according to the American College of Cardiology/American Heart Association classification) were studied. After a median follow-up of 1160 days, MACE occurred in 10.0% of patients, whereas the rates of cardiac death/MI and definite/probable ST were found to be 5.4 and 1.9%, respectively. The incidence of MACE was more common in patients aged at least 65 years [hazard ratio (HR)=1.69, 95% confidence interval (CI)=1.13-2.52, P=0.01] and diabetics (HR=1.71, 95% CI=1.18-2.47, P=0.004). The incidence of cardiac death/MI was more common in patients aged at least 65 years (HR=2.21, 95% CI=1.32-3.70, P=0.003). The baseline risk profile did not impact the occurrence of target lesion revascularization., Conclusion: In this large cohort of unselected PCI patients treated in India, PF-SES shows a sustained safety and efficacy at long-term follow-up.

Objective: The aim of this study was to evaluate the effects of intracoronary administration of anisodamine on myocardial reperfusion in patients with ST-segment elevation myocardial infarction (STEMI) undergoing a primary percutaneous coronary intervention (pPCI)., Methods: Patients with acute STEMI undergoing pPCI were enrolled in this randomized-controlled study (January 2014-June 2015) and divided randomly into four groups: group A (normal saline), group B (1000 μg anisodamine), group C (2000 μg anisodamine), and group D (4000 μg anisodamine)., Results: The study group included 140 patients. Percentages of thrombolysis in myocardial infarction (TIMI) myocardial perfusion grade 3, increased values of TIMI myocardial perfusion grade after stenting, and decreased values of corrected TIMI frame count in groups B, C, and D were all significantly higher than those in group A (P=0.031, 0.027, 0.003, and P<0.001, respectively). TIMI frame count after stenting in groups B, C, and D was significantly lower than that in group A (P=0.001). Left ventricular ejection fraction at 1 week after pPCI and at the 3-month follow-up, as well as the major adverse cardiac event-free survival rate in groups B, C, and D were higher than those in group A (P=0.027, 0.016, and 0.019, respectively)., Conclusion: Intracoronary administration of anisodamine at different doses improved myocardial reperfusion in patients with STEMI undergoing pPCI and reduced major adverse cardiac events. The protective effect of anisodamine at a dose of 4000 μg might be better than the doses at 1000 and 2000 μg.

Background: Compared with the zotarolimus-eluting stent (ZES), the everolimus-eluting stent (EES) has reduced the risk of stent restenosis and thrombosis as found in a number of randomized-controlled trials (RCTs). However, the benefits have been variable., Materials and Methods: We evaluate the long-term effect of EES and ZES on the risk of stent thrombosis and target lesion revascularization in patients receiving PCI. We identified RCTs by a systematic search of MEDLINE, EMBASE, and Cochrane Database., Results: Five RCTs (9853 patients) were included. Overall, EES significantly reduced the risk of target lesion revascularization [odds ratio (OR), 0.77; 95% confidence interval (CI), 0.62-0.95; P=0.01] compared with ZES therapy. However, there was no difference in the risk of target vessel revascularization (OR, 0.93; 95% CI, 0.78-1.10; P=0.38) and definite/probable stent thrombosis (OR, 0.83; 95% CI, 0.56-1.25; P=0.37) between the two groups. Furthermore, the risk of mortality (OR, 1.04; 95% CI, 0.84-1.27; P=0.73), myocardial infarction (OR, 0.95; 95% CI, 0.74-1.23; P=0.70), and major adverse cardiac event (OR, 0.96; 95% CI, 0.84-1.10; P=0.53) was similar between the two groups., Conclusion: The new-generation Resolute-ZES and EES have a similar long-term safety and efficacy profile.

Objectives: The aim of this study was to evaluate the extent of neointimal response after the implantation of a second-generation drug-eluting stent, zotarolimus-eluting stent (ZES-ER, Endeavor Resolute) or everolimus-eluting stent (EES, Xience V), using intravascular ultrasound (IVUS) in diabetic patients., Materials and Methods: In all, 154 diabetic patients with de-novo coronary lesions were randomized to be implanted with a ZES-ER or EES, and the angiographic follow-up at 9 months combined with a complete IVUS study was available for 96 patients with 101 lesions., Results: Baseline demographic and lesion parameters were similar in both groups at index percutaneous coronary intervention. On follow-up angiography, in-stent late lumen loss and minimal lumen diameter were not different between the two groups. On IVUS study, neointimal hyperplasia volume [median (interquartile range): ZES-ER vs. EES; 2.25 mm (0.57-6.25) vs. 1.59 mm (0.45-8.37), P=0.615] and in-stent percentage of volume obstruction [median (interquartile range): ZES-ER vs. EES; 1.16% (0.33-3.61) vs. 0.77% (0.29-4.01), P=0.615] showed similar results between the two groups., Conclusion: In diabetic patients, the second-generation drug-eluting stents, ZES-ER and EES, were comparable in inhibiting neointimal proliferation.

Objectives: We aimed to investigate, in patients with ST-segment elevation myocardial infarction (STEMI), whether the previously reported clinical benefits of sirolimus-eluting stent(s) (SES) in terms of reducing a major adverse cardiac and cerebrovascular event (MACCE) compared with bare-metal stent(s) (BMS) were maintained over a 5-year time period., Background: In the prospective single-centre randomized DEBATER trial, SES significantly reduced the rate of MACCE in STEMI patients within 1 year compared with BMS, mainly driven by a reduction of target lesion revascularization. Randomized data on the long-term safety and efficacy of SES in STEMI patients are conflicting and limited., Patients and Methods: Between January 2006 and May 2008, a total of 907 STEMI patients were randomized to receive SES or BMS. The primary endpoint was MACCE defined as the composite of death, myocardial infarction, stroke, repeat revascularization and bleeding. Five-year follow-up data were collected by reviewing hospital records, telephone calls and a written questionnaire., Results: At 5 years, the rate of MACCE between the SES group and the BMS group was no longer significantly different (33.3 vs. 39.3%, P=0.12). The cumulative incidence of death and myocardial infarction was similar in both groups (11.0 vs. 9.7%, P=0.51). Repeat revascularization was performed in 21.1 and 25.8% of patients, respectively (P=0.12). The rate of very late stent thrombosis (1-5 years of follow-up) was very low in both groups (2.0 vs. 0.7%, P=0.12)., Conclusion: The benefits of SES in STEMI patients in terms of reducing MACCE faded over time. We found no safety concerns in terms of SES in the long term, with extremely low rates of very late stent thrombosis.

Objectives: Everolimus-eluting stent (EES) reduces the risk of late and very late stent thrombosis (ST) in a number of randomized controlled trials (RCTs). However, the benefits have been variable., Materials and Methods: We evaluated the effect of EES and paclitaxel-eluting stent (PES) on the risk of late and very late ST in patients with coronary artery disease., Results: We identified RCTs by a systematic search of MEDLINE, EMBASE, and Cochrane Database. Seven RCTs (8162 patients) were included. Overall, EES therapy lowered the risk of very late ST significantly [relative risk (RR), 0.40; 95% confidence interval (CI), 0.20-0.80; I(2)=0.0%; P=0.009] compared with PES. Meanwhile, EES was associated with a significantly lower incidence of major adverse cardiac events (RR, 0.76; 95% CI, 0.67-0.86; I(2)=34.2%; P=0.00) driven by a markedly lower rate of myocardial infarction and target-vessel revascularization in the EES group. However, there was no significant difference in the risk of late ST (RR, 0.45; 95% CI, 0.15-1.39; I(2)=30.7%; P=0.166) between the two groups. A subgroup analysis showed that EES might not decrease the risk of very late ST significantly in patients older than 63.5 years or in patients with diabetes, those presenting with acute coronary syndrome, or those with a longer follow-up., Conclusion: Compared with PES, EES treatment decreased risk of very late ST significantly. However, the risk of late ST was similar between the two groups. More studies are needed to confirm the subgroup findings.

Objective: The aim of this study was to compare the 2-year clinical outcomes of overlapping second-generation everolimus-eluting stents (EES) with those of overlapping resolute zotarolimus-eluting stents (R-ZES) in the treatment of long coronary artery lesions., Materials and Methods: This retrospective analysis included 256 patients treated with overlapping EES (n=121) and R-ZES (n=135) for long coronary artery lesions (total stent length per lesion ≥34 mm). Study endpoints included major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction, and target-vessel revascularization (TVR), as well as target-lesion revascularization and definite stent thrombosis separately at 2 years., Results: In the two groups, the mean age was older and the average number of disease vessel was higher in the R-ZES group. The mean lesion length and total stent length per lesion were longer in the R-ZES group. EES were more frequently implanted in the left anterior descending coronary artery. No significant differences in the estimated MACE (5.8% for EES vs. 8.1% for R-ZES; P=0.548) or TVR (3.4% for EES vs. 4.0% for R-ZES; P=0.806) rates were noted between the two groups at 2-year follow-up. The incidence of definite stent thrombosis was low and similar in both groups (0.83% for EES vs. 0% for R-ZES; P=0.473). No significant differences were noted with respect to MACE or TVR between the two groups following propensity score matching., Conclusion: Stent overlap with second-generation EES or R-ZES was associated with low rates of MACE, TVR, and stent thrombosis at 2-year follow-up. Our results suggest that the use of overlapping EES or R-ZES in long coronary lesions is associated with good long-term clinical outcomes. These results need to be validated with randomized controlled trials.

Background: Everolimus-eluting stents (EES) have shown favorable clinical outcomes. However, there have been no studies evaluating early vascular response after EES implantation. We designed a prospective study to compare the neointimal response between zotarolimus-eluting stents (ZES) and EES at 3 and 12 months using serial optical coherence tomography examinations., Methods and Results: Sixty patients who underwent 3-month and 12-month follow-up optical coherence tomography (36 EES, 24 ZES) were included. Neointimal coverage and malapposition were evaluated using a strut-based analysis at both 3 and 12 months. Neointimal hyperplasia area and thrombus were assessed. ZES showed a higher incidence of covered struts (81.5 vs. 77.1%, P<0.0001) and lower incidence of malapposed struts (1.4 vs. 2.3%, P=0.001) than EES at 3 months. However, at 12 months, EES showed a slightly higher incidence of covered struts (96.4 vs. 93.6%, P<0.0001) and a lower incidence of malapposed struts (0.9 vs. 1.1%, P=0.03) than ZES. Neointimal hyperplasia area was greater in the ZES group than in the EES group at both 3 and 12 months (0.77 vs. 0.49 mm, P=0.03 and 1.50 vs. 0.97 mm, P=0.01, respectively). No significant difference in the incidence of thrombus was observed at both 3 and 12 months., Conclusion: ZES showed rapid neointimal healing compared with EES at 3 months. However, at 12 months, EES had a slightly better vascular healing profile than ZES.

Objective: Drug-eluting stents are more effective in reducing restenosis than bare-metal stents. Paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) are the most widely used first-generation drug-eluting stents, but long-term comparative data on these are scant. The aim of the present report is to investigate the 6-year clinical outcomes of PES versus SES in a matched cohort of single-center registry patients., Materials and Methods: Data were obtained from the observational, monocentric registry of 632 consecutive patients who underwent percutaneous coronary intervention between September 2002 and September 2005 with PES or SES. We assessed the composite and separate occurrence of the major adverse cardiac events (MACE), including death, nonfatal myocardial infarction, and target lesion revascularization (TLR)., Results: After a propensity 1 : 1 matching analysis, baseline clinical, procedural, and angiographic characteristics were well balanced between the two groups. Throughout the 6 years of follow-up, there were no significant differences between PES and SES in terms of MACE (P=0.52), all-cause death (P=0.24), myocardial infarction (P=0.25), stent thrombosis (P=0.38), and TLR (P=0.68). The sensitivity analysis on the total unmatched population confirmed this result, the stent type not being predictive of MACE (PES vs. SES group, hazard ratio 0.97, 95% confidence interval 0.66-1.41, P=0.87) or TLR (PES vs. the SES group, hazard ratio 1.35, 95% confidence interval 0.69-2.64, P=0.38)., Conclusion: In this 'real-life' registry, PES and SES showed a comparable safety and efficacy profile throughout the 6 years of follow-up. The increase in the rate of TLR was slow and comparable between the two groups, even though the 'late catch-up' phenomenon showed a different temporal pattern between PES and SES.

Objective: This study was carried out to determine the effect of the use of dual antiplatelet therapy (DAPT) for more than 12 months on long-term clinical outcomes in patients who had undergone a percutaneous coronary intervention with the first and second generations of drug-eluting stents (DES)., Background: The potential benefits of the use of DAPT beyond a 12-month period in patients receiving DES have not been established clearly. Moreover, it is also unclear whether the optimal duration of DAPT is similar for all DES types., Methods: A total of 2141 patients with coronary artery disease treated exclusively with Cypher sirolimus-eluting stents (SES) or Endeavor zotarolimus-eluting stents (ZES) were considered for retrospective analysis. The primary endpoint [a composite of all-cause mortality, nonfatal myocardial infarction (MI), and stroke] was compared between the 12-month DAPT and the >12-month DAPT group., Results: A total of 1870 event-free patients on DAPT at 12 months were identified. The average follow-up was 28.2±7.4 months. The primary outcomes were similar between the two groups (4.1% 12-month DAPT vs. 1.9% >12-month DAPT; P=0.090). Incidences of death, MI, stroke, and target vessel revascularization did not differ significantly between the two groups. Subgroup analysis showed that in the patients with hypertension, >12-month DAPT significantly reduced the occurrence of death/MI/stroke compared with that in the 12-month DAPT group (P=0.04). In patients implanted with SES, the primary outcome was significantly lower with the >12-month DAPT group (5.2% 12-month DAPT vs. 1.6% >12-month DAPT; P=0.016), whereas in patients with ZES, the primary outcome was comparable between the two groups (2.3% 12-month DAPT vs. 2.0% >12-month DAPT; P=0.99)., Conclusion: In our study, for all patients, >12-month DAPT in patients who had received DES was not significantly more effective than 12-month DAPT in reducing the rate of death/MI/stroke. Our findings, that patients who received SES benefit from >12-month DAPT whereas extended use of DAPT was not significantly more effective in those implanted with ZES, implied that the optimal duration of DAPT was different depending on different types of DES.

Objective: The aim of this study is to evaluate the acute and long-term outcomes of ostial stentings among bare-metal stents (BMS), sirolimus-eluting stents, and paclitaxel-eluting stents., Materials and Methods: According to the CAPTAIN (Cardiovascular Atherosclerosis and Percutaneous TrAnsluminal INterventions) registry, from November 1995 to June 2011, 420 patients with ostial lesions were treated using BMS implantations (243 patients with 247 lesions), CYPHER implantations (77 patients with 77 lesions), or TAXUS implantations (100 patients with 104 lesions)., Result: Compared with the CYPHER and TAXUS groups, the BMS group had larger late loss (0.29±0.53, 0.64±0.78, and 1.30±0.79 mm, respectively, P=0.006) and restenosis rate (6, 8, and 33%, respectively, P<0.001). During the long-term follow-up, the BMS group had higher target lesion revascularization than the CYPHER and TAXUS groups (17, 4, and 6%, respectively, P=0.002). The cardiac event-free survival rate, as determined by the Kaplan-Meier analysis, was also lower in the BMS group than in the CYPHER and TAXUS groups (55, 86, and 76%, respectively, P<0.001)., Conclusion: Intracoronary stenting with drug-eluting stent for ostial lesions was associated with lower angiographic restenosis and late loss, and a more favorable long-term clinical outcome than BMS.

Objective: To report the final, cumulative, 5-year outcomes from the TAXUS ATLAS program, which studied the use of the TAXUS Liberté paclitaxel-eluting stent in de-novo coronary artery lesions., Methods: TAXUS ATLAS Workhorse, Small Vessel, and Long Lesion are nonrandomized studies comparing TAXUS Liberté (N=871), TAXUS Liberté 2.25 mm (N=261), and TAXUS Liberté 38 mm (N=150) stents, respectively, with case-matched TAXUS Express historical controls., Results: In the unadjusted analysis, TAXUS Liberté showed comparable 5-year rates of major adverse cardiac events (27.1% TAXUS Express vs. 26.2% TAXUS Liberté, P=0.70) in workhorse lesions and greater 5-year cumulative freedom from target lesion revascularization (78.4 vs. 87.3%, P=0.03) in small vessels. In addition, a lower periprocedural myocardial infarction rate (MI, 4.1 vs. 0.0%; P=0.01) was observed in long lesions versus TAXUS Express. After propensity score adjustment, no statistically significant effect of TAXUS Liberté on the 5-year rates of TLR in small vessels (17.9 vs. 13.3%, P=0.36) or MI in long lesions (9.1 vs. 7.0%, P=0.53) was found, although the rates remained numerically lower with TAXUS Liberté., Conclusion: Cumulative 5-year results of the TAXUS ATLAS studies suggest that the TAXUS Liberté stent provides similar safety and effectiveness in workhorse lesions, and may provide lower revascularization rates in small vessels and lower periprocedural MI rates in long lesions compared with the TAXUS Express stent, although no statistically significant differences were found following propensity adjustment.

Objectives: The present study aimed to investigate differences in plaque morphology and components in between the target coronary artery lesion with and without late-acquired incomplete stent apposition (LISA) using radiofrequency analysis (virtual histology) of intravascular ultrasound data., Background: Incomplete stent apposition is frequently observed in patients with very late stent thrombosis after sirolimus-eluting stent implantation., Methods: The study group consisted of 70 coronary artery lesions in 43 patients who underwent elective coronary stenting for stable angina pectoris. Virtual histology intravascular ultrasound was performed at the implantation of stent and 12-month follow-up. LISA was defined as a separation of stent struts from the intimal surface of the arterial wall that had not been present at the time of stent implantation. The plaque eccentricity index (EI) was calculated as (lumen radius+maximal plaque thickness)/(lumen radius+minimal plaque thickness)., Results: At 12-month follow-up, LISA occurred in 15 plaques (LISA group). Compared with the non-LISA group, the LISA group had significantly longer stents, a higher EI, smaller amount of fibro-fatty component (7.7±4.2 vs. 12.5±7.0%, P=0.01) and larger amount of necrotic core component (16.6±9.8 vs. 11.1±6.4%, P=0.06). Multivariate logistic regression analysis revealed that amount of necrotic core and plaque EI were independent positive predictors for LISA (odds ratio=1.4, 95% confidence interval=1.1-1.6, P=0.04 and 11.2, 1.9-64.9, P<0.01, respectively)., Conclusion: Plaques with increased amounts of necrotic core and higher eccentricity are associated with subsequent LISA after sirolimus-eluting stent implantation., (© 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins.)

Background: The efficacy of drug-eluting stents (DES) for the treatment of in-stent restenosis (ISR) after DES implantation is not well defined. This study compared the clinical outcome after the use of everolimus-eluting stents (EES) for the treatment of bare-metal stent (BMS) versus DES restenosis., Method: Ninety-four patients with 94 ISR were included in this study. Sixty-four patients had BMS-ISR and 30 patients had DES-ISR. Patients were treated by repeat PCI using an EES. The primary endpoint of the study was survival free of target lesion revascularization (TLR) at 12 months or DES-ISR versus BMS-ISR patients. The secondary endpoints were survival free of major adverse cardiac events (MACE) and definite stent thrombosis., Results: The baseline clinical and angiographic parameters were comparable between the two groups. Treatment of DES-ISR was associated with higher rates of recurrent TLR, myocardial infarction (MI), and MACE at the 12-month follow-up compared with the treatment of BMS-ISR (23.3 versus 1.6%, P=0.002 for TLR; 13.3 versus 0%, P=0.017 for MI; and 30 versus 4.6%, P=0.003 for MACE). There were no differences in mortality and definite stent thrombosis between both groups (P=0.5686 and 0.6927, respectively). Initial stent number (odds ratio=1.13, 95% confidence interval 1.02-1.25; P=0.024) and initial stent type being a DES (odds ratio=8.11, 95% confidence interval 5.99-10.45; P<0.001) were independent predictors of recurrent TLR after the treatment of ISR using an EES., Conclusion: EES used for the treatment of DES-ISR is associated with higher rates of recurrent revascularization, MI, and MACE compared with EES for the treatment of BMS-ISR., (© 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins.)

Background: Although edge stenosis (ES) is a main limitation of drug-eluting stents, the predictors for ES are not well known. We evaluated the predictors for ES after paclitaxel-eluting stent implantation., Methods: One hundred and eleven angina patients (64 men; 62.2±8.4 years of age) were divided into ES (n=9) and non-ES groups (n=102). The clinical findings, procedural factors, and intravascular ultrasound (IVUS) parameters were analyzed., Results: Although clinical characteristics were not different between groups, diabetes mellitus (DM) was more common in the ES group (P=0.002). The vessel, plaque, and lumen areas of the lesions were not different between groups; however, the vessel area of the proximal and distal reference artery was smaller in the ES group. Lesions with positive remodeling were more common in the ES group (P=0.015). On the basis of univariate analysis, predictors of ES included DM, lesions with positive remodeling, IVUS parameters, and procedural factors. After adjusting for clinical findings, angiographic factors, and IVUS parameters, the presence of DM [odds ratio (OR): 9.20; 95% confidence interval (CI): 1.40-60.62, P=0.021] and lesions with positive remodeling (OR: 5.93; 95% CI: 1.13-31.02, P=0.035) were independent predictors of ES. The lumen area in the distal 1 mm reference segment was a protective factor for ES (OR: 0.05; 95% CI: 0.00-0.74, P=0.029)., Conclusion: The risk of ES after paclitaxel-eluting stent implantation was higher in patients who had DM and lesions with positive remodeling. Of the IVUS parameters, the lumen area in the distal 1 mm reference segment was a protective factor against ES.

Background: Coronary stenting in women has been associated with worse results in terms of morbidity, mortality, and restenosis rate in the bare-metal stent era, possibly due to higher risk profile and smaller coronary vessels. Although drug-eluting stents have equalized clinical results, no data are available on long-term outcomes between sexes., Objectives: To evaluate the role of sex in acute, mid-term, and long-term clinical outcome after sirolimus-eluting stent (SES) implantation., Methods: We retrospectively evaluated 1186 patients, 970 (81.8%) male and 216 (18.2%) female, treated with SES implantation between April 2002 and December 2005., Results: Women were older (P=0.049), more likely to have hypertension (43.5 vs. 33.7%, P=0.006), single-vessel disease (63.9 vs. 42.5%, P=0.03), and unstable angina (16.6% vs. 9.2%, P=0.001) and more frequently received small (≤ 2.75 mm) vessel stenting (39.3 vs. 28.2%, P=0.001). The two groups were similar for lesion and procedural characteristics. Overall, the stent thrombosis rate was 0.4% (0.5% in women vs. 0.3% in men, P=not significant). At 6-month follow-up, no significant difference in major adverse cardiac event was observed. Long-term follow-up (median time 33.2 months), available in 180 (83.3%) women and 720 (75%) men, showed higher angina recurrence rate (17.7 vs. 11%, P=0.013), percutaneous coronary re-intervention (16.1 vs. 8.7%, P=0.001) and target vessel revascularization (3.9 vs. 0.9%, P=0.001) in women compared with men. Late stent thrombosis, need for coronary artery bypass grafting, and mortality were similar in both groups., Conclusion: No sex difference was observed in acute and 6-month outcome after SES implantation despite older age, more unstable clinical presentation, and more frequent small vessel stenting in women. However, long-term clinical follow-up (up to 5 years) in women showed higher symptom recurrence and target vessel revascularization rate but no difference in overall major adverse cardiac events.

Background: The optimal stenting strategy in true coronary artery bifurcation lesions has not been determined. In this study, a strategy of always stenting both the main vessel and the side branch (MV plus SB) was compared with a strategy of stenting the MV only with optional stenting of the SB. Stents used were sirolimus-eluting stents and paclitaxel-eluting stents., Methods: A total of 108 patients with true coronary bifurcation lesions were randomly assigned to either routine stenting with drug-eluting stents (DES) in both the branches (group MV plus SB) or provisional stenting with DES placement in the main branch and DES placement in the SB only if MV stenting alone provided inadequate results (group MV). The primary end points were major adverse cardiac events (MACE) at 8 months, including myocardial infarction, cardiac death, and stent thrombosis or target vessel revascularization by either percutaneous coronary intervention or coronary artery bypass grafting., Results: Angiographic follow-up revealed 28.91+/-20.43% stenosis of the SB after provisional stenting and 18.93+/-15.34% (P<0.01) after routine stenting. The corresponding binary restenosis rates were 35.2 and 14.8% (P=0.015). SB stents were implanted in 16.7% of patients in the provisional stenting group and 94.4% of patients in the routine stenting group. In the main branch, binary restenosis rates prebifurcation were 11.1% after provisional and 7.4% after routine stenting (P=0.51), whereas binary restenosis rates postbifurcation were 14.8 and 9.3% (P=0.38), respectively. The overall 8-month incidence of target lesion reintervention was 31.5% after provisional and 7.4% after routine stenting (P<0.01), and cumulative MACE were 38.9 and 11.1% (P<0.01), respectively., Conclusion: Routine stenting significantly improved the MACE outcome of percutaneous coronary intervention in true coronary bifurcation and bifurcation angle of 60 or less lesions as compared with provisional stenting.

Objective: Cardiac fibroblasts (CFs) regulate myocardial fibrosis and remodeling through proliferation and differentiation. Transforming growth factor-beta1 (TGF-beta1) plays a critical role in the development of myocardial fibrosis after myocardial infarction (MI). The aim of this study was to investigate the effects of inhibiting TGF-beta1 action on myofibroblast differentiation and cardiac function after MI., Methods: CFs were cultured and treated, respectively with PBS, TGF-beta1, soluble TGF-beta1 receptor II (sTbetaRII), and TGF-beta1 plus sTbetaRII. Proliferation CFs were measured by 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) assay. Myofibroblast differentiation was examined by alpha-smooth muscle actin immunostaining. Expression of P-Smad2 and Smad2/3 was determined by immunostaining and western blot analysis. Four days after ligation of left anterior descending coronary artery, sTbetaRII was injected into injured heart. Two weeks after sTbetaRII administration, myofibroblast differentiation was measured with alpha-smooth muscle actin immunostaining. Four weeks after sTbetaRII administration, cardiac function was evaluated by hemodynamic measurements. Weight parameters, infarct size, and collagen fiber were detected with an earlier experimental method., Results: Compared with TGF-beta1, TGF-beta1 plus sTbetaRII significantly decreased cell proliferation, myofibroblast differentiation, and expression of P-Smad2 in CFs (P<0.05). Two weeks after sTbetaRII administration, myofibroblast differentiation in MI rats treated with sTbetaRII was reduced compared with MI group (P<0.05). Four weeks after sTbetaRII administration, MI rats that received sTbetaRII showed significantly higher cardiac function and lower in weight parameters, infarct size, and collagen fiber than that of MI group (P<0.05)., Conclusion: sTbetaRII could inhibit TGF-beta1-induced myofibroblast differentiation, alleviate myocardial fibrosis and remodeling, and improve ischemic cardiac function after MI.

Background: This study sought to examine whether circulatory levels of endothelial dysfunction biomarkers [vascular cell adhesion molecule (sVCAM-1), intercellular adhesion molecule (sICAM-1), sE-selectin, von Willebrand factor (vWF), tissue plasminogen activator (t-PA) and plasminogen activator inhibitor (PAI-1)] are associated with occurrence of late or very late stent thrombosis (ST) after percutaneous coronary intervention with sirolimus-eluting stent implantation, and to assess the possible influence of genetic variants of these proteins on ST., Methods: Serum levels of sVCAM-1, sICAM-1, sE-selectin, vWF, t-PA and PAI-1 were measured, and polymorphisms of vWF (-1234C/T, -1185A/G and -1051G/A), t-PA (insertion/deletion) and PAI-1 genes (4G/5G) were determined in 41 patients who experienced at least one episode of late or very late ST. Eighty-two patients without ST randomly selected from the same study period served as controls., Results: Serum levels of vWF, sVCAM-1 and sICAM-1 were significantly increased in patients with ST than in controls (all P<0.01). No significant difference was observed in the genotype and allele distribution of the vWF, t-PA and PAI-1 gene polymorphisms. Multivariable logistic regression analysis showed that vWF, sVCAM-1, discontinuation of clopidogrel therapy and left ventricular ejection fraction of less than 50% were independent determinants of late ST., Conclusion: Increased serum vWF and sVCAM-1 levels are associated with late ST, suggesting that endothelial dysfunction contributes to the development of late or very late ST.

Objectives: Stent fracture (SF) of sirolimus-eluting stents (SES) has emerged recently in the literature and shown to be associated with an increased risk of restenosis; however, little is known regarding SF after bare-metal stent implantation. We sought to assess whether the use of SES was associated with an increased risk of SF compared with its bare-metal platform, the Bx-velocity stent (BX-BMS)., Methods: A total of 478 lesions in 416 patients undergoing SES implantation and subsequent angiography 6-9 months after the index procedure were compared with 152 lesions in 142 consecutive patients treated with BX-BMS. Stented lesions with total stent-length greater than 40 mm were excluded., Results: There were no significant differences in overall baseline clinical and anatomic features between the SES and BX-BMS groups, or in SF frequencies at 6-9 month follow-up (4.4% for SES and 1.3% for BX-BMS, P= 0.078). In-stent restenosis was observed more often in SF lesions versus non-SF lesions (34.8 vs. 7.7%, P< 0.001) in association with a higher 3-year adverse events rate (27.3 vs. 13.6%, P = 0.076). The risk of SF at 6-9 months was independently associated with total stent length [odds ratio (OR), 2.13; 95% confidence interval (CI), 1.18-3.83; P = 0.012], angulated lesions (OR, 4.25; 95% CI, 1.80-10.00; P = 0.001), and right coronary artery lesions (OR, 3.55; 95% CI, 1.46-8.62; P = 0.005) but not with SES use., Conclusion: Stent implantation in right coronary artery lesions, tortuous lesions, and/or longer lesions covered with longer stents, and not SES versus BX-BMS use, may be associated with increased likelihood of SF.

Objectives: This study aimed to evaluate the impact of angiographic and intravascular ultrasound (IVUS) features on clinical outcome in nondiabetic and type 2 diabetic patients after percutaneous coronary intervention (PCI) with sirolimus-eluting stent (SES) implantation., Methods: Repeat coronary angiography with IVUS imaging was performed after SES-based PCI for de-novo lesions in 128 diabetic and 327 nondiabetic patients (189 lesions and 504 lesions, respectively). The rate of major adverse cardiac events including cardiac death, non fatal myocardial infarction (MI), and target lesion revascularization during clinical follow-up was recorded., Results: In-stent and in-segment late loss, intimal hyperplasia volume, and percentage volumetric obstruction were similar, but stented external elastic membrane cross-sectional area and reference/stented segment ratio were lower in diabetic than in nondiabetic patients. Incomplete stent apposition (ISA) was less frequent, but occurrence of new coronary lesions was higher in diabetic than in nondiabetic patients. Despite similar target lesion revascularization, cumulative survival rates freedom from composite cardiac death and nonfatal MI or major adverse cardiac events were reduced in diabetic patients. Cox proportional hazards model identified diabetes, left ventricular ejection fraction, minimal stent CSA, maximal ISA area, atherosclerotic progression and lesion length as independent predictors of non fatal MI or mortality at follow-up., Conclusion: In diabetic patients, PCI with SES implantation neutralizes the excess risk of intimal hyperplasia and decreases occurrence of ISA, but could not modify the propensity of increased adverse clinical outcomes at follow-up.

Although originally the practice of using balloon catheters proved successful in the short term, the long-term prognosis was less promising because of restenosis, which occurred in >or=30% of patients. This prompted the development of new techniques and mechanical adjuncts, or stents, to maintain lumen patency after balloon angioplasty. Bare metal stents (BMS), the first type of stent used in percutaneous coronary intervention, were designed to address the issues met by balloon angioplasty. BMS reduced the angiographic and clinical restenosis rates in de novo lesions compared to percutaneous transluminal coronary angioplasty alone and decreased the need for emergency coronary artery bypass graft surgery. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred after 6 months in about 20% of cases, necessitating repeat procedures. Drug-eluting stents (DES) improved on the principle of BMS by also delivering drugs locally to inhibit neointimal hyperplasia. DES greatly reduced the incidence of restenosis and resulted in a better safety profile as compared to radiation or systemic drug administration. These advantages and a lower cost compared to surgical interventions make DES an attractive option to treat coronary artery disease. Currently, five DES are available in the USA: the CYPHER sirolimus-eluting stent from Cordis (approved by FDA on 24 April 2003), the TAXUS Express(2) and Liberté paclitaxel-eluting stents from Boston Scientific (approved by FDA on 4 March 2004 and 10 October 2008, respectively) (hereafter TAXUS Express is referred to as TAXUS), the ENDEAVOR zotarolimus-eluting stent from Medtronic (approved by FDA on 1 February 2008), and the XIENCE V everolimus-eluting stent from Abbott Vascular (approved by FDA on 2 July 2008). Following the approval of CYPHER and TAXUS, the clinical data suggested a potential small increase in the rate of stent thrombosis (ST) in DES compared with BMS after implantation. To determine the differences in ST and other rare events between different stents, some modifications have been made to DES clinical trial design, and postmarket surveillance programs have been included to further evaluate the safety and efficacy of each DES. In this review, we will discuss the key clinical outcomes of DES clinical trials, design and key features of the current coronary stents, and major clinical development programs. Postmarket trials, designed to establish long-term safety around ST and other rare clinical events, are also discussed. The future of DES design technologies will also be outlined.

Background: Calcified coronary lesions have commonly been considered as a challenge for interventional cardiologists, and few previous studies of sirolimus-eluting stent (SES) for calcified lesion have been limited by small sample size. Therefore, we evaluated the effectiveness of SES implantation for the treatment of calcified lesions in a large Chinese cohort of real world practice., Methods: A total of 956 consecutive patients who successfully received SES placement were enrolled in this study, and were divided into the two groups according to whether the mild-moderate calcified lesion treated with SES exists or not: noncalcified group (n = 637) and calcified group (n = 319). Lesions treated with SES were subjected to quantitative coronary angiography immediately and 8 months after stenting., Results: Baseline characteristics including clinical, demographic or angiographic data were well balanced between the noncalcified and calcified groups. In the angiographic follow-up at 8 months, the in-stent restenosis and in-segment restenosis rates were similar in both the groups (in-stent restenosis: 3.8 vs. 4.0%, P>0.05; in-segment restenosis: 8.5 vs. 9.7%, P>0.05). The target lesion revascularization was not different between the two groups (5.2 vs. 6.8%; P>0.05). In addition, the in-stent late loss and overall thrombosis rate were also similar in both the groups (0.17+/-0.41 vs. 0.18+/-0.35 mm and 1.8 vs. 1.8%, P>0.05, respectively)., Conclusion: Although stenting of the calcified lesion was hard, successful treatment with SES for mild-moderate calcified lesions was conferred to similar favorable results compared with noncalcified lesions in patients with coronary artery disease.