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Objectives: To evaluate the safety and technical utility of the short track sliding (STS) balloon catheter., Background: An STS balloon catheter is designed to ensure a low profile at the shaft and perform distal anchoring using a single guidewire. However, its clinical practice with the STS balloon catheter has not been reported., Methods: This prospective multi-center registry enrolled 100 patients with significant coronary artery disease who had undergone percutaneous coronary intervention using an STS balloon catheter at three hospitals in Korea from March 2019 to July 2020. Overall safety was assessed as any occurrences of device-related malfunction during the pre-dilation of the lesions. Its technical success rates of the kissing balloon technique or the distal anchoring technique using a single guidewire were also evaluated., Results: Of the 118 lesions pre-dilated using the STS balloon, no significant complication was observed except for three significant coronary dissections, which were completely covered with stents. There was no incidence of balloon catheter malfunction, such as fracture, entrapment, or perforation. With 13 attempts of kissing ballooning techniques with the STS balloon with a 6F guiding catheter, all cases were successful. The distal anchoring techniques were attempted in 10 cases, the stent was successfully crossed to the target lesion in all 10 cases., Conclusions: The novel STS balloon catheter can be safely applied in routine coronary intervention with minimal complications. In addition, this catheter could be useful for performing the kissing balloon technique with a small-caliber guiding catheter and distal anchoring technique with a single guidewire., (© 2021 Wiley Periodicals LLC.)

Background: Research has shown that the prognosis of in-stent restenosis (ISR) lesions after drug-coated balloon (DCB) angioplasty can differ in relation to in-stent neointimal characteristics. However, changes in neointima characteristics after DCB have not been studied. This study sought to investigate changes in neointima characteristics after DCB for ISR., Methods: From the Yonsei Optical Coherence Tomography (OCT) registry, data on DCBs performed in patients with ISR were collected. Neointima characteristics were categorized as homogeneous, heterogeneous, layered neointima, and neoatherosclerosis in each OCT procedure. Homogeneous and layered neointima were classified as a favorable neointima, while heterogeneous neointima and neoatherosclerosis were classified as an unfavorable neointima. The data of 67 ISR patients were analyzed., Results: The median duration between initial and follow-up OCT was 9.6 months. Patients with homogeneous and layered neointima on the initial OCT before DCB mostly appeared as homogeneous (66.7 and 68.2%, respectively) on the follow-up OCT, whereas most of the patients with heterogeneous neointima on the initial OCT remained unaltered (70%). Patients with unfavorable neointima at either the initial (P = 0.023) or the follow-up OCT (P = 0.037) had a worse major adverse cardiovascular event-free survival than the other patients. Patients who showed unfavorable neointima at both the initial and the follow-up OCT had the worst event-free survival (P = 0.038)., Conclusions: The follow-up OCT neointimal characteristics after DCB for ISR was associated with initial OCT characteristics. Sustained unfavorable neointima in serial OCT imaging may reflect poor prognosis in patients with ISR treated with DCB.

Drug-coated balloon (DCB) angioplasty has been shown to be a promising option for the treatment of coronary in-stent restenosis (ISR). We compared the clinical outcomes of patients with ISR who were treated with two commonly used paclitaxel-containing DCBs, the Pantera Lux (PL) and SeQuent Please (SP). A total of 491 patients with 507 ISR lesions [PL-DCB in 127 (26%) patients and SP-DCB in 364 (74%) patients] underwent DCB angioplasty for ISR lesions. The major adverse cardiac events (MACEs), including cardiac death, target lesion-related myocardial infarction, and target lesion revascularization, were assessed. There were no significant differences in each occurrence of MACE and cardiac death: 16 MACEs (61 per 1000 person-years) in the PL-DCB group and 55 (60 per 1000 person-years) MACEs in the SP-DCB group, log-rank p = 0.895, and three cardiac deaths (11 per 1000 person-years) in the PL-DCB group and ten cardiac deaths (11 per 1000 person-years) in the SP-DCB group, log-rank p = 0.849. Diabetes mellitus under insulin treatment [hazard ratio (HR) 2.71; 95% confidence interval (CI) 1.31-5.60; p = 0.007], chronic kidney disease (HR 1.99; 95% CI 1.01-3.92; p = 0.045), early-onset ISR (HR 1.99; 95% CI 1.18-3.36; p = 0.010), and recurrent ISR (HR 1.89; 95% CI 1.08-3.32; p = 0.026) were associated with the occurrence of MACE after DCB angioplasty. There was no significant difference of MACE between PL-DCB and SP-DCB treatment in patients with ISR. Patients with insulin-treated diabetes, chronic kidney disease, early-onset ISR, and recurrent ISR were at a higher risk of MACE after DCB angioplasty.

Background: There are few data of clinical outcomes after drug-coated balloon (DCB) angioplasty according to neointimal characteristics. This study investigated long-term clinical outcomes according to timing of in-stent restenosis (ISR) and neointimal characteristics in patients with drug-eluting stent (DES) ISR after DCB angioplasty. Methods and Results: In all, 122 patients (122 ISR lesions), treated with DCB under optical coherence tomography (OCT) examination before and after DCB, were categorized as early ISR (<12 months; E-ISR; n=21) and late ISR (≥12 months; L-ISR; n=101). Associations between OCT-based neointima characteristics and period of ISR, as well as clinical outcomes after DCB were evaluated. Major adverse cardiac events (MACE) were a composite of cardiac death, non-fatal myocardial infarction, or target lesion revascularization (TLR). Quantitative parameters of the neointima were similar, but qualitative characteristics showed significant differences between the E-ISR and L-ISR groups. The incidence of MACE (33.3% vs. 20.8%; P=0.069) and TLR (33.3% vs. 18.5%; P=0.040) was higher in the E-ISR group. In addition, the incidence of MACE was significantly higher for heterogeneous than non-heterogeneous neointima (43.7% vs. 19.6%; P=0.018), but was not significantly associated with neoatherosclerosis (33.4% vs. 18.4%; P=0.168)., Conclusions: DCB angioplasty is less effective for heterogeneous neointima in DES ISR. OCT-based neointimal evaluation may be helpful in guiding treatment of DES ISR.

Even though drug-coated balloon (DCB) angioplasty has emerged as a treatment option for drug-eluting stent in-stent restenosis (DES-ISR), the most effective treatment strategy for DES-ISR is still under debate. Therefore, we compared long-term clinical outcomes following DCB treatment of DES-ISR with those following 2nd-generation drug-eluting stent (DES) treatment. We identified 248 DES-ISR lesions in 238 patients that were treated with either 2nd-generation DES implantation (n = 56) or DCB angioplasty (n = 192). We compared the incidences of major adverse cardiac events (MACEs) in the two groups during the 2-year period following treatment. MACE was defined as cardiac death, non-fatal myocardial infarction, or target-vessel revascularization. The percentage of patients with diabetes and the mean age of patients in the DCB group were greater than in the DES group. The DCB group also had a smaller reference vessel diameter. The DES group had a larger post-intervention minimal luminal diameter. We found no significant difference in the MACE rate between the two groups during the 2 years following treatment (11.0 % in the DCB group vs. 8.9 % in the DES group, p = 0.660). Reference segment diameter was the only independent predictive factor for MACE in the post-treatment period (hazard ratio 0.35, 95 % confidence interval: 0.15-0.82, p = 0.016). Clinical efficacy of DCB angioplasty for treatment of DES-ISR was comparable to that of 2nd-generation DES implantation as measured by the rate of MACEs in the two groups. Reference segment diameter was the only statistically significant independent predictor for MACE in the 2-year period following treatment.

Background: There has not been sufficient data to evaluate the serial vascular healing pattern after everolimus-eluting stent (EES) implantation. Using optical coherence tomography, we compared serial changes in strut coverage of the EES and the first-generation sirolimus-eluting stent (SES)., Methods: Sixty patients were randomly assigned to receive either EES (n = 30) or first-generation SES (n = 30) for coronary artery disease. Serial optical coherence tomography evaluation immediately after the procedure, and 3- and 12-month follow-ups were performed in 50 patients with 54 stents (25 patients with 28 EES vs. 25 patients with 26 SES). The percentage of uncovered struts was defined as the ratio of uncovered struts to total struts. The primary end point was the percentage of uncovered struts at 12-month follow-up. The secondary primary end point was the percentage of uncovered struts at the 3-month follow-up and the comparative percentage change (Δ) of uncovered struts at 3- and 12-month follow-ups of EES vs SES., Results: The percentage of uncovered struts was significantly lower in the EES group compared with the SES group (median value, 6.9%; interquartile range [IQR], 3.9-10.6% vs. 11.1%; IQR, 5.5-29.4%, respectively) at the 3-month follow-up (P = 0.03), and at the 12-month follow-up (median value, 1.3%; IQR, 0.3-3.5% vs. 3.6%; IQR, 1.0-9.4%; P = 0.02). The percentage Δ of uncovered struts from the 3- to the 12-month follow-up was similar (-7.0 ± 6.9% in EES vs. -10.5 ± 13.6% in SES; P = 0.24)., Conclusions: The EES group showed more favourable stent strut coverage than the first-generation SES group at the early and late periods after stent implantation. These findings suggest that EES have a more beneficial effect for vascular healing., (Copyright © 2015 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

We sought to evaluate the temporal course of neointimal hyperplasia (NIH) after drug-eluting stent (DES) implantation, using serial optical coherence tomography (OCT). We identified 89 DES (82 patients) that had at least three consecutive cross-sections with a mean NIH thickness >100 µm on first follow-up OCT. Qualitative and quantitative changes in NIH were then assessed at a second follow-up OCT. NIH regression and progression were defined as a decrease or increase in mean NIH cross-sectional area >0.2 mm2, respectively, between the two studies. Between the first and second OCT there was a decrease in NIH in 29 lesions (32.6%), and an increase in NIH in 37 lesions (41.6%). Compared to patients with neointimal progression, those with regression showed lower levels of high sensitivity C-reactive protein (hsCRP) (p = 0.036) and higher levels of high-density lipoprotein (p = 0.012). Between the first and the second OCT, there were no significant changes in NIH morphologic patterns in 67 (75.3%) of 89 DES. In lesions with NIH regression, the evolution of heterogeneous to homogeneous neointima was observed, while the evolution of heterogeneous or homogeneous to layered neointima or the evolution of heterogeneous, homogeneous, or layered neointima to neoatherosclerosis was detected in lesions with NIH progression (p < 0.001). The hsCRP level at index procedure was significantly associated with neointimal regression in multivariate model (odds ratio 0.891, 95% confidence interval 0.796-0.999, p = 0.048). During late follow-up, OCT shows both NIH progression and regression that are paralleled by qualitative changes indicating increasing stability (in regression) and increasing instability (in progression).

The use of drug-eluting stent (DES) has been associated with incomplete endothelialization and coronary endothelial dysfunction. However, the relationship between endothelial vasomotor function and strut coverage evaluated by optical coherence tomography (OCT) has not been sufficiently assessed. Therefore, we evaluated the relationship between endothelial vasomotor function and the degree of stent strut coverage after DES implantation. Coronary angiography and OCT were performed in 112 patients at the 6-month follow-up after DES implantation. The patients were divided into tertiles according to the degree of strut coverage as was assessed by OCT. Endothelial vasomotor function was evaluated with intracoronary infusion of incremental doses of acetylcholine (Ach; 10(-8)-10(-6) mol/L). Vascular responses at the proximal and distal segments to the stent margin were evaluated by quantitative coronary angiography analysis before and after Ach infusion. The percentage of uncovered struts in tertiles 1-3 was 4.2 ± 3.3, 17.3 ± 4.2 and 44.5 ± 14.4 %, respectively, (p < 0.001). The percentage of maximal vasoconstriction in tertiles 1-3 was 8.3, 9.1 and 8.1 % at proximal segment to the stent margin (p = 0.95), respectively, and 13.9, 11.1 and 14.2 % at distal segment to the stent margin (p = 0.74), respectively. The percentage of uncovered struts was not correlated with the degree of vasomotor function (r = -0.01, p = 0.92 at the proximal segment; r = -0.07, p = 0.47 at the distal segment). The percentage of strut coverage was not associated with the degree of abnormal vasoconstriction in response to intracoronary infusion of Ach 6 months after DES implantation.

Objectives: The goal of this study was to evaluate shorter duration (3 months) dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation., Background: There have been few published reports of prospective randomized clinical studies comparing the safety and efficacy of shorter duration DAPT after DES implantation., Methods: We randomly assigned 2,117 patients with coronary artery stenosis into 2 groups according to DAPT duration and stent type: 3-month DAPT following Endeavor zotarolimus-eluting stent (E-ZES) implantation (E-ZES+3-month DAPT, n=1,059) versus 12-month DAPT following the other DES implantation (standard therapy, n=1,058). We hypothesized that the E-ZES+3-month DAPT would be noninferior to the standard therapy for the primary composite endpoint (cardiovascular death, myocardial infarction, stent thrombosis, target\vessel revascularization, or bleeding) at 1 year., Results: The primary endpoint occurred in 40 (4.7%) patients assigned to E-ZES+3-month DAPT compared with 41 (4.7%) patients assigned to the standard therapy (difference: 0.0%; 95% confidence interval [CI]: -2.5 to 2.5; p=0.84; p<0.001 for noninferiority). The composite rates of any death, myocardial infarction, or stent thrombosis were 0.8% and 1.3%, respectively (difference: -0.5%; 95% CI: -1.5 to 0.5; p=0.48). The rates of stent thrombosis were 0.2% and 0.3%, respectively (difference: -0.1%; 95% CI: -0.5 to 0.3; p=0.65) without its further occurrence after cessation of clopidogrel in the E-ZES+3-month DAPT group. The rates of target vessel revascularization were 3.9% and 3.7%, respectively (difference: 0.2%; 95% CI: -2.3 to 2.6; p=0.70)., Conclusions: E-ZES+3-month DAPT was noninferior to the standard therapy with respect to the occurrence of the primary endpoint. (REal Safety and Efficacy of a 3-month dual antiplatelet Therapy following E-ZES implantation [RESET]; NCT01145079)., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

There have been little data regarding major determinants for the uncovered stent struts after drug-eluting stent (DES) implantation on optical coherence tomography (OCT). We investigated the major determinants of incomplete neointimal coverage of DES struts on OCT after implantation in a large cohort of patients. A total of 261 patients with 279 lesions who were treated with various DESs were selected from the OCT registry database. The lesions were divided into two groups based on the ratio of uncovered struts to total struts in all OCT cross-sections; an uncovered group (highest quartile with % uncovered struts ≥5.4%, n = 70), and covered group (the remaining lower quartiles with % uncovered struts <5.4%, n = 209). The uncovered group was more likely to have complex lesions, smaller reference vessel and stent diameter, and longer stent, more use of sirolimus-eluting stents, and less use of zotarolimus-eluting stents compared with the covered group. Of these variables, the most significant determinant of uncovered stent struts was DES type (odds ratio [OR] = 2.75, 95% confidence interval [CI] = 1.94-3.89, P < 0.001). The use of sirolimus-eluting stents (OR = 2.44, 95% CI, 1.15-5.47, P = 0.023) and zotarolimus-eluting stents (OR = 0.02, 95% CI = 0.01-0.25, P = 0.002) were the only significant risk and protective factors for uncovered stent struts, respectively. This study demonstrated that DES type might be associated with the most important determinants of uncovered struts compared to any other clinical or angiographic factor.

Previous optical coherence tomography (OCT) studies in patients with drug-eluting stents (DESs)-related very late stent thrombosis (VLST) were scarce. Therefore, we investigated OCT findings of VLST after implantation of DESs. Using OCT, we analyzed the status of stent struts and neointimal characteristics in 18 patients who developed VLST after DES implantation. These results were compared to those in 57 patients with neointimal hyperplasia causing >40% diameter stenosis. Lipid-laden neointima was defined as a region with marked signal attenuation and a diffuse border. Four (22.2%) of 18 patients with VLST had ruptured and lipid-laden neointima inside DESs without uncovered or malapposed stent struts. In the remaining 14 patients who developed VLST without neointimal rupture, uncovered and malapposed struts were observed in nine and seven patients, respectively, and lipid-laden neointima in four patients. Lipid-laden neointima was more frequently observed in four patients with neointimal rupture than in 14 patients without neointimal rupture (100% vs. 28.6%, respectively, P = 0.023). Of 57 patients with neointimal hyperplasia, eight (14.0%) had lipid-laden neointima. Time to OCT study after DES implantation was significantly longer in the eight patients with lipid-laden neointima than in 49 patients without lipid-laden neointima (45.5 ± 17.7 months vs. 11.7 ± 7.2 months, respectively, P < 0.001). Lipid-laden neointima was detected in some patients with neointimal hyperplasia > 1 year after DES implantation. In addition to uncovered or malapposed struts, rupture of lipid-laden neointima inside DESs was identified in some patients with DES-related VLST.

Recent studies reported favorable angiographic and clinical outcomes after everolimus-eluting stent (EES) implantation. However, there were no studies to assess vascular responses after EES implantation using optical coherence tomography (OCT). Therefore, the OCT findings in EES were investigated and compared with those in sirolimus-eluting stent (SES). Follow-up OCT studies were performed in 110 lesions (40 EES and 70 SES) of 104 patients at 9 months after stent implantation. The strut apposition, neointimal hyperplasia (NIH) thickness and stent coverage on each stent struts were evaluated. The mean NIH thickness was significantly greater in EES-treated lesions than in SES-treated lesions (115 ± 52 μm vs. 89 ± 58 μm, P = 0.001, respectively). The percentage of uncovered strut was significantly smaller in EES-treated lesions than in SES-treated lesions (4.4 ± 4.7% vs. 10.5 ± 12.7%, P = 0.016, respectively). There was no significant difference in the percentage of malapposed strut between the two groups (0.4 ± 0.8% in EES vs. 1.7 ± 4.5% in SES, P = 0.344). The incidence of intracoronary thrombus was significantly lower in EES-treated lesions than in SES-treated lesions (5.0% vs. 34.3%, P < 0.001, respectively). EES showed a significantly lower incidence of uncovered stent struts and intracoronary thrombus than SES in 9-month follow-up OCT examination. Compared to SES, EES might have more favorable vascular responses after stent implantation.

There is currently no established standard treatment for in-stent restenosis (ISR) after the implantation of a drug-eluting stent (DES). The aim of this study was to investigate the efficacy of DES versus balloon angioplasty (BA) for the treatment of DES ISR in a multicenter registry cohort. After matching propensity scores of 805 patients with DES ISR treated with either DES (n = 422) or BA (n = 383), 268 matched pairs were selected and analyzed for major adverse cardiac events, a composite of death, myocardial infarction, and target-vessel revascularization, as the primary end point. Baseline clinical and lesion characteristics of the matched pairs were similar. Survival free of major adverse cardiac events at 2 years was higher with DES compared to BA (88.9% vs 78.7%, p <0.001), mainly because of higher TVR-free survival (92.4% vs 81.0%, p <0.001). Among various baseline variables, BA (hazard ratio 2.546, 95% confidence interval 1.412 to 4.593, p = 0.002) was the most important independent risk factor for recurrent target vessel revascularization, followed by acute coronary syndromes as the clinical presentation of DES ISR, and previous implantation of a sirolimus-eluting stent. Survival free of death, myocardial infarction, or stent thrombosis did not differ between the 2 groups. Whereas there was no significant difference in survival free of target vessel revascularization between DES and BA for focal ISR lesions, DES was superior to BA in diffuse ISR lesions (94.3% vs 75.2% at 2 years, p <0.001). In conclusion, compared to BA, the implantation of DES was safe and more effective in the treatment of DES ISR., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Background: This study investigated the efficacy and the safety of the upstream glycoprotein (Gp) IIb/IIIa inhibitor (clotinab; ISU ABXIS, Seoul, Republic of Korea) under 600-mg clopidogrel pretreatment compared with provisional use in ST-elevation myocardial infarction (STEMI)., Methods and Results: A total of 786 STEMI patients were randomized to upstream use in the emergency room (ER) (n = 392) or provisional use during percutaneous coronary intervention (PCI) (n = 394). All patients were prescribed 600-mg clopidogrel in the ER. The primary endpoint was the 30-day incidence of composite events including death, nonfatal myocardial infarction, target vessel revascularization, and stroke. There was no significant difference in the events that occurred in 40 patients (10.2%) in the upstream arm and 55 patients (14.0%) in the provisional arm during the 30 days (odds ratio 0.70, 95% confidence interval 0.45-1.08). Major bleeding was higher in the upstream arm (1.5% vs. 0%, P = 0.02). However, there was a significant reduction in 30-day composite events in the upstream arm in the high-risk population (Killip class ≥II or GRACE score >140)., Conclusions: The upstream use of clotinab under a 600-mg clopidogrel loading may not significantly reduce cardiac events following primary PCI but may improve the clinical outcome in high-risk patients.

Objective: To investigate the long-term prognostic implications of contrast-induced acute kidney injury (CI-AKI) with transient or persistent renal dysfunction in acute myocardial infarction (AMI) patients undergoing percutaneous coronary intervention (PCI)., Design: A retrospective observational registry study., Setting: Clinical follow-up after PCI. Patients and methods A total of 1041 PCI-treated AMI patients from the Infarction Prognosis Study registry. CI-AKI was defined as an increase in serum creatinine (>25% or >0.5 mg/dl (>44.2 μmol/l)) within 2 days after PCI. Main outcome measures Two-year cumulative event rate of all-cause death or renal failure requiring dialysis., Results: CI-AKI was observed in 148 patients (14.2%). Patients with CI-AKI had a higher rate of death or dialysis (25.4% vs. 6.3%, p<0.001) at 2 years compared with patients without CI-AKI. CI-AKI was an important independent predictor of death or dialysis (HR 2.76, 95% CI 1.61 to 4.73, p<0.001) Persistent renal dysfunction after CI-AKI was documented in 68 patients (45.9%). Patients with transient renal dysfunction showed a lower 2-year event rate of death or dialysis compared with those with persistent renal dysfunction (17.9% vs. 34.1%, p=0.013); however, they showed a higher event rate compared with those without CI-AKI (17.9% vs. 6.3%, p<0.001)., Conclusion: Transient and persistent renal dysfunction after CI-AKI was associated with increased short and long-term mortality and morbidity in AMI patients treated by PCI. Better preventive strategies are needed to improve clinical outcomes in AMI patients at high risk of developing CI-AKI.

Late stent thrombosis (LST) which is a life threatening complication has emerged as a serious problem of drug-eluting stents (DES). Several studies have suggested that incomplete neointimal coverage of stent struts contributes to LST. Progressive atherosclerosis within the neointima is an another possible cause of LST, but this phenomenon has seldom been reported in DES. We present a case of LST following DES implantation after a period of 28 months due to ruptured atheromatous plaque, despite complete neointimal coverage of stent struts proven by optical coherence tomography.

Hyperhomocysteinemia induces oxidative stress and endothelial dysfunction, which share the proposed pathophysiologic mechanisms of contrast-induced nephropathy (CIN). However, no study has investigated the relation between hyperhomocysteinemia and CIN. The aim of the present study was to evaluate the effects of hyperhomocysteinemia on CIN in patients undergoing percutaneous coronary intervention. This was an observational cohort study that included 572 patients who underwent percutaneous coronary intervention. CIN was defined as an absolute ≥0.5 mg/dl or a relative ≥25% increase in the serum creatinine level at 48 hours after the procedure. The incidence of CIN was significantly greater in patients in the third homocysteine tertile (from lowest to highest, 4.7%, 7.3%, and 24.2%, p <0.001). Furthermore, the homocysteine levels were significantly greater in patients with CIN than in those without CIN (16.9 ± 4.9 vs 13.5 ± 4.2 μmol/L, p <0.001). In multiple logistic regression models, hyperhomocysteinemia was an independent risk factor for CIN (per the SD change in the plasma homocysteine level [4.44 μmol/L], odds ratio 1.70, 95% confidence interval 1.07 to 2.71, p = 0.025) after adjusting for major risk factors such as age, diabetes, and baseline cardiac and renal function. In subgroup analyses according to diabetes, acute coronary syndrome, or baseline estimated glomerular filtration rate, significant, graded associations were found between the homocysteine level and the incidence of CIN. In conclusion, hyperhomocysteinemia is independently associated with a greater risk of CIN in patients undergoing percutaneous coronary intervention., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Background: Characterization of neointimal tissue is essential to understand the pathophysiology of in-stent restenosis (ISR) after drug-eluting stent (DES) implantation. Using optical coherence tomography (OCT), we compared the morphologic characteristics of in-stent neointimal tissue from 33 ISR lesions with those of 192 non-ISR lesions after DES implantation., Hypothesis: We hypothesized that the morphologic characteristics of in-stent neointimal tissue from ISR lesions were different from those of non-ISR lesions after DES implantation., Methods: The DES were coated with sirolimus (n=52), paclitaxel (n=57), zotarolimus (n=84), or everolimus (n=32). In-stent restenosis was defined as ≥50% diameter stenosis at the follow-up angiogram. Lesions with ≥10% neointimal burden ([neointima area × 100]/[stent area]), as determined by OCT, were included in this study. A follow-up OCT (mean follow-up duration, 12.0 ± 10.5 mo) was performed in 209 patients with 225 lesions (ISR lesions, n=33; non-ISR lesions, n=192). Qualitative OCT was used to assess tissue structure, backscatter, visible microvessels, and presence of intraluminal material., Results: The following characteristics were more common in ISR lesions than in non-ISR lesions: heterogeneous or layered tissues (78.8% vs 22.9%, P<0.001), low backscatter (60.6% vs 20.8%, P<0.001), and microvessels (48.5% vs 5.7%, P<0.001). The independent predictors for heterogeneous or layered neointimal tissues were increased neointima burden (odds ratio [OR]: 1.218, 95% confidence interval [CI]: 1.096-1.354, P<0.001), lumen area (OR: 4.672, 95% CI: 1.371-15.914, P = 0.014), and hypertension (OR: 0.415, 95% CI: 0.186-0.926, P = 0.032)., Conclusions: This follow-up OCT study demonstrated that morphologic characteristics of neointimal tissues of ISR lesions differ from those of non-ISR lesions., (© 2011 Wiley Periodicals, Inc.)

Background: Loss of side-branch vessels is a serious complication following stent implantation in parent vessels of bifurcation lesions. The purpose of this study was to introduce and test a new stent design for the protection of side-branch vessels in the management of bifurcation lesions., Methods and Materials: This stent has multiple radio-opaque markers in its central portion, whose presence is useful in avoiding stent-strut placement across the side-branch orifice and in correctly directing the insertion of a second guide wire through the struts into the side branch to minimize jailing of side branches during stent deployment in the parent vessel. In vitro tests of the acrylic resin bifurcation phantom model were performed under fluoroscopic guidance in the catheterization laboratory with 10 stents with multiple radio-opaque markers and 10 stents without. Kissing balloon angioplasty was performed across the side branch after stent implantation in the parent vessel in both groups. Side-branch jailing by the stent (presence of any stent struts crossing the side-branch orifice) was determined visually and compared between the two groups., Results: The jailed side branch with the stent struts was observed in one of 10 new stents and in five of 10 conventional stents without them., Conclusions: The in vitro tests demonstrated the superiority of a new stent design for the reduction of side-branch jailing in bifurcation lesions., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Purpose: It is unknown whether cilostazol pretreatment reduces postprocedural myonecrosis (PPMN). Cilostazol pretreatment reduces PPMN after percutaneous coronary intervention (PCI)., Materials and Methods: A total of 120 patients with stable angina scheduled for elective PCI were randomly assigned to a 7-day pretreatment with Cilostazol (200 mg/day) or to a control group. Creatine kinase-MB (CK-MB) and cardiac troponin I (cTnI) levels were measured at baseline and at 6 and 24 hours after PCI. The primary end-point was the occurrence of PPMN, defined as any CK-MB elevation above the upper normal limit (UNL). Aspirin and clopidogrel were co-administered for 7 days before PCI, and resistance to these agents was then assayed using the VerifyNow System., Results: There was no difference in baseline characteristics between the final analyzable cilostazol (n=54) and the control group (n=56). Despite a significantly greater % inhibition of clopidogrel in the cilostazol group (39±23% versus 25±22%, p=0.003), the incidence of PPMN was similar between the cilostazol group (24%) and the control group (25%, p=1.000). The rate of CK-MB elevation at ≥3 times UNL was also similar between the two groups (6% versus 5%, p=0.583). The incidence of cTnI increase over the UNL or to 3 times the UNL was not different between the two groups. There was no significant difference in terms of the rate of adverse events during follow- up, although the cilostazol group showed a tendency to have a slightly higher incidence of entry site hematoma., Conclusion: This trial demonstrated that adjunctive cilostazol pretreatment might not significantly reduce PPMN after elective PCI in patients with stable angina.

Many studies have demonstrated that late or very late thrombosis after drug-eluting stent (DES) implantation may be related with incomplete neointimal coverage. We investigated long-term (≥2 years) results of neointimal coverage following sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) implantation using optical coherence tomography (OCT). A follow-up angiography with OCT examination was performed in 29 patients with 32 lesions for more than 2 years (group 1; 1,066 ± 381 days) and 101 patients with 104 lesions at 9 months (group 2; 273 ± 33 days) after the index procedure. The status of neointimal coverage and stent apposition was evaluated. The number of stents with completely covered struts was higher (25.0% in group 1 vs. 13.5% in group 2, P = 0.12). The percentage of uncovered struts (5.4 ± 7.5% in group 1 vs. 8.5 ± 11.6% in group 2, P = 0.19) and that of malapposed strut (0.5 ± 1.4% vs. 1.5 ± 4.2%, respectively, P = 0.19) were lower in group 1. While the percentage of uncovered and malapposed struts were quite similar in the PES groups between the two groups (P = 0.54 and 0.65, respectively), there were lower trends in the percentage of uncovered and malapposed struts in the SES group (P = 0.09 and 0.09, respectively). In conclusion, incomplete neointimal coverage was still observed in a majority of DESs and considerable struts were not covered with neointima even at more than 2 years after DES implantation. The pattern of neointimal coverage between 9-month and 2-year appeared to be somewhat different between PES and SES.

Background: Various platelet function tests are currently used to measure responsiveness to antiplatelet therapy. We sought to compare 2 point-of-care platelet function tests, VerifyNow Assay (Accumetrics, San Diego, CA) and Multiple Electrode Platelet Aggregometry (MEA) (Dynabyte, Munich, Germany), for predicting early clinical outcomes after percutaneous coronary intervention., Methods: Platelet reactivity in the arachidonic acid-induced and adenosine diphosphate (ADP)-induced platelet aggregation was measured simultaneously with the VerifyNow Assay and MEA in 222 patients undergoing percutaneous coronary intervention between August and October 2009. We investigated the correlations between the 2 tests and performed receiver operating characteristic curve analysis for major adverse cardiovascular events (MACE), a composite of death, myocardial infarction (MI), stroke, and target vessel revascularization, at 30 days., Results: Major adverse cardiovascular events occurred in 19 patients (8.6%), including 14 patients with periprocedural MI and 5 patients with stroke. Correlations were weak between the 2 tests in the arachidonic acid-induced (Spearman r = 0.189, P = .006) and ADP-induced platelet reactivity (Spearman r = 0.390, P < .001). Although the VerifyNow P2Y12 Assay (Accumetrics) was able to predict periprocedural MI (area under the aggregation curve 0.680, P = .024) and 30-day MACE (area under the aggregation curve 0.649, P = .032), VerifyNow Aspirin Assay (Accumetrics), MEA ASPI test, and MEA ADP test failed to predict such clinical events. Hyporesponsiveness to clopidogrel based on the VerifyNow Assay was associated with about a 6-fold increased risk of MACE at 30 days., Conclusions: Hyporesponsiveness to clopidogrel measured by VerifyNow Assay was able to identify patients with dual antiplatelet therapy who were at higher risk for periprocedural MI and MACE at 30 days. Further randomized studies are required to validate the effectiveness of different platelet function tests for predicting long-term clinical outcomes., (Copyright © 2011 Mosby, Inc. All rights reserved.)

Objectives: The aims of this study were to identify the efficacy of optimal stent expansion (OSE) according to the Multicenter Ultrasound Stenting in Coronaries Study (MUSIC Study) criteria in drug-eluting stent (DES) and compare paclitaxel-eluting stent (PES) to sirolimus-eluting stent (SES)., Background: Although poststent high-pressure balloon dilatation is proposed after bare metal stent implantation according to OSE, defined by the criteria of the MUSIC Study, very little data are available in DES., Methods: Two hundred fifty patients (M:F = 149:101; age, 61.5 ± 9.2 years) who underwent 9-month follow-up angiography in the Poststent Optimal Stent Expansion Trial (POET) were included in this study. We assessed angiographic in-stent restenosis (ISR) and neointima volume (NV) using IVUS at 9 months., Results: At 9-month follow up, there were no significant differences in ISR and NV index (NV/stent length, mm(2) ) between patients with and without OSE. However, the rate of ISR and NV index were higher in PES [ISR: 18 (13.7%) and 4 (3.4%), P = 0.004; NV index: 1.02 ± 0.99 mm(2) and 0.21 ± 0.37, P < 0.001 in PES and SES]., Conclusions: OSE according to the MUSIC Study criteria was not related to ISR and NV in the DES era but PES had a significantly higher ISR rate and NV than SES after poststent high-pressure balloon dilatation., (Copyright © 2010 Wiley-Liss, Inc.)

Background: One of the most important reasons for failure of percutaneous coronary intervention (PCI) in chronic total occlusion (CTO) is calcified plaque, which either prevents passage of guide wire or ruptures after balloon inflation. We sought to evaluate whether quantified calcium contents of CTO on multi-detector computed tomography (MDCT) correlate with immediate procedural outcomes., Methods: Sixty-four patients with 72 CTO lesions who underwent 64-slice MDCT prior to PCI were investigated. The lesions were divided into 2 groups according to procedural outcomes (55 lesions with PCI-success group, 17 lesions with PCI-failure group). Clinical, angiographic and MDCT parameters, including regional calcium volume (RCaV), regional calcium score (RCaS), regional calcium equivalent mass (RCaEq), and relative calcium area at the most calcified cross section of CTO (%CaS/CSA), were compared between the two groups., Results: The duration of CTO was shorter in PCI-success group than PCI-failure group (7.16 ± 10.5 vs 15.59 ± 14.92 months, p=0.011), and the procedural success rate was 76.3%. Regional calcium-related parameters (RCaV 52.86 ± 58.39 vs 7.26 ± 15.27 mm(3), p<0.001; RCaS 72.71 ± 78.4 vs 9.66 ± 20.2, p<0.001; RCaEq 12.58 ± 12.97 vs 1.84 ± 3.716 mgCaHA, p<0.001; %CaS/CSA 53.9 ± 20.3 vs 30.4 ± 17.1%, p=0.009) in the occluded segment were higher and the occlusion length was longer (37.44 ± 27.48 vs 22.00 ± 18.04 mm, p<0.021) in PCI-failure group compared to PCI-success group. Multivariate regression analysis showed that only %CaS/CSA was a significant determinant of PCI-failure., Conclusions: Precise quantification of regional calcification and measurement of the occluded segment by high resolution MDCT can deliver important information for predicting procedural outcomes in PCI of CTO., (Copyright © 2009 Elsevier Ireland Ltd. All rights reserved.)

Background: Measurement of fractional flow reserve (FFR) has been frequently used to optimize the results of coronary stenting in patients with significant narrowing of coronary arteries., Hypothesis: There has been a consensus that an FFR value > 0.90 after stenting is a useful surrogate for favorable long-term clinical outcome. We evaluated the efficacy of FFR measurement at side branch vessels of true coronary bifurcation lesions that were treated with the crush stenting technique., Methods: This study included 12 patients with significant narrowing in both a main coronary vessel and side branch vessel who underwent the crush stenting procedure., Results: After crush stenting, FFR measurement was performed at the side branch vessel prior to and after kissing balloon angioplasty (KBA). FFR values increased significantly, from 0.94 +/- 0.04 pre-KBA to 0.97 +/- 0.03 post-KBA (P = 0.011). FFR values after crush stenting but prior to KBA already measured > 0.90 in 9 of the 12 patients (75%). FFR values for the remaining 3 patients were 0.88, 0.88, and 0.90, respectively., Conclusions: FFR measurement at side branch vessels of coronary bifurcation lesions treated with crush stenting may not contribute to adequate decision-making for improvement of long-term clinical outcomes. KBA should be strongly considered for patients with bifurcation lesions treated with crush stenting.

The status of neointimal coverage on the drug-eluting stent (DES) struts, which are placed across the side-branch vessels, remains unclear. The degree of neointimal coverage of stent struts crossing the side-branch vessel was evaluated according to the different types of DESs. Follow-up optical coherence tomography images at 9.3 months after the index procedure were identified in 51 patients who had undergone DES (sirolimus-eluting stents [SESs] in 22 patients, paclitaxel-eluting stents [PESs] in 15, and zotarolimus-eluting stents [ZESs] in 14) implantation with crossover of the side-branch vessels (size >2.0 mm). The enrolled patients were classified as a covered group if every unapposed strut showed neointimal coverage or an uncovered group if any struts lacked neointimal coverage. The neointimal hyperplasia thickness was also measured. The number of patients in the covered group was 15 (29%), with 36 patients in the uncovered group. Significant differences were found in the proportion of the covered group among the 3 DES types (6 [27%] of 22 with SESs, 1 [7%] of 15 with PESs, and 8 [57%] of 14 with ZESs; p = 0.011). The percentage of neointimal coverage in the overall stent struts was also significantly different among the 3 DES types (65% of 356 struts, 20% of 165 struts, and 83% of 143 struts for the SESs, PESs, and ZESs, respectively; p<0.001). The neointimal hyperplasia thickness in the PES group was significantly smaller than those of the ZES and SES groups (0.02 +/- 0.02 mm vs 0.08 +/- 0.06 mm and 0.04 +/- 0.03 mm, respectively; p = 0.002). In conclusion, different patterns of neointimal coverage of the stent struts crossing the side branch vessels were observed according to the type of DES., (Copyright 2010 Elsevier Inc. All rights reserved.)

The introduction of optical coherence tomography has provided a new method for evaluating the vascular response to drug-eluting stents (DESs). We used optical coherence tomography to compare neointimal coverage and stent malapposition among DESs in patients with ST-segment elevation myocardial infarction. Optical coherence tomography was performed at 9 months after implantation of 3 types of DESs at the culprit lesions in 46 patients with ST-segment elevation myocardial infarction (16 sirolimus-eluting stents [SESs, Cypher Select], 11 paclitaxel-eluting stents [PESs, Taxus Liberte], and 19 zotarolimus-eluting stents [ZESs, Endeavor Sprint]). The neointimal thickness and apposition at each strut at each 1-mm interval and the presence of thrombi in each stent were evaluated. A total of 11,512 stent struts were analyzed. SESs had the thinnest neointimal thickness (SES 62 +/- 43 mum vs PES 244 +/- 142 mum vs ZES 271 +/- 128 mum, p <0.001). The incidence of uncovered struts and malapposed struts were significantly greater in SESs and PESs than in ZESs (SES vs PES vs ZES, 16.2 +/- 17.8% vs 4.7 +/- 7.4% vs 0.6 +/- 1.5%, respectively, p = 0.001; and 4.0 +/- 8.2% vs 2.1 +/- 4.5% vs 0 +/- 0%, respectively, p = 0.001). Thrombus was also detected more often in SESs and PESs than in ZESs (SES, 6 [38%] vs PES, 3 [27%] vs ZES, 1 [5%], p = 0.02). In conclusion, the rate of stent strut coverage and malapposition were significantly different among the DES types in ST-segment elevation myocardial infarction. In particular, most stent struts in ZESs were covered with neointima and well-apposed. These findings imply that the type of DES might affect the vascular response in thrombotic lesions of ST-segment elevation myocardial infarction., (Copyright 2010 Elsevier Inc. All rights reserved.)

Objectives: This study sought to determine the efficacy of high-dose atorvastatin in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI)., Background: Previous randomized trials have demonstrated that statin pre-treatment reduced major adverse cardiac events (MACEs) in patients with stable angina pectoris and acute coronary syndrome. However, no randomized studies have been carried out with STEMI patients in a primary PCI setting., Methods: A total 171 patients with STEMI were randomized to 80-mg atorvastatin (n = 86) or 10-mg atorvastatin (n = 85) arms for pre-treatment before PCI. All patients were prescribed clopidogrel (600 mg) before PCI. After PCI, both groups were treated with atorvastatin (10 mg). The primary end point was 30-day incidence of MACE including death, nonfatal MI, and target vessel revascularization. Secondary end points included corrected thrombolysis in myocardial infarction frame count, myocardial blush grade, and ST-segment resolution at 90 min after PCI., Results: MACE occurred in 5 (5.8%) and 9 (10.6%) patients in the 80-mg and 10-mg atorvastatin pre-treatment arms, respectively (p = 0.26). Corrected thrombolysis in myocardial infarction frame count was lower in the 80-mg atorvastatin arm (26.9 +/- 12.3 vs. 34.1 +/- 19.0, p = 0.01). Myocardial blush grade and ST-segment resolution were also higher in the 80-mg atorvastatin arm (2.2 +/- 0.8 vs. 1.9 +/- 0.8, p = 0.02 and 61.8 +/- 26.2 vs. 50.6 +/- 25.8%, p = 0.01)., Conclusions: High-dose atorvastatin pre-treatment before PCI did not show a significant reduction of MACEs compared with low-dose atorvastatin but did show improved immediate coronary flow after primary PCI. High-dose atorvastatin may produce an optimal result for STEMI patients undergoing PCI by improving microvascular myocardial perfusion. (Efficacy of High-Dose AtorvaSTATIN Loading Before Primary Percutaneous Coronary Intervention in ST-Elevation Myocardial Infarction [STATIN STEMI]; NCT00808717)., (Copyright (c) 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The differences between using sirolimus-eluting stents (SESs) and paclitaxel-eluting stents (PESs) in the vascular response at 9 months after implantation were examined with optical coherence tomography (OCT)., Methods and Results: OCT was carried out in 33 SESs [33 patients, 19 with acute coronary syndrome (ACS) and 14 with stable angina pectoris (SAP)] and 27 PESs (27 patients, 15 with ACS and 12 with SAP) at 9 months after stent implantation. Stent strut coverage and apposition at each strut were evaluated. The frequency of uncovered struts was significantly higher in SES (12.5+/-15.2 vs 4.9+/-7.9 %, P=0.01). The incidence of complete covered stents with neointima was 9.1% (3/33) in SES and 29.6% (8/27) in PES (P=0.05). The pattern of neointima in PES was more heterogeneous than that in SES (1.3+/-0.5 for SES vs 2.0+/-0.6 for PES, P<0.001). The intracoronary thrombus was frequently detected in SES [10 (30.3%) in SES vs 5 (18.5%) in PES, P=0.29]., Conclusions: Uncovered struts were frequently observed in SES, but the pattern of neointima was more heterogeneous in PES at 9 months. In addition, stent coverage was incomplete in both stent groups at 9 months after stent implantation.

Background: There has been much debate for the adequate treatment strategies for true bifurcation lesions. The purpose of this study is to introduce and test a novel stent design for the treatment of true bifurcation lesions., Methods: This side branch stent is composed of three parts: proximal, connecting, and distal parts. The distal part for the side branch vessel has a slope-side stent margin for circumferential coverage of the ostium and one radio-opaque marker for targeting the carina. The proximal part with two radio-opaque markers operates for safe stent delivery and useful guidance for a more precise placement of the distal part on the side branch ostium. Results of the in vitro test in the acrylic resin-made bifurcation phantom model were evaluated with microcomputer tomography. Animal experiments with this new stent platform were also performed in five pigs., Results: In vitro test and microcomputer tomography showed complete coverage of the side branch ostium circumferentially with stent struts, and the absence of stent struts in the main vessel above the side branch ostium level. This side branch stents were successfully deployed in all 5 pigs. The results of animal experiments were also similar to those of in vitro tests., Conclusions: In vivo and vitro tests demonstrated the effective modality of this side branch stent for the treatment of true bifurcation lesions.

Background: We compared the effect of arterial remodeling on intimal hyperplasia (IH) after the implantation of a sirolimus-eluting stent (SES) and a paclitaxel-eluting stent (PES)., Methods: The study population consisted of patients with positive or intermediate remodeling and negative remodeling., Results: Sixty-nine patients had positive or intermediate remodeling and 107 patients had negative remodeling. At follow-up, late loss was significantly larger (0.58 +/- 0.65 vs. 0.38 +/- 0.55 mm; p = 0.026) in the patients with positive or intermediate remodeling. The IH volume (22.6 +/- 26.2 vs. 12.4 +/- 17.4 mm(3); p = 0.002) and the percent IH (12.9 +/- 14.8 vs. 7.0 +/- 9.6%; p = 0.002) were significantly higher in the patients with positive or intermediate remodeling. Compared to negative remodeling, the IH volume was higher in the PES patients with positive or intermediate remodeling, but this difference was not noted in the SES patients. Multiple-regression analysis revealed that arterial remodeling was a significant independent variable for predicting IH volume in the PES patients (p = 0.018). A positive correlation was found between the remodeling index and the IH volume in the PES patients (r = 0.234, p = 0.028), but not in the SES patients., Conclusions: This prospective observational intravascular ultrasound study showed that drug-eluting stents may have a different effect on reducing IH accumulation in lesions with preinterventional positive remodeling characteristics which may be related to the different properties of the drug and delivery platform., (Copyright 2010 S. Karger AG, Basel.)

Objectives: We performed this study to investigate the vascular response in early period after zotarolimus-eluting stent (ZES) (Endeavor Sprint, Medtronic CardioVascular, Minneapolis, Minnesota) implantation., Background: The ZES has different characteristics, with biocompatible polymer and rapid drug-elution, compared with the first-generation drug-eluting stents (DES)., Methods: The ENDEAVOR OCT (Evaluation in 3 Months Duration of Neointimal Coverage after Zotarolimus-Eluting Stent Implantation by Optical Coherence Tomography) trial is a prospective, single-center study evaluating vascular healing patterns with optical coherence tomography (OCT) at 3 months after stent implantation. A total of 31 ZES in 30 patients underwent serial OCT at immediate post-intervention and 3 months. Neointimal growth and malapposition were analyzed at each stent strut of cross-sectional OCT images with 0.5-mm intervals., Results: The incidence of malapposition at post-intervention and 3 months was 6.0% and 0.2%, respectively. However, late acquired malapposition was not detected at 3 months. Of 31 stents, 27 stents (87.1%) were covered completely with neointima, but the remaining 4 stents had 2 (0.8%), 4 (0.9%), 4 (1.2%), and 6 (1.4%) uncovered struts. Overall mean percentage of covered stent struts was 99.9 +/- 0.4%. This finding was consistent among groups with acute coronary syndrome and stable angina pectoris (99.9 +/- 0.3% vs. 99.9 +/- 0.4%, p = 0.92). Intracoronary thrombus was documented in 1 stent (3.2%) among 31 stents., Conclusions: Most of the stent struts were covered with neointima, and late acquired malapposition was not found at 3 months after ZES implantation. Therefore, the current study demonstrated that ZES might have a favorable in vivo vascular response at 3 months after stent implantation. (Evaluation of Zotarolimus Eluting Stent at 3 Months Using Optical Coherence Tomography [ENDEAVOR OCT]; NCT00815139).

Objectives: Coronary collaterals have been shown to protect ischemic myocardium from necrosis in patients with acute myocardial infarction (AMI). We sought to determine the impact of collateral circulation on infarct size in AMI using serial cardiac magnetic resonance (CMR)., Methods: A total of 46 anterior AMI patients (age, 58.9+/-10.6 years; male 72.3%) undergoing primary percutaneous coronary intervention (PCI) were investigated. The infarct size was measured on serial CMR performed within 7 days after primary PCI (acute stage) and 3 months later (chronic stage)., Results: Thirty-four patients (73.9%) showed collateral flow before primary PCI. CMR taken at the acute stage showed no significant difference in infarct size between two groups. However, follow-up CMR revealed significantly smaller percentage of infarct thickness (51.8+/-14.0 vs. 62.5+/-11.7%, P = 0.035) and mass (22.3+/-9.9 vs. 30.9+/-11.6%, P = 0.042) in patients with collaterals. There were significant changes from the acute to chronic stage regarding left ventricular end-systolic (-18.2+/-10.0 vs. 0.8+/-2.5 ml, P = 0.022) and end-diastolic volume (-14.8+/-9.2 vs. 2.6+/-13.7 ml, P = 0.031), percentage of infarct mass (-6.1+/-2.8 vs. -0.8+/-1.1%, P = 0.034), and thickness (-8.9+/-3.3 vs. -3.1+/-2.8%, P = 0.029) in collateral group compared with noncollateral group on serial CMR., Conclusion: Serial CMR revealed the effect of collaterals in patients with AMI on reduction of infarct size and improvement of myocardial remodeling at the chronic stage.

Background: Several reports have suggested that stent fractures in sirolimus-eluting stents (SESs) might be related to in-stent restenosis (ISR). However, the role of stent strut fracture in ISR has not been clearly elucidated. Therefore, we investigated the association of the SES fracture and ISR., Methods: From 2003 to 2006, SES implantations with follow-up coronary angiography (CAG) for 628 lesions in 557 patients were analyzed. We reviewed clinical and procedural factors that might affect SES fracture and ISR. The median time interval from stent implantation to follow-up CAG was 9 months (range: 2-30 months)., Results: ISR occurred in 38 patients (5.7%), and 21 stent fractures (3.3%) were identified by follow-up CAG. Fourteen cases occurred in the left anterior descending artery, and seven occurred in the right coronary artery. The binary ISR rate in the stent fracture group was higher compared with that of the nonfracture group (38.1% vs. 4.6%, P<0.001). Predictors of ISR as estimated by multivariate analysis were a stent diameter less than 2.75 mm [odds ratio (OR)=2.76, P=0.012], a stent length over 28 mm (OR=3.30, P=0.024), and stent fracture (OR=11.03, P<0.001) after controlling for the angiographic and clinical risk factors of ISR., Conclusion: Stent fracture was an independent predictor of ISR and may be one of the crucial mechanisms of ISR after implantation of an SES.

Background: There is some controversy on long-term cardiac outcomes between sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in diabetes mellitus (DM). We compared cardiac adverse events after SES and PES implantation in patients with DM over a period of 3 year., Methods: A total of 634 patients with DM treated with SES (n = 428) or PES (n = 206) were consecutively enrolled in the KOMATE registry from 2003 to 2004. We assessed major adverse cardiac events (MACEs, cardiovascular death, nonfatal myocardial infarction, ischemia driven target vessel revascularization) and stent thrombosis (ST) according to the definitions set by the Academic Research Consortium., Results: Propensity score (PS) analysis was performed to adjust different baseline characteristics. The mean follow-up duration was 38 +/- 8 month (at least 36 month and up to 53 month). The 3-year MACE rate did not show a significant difference between the two groups [52 (12.1%) in SES vs. 29 (14.1%) in PES, P = 0.496]. The definite and probable ST at 3 year were similar in both SES and PES [12 (2.8%) in SES vs. 7 (3.4%) in PES, P = 0.681]. There were no differences in hazard ratio for MACE and ST between two stents [MACE, crude: 0.844 (0.536-1.330) and adjusted for PS: 0.858 (0.530-1.389); ST, crude: 0.820 (0.323-2.083) and adjusted for PS: 0.960 (0.357-2.587)]., Conclusions: The present study demonstrated that long-tem cardiac outcomes including ST were not significantly different between SES and PES in patients with DM., ((c) 2008 Wiley-Liss, Inc.)

Background: The aim of the present study was to determine whether the parameters of cardiac magnetic resonance imaging (CMRI) might correlate with early ST-segment resolution (STR) after primary percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI)., Methods and Results: CMRI was performed in 45 STEMI patients (age: 56.6+/-13.0 years) at 8.2+/-8.0 days (early phase) and 3.3+/-1.1 months (late phase) after successful PCI. CMRI parameters were compared between 2 groups: > or = 70% STR (group 1, n = 21) and < 70% STR (group 2, n = 24). Both groups had similar baseline characteristics, except for a higher frequency of > or = 2 myocardial blush grade and shorter pain-to-balloon time in group 1. Early-phase CMRI showed that persistent microvascular obstruction (PMO) (38.1% vs 91.7%, p < 0.001) occurred less frequently and the percent infarct mass against total left ventricular (LV) mass (17.7+/-8.7% vs 29.1+/-13.4%, p = 0.001) was smaller in group 1. Late-phase CMRI revealed a significant increase in LV end-diastolic volume (-1.5+/-8.7 vs 14.5+/-25.5 ml, p = 0.026) and reduced ejection fraction (55.0+/-9.9% vs 47.8+/-11.1%, p = 0.027) in group 2., Conclusions: CMRI demonstrated that early STR might be related to PMO and infarct size, and predicts LV dysfunction and adverse LV remodeling. Also, early-phase CMRI findings are comparable to late-phase CMRI in association with early STR.

The impact of type of balloon such as noncompliant (NC; Quantum) or semicompliant (SC; Maverick(2)) used after stent dilation on optimal stent expansion (OSE) has not been established for drug-eluting stents (DESs). We conducted a prospective multicenter, randomized study to compare NC with SC balloons after stent balloon dilatation. A total of 301 patients (127 men, 83 women, 62 +/- 9 years of age) treated with a DES (sirolimus-eluting stent [SES], n = 152; paclitaxel-eluting stent, n = 149) were included. OSE followed the definition of the Multicenter Ultrasound Stenting in Coronaries (MUSIC) study. The primary end point was the incidence of OSE using intravascular ultrasound according to type of balloon. Baseline characteristics of each group showed no significant differences. OSE in the SC balloon group was achieved at higher rates than the NC balloon group (53 +/- 35%, vs 73 +/- 48%, p = 0.022 in all stents; 25 +/- 33%, vs 36, 48%, p = 0.051 in SESs). However, any differences in the achievement of OSE between the NC and SC balloon groups were not present in paclitaxel-eluting stents. In conclusion, despite postadjuvant balloon inflations with high pressures, underexpansion of the DES was seen commonly. Between the 2 types of balloon for adjuvant dilation after DES implantation, same-size SC balloons could be more useful for obtaining OSE than NC balloons, especially in SESs.

Purpose: This study was designed as a multicenter, randomized, open-label study to evaluate the efficacy and tolerability of Clotinab. We expected to obtain same results as with ReoPro in improving ischemic cardiac complications in high-risk patients who were about to undergo percutaneous coronary intervention (PCI)., Patients and Methods: Patients of 19-80 years of age with acute coronary syndrome (ACS) who were about to undergo PCI were enrolled. After screening and confirmation of eligibility, patients were randomly assigned to different groups. Clotinab was given to 84 patients (58.7+/-10.6 years, M:F=68:16)and ReoPro(59.0+/-10.5 years, M:F=30:10) was given to 40 patients before PCI. The primary efficacy endpoint was the onset of major adverse cardiac event (MACE) within 30 days from day 1. The tolerability endpoints were assessed based on bleeding, thrombocytopenia, change in Hb/Hct, human antichimetric antibody development, and adverse events., Results: The number of Clotinab patients experiencing MACE was 0 out of 76 per protocol (PP) patients. The MACE rate was 0%, and its 95% exact CI was [0.00-4.74%]. A major bleeding event developed in 3 patients in the ReoPro group. The probability of MACE onset in Clotinab was estimated to be less than 5%. There was no clinically significant result in tolerability variables., Conclusion: Clotinab is an effective and safe medicine in preventing ischemic cardiac complications for high-risk patients who will receive PCI.

Background: Interaction between advanced glycosylation end products (AGEs) and receptor for AGEs (RAGE) in vessel wall may lead to inflammation, smooth muscle cell proliferation, and extracellular matrix production, culminating in exaggerated intimal hyperplasia and restenosis. We investigated the possibility that single nucleotide polymorphisms of the genes encoding RAGE are associated with in-stent restenosis after coronary stenting., Methods: Our study included 334 consecutive non-diabetic male patients with symptomatic coronary artery disease who underwent bare metal stent implantation. Follow-up angiography was performed in 297 patients (88.9%), 6 months after intervention. We screened -1106T-->C, -443T-->C, -388T-->A, -257G-->A, +557G-->A and +1704G-->T RAGE polymorphisms in these patients. Genotyping was performed by single base extension with amplifying primers and probes for TaqMan., Results: A total of 355 target lesions were evaluated, in 297 patients. There was no significant association of the -1106T-->C, -443T-->C, -388T-->A, -257G-->A, +557G-->A or +1704G-->T polymorphisms with in-stent restenosis after coronary artery stenting. We did not observe a significant difference between the genotype distributions and the rates of angiographic restenosis between the polymorphisms. In a multivariate analysis of angiographic restenosis, we examined the possible influence of the baseline, lesion-related, and procedural variables. After adjustment for these potentially confounding factors, the multivariate analysis did not reveal an association of polymorphism with angiographic restenosis., Conclusion: Our observation suggests that the RAGE gene polymorphism is not associated with in-stent restenosis after coronary artery stenting in non-diabetic patients in the Korean population., (2007 S. Karger AG, Basel)

Background: Besides distal embolization of thrombus and plaque debris, locally increased inflammatory markers at the site of ruptured plaque in acute myocardial infarction (AMI) are thought to have an adverse impact on myocardial reperfusion during primary percutaneous coronary intervention (PCI). However, there is lack of data on such factors. Therefore, we investigated the presence of locally increased inflammatory and vasoactive factors in culprit coronary artery., Methods: We performed primary PCI with PercuSurge GuideWire system in 18 AMI patients. We collected blood samples from the femoral artery before PCI and from culprit coronary artery after first predilation while inflating the distal protection balloon and after completing PCI. We determined concentrations of C-reactive protein, soluble CD40 ligand, Interleukin (IL-6), serotonin, tissue factor, and factor VIIa., Results: While the concentrations of soluble CD40 ligand (2.84+/-3.74 vs 0.98+/-0.63 ng/mL, p=0.004), IL-6 (33.67+/-32.63 vs 17.08+/-21.41 pg/mL, p<0.001), serotonin (2.05+/-0.76 vs 0.92+/-0.60 ng/mL, p<0.001), tissue factor (257.17+/-84.34 vs 154.60+/-87.99 pg/mL, p<0.001) and factor VIIa (34.30+/-27.30 vs 24.19+/-28.00 ng/mL, p=0.016) were significantly higher in the culprit coronary artery than in the femoral artery, CRP levels did not differ. The locally elevated concentrations of various factors were successfully reduced after multiple aspirations of blood using the PercuSurge GuideWire system., Conclusions: We found increased levels of soluble CD40 ligand, IL-6, serotonin, tissue factor and factor VII in the culprit coronary artery compared to those in peripheral blood. The clinical impact of such locally increased soluble factors in the culprit coronary artery needs to be investigated in further studies.

Essential thrombocythemia (ET) is a clonal disorder of myeloid stem cells that causes thrombocytosis. As a result, ET can lead to vascular thrombosis and tissue ischemia; the association of coronary artery abnormalities such as myocardial infarction or unstable angina is rare. Here we describe a 45,-year-old male patient with essential thrombocythemia who presented with unstable angina. Elective coronary angiography showed total occlusion of mid right coronary artery and mid left anterior descending coronary artery. ET was confirmed by a bone marrow biopsy; treatment was started with antiplatelet therapy including aspirin and clopidogrel along with cytostatic therapy with hydroxyurea and anagrelide. After the initiation of the treatment, the platelet count decreased to 20 x 10(4)/microL. In addition, percutaneous coronary angioplasty was successfully performed with stent placement at the right coronary artery without hemorrhagic or thrombotic complications.

Background: Neointimal hyperplasia and resulting restenosis limit the long-term success of coronary stenting. Heavy metal ions induce an inflammatory and allergic reaction, and result in in-stent restenosis. However, a carbon ion-implanted surface might prevent heavy metal ions from diffusing into surrounding tissue., Methods: 140 lesions in 140 patients with coronary lesions underwent implantation of carbon-implanted surface stents (Arthos(inert) stent group, n=70) or control stents (Arthos stent group, n=70). The primary end point was the in-stent restenosis and the secondary end point was the value of hs-CRP at 48 h and 6 months after coronary stenting. Clinical and angiographic follow-ups were performed at 6 months., Results: The rate of in-stent restenosis was lower in the Arthos(inert) stent group (15.9%, 10/63) than in the Arthos stent group (20.9%, 13/62), but there were no significant differences between both groups (p=0.56). The value of hs-CRP at 48 h was lower in the Arthos(inert) stent group (13.9+/-13.4 mg/dl) than in the Arthos stent group (24.5+/-26.0 mg/dl) with significant differences (p=0.04). However, the differences between two groups were not statistically significant at 6 months (p=0.76)., Conclusions: As compared with a standard coronary stent, a carbon ion-implanted stent shows no considerable benefit for the prevention of in-stent restenosis within the range of this study. Despite all the limitations of this study, a positive effect of a carbon ion-implanted stent in reducing inflammatory reaction after coronary revascularization seems likely., (Copyright (c) 2005 S. Karger AG, Basel.)

Background: Brachytherapy is the only effective treatment for in-stent restenosis (ISR). The preliminary data regarding cutting balloon angioplasty (CBA) are encouraging and suggest a possible additive effect of CBA with combination with vascular brachytherapy. Hence, in this study, we evaluated the efficacy, feasibility and safety of cutting balloon angioplasty followed by intracoronary Holmium (166Ho) brachytherapy for the treatment of in-stent restenosis., Methods and Materials: Fifty-six patients with in-stent restenosis were treated with cutting balloon angioplasty and intracoronary 166Ho brachytherapy. For irradiation, a balloon approximately 10 mm longer than the initially deployed stent was filled with liquid 166Ho and placed at the in-stent restenosis lesion. The patients were followed angiographically at 6 months and clinically for 19.0+/-9.8 months., Results: The initial procedures were successful in all of the patients. The preprocedural average minimal luminal diameter (MLD) and stenosis rate were 0.57+/-0.30 mm and 80.2+/-11.6%, respectively. The MLD and residual stenosis immediately after the procedure was 2.43+/-0.37 and 13.8+/-9.9%, respectively. Thirty-nine (69.6%) patients have completed their angiographic follow-up at 6 months. The MLD, late loss and loss index at follow-up were 1.97+/-0.79 mm, 0.72+/-0.69 mm and 0.36+/-0.34, respectively. The target lesion restenosis rate was 20.5% and the target lesion revascularization rate was 3.6%. None of these patients presented with adverse coronary events such as MI, sudden cardiac death or stent thrombosis during the follow up period., Conclusion: The combination therapy using cutting balloon angioplasty and intracoronary 166Ho brachytherapy may be an effective new treatment modality for in-stent restenosis.