Edge restenosis has gained attention as a main cause of restenosis after first-generation drug-eluting stent (DES) implantation. The aim of this study was to assess the incidence of edge restenosis ...and identify the predictors of edge restenosis after second-generation DES implantation. Data were obtained from several postmarketing surveillance (PMS) studies on a cobalt-chromium everolimus-eluting stent (CoCr-EES; Xience V/PROMUS, Xience Prime, Xience Prime SV, and Xience Expedition SV), a second-generation DES, in Japan. Angiographic analysis was conducted at the baseline and after eight months on the following subsegments: in-stent region, proximal edge, and distal edge. Restenosis was defined as ≥ 50% diameter stenosis (DS) at follow-up. We used multivariate logistic regression (with lesions as a random effect) to compare the instances of restenosis between the proximal and the distal edges. Univariate and multivariate analyses of the risk factors for restenosis were performed for each subsegment. We analyzed 1,966 lesions in 1,687 patients. The restenosis rates at the in-stent region, proximal edge, and distal edge were 4.4%, 3.0%, and 1.1%, respectively. The risk of restenosis at the distal edge was significantly lower than that at the proximal edge, when adjusted for 13 variables. The predictors of restenosis were postprocedural % diameter stenosis (%DS), postprocedural reference diameter, ≥ 45° bending, stent overlap at the proximal edge, and postprocedural %DS at the distal edge. Our analysis of eight-month angiographic outcomes from CoCr-EES PMS demonstrated that postprocedural %DS is a major predictor of edge restenosis. Edge restenosis is more likely attributable to postprocedural angiographic results than to the patient's background.
Abstract Background The autonomic nervous system involves the genesis of premature ventricular contractions (PVCs). Previous studies demonstrated that heart rate (HR) dependency of idiopathic PVCs ...has different autonomic mechanisms. Recently, the bisoprolol patch, a novel transdermal β1-blocker formulation containing bisoprolol, became clinically available. We examined the efficacy of the bisoprolol patch for treating frequent PVCs in patients without structural heart disease (SHD) regarding the HR dependency of PVCs. Methods This prospective study included 44 consecutive patients without SHD (25 men, mean age, 63.6 ± 12.3 years) with PVC counts≥3000 beats as measured by 24-hour Holter electrocardiograms (ECGs). PVCs were divided into positive HR-dependent PVCs (P-PVCs) and non-positive HR-dependent PVCs (NP-PVCs) based on the relationship between the hourly PVC density and hourly mean HR. A bisoprolol patch was administered once daily at a dose of 4 mg. The 24-hour Holter ECGs were performed before and 1 month after the initiation of the therapy. Results In 44 patients, there were 24 P-PVCs and 20 NP-PVCs. The bisoprolol patch reduced the PVC count significantly (from 16,563 ± 10,056 to 7892 ± 8817 beats/24 hours, p < 0.001) in the P-PVC group, while the PVC count did not change significantly (from 16,409 ± 9571 to 13,476 ± 12,191beats/24 hours, p = 0.34) in the NP-PVC group. Moreover, in the P-PVC group, the patients with mean HRs ≥80 beats/minute had a significantly higher percent improvement in the PVC count than those with mean HRs <80 beats/minute ( p = 0.0080). The bisoprolol patch resulted in a significant reduction in the PVC count from baseline during each time period for the changes within a 24-hour period in the P-PVC group. Conclusions The transdermal bisoprolol patch was effective for a PVC reduction in patients with P-PVCs, particularly in those with faster mean HRs. Furthermore, it demonstrated a stable PVC-reducing effect during the 24-hour period in the P-PVC group.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Hemodialysis (HD) is associated with a high in-stent restenosis (ISR) rate even in the second-generation era. Drug-coated balloons (DCB) generally provide excellent clinical outcomes in patients with ...ISR lesions. Nonetheless, safety and efficacy of DCB for ISR lesions in HD patients are largely unknown. A total of 17 centers across Japan participated in this study. Patients were eligible for the study if ISR lesions were treated with DCB. Enrolled patients were divided into 2 groups (HD and non-HD groups). Angiographic, OCT, and clinical outcomes were compared between the HD and the non-HD groups. A total of 210 patients were enrolled (36 patients in the HD group, and 174 patients in the non-HD group). At 8 months, the binary restenosis rate was significantly higher (26.3% versus 11.3%,
p
= 0.02) and in-segment late loss was significantly higher (0.49 ± 0.61 mm versus 0.23 ± 0.33 mm,
p
= 0.02) in the HD group than the non-HD group. In the OCT analyses, change of minimum stent area between post- and pre-procedure was significantly smaller in the HD group compared to the non-HD group (0.08 ± 0.95 mm
2
versus 0.68 ± 1.07 mm
2
,
p
= 0.004). Target vessel failure (TVF) rate at 2 years was significantly different between the 2 groups (25.0% in the HD group and 12.1% in the non-HD group,
p
= 0.04). In the multivariate analysis, HD was a significant predictor for TVF (Hazard ratio 5.81, 95% CI 1.28–26.4,
p
= 0.02). Clinical and angiographic outcomes following OCT-guided DCB treatment in ISR lesions were significantly worse in HD patients compared to non-HD patients.
Clinical Trial Registration Information:
https://clinicaltrials.gov/ct2/show/NCT02300454
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
We sought to examine the intravascular ultrasound (IVUS) findings of stent fracture. Stent fracture has been implicated as a cause of drug-eluting stent failure. IVUS is more likely to identify ...mechanisms of stent failure—including stent fracture—than angiography. Twenty stent fractures diagnosed by IVUS in 17 patients were evaluated. Eighteen stent fractures (90%) occurred in sirolimus-eluting Cypher stents, and 2 stent fractures (10%) occurred in bare metal stents, but none occurred in paclitaxel-eluting Taxus stents. Half of the stent fractures presented ≤1 year after implantation, and ½ presented >1 year after implantation. IVUS analysis showed that 9 stent fractures were complete (45%) and 11 were partial (55%); 10 (50%) were adjacent to stent metal overlap; and 5 occurred in a coronary aneurysm accompanied by malapposition (all Cypher stents) despite the absence of an aneurysm at index stenting. Compared with 60 matched control segments in patients without stent fracture, but with similar clinical events, the stent fracture group had longer stent segments (45.2 ± 23.0 vs 28.5 ± 14.9 mm, p = 0.003). Comparing stent fractures associated with an aneurysm (n = 5) with those that did not occur in association with an aneurysm (n = 15) showed that complete stent fracture was more frequent (100% vs 27%, p = 0.008), and all presented >1 year after index stenting (vs 33%, p = 0.03). In conclusion, IVUS is helpful to identify stent fracture as a cause of stent failure and to understand possible mechanisms of stent fracture such as aneurysm formation.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
•Brachial-ankle pulse wave velocity (baPWV) is a marker of arterial stiffness.•Prognostic impact of baPWV after transcatheter aortic valve replacement is unknown.•High baPWV was associated with ...1-year adverse clinical events.•In addition, high baPWV was associated with delayed left ventricular reverse remodeling.•Patients with increased arterial stiffness may need careful follow-up and management.
Increased left ventricular (LV) afterload in patients with aortic stenosis consists of valvular and vascular loads; however, the effects of vascular load induced by arterial stiffness on clinical outcomes after transcatheter aortic valve replacement (TAVR) remain unclear. This study evaluated the prognostic value of brachial–ankle pulse wave velocity (baPWV) after TAVR.
A retrospective study including 161 consecutive patients who underwent TAVR with a pre-procedural baPWV assessment was conducted. We investigated the association between baPWV and the 1-year composite outcome comprising all-cause death and rehospitalization related to heart failure. Echocardiographic measurements including the LV mass index (LVMi) and LV diastolic function at 1, 6, and 12 months after TAVR were assessed.
Of the 161 patients, 31 patients experienced composite outcome within 1 year after TAVR. The receiver operating characteristic curve analysis revealed that the discriminating baPWV level to discern 1-year composite outcome was 1,639 cm/s, and all subjects were allocated to two groups based on the result. Baseline characteristics were comparable between the high baPWV (n = 72) and low baPWV groups (n = 89). The Kaplan–Meier curve revealed a significantly higher cumulative 1-year composite outcome in the high baPWV group than in the low baPWV group (31% vs. 10%; log-rank test, p<0.001). High baPWV was an independent predictor of the 1-year composite outcome (adjusted hazard ratio, 3.42; 95% confidence interval, 1.62–7.85; p = 0.002). Furthermore, post-procedural echocardiography revealed that the high baPWV group had less LVMi regression and higher E/e’ after TAVR compared to the low baPWV group. The delayed reversal in LVMi and diastolic function attributable to arterial stiffness might be linked to impaired clinical outcomes after TAVR.
Higher baPWV could be associated with adverse clinical outcomes and delayed reverse LV remodeling after TAVR.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Coronary calcification (CCA) is one of the independent predictors for major adverse cardiac events (MACEs) in coronary intervention. Post-marketing surveillance study Japan is a prospective registry ...designed to evaluate the safety and efficacy of the everolimus-eluting stent (EES, XIENCE V/PROMUS Stent) in routine clinical practice at 47 centers. In this study, 1848 lesions (1546 patients) were assessed using quantitative coronary angiography. In these 1546 patients, renal function data were unknown in 26 patients. Three patients in 70 patients with dialysis and 56 patients in 1450 patients with no dialysis were excluded, because they had multiple lesions with mixed calcification lesions. We evaluated the effects of CCA on 8-month angiographic and 3-year clinical outcomes in dialysis and non-dialysis patients. Moderate-to-severe (Ca group) and none-to-mild CCA (non-Ca group) were observed in 33 lesions (30 patients) and 48 lesions (37 patients) in dialysis patients, and these were observed in 306 lesions (286 patients) and 1303 lesions (1108 patients) in non-dialysis patients, respectively. In non-dialysis patients, the ischemic-driven target lesion revascularization (ID-TLR) and MACE rate over the 3 years were significantly higher in the Ca group than in the non-Ca group (5.8 vs. 3.1%,
p
= 0.025 and 10.0 vs. 5.0%,
p
= 0.0011). In dialysis patients, ID-TLR and MACE rates were high in both groups (14.3 vs. 17.9%,
p
= 0.85 and 17.5 vs. 36.1%,
p
= 0.16). In non-dialysis patients, 8-month angiographic and 3-year clinical outcomes were worse in the Ca group. However, in dialysis patients, both outcomes were worse regardless of CCA.
Clinical Trial registration
https://clinicaltrials.gov/ct2/show/NCT01086228
.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
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