Background:The Cobalt-Chromium Everolimus-Eluting Stent (CoCr-EES) Post-marketing Surveillance (PMS) is a prospective multicenter registry designed to evaluate the safety and efficacy of XIENCE ...V/PROMUS everolimus-eluting stents in routine clinical practice at 47 centers representative of the clinical environment in Japan.Methods and Results:We enrolled 2,010 consecutive patients (2,649 lesions) who underwent PCI using CoCr-EES. Clinical outcomes were evaluated for up to 3 years. Clinical follow-up was available in 1,930 patients (96%) at 3 years. Major adverse cardiovascular events (MACE) occurred in 6.8% of patients, including cardiac death (1.7%), myocardial infarction (1.5%), and clinically driven target lesion revascularization (CD-TLR, 4.2%). Late CD-TLR rate was 0.8% from 1 to 2 years, and 0.5% from 2 to 3 years. Definite or probable stent thrombosis occurred in 7 patients (0.3%) up to 1 year. There was no very late definite or probable stent thrombosis from 1 to 3 years. Significant independent predictors for MACE were hemodialysis, prior coronary intervention, triple-vessel coronary artery disease, and age >70 years.Conclusions:Three-year clinical outcomes from the CoCr-EES PMS demonstrated a low incidence of clinical events. There was no major concern about very late stent thrombosis or late catch-up phenomenon in patients treated with EES in routine clinical practice in Japan. (Circ J 2016; 80: 906–912)
Background:Selective use of distal filter protection during percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS) decreased the incidence of no-reflow phenomena and in-hospital ...serious adverse cardiac events compared with conventional PCI in patients with attenuated plaque ≥5 mm; however, its long-term clinical outcome remains unknown.Methods and Results:Patients who had ACS with attenuated plaque ≥5 mm were assigned to receive distal protection (DP) (n=98) or conventional treatment (CT) (n=96). The rate of major adverse cardiovascular events (MACE), a composite of death from any cause, non-fatal myocardial infarction, or target vessel revascularization (TVR) at 1 year, was the pre-specified secondary endpoint of the trial. MACE at 1 year occurred in 12 patients (12.2%) in the DP group and 3 patients (3.1%) in the CT group (P=0.029), which was driven by a higher risk of TVR (11 11.2% vs. 2 2.1%, P=0.018). In patients treated with bare-metal stents (n=42), MACE occurred in 25.0% of the patients in the DP group and in none of the patients in the CT group (P=0.029), whereas in patients treated with drug-eluting stents (n=151), rates of MACE were similar in the groups (8.1% vs. 3.9%, P=0.32).Conclusions:In ACS patients with attenuated plaque ≥5 mm, the 1-year rates of MACE were higher in the DP group than in the CT group. This effect might be mitigated by the use of drug-eluting stents.
Recently developed coronary angiography with intraprocedural 320-row computed tomography can be performed in a catheterization laboratory (XACT) by injecting contrast medium from a place close to the ...coronary arteries, thereby requiring a minimal amount of contrast medium. However, its clinical application has not yet been established. This study aimed to evaluate the diagnostic accuracy of XACT angiography with a minimal volume of contrast medium in patients with suspected coronary artery disease (CAD). A total of 167 coronary segments were analyzed in 14 patients (9 males, median age 70 years) with suspected CAD by XACT angiography with 7.5 ml of contrast medium and invasive coronary angiography (ICA) with standard techniques. The segmental-based diagnostic accuracy of XACT angiography in detecting stenosis of ≥ 50% and ≥ 75% and visualized by ICA was good (sensitivity: 74% and 62%, specificity: 99% and 99%, positive predictive value: 93% and 80%, and negative predictive value: 97% and 97%, respectively). These results suggest that XACT angiography with a very low amount of contrast medium may have strong clinical utility for screening coronary arteries in patients with renal dysfunction or undergoing clinical procedures such as pacemaker implantation.
Abstract Using a novel combined angiography-computed tomography (CT) system, we evaluated the impact of the intra-aortic root position of a right coronary artery (RCA) catheter on its coaxiality. We ...retrospectively enrolled 19 patients who underwent CT scans during bilaterally engaged percutaneous coronary intervention (PCI). Coaxiality was defined as the angle between the RCA and the RCA catheter. The coaxiality was better when the RCA catheter was placed anterior to the left main coronary artery (LMCA) catheter (median 27.0 vs. 53.7 degrees, p = 0.02). The position of the RCA catheter had a significant impact on the coaxiality of it, with a coaxiality improvement ratio of 0.506 (95% confidence interval 0.294 - 0.871, p = 0.017). Three-dimensional reconstructed CT images of the right anterior oblique (RAO) projection could determine the position of catheters in all cases. In conclusion, the RCA catheter should be placed anterior, rather than posterior, to the LMCA catheter for better coaxiality during bilaterally engaged PCI. The RAO projection is useful for determining the catheter position.
The Cobalt Chromium Everolimus-Eluting Stent (CoCr-EES) Post Marketing Surveillance (PMS) Japan study is a prospective multicenter registry designed to evaluate the safety and efficacy of XIENCE ...V/PROMUS everolimus-eluting stents in routine clinical practice at 47 centers representative of the clinical environment in Japan. We enrolled 2010 consecutive patients (2649 lesions) who underwent percutaneous coronary intervention using CoCr-EES. Clinical outcomes were evaluated through 5 years. Mean age was 68.8 years, 41.9% had diabetes, 4.9% received hemodialysis. Five-year clinical follow up was available for 1704 (84.8%) patients. Major adverse cardiovascular events (MACE) occurred in 10.7% of patients, including cardiac death (3.8%), myocardial infarction (1.8%), and clinically driven target lesion revascularization (TLR) (6.0%). Beyond 1 year, annual incidence of clinically driven TLR was 0.5–0.8%. Definite or probable stent thrombosis occurred in 9 (0.5%) patients at 5 years. After 1 year, definite stent thrombosis occurred in only 1 patient. Significant predictors for MACE were dialysis (ODDs ratio 4.58, 95% CI 2.75–7.64), prior cardiac intervention (ODDs ratio 2.47, 95% CI 1.75–3.49), total stent length (ODDs ratio 1.01, 95% CI 1.01–1.02), and number of diseased vessels (ODDs ratio 1.66, 95% CI 1.08–2.55). Five-year clinical outcomes from the CoCr-EES PMS Japan study demonstrated a low incidence of clinical events in the daily practice up to 5 years.
Clinical Trial Registration Information:
https://clinicaltrials.gov/ct2/show/NCT01086228
.
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.
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
.
Background: Peri-stent contrast staining (PSS) has been recognized as a predictor of late stent thrombosis following drug-eluting stent (DES) implantation. However, the intravascular conditions at ...PSS sites remain unclear. Methods and Results: We evaluated 10 patients (median age 72 years, 80% male) with stable angina pectoris by coronary angioscopy. The patients had a total of 11 DES implantations (5 sirolimus-eluting stents; 4 paclitaxel-eluting stents; 2 everolimus-eluting stents) that showed PSS. Neointimal coverage (NIC), presence of thrombus, and yellow plaques underneath the stent were compared between PSS and non-PSS sites for each stent. NIC was graded as: grade 0, struts exposed; grade 1, struts bulging into the lumen, although covered; grade 2, struts embedded by neointima, but translucent; grade 3, struts fully embedded and invisible. Mean follow-up was 394±206 days (median: 289). NIC grade was lower at PSS sites (P=0.021) with 8 out of 11 stents (73%) having grade 0. Angioscopy detected a thrombus more frequently at PSS sites than at non-PSS sites (64% vs. 9%, P=0.012). Yellow plaques tended to be more significant at PSS sites than at non-PSS sites (82% vs. 45%, P=0.091). Conclusions: The angioscopic findings suggest high thrombogenicity at PSS sites. (Circ J 2014; 78: 122–127)
Aims
Nutritional status as well as physical capacity is related to prognosis in patients with heart failure. The purpose of this study was to explore a simple prognostic indicator in patients with ...acute decompensated heart failure (ADHF) by including both nutritional status and physical capacity.
Methods and results
Patients hospitalized with ADHF (N = 203; mean age, 81 years) were enrolled. We evaluated the geriatric nutritional risk index (GNRI) on hospital admission and at discharge. A GNRI score < 92 was defined as malnutrition. Physical capacity was evaluated by simple walking test to determine if patients could walk 200 m, with a Borg scale score ≤ 13, without critical changes in vital signs. Primary endpoints were mortality and heart failure rehospitalization within 2 years. A total of 49% and 48% of patients showed malnutrition on admission and at discharge, respectively. Malnutrition at discharge was more strongly related to mortality hazard ratio (HR) 3.382, 95% confidence interval (CI) 1.900–6.020, P < 0.0001) than that on admission (HR 2.448, 95% CI 1.442–4.157, P = 0.001) by univariable analysis. Malnutrition at discharge was related to mortality (HR 2.370, 95% CI 1.166–4.814, P = 0.02), but malnutrition on admission was not related (HR 1.538, 95% CI 0.823–2.875, P = 0.18) by multivariable analysis. Almost half of patients (45%) could not walk 200 m, which was significantly related to mortality by univariable analysis (HR 3.303, 95% CI 1.905–5.727, P < 0.0001), but was not by multivariable analysis (HR 1.990, 95% CI 0.999–3.962, P = 0.05). The combined index including both GNRI and simple walking test was an independent and stronger predictor of mortality than either index alone by multivariable analysis (HR 2.249, 95% CI 1.362–3.716, P < 0.01). Neither malnutrition nor low physical capacity was related to heart failure rehospitalization by univariable analysis (HR 0.702, 95% CI 0.483–1.020, P = 0.06; HR 1.047, 95% CI 0.724–1.515, P = 0.81, respectively). Malnutrition at discharge significantly reduced heart failure rehospitalization by multivariable analysis (HR 0.431, 95% CI 0.266–0.698, P < 0.01). When patients were classified into Group G (both nutritional status and physical capacity at discharge were good), Group E (either was good), and Group B (both were bad), mortality rates were significantly different among the groups (log rank P < 0.0001).
Conclusion
A simple indicator including both nutritional status and physical capacity may predict 2 year mortality in elderly patients with ADHF.
Drug-eluting stents (DES) have demonstrated reduced late loss (LL) and low target lesion revascularization (TLR) rates through an inhibitory effect on neointimal hyperplasia but might have a risk of ...late or very late stent thrombosis due to incomplete neointimal coverage (NIC) (1-3). Considering the risk of stent thrombosis due to incomplete NIC, it is preferable for DES to have sufficient neointimal volume no greater than LL of 0.65 mm. Although the single-center, nonrandomized, matched-control, and observational nature with a small sample size of this study should be noted as a limitation, this study suggests that arterial endothelial healing after stenting is more competent in ZES than in SES.
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