Preprocedural physiological assessment of coronary disease patterns to predict haemodynamic outcomes post-PCI.

BACKGROUND: Even with intracoronary imaging-guided stent optimisation, suboptimal haemodynamic outcomes post-percutaneous coronary intervention (PCI) can be related to residual lesions in non-stented segments. Preprocedural assessment of pathophysiological coronary artery disease (CAD) patterns could help predict the physiological response to PCI. AIMS: The aim of this study was to assess the relationship between preprocedural pathophysiological haemodynamic patterns and intracoronary imaging findings, as well as their association with physiological outcomes immediately post-PCI. METHODS: Data from 206 patients with chronic coronary syndrome enrolled in the ASET-JAPAN study were analysed. Pathophysiological CAD patterns were characterised using Murray law-based quantitative flow ratio (µQFR)-derived indices acquired from pre-PCI angiograms. The diffuseness of CAD was defined by the pullback pressure gradient (PPG) index. Intracoronary imaging in stented segments after stent optimisation was also analysed. RESULTS: In the multivariable analysis, diffuse disease - defined by the pre-PCI µQFR-PPG index - was an independent factor for predicting a post-PCI µQFR <0.91 (per 0.1 decrease of PPG index, odds ratio 1.57, 95% confidence interval: 1.07-2.34; p=0.022), whereas the stent expansion index (EI) was not associated with a suboptimal post-PCI µQFR. Among vessels with an EI ≥80% and post-PCI µQFR <0.91, 84.0% of those vessels had a diffuse pattern preprocedure. There was no significant difference in EI between vessels with diffuse disease and those with focal disease. The average plaque burden in the stented segment was significantly larger in vessels with a preprocedural diffuse CAD pattern. CONCLUSIONS: A physiological diffuse pattern preprocedure was an independent factor in predicting unfavourable immediate haemodynamic outcomes post-PCI, even after stent optimisation using intracoronary imaging. Preprocedural assessment of CAD patterns could identify patients who are likely to exhibit superior immediate haemodynamic outcomes following PCI.

Clinical use of physiological lesion assessment using pressure guidewires: an expert consensus document of the Japanese association of cardiovascular intervention and therapeutics-update 2022.

Fractional flow reserve and instantaneous wave-free ratio are widely accepted and recommended in Western and Japanese guidelines for appropriate percutaneous coronary intervention. There are, however, many differences in clinical situations between Japan and Western countries. Therefore, the Task Force on coronary physiology of the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) has proposed an expert consensus document to summarize current evidence and suggest the practical use of physiological lesion assessment in Japan.

Cost-effectiveness of 12 months of capecitabine as adjuvant chemotherapy for stage III colon cancer: preplanned cost-effectiveness analysis of the JFMC37-0801 study.

OBJECTIVES: We evaluated the cost-effectiveness of a 12-month regimen of oral capecitabine versus a standard 6-month regimen as postoperative adjuvant chemotherapy for stage III colon cancer. METHODS: We utilized patient-level data from a multi-institutional randomized controlled trial (JFMC37-0801) that investigated prolonged oral fluoropyrimidine monotherapy. The analysis considered three health states: stable disease, post-metastasis, and death. A parametric statistical model with a cure model was used to estimate the survival curve. The analysis was conducted from the Japanese public healthcare payer's perspective, considering only direct medical costs. A lifetime horizon was used, with a discount rate of 2% for both cost and health outcomes. Health outcomes were evaluated in terms of quality-adjusted life-years (QALYs). RESULTS: The estimated cure rates for colon cancer were 0.726 [95% confidence interval (CI) 0.676-0.776] and 0.694 (95% CI 0.655-0.733) with the 12- and 6-month regimens, respectively; and the estimated 5-year relapse-free survival rates were 74.4% and 69.8%, respectively. The estimated lifetime cost for 12 months of capecitabine was JPY 3.365 million (USD 31,159), compared with JPY 3.376 million (USD 31,262) for 6 months. The estimated QALY were 12.48 and 11.77 for the 12- and 6-month regimens, respectively. Thus, the 12-month capecitabine regimen was dominant. Using a willingness-to-pay threshold of JPY 5 million per QALY, we determined a 97.4% probability that the 12-month capecitabine regimen is more cost-effective than the 6-month regimen. CONCLUSIONS: Twelve months of capecitabine is the favorable option for postoperative adjuvant chemotherapy for stage III colon cancer from the perspective of cost-effectiveness.

Lesion size and adjacent tissue damage assessment with high power and short duration radiofrequency ablation: comparison to conventional radiofrequency ablation power setting.

There is increased interest in creating high-power short duration (HPSD) ablation lesions in the field of atrial fibrillation (AF) radiofrequency ablation (RFA). We evaluated the lesion characteristics and collateral damage using two separate RFA protocols setting (HPSD: 50 W and 7 s vs control: 25 W and 30 s) in vitro model. Sixteen freshly killed porcine hearts were obtained, and the atrium and ventricle slabs were harvested for ablation. The each slabs were placed in a tissue bath with circulating 0.9% NaCl at maintained temperature 37 °C. RFA was performed with 4 mm tip irrigated force sensing catheter. All lesions were ablated under recording the electrical parameters using with Ensite Navx system (St. Jude Medical, St. Paul, Minnesota). After RFA, lesion characteristics were assessed for each lesion. Thirty-five lesions were made for each ablation protocol (total 70 lesions for analysis). Ablation parameters were similar between two groups (HPSD vs control; impedance drop (Ω): 34.2 ± 13.1 vs 36.1 ± 8.65 P = 0.49, contact force (g): 13.9 ± 4.37 vs 14.6 ± 5.09, P = 0.51, lesion size index: 4.8 ± 0.52 vs 4.73 ± 0.59, P = 0.62). Although the lesion volume was similar, the HPSD ablation creates wider but more shallower lesions compared to control group (HPSD vs control; lesion volume: 29.6 ± 18.1 mm3 vs 35.5 ± 17.1 mm3 P = 0.16, lesion diameter: 4.98 ± 0.91 mm vs 4.45 ± 0.74 mm P = 0.0095, lesion depth: 2.2 ± 0.76 mm vs 2.8 ± 1.56 mm P = 0.046). Of these, 38 lesions were assessed for adjacent tissue damage and adjacent tissue damages were more frequent seen in control group (HPSD vs control; 1/19 (5.26%) vs 6/19 (31.5%), P = 0.036). Effective lesions were made with HPSD, thereby reducing RFA procedure time. Although the lesion volume was similar between two groups, collateral damage was less seen in HPSD group attributed by lesion characteristics.

Correction to: Clinical use of physiological lesion assessment using pressure guidewires: an expert consensus document of the Japanese Association of Cardiovascular Intervention and Therapeutics.

In the original publication of the article, author group affiliation was published incorrectly. The correct affiliation for author group is given in this correction.

Design of the Japanese Comprehensive Health-Economic Assessment for Appropriate Cardiac Imaging Strategy Including Outcome and Cost-Effectiveness in Stable Coronary Artery Disease Study (J-CONCIOUS).

Background: The evaluation of stable coronary artery disease (SCAD) has evolved, and contemporary clinical practice guidelines emphasize the importance of in-depth consideration of procedure indications, risk stratification, and results of non-invasive imaging tests. However, little is known about the appropriate selection of imaging modalities for ischemia evaluation and the comparative cost-effectiveness in real-world clinical practice. Methods and Results: The Japanese Comprehensive Health-Economic Assessment for Appropriate Cardiac Imaging Strategy including Outcome and cost-effectiveness in Stable Coronary Artery Disease Study (J-CONCIOUS), a multicenter observational study, was designed to prospectively enroll 2,500 patients with suspected or known SCAD, register clinical information and administrative records, and follow patients for 3 years. Any diagnostic or cardiac imaging modality (including stress tests using electrocardiography, echocardiography, or myocardial perfusion imaging; coronary computed tomographic angiography; and/or invasive coronary angiography with or without fractional flow reserve assessment) is acceptable. Clinical endpoints, such as all-cause mortality, cardiac death, and non-fatal myocardial infarction, will be obtained, along with quality of life assessment using the Seattle Angina Questionnaire. The cost-effectiveness of individual assessment patterns will be quantified by analysis of Diagnosis Procedure Combination (DPC) data, and quality-adjusted life years and the incremental cost-effectiveness ratio will be calculated. Conclusions: J-CONCIOUS is expected to establish a risk-based and cost-effective imaging strategy for the detection and evaluation of functional myocardial ischemia and/or anatomical coronary imaging in Japan.

Primary Percutaneous Coronary Intervention in Elderly Patients With Acute Myocardial Infarction　- An Analysis From a Japanese Nationwide Claim-Based Database.

BACKGROUND: Primary percutaneous coronary intervention (pPCI) is strongly recommended by guidelines for patients presenting with acute myocardial infarction (AMI), but its applications in elderly patients are less clear.Methods and Results:The JROAD-DPC is a Japanese nationwide registry for patients with cardiovascular diseases combined with an administrative claim-based database. Among 2,369,165 records from 2012 to 2015, data for 115,407 AMI patients were extracted for this study. Elderly patients (≥75 years) comprised 45,645 subjects (39.6%), and received pPCI less frequently (62.2%) than younger patients (79.2%, P<0.001). Clinical variables such as higher age, female sex, higher Killip class, and renal dysfunction, but not functional status on admission, were predictors of non-application of pPCI. Endpoint 30-day mortality increased with aging, and was significantly higher in elderly patients (10.7%) than in younger patients (3.8%, P<0.001). Indeed, pPCI was independently associated with lower 30-day mortality only in subgroups of patients aged ≥60 years. Propensity score-matching analysis confirmed a similar reduction in endpoint 30-day mortality with pPCI in elderly patients. Duration of hospitalization was significantly shorter and functional ability on discharge was significantly better in elderly patients who underwent pPCI. CONCLUSIONS: Elderly patients with AMI underwent pPCI less frequently, but it was consistently associated with better clinical outcome in these patients. Our findings support the proactive application of pPCI for elderly AMI patients when they are eligible for an invasive strategy.

Treatment strategy modification and its implication on the medical cost of fractional flow reserve-guided percutaneous coronary intervention in Japan.

BACKGROUND: Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) could improve outcome compared with angiography-guided PCI. However, the economic impact of FFR-guided PCI remains largely unknown in the medical system in Japan. We evaluated the impact of treatment strategy modification by FFR measurement on the direct medical cost using a model analysis with a decision tree model in Japan. METHODS: For the clinical parameters set in the model, the findings from CVIT-DEFER registry were adopted. Cost parameters were considered on the assumption that coronary angiography, FFR measurement, and the treatment are performed at Diagnosis Procedure combination (DPC) hospitals, and the costs were calculated based on the medical fee reimbursement systems in Japan. RESULTS: The probability of deferral of PCI in patients who were allocated to PCI based on coronary angiography was set as 90.1% based on the CVIT-DEFER registry. In the model analysis, the cost of tests was increased by 185,660 JPY per patient by the addition of FFR measurement, but the cost of treatment with PCI was reduced by 561,425 JPY per patient, and the entire cost of treatment was reduced by 322,675 JPY, resulting in the expected reduction in the total expected medical cost by 137,015 JPY per patient. CONCLUSION: Under contemporary Japanese practice, FFR-guided PCI has potential to reduce the medical cost by effective reassessment of coronary stenosis and reducing inappropriate application of PCI.

Clinical use of physiological lesion assessment using pressure guidewires: an expert consensus document of the Japanese Association of Cardiovascular Intervention and Therapeutics.

In this document, the background, concept, and current evidence are briefly summarized. The focus is on the clinical application of physiological lesion assessment from a practical standpoint for facilities that do not have ample experience. Finally, the characteristics of new resting indexes are summarized.

Serial assessment of endothelial vasomotor function using optimal medical therapy predicts clinical outcomes in patients after complete coronary revascularization.

OBJECTIVE: Previous studies have demonstrated the importance of intensive optimal medical therapy (OMT) in patients with coronary artery disease (CAD). To investigate our hypothesis that patients with and without OMT achievement differed with respect to the risk of future cardiac events, we investigated the endothelial function in patients with CAD who underwent percutaneous coronary intervention (PCI) and contemporary medical therapy. METHODS: We conducted a prospective longitudinal cohort study to evaluate the endothelial function in 96 consecutive patients at 12 h after admission and 3 months at <12 h after admission and at 3 months after discharge by measuring the brachial artery dilatation after 5 min of forearm ischemia flow-mediated dilation (FMD). OMT achievement was defined as systolic blood pressure of ≤130 mm Hg, low-density lipoprotein cholesterol of ≤100 mg/dl, and hemoglobin A1c level of ≤7.0%. The primary endpoint was the incidence of composite major adverse cardiac or cerebrovascular events (MACCE) at 36 months. RESULTS: Forty-nine (51%) patients achieved all three risk factor targets at 3 months. Although baseline FMD values did not differ between the OMT achievement and non-achievement groups, the 3-month FMD significantly improved in the OMT achievement group (6.6±3.5 vs. 5.2±2.9, p=0.03). Patients with improved FMD at 3 months had a lower rate of 36-month MACCE than those with persistently impaired FMD. A multiple Cox hazards analysis showed that OMT was a protective predictor of MACCE (hazard ratio, 0.19; 95% confidence interval, 0.04-0.88, p=0.03). CONCLUSION: This study demonstrated a significant association between the serial measurement of endothelial function with OMT and the clinical outcome in patients after PCI.

Impact of Institutional and Operator Volume on Short-Term Outcomes of Percutaneous Coronary Intervention: A Report From the Japanese Nationwide Registry.

OBJECTIVES: The aim of this study was to assess the volume-outcome relationship for PCI within the nationwide registration system in Japan. BACKGROUND: The effect of site and operator case load for percutaneous coronary intervention (PCI) on outcomes has not been investigated thoroughly in non-Western regions. METHODS: In the present study, PCI procedural data recorded between January 2014 and December 2015 in the Japanese PCI registry, a nationwide registration system, were analyzed. Institutions and operators were categorized into deciles based on the number of PCIs performed per year. Odds ratios (ORs) for in-hospital mortality and the composite endpoint (in-hospital death and periprocedural complications) were estimated for each decile (with the lowest volume group as a reference group). RESULTS: A total of 323,322 PCIs (at 625 hospitals [median PCI cases/year: 216; quartiles: 121 to 332] by 4,211 operators [median PCI cases/year: 28; quartiles: 10 to 56]) were analyzed, of which 2,959 patients (0.9%) and 7,205 patients (2.2%) experienced in-hospital mortality and the composite endpoint after PCI, respectively. The adjusted risk for in-hospital mortality and the composite endpoint was significantly higher in hospitals included in the lowest decile (<150 PCIs/year); the risk remained consistently low across the remaining deciles. Contrastingly, no significant volume-outcome relationship was observed between operator volume and outcomes. A similar trend was observed when the analysis was confined to emergency/urgent PCI cases. CONCLUSIONS: In contemporary Japanese PCI practice, lower institutional volume was related inversely to in-hospital outcomes, but the association of annual operator volume with outcomes was less clear.

Combined assessment of EGFR-related molecules to predict outcome of 1st-line cetuximab-containing chemotherapy for metastatic colorectal cancer.

Several studies have reported that epidermal growth factor receptor (EGFR)-related molecules may serve as predictors of cetuximab treatment for metastatic colorectal cancer (mCRC), such as EGFR gene copy number (GCN), expression of 2 ligands of EGFR, amphiregulin (AREG) and epiregulin (EREG), and EGFR CA simple sequence repeat 1 (CA-SSR1) polymorphism; however, these biomarkers still remain not useful in clinical practice since they have been evaluated using cohorts with patients treated in various settings of chemotherapy. We therefore analyzed associations of mRNA expression of AREG and EREG, EGFR GCN, and CA-SSR1 polymorphism [short (S;≤ 19) / long (L; ≥ 20)] with clinical outcomes in 77 Japanese patients with KRAS exon 2 wild-type mCRC enrolled in phase II trials of FOLFOX (n = 28/57, UMIN000004197) or SOX (n = 49/67, UMIN000007022) plus cetuximab as first-line therapy. High AREG expression correlated with significantly better progression-free survival (median 11.6 vs. 66 months, HR 0.52, P = 0.037); moreover, it remained statistically significant in multivariate analysis (HR: 0.48, P = 0.027). S/S genotype of CA-SSR1 predicted severe skin toxicity (P = 0.040). Patients with both AREG-low and EGFR low-GCN had significantly shorter overall survival than the others (median 22.2 vs. 42.8 months, HR 2.34, P = 0.042). The multivariate analysis showed that molecular status with both AREG-low and EGFR low-GCN was a predictor of worse survival (P = 0.006). In conclusion, AREG mRNA expression and EGFR CA-SSR1 polymorphism predict survival and skin toxicity, respectively, of initial chemotherapy with cetuximab. Our results also suggest potential prognostic value of the combined assessment of AREG and EGFR GCN for first-line cetuximab treatment.

Assessment of vascular response after drug-eluting stents implantation in patients with diabetes mellitus: an optical coherence tomography sub-study of the J-DESsERT.

Even in the drug-eluting stent era, diabetes mellitus (DM) patients have high incidences of restenosis and repeat revascularization after percutaneous coronary intervention. The aim of this study was to compare vascular response after stent implantation between sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) by using optical coherence tomography (OCT) in DM patients as well as in non-DM patients. In the Japan-Drug Eluting Stents Evaluation; a Randomized Trial (J-DESsERT), the OCT sub-study enrolled 75 patients who underwent 8 months follow-up imaging after SES or PES implantation. Mean neointimal hyperplasia (NIH) thickness was significantly thinner in SES than PES in the DM group (77 ± 47 vs. 201 ± 114 µm, p < 0.001) and in the non-DM group (84 ± 37 vs. 212 ± 128 µm, p < 0.001). Unevenness of NIH thickness in longitudinal axis was significantly smaller in SES than PES in the DM group (348 ± 191 vs. 726 ± 385 µm, p < 0.001) and in the non-DM group (344 ± 174 vs. 679 ± 314 µm, p < 0.001). The percentage of uncovered struts was significantly greater in SES than PES in the DM group (24 ± 4 vs. 9 ± 14 %, p < 0.001) and in the non-DM group (16 ± 16 vs. 3 ± 4 %, p = 0.002). Compared with PES, SES showed more potent NIH inhibition in DM patients as well as in non-DM patients.

[Peripheral artery disease: treatment overview].

The known natural history of peripheral artery disease (PAD) is determined by the generalization of atherosclerosis with resulting high cardiovascular and cerebrovascular morbidity and mortality. In the meantime PAD patients are not receiving secondary prevention therapies even though there is enough evidence. It is difficult to diagnose PAD by symptoms alone and furthermore, over 50% PAD patients are asymptomatic. Measurement of the ankle brachial pressure index (ABI) is cost effective and simple means of identifying PAD. Targeted ABI screening and subsequent treatment in primary care practices will save health care costs by reducing cardiovascular and cerebrovascular morbidity and mortality. But we should discuss carefully whether to antiplatelet therapy benefits for asymptomatic individuals with screen-detected PAD are not established.

Assessment of cyclic changes in the diameter of the aortic annulus using speckle-tracking trans-esophageal echocardiography.

It is uncertain whether dynamic variation in the diameter of the aortic annulus occurs during the cardiac cycle in humans. The purpose of this study was to analyze cyclic changes of the aortic annulus using speckle-tracking trans-esophageal echocardiography. The subjects were 40 patients with aortic stenosis and 40 controls. Absolute and relative changes in the diameter of the aortic annulus and the times at which the maximum and minimum diameters occurred during the cardiac cycle were determined using speckle-tracking trans-esophageal echocardiography. The maximum and minimum diameters were 22.9 ± 2.7 and 20.0 ± 2.9 mm, respectively, in controls. The change in diameter of the aortic annulus was 2.9 ± 0.7 mm, and the relative change was 12.9 ± 3.5%. The maximum aortic annulus diameter was reached at the onset of aortic valve opening, and the minimum diameter occurred in the rapid filling phase. The change in diameter of the aortic annulus was significantly smaller (2.2 ± 0.6 mm vs. 2.9 ± 0.7 mm, p < 0.0001), and the time to reach the maximum diameter was significantly longer (98.5 ± 17.5 ms vs. 83.4 ± 18.2 ms, p = 0.0004), in the aortic stenosis group than in the control group. The study found that dynamic changes of the aortic annulus occur in the cardiac cycle and can be measured using speckle-tracking trans-esophageal echocardiography. We also found that aortic stenosis has an effect on the extent and timing of these changes. This suggests that accurate assessment of aortic annulus diameter requires consideration of the timing of the cardiac cycle.

Combined assessment of chronic kidney disease and subclinical peripheral artery disease used to predict future cardiac events.

BACKGROUND: Both the presence of peripheral arterial disease and chronic kidney disease has been reported to be independent risk factors associating with poor prognosis. However, the impact of combination of peripheral arterial disease and chronic kidney disease remains unknown. METHODS: The long-term outcome in 715 consecutive patients who had undergone coronary angiogram for the evaluation of chest pain was analyzed. Patients on haemodialysis were excluded from this analysis. Cohort patients were divided into four groups according to the Ankle Brachial Index (ABI <0.9) and glomerular filtration rate (GFR <60 mL/min per m(2)): group A (n= 498; ABI >0.9, GFR >60); B (n = 65, ABI <0.9, GFR >60); C (n = 99; ABI >0.9, GFR <60); and D (n = 53; ABI <0.9, GFR <60). The mean follow-up period was 620 +/- 270 days and evaluated the major cardiac adverse events included survival, stroke, acute coronary syndrome and heart failure. RESULTS: The mean follow-up period was 620 +/- 270 days. Total long-term event was present in 89 patients (groups A-D were 9.4%, 18.5%, 15.2% and 28.3%, respectively). Long-term event rate was 28.3% for patients with the presence of peripheral arterial disease and chronic kidney disease, compared to 9.4% for those without peripheral arterial disease and chronic kidney disease (P < 0.0001). Kaplan-Meier event-free survival curves also showed that the combination of peripheral arterial disease and chronic kidney disease predicted long-term event rate. CONCLUSION: The combination of chronic kidney disease and ABI of less than 0.9 undergoing coronary angiogram is strongly associated with long-term event rate.

The clinical impact of routine angiographic follow-up in randomized trials of drug-eluting stents: a critical assessment of "oculostenotic" reintervention in patients with intermediate lesions.

OBJECTIVES: The aim of this study was to study the long-term clinical effects of routine angiographic follow-up and related reintervention after drug-eluting stenting. BACKGROUND: Prior stent trials have shown that protocol-mandated angiographic follow-up increases repeat interventions compared with clinical follow-up alone. The long-term clinical impact of this practice is unknown. METHODS: Long-term outcomes of patients assigned to routine angiographic follow-up in 3 large-scale TAXUS (Boston Scientific, Natick, Massachusetts) trials were compared with patients assigned to clinical follow-up alone, in a propensity score-adjusted patient-level meta-analysis. Outcomes were also compared in patients with treated versus untreated nonischemic intermediate lesions (quantitative angiographic stenosis between >or=40% and <70%) detected at angiographic follow-up. RESULTS: Target lesion revascularization (TLR) rates at 5 years were significantly higher in the angiographic compared with clinical follow-up cohort (18.3% vs. 11.1%, p < 0.001). This was due to more frequent treatment of intermediate lesions, but there was no associated reduction in rates of cardiac death or myocardial infarction (8.9% vs. 8.8%, p = 0.93). Of patients with nonischemic intermediate lesions, 17% who were not revascularized at the time of angiographic follow-up had a subsequent TLR, whereas 7% of patients who had TLR at this follow-up angiogram required additional revascularization during long-term follow-up. CONCLUSIONS: A strategy of routine angiographic follow-up increases oculostenotic revascularization of nonischemic intermediate lesions without affecting subsequent rates of cardiac death or myocardial infarction, and TLR was not required in 83% of those lesions. A conservative approach, in which repeat angiography is limited to patients with recurrent ischemia or progressive symptoms, minimizes repeat revascularization of nonischemic intermediate lesions and optimizes long-term event-free survival after drug-eluting stent implantation.

Assessment of sirolimus-eluting coronary stent implantation with aspirin plus low dose ticlopidine administration: one year results from CYPHER Stent Japan Post-Marketing Surveillance Registry (J-PMS).

BACKGROUND: Clinical data of sirolimus-eluting stent (SES) implantation are under investigation in Japan. METHODS AND RESULTS: The CYPHER stent Japan Post-Marketing Surveillance Registry (J-PMS) was conducted at 50 medical centers to assess the results of SES in daily clinical practice exclusively under aspirin plus low dose ticlopidine (200 mg/day). A total of 2,459 lesions in 2,054 patients were treated with 3,285 SES. The mean age was 67.1 +/-10.1 years, 75.6% were men and 43.3% were diabetics. Intravascular ultrasound was used in 77.2%. The 8-month angiographic and 1-year clinical follow-up data were available in 85.4% and 96.8%, respectively. Quantitative coronary angiography showed the reference vessel diameter and percentage diameter stenosis at baseline were 2.47 +/-0.58 mm and 72.0 +/-16.1%. The 8-month late loss was 0.20 +/-0.50 mm. The major adverse cardiovascular events at 1 year was 7.3%; cardiac death: 1.1%, myocardial infarction (MI): 1.2%, and target lesion revascularization (TLR): 4.2%. The rates of definite and probable stent thrombosis at 1 year were 0.30% and 0.10%, respectively. Hemodialysis was the strongest predictor of death/MI or TLR. CONCLUSIONS: J-PMS showed the effectiveness of SES implantation under aspirin plus low dose ticlopidine administration at 1 year, although further studies are necessary to demonstrate the safety.

Combined assessment of cardiac systolic dysfunction and coronary atherosclerosis used to predict future cardiac deaths after starting hemodialysis.

BACKGROUND/AIMS: Identification of end-stage renal disease (ESRD) patients at high risk for cardiac events is important for clinical dialysis management. The present study determined whether the combination of cardiac function and coronary atherosclerosis could predict future cardiac events after starting renal replacement therapy (RRT). METHODS: We prospectively assessed left ventricle ejection fraction (EF) and Gensini score (GS) using angiographic severity of coronary atherosclerosis in 88 consecutive ESRD patients [mean age 62 years; 69 males (78%); 55 patients (64%) with diabetic nephropathy] at the initiation of RRT. EF was analyzed by echocardiogram, and GS was scored by coronary angiography within 3 months after starting RRT. The study end point was cardiac death. For analysis of the association between cardiac death and EF and GS measures, the univariate and multivariate Cox proportional hazards model was used. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value, and accuracy of event-free prediction were evaluated. RESULTS: Twenty-four patients (27%) had low cardiac function (EF <50%; low EF) and 44 patients (50%) had severe coronary atherosclerosis (GS >15; high GS). During a follow-up period of 3 years, cardiac death occurred in 21 patients (24%). The PPV of low EF and high GS was 42 and 39%, respectively; the highest PPV (53%) was obtained when low EF and high GS were combined. The cumulative survival rate at 5 years in patients with both low EF and high GS was significantly lower than those with high EF and low GS (91 vs. 22%, p < 0.0005). CONCLUSION: The combined assessment of cardiac function and coronary atherosclerosis at the initiation of RRT strongly predicts future cardiac events.