Relationship between sleep disordered breathing and heart rate turbulence in non-obese subjects.

Heart rate turbulence (HRT) is regarded as a parameter of cardiac autonomic dysfunction. Several studies have suggested that patients with sleep disordered breathing (SDB) have an impaired HRT, which play a role in the relationship between SDB and risk of cardiovascular morbidity and mortality. However, the impact of SDB on HRT independent from obesity is still debatable. Data of eligible subjects who underwent sleep test and 24 h Holter electrocardiogram (ECG) recording from 2009-2012 were analyzed. HRT parameters, turbulence onset (TO), and turbulence slope (TS) in the 24 h recording, while awakening, and sleeping (TO-24 h, TO-awake, TO-sleep, TS-24 h, TS-awake, and TS-sleep, respectively) were compared across subjects with no-to-mild, moderate, and severe SDB. Univariable and multivariable regression analyses including TO or TS as a dependent variable were performed. Data from 41 subjects were evaluated. Compared with the no-to-mild and moderate SDB groups, in the severe SDB group, the TO-24 h and TO-awake were significantly greater, and the TS-24 h, TS-awake, and TS-sleep were significantly lower. In multivariable analyses, the apnea-hypopnea index (AHI) was correlated directly with TO-24 h (coefficient, 0.36; P = 0.03) and TO-awake (coefficient, 0.40; P = 0.01). SDB severity, as represented by AHI, is related to HRT impairments in non-obese subjects. SDB, independent from obesity, may affect cardiac autonomic dysfunction.

Vascular response to biolimus A-9 eluting stent in patients with shorter and prolonged dual antiplatelet therapy: optical coherence tomography sub-study of the NIPPON trial.

Dual antiplatelet therapy (DAPT) with thienopyridine and aspirin is the standard care for the prevention of stent thrombosis. However, the optimal duration and effect of the duration of DAPT on intra-stent thrombus (IS-Th) formation are unknown. The NIPPON study (Nobori Dual Antiplatelet Therapy as Appropriate Duration) was an open label, randomized multicenter, assessor-blinded, trial designed to demonstrate the non-inferiority of shorter (6-month) DAPT to prolonged (18-month) DAPT, after biolimus A9 eluting stent implantation in 3773 patients at 130 sites in Japan. Among them, 101 patients were randomly allocated for an optical coherence tomography (OCT) sub-study to assess the difference of local IS-Th formation between the two groups. In addition to standard OCT parameters, the number of IS-Th formed was counted in each target stent at 8 months. Baseline patient characteristics were not different between the 6- and 18-month groups. IS-Th was detected in 9.8% of the cases and the presence of IS-Th was not significantly different between the two groups (10.9% in 6-month vs. 9.1% in 12-month, P = 0.76). Furthermore, the number of IS-Th formed was not significantly different between the two groups. This OCT sub-study was in line with the main NIPPON study which demonstrated the non-inferiority of 6-month DAPT to 18-month DAPT. Shorter DAPT duration did not promote progressive IS-Th formation at the mid-term time point.

Craniofacial anatomical risk factors in men with obstructive sleep apnea and heart failure: a pilot study.

PURPOSE: Obstructive sleep apnea (OSA) is complicated with heart failure (HF); however, the reason for this is not well understood. Craniofacial anatomic risk factors may contribute to OSA pathogenesis in HF patients. However, there are no data about cephalometric findings among OSA patients with HF. METHODS: Consecutive patients with HF and OSA (defined as total apnea-hypopnea index (AHI) ≥15/h) were enrolled. As controls, OSA patients without HF but matching the test group in age, BMI, and obstructive AHI were also enrolled. RESULTS: Overall, 17 OSA patients with HF and 34 OSA patients without HF were compared. There are no significant differences in the characteristics or polysomnographic parameters between 2 groups. In the cephalometric findings, compared with patients without HF, patients with HF showed a significantly greater angle between the line SN to point "A" (SNA) and a longer inferior airway space and greater airway area. However, the tongue area of patients with HF was more than those without HF. CONCLUSIONS: The craniofacial structures of OSA patients with HF were different from those without HF. OSA patients with HF had an upper airway anatomy that is more likely to collapse when sleeping while recumbent, despite having a larger airway space.

Relationship between atrial conduction delay and obstructive sleep apnea.

Prolonged P-wave duration, indicating atrial conduction delay, is a marker of left atrial abnormality and is reported as a potent precursor of atrial fibrillation (AF). Several studies have shown that obstructive sleep apnea (OSA) is associated with AF. We evaluated the relationship between OSA and prolonged P-wave duration. Consecutive subjects who underwent overnight polysomnography and showed a normal sinus rhythm, had no history of AF or ischemic heart disease, and showed no evidence of heart failure were enrolled. Apnea-hypopnea index (AHI) is defined as the number of apnea and hypopnea events per hour of sleep. P-wave duration was determined on the basis of the mean duration of three consecutive beats in lead II from a digitally stored electrocardiogram. A total of 250 subjects (middle-aged, predominantly male, mildly obese, with a mean P-wave duration of 106 ms) were enrolled. In addition to age, male gender, body mass index (BMI), hypertension, dyslipidemia, and uric acid and creatinine levels, AHI (r = 0.56; P < 0.001) had significant univariable relationship with P-wave duration. Multivariate regression analysis showed that age, BMI, male gender, and AHI (partial correlation coefficient, 0.47; P < 0.001) were significantly independently correlated to P-wave duration. Severity of OSA is significantly associated with delayed atrial conduction time. Obstructive sleep apnea may lead to progression of atrial remodeling as an AF substrate.

Deep vein thrombosis risk stratification.

Pulmonary thromboembolism (PTE) is a life-threatening disease which always presents in patients with deep vein thrombosis (DVT). There are few statements in guidelines regarding indications for anticoagulation based on the location of DVT. We investigated whether the relative risk of PTE depends on thrombus location and bleeding complications with anticoagulation therapy. Between January 1 and July 10, 2007, 461 patients underwent lower extremity venous ultrasound studies, and 129 patients were diagnosed as DVT (60 males, 66.9 ± 13.3 years). We retrospectively studied the incidence of PTE and bleeding complications associated with anticoagulation therapy. Average follow-up period was 536 ± 324 days. Above and below knee thrombosis was present in 60 and 69 patients, respectively. Warfarin was administered in 60 patients. Nine patients developed PTE. Multivariate analysis showed the absence of anticoagulation therapy and location of DVT (above knee) to be significantly correlated with onset of PTE (anticoagulation; P < 0.01, location; P = 0.02). However, the incidence of bleeding was not significantly different between above knee and below knee vein thrombosis (P = 0.72). In conclusion, below knee vein thrombosis carries a relatively low risk of PTE, but the incidence of bleeding complications does not depend on thrombosis location. This suggests that the indication of anticoagulation therapy should be based on DVT location.

Sirolimus eluting coronary stent implantation in patients on maintenance hemodialysis: the OUCH study (outcome of cypher stent inhemodialysis patients).

BACKGROUND: Pivotal studies on drug-eluting stents have excluded hemodialysis (HD) patients. No quantitative coronary angiography (QCA) analysis has been reported. METHODS AND RESULTS: The OUtcome of Cypher stent in Hemodialysis patients (OUCH) Study is a prospective non-randomized single-arm registry designed to assess the results of sirolimus-eluting stents in HD patients, with follow-up QCA in an independent core laboratory. The primary endpoint was the occurrence of target-vessel failure (TVF) defined as cardiac death, myocardial infarction (MI), and target-vessel revascularization (TVR) at 1 year. A total of 117 patients were enrolled. The TVF rate was 24.9% (2.6% cardiac death, 1.4% MI, 23.9% TVR), and stent thrombosis was documented in 1 patient (0.9%). Coronary calcification was a predictor of TVF. Late lumen loss (LLL) averaged 0.69±0.93mm. The histogram of LLL showed that a total of 76% of lesions were distributed the same normally as that in normal renal function (average LLL 0.20±0.29mm), but 24% of lesions were outliers (average LLL 2.07±0.62mm). CONCLUSIONS: This report describes different clinical and QCA results in HD patients as higher TVF rate, different predictive factors, and different histogram of LLL compared with normal renal function. The different histogram of LLL was the existence of many outliers with the same average and the same deviation, suggesting the loss of sirolimus had an effect on a significant number of HD patients.

Aortic dissection is associated with intermittent hypoxia and re-oxygenation.

Aortic dissection is a life-threatening cardiovascular disease with high in-hospital mortality. However, the risk factors of aortic dissection have not been fully elucidated. Obstructive sleep apnea (OSA) has been increasingly recognized as an independent cardiovascular risk factor. Among the underlying mechanisms to explain the association between OSA and cardiovascular morbidity, previous studies reported that intermittent hypoxia and re-oxygenation (IHR) might induce cardiovascular diseases via atherosclerosis. However, little is known about an association between aortic dissection and IHR. The aims of the study were to investigate the prevalence of nocturnal IHR among patients with aortic dissection and compared with that in subjects without aortic dissection, and to investigate whether there is an independent association between aortic dissection and IHR. We enrolled 29 patients with aortic dissection and 59 control subjects. We performed sleep studies and compared the results between the groups. Frequency of IHR is expressed as 3% oxygen desaturation index (ODI). Multivariate analysis was performed to identify determinants of aortic dissection. The percentage of either moderate-to-severe IHR or severe IHR was significantly higher in the aortic dissection group (p = 0.04 and <0.001, respectively) than in the control group. The mean 3% ODI of patients with aortic dissection was significantly higher than that of control subjects (34.8 ± 23.1 and 19.0 ± 14.1, p = 0.003). In multivariate analysis, 3% ODI was significantly associated with aortic dissection (odds ratio 1.44; 95% confidence interval 1.08-1.91; p = 0.01). The present study showed the close association between aortic dissection and, IHR, a major component of OSA.

Comparison of haemodialysis patients and non-haemodialysis patients with respect to clinical characteristics and 3-year clinical outcomes after sirolimus-eluting stent implantation: insights from the Japan multi-centre post-marketing surveillance registry.

AIMS: Long-term outcomes after sirolimus-eluting stent (SES) implantation in haemodialysis (HD) patients have remained controversial. We investigated the impact of HD on outcomes after SES implantation. METHODS AND RESULTS: We analysed the data on 2050 patients who underwent SES implantation in a multi-centre prospective registry in Japan. Three-year clinical outcomes were compared between the HD group (n = 106) and the non-haemodialysis (NH) group (n = 1944). At the 3-year clinical follow-up, the rates of unadjusted cardiac mortality (HD: 16.3 vs. NH: 2.3%) and target-lesion revascularization (TLR) (HD: 19.4 vs. NH: 6.6%) were significantly higher in the HD group than the NH group (P < 0.001). Although HD group had a numerically higher stent thrombosis rate, the difference in stent thrombosis between the two groups (HD: 2.0 vs. NH: 0.7%) did not reach statistical significance. Using Cox's proportional-hazard models with propensity score adjustment for baseline differences, the HD group had higher risks of TLR [HD: 16.3 vs. NH: 6.1%; hazard ratio, 2.83; 95% confidence interval (CI): 1.62-4.93, P = 0.0003] and cardiac death (HD: 12.3 vs. NH: 2.3%; hazard ratio, 5.51; 95% CI: 2.58-11.78, P < 0.0001). The consistent results of analyses, whether unadjusted or adjusted for other baseline clinical and procedural differences, identify HD as an independent risk factor for cardiac death and TLR. CONCLUSIONS: Percutaneous coronary intervention with SES in HD patients has a higher incidence of repeat revascularization and mortality compared with those in NH patients. Haemodialysis appears to be strongly associated with mortality and repeat revascularization even after SES implantation.

Effects of olmesartan on blood pressure and insulin resistance in hypertensive patients with sleep-disordered breathing.

The increased risk of cardiovascular morbidity and mortality among patients with sleep-disordered breathing (SDB) has been linked to arterial hypertension and insulin resistance. However, an effective antihypertensive agent for patients with SDB has not been identified. We investigated the effect of the angiotensin II subtype 1 receptor blocker olmesartan in hypertensive patients with SDB. This prospective, one-arm pilot study included 25 male patients with untreated SDB (mean age, 52.7 ± 11.4 years). We measured blood pressure, oxygen desaturation index (ODI), cardiac function using echocardiography, and insulin resistance using the homeostasis model assessment (HOMA) before and after 12 weeks of olmesartan therapy (mean dose, 17.6 ± 4.4 mg/day). Olmesartan significantly decreased systolic blood pressure (151.4 ± 8.0 vs. 134.0 ± 7.4 mmHg; P < 0.001), diastolic blood pressure (93.4 ± 7.1 vs. 83.9 ± 6.3 mmHg; P < 0.001), and HOMA index (3.7 ± 2.9 vs. 2.8 ± 1.9; P = 0.012). Furthermore, left ventricular ejection fraction significantly increased at 12 weeks (68.1 ± 5.1 vs. 71.6 ± 5.4%; P = 0.009). However, body mass index (BMI) and degree of SDB did not change (BMI, 26.6 ± 4.0 vs. 26.6 ± 4.2 kg/m2, P = 0.129; 3% ODI, 29.5 ± 23.1 vs. 28.2 ± 21.0 events/h, P = 0.394). Olmesartan significantly reduced blood pressure and insulin resistance in hypertensive patients with SDB without changing BMI or SDB severity.

Evaluation of the Apnea-Hypopnea Index Determined by Adaptive Servo-Ventilation Devices in Patients With Heart Failure and Sleep-Disordered Breathing.

Introduction: Adaptive servo-ventilation (ASV) devices are designed to suppress central respiratory events, and therefore effective for sleep-disordered breathing (SDB) in patients with heart failure (HF) and provide information about their residual respiratory events. However, whether the apnea-hypopnea index (AHI), determined by the ASV device AutoSet CS (ASC), correlates with the AHI calculated by polysomnography (PSG) in patients with HF and SDB remains to be evaluated. Methods: Consecutive patients with SDB titrated on ASC were included in the study. We assessed the correlation between AHI determined by manual scoring during PSG (AHI-PSG) and that determined by the ASC device (AHI-ASC) during an overnight session. Results: Thirty patients with HF and SDB (age, 68.8 ± 15.4 years; two women; left ventricular ejection fraction, 53.8 ± 17.9%) were included. The median AHI in the diagnostic study was 28.4 events/h, including both obstructive and central respiratory events. During the titration, ASC markedly suppressed the respiratory events (AHI-PSG, 3.3 events/h), while the median AHI-ASC was 12.8 events/h. We identified a modest correlation between AHI-PSG and AHI-ASC (r = 0.36, p = 0.048). The Brand-Altman plot indicated that the ASC device overestimated the AHI, and a moderate agreement was observed with PSG. Conclusions: There was only a modest correlation between AHI-PSG and AHI-ASC. The discrepancy may be explained by either the central respiratory events that occur during wakefulness or the other differences between PSG and ASC in the detected respiratory events. Therefore, clinicians should consider this divergence when assessing residual respiratory events using ASC.

Characteristics of revascularization treatment for arteriosclerosis obliterans in patients with and without hemodialysis.

BACKGROUND: Limb ischemia is a major complication in patients who are receiving hemodialysis (HD). In this study, distinctive features and factors affecting the outcome of HD patients with limb ischemia are identified. METHODS AND RESULTS: One hundred and eighty consecutive symptomatic limb ischemic patients who were or were not receiving HD and who successfully underwent surgical bypass grafting (bypass, n=75) or endovascular angioplasty (percutaneous transluminal angioplasty (PTA), n=105) were retrospectively compared at our hospital. The endpoint of this study was amputation of the ischemic leg or death. Median follow up was 2.25 years. The amputation-free survival of HD patients was significantly lower than that of non-HD patients (P<0.0001). In the bypass group, the amputation-free survival of HD patients was significantly lower than that of non-HD patients (P=0.0002), even if the graft was patented or not (P=0.77). In contrast, in the PTA group, the amputation-free survival of HD patients was lower than that of non-HD patients (P=0.03), and with a significantly lower patency rate (P=0.0004). Predictors of amputation-free survival differed between HD and non-HD patients; predictors were diabetes mellitus and gender in HD patients, while they were Fontaine classification and hyperlipidemia in non-HD patients. The infectious death rate was higher in HD patients than in non-HD patients (53% vs 22%, P<0.05). CONCLUSIONS: This study clearly showed a poorer prognosis in HD patients than in non-HD patients especially after bypass surgery, even if the the graft was patented or not.

Association between Obstructive Sleep Apnea and SYNTAX Score.

Obstructive sleep apnea (OSA) is related to an increased risk of cardiovascular diseases, including coronary artery disease (CAD). We investigated the association between OSA and the severity of CAD by assessing coronary angiography findings. We retrospectively analyzed patients who underwent their first coronary angiography to evaluate CAD and polysomnography (PSG) to investigate the severity of OSA in our hospital from March 2002 to May 2015. The severity of CAD was determined based on coronary angiography findings using the SYNTAX score. The patients were divided into two groups according to the apnea-hypopnea index (AHI): mild OSA (AHI < 15/h) and moderate-to-severe OSA (AHI ≥ 15/h). Overall, 98 patients were enrolled. The SYNTAX score was significantly different between the two groups (p = 0.001). After adjustment for other risk factors, including age, sex, obesity, hypertension, hyperlipidemia, diabetes mellitus, smoking status, and family history of CAD, moderate-to-severe OSA significantly correlated to the SYNTAX score (partial correlations = 0.24, p = 0.039). These results suggest that the severity of CAD is related to moderate-to-severe OSA.

Prognosis of patients with heart failure and obstructive sleep apnea treated with continuous positive airway pressure.

BACKGROUND: Therapy with continuous positive airway pressure (CPAP) provides several benefits for patients with heart failure (HF) complicated by obstructive sleep apnea (OSA). However, the effect on the prognosis of such patients remains unknown. AIMS: To determine whether CPAP therapy and compliance affects the prognosis of HF patients with OSA. METHODS: We classified 88 patients with HF and moderate-to-severe OSA into a CPAP-treated group (n = 65) and an untreated group (n = 23), and then those treated with CPAP were further subclassified according to CPAP therapy compliance. The frequency of death and hospitalization was analyzed using multivariate analysis. RESULTS: During a mean (+/- SD) period of 25.3 +/- 15.3 months, 44.3% of the patients died or were hospitalized. Multivariate analysis showed that the risk for death and hospitalization was increased in the untreated group (hazard ratio [HR], 2.03; 95% confidence interval [CI], 1.07 to 3.68; p = 0.030) and in less compliant CPAP-treated patients (HR, 4.02; 95% CI, 1.33 to 12.2; p = 0.014). CONCLUSION: Therapy with CPAP significantly reduced the risk of death and hospitalization among patients with HF and OSA. However, reduced compliance with CPAP therapy was significantly associated with an increased risk of death and hospitalization.

Dual Antiplatelet Therapy for 6 Versus 18 Months After Biodegradable Polymer Drug-Eluting Stent Implantation.

OBJECTIVES: The NIPPON (Nobori Dual Antiplatelet Therapy as Appropriate Duration) study was a multicenter randomized investigation of the noninferiority of short-term versus long-term dual antiplatelet therapy (DAPT) in patients with implantation of the Nobori drug-eluting stent (DES) (Terumo, Tokyo, Japan), which has a biodegradable abluminal coating. BACKGROUND: The optimum duration of DAPT for patients with a biodegradable polymer-coated DES is unclear. METHODS: The subjects were 3,773 patients with stable or acute coronary syndromes undergoing Nobori stent implantation. They were randomized 1:1 to receive DAPT for 6 or 18 months. The primary endpoint was net adverse clinical and cerebrovascular events (NACCE) (all-cause mortality, myocardial infarction, stroke, and major bleeding) from 6 to 18 months after stenting. Intention-to-treat analysis was performed in 3,307 patients who were followed for at least 6 months. RESULTS: NACCE occurred in 34 patients (2.1%) receiving short-term DAPT and 24 patients (1.5%) receiving long-term DAPT (difference 0.6%, 95% confidence interval [CI]: 1.5 to 0.3). Because the lower limit of the 95% CI was inside the specified margin of -2%, noninferiority of short-term DAPT was confirmed. Mortality was 1.0% with short-term DAPT versus 0.4% with long-term DAPT, whereas myocardial infarction was 0.2% versus 0.1%, and major bleeding was 0.7% versus 0.7%, respectively. The estimated probability of NACCE was lower in the long-term DAPT group (hazard ratio: 1.44, 95% CI: 0.86 to 2.43). CONCLUSIONS: Six months of DAPT was not inferior to 18 months of DAPT following implantation of a DES with a biodegradable abluminal coating. However, this result needs to be interpreted with caution given the open-label design and wide noninferiority margin of the present study. (Nobori Dual Antiplatelet Therapy as Appropriate Duration [NIPPON]; NCT01514227).

Prevalence and distribution of coronary calcium in asymptomatic Japanese subjects in lung cancer screening computed tomography.

BACKGROUND: Coronary artery calcium (CAC) is associated with a risk of coronary heart disease. The prevalence and distribution of the CAC score have been examined in Western countries, but few studies have been performed in Asia, and especially in Japan. The goal of this study was to investigate CAC scores in an asymptomatic Japanese population. METHODS: CAC score and risk factors were analyzed in 1834 asymptomatic subjects who underwent lung cancer screening computed tomography. RESULTS: CAC was present in 26.9% of all the subjects, 29.8% of the males, and 17.1% of the females. In all age groups, the CAC score was higher in males. In multivariate analysis, male gender [odds ratio (OR) 2.461, 95% confidence interval (CI) 1.361-4.452, p=0.002], aging (OR 1.102, 95% CI 1.081-1.123, p<0.001), dyslipidemia (OR 1.740, 95% CI 1.216-2.490, p=0.002), and fasting glucose (OR 1.008, 95% CI 1.002-1.015, p=0.012) were significantly associated with a CAC score >100. CONCLUSION: The results of this study provide a pattern of CAC distribution based on age and gender in asymptomatic Japanese subjects. This pattern was similar to that in Western countries, although the absolute CAC scores were lower. High CAC scores were associated with male gender, aging, dyslipidemia, and fasting glucose.

A case of Takotsubo cardiomyopathy that was confirmed by cardiac catheterization at all three times of onset.

Takotsubo cardiomyopathy (TTC) is a cardiomyopathy associated with emotional and physiological stress which can be recurrent. We report a case of recurrent TTC (total 3 times) induced by emotional stress, which was diagnosed accurately by coronary angiography (CAG) and left ventriculography (LVG). A 77-year-old female was referred to our institute because of stomach ache, nausea, dizziness, and vomiting. She had developed TTC associated with emotional stress twice, and she took an angiotensin receptor blocker for preventing recurrence. She was admitted for treatment of electrolyte imbalance. After the admission, she suddenly suffered from chest pain with ST segment elevation in II, III, aVF, V3, V4, V5, and V6 leads in electrocardiography. Emergency CAG showed normal coronary arteries, while LVG revealed apical akinesia and basal hyperkinesia. These findings were compatible with TTC. Follow-up ultrasonic cardiogram showed left ventricular contractile normalization in a week. She was discharged in 22 days. A few cases of repeated recurrence have been reported, but they were not diagnosed by cardiac catheterization. In the present case, 3 episodes of TTC were all diagnosed in CAG and LVG. We suggest that antianxiety drugs have potential to prevent the recurrence of TTC in a case induced by emotional stress. .

Characteristics and trends of POBA in current DES Era.

The aim of this study is to clarify the characteristics and trends of POBA in current drug-eluting stent (DES) era. We examined retrospectively the cases of POBA performed in our institute during the years from 2008 to 2012. For control, bare metal stents (BMS) and DES implantation done in 2011 were analyzed. During the period, 85 cases of POBA, 63 BMS and 132 DES were identified. In the result, the rate of restenosis in POBA was significantly higher than BMS and DES (39.7, 14.9, 3.7%, POBA, BMS, DES, respectively, p < 0.001). We assumed three categories depending on the reasons for selecting POBA. (1) Stent delivery failure or expected difficulty of stent delivery due to calcification, etc. (n = 14), (2) intervention for in-stent restenosis or stent thrombosis (n = 34), (3) successful POBA applied to small vessels without complication (n = 14). According to it, category 1 showed significantly high probability of restenosis compared with others [(1) 10/14, 71.4%, (2) 12/34, 35.3%, 3; 2/14, 14.3%, p < 0.05]. In addition, category 3 showed nearly as good as BMS. Balloons used in POBA contained 32 non-compliant balloons and 14 scoring balloons, whereas 30 were semi-compliant balloons only. ACC/AHA lesion type B2/C was 85.7, 45.7 and 50.0%, and cases treated only with semi-compliant balloon were 57.1, 14.3, 92.9% (category (1), (2) and (3), respectively, both p < 0.05). Therefore, this fact shows that a case of small vessel of which diameter is less than 2.5 mm would have a favorable outcome with POBA when treated well only with semi-compliant balloon under the current DES era.

Modification of treatment strategy after FFR measurement: CVIT-DEFER registry.

The impact of the fractional flow reserve (FFR) on clinical decision-making remains unclear in daily practice. The CVIT-DEFER registry is a prospective multicenter registry enrolling consecutive patients with angiographically intermediate coronary stenosis for whom FFR measurement is clinically indicated. The treatment strategy determined from angiographic findings alone and the strategy selected after FFR measurement were compared. Data on the treatment strategy were obtained for 3093 subjects. The average age of these subjects was 69.5 ± 10.2 years and 73.8 % were men. The majority had stable coronary artery disease, including 60.4 % with stable angina pectoris. The treatment strategy based on angiographic findings was medical management in 34.5 %, percutaneous coronary intervention (PCI) in 63.5 %, and coronary artery bypass grafting in 2.1 %. The FFR was ≤0.8 in 1566 lesions (42.2 %). After FFR measurement, medical treatment was changed to revascularization in 19.7 %, while PCI was switched to medical treatment in 57.4 % at the lesion level. As a result, reclassification of the treatment strategy at the patient level was done in 39.0 % of the patients. Revascularization was frequently switched to medical treatment after FFR measurement. These findings support the clinical utility of employing FFR data to guide selection of PCI.

Clinical and angiographic outcomes of paclitaxel-eluting coronary stent implantation in hemodialysis patients: A prospective multicenter registry: The OUCH-TL study (outcome in hemodialysis of TAXUS Liberte).

BACKGROUND: The outcome of percutaneous coronary intervention (PCI) has been reported to be poor in hemodialysis (HD) patients even in the drug-eluting stent era. We have reported relatively poor outcomes after sirolimus-eluting stent implantation in the OUCH study. METHODS: The OUCH-TL study is a prospective, non-randomized, single-arm registry designed to assess the results of paclitaxel-eluting stent (PES) in HD patients with follow-up quantitative coronary angiography analysis. The primary endpoint was the occurrence of target-vessel failure (TVF) defined as cardiac death, myocardial infarction (MI), and target-vessel revascularization (TVR) at 12 months. RESULTS: A total of 119 patients with 154 lesions were enrolled (one withdrawal). Mean age was 65±10 years, male gender was 79%, 89% of cases had stable coronary disease. Diabetic nephropathy was diagnosed in 61% of the patients. American College of Cardiology/American Heart Association type B2/C accounted for 96% of lesions and 22.7% of lesions were treated with Rotablator (Boston Scientific Corporation, Natick, MA, USA). Rates of TVF, death, MI, stent thrombosis and TVR at 12 months were 20.2%, 5.9%, 5.0%, 1.4%, and 12.6%, respectively. TVR was performed in 8.4% of the patients up to 12 months. Late loss in-stent was 0.48±0.61mm, and late loss in-segment was 0.37±0.61mm at 9 months. Binary restenosis in-stent was 10.3% and in-segment was 14.5%. CONCLUSIONS: Outcomes of PES implantation in hemodialysis patients appears comparable to those of non-hemodialysis patients.