Sex Differences in Clinical Outcomes After Percutaneous Coronary Intervention.

BACKGROUND: There is a scarcity of studies comparing the clinical outcomes after percutaneous coronary intervention (PCI) for women and men stratified by the presentation of acute coronary syndromes (ACS) or stable coronary artery disease (CAD).Methods and Results: The study population included 26,316 patients who underwent PCI (ACS: n=11,119, stable CAD: n=15,197) from the CREDO-Kyoto PCI/CABG registry Cohort-2 and Cohort-3. The primary outcome was all-cause death. Among patients with ACS, women as compared with men were much older. Among patients with stable CAD, women were also older than men, but with smaller difference. The cumulative 5-year incidence of all-cause death was significantly higher in women than in men in the ACS group (26.2% and 17.9%, log rank P<0.001). In contrast, it was significantly lower in women than in men in the stable CAD group (14.2% and 15.8%, log rank P=0.005). After adjusting confounders, women as compared with men were associated with significantly lower long-term mortality risk with stable CAD but not with ACS (hazard ratio [HR]: 0.75, 95% confidence interval [CI]: 0.69-0.82, P<0.001, and HR: 0.92, 95% CI: 0.84-1.01, P=0.07, respectively). There was a significant interaction between the clinical presentation and the mortality risk of women relative to men (interaction P=0.002). CONCLUSIONS: Compared with men, women had significantly lower adjusted mortality risk after PCI among patients with stable CAD, but not among those with ACS.

Clinical features and prognosis of patients with and without diabetes mellitus undergoing endovascular aortic aneurysm repair.

BACKGROUND: This study aimed to compare the clinical features and prognoses of patients with and without diabetes mellitus (DM) who underwent endovascular repair for aortic aneurysm (AA). METHODS: We analyzed the clinical database of a prospective multicenter study, registering 929 patients who underwent their first endovascular AA repair in Japan between January 2016 and June 2018. The baseline characteristics and prognoses (including all-cause mortality and cardiovascular events) after repair were compared between the DM and non-DM groups. Prognoses were also compared between the groups after propensity score matching. RESULTS: In total, 226 patients (24.3%) had DM. Compared with non-DM patients, DM patients had higher pack-years of smoking (P = 0.011), higher body mass index (P = 0.009), lower high-density lipoprotein cholesterol levels (P = 0.038), higher triglyceride levels (P = 0.025), and lower left ventricular ejection fraction (P = 0.005). Meanwhile, the low-density lipoprotein cholesterol and blood pressure levels showed no significant intergroup difference (all P > 0.05). DM patients had a higher prevalence of myocardial infarction (P = 0.016), history of coronary revascularization (P = 0.015), and lower extremity artery disease (P = 0.019). Lesion characteristics and procedures were similar between the groups (all P > 0.05). DM patients had a higher risk of all-cause mortality and cardiovascular events than non-DM patients (both P < 0.001). Subsequent propensity score matching also demonstrated that DM patients had a significantly lower rate of overall survival (P = 0.001) and freedom from cardiovascular events (P = 0.010). The Kaplan-Meier estimates at 1 year for the overall survival were 85.6% (95% confidence interval [CI], 80.9% to 90.5%) and 94.3% (95% CI, 91.7% to 97.0%) for patients with and without DM, respectively. The corresponding estimates for freedom from cardiovascular events were 79.8% (95% CI, 74.5% to 85.5%) and 87.7% (95% CI, 84.2% to 91.3%), respectively. CONCLUSIONS: Among patients undergoing endovascular AA repair, those with DM had more cardiovascular risk factors. DM patients had a higher incidence rate of all-cause mortality and cardiovascular events. Matching analysis indicated that DM per se would be a risk factor for poor prognoses after AA repair.

Ischemic and bleeding risk after complex percutaneous coronary intervention in patients with or without high bleeding risk.

OBJECTIVES: To evaluate utility of the complex percutaneous coronary intervention (PCI) criteria in real-world practice. BACKGROUND: Applicability of procedural complexity criteria for risk stratification has not been adequately evaluated in real-world practice. METHODS: Among 13,087 patients undergoing first PCI in the CREDO-Kyoto registry cohort-2, the study population consisted of 7,871 patients after excluding patients with acute myocardial infarction and those without stent implantation. Complex PCI was defined as PCI, which fulfills at least one of the followings: three vessels treated, > = 3 stents implanted, > = 3 lesions treated, bifurcation with two stents, >60 mm total stent lengths, and target of chronic total occlusion. RESULTS: The cumulative incidences of and adjusted risks for the primary ischemic (myocardial infarction/ischemic stroke), and bleeding (GUSTO moderate/severe) endpoints were significantly higher in patients with complex PCI (N = 2,777 [35%]) than in those with noncomplex PCI (N = 5,094 [65%]) (15.4% vs. 10.9%, log-rank p < .001; odds ratio (OR): 1.53, 95% confidence interval (CI): 1.31-1.79, p < .001, and 11.9% vs. 9.9%, log-rank p = .004; OR: 1.24, 95% CI: 1.05-1.46, p = .01). In the 30-day landmark analysis, the higher risks of patients with complex PCI for ischemic and major bleeding events were only seen within 30 days after PCI (ischemic; within 30 days: HR: 2.19, 95% CI: 1.79-2.69, p < .001; beyond 30 days: HR: 1.11, 95% CI: 0.92-1.34, p = .26, and bleeding; within 30 days: HR: 1.56, 95% CI: 1.13-2.16, p = .007; beyond 30 days: HR: 1.11, 95% CI: 0.94-1.31, p = .22). CONCLUSIONS: Patients with complex PCI as compared with patients with noncomplex PCI had a higher risk for both ischemic and bleeding events mainly within 30 days after PCI.

Overview of the 84th Annual Scientific Meeting of the Japanese Circulation Society　- Change Practice!

Due to the COVID-19 pandemic, the 84thAnnual Meeting of the Japanese Circulation Society (JCS) was held in a web-based format for the first time in its history as "The Week for JCS 2020" from Monday, July 27 to Sunday, August 2, 2020. All sessions, including general abstracts, were streamed live or on-demand. The main theme of the meeting was "Change Practice!" and the aim was to organize the latest findings in the field of cardiovascular medicine and discuss how to change practice. The total number of registered attendees was over 16,800, far exceeding our expectations, and many of the sessions were viewed by far more people than at conventional face-to-face scientific meetings. At this conference, the power of online information dissemination was fully demonstrated, and the evolution of online academic meetings will be a direction that cannot be reversed in the future. The meeting was completed with great success, and we express our heartfelt gratitude to all affiliates for their enormous amount of work, cooperation, and support.

Application of the Modified High Bleeding Risk Criteria for Japanese Patients in an All-Comers Registry of Percutaneous Coronary Intervention　- From the CREDO-Kyoto Registry Cohort-3.

BACKGROUND: The prevalence of and expected bleeding event rate in patients with the Japanese version of high bleeding risk (J-HBR) criteria are currently unknown in real-world percutaneous coronary intervention (PCI) practice.Methods and Results:We applied the J-HBR criteria in the multicenter CREDO-Kyoto registry cohort-3 that enrolled 13,258 consecutive patients who underwent first PCI. The J-HBR criteria included Japanese-specific major criteria such as heart failure, low body weight, peripheral artery disease and frailty in addition to the Academic Research Consortium (ARC)-HBR criteria. There were 8,496 patients with J-HBR, and 4,762 patients without J-HBR. The J-HBR criteria identified a greater proportion of patients with HBR than did ARC-HBR (64% and 48%, respectively). Cumulative incidence of the Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding was significantly higher in the J-HBR group than in the no-HBR group (14.0% vs. 4.1% at 1 year; 23.1% vs. 8.4% at 5 years, P<0.0001). Cumulative 5-year incidence of BARC 3/5 bleeding was 25.1% in patients with ARC-HBR, and 23.1% in patients with J-HBR. Cumulative incidence of myocardial infarction or ischemic stroke was also significantly higher in the J-HBR group than in the no-HBR group (6.9% vs. 3.6% at 1 year; 13.2% vs. 7.1% at 5 years, P<0.0001). CONCLUSIONS: The J-HBR criteria successfully identified those patients with very high bleeding risk after PCI, who represented 64% of patients in this all-comers registry.

Percutaneous coronary intervention versus coronary arterial bypass grafting in patients with multi-vessel coronary revascularization (from the CREDO-Kyoto PCI/CABG registry/cohort-2).

OBJECTIVE: To assess long-term outcomes after percutaneous coronary intervention (PCI) with drug-eluting stent only compared with coronary artery bypass grafting (CABG) in patients with triple-vessel disease. BACKGROUND: Selection between PCI and CABG is still a clinically relevant issue in the management of patients with multi-vessel coronary artery disease. METHODS: Among 15,939 patients enrolled in the CREDO-Kyoto PCI/CABG registry/cohort-2, the current study population consisted of 2,193 patients who underwent elective multi-vessel coronary revascularization including left anterior descending coronary artery (LAD) either by PCI with sirolimus-eluting stent (SES) only (N = 945) or CABG (N = 1,248). RESULTS: The cumulative 5-year incidence of and the adjusted risk for the primary outcome measure (a composite of all-cause death, myocardial infarction [MI], or stroke) were not significantly different between PCI and CABG groups (22.6% vs. 23.0%, p = .40, and HR: 1.13, 95%CI: 0.91-1.40, p = .26). The risk of PCI relative to CABG for all-cause death and stroke was also insignificant (HR: 1.19, 95%CI: 0.92-1.53, p = .19; HR: 0.89, 95%CI: 0.62-1.27, p = .51). The adjusted 5-year risk for MI, hospitalization for heart failure (HF), any coronary revascularization and major bleeding was significantly different between the groups (HR: 1.59, 95%CI: 1.10-2.30, p = .01; HR: 1.49, 95%CI: 1.05-2.11, p = .02; HR: 3.70, 95%CI: 2.91-4.70, p < .0001; HR: 0.18, 95%CI: 0.14-0.22, p < .0001). CONCLUSIONS: In patients who underwent coronary revascularization for multiple vessels including LAD, PCI using SES as compared with CABG was associated with a comparable 5-year risk for death/MI/stroke as well as for mortality, but with a markedly higher risk for any coronary revascularization.

Diabetes Mellitus and Long-Term Risk for Heart Failure After Coronary Revascularization.

BACKGROUND: The effect of diabetes mellitus (DM) status on the long-term risk for heart failure (HF) in patients undergoing coronary revascularization has not been adequately evaluated.Methods and Results:In this study, 15,231 patients who underwent coronary revascularization in the CREDO-Kyoto Registry Cohort-2 were divided into 2 groups according to DM status (DM group: n=5,999; Non-DM group: n=9,232). The DM group was further divided into 2 groups according to insulin treatment (insulin-treated DM [ITDM]: n=1,353; non-insulin-treated DM [NITDM]: n=4,646). The primary outcome measure was HF hospitalization. The cumulative 5-year incidence of HF hospitalization was significantly higher in the DM than non-DM group (11.0% vs. 6.6%, respectively; log-rank P<0.0001), and in the ITDM than NITDM group (14.6% vs. 10.0%, respectively; log-rank P<0.0001). After adjusting for confounders, the increased risk of HF hospitalization with DM relative to non-DM remained significant (hazard ratio [HR] 1.47, 95% confidence interval [CI] 1.30-1.67, P<0.0001), whereas the risk associated with ITDM relative to NITDM was not significant (HR 1.17, 95% CI 0.96-1.43, P=0.12). CONCLUSIONS: The adjusted long-term risk for HF hospitalization after coronary revascularization was significantly higher in DM than non-DM patients, regardless of revascularization strategy, but did not differ between ITDM and NITDM patients.

Editor's Choice - Endovascular Repair Versus Surgical Repair for Japanese Patients With Ruptured Thoracic and Abdominal Aortic Aneurysms: A Nationwide Study.

OBJECTIVE: This study compared outcomes after endovascular aneurysm repair (ER) and open surgical repair (OR) of ruptured descending thoracic aortic aneurysms (rDTAA) and ruptured abdominal aortic aneurysms (rAAA) through a nationwide analysis performed in Japan. METHODS: This was a national registry based retrospective comparative study using data from the Japanese Registry of all Cardiac and Vascular Diseases Diagnostic Procedure Combination (JROAD-DPC) database, a nationwide claim based database from more than 600 hospitals. Patients admitted to certificated teaching hospitals with rDTAA and rAAA and treated by either ER or OR between 1 April 2012 and 31 March 2015 were identified. A propensity score matched analysis was performed to compare ER and OR. RESULTS: About 40% of the total cohort (n = 8,302) were managed conservatively for various reasons, including limited options in primary care facilities in certain areas. In total, 983 patients had rDTAA (OR = 511; ER = 472) and 2,320 (OR = 1,754; ER = 566) had rAAA. Altogether, 604 and 1,080 patients were matched with rDTAA and rAAA, respectively. Compared with OR, ER was associated with significantly better in hospital mortality in patients with rDTAA (ER = 22.5%; OR = 29.8% [p < .001]) and similar mortality for those with rAAA (ER = 25.7%; OR = 24.3% [p = .57]). ER involved significantly shorter hospital stays for rDTAA (ER = 25.5; OR = 32 days [p < .001]) and rAAA (ER = 16; OR = 21 days [p < .001]). The median Barthel Index at discharge was ≥75/100 for all groups, and there were no differences between ER and OR. Total medical costs were significantly lower for ER for rDTAA (ER = ¥6.47 million, OR = ¥7.28 million [p < .001]) but were higher for rAAA (ER = ¥4.65 million; OR = ¥3.43 million [p < .001]). CONCLUSION: A Japanese nationwide observational study showed that in hospital outcomes for ER vs. OR were more favourable for rDTAA and comparable for rAAA. ER resulted in an equivalently favourable functional status at discharge and significantly shorter hospital stays.

A novel guidewire-integrated embolic protection filter device with a handy-folding system: In vitro and in vivo performance assessment.

OBJECTIVES: We developed a novel guidewire-integrated filter device with a handy-folding system (IFD: Inoue filter device). In vitro and in vivo studies were conducted to evaluate the feasibilityof the IFD. BACKGROUND: Although distal atheromatous and thrombotic embolizations remain unresolved critical issues during catheter interventions, distal protection devices are infrequently used partly because of reduced lower maneuverability. METHODS: In the in vitro experiment, we created an experimental circulation model composed of silicone latex tubes, a reservoir, and a roller pump. After the filter device was deployed in the tube, polystyrene fluorescent microspheres were injected and the capture rate was calculated. Ten trials were performed using the IFD and Spider FX. In the in vivo study, five independent operators deployed, and they retrieved the IFD in swine common iliac and internal carotid arteries. The procedural success rate as well as the delivery and retrieval time was evaluated. RESULTS: In the in vitro study, the mean capture rate was 94% and 35% in the IFD and Spider groups, respectively. In the in vivo study, all procedures were successful, with no complications. The mean delivery time was 281 ± 87 s and 194 ± 67 s and the mean retrieval time was 24 ± 9 and 13 ±1 s in the left internal carotid and the left common iliac arteries, respectively. CONCLUSION: Although further studies and improvements are required, the study results indicate that the IFD is feasible.

Comparison of 3-year clinical outcomes after endovascular therapy for aortoiliac artery occlusive disease between patients with and without hemodialysis: Subanalysis of the REAL-AI registry.

PURPOSE: The impact of hemodialysis (HD) on aortoiliac (AI) occlusive lesions remains unknown. Here, we report the 3-year clinical outcomes of endovascular treatment (EVT) for AI occlusive lesions in propensity-matched populations of patients who did and did not undergo HD. METHODS: The cohort of this large-scale, multicenter, retrospective registry study included 574 consecutive patients with AI occlusive disease. Propensity score-matched analysis was performed to compare AI occlusive lesions between patients who did and did not undergo HD. The endpoints were primary patency, assisted primary patency, and secondary patency as well as overall survival and major adverse limb events (MALEs). RESULTS: A total of 57 matched pairs of patients who did and did not undergo HD were analyzed after propensity score-matched analysis. No significant difference was observed in primary patency, assisted primary patency, secondary patency, and MALEs at 3 years. The survival rate was significantly lower in the HD group than in the without-HD group (68% vs. 93%, P = 0.03). CONCLUSIONS: Although the survival rate of HD patients was poor, the results of EVT for AI occlusive lesions were reasonable in these patients.

[Successful Echo-guided Deployment of Stent Graft for Intraoperative Retrograde Aortic Dissection and Rupture;Report of a Case].

We report a case of chronic dissecting thoracoabdominal aneurysm with intraoperative retrograde aortic dissection and rupture at proximal descending aorta, which was successfully treated by echoguided stent-graft insertion. An 82-year old male underwent thoracoabdominal aortic replacement for dilatation of infra-diaphragmatic aorta. Under F-F bypass, his thoracoabdominal aorta was replaced by a Dacron graft with 4-branches. After he weaned from F-F bypass, we found massive bleeding from proximal descending aorta. Trans-esophageal echocardiography (TEE) showed aortic dissection from the clamp site to the distal anastomotic site of the former total arch replacement. We temporary got hemostasis by suture and surgical glue, and anastomosed a 10 mm-graft to the thoracoabdominal main graft as conduit, then inserted and deployed 2 pieces of stent-graft. Direct echo and TEE contributed to the accurate positioning of them. Bleeding was completely controlled. He well recovered without paraplegia. Post-operative computed tomography (CT) showed good positioning and dilatation of the stentgraft and the perfect reverse remodeling of thoracic aorta.

Thoracic endovascular aortic repair with branched Inoue Stent Graft for arch aortic aneurysms.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) for thoracic aortic aneurysms (TAAs) is in rapid expansion due to its minimal invasiveness. However, TEVAR for an arch aneurysm with a straight stent graft needs surgical reconstruction for supra-aortic vessels. A branched stent graft pioneered by Inoue (branched Inoue Stent Graft [ISG]) has been expected to resolve this problem, but its utility remains to be established in the real clinical setting. This study evaluated the long-term clinical outcome of branched ISGs for TAAs. METHODS: Among 217 consecutive patients who underwent TEVAR with ISGs between March 2003 and September 2013, 89 patients with TAAs were treated with implantation of the branched ISG (single branch: n = 64; double branch: n = 18; triple branch: n = 7). The primary end point was freedom from aneurysm-related death. Secondary end points included periprocedural adverse events, freedom from all-cause death and major adverse events (composite of aneurysm-related death, surgical conversion, aneurysm rapture, persistent type I or III endoleak, graft infection, graft occlusion, graft migration, and aneurysm expansion), changes of aneurysm diameter, stroke, and any endovascular reintervention during follow-up. RESULTS: All deployments of branched ISGs were successful. The 30-day mortality was 4.5% (single branch, 3.1%; double branch, 0%; triple branch, 29%), and periprocedural stroke was 16% (single branch, 7.8%; double branch, 33%; triple branch, 42%). At 1 and 5 years, freedom from aneurysm-related death was 93% and 93%, respectively, and freedom from all-cause death was 85% and 59%, respectively. Survival free of major adverse events was 76% at 5 years. The cumulative incidence of stroke was 11% at 5 years. Three patients underwent surgical conversion because of persistent type I endoleak. One branch graft occlusion was observed at the left subclavian artery in a patient who received a double-branched graft. CONCLUSIONS: Periprocedural outcome of the single-branched ISG was acceptable, and long-term safety and efficacy were demonstrated. However, the procedural complications of the multibranched ISG leave room for improvement.

Two susceptibility loci to Takayasu arteritis reveal a synergistic role of the IL12B and HLA-B regions in a Japanese population.

Takayasu arteritis (TAK) is an autoimmune systemic vasculitis of unknown etiology. Although previous studies have revealed that HLA-B*52:01 has an effect on TAK susceptibility, no other genetic determinants have been established so far. Here, we performed genome scanning of 167 TAK cases and 663 healthy controls via Illumina Infinium Human Exome BeadChip arrays, followed by a replication study consisting of 212 TAK cases and 1,322 controls. As a result, we found that the IL12B region on chromosome 5 (rs6871626, overall p = 1.7 × 10(-13), OR = 1.75, 95% CI 1.42-2.16) and the MLX region on chromosome 17 (rs665268, overall p = 5.2 × 10(-7), OR = 1.50, 95% CI 1.28-1.76) as well as the HLA-B region (rs9263739, a proxy of HLA-B*52:01, overall p = 2.8 × 10(-21), OR = 2.44, 95% CI 2.03-2.93) exhibited significant associations. A significant synergistic effect of rs6871626 and rs9263739 was found with a relative excess risk of 3.45, attributable proportion of 0.58, and synergy index of 3.24 (p ≤ 0.00028) in addition to a suggestive synergistic effect between rs665268 and rs926379 (p ≤ 0.027). We also found that rs6871626 showed a significant association with clinical manifestations of TAK, including increased risk and severity of aortic regurgitation, a representative severe complication of TAK. Detection of these susceptibility loci will provide new insights to the basic mechanisms of TAK pathogenesis. Our findings indicate that IL12B plays a fundamental role on the pathophysiology of TAK in combination with HLA-B(∗)52:01 and that common autoimmune mechanisms underlie the pathology of TAK and other autoimmune disorders such as psoriasis and inflammatory bowel diseases in which IL12B is involved as a genetic predisposing factor.

Clinical impact of left ventricular outflow tract obstruction in takotsubo cardiomyopathy.

BACKGROUND: A hyperdynamic state of the basal left ventricle sometimes results in obstruction of the left ventricular outflow tract (LVOT). However, the prevalence, clinical presentation, and prognostic effect of LVOT obstruction in takotsubo cardiomyopathy (TC) have not been fully evaluated. METHODS AND RESULTS: Among 933 consecutive patients who underwent emergency coronary angiography for suspected acute coronary syndrome, 35 patients (3.8%) were diagnosed as TC. The cumulative 3-year incidence of all-cause death, cardiac death, hospitalization for congestive heart failure (CHF), and recurrent TC was 24.2%, 0.0%, 6.5%, and 12.2%, respectively. Among 27 patients with information of a LVOT pressure gradient, LVOT obstruction was present in 9 (33%). The prevalence of moderate to severe mitral regurgitation (67% vs. 11%, P=0.003), CHF (78% vs. 28%, P=0.02), and hypotension (56% vs. 5.6%, P=0.008) was significantly higher in patients with LVOT obstruction than in those without. Nevertheless, the cumulative 3-year incidence of all-cause death was not significantly different between the 2 groups (49.2% vs. 23.0%, P=0.22) with no cardiac deaths in either group. Hospitalization for CHF and recurrent TC were significantly more frequent in patients with LVOT obstruction (25.0% vs. 0.0%, P=0.04, and 25.0% vs. 6.7%, P=0.02). CONCLUSIONS: In 35 consecutive patients with TC, those with significant LVOT obstruction (33%) had a more serious clinical presentation such as CHF and hypotension, but had similar 3-year mortality rate as compared with those without.

Response of urinary liver-type fatty acid-binding protein to contrast media administration has a potential to predict one-year renal outcome in patients with ischemic heart disease.

Urinary liver-type fatty acid-binding proteins (uL-FABP) have recently been recognized as a useful biomarker for predicting contrast-induced nephropathy. Although accumulating studies have evaluated short-term outcomes, its prognostic value for long-term renal prognosis in patients undergoing coronary angiography (CAG) has not been fully examined. This study aimed to evaluate the predictive value of uL-FABP for long-term renal outcome in patients with ischemic heart disease (IHD). Consecutive 24 patients with impaired renal function (serum creatinine >1.2 mg/dL) who underwent CAG were enrolled. uL-FABP was measured before CAG, 24 and 48 h after CAG. The changes in estimated glomerular filtration rate (eGFR) throughout CAG and at 1 year later were compared with the uL-FABP levels. The patients with a greater decrease in eGFR 1 year later had higher uL-FABP levels at all points, but only the value at 48 h after CAG reached statistical significance (lower vs. higher decreased eGFR group, 4.61 ± 3.87 vs. 17.71 ± 12.96; P < 0.01). Measurement of uL-FABP at 48 h after CAG (48h-uL-FABP) showed better correlation with the change in eGFR (pre-CAG uL-FABP vs. 48h-uL-FABP: R = 0.27, P = 0.20 vs. R = 0.65, P < 0.01). Moreover, the high-pre and high-48h-uL-FABP group showed a significantly larger decrease in eGFR compared with the high-pre and low-48h-uL-FABP group (change in eGFR; 8.12 ± 4.06 vs. 1.25 ± 2.23 mL/min/1.73 m2, P < 0.01), although the baseline eGFR levels were similar between these two groups. In this pilot study, measurement of uL-FABP levels at 48 h after CAG may be useful in detecting renal damage, and in predicting 1-year renal outcome in IHD patients undergoing CAG.

Noninvasive Detection of Functional Myocardial Ischemia: Multifunction Cardiogram Evaluation in Diagnosis of Functional Coronary Ischemia Study (MED-FIT).

BACKGROUND: Multifunction cardiogram (MCG) is a computer-enhanced, resting electrocardiogram analysis developed to detect hemodynamically relevant coronary artery disease (CAD). Based on data from previous studies suggesting excellent diagnostic accuracy in detecting CAD, MCG (approved by the Food and Drugs Administration) received a Current Procedure Terminology (CPT) code in 2010 in United States. However, there is no previous study validating MCG by using fractional flow reserve (FFR) as the reference standard. METHODS: Multifunction cardiogram Evaluation in Diagnosis of Functional coronary Ischemia sTudy (MED-FIT) was designed as a single-center, prospective study enrolling 100 stable patients with suspected CAD scheduled for coronary angiography. The primary and secondary analyses evaluated the diagnostic performance of the MCG severity score to detect functional myocardial ischemia by FFR ≤0.80, and angiographically significant coronary stenosis (percent diameter stenosis ≥50%) by quantitative coronary angiography. RESULTS: The current analysis set consisted of 91 patients in whom MCG data with adequate quality was obtained. The prevalence of positive functional myocardial ischemia and angiographically significant stenosis in the current study was 42.7% and 41.8%, respectively. Area under the receiver operating characteristics curve (AUC) of the MCG severity score for functional myocardial ischemia and angiographically significant stenosis was low (AUC 0.51, 95% confidence interval [CI] 0.38-0.63, and AUC 0.58, 95%CI 0.46-0.70, respectively). Sensitivity, and specificity of the MCG severity score for functional myocardial ischemia and angiographically significant stenosis was also low (32%/67%, and 37%/72%) using a cutoff value of 4.0. CONCLUSIONS: Diagnostic performance of the MCG severity score was poor for both functional myocardial ischemia, and angiographically significant stenosis.

Clinical efficacy of infrapopliteal endovascular procedures for hemodialysis patients with critical limb ischemia.

PURPOSE: To investigate 5-year clinical outcomes after infrapopliteal endovascular therapy (EVT) for critical limb ischemia (CLI) patients on or not on hemodialysis (HD), and compare the clinical efficacy of EVT between the 2 groups. METHODS: The subjects were 1091 CLI patients (1310 limbs) who underwent EVT for isolated infrapopliteal lesions from 2004 to 2012, and were classified into 2 groups for comparative study: the patients on HD group (670 patients, 830 limbs) and not on HD group (421 patients, 480 limbs). RESULTS: The HD group had a significantly lower rate of freedom from major adverse limb events or perioperative death (HD 78.4% vs. non-HD 86.0% at 1 year, HD 70.3% vs. non-HD 82.4% at 5 years, P = 0.01), or amputation-free survival (AFS) rate (HD 65.7% vs. non-HD 78.7% at 1 year, HD 34.4% vs. non-HD 59.8% at 5 years, P < 0.01) after EVT compared with the non-HD group. Independent predictors of AFS in HD patients were nonambulatory, diabetes mellitus, albumin <3.0 g/dL, ejection fraction ≤0.48, and no patent pedal arch arteries before EVT. AFS at 1 year was 81% in patients with 0 or 1 predictor, surpassing the suggested AFS objective performance goal (OPG) end points of 68%, but AFS in patients with 2 or more predictors failed to reach the OPG. CONCLUSIONS: In comparison with non-HD patients, the clinical efficacy of infrapopliteal EVT for HD patients was poor. Preoperative risk stratification based on AFS predictors can be used as an index for predicting the prognosis.

Impact of statin therapy on patients with coronary heart disease and aortic aneurysm or dissection.

OBJECTIVE: The impact of statin therapy on cardiovascular outcome in coronary artery disease (CAD) patients with aortic aneurysm or dissection (AD) is still unclear. The aim of this study was to elucidate the effect of statins at discharge to improve outcomes in CAD patients with AD. METHODS: Among 14,834 consecutive patients who underwent first coronary revascularization in the CREDO-Kyoto PCI/CABG registry, we identified 699 patients (4.7%) with AD. The primary outcome measure was defined as a composite of all-cause death, myocardial infarction, and stroke. The effect of statin therapy was assessed by a Cox proportional hazards model incorporating clinically relevant factors. RESULTS: The risk for the primary outcome measure was significantly higher in patients with AD (adjusted hazard ratio [HR], 1.43; 95% confidence interval [CI], 1.23-1.66; P < .0001). In patients with AD, 215 patients (31%) had already undergone aneurysm repair, and only 274 patients (39%) were treated with statins at discharge. Patients treated with statins were younger, had higher body mass index, and were more often treated with percutaneous coronary intervention. Heart failure, anemia, and hemodialysis were more prevalent in patients treated without statins. In patients without AD, 7014 patients (50%) were treated with statins. Patients treated with statins were younger and had higher body mass index, and more patients were treated for CAD due to myocardial infarction. Heart failure, prior stroke, hemodialysis, anemia, and malignant disease were more prevalent in patients treated without statins. The use of statins was associated with lower risk for the primary outcome measure in patients with AD (adjusted HR, 0.71; 95% CI, 0.51-0.99; P = .045) as well as in patients without AD (adjusted HR, 0.79; 95% CI, 0.73-0.85; P < .0001). The effect size of statin use was similar between the patients with AD and those without AD (P interaction = .69). CONCLUSIONS: CAD patients with AD had significantly higher long-term risk for cardiovascular events. Statin therapy was associated with lower risk for cardiovascular events in patients with CAD with AD as well as in patients without AD.

Long-term outcomes of endovascular therapy for aortoiliac bifurcation lesions in the real-AI registry.

PURPOSE: To report long-term outcomes of endovascular therapy (EVT) for aortoiliac bifurcation lesions. METHODS: Patients enrolled in the multicenter REtrospective AnaLysis of Aorto-Iliac stenting (REAL-AI) registry in Japan were pooled. Of 2096 patients who underwent EVT for de novo aortoiliac disease between January 2005 and December 2009, 190 patients (148 men; mean age 70±9 years) had aortoiliac bifurcation lesions that were treated with stents, whose configuration (single, V, or kissing) and type (balloon-expandable or self-expanding) were subjected to regression analysis to determine any impact on primary patency along with other demographic, clinical, and lesion characteristics, including Trans-Atlantic Inter-Society Consensus II C/D classification. The primary endpoints were restenosis and target lesion revascularization (TLR). Secondary endpoints were all-cause death, major cardiovascular events, and major cardiovascular + limb events. RESULTS: The overall complication rate was 6.3%, and 1- and 5-year primary patency rates were 87% and 73%, respectively. Over a mean follow-up of 31±15 months, there were 36 (19.0%) restenoses, 22 (11.6%) TLRs, and 4 (2.1%) reocclusions; stent fracture (2, 1.1%) and major amputation (2, 1.1%) were rare. Only female gender [adjusted hazard ratio (AHR) 4.26, 95% CI 1.89 to 9.71, p<0.001] and residual diameter stenosis (AHR 1.04, 96% CI 1.01 to 1.06, p=0.01) were independent predictors of primary patency. CONCLUSION: Stenting for aortoiliac bifurcation lesions was found to be safe and effective. Neither stent configuration nor type appeared to affect vessel patency in true bifurcation lesions.