Abstract Background We and others have previously reported that the Great East Japan Earthquake (GEJE) caused a significant but transient increase in cardiovascular diseases and deaths in the ...disaster area. However, it remains to be examined whether the GEJE had a long-term prognostic influence in large-scale cohort studies. This point is important when analyzing the data before and after the GEJE in the cohort studies in the disaster area. Methods We examined 8676 patients registered in our Chronic Heart Failure Analysis and Registry in the Tohoku District-2 (CHART-2) Study ( N = 10,219) between 2006 and 2010 and were alive after March 10, 2011. Results There were 48 GEJE-related deaths, causing a sharp and transient increase in all-cause death within a month after the GEJE. However, after excluding the GEJE-related deaths, the cubic polynomial spline smoothing showed no significant increase in all-cause death, heart failure admission, non-fetal acute myocardial infarction, or non-fetal stroke during the median 3-year follow-up after the GEJE. The extrapolation curves beyond the GEJE, which were obtained by the parametric survival models based on the survival data censored on the GEJE, were not significantly different from the Kaplan–Meier curves estimating the survival functions of deaths and cardiac events during the total follow-up period without considering the impacts of the GEJE. Furthermore, the multivariate Cox proportional hazard model applied to the matched cohort of the baseline data and the data after the GEJE showed no significant differences in the impacts of prognostic factors on all-cause mortality before and after the GEJE. Conclusions These results indicate that the GEJE had no significant long-term prognostic impact after the earthquake in cardiovascular patients in the disaster area.
Abstract Background Although angiotensin receptor blockers (ARBs) are now one of the first-line drug classes for the management of hypertension, recommendations for the management of chronic heart ...failure (CHF) are limited. The supplemental benefit of angiotensin receptor blocker in hypertensive patients with stable heart failure using olmesartan (SUPPORT) trial investigates whether an additive treatment with an ARB, olmesartan, reduces the mortality and morbidity in hypertensive patients with stable chronic heart failure. Methods and results The SUPPORT trial is a prospective randomized open-label blinded endpoint study. Between October 2006 and March 2010, 1147 stable CHF patients treated with evidence-based medications were successfully randomized to either olmesartan or control group. In the olmesartan group, the ARB was initiated at the dose of 5.0–10 mg, and was then increased up to 40 mg/day, when possible. No ARBs were allowed in the control group. Primary outcome measure in the SUPPORT trial is the composite of all-cause death, non-fatal acute myocardial infarction, non-fatal stroke and hospital admission due to worsening heart failure. The participants will be followed for at least 3 years until March 2013. Conclusions The SUPPORT trial will elucidate the supplemental benefits of an ARB, olmesartan, in hypertensive patients with CHF.
Abstract The long-term outcomes of patients undergoing paclitaxel-coated balloon (PCB) angioplasty for drug-eluting stent restenosis (DES-ISR) remain unclear. We investigated the 5-year safety and ...efficacy outcomes of PCB angioplasty for DES-ISR. The study included 185 patients with 216 DES-ISR lesions undergoing PCB angioplasty between September 2008 and December 2010. Two serial angiographic follow-ups were routinely scheduled at 6 and 18 months after the index procedure. Five-year clinical outcomes were investigated. The mean duration of follow-up was 2052 ± 352.5 days, and 94.1% of the patients completed the 5-year follow-up. Recurrent restenosis was observed in 48 lesions (22.2%) at the 6-month follow-up and late restenosis was observed in 21 lesions (13.6%) at the 18-month follow-up. Very late restenosis was observed in 4 lesions (6.8%), and target lesion revascularization (TLR) was performed for 8 lesions (13.6%) beyond 24 months after the procedure. The cumulative rates of TLR at 1, 2, and 5 years were 16.4%, 28.9%, and 34.1%, respectively. In patients undergoing TLR, 87% (52/60 patients) underwent TLR within the first 2 years after the index procedure. Multivariable analysis revealed that in-stent occlusion lesion (OR, 4.04; 95%CI, 1.14-16.5; p = 0.04), post-procedural percent diameter stenosis >35% (OR, 3.29; 95%CI, 1.60-6.88; p = 0.001), and right coronary artery ostial lesions (OR, 3.95; 95%CI, 1.09-15.25; p = 0.04) were independent predictors of recurrent restenosis. In conclusion, our results suggest that long-term outcomes after PCB angioplasty are acceptable; however, close follow-up during the first 2 years following this procedure may be necessary.
Abstract Objective We aimed to investigate the clinical outcomes up to 10 years after sirolimus-eluting stent (SES) implantation. Background Little is known about the long-term outcomes after first ...generation SES implantation. Methods The study population comprised 342 patients (504 lesions) who underwent SES implantation between January 2002 and December 2004. The median duration of follow-up was 3801 days (interquartile range Q1–Q3: 3582 – 3864 days). Results The cumulative event rate of definite stent thrombosis was 3.9 %. The cumulative rate of target lesion revascularization (TLR) at 1, 5, and 10 years was 8.7%, 18.8%, and 31.1%, respectively, and the annual rate of TLR was 3.1%. Clinically driven TLR occurred at relatively constant rate during 10 years (2.0%/year). In a multivariate analysis, higher body mass index, hemodialysis, in-stent restenosis (ISR) target lesion, and total stent length >30 mm were independent risk factors of TLR within 5 years. An independent risk factor of TLR beyond 5 years was ISR target lesion. Conclusions Late TLR after SES implantation is a long-term hazard, lasting up to 10 years. The ISR target lesion is a risk factor of TLR during 10 years.
Abstract Background Prognostic impact of body mass index (BMI) in Japanese patients with chronic heart failure (HF) remains unclear. Methods and Results We examined the relationship between BMI and ...the prognosis of Japanese HF patients in the Chronic Heart Failure Analysis and Registry in the Tohoku District (CHART) study. The study sample was 972 Japanese chronic HF patients (mean age, 68.2 ± 13.5; male 65.2%). We categorized them into 5 groups; BMI <18.5, 18.5 to 22.9, 23.0 to 24.9 (reference), 25.0 to 29.9, and ≥30.0. Using a Cox hazards model, the relationships between BMI and deaths or admission for worsening HF were studied in detail. Mean follow-up period was 3.4 ± 1.7 years. Multivariate analysis showed that, as compared with reference group (BMI 23.0 to 24.9), hazard ratios (HR) for all-cause death showed a U-shaped association with 1.70 (95% confidence interval; 1.04–2.76), 1.23 (0.85–1.78), 1.26 (0.84–1.90), and 2.75 (1.51–5.00) among those with BMI<18.5, 18.5 to 22.9, 25.0 to 29.9, and ≥30.0, respectively. There were significant and suggestive U-shaped associations between BMI and cardiac-cause death or admission for worsening HF. Conclusions Both high and low BMIs were associated with increased outcomes, suggesting that extreme obesity is not beneficial in improving the prognosis of Japanese chronic HF patients.
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