Long-Term (>10 Years) clinical outcomes of first-in-human biodegradable poly-l-lactic acid coronary stents: Igaki-Tamai stents.

BACKGROUND: The purpose of this study was to evaluate the long-term safety of the Igaki-Tamai stent, the first-in-human fully biodegradable coronary stent made of poly-l-lactic acid. METHODS AND RESULTS: Between September 1998 and April 2000, 50 patients with 63 lesions were treated electively with 84 Igaki-Tamai stents. Overall clinical follow-up (>10 years) of major adverse cardiac events and rates of scaffold thrombosis was analyzed together with the results of angiography and intravascular ultrasound. Major adverse cardiac events included all-cause death, nonfatal myocardial infarction, and target lesion revascularization/target vessel revascularization. During the overall clinical follow-up period (121 ± 17 months), 2 patients were lost to follow-up. There were 1 cardiac death, 6 noncardiac deaths, and 4 myocardial infarctions. Survival rates free of all-cause death, cardiac death, and major adverse cardiac events at 10 years were 87%, 98%, and 50%, respectively. The cumulative rates of target lesion revascularization (target vessel revascularization) were 16% (16%) at 1 year, 18% (22%) at 5 years, and 28% (38%) at 10 years. Two definite scaffold thromboses (1 subacute, 1 very late) were recorded. The latter case was related to a sirolimus-eluting stent, which was implanted for a lesion proximal to an Igaki-Tamai stent. From the analysis of intravascular ultrasound data, the stent struts mostly disappeared within 3 years. The external elastic membrane area and stent area did not change. CONCLUSION: Acceptable major adverse cardiac events and scaffold thrombosis rates without stent recoil and vessel remodeling suggested the long-term safety of the Igaki-Tamai stent.

Bare metal stent implantation in large-sized unprotected left main coronary artery stenosis in the drug-eluting stent era.

Recently, drug-eluting stent (DES) has been recommended as the first choice in those patients who need stent implantation in unprotected left main coronary artery (ULMCA) stenosis. However, the long-term safety and efficacy of this procedure is still controversial. The objective of this study was to evaluate the safety and efficacy of bare metal stent (BMS) implantation in ULMCA stenting in the DES era. We implanted BMS (mainly 4 mm-diameter) in large-sized ULMCA after December 2004 when DES became available. The results of BMS implantation (n = 19) were compared with those of DES implantation (n = 39). There was no significant difference between the 2 groups regarding age, gender and coronary risk factors. Emergency procedures were more frequently performed in the BMS group than in the DES group (53% vs. 26%, p = 0.08). The initial mortality was 10.5% (n = 2) in the BMS group and 2.6% (n = 1) in the DES group (p = 0.25). There was no stent thrombosis, Q-wave myocardial infarction or emergent bypass surgery in either group during their hospital stay. The restenosis rate was 0% (n = 45) in both groups, and the target vessel revascularization rate was 5.9% in the BMS group (1/17) and 2.6% (1/38) in the DES group (p = 0.53). Therefore, there were no statistically significant differences in outcomes between the two study groups. These results indicate that BMS implantation in a large-sized ULMCA may be a safe and effective treatment even in the DES era.

The importance of serial cardiac troponin measurement for evaluating the response to immunosuppressive therapy for myocarditis.

A 71-year-old woman was admitted to our department because of acute myocarditis. She was ameliorated with conventional heart failure treatment, however she developed left ventricular dilatation and cardiac troponin T (cTnT) was elevated again to >1.0 ng/ml 6 month after the first admission. She was re-admitted because of recurrent decompensated heart failure in spite of conventional treatment. Right ventricular endomyocardial biopsy revealed active myocarditis. Immunosuppressive therapy with prednisolone and azathioprine improved her symptoms and left ventricular function accompanied by a striking decrease of cTnT levels. The decreased cTnT level indicated an effective response to immunosuppression early after the beginning of treatment. These findings suggested that it is possible to evaluate the response to immunosuppressive therapy by serial measurement of cardiac troponin.

Relationship of cardio-ankle vascular index (CAVI) to carotid and coronary arteriosclerosis.

BACKGROUND: The cardio-ankle vascular index (CAVI) has been recently reported as a new index of aortic stiffness, which is less influenced by blood pressure than pulse wave velocity (PWV). The present study investigated the relationship between the levels of CAVI and carotid and coronary arteriosclerosis. METHODS AND RESULTS: The 443 consecutive patients who underwent CAVI, carotid sonography, and coronary angiography in hospital were examined. Intima-media thickness (IMT) and carotid plaque were evaluated by ultrasonography. The severity of coronary artery disease (CAD) was evaluated by coronary angiography and the subjects were divided into 4 groups (0, no significant organic stenosis: 1, 1-vessel disease: 2, 2-vessel disease: 3, 3-vessel disease). Univariate analyses showed that both CAVI and brachial-ankle PWV (baPWV) were associated with IMT and the presence of carotid plaque. Multiple stepwise regression analyses revealed that CAVI (p=0.0427), but not baPWV, was associated with the IMT. Both CAVI (p<0.0001) and baPWV (p=0.0140) were significantly associated with the severity of CAD. Multiple logistic analyses revealed that CAVI (p=0.0342), but not baPWV (p=0.8027), was associated with the presence of multivessel disease. CONCLUSION: High CAVI implies progression of carotid and coronary arteriosclerosis. CAVI may be more closely linked with arteriosclerosis than baPWV.

Long-term effects of early statin therapy for patients with acute myocardial infarction treated with stent implantation.

OBJECTIVES: Statins are widely administered to patients with acute myocardial infarction (AMI), but knowledge of the effects of early statin therapy on the long-term mortality of AMI patients after stent implantation is still limited, especially for beyond low-density lipoprotein cholesterol (LDL-C) lowering effects. METHODS: Our 378 consecutive AMI patients who were discharged alive from the hospital with successful stent implantation between 1997 and 2005 were included. We retrospectively evaluated the effects of statin therapy on major adverse cardiovascular events (MACE), including all-cause death, reinfarction, coronary artery bypass grafting, heart failure requiring rehospitalization, and target lesion revascularization. RESULTS: Statins were given to 271 patients according to the physician to achieve a LDL-C level of less than 100mg/dL. The achieved LDL-C levels in the statin group were 100.7, 95.1, 96.7, and 102.8mg/dL at discharge, 6 months, 1 year, and 3 years, respectively, whereas those in the non-statin group were 103.2, 107.3, 102.8, and 103.0mg/dL. These levels were not significantly different between the groups during 3 years. Based on Kaplan-Meier estimates, statin therapy was associated with a reduction of long-term mortality (log-rank test P=0.007). Multivariate Cox regression analysis revealed that statin therapy (P=0.015, hazard ratio: 0.10; 95% confidence interval: 0.01-0.64) was a significant predictor of favorable prognosis. Multivariate analysis revealed that statin treatment had a beneficial effect against MACE over 3 years (P=0.008). CONCLUSIONS: Early statin therapy was beneficial for long-term mortality of AMI patients treated with stenting.

Relationship of serum adiponectin level to adverse cardiovascular events in patients who undergo percutaneous coronary intervention.

BACKGROUND: Hypoadiponectinemia has been reported to indicate an increased risk of cardiovascular disease, so the present study investigated the significance of serum adiponectin (APN) levels for predicting clinical outcomes after percutaneous coronary intervention (PCI). METHODS AND RESULTS: The APN levels were evaluated in 184 consecutive patients who underwent PCI. The patients were divided into Group A [the lowest quartile of APN levels (APN < or =4.5 microg/ml), n=46] and Group B [the upper 3 quartiles of APN levels (APN >4.5 microg/ml), n=138]. During a mean follow-up period of 27.3 months, the rate of major adverse cardiac and cerebrovascular events (MACCE: death from any cause, re-infarction, repeat coronary revascularization, hospitalization because of congestive heart failure, and cerebral infarction) was higher in Group A (58.7%) than in Group B (37.0%, p=0.0101). Moreover, when the APN levels were calculated by adjusting for sex, age, body mass index, and triglyceride levels, patients in the lowest quartile of residual APN levels had a higher risk of MACCE (p=0.0405). Multiple logistic analyses showed that hypoadiponectinemia (APN < or =4.5 microg/ml) was independently correlated with MACCE. Kaplan-Meier analysis demonstrated a higher MACCE rate in Group A than in Group B (Log-rank chi(2)=7.89, p=0.0050). CONCLUSION: The APN level may be helpful for predicting clinical outcomes after PCI.

[Hypoadiponectinemia implies the development of atherosclerosis in carotid and coronary arteries].

OBJECTIVES: Adiponectin is an adipocyte-derived endocrine factor. Hypoadiponectinemia has been observed in obese patients, and plasma adiponectin levels are reported to increase during weight reduction. Moreover, hypoadiponectinemia has also been observed in patients with coronary artery diseases. The present study investigated the relationships between levels of adiponectin and carotid intimal-medial thickness, a marker of early vascular disease, and carotid artery plaque and the severity of coronary artery disease, a marker of advanced vascular disease. METHODS: Four hundred thirty-one consecutive patients were enrolled from inpatients without acute coronary syndrome who underwent coronary angiography between August 2001 and August 2003. The residual adiponectin levels were calculated by adjusting for sex, age, and body mass index, and a logarithmic transformation was applied. The severity of coronary artery disease was evaluated by coronary angiography and divided into four groups (Group 0: no significant organic stenosis, Group 1: 1-vessel disease, Group 2: 2-vessel disease, Group 3: 3-vessel disease or left main coronary trunk disease). Carotid plaque was evaluated by ultrasonography and divided into two groups [Group(-) : patients without carotid plaque, Group (+): patients with carotid plaque]. The intimal-medial thickness was measured on a longitudinal scan of the common carotid artery at a point 1 cm proximal from the bifurcation bulb. RESULTS: The logarithmic-transformed levels of residual adiponectin were associated with severity of coronary artery disease (Group 0: 0.18 +/- 0.59 microg/ml, Group 1: -0.02 +/- 0.56 microg/ml, Group 2: - 0.09 +/- 0.58 microg/ml, Group 3: - 0.10 +/- 0.66 microg/ml, p = 0.0013). The logarithmic-transformed levels of residual adiponectin were decreased in patients with carotid plaque [Group (-): 0.08 +/- 0.59 microg/ml, Group (+): - 0.08 +/- 0.59 microg/ml, p = 0.045]. However, the logarithmic-transformed levels of residual adiponectin were not associated with intimal-medial thickness (p = 0.6398). CONCLUSIONS: Hypoadiponectinemia adjusted for sex, age, body mass index implies the progression of carotid and coronary sclerosis.