Initial and 6-month results of biodegradable poly-l-lactic acid coronary stents in humans.

BACKGROUND: Although metallic stents are effective in preventing acute occlusion and reducing late restenosis after coronary angioplasty, many concerns still remain. Compared with metallic stents, poly-l-lactic acid (PLLA) stents are biodegradable and can deliver drugs locally. The aim of this study was to evaluate the feasibility, safety, and efficacy of the PLLA stent. METHODS AND RESULTS: Fifteen patients electively underwent PLLA Igaki-Tamai stent implantation for coronary artery stenoses. The Igaki-Tamai stent is made of a PLLA monopolymer, has a thickness of 0.17 mm, and has a zigzag helical coil pattern. A balloon-expandable covered sheath system was used, and the stent expanded by itself to its original size with an adequate temperature. A total of 25 stents were successfully implanted in 19 lesions in 15 patients, and angiographic success was achieved in all procedures. No stent thrombosis and no major cardiac event occurred within 30 days. Coronary angiography and intravascular ultrasound were serially performed 1 day, 3 months, and 6 months after the procedure. Angiographically, both the restenosis rate and target lesion revascularization rate per lesion were 10.5%; the rates per patient were 6.7% at 6 months. Intravascular ultrasound findings revealed no significant stent recoil at 1 day, and they revealed stent expansion at follow-up. No major cardiac event, except for repeat angioplasty, developed within 6 months. CONCLUSIONS: Our preliminary experience suggests that coronary PLLA biodegradable stents are feasible, safe, and effective in humans. Long-term follow-up with more patients will be required to validate the long-term efficacy of PLLA stents.

Intramural delivery of a specific tyrosine kinase inhibitor with biodegradable stent suppresses the restenotic changes of the coronary artery in pigs in vivo.

OBJECTIVES: This study was designed to examine whether or not intramural delivery of ST638 (a specific tyrosine kinase inhibitor) with biodegradable stent can suppress the restenotic changes of the coronary artery in vivo. BACKGROUND: Clinical and animal studies demonstrated that restenosis after coronary intervention results from a combined effect of neointimal formation and geometric remodeling (decrease in total cross-sectional area). Thus, the most effective strategy to prevent the restenosis appears to inhibit both the neointimal formation and geometric remodeling by antiproliferative agent and stent, respectively. We have previously shown that ST638 markedly suppresses the restenotic changes of the porcine coronary artery when applied from the adventitial site. METHODS: A poly-L-lactic acid biodegradable stent was coated with either ST638 (0.8 mg) or equimolar of its inactive metabolite, ST494. A pair of these stents were implanted alternatively in the left anterior descending or circumflex coronary artery in pigs (n=6). Three weeks after the procedure, coronary stenosis was assessed by angiography followed by histological examination. RESULTS: Coronary stenosis was significantly less at the ST638 stent site than at the ST494 stent site (47+/-5% vs. 25+/-4%, p < 0.01). Histological examination also showed that the extent of neointimal formation and that of geometric remodeling were significantly less at the ST638 stent site than at the ST494 stent site (p < 0.05). CONCLUSIONS: These results indicate that intramural delivery of a specific tyrosine kinase inhibitor with biodegradable stent overcomes the proliferative stimuli caused by balloon injury, the stent itself, and the drug coating on the stent, resulting in the suppression of the restenotic changes of the coronary artery in vivo. This strategy might also be useful in the clinical setting in humans.

Effects of fructose ingestion on carbohydrate and lipid metabolism during prolonged exercise in distance runners.

The effects of ingestion of fructose (F), as well as of arginine (A) and citric acid (C) on both carbohydrate metabolism and lipid metabolism during prolonged exercise in seven distance runners on treadmill running were investigated by comparing it with those of glucose + arginine + citric acid (GAC) and placebo. With the values of the plasma glucose, though FAC as well as placebo contrastively indicated almost a flat distribution, GAC increased from 30 min rest before the exercise (i.e., the time for 500 ml intake of GAC) to the beginning of the exercise. The plasma glucose for GAC showed significantly higher values (138 +/- 22 mg/dl) than that for FAC or placebo, whose values were 102 +/- 18 mg/dl and 93 +/- 8 mg/dl, respectively. The plasma glucose for GAC was likely to decrease gradually as the exercise progressed more. At the end of exercise, however, the plasma glucose for FAC indicated significantly higher values (100 +/- 12 mg/dl) than that for GAC, whose values were 89 +/- 12 mg/dl. Though the serum free fatty acid showed upward tendencies of values in all cases of FAC, placebo, and GAC as the exercise progressed, no significant difference of the values in those cases was observed (the following values were drawn at the end of the exercise; FAC:655 +/- 185 microEq/l, placebo:603 +/- 289 microEq/l, GAC:485 +/- 140 microEq/l).(ABSTRACT TRUNCATED AT 250 WORDS)

Neutron activation analysis of nickel purified by floating zone-refining and anion exchange.

Nondestructive neutron activation analysis was performed on the nickel purified by floating zone-refining and anion exchange. It is found that floating zone-refining in vacuum is effective to remove Na, Sc, Cr, Zn, As, Ag, Sb and Hg through vaporization in addition to elimination of Se, Sb, Ta, Sm and Tb through segregation. Anion exchange method is also effective to separate Fe, Co, Zn, Mo, Hg, Th and U usually contained in the commercial nickel sources. It is concluded that combination of these two purification methods is required to obtain high purity nickel, since floating zone-refining is known ineffective to eliminate Fe and Co, main impurities in commercial nickel sources.

Study on trace impurity elements in highly purified iron and aluminum by neutron activation analysis.

Activation analysis was carried out on the purified iron and aluminum to study the behavior of trace impurities on purification process, and to estimate the purity of the purified samples. Thermal neutrons with high Cd ratio through D2O column or graphite column were used for the activation of samples to reduce the interference effects by fast neutrons, the reactions, (n, p) or (n, a), from matrix elements. On the zone refined aluminum, the segregation of impurity elements was cleary observed. In the case of iron, decrease of impurity content was confirmed on superposing the various purification processes.