Prospective randomized comparison of early and late results of 4 different stent designs

Background

Late results of interventional procedures using coronary stents are largely determined by the rate of restenosis. So far, few data are available addressing the effect of stent design on this crucial variable and on early and late adverse events after stent implantation.

Methods

From 1996 through1998, a total of 965 lesions in 925 patients with coronary artery disease were randomized to treatment with 1 of 4 different stent designs (Micro stent II [M] AVE, Düsseldorf, Germany; Sito [S] Sitomed, Rangendingen, Germany; Pura Vario [PV], Devon, Hamburg, Germany; Inflow [ID] Inflow Dynamics, München, Germany). The primary end point of the study was the degree of diameter stenosis measured by quantitative coronary angiography 6 months after stent implantation.

Results

Diameter stenosis at 6 months follow-up was not different in the 4 study arms (M 40.3 ± 24.1, S 42.8 ± 27.0, PV 42.6 ± 26.9 and ID 42.3 ± 26.8, P = .7). No significant differences could be detected in net lumen gain and late lumen loss, resulting in comparable restenosis rates (≥50% diameter stenosis) at follow-up (M 26.0%, S 30.5%, PV 31.3%, and ID 28.7%, P = .7). Early adverse events like stent loss, stent thrombosis, periinterventional acute myocardial infarctions and emergency coronary artery bypass graft also showed no significant differences. Multivariate regression analyses revealed reference vessel diameter <3.0 mm, overall stented length, a history of bypass grafting, localization of the target lesion in the left anterior descending coronary artery, type C lesions, dissection before stent implantation, and diabetes mellitus to be independent predictors for restenosis.

Conclusion

Stent design does not have significant influence on development of restenosis. Adverse event rates were similar with all stent types used in this trial.     

Incidence of cervical node involvement in metastatic cutaneous malignancy involving the parotid gland

BACKGROUND: The parotid lymph nodes represent an important group of nodes at risk for metastatic involvement from cutaneous malignancies of the head and neck. When treating patients with metastatic disease in the parotid gland it has been our custom to also remove the lymph nodes of the neck on the basis that these nodes represent other nodal groups at risk for metastatic involvement. The aim of this study is to determine the incidence of cervical node involvement among patients with clinical metastatic SCC or melanoma of the parotid to determine whether treatment of the clinically negative neck is warranted. METHODS: The study group consists of 123 prospectively accessioned patients with clinical metastatic cutaneous squamous cell carcinoma (SCC) (n = 73) or melanoma (n = 50) involving the parotid gland and a minimum of 2 years of follow up, irrespective of the clinical status of the neck. RESULTS: Among 73 patients with metastatic SCC in the parotid, 19 (26%) had clinical neck involvement, and 16 of these were pathologically positive (84%). A total of 37 patients had elective neck dissections, and 13 were pathologically positive, which is an overall rate of 52% neck involvement among patients having neck dissection. Among 50 patients with metastatic melanoma in the parotid, 19 (38%) patients were initially seen with clinical neck disease, and all were pathologically positive. Among 31 patients with clinically negative necks, 26 had neck dissections and seven had positive nodes (27%). Overall, 58% of patients with melanoma who had a neck dissection had positive nodes. CONCLUSION: Patients with metastatic cutaneous SCC and melanoma involving the parotid gland had a high incidence of clinical (26% and 38%, respectively) and occult neck disease (35% and 27%). Treatment of the clinically negative neck in the presence of clinical metastatic parotid cancer should be considered to reduce the likelihood of failure in cervical nodes, to define the extent of disease, and to assist with patient selection for adjuvant therapy.     

Severe cardiovascular complications relating to Gemeprost therapy

The use of gemeprost vaginal pessaries is generally thought to be a method with little complications used for cervical softening within the first two trimesters of pregnancy. Though in our hospital two cases presented with severe cardiovascular reactions, to be attributed to the effect of prostaglandins. The first patient experienced a severe cardiogenic shock due to vasospasm several hours after primary administration of gemeprost vaginal pessaries and a cerebral stroke some hours later. The second patient suffered of a myocardial infarction ensuing from coronary spasm.     

Protein tyrosine kinase activation by polycyclic aromatic hydrocarbons in human HPB-ALL T cells

It has been well established that certain polycyclic aromatic hydrocarbons (PAHs), such as 7,12-dimethylbenz[a]anthracene (DMBA), 3-methylcholanthrene (3MC), and benzo[a]pyrene (BaP), produce immunotoxicity and cancer in rodents and that these effects are also likely seen in humans. Our laboratory has found that polycyclic aromatic hydrocarbons (PAHs) produce an increase in intracellular Ca2+ in lymphocytes that appears to correlate with their immunotoxicity. Specifically, immunotoxic PAHs, such as DMBA and BaP, have been shown to produce a sustained increase in intracellular Ca2+ in lymphocytes, whereas nonimmunosuppressive PAHs, such as benzo[e]pyrene (BeP) and anthracene, do not. Our studies previously demonstrated that the rapid increase in intracellular Ca2+ produced by DMBA in HPB-ALL T cells was caused by protein tyrosine kinase (PTK) activation in human T cells, leading to tyrosine phosphorylation of phospholipase C (PLCgamma) and IP3-dependent Ca2+ mobilization. However, the specificity of PTK activation by PAHs was not established. In the present studies, we extend our observations of PTK activation by examining a number of PAHs for their effects on total and specific (Fyn and ZAP-70) PTK activity. We show that 10 microM concentrations of PAHs nonspecifically and rapidly (within 5 min) stimulate PTKs in the HPB-ALL human T cell line. BeP and anthracene were found to be nearly as effective at increasing total tyrosine kinase activity as DMBA, 3MC, and BaP, observed 5 min after exposure. We found that only immunotoxic PAHs activated the Fyn and ZAP-70 PTKs at 10 min, but total PTK activity was still increased by nonimmunotoxic PAHs, BeP, or anthracene after 10 min of exposure. These studies demonstrate that immunotoxic PAHs increase total and specific PTK activity in the human HPB-ALL T cell line. Thus the rapid increase in PTK activity produced by PAHs may not correlate with the immunotoxicity of these agents.     

Complete surgical excision is effective treatment for children with immature teratomas with or without malignant elements: A Pediatric Oncology Group/Children's Cancer Group Intergroup Study.

PURPOSE: To determine whether the 3-year event-free survival (EFS) of children with completely resected immature teratomas is greater than 85%. PATIENTS AND METHODS: Patients with immature teratomas treated at Pediatric Oncology Group or Children's Cancer Group institutions were eligible. Pathology was centrally reviewed to confirm diagnosis and tumor grading. Follow-up included physical examination, measurement of tumor markers (alpha fetoprotein and human chorionic gonadotropin), and imaging. All patients were monitored for events, defined as tumor recurrence, second malignancy, or death. RESULTS: Seventy-three children (median age, 7.8 years) with extracranial immature teratomas were enrolled on study. Primary tumor sites included ovarian (n = 44), testicular (n = 7), and extragonadal (n = 22). However, on review, 23 patients had foci of yolk sac tumor (n = 21) or primitive neuroectodermal tumor (n = 2), whereas 50 had pure immature teratomas. Twenty-five patients had increased alpha fetoprotein (n = 18), human chorionic gonadotropin (n = 5), or both (n = 2); nine had foci of yolk sac tumor on review. Pathology review identified 23 patients with grade 1, 29 with grade 2, and 21 with grade 3 immature teratomas. With a median follow-up of 35 months, the overall 3-year EFS was 93% (95% confidence interval, 86% to 98%), with 3-year EFS of 97.8%, 100%, and 80% for patients with ovarian, testicular, and extragonadal tumors, respectively. Only four of 23 patients with immature teratoma and malignant foci developed recurrence, suggesting that surgical resection followed by close observation are effective treatment. Overall, five patients had disease recurrence 4 to 7 months from diagnosis, and four (80%) are disease free after platinum-based therapy. The fifth patient has residual tumor after cisplatin, etoposide, and bleomycin treatment requiring further therapy. CONCLUSION: Surgical excision is safe and effective treatment for 80% to 100% of children with immature teratoma.     

POSTNATAL DEVELOPMENT OF RENAL FUNCTION IN PRE-TERM AND FULL-TERM INFANTS

ABSTRACT. Aperia, A., Broberger, B., Klinder, G., Herin, P. and Zetterström, R. (Department of Paediatrics, Karolinska Institute, St. Göran's Children's Hospital, Stockholm and Huddinge Hospital, Huddinge, Sweden). Postnatal deveopment of renal function in preterm and full-term infants. Acta Paediatr Scand, 70:183, 1981. –This study has been designed to examine the effect of gestational age (GA) on the postnatal development of renal function and has been performed in pre-term (PT) infants (GA=30–34 weeks) and in full-term (FT) infants (GA=39–41 weeks). Postnatal age has ranged from 1–35 days. From 8 hour urine samples collected after spontaneous voiding and a capillary blood sample, determinations have been made of the clearance of creatinine (C_Cr), the fractional excretion of β₂-microglobulin (FE_β2) and the fractional excretion of sodium (FE_Na). In some infants receiving fluid parenterally, simultaneous determinations were made of the clearance of creatinine and inulin. As judged from this study, C_Cr is a reliable indicator of the glomerular filtration rate (GFR). GFR was almost the same in newborn PT and FT, but from 0.3–1 week of age GFR increased significantly more rapidly in FT than in PT. From 1–5 weeks of age GFR increased at approximately the same rate in PT and FT infants. The absolute value for GFR in 3–5 weeks old infants was lower in PT than in FT. FE_β2 was higher in PT than in FT infants during the entire first month of life and FE_Na was higher in PT than in FT infants during the first week of life, suggesting a glomerular tubular imbalance at least at the level of the proximal tubule in PT infants. It is concluded that different stages of maturation will alter the preconditions for the renal adaptation to extrauterine life during at least the first month of life. Therefore special attention must be paid to the limited renal function in PT during their entire first month of life.     

A putative enolpyruvyl transferase gene involved in nikkomycin biosynthesis

The nikO gene encoding a putative enolpyruvyl transferase has been identified within the Streptomyces tendae Tü901/8c nikkomycin gene cluster. nikO encodes a deduced protein of 471 amino acid residues which exhibits significant sequence similarity to UDP-N-acetylglucosamine enolpyruvyl transferase and 5-enol-pyruvylshikimate 3-phosphate synthase from various origin. The nikO gene was inactivated by inserting a kanamycin resistance cassette; the mutant did not produce biologically active nikkomycins I, J, X, and Z nor the nucleoside moieties, nikkomycins C(x) and C(z), but accumulated the novel component RT 2.0. RT 2.0 has been isolated from culture filtrate and its structure was determined by using mass spectrometry and NMR analyses as ribofuranosyl-4-formyl-4-imidazolone which represents a novel nucleoside. The putative activity of the nikO gene product in nikkomycin biosynthesis will be discussed.