Sherry Laurent

Outcomes With Drug-Eluting Versus Bare-Metal Stents in Saphenous Vein Graft Intervention: Results From the STENT (Strategic Transcatheter Evaluation of New Therapies) Group

OBJECTIVES This study compares outcomes of drug-eluting stents (DES) versus bare-metal stents (BMS) in patients undergoing saphenous vein graft (SVG) intervention. BACKGROUND The safety and efficacy of DES in patients undergoing SVG intervention is controversial. METHODS The STENT (Strategic Transcatheter Evaluation of New Therapies) registry is a multicenter U.S. registry evaluating outcomes with DES. Our study population includes patients undergoing PCI of SVG lesions with DES (n = 785) or BMS (n = 343) who completed 9-month or 2-year follow-up. Outcomes were adjusted with propensity analyses. RESULTS The DES patients had fewer emergent procedures but had smaller vessels and longer lesions. The DES patients had less death or myocardial infarction at 9 months (hazard ratio [HR]: 0.52, 95% confidence interval [CI]: 0.33 to 0.83, p = 0.006) and less death at 2 years (HR: 0.60, 95% CI: 0.36 to 0.98, p = 0.041). Target vessel revascularization (TVR) was less with DES at 9 months (7.2% vs. 10.0%, HR: 0.36, 95% CI: 0.22 to 0.61, p < 0.001) but was no different by 2 years (18.3% vs. 16.9%, p = 0.86), although adjusted TVR rates were lower (HR: 0.60, 95% CI: 0.40 to 0.90, p = 0.014). The DES reduced TVR at 9 months in SVG lesions with diameter <3.5 mm (8.0% vs. 17.2%, p = 0.013) but not >or=3.5 mm (6.0% vs. 6.6%, p = 0.74). CONCLUSIONS Treatment of SVG lesions with DES vs. BMS is effective in reducing TVR at 9 months, although most of this advantage is lost at 2 years. The DES seem safe with less death or myocardial infarction, although selection bias might have affected these results. Our data suggest that DES might have short-term advantages over BMS in SVG lesions with diameter <3.5 mm.

Predictive factors from cold knife conization for residual cervical intraepithelial neoplasia in subsequent hysterectomy

OBJECTIVE The optimal management of cervical intraepithelial neoplasia after cold knife conization remains controversial. Reliable predictors of residual dysplasia in the cervix after cold knife conization have not been consistently identified. This study was initiated to examine the accuracy of the traditional factors used to predict residual dysplasia in hysterectomy specimens after cold knife conization. STUDY DESIGN A retrospective 10-year chart review identified a cohort of 1272 patients who underwent cold knife conization, of whom 311 had a subsequent hysterectomy within 1 year of conization. Residual disease was defined as cervical intraepithelial neoplasia or cancer in the hysterectomy specimen. All cone specimens were completely submitted for pathologic examination, and the following factors were analyzed for their predictive value: degree of dysplasia, margin involvement, endocervical gland involvement, and status of the endocervical curettage. The predictive value of age, race, gravidity, parity, socioeconomic status, cigarette smoking, and marital status were also examined. The chi 2 test, t test, and logistic regression were used for statistical analysis. RESULTS Dysplasia or cancer were identified in 1066 (84%) of the 1272 patients who underwent cold knife conization. Of the 311 patients having a subsequent hysterectomy, 106 (34%) had residual disease in their hysterectomy specimen. By multivariate analysis only increasing age and degree of dysplasia were predictive of residual disease. The odds ratio of residual disease in the hysterectomy specimen for a 25-year-old woman was 2.7 (95% confidence interval 1.6 to 4.4) compared with a 40-year-old woman whose odds ratio was 4.9 (95% confidence interval 2.2 to 10.8). The presence of dysplasia in the cold knife conization specimen conferred an odds ratio of 12.1 (95% confidence interval 2.7 to 54.5) of identifying residual disease. Dysplasia involving the ectocervical margin, endocervical margin, and endocervical glands was not predictive of disease in the hysterectomy specimens. Endocervical curettage was not performed in 44% of the patients, preventing reliable statistical evaluation. Further analysis indicated that residual disease was found in 32% of the hysterectomy specimens with negative margins, in 31% with no endocervical gland involvement, and in 23% with a negative endocervical curettage sample. CONCLUSIONS The presence or absence of dysplasia in the cold knife conization ectocervical margin, endocervical margin, and endocervical glands was not predictive of residual dysplasia in post-cold knife conization hysterectomy specimens. Increasing age and severity of disease in the cone specimen were the only factors that accurately predicted residual dysplasia. The traditional factors used to justify hysterectomy after cold knife conization may not be valid on the basis of these results.

The prognostic value of serum progesterone and quantitative β-human chorionic gonadotropin in early human pregnancy

Objective: Our purpose was to determine whether serum progesterone, with or without quantitative β-human chorionic gonadotropin, is predictive of pregnancy outcome within the first 8 weeks of gestation in asymptomatic women. Study Design: Asymptomatic patients at Results: Seventy-four patients were evaluated in this study. The mean serum progesterone level for viable pregnancies was 22.1 ng/ml, which was significantly greater than that for the nonviable gestations, 10.1 ng/ml ( p p p = 0.59). Conclusions: Serum progesterone alone, within the first 8 weeks of gestation, is predictive of pregnancy outcome.

A prospective randomized clinical trial comparing two oxytocin induction protocols.

OBJECTIVE Our objective was to compare the safety and efficacy of two accepted oxytocin induction protocols that differ in oxytocin dose increments. STUDY DESIGN At the Carolinas Medical Center in Charlotte, North Carolina, 151 women with indications for induction of labor were prospectively randomized into one of two oxytocin induction protocols. Safety and efficacy of the two protocols were analyzed with two-tailed t tests and chi 2. RESULTS Time from induction to establishment of a regular labor pattern was significantly shorter in the experimental group compared with the traditional group (p = 0.03). However, no significant difference was seen from onset of induction to time of delivery. Incidences of hyperstimulation were not significantly different between the two protocols, but there was a trend toward a higher incidence of fetal heart rate changes in the experimental group (p = 0.08). CONCLUSION These data suggest that induction with larger dose increments will shorten time to adequate labor without an associated increase in uterine hyperstimulation or poor neonatal outcome. The differences in heart rate changes are concerning and merit further investigation. If confirmed by further studies, an increased risk of cord compression could outweigh the benefit of a faster onset of contractions.

Use of norplant contraceptive implants in the immediate postpartum period: Safety and tolerance

OBJECTIVE Our purpose was to determine the safety and tolerance of levonorgestrel contraceptive implants (Norplant, Wyeth-Ayerst, Philadelphia) when inserted immediately post partum, to document the effects on weight and blood pressure, and to determine the side effects. STUDY DESIGN After vaginal delivery, 250 women were randomized to receive Norplant within 48 hours of delivery (study group) or at the 4- to 6-week postpartum visit (control group). Baseline measurements were recorded and compared with those obtained at the 4- to 6-week follow-up visit. A diary was maintained by patients who recorded bleeding and side effects. Statistical analysis was performed with t test and chi 2 analysis. RESULTS There were no episodes of acute postpartum hemorrhage or clinically significant bleeding. Compared with the control group, the immediate group reported significantly more bleeding days (p < 0.01). There was no significant difference between the two groups in the hemoglobin values obtained at 4 to 6 weeks post partum. The immediate insertion group reported significantly more headaches (p < 0.01) and acne (p = 0.01). CONCLUSION Norplant is well tolerated and should be available for interested patients immediately post partum.

Outcomes with drug-eluting stents versus bare metal stents in acute ST-elevation myocardial infarction: Results from the Strategic Transcatheter Evaluation of New Therapies (STENT) Group†

This study compares outcomes with drug‐eluting stents (DES) versus bare metal stents (BMS) in patients with ST‐elevation myocardial infarction (STEMI).

Primary care by obstetricians and gynecologists: Attitudes of the members of The South Atlantic Association of Obstetricians and Gynecologists

OBJECTIVE Our purpose was to determine the extent of primary care delivered by obstetrician-gynecologists and compare practice patterns with published primary care and preventive service guidelines. STUDY DESIGN All 277 active fellows of The South Atlantic Association of Obstetricians and Gynecologists were mailed a self-administered questionnaire. The type of primary care offered by these physicians and their attitudes about the training of residents in obstetrics and gynecology were surveyed. Physicians were categorized as generalists or specialists on the basis of the completion of a fellowship program. Descriptive statistics and chi 2 analysis were used for statistical analysis. RESULTS Completed surveys were returned by 82% of the fellows. The majority of the respondents perceived their practice as specialty care for women. Generalists offered recommended screening services to women of all ages with greater frequency than the specialists did (p = 0.05). Both groups did not provide care for the chronic medical illnesses most commonly seen in a primary care practice. The respondents favored more residency training in those common acute illnesses frequently encountered in a primary care setting. CONCLUSIONS Obstetrician-gynecologists in The South Atlantic Association of Obstetricians and Gynecologists selectively practice primary care. These physicians did not support caring for chronic medical problems frequently treated in an ambulatory care practice.

An integer based risk score for predicting 30-day major adverse cardiac or cerebrovascular events after percutaneous coronary intervention with drug-eluting stents: results from a large prospective multicentre registry, the STENT Group

AIMS Previous risk models predicting in-hospital major adverse cardiac or cerebrovascular events (MACCE) after percutaneous coronary interventions (PCI) may underestimate actual short-term post-procedure complications due to the trend toward early discharge of patients. METHODS AND RESULTS Using a subset (N=10,679) from the STENT Group registry, a logistic regression model was developed to predict 30-day MACCE which includes death, myocardial infarction, target vessel revascularisation and stroke. An integer-based risk score was created from the model and validated in another subset (N=3,099). In the study subset, there was significant difference between in-hospital and 30-day MACCE N=443 (2.0%) vs. 131 (4.2), p<0.01, respectively. A final risk model included nine variables; absence of pre-procedural statin (odds ratio=1.3, 95% confidence interval=1.0-1.5), haemoglobin level (0.9/1 gm increase, 0.8-0.9), cardiogenic shock (4.4, 3.1-6.3), acute congestive heart failure (1.6, 1.2-2.3), left main disease (2.2, 1.3-3.7), left anterior descending artery lesion (1.3, 1.0-1.5), ostial lesion (1.6, 1.2-2.1), coronary thrombosis (2.0, 1.4-2.9) and ACC/AHA type C lesion (1.3, 1.1-1.6). The c-statistics of the final model were 0.653 and 0.692 in the study and validation subset, respectively. CONCLUSIONS In this large real world registry of DES, in-hospital MACCE did not represent short-term post-procedure prognosis. The risk model consisting of nine variables predicted 30-day MACCE with modest discriminatory value.

1044-58 Drug-eluting stent utilization and outcomes from the strategic evaluation of new transvascular therapies (STENT) group: A large prospective multicenter “Real-World” registry of percutaneous coronary intervention

Background. Several studies demonstrated superiority of drug-eluting stents compared to bare metal stents in relative simple lesions and patients.Aim. The aim of the study was to analyze the results of paclitaxel eluting stents in patients with complicated lesions or in diabetics and to compare with bear metal stent patients having similar characteristics. Patients were selected from the randomized TAXUS II study. Methods. The TAXUS II study was a randomized, prospective study in 536 patients evaluating immediate and 12 months results in patients implanted with slow and moderate release paclitaxel stent with versus bare metal stent. From the baseline population, the subgroups of patients with complicated lesion were selected as follows (Taxus vs Controls): diabetics (32 vs 40 patients), female (68 vs 59 pts) small vessel of <2.75mm (130 vs 145), lesion length of >10 mm (130 vs 140), multiple stents (14 vs 19), or use of GP IIb/IIIa inhibitors (41 vs 47 pts). Results were expressed as a target lesion revascularization (TLR) rate at a follow-up time of 12 months. Results. Table shows the TLR rate.