Showing papers by "Rambam Health Care Campus published in 2003"

Imatinib mesylate (STI571) in preparation for allogeneic hematopoietic stem cell transplantation and donor lymphocyte infusions in patients with Philadelphia-positive acute leukemias.

Abstract: Chronic myeloid leukemia in blast crisis (BC) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph(+) ALL) are associated with extremely poor outcome. Allogeneic transplantation during BC or active leukemia is most often unsuccessful due to high-rates of both treatment-related complications and relapse. Long-term results are significantly better if a second chronic phase or remission can be achieved prior to transplantation. Similarly, DLI given for the treatment of post-transplant relapse is more successful when given during a second remission. In this study we report our results with a previously unreported approach consisting of short-term treatment with imatinib mesylate (formerly, STI571) to induce or maintain remission, followed by allogeneic transplantation or DLI and the impact on transplantation/DLI outcome. Sixteen patients were treated either in preparation for transplantation (n = 12), for DLI (n = 1), or for both (n = 3). Ten had CML in BC; seven myeloid and three lymphoid BC. Six patients had Ph(+) ALL. The donors were matched unrelated (n = 9), matched siblings (n = 5) or haplo-identical (n = 2). Eleven of 15 patients given imatinib pre-transplant were transplanted in complete hematologic response. Engraftment and GVHD rates were not different from expected. Seven patients had grade II-III hepatic toxicity after transplantation. After a median follow-up of 10 months (range, 3-16 months) six remain alive, two after further therapy. The 1-year survival rate was 25%. Four patients were given imatinib prior to DLI, all had complete response. Two remain in remission >6 months from relapse. In conclusion, treatment with imatinib allows transplantation in a more favorable status or maintaining remission with low toxicity until transplantation is feasible. Pre-transplant imatinib seems safe and not associated with excess post-transplant complications. Imatinib may have substantial activity in combination with DLI. Further study of a larger group of patients is required to assess the impact on long-term outcome and the role of post-transplant imatinib in controlling residual disease.

Comparison of two platelet glycoprotein IIb/IIIa inhibitors, eptifibatide and abciximab: outcomes, complications and thrombocytopenia during percutaneous coronary intervention.

Abstract: Background Platelet glycoprotein IIb/IIIa inhibitors have significantly reduced the incidence of 30-day ischemic events during percutaneous coronary interventions (PCI). However, each of the three currently available agents has different pharmacological characteristics, safety, efficacy and costs. There has not been a direct comparison between eptifibatide and abciximab in the rates of major adverse cardiac events, major complications and thrombocytopenia. Methods. A total of 642 consecutive patients underwent PCI at our institution between January 2000 and December 2001 and were treated with either eptifibatide (n = 342) or abciximab (n = 300) during the procedure. The selection of the IIb/IIIa inhibitor was arbitrary and left to the discretion of the operator. Complete blood counts were performed by routine protocol on all patients 2 and 4 hours after initiation of the drug. We analyzed the in-hospital clinical outcomes and the incidence of thrombocytopenia in this cohort. Results. Baseline clinical and angiographic characteristics and concomitant drug treatment were similar between the 2 groups, except for a higher incidence of diabetes in the eptifibatide group. The rates of in-hospital death (1.2% eptifibatide group versus 1.0% abciximab group; p = 0.7), stroke (0% for both groups), target vessel revascularization (1.2% eptifibatide group versus 1.0% abciximab group; p = 0.8) and major bleeding complications (1.7% eptifibatide group versus 0.7% abciximab group; p = 0.2) were similar between the 2 groups. Thrombocytopenia was more frequent in the abciximab-treated patients (6%, versus 0% in the eptifibatide group; p < 0.001), including 5 patients who developed profound thrombocytopenia (< 20,000 cells/mm 3 ). Conclusion. Both agents, eptifibatide and abciximab, proved to have the same rates of in-hospital major adverse cardiac events, bleeding and vascular complications. Abciximab therapy was associated with a significantly higher incidence of thrombocytopenia within 4 hours of drug initiation, which prompted immediate drug discontinuation, but was not associated with increased risk of bleeding, vascular or other complications.

Natural history of moderate mitral valve stenosis.

Abstract: BACKGROUND With the introduction of surgery and percutaneous balloon valvuloplasty for relieving severe mitral stenosis the natural history of the disease has markedly altered. OBJECTIVES To determine the natural history of the disease in patients with moderate mitral valve stenosis. METHODS Demographic, clinical and echocardiographic data were evaluated in 36 patients with moderate mitral stenosis during a follow-up of 71 +/- 15 months. RESULTS The 36 patients comprised 32 women and 4 men with a mean age of 43.7 +/- 12.2 years; 28 were Jewish and 8 were of Arab origin. During follow-up, there was a significant decrease in mitral valve area, with an increase in mean mitral valve gradient and score. Mean loss of mitral valve area was 0.04 +/- 0.11 cm 2/year. No correlation was found between disease progression and age, past mitral valve commissurotomy, baseline mean gradient or mitral valve score. Larger baseline mitral valve area (P = 0.007) and Arab origin (P = 0.03) had an independent correlation to loss of mitral valve area. Fifteen patients (42%) did not demonstrate any loss in mitral valve area during the follow-up period. CONCLUSIONS The rate of mitral valve narrowing in patients with moderate mitral stenosis is variable and cannot be predicted by patient's age, past commissurotomy, valve score or gradient. Secondly, larger baseline mitral valve area and Arab origin showed an independent correlation to loss of mitral valve area; and finally, in many patients valve area did not change over a long observation period.

Comparison of bypass surgery and stenting for the treatment of multivessel disease: results from the ARTS trial in Israel.

Abstract: BACKGROUND The Arterial Revascularization Therapies Study was a multicenter, randomized trial designed to compare percutaneous coronary intervention with stenting versus coronary artery bypass graft surgery in 1,205 patients with multivessel coronary artery disease. The most appropriate type of treatment for these patients is still a matter of considerable debate. OBJECTIVES To evaluate the clinical characteristics of patients enrolled in the ARTS trial in Israel in comparison to those worldwide, and to assess the 1 year outcome in these patients. METHODS Between April 1997 and June 1998, a total of 1,205 patients with multivessel coronary artery disease, who were considered to be equally treatable with both modalities, were randomized to either stenting (n = 600) or CABG (n = 605) at 67 centers around the world. In Israel, 53 patients at four participating medical centers were randomized to either PCI with stents (n = 27) or CABG (n = 26). RESULTS Clinical and angiographic characteristics were similar in the two groups, except for a significantly higher incidence of diabetic patients in Israel who were randomized to CABG, compared to those worldwide (35% vs. 16%, P = 0.01). Also, there were more patients with unstable angina in Israel (63 vs. 37%, P = 0.006). At 1 year follow-up, overall mortality and cerebrovascular accident rates were similar between the two groups and equivalent to results obtained around the world. There was a significantly higher incidence of myocardial infarction rates in patients randomized to stenting in Israel compared to patients worldwide (7.4 vs. 5.3%, P = 0.01) or to patients randomized to CABG in Israel (7.4 vs. 0%, P = 0.006). Similar to the overall ARTS results, there was a higher incidence of repeat revascularization procedures in patients assigned to the PCI with stenting arm (22.2 vs. 3.8%, P = 0.004) compared to those randomized to CABG, respectively. CONCLUSIONS The results of this analysis of the Israeli ARTS population indicate that coronary stenting and bypass surgery yield similar findings with regard to mortality and stroke and are comparable to those obtained in the whole study group. Likewise, coronary stenting was associated with an increased incidence of repeat revascularization procedures as compared to CABG. However, patients in Israel randomized to stenting had a higher rate of myocardial infarction as compared to the overall results and to patients who underwent CABG in Israel. The present analysis provides important data for the safety and efficacy of either stenting or bypass surgery in treating patients with multivessel disease in Israel.

Hereditary dysautonomias: current knowledge and collaborations for the future

Abstract: The hereditary dysautonomias (H-Dys) are a large group of disorders that affect the autonomic nervous system. Research in the field of H-Dys is very challenging, because the disorders involve interdisciplinary, integrative, and "mind-body" connections. Recently, medical scientists, NIH/NINDS representatives, and several patient support groups gathered for the first time in order to discuss recent findings and future directions in the H-Dys field. The H-Dys workshop was instrumental in promoting interactions between basic science and clinical investigators. It also allowed attendees to have an opportunity to meet each other, understand the similarities between the various forms of dysautonomia, and experience the unique perspective offered by patients and their families. Future advances in H-Dys research will depend on a novel multi-system approach by investigators from different medical disciplines, and it is hoped that towards a common goal, novel "bench-to-bedside" therapeutics will be developed to improve the lives of, or even cure, patients suffering from dysautonomic syndromes.