First International New Intravascular Rigid-Flex Endovascular Stent Study (FINESS): Clinical and Angiographic Results After Elective and Urgent Stent Implantation

Objectives. The purpose of this study was to determine the feasibility, safety and efficacy of elective and urgent deployment of the new intravascular rigid-flex (NIR) stent in patients with coronary artery disease.Background. Stent implantation has been shown to be effective in the treatment of focal, new coronary stenoses and in restoring coronary flow after coronary dissection and abrupt vessel closure. However, currently available stents either lack flexibility, hindering navigation through tortuous arteries, or lack axial strength, resulting in suboptimal scaffolding of the vessel. The unique transforming multicellular design of the NIR stent appears to provide both longitudinal flexibility and radial strength.Methods. NIR stent implantation was attempted in 255 patients (341 lesions) enrolled prospectively in a multicenter international registry from December 1995 through March 1996. Nine-, 16- and 32-mm long NIR stents were manually crimped onto coronary balloons and deployed in native coronary (94%) and saphenous vein graft (6%) lesions. Seventy-four percent of patients underwent elective stenting for primary or restenotic lesions, 21% for a suboptimal angioplasty result and 5% for threatened or abrupt vessel closure. Fifty-two percent of patients presented with unstable angina, 48% had a previous myocardial infarction, and 45% had multivessel disease. Coronary lesions were frequently complex, occurring in relatively small arteries (mean [±SD] reference diameter 2.8 ± 0.6 mm). Patients were followed up for 6 months for the occurrence of major adverse cardiovascular events.Results. Stent deployment was accomplished in 98% of lesions. Mean minimal lumen diameter increased by 1.51 ± 0.51 mm (from 1.09 ± 0.43 mm before to 2.60 ± 0.50 mm after the procedure). Mean percent diameter stenosis decreased from 61 ± 13% before to 17 ± 7% after intervention. A successful interventional procedure with <50% diameter stenosis of all treatment site lesions and no major adverse cardiac events within 30 days occurred in 95% of patients. Event-free survival at 6 months was 82%. Ninety-four percent of surviving patients were either asymptomatic or had mild stable angina at 6 month follow-up.Conclusions. Despite unfavorable clinical and angiographic characteristics of the majority of patients enrolled, the acute angiographic results and early clinical outcome after NIR stent deployment were very promising. A prospective, randomized trial comparing the NIR stent with other currently available stents appears warranted.     

Wiktor Stent for Treatment of Chronic Total Coronary Artery Occlusions: Short- and Long-Term Clinical and Angiographic Results From a Large Multicenter Experience

Objectives. This study reports the first multicenter experience with the Wiktor coil stent for treatment of chronic total coronary artery occlusions (CTOs).Background. Percutaneous transluminal coronary angioplasty (PTCA) of CTO is associated with very high restenosis and reocclusion rates. Coronary stenting has been proposed as a means of improving outcome. However, the Wiktor device for CTOs has never been tested in a large patient sample.Methods. From January 1993 to December 1996, 89 patients with 91 CTOs underwent Wiktor stent implantation after successful PTCA. The post-stenting regimen consisted of warfarin (Coumadin) plus aspirin in the initial 49 patients (55%) and aspirin plus ticlopidine in 40 patients (45%).Results. Stenting was successful in 87 patients (98%). At 1 month, 6% of patients had subacute stent thrombosis, 3% had a major bleeding event, and 1% had access-site complications. Subacute stent thrombosis showed univariate association with warfarin therapy (p = 0.009). Angiographic follow-up was obtained in 76 (93%) of 82 eligible patients. The restenosis rate was 32%, including 4% reocclusions. By multiple logistic regression analysis, restenosis was independently associated with multiple stents (adjusted odds ratio [OR] 27.67, 95% confidence interval [CI] 4.25 to 79.95, p = 0.0008) and increasing values of occlusion length (adjusted OR 1.23, 95% CI 1.09 to 1.39, p = 0.001). Freedom from death, myocardial infarction or stented vessel revascularization was 87% and 72% at 1 and 3 years, respectively.Conclusions. Short- and long-term clinical and angiographic outcomes are favorable in patients undergoing Wiktor stent implantation in CTO. Further technical improvement is needed to reduce the restenosis rate in patients with long lesions and multiple stents.     

Angiographic Results and Late Clinical Outcomes Utilizing a Stent Synergy (Pre-Stent Atheroablation) Approach in Complex Lesion Subsets

To investigate the strategy of òdebulkingó in complex lesions before stent implantation (stent synergy) to improve procedural safety and achieve optimal acute and long-term results, we reviewed our experience in 389 patients with 504 lesions undergoing a combined stent procedure (45% rotational atherectomy, 24% laser angioplasty, 20% directional atherectomy, and 11% transluminal extraction atherectomy before stent implantation). Procedural success was achieved in 94.5%, with 4% major ischemic complications (1.1% death, 1.9% Q-wave myocardial infarction, and 2.3% emergency coronary artery bypass surgery). Overall, subacute stent thrombosis occurred in 1.5% of patients. Target-lesion revascularization during follow-up was required in 9.8% of the patients. We conclude that a strategy of selective pre-stent atheroablation in complex lesion subsets results in excellent procedural outcomes with acceptable complications and favorable long-term results.     

Prospective,Multicenter Study of the Safety and Feasibility of Primary Stenting in Acute Myocardial Infarction: In-Hospital and 30-Day Results of the PAMI Stent Pilot Trial

Objectives. The goals of this study were to examine the safety and feasibility of a routine (primary) stent strategy in acute myocardial infarction (AMI).Background. Limitations of reperfusion by primary percutaneous transluminal coronary angioplasty (PTCA) in AMI include in-hospital recurrent ischemia or reinfarction in 10% to 15% of patients, restenosis in 37% to 49% and late infarct-related artery reocclusion in 9% to 14%. By lowering the residual stenosis and sealing dissection planes created by PTCA, primary stenting may further improve short- and long-term outcomes after mechanical reperfusion.Methods. Three hundred twelve consecutive patients treated with primary PTCA for AMI at nine international centers were prospectively enrolled. After PTCA, stenting was attempted in all eligible lesions (vessel size 3.0 to 4.0 mm; lesion length ≤2 stents; and the absence of giant thrombus burden after PTCA, major side branch jeopardy or excessive proximal tortuosity or calcification). Patients with stents were treated with aspirin, ticlopidine and a 60-h tapering heparin regimen.Results. Stenting was attempted in 240 (77%) of 312 patients, successfully in 236 (98%), with Thrombolysis in Myocardial Infarction grade 3 flow restored in 230 patients (96%). Patients with stents had low rates of in-hospital death (0.8%), reinfarction (1.7%), recurrent ischemia (3.8%) and predischarge target vessel revascularization for ischemia (1.3%). At 30-day follow-up, no additional deaths or reinfarctions occurred among patients with stents, and target vessel revascularization was required in only one additional patient (0.4%).Conclusions. Primary stenting is safe and feasible in the majority of patients with AMI and results in excellent short-term outcomes.     

Predictors and Outcomes of Recurrent Stent Thrombosis: Results From a Multicenter Registry

ObjectivesThe aim of this study was to determine the incidence, predictors, and outcomes of recurrent stent thrombosis (rST).BackgroundPatients who had an initial stent thrombosis (ST) develop may be at high risk of rST.MethodsWe analyzed a multicenter California registry of angiographic definite ST at 5 academic hospitals from 2005 to 2013. A detailed review of the angiogram and procedure was performed of patients with and without rST.ResultsAmong 221 patients with a median follow-up of 3.3 years, definite or probable rST developed in 29, including 19 with angiographic definite rST. The cumulative hazard ratio (HR) of definite or probable rST was 16% at 1 year and 24% at 5 years, whereas the cumulative HR of angiographic definite rST was 11% at 1 year and 20% at 5 years. Despite similar angiographic results, patients who had rST develop had significantly greater peak creatine kinase at the time of initial ST (mean, 2,655 mg/dl vs. 1,654 mg/dl; p = 0.05) than those without rST. The 3-year rate of major adverse cardiovascular events was 50% for patients with rST compared with 22% for patients with a single ST (p = 0.01). After multivariable adjustment, independent predictors of definite/probable rST were age (HR: 1.4; 95 confidence interval [CI]: 1.1 to 1.8 per 10 years), bifurcation ST (HR: 4.4; 95% CI: 1.8 to 10.9), and proximal vessel diameter (HR: 1.8; 95% CI: 1.1 to 3.2 per millimeter).ConclusionsrST represents an important cause of long-term morbidity and mortality after an initial ST. Bifurcation ST and a larger proximal reference vessel diameter are independently associated with an increased risk of rST.     

Two Types of Haemophilia (A+ and A−): A Study of 48 Cases

S ummary . The inhibitor-neutralizing ability of plasma and Factor-VIII concentrates from a group of 48 haemophilic patients and 30 normal persons has been studied. Factor-VIII inhibitors were neutralized by the material from four of the haemophilic patients and all the normal subjects. The material from the larger group of 44 haemophilic patients showed no significant inhibitor-neutralizing ability. The former group have been designated Haemophilia A⁺ because of the presence of material antigenically related to Factor VIII, and the latter group Haemophilia A⁻ because of the lack of such material.     

Ethanol and (Na+,K+)-ATPase: Alteration of Na+-K+ Selectivity

Relative internal concentrations of Na+ and K+ are important in regulating (Na+,K+)-ATPase in situ. Ethanol is known to inhibit (Na+,K+)-ATPase and to reduce K+ affinity, but the concentrations required for these effects in vitro are large compared with those probably attainable in vivo. Yet, there is evidence suggesting that ethanol has physiologically relevant effects on (Na+,K+)-ATPase. We have investigated the effects of ethanol on selectivity for Na+ versus K+. At 150 mM, ethanol had little effect on (Na+,K+)-ATPase activity under the usual assay conditions, slightly (but nonsignificantly) reduced K+ affinity, and had no effect on extrapolated Na+ affinity in the absence of K+. However, ethanol had marked effects on cation selectivity, doubling the Ki for K+ on Na+ affinity and halving the Ki for Na+ on K+ affinity. These data show that ethanol, at concentrations too small for effects on (Na+,K+)-ATPase activity under optimal assay conditions, can alter its responses to changes in Na+ or K+.     

Coronary Stenting with the Sirolimus-Eluting Stent in Clinical Practice: Final Results from the Prospective Multicenter German Cypher Stent Registry

Aims: Drug-eluting coronary stents (DES) have gained widespread use for the treatment of coronary artery disease. However, because of safety concerns and frequent "off-label" use data from "real life," registries are necessary to monitor indications and outcome of DES in daily clinical practice.
Methods and Results: We evaluated data from the German Cypher Stent Registry. A total of 10,894 patients treated with at least one sirolimus-eluting stent (SES) at 152 hospitals were included. Follow-up at a median of 6.4 months was available in 10,006 patients (92%). Median age was 64.8 years and 75.5% were male. Per lesion a mean of 1.09 ± 0.41 SES were implanted with a mean length of 21.1 ± 11.5mm. During follow-up, death rate was 1.8% and the rates of myocardial infarction or stroke were 2.1% and 0.5%. Any target vessel revascularization (TVR) was performed in 8.0% of patients. Independent predictors for death, myocardial infarction, or stroke were: cardiogenic shock, acute coronary syndromes, reduced left ventricular function, renal insufficiency, diabetes mellitus, advanced age, three-vessel disease, degree of stenosis, and prior myocardial infarction. Predictors for a TVR were: two- or three-vessel disease, target vessel = coronary bypass, advanced age, stent diameter, ostial lesions, indication in-stent restenosis, renal failure, and target vessel = left anterior descended artery.
Conclusions: These results demonstrate that SES use in clinical practice is safe and effective. The main predictors of clinical events during follow-up are clinical parameters whereas as predictors of TVR mainly are angiographic parameters. (J Interven Cardiol 2010;23:18–25)     

Neonatal Alloimmune Thrombocytopenia due to Anti-HPA-1b (PLA2) (Zwb)

Background : Neonatal alloimmune thrombocytopenia is a rare condition due to passively acquired maternal antibodies directed against paternal platelet antigens inherited by the infant. Only 5 cases have been reported due to antibodies against HPA-lb (PL^A2) (Zw^b). Case Report : We report a case of neonatal alloimmune thrombocytopenia due to anti-HPA-lb in the second pregnancy of a 26-year-old Caucasian female. The male infant was treated with a 5-day course of intravenous immunoglobulin without complications. We report the HLA phenotype of the infant's mother and summarize the previous case reports due to anti-HPA-lb. Conclusion : Based on this case and a review of the literature, intravenous immunoglobulin as well as random donor exchange transfusion and random donor platelet transfusions are effective in the treatment of neonatal alloimmune thrombocytopenia due to anti-HPA-lb. Obvious associations between HLA alleles and sensitization to HPA-lb have not been elucidated.     

A New Antigen, Yka (York), and its Relationship to Csa (Cost)

The antigen Yk-a is detected in 92 and 98% of the American Caucasian and Negro populations, respectively. In population studies with anti-Yk-a and anti-Cs-a, association was demonstrated between the two antigens; however, in two of three informative families Yk-a and Cs-a segregated independently. The possibility that these antigens have a relationship with leucocyte antigens is discussed.     

Complications of Methaqualone-Diphenhydramine (MandraxR) Abuse

This material has been reviewed by the office of The Surgeon General, Department of the Army, and there is no objection to its publication. This review does not imply any endorsement of the opinions advanced or any recommendation of such products as may be named.     

Study of Anti-Fya in Five Black Fy(a-b-) Patients

Fya antibodies were detected in 5 Fy(a-b-) black patients during a 5-year period. The Duffy phenotype was confirmed using anti-Fya, anti-Fyb, and anti-Fy3 by an adsorption-elution technique. These 5 patients had sickle cell disease and had received multiple blood transfusions. The antibodies were all found during the investigation of a hemolytic transfusion reaction or failure to achieve the desired red cell increments after transfusion.