Search PubMed⌕ Search

Biomedical subjects

K Pieper

Publications and source records attributed to K Pieper.

At least 19 recordsLinked to original sources

Junctional epidermolysis bullosa: a case report.

Epidermolysis bullosa (EB) is a group of genetically determined disorders characterized by blistering of the skin and mucosae. There are three major forms--simple, junctional and dystrophic--and each has several varieties. The present case report describes a male child with junctional EB. The aim of the report is to present the dietary situation and the dental status of the child, examples of potential dental and nutritional consequences, and the therapeutic interventions possible for children with this disease.

Child, Preschool↗

Treatment of reinfarction after thrombolytic therapy for acute myocardial infarction: an analysis of outcome and treatment choices in the global utilization of streptokinase and tissue plasminogen activator for occluded coronary arteries (gusto I) and assessment of the safety of a new thrombolytic (assent 2) studies.

BACKGROUND: Early reinfarction after thrombolytic therapy is associated with adverse outcomes and increased mortality. Among patients with reinfarction in the 1992 Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO I) and the 1998 Assessment of the Safety of a New Thrombolytic (ASSENT 2) trials, we investigated temporal and regional differences in the use of repeat thrombolysis, revascularization (angioplasty and/or bypass surgery), or conservative measures and the outcomes of each management strategy. METHODS AND RESULTS: Data from the 4% of patients (n=2301) who experienced reinfarction after thrombolytic therapy were studied. Baseline characteristics, 30-day mortality, and incidence of total and hemorrhagic strokes were compared among the 3 treatment groups. The 30-day mortality did not differ between the repeat thrombolysis and revascularization groups (P=0.72), and it was significantly lower among patients treated by these 2 strategies than in those treated conservatively (11% and 11% versus 28%, respectively; P<0.001). Stroke rates did not differ significantly between the 3 treatment strategies (P=0.49). From 1992 to 1998, the percentage of reinfarction patients treated with repeat thrombolysis decreased from 29.3% to 18.5% in US centers and from 51.4% to 41.9% in all other centers (P<0.001). In contrast, use of revascularization procedures increased from 33.5% to 47.9% in US centers and from 8.1% to 23.0% in all other centers (P<0.001). CONCLUSIONS: Repeat thrombolysis and revascularization are associated with significantly lower mortality among reinfarction patients. Randomized trials are necessary to assess the exact risks and benefits of rethrombolysis versus interventional revascularization in this subset of high-risk patients presenting with reinfarction after thrombolytic therapy.

Aged↗

Severity of renal vascular disease predicts mortality in patients undergoing coronary angiography.

BACKGROUND: Renal artery stenosis (RAS) is a relatively uncommon but potentially reversible cause of renal failure. In a previous report, we demonstrated that the presence of RAS is independently associated with mortality in a group of patients undergoing coronary angiography. Our current study expands on this cohort, investigating the effect of the severity of RAS on all-cause mortality. METHODS: A total of 3987 patients underwent abdominal aortography immediately following coronary angiography. For the purpose of survival analysis, significant RAS was defined as > or =75% narrowing in the luminal diameter. RESULTS: Significant RAS was present in 4.8% of patients studied and was bilateral in 0.8%. Factors associated with the presence of RAS included female gender, older age, hypertension, congestive heart failure, elevated serum creatinine, and congestive heart failure. The four-year unadjusted survivals for patients with and without significant RAS were 57 and 89%, respectively (P < 0.001). Using the Cox proportional hazards model, the factors independently associated with decreased survival were the presence of RAS, increased age, the severity of coronary artery disease, the presence of comorbid disease, reduced ejection fraction, symptoms of congestive cardiac failure, and the mode of treatment of coronary artery disease. In the multivariate model, the presence of RAS conferred a hazard ratio of 2.01 (95% CI, 1.51 to 2.67, P < 0.001). We demonstrated an incremental effect on mortality according to the severity of RAS at baseline. Four-year adjusted survival for patients with 50%, 75%, and > or =95% stenosis was 70%, 68%, and 48%, respectively. In addition, bilateral disease was associated with four-year survival of 47% as compared with 59% for patients with unilateral disease (P < 0.001). The impact of RAS on survival remained robust regardless of the manner of treatment of coronary artery disease [that is, medical, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass graft (CABG)]. CONCLUSIONS: In this patient population, the presence of RAS is a strong independent predictor of mortality. Increasing severity of RAS has an incremental effect on survival probability.

Aged↗

Leukocyte-platelet aggregation, platelet surface P-selectin, and platelet surface glycoprotein IIIa after percutaneous coronary intervention: Effects of dalteparin or unfractionated heparin in combination with abciximab.

BACKGROUND: Plaque disruption with resultant platelet activation and leukocyte-platelet aggregation is a pathophysiologic process common to both acute coronary syndromes and percutaneous coronary interventions. Unfractionated heparin is a standard antithrombotic therapy in patients with both acute coronary syndromes and in those undergoing percutaneous coronary interventions. Low-molecular-weight heparins have been reported to cause less platelet activation than unfractionated heparin. METHODS: Monocyte-platelet aggregates, neutrophil-platelet aggregates, platelet surface P-selectin, and platelet surface glycoprotein (GP) IIIa were measured serially by whole blood flow cytometry in 40 patients with unstable angina (randomly assigned to either unfractionated heparin 70 U/kg or the low-molecular-weight heparin dalteparin 60 IU/kg) undergoing coronary intervention with planned abciximab administration (in 2, one-half-dose boluses). Assays were performed at baseline, 5 minutes after administration of either type of heparin, 10 minutes after the first bolus of abciximab, 10 minutes after second bolus of abciximab, and 8 to 10 and 16 to 24 hours after administration of either heparin. RESULTS: No significant differences in clinical outcomes were observed between patients receiving either unfractionated heparin or dalteparin. The number of circulating P-selectin-positive platelets was increased by unfractionated heparin but not dalteparin, and abciximab reversed this increase. The number of circulating P-selectin-positive platelets was reduced below baseline levels in both treatment groups 8 to 10 and 16 to 24 hours after study drug administration. At 8 to 10 and 16 to 24 hours after administration of study drug, platelet degranulation in response to iso-thrombin receptor agonist peptide 1.5 mmol/L was significantly reduced by almost 50% (compared with immediately after study drug administration). Both unfractionated heparin and dalteparin significantly increased the numbers of circulating monocyte-platelet and neutrophil-platelet aggregates, which were subsequently reduced to baseline levels after administration of the second abciximab bolus and to below baseline at both 8 to 10 and 16 to 24 hours in all patients. After both unfractionated heparin and dalteparin administration, platelet surface GP IIIa expression was significantly increased compared with baseline at both 8 to 10 and 16 to 24 hours. CONCLUSIONS: Dalteparin in combination with abciximab in patients with unstable angina undergoing coronary intervention appears to be safe. Unfractionated heparin, but not dalteparin, degranulates platelets in patients with unstable angina. Both heparins increase the number of circulating monocyte-platelet and neutrophil-platelet aggregates. Abciximab therapy during coronary interventions rapidly reduces the number of degranulated platelets and leukocyte-platelet aggregates.

Abciximab↗

Hydrogen peroxide, potassium currents, and membrane potential in human endothelial cells.

BACKGROUND: Hydrogen peroxide (H2O2) and reactive oxygen species are implicated in inflammation, ischemia-reperfusion injury, and atherosclerosis. The role of ion channels has not been previously explored. METHODS AND RESULTS: K+ currents and membrane potential were recorded in endothelial cells by voltage- and current-clamp techniques. H2O2 elicited both hyperpolarization and depolarization of the membrane potential in a concentration-dependent manner. Low H2O2 concentrations (0.01 to 0.25 micromol/L) inhibited the inward-rectifying K+ current (KIR). Whole-cell K+ current analysis revealed that H2O2 (1 mmol/L) applied to the bath solution increased the Ca2+-dependent K+ current (KCa) amplitude. H2O2 increased KCa current in outside-out patches in a Ca2+-free solution. When catalase (5000 micro/mL) was added to the bath solution, the outward-rectifying K+ current amplitude was restored. In contrast, superoxide dismutase (1000 u/mL) had only a small effect on the H2O2-induced K+ current changes. Next, we measured whole-cell K+ currents and redox potentials simultaneously with a novel redox potential-sensitive electrode. The H2O2-mediated KCa current increase was accompanied by a whole-cell redox potential decrease. CONCLUSIONS: H2O2 elicited both hyperpolarization and depolarization of the membrane potential through 2 different mechanisms. Low H2O2 concentrations inhibited inward-rectifying K+ currents, whereas higher H2O2 concentrations increased the amplitude of the outward K+ current. We suggest that reactive oxygen species generated locally increases the KCa current amplitude, whereas low H2O2 concentrations inhibit KIR via intracellular messengers.

Calcium↗

Predictors and significance of atrial rhythm before and six months after percutaneous balloon mitral commissurotomy.

Clinical, echocardiographic, and cardiac catheterization data were evaluated in 263 patients with mitral stenosis who were undergoing balloon commissurotomy to determine the predictors of atrial rhythm and its effect on functional status. Conversion from atrial fibrillation to sinus rhythm at 6 months after the procedure occurred in 16 of 86 patients (19%) and was predicted by the duration of atrial fibrillation, baseline functional class, and antiarrhythmic therapy; patients who remained in atrial fibrillation had a poorer functional status compared with those in sinus rhythm despite similar procedural results.

Adult↗

Indole glucosinolate and auxin biosynthesis in Arabidopsis thaliana (L.) Heynh. glucosinolate mutants and the development of clubroot disease.

Mutants and wild type plants of Arabidopsis thaliana were analysed for differences in glucosinolate accumulation patterns, indole-3-acetic acid (IAA) biosynthesis and phenotype. A previously identified series of mutants, termed TU, with altered glucosinolate patterns was used in this study. Only the line TU8 was affected in shoot phenotype (shorter stems, altered branching pattern). Synthesis of IAA and metabolism were not much affected in the TU8 mutant during seedling development, although the content of free IAA peaked earlier in TU8 during plant development than in the wild type. Indole glucosinolates and IAA may, however, be involved in the development of clubroot disease caused by the obligate biotrophic fungus Plasmodiophora brassicae since the TU3 line had a lower infection rate than the wild type, and lines TU3 and TU8 showed decreased symptom development. The decline in clubroot formation was accompanied by a reduced number of fungal structures within the root cortex and slower development of the fungus. Indole glucosinolates were lower in infected roots of TU3 and TU8 than in control roots of these lines, whereas in wild-type plants the differences were not as prominent. Free IAA and indole-3-acetonitrile (IAN) were increased in infected roots of the wild type and mutants with normal clubroot symptoms, whereas they were reduced in infected roots of mutants TU3 and TU8. These results indicate a role for indole glucosinolates and IAN/IAA in relation to symptom development in clubroot disease.

Arabidopsis↗

Longevity of cast gold inlays and partial crowns--a retrospective study at a dental school clinic.

From 1963 to 1993, 890 patients were treated with 3518 cast gold restorations by students and postgraduate dentists. The longevity of these restorations was studied retrospectively using the patient files. Longevity was calculated using the method described by Kaplan and Meier. After the observation period, 111 (3.2%) of the examined restorations were not in place anymore. The most frequent reasons for failure were caries (33.7%), lack of retention (32.7%), endodontic treatment (29.6%), insufficient marginal adaptation (3.1%) and extraction (1%). The cumulative survival rate and a 95% interval of confidence was calculated for all restorations and for each of the locations and surfaces included in the trial. The 10-year survival rate for occlusal inlays was, 76.1% (12.1) for MO inlays 88.3% (4.2), for DO inlays 83.4% (4.6), for MOD inlays 87.5% (2.4), for partial crowns 86.1% (3.3) and 85.7% (1.7) for all restorations. Based on the statistical method used, the cast gold restorations demonstrated satisfactory longevity results.

Adult↗

Urinary incontinence and depression.

PURPOSE: Serotonergic neuronal systems have been implicated in anxiety and depression. Because descending serotonin pathways from the brain stem inhibit bladder contractions, we postulated that depression associated with altered serotonin function may predispose to urge incontinence. We demonstrate an association between depression and idiopathic urge incontinence. MATERIALS AND METHODS: A total of 115 consecutive incontinent patients presenting to an incontinence clinic were compared to 80 continent controls. Patients were queried for a history of depression and completed a Beck Depression Inventory (BDI). Cases were classified by history and video urodynamics as genuine stress (36), urge (44) or mixed (35) incontinence. RESULTS: A BDI of greater than 12 and/or a history of depression was noted in 30% of incontinent patients and 17% of controls (odds ratio 2.3, 95% confidence interval 1.0 to 5.0, p = 0.044). An abnormal BDI or history of depression was revealed in 60% of patients with idiopathic urge incontinence (p<0.001). Patients with stress or urge incontinence due to neuropathology or obstruction had no greater odds of having depression than continent controls. CONCLUSIONS: These data suggest a strong association between depression and idiopathic urinary incontinence. This link may be due to altered serotonin function and may help explain the efficacy of serotonergic based antidepressants in the treatment of urge incontinence.

Depression↗

[Pleural reaction pattern after talc pleurodesis].

Because of the rising importance of talcum pleurodesis in the therapeutic management of malignant and benign pleural effusions in Germany, pleural samples after talcum pleurodesis were compared to microscopic, immunohistochemical, and scanning electron microscopy findings after Tetracyclin and Novantron pleurodesis in 24 patients up to 18 months after intrapleural therapy. The histomorphological findings after talcum pleurodesis show an early phase of up to 4 weeks, characterized by the presence of talcum-containing granulation tissue with giant-cell foreign-body reaction, and a subsequent late phase with organization of the granulation tissue and connective tissue formation and obliteration of the pleura sheets. The resulting characteristic linear talcum zone in the pleural connective tissue is missing in cases with tumorous infiltration of the pleura. Continuous fibroblast activation, e.g., by macrophage or foreign-body giant-cell-released mediators, seems to be the decisive factor in the fibrosing process. No therapy-related tumor growth alterations could be demonstrated.

Follow-Up Studies↗

Prevalence and quality of root canal fillings in a German adult population. A survey of orthopantomograms taken in 1983 and 1992.

The few studies in which prevalence, technical quality, and success rates of root canal fillings performed in daily practice have been assessed demonstrated a high proportion of inappropriate root fillings and a great variety of periapical radiolucencies (25-60%). The aim of the present retrospective radiographic study was to determine if changes in prevalence, technical quality, and success of root canal fillings had occurred within a decade. To achieve this goal, orthopantomograms taken in patients who attended a University Dental Clinic for the first time in 1983 (group A) and in 1992 (group B) were evaluated by a calibrated examiner. The following criteria were applied to assess the root-filled teeth: length and homogeneity of the root fillings and the periapical state. The prevalence of root-filled teeth increased significantly from an average 0.5 per person in 1983 to 0.8 per person in 1992. The increase was proportionally greater in older patients. In group A, 55.2% of the root fillings ended 0-2 mm before the radiographic apex and in group B this percentage was 56.8. Insufficient homogeneity was found in 25.0% (group A) and 21.9% (group B) of the root fillings. The prevalence of root-filled teeth without periapical destructions was 76.1% (group A) and 74.1% (group B). It is concluded that, in the future, endodontic treatment need will increase because of the steadily growing number of older people. Further efforts in research and dental education should focus on the treatment of curved root canals.

Adolescent↗

The electrical resistance of enamel-dentine cylinders. Influence of NaCl content in storage solutions.

OBJECTIVES: To investigate the influence of different electrolyte concentrations on the electrical resistance of sound human enamel-dentine cylinders in vitro. METHODS: Forty cylinders of 3-mm diameter and 2-mm length were drilled from 40 extracted caries-free third molar teeth. For ease of handling the samples were fixed in Perspex discs by means of a cyanoacrylate-adhesive. An a.c. source (frequency 500 Hz, amplitude 1 microA) with a high internal resistance was applied. Only Ohm's resistance was measured. The resistance measurements on the samples were made after storage in distilled water, 0.16 mM NaCl, 1.6 mM NaCl and 16 mM NaCl and 160 mM NaCl for 24 h. RESULTS: The mean resistance values were 2026 +/- 152, 1835 +/- 178, 1605 +/- 364, 483 +/- 265 and 60 +/- 33 k omega, respectively. All values were statistically significantly different (Wilcoxon test; P < 0.0001). CONCLUSION: It is concluded that the choice of electrolyte solution influences the resistance values of the enamel-dentine samples. This effect should be taken into account when measuring electrical resistances in vivo and in vitro.

Cyanoacrylates↗

Influence of a randomized clinical trial on practice by participating investigators: lessons from the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT). CAVEAT I and II Investigators.

OBJECTIVES: We sought to determine whether the results of the first Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I) influenced subsequent practice patterns among the investigators. BACKGROUND: CAVEAT-I demonstrated that directional coronary atherectomy (DCA) resulted in higher rates of early complications at a higher cost and with no clinical benefit. We sought to determine whether these results influenced subsequent use of procedures among CAVEAT-I investigators. METHODS: We compared the results of a week-long registry of all coronary interventions performed at 35 CAVEAT-I sites in 1994 with those of a similar registry obtained in 1992 before the trial, the results of which were published in 1993. For control purposes, the use of procedures was studied at 24 additional sites to provide insight into practice at hospitals not participating in the trial. A total of 1,465 interventions were analyzed. RESULTS: Ninety-four percent of CAVEAT-I sites responded. Utilization rates differed between CAVEAT-I and CAVEAT-I follow-up (p < 0.001). Balloon angioplasty decreased from 83.8% to 68.5%, DCA increased slightly from 10.7% to 14.1%, and the use of other devices increased from 5.4% to 17.5%. Stand-alone balloon use was more prevalent at nonparticipating control sites than at sites that took part in CAVEAT-I (p < 0.001). CONCLUSIONS: Paradoxically, despite the negative findings of CAVEAT-I, there was a noteworthy trend toward an increase in the use of DCA and other devices at CAVEAT-I sites. Our findings suggest that among investigators in the trial, there may have been a lack of influence of trial data on clinical practice patterns 1 year after publication of the results. Ethics of protocol: Both CAVEAT I and II were approved by the Institutional Review Board at each study site.

Adult↗

Circulating leukocyte integrin expression in Wegener's granulomatosis.

Leukocyte adhesion and infiltration are important in the pathogenesis of Wegener's granulomatosis (WG). We tested the hypothesis that the expression of the beta 1-chain integrin VLA-4 (CD49d/CD29) and the beta 2-chain integrins LFA-1 (CD11a/CD18), Mac-1 (CD11a/CD18), and gp150,95 (CD11c/CD18) is increased on leukocytes in patients with active WG. Fifteen patients with active WG as defined by positive antineutrophil cytoplasmic autoantibody (cANCA) titers and biopsy, 30 patients with WG in remission as defined by negative cANCA titers and/or immunosuppressive therapy, 25 normal control subjects, and 12 patients with other inflammatory renal and systemic diseases were studied. Surface expression of LFA-1, Mac-1, p150, 95, and VLA-4 on neutrophils, lymphocytes, and monocytes was measured by fluorescent antibody cell sorting with monoclonal antibodies against CD11a, CD11b, CD11c, CD18, CD49d, and CD29 respectively. Immunocytochemistry and confocal microscopy were also utilized. beta 1 (CD29) and beta 2 (CD18) integrin subunit expression on neutrophils, monocytes, and lymphocytes from patients with acute WG was significantly increased compared with healthy persons and compared with patients with treated vasculitis. Furthermore, the alpha-integrin subunit CD11b expression was increased on granulocytes and monocytes, but not on lymphocytes. Finally, the alpha-integrin subunit CD11a expression was increased on monocytes. Immunocytochemistry showed that the increased immunoreactivity on neutrophils was evenly distributed on the plasma membrane and in the cytosol. Immunosuppression resulted in decreased expression of the beta 1 and beta 2-integrin subunits. It was concluded that the integrin adhesion molecules, particularly Mac-1 (CD11b/CD18), are upregulated on leukocytes in active WG. This finding suggests a role for integrin expression in the pathogenesis of WG and a possible clue for treatment.

Follow-Up Studies↗

Predictors and sequelae of distal embolization during saphenous vein graft intervention from the CAVEAT-II trial. Coronary Angioplasty Versus Excisional Atherectomy Trial.

BACKGROUND: The purpose of this study was to identify the predictors and sequelae of distal embolization from a multicenter, randomized trial of saphenous vein graft intervention. The CAVEAT-II trial demonstrated that saphenous vein graft directional coronary atherectomy (DCA) was associated with greater angiographic success and less need for repeat intervention compared with percutaneous transluminal coronary angioplasty (PTCA) but at the cost of more acute complications--notably distal embolization. METHODS AND RESULTS: In CAVEAT-II, 305 patients were randomly assigned to DCA (149 patients) or PTCA (156 patients) for lesions with > 60% diameter stenosis in vein grafts > or = 3 mm in diameter. Distal embolization occurred in 20 patients (13.4%) assigned to DCA and 8 patients (5.1%) assigned to PTCA (P = .011). Independent predictors of distal embolization were use of DCA (71% in distal embolization patients versus 47% in patients without distal embolization, P = .011) and presence of thrombus (39% in distal embolization patients versus 14% in patients without distal embolization, P < .00). In-hospital adverse events were more frequent after distal embolization; 71% versus 20%, odds ratio plus (95% confidence intervals) 9.87 (4.65, 20.94). At 12-month follow-up, adverse event rates were also higher in patients with distal embolization (odds ratio, 3.05 [1.95, 4.76]). CONCLUSIONS: In this first prospective multicenter trial of saphenous vein graft intervention, distal embolization was more common after DCA than PTCA and in lesions containing thrombus. It also was associated with worse in-hospital and 12-month outcomes. The risk and sequelae of distal embolization should be considered when choosing a treatment strategy for vein graft disease.

Aged↗

Directional atherectomy versus balloon angioplasty for coronary ostial and nonostial left anterior descending coronary artery lesions: results from a randomized multicenter trial. The CAVEAT-I investigators. Coronary Angioplasty Versus Excisional Atherectomy Trial.

OBJECTIVES: We hypothesized that atherectomy would be superior to balloon angioplasty for ostial and nonostial left anterior descending coronary artery lesions. BACKGROUND: Balloon angioplasty of ostial coronary artery lesions has been associated with a lower procedural success rate and a higher rate of complications and of restenosis than angioplasty of nonostial stenoses. Directional coronary atherectomy has been proposed as an alternative therapy for ostial lesions. METHODS: In the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I), 1,012 patients were randomized to undergo either procedure; 563 patients had proximal left anterior descending coronary artery lesions, of which 74 were ostial. We compared balloon angioplasty with directional atherectomy for early and 6-month results for ostial as well as nonostial proximal left anterior descending coronary artery lesions. RESULTS: Directional atherectomy led to an initially higher gain in minimal lumen diameter for ostial lesions (1.13 vs. 0.56 mm, respectively, p < 0.001) but a higher rate of adjudicated non-Q wave myocardial infarction (24% vs. 13%, respectively, p < 0.001) than balloon angioplasty and no improvement in restenosis rates (48% vs. 46%, respectively). In the nonostial proximal left anterior descending coronary artery lesions, angiographic restenosis was reduced (51% vs. 66%, p = 0.012), but this was also associated with a higher rate of periprocedural myocardial infarction (8% vs. 2%, p = 0.008 by site and 24% vs. 8%, p < 0.001 by adjudication) and no difference in the need for subsequent coronary artery bypass surgery (7.3% vs. 8.4%, respectively) or repeat percutaneous coronary intervention (24% vs. 26%, respectively). CONCLUSIONS: For ostial left anterior descending coronary artery stenoses, both procedures yielded similar rates of initial success and restenosis, but atherectomy was associated with more non-Q wave myocardial infarction. In this trial the predominant angiographic benefit (increased early gain and less angiographic restenosis) of atherectomy for the left anterior descending coronary artery was in proximal nonostial lesions. However, the tradeoffs for this angiographic advantage were more in-hospital myocardial infarctions and no decrease in clinical restenosis.

Angioplasty, Balloon↗

Peripheral vascular complications in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I).

OBJECTIVES: In-hospital peripheral vascular complications of balloon angioplasty were compared with those of directional atherectomy in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I) to identify patients at risk and evaluate costs and outcomes. BACKGROUND: The incidence, costs and outcomes of peripheral vascular complications after coronary intervention have not been fully characterized as a function of randomly assigned therapy. METHODS: At 35 sites in the United States and Europe, 1,012 patients were randomized. Peripheral vascular complications were defined as the composite of pulse loss, pseudoaneurysm, hematoma > 4 cm in diameter or groin hemorrhage necessitating blood transfusion. Logistic models were derived to 1) predict these complications from baseline and procedural characteristics, 2) test the relevance of randomization assignment, and 3) assess their impact on hospital costs and long-term outcomes. RESULTS: Sixty-seven patients (6.6%) developed peripheral vascular complications, of whom 15 (22.4%) required a blood transfusion, 14 (20.9%) underwent vascular surgery, and 2 (3.0%) died. Both in-hospital deaths occurred in patients with peripheral vascular complications. There was no difference in composite peripheral vascular complication rates among patients randomized to angioplasty or atherectomy. Greater age, female gender, postprocedural heparin and intraaortic balloon counterpulsation were predictive of increased risk. In a representative 60% subset, mean hospital costs increased from $9,583 in patients without to $18,350 in those with peripheral vascular complications (p = 0.0001). The unadjusted mortality rate at 1 year was 7.5% for patients with peripheral vascular complications compared with 1.1% for all others (p = 0.0001). These complications identified patients at greater risk of death, myocardial infarction or repeat revascularization at 30 days and 1 year. The atherectomy group had a trend toward more frequent deaths and myocardial infarction. CONCLUSIONS: Directional atherectomy and balloon angioplasty had similar in-hospital peripheral vascular complication rates. Female gender, greater age, postprocedural heparin and intraaortic balloon counterpulsation were predictive of higher risk. The twofold increase in cost and sevenfold increase in long-term deaths highlight the need to prevent these periprocedural events and monitor patients closely.

Angioplasty, Balloon, Coronary↗