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Biomedical subjects

S Coccheri

Publications and source records attributed to S Coccheri.

At least 37 records · Page 2Linked to original sources
PubMed1999

Contribution of a new, rapid, quantitative and automated method for D-dimer measurement to exclude deep vein thrombosis in symptomatic outpatients.

Ninety-nine consecutive outpatients with symptoms suggestive of deep vein thrombosis (DVT) were tested for the presence of D-dimer using a new, rapid method (BC D-Dimer) based on the agglutination principle and performed on a BCT analyzer. Dimertest Gold EIA and VIDAS D-Dimer devices were used as comparative methods. Venography was performed in all patients, with DVT diagnosed in 39 of them (34 proximal). The BC D-Dimer test proved to be rapid, automated and well suited for individual tests with a good reproducibility (coefficient of variation % 1.5-5.3). Its performance was comparable with that of the other methods, as indicated by the areas under the receiver operating characteristic curves (Gold EIA 0.95; VIDAS 0.95; BC D-Dimer 0.91) and the coefficients of correlation (Pearson's coefficients from 0.832 to 0.876). On the basis of the Kappa coefficients, there was quite a good concordance between the three tests. At the cut-off levels that provided the highest sensitivity (97.4%, for all the tests), the negative predictive values were similar for all methods, at over 95%. The corresponding specificity ranged from 62.7 to 81.7%. In conclusion, this study shows that the new method can be included in prospective clinical trials to test the utility of D-dimer measurement in combination with other non-invasive diagnostic procedures in the management of the diagnosis of DVT.

Adult↗
PubMed1999

Oral anticoagulant therapy: efficacy, safety and the low-dose controversy.

The issue of optimal duration of oral anticoagulant therapy after a first episode of venous thromboembolism is still unresolved. However, recent data suggest that short (6 weeks to 3 months), intermediate (3- 6 months) or indefinite-term anticoagulant therapy should be adopted on the basis of the classification of patients into low-, intermediate- and high-recurrence-risk groups, respectively. Oral anticoagulants have been shown to effectively prevent cardioembolic stroke in nonvalvular atrial fibrillation. Recent data seem to suggest that their safety can be ameliorated with adequate risk stratification on the basis of clinical and echocardiographic features. After unstable angina and non-Q-wave myocardial infarction, oral anticoagulant therapy (INR range 2-3) combined with aspirin has been shown to be advantageous over aspirin alone, although at the cost of a slight increase in bleeding. Bleeding complications are major drawbacks of oral anticoagulant therapy thus limiting their generalized adoption in recognized indications. To sharply reduce the bleeding risk and need of laboratory control, the low- or fixed-dose oral anticoagulant approach has been evaluated. In primary prevention and in low or low-to-moderate thrombotic risk, minidose warfarin treatment has been shown to be advantageous. In secondary prevention, and in patients at high risk for recurrent venous or arterial thrombotic events, standard range (INR 2-3) or higher level of anticoagulation is needed.

Administration, Oral↗
PubMed1999

Dermatan sulphate for the prevention of postoperative venous thromboembolism in patients with cancer. DOS (Dermatan sulphate in Oncologic Surgery) Study Group.

BACKGROUND: Patients undergoing surgery for cancer are at high risk for venous thromboembolism (VTE). Agents that selectively inhibit thrombin, such as dermatan sulphate, have potential for a favourable benefit-risk ratio in the prevention of this complication. METHODS: Patients scheduled for elective abdominal, thoracic, gynecologic or urologic surgery for cancer resection, were randomised to dermatan sulphate (600 mg intramuscularly on the second day before surgery, then 300 mg once daily), or calcium heparin (5,000 IU subcutaneously t.i.d., starting 2 hours before operation). Both treatments were continued until postoperative day 7 or until adequate mobilisation was achieved. Bilateral venography was scheduled at the end of treatment. Venograms were centrally assessed in blind conditions. The study outcomes were VTE (venographically proven deep vein thrombosis IDVT] or symptomatic, objectively confirmed pulmonary embolism) and bleeding complications. RESULTS: At 27 centres, 842 patients were randomised and underwent surgery (418 dermatan sulphate, 424 heparin). Efficacy was assessed in 521 patients with adequate venography and/or confirmed pulmonary embolism. DVT was observed in a total of 96 patients; symptomatic non-fatal pulmonary embolism developed in 2 patients (one per group), who also had DVT at venography. Postoperative VTE occurred in 40 of 267 patients on dermatan sulphate, 15.0%, versus 56 of 254 patients on heparin. 22.0% (p = 0.033). Relative risk reduction was 32.7% (95% confidence interval, 3.1 to 53.2%). The rate of bleeding complications in all operated patients was 6.9% with dermatan sulphate and 7.5% with heparin (confidence interval for the absolute risk difference, -4.1 to 2.9%). The inhospital mortality rate was 1.2% and 1.4%, respectively. CONCLUSIONS: In oncologic surgery, dermatan sulphate prevents VTE more effectively than heparin without increasing bleeding complications.

Aged↗
PubMed1997

Efficacy and safety of a low-molecular-weight heparin and standard unfractionated heparin for prophylaxis of postoperative venous thromboembolism: European multicenter trial.

A randomized, double-blind multicenter trial was performed to compare the safety and efficacy of a new low-molecular-weight heparin (LMWH) (LU 47311, Clivarine) and standard unfractionated heparin for the prophylaxis of postoperative venous thromboembolism. Altogether 1351 patients scheduled to undergo abdominal surgery were included. Main outcome measures included the incidence of thromboembolic events (deep vein thrombosis, pulmonary embolism, or both) and bleeding complications, including wound hematoma. A total of 655 patients received 1750 anti-Xa IU of LMWH plus a placebo injection daily; 677 patients received 5000 IU of unfractionated heparin (UFH) twice a day. Both drugs were found to be equally effective, as 4.7% of patients in the LMWH group and 4.3% in the UFH group developed postoperative thromboembolic complications. However, the incidence of bleeding complications was significantly reduced in the LMWH group: 55 (8.3%) patients in the LMWH group and 80 (11.8%) in the UFH group developed bleeding complications, a relative risk (RR) of 0.70 (95% CI 0.51-0.97;p = 0.03); wound hematoma occurred in 29 (4.4%) of the LMWH group compared with 55 (7.7%) in those in the UFH group for an RR of 0.57 (95% CI 0.37-0.88;p = 0.01). This study confirmed that a very low dose of 1750 anti-Xa IU daily of this new LMWH is as effective as 10,000 IU of UFH for preventing postoperative deep vein thrombosis. At this dose its administration is associated with a significant reduction in the risk of bleeding including wound hematoma.

Adult↗
PubMed1997

Comparison of new rapid methods for D-dimer measurement to exclude deep vein thrombosis in symptomatic outpatients.

Eighty-seven outpatients consecutively admitted to the emergency unit of our hospital with clinically suspected first deep vein thrombosis (DVT) of a leg had D-dimer levels measured by the following recently introduced fast methods: VIDAS (bioMerieux), LPIA (Mitsubishi), Nephelotex (Biopool), Nycocard (Nycomed) and Instant.I.A. (Diagnostica Stago). A latex agglutination test (Minutex, Biopool) was also performed and a classical ELISA (Gold EIA, Agen) used as reference. Venography was performed in all patients, with DVT diagnosed in 42 (37 proximal). All the new methods can be adopted in emergency situations, since they are suited for individual tests, are rapid and the reagents ready to use. All the methods proved to have a good interassay reproducibility. The new D-dimer and latex agglutination tests showed negative (88-96%) and positive (63-81%) predictive values similar to those of ELISA (92% and 71%, respectively), though the still wide confidence intervals suggest larger patient population series be investigated. As regards clinical application, the use of these tests to rule out DVT should be tested in prospective clinical follow-up trials where anticoagulation is withheld in subjects with negative non-invasive reliable vascular tests and normal D-dimer levels.

Biological Assay↗
PubMed1997

Hyperhomocyst(e)inemia and a common methylenetetrahydrofolate reductase mutation (Ala223Val MTHFR) in patients with inherited thrombophilic coagulation defects.

To assess whether certain abnormalities of the sulfated amino acid metabolism are associated with the occurrence of thromboembolic events in patients with inherited thrombophilic conditions, the levels of homocyst(e)ine, before or after methionine load, and the presence of the Ala223Val substitution in the 5,10-methylenetetrahydrofolate reductase (MTHFR) were evaluated in 119 subjects with a congenital single thrombophilic condition (type I deficiency of antithrombin n = 10, protein C n = 24, protein S n = 16; activated protein C resistance due to factor V Leiden mutation n = 69). Sixty-three subjects had experienced at least one documented thrombotic event, while the remaining 56 subjects were still free from any thrombotic symptom. Our results show that (1) high homocyst(e)ine levels, either in fasting condition or after methionine load, were not more frequent in subjects with inherited thrombophilic alterations (14.4%) than in normal control subjects (10% by definition) and (2) the frequency of hyperhomocyst(e)inemia was similar in thrombophilic subjects, who already have (14.3%) or have not (14.6%) experienced thrombotic events. As regards the MTHFR mutation, the homozygous condition was present in 23.2% of the thrombophilic patients versus 17.5% in the control subjects, a nonsignificant difference. The mutation was slightly more frequent in those thrombophilic subjects who had suffered a thrombotic episode (25.5%) versus those with no thrombosis (20.8%), with odds ratios of 1.61 (confidence interval (CI) = 0.58-4.52) and 1.24 (CI = 0.42-3.43), respectively. These differences were also nonsignificant. It is concluded that in subjects with inherited thrombophilias, a condition of hyperhomocyst(e)inemia "per se" is not a factor increasing the risk of thrombosis. The risk enhancement conferred by the MTHFR mutation, if any, seems to be slight or limited, and its significance could be ascertained only in a large multicenter trial.

Adult↗
PubMed1997

Indobufen versus warfarin in the secondary prevention of major vascular events in nonrheumatic atrial fibrillation. SIFA (Studio Italiano Fibrillazione Atriale) Investigators.

BACKGROUND AND PURPOSE: The results of a large prospective randomized trial have shown the efficacy of oral anticoagulation in the secondary prevention of major vascular events in patients with nonrheumatic atrial fibrillation (NRAF); less well established is the role of antiplatelet agents. The present study compared the effects of indobufen, a reversible inhibitor of platelet cyclooxygenase, with those of warfarin in this setting. METHODS: A total of 916 patients with NRAF and a recent (< or = 15 days) cerebral ischemic episode were admitted to this multicenter, randomized study, during which they were treated with either indobufen (100 or 200 mg BID) or warfarin (to obtain an international normalized ratio of 2.0 to 3.5) for 12 months. The two groups (462 on indobufen and 454 on warfarin) were well balanced in terms of their main baseline characteristics. The primary outcome of the study was the combined incidence of nonfatal stroke (including intracerebral bleeding), pulmonary or systemic embolism, nonfatal myocardial infarction, and vascular death. RESULTS: At the end of follow-up, the incidence of primary outcome events was 10.6% in the indobufen group (95% confidence interval, 7.7% to 13.5%) and 9.0% in the warfarin group (95% confidence interval, 6.3% to 11.8%), with no statistically significant difference between treatments. The frequency of noncerebral major bleeding complications was low: only four cases (0.9%) of gastrointestinal bleeding were observed, all of them in the warfarin group. CONCLUSIONS: We conclude that, within the limitations of its design, this study may help the medical community in devising appropriate antithrombotic strategies for NRAF patients for whom oral anticoagulants are contraindicated or do not represent a feasible approach to treatment.

Adult↗
PubMed1997

[Hemorrhagic complications of oral anticoagulant therapy: results of a prospective multicenter study ISCOAT (Italian Study on Complications of Oral Anticoagulant Therapy)].

BACKGROUND: To assess the incidence of bleeding complications during oral anticoagulant therapy (OAT) in a population of patients representative of daily practice in Italian anticoagulation clinics. METHODS DESIGN: prospective, inception-cohort, multicentre. SETTING: Thirty-four anticoagulation clinics federated in the Italian Federation of Anticoagulation Clinics. PATIENTS: 2745 consecutive patients, included from beginning of their first OAT course. Most patients were aged between 60 and 79 y (57.8%), with 8% being > or = 80 y. Venous thromboembolism was the most frequent indication for OAT (one third of all the patients), followed by non ischemic heart disease which mainly included atrial fibrillation (16.8% of patients). Warfarin (in 63.8% of patients) and acenocoumarol were the only anticoagulant drugs used. The targeted anticoagulation intensity was low (INR < or = 2.8) in 71% of patients and high (INR > 2.8) in the remainder. OUTCOMES: Fatal, major and minor bleeding events. Thrombotic events were also recorded, though not analyzed in the present report. FINDINGS: During the 2011 patient-years (pt-y) of follow-up, 153 bleeding complications (7.6% pt-y) were recorded--5 fatal (all cerebral haemorrhages, 0.25% pt-y), 23 major (1.1% pt-y) and 125 minor (6.2% pt-y). The rate of events did not vary according to sex, coumarin type, size of enrolling centre or targeted therapeutic range; it was higher in older patients (10.5% pt-y in those aged > or = 70 y, relative risk--RR--1.75, p < 0.001), in cases where indication for anti-coagulant treatment was peripheral and/or cerebrovascular disease (12.5% pt-y; RR 1.80, p < 0.01) and during the first 90 days of treatment (11% pt-y, RR 1.75, p < 0.001). One fifth of bleeding events occurred at a very low anticoagulation intensity (INR < 2; the category rate being 7.7% pt-y); the rate was 4.8% pt-y in the 2.0-2.9 INR category, reaching 9.5% pt-y, 40.5% pt-y and 200% pt-y in the 3-4.4, 4.5-6.9 and > or = 7 INR categories respectively (RR for INR levels > 4.5 = 7.91, p < 0.0001). CONCLUSIONS: The overall rate of bleeding events recorded in the present study was much lower than that recorded in other (including recent) observational and experimental studies. The risk of bleeding increased in the following cases: age > 70 y; arterial vascular disease as indication for OAT; first 3 months of treatment; INR values > or = 4.5. OAT has become safer in recent years, particularly if monitored in special anticoagulation clinics. Caution should be exercised when prescribing OAT in elderly patients and the intensity anticoagulation levels should be closely monitored to minimize incidental periods of overanticoagulation.

Aged↗
PubMed1997

Assessment of mental ability in elderly anticoagulated patients: its reduction is associated with a less satisfactory quality of treatment.

Mental capacity was assessed in 311 apparently self-sufficient patients (> or = 60 years of age, 170 men) under stabilised oral anticoagulant treatment (OAT) by administering the Hodkinson's Abbreviated Mental Test (AMT). The international normalized ratios (INR) recorded during the 3 months before and the 3 after the data of test administration were examined by the INR-Day software program. The percentage of time spent within, below or above the intended therapeutic range was calculated in patients who scored abnormally at AMT, and compared with matched controls with normal AMT results. Forty patients [12.9%; 28 women (19.8%) and 12 men (7.1%), P < 0.0011] had abnormal AMT results; the rate seemed to increase with age. Most of these patients (35, 75%) had only elementary education. Patients with abnormal AMT results spent more time outside the intended therapeutic ranges than 40 matched controls (20.9% of the observed time vs 13.7%, P < 0.0001; odds ratio 1.68, CI 1.53-1.84). Unsuspected reduction of mental ability or attention levels was found in a number of elderly patients receiving OAT; these patients presented longer periods of either under- or over-anticoagulation and were, therefore, exposed to a higher risk of thrombotic or bleeding complications. Anticoagulation clinics would be advised to assess mental abilities in elderly patients before starting OAT.

Aged↗
PubMed1997

Thrombotic events during oral anticoagulant treatment: results of the inception-cohort, prospective, collaborative ISCOAT study: ISCOAT study group (Italian Study on Complications of Oral Anticoagulant Therapy).

The paper reports on rate and type of thrombotic events occurring during the observational, prospective, inception-cohort, multicenter ISCOAT study. 2,745 unselected, daily practice patients, consecutively referring to 34 Italian anticoagulation clinics to monitor the oral anticoagulant treatment, were included in the study from beginning of their first anticoagulant course. During a total follow-up of 2,011 patient-years of treatment 70 thrombotic events (3.5 per 100 patient years) were recorded in 67 patients: 20 fatal (1%), 39 major (1.9%) and 11 minor (0.6%). 34/70 events occurred within the first 90 days of treatment (relative risk - at multivariate analysis - of < or =90 days vs. >90 = 20.6, C.I. 12.7-33.5; p <0.0001). The risk was higher in patients aged > or =70 y (1.62, C.I. 1.0-2.61; p <0.05), and when indication for anticoagulant treatment was peripheral/cerebral arterial disease (1.84, C.I. 1.01-3.36; p <0.05). The frequency of thrombotic events was 17.5% when international normalised ratio (INR) levels were < 1.5, decreasing to 2.3% for INRs within the 2-2.99 category (relative risk of INRs <2.0 vs. > or =2 = 1.88, C.I. 1.16-3.07; p <0.05). The recorded rate of thrombotic events was lower than that reported in the few available studies. A greater risk should be expected during the first 90 days of treatment, when anticoagulation levels are <2.0 INR, in patients > 70 years and in those with cerebrovascular/peripheral arterial disease.

Administration, Oral↗
PubMed1997

[Deep venous thrombosis. Evaluation of a non-invasive diagnostic procedure based on compression ultrasonography and measurement of D-dimer plasma levels].

BACKGROUND: Clinical diagnosis of deep venous thrombosis (DVT) of the leg is unreliable. An accurate diagnosis is important for therapeutic decision since anticoagulant treatment, though potentially dangerous, is useless in case of a false positive diagnosis, whereas a false negative diagnosis may lead to withdrawal of an extremely necessary anticoagulation. Contrast venography is still recognized as the gold standard method for the diagnosis of DVT, but in recent years a variety of accurate non-invasive methods has been developed. The ultrasound compression sonography (CUS) is considered a simple non invasive test highly sensitive and specific for proximal DVT in symptomatic outpatients, though non adequately sensitive and specific for isolated calf DVT. Plasma D-dimer levels (DD, fibrin degradation products) have a high negative predictive value for DVT. The aim of this study, performed in outpatients with suspected leg DVT, was to validate, versus venography, a non-invasive, easy to perform and fast diagnostic procedure based on a combination of CUS and D-dimer test. End points of the procedure were: confirmation or exclusion of proximal DVT; suspicion of isolated calf DVT in which case the test would be repeated in a few days to detect any possible proximalization of thrombosis. MATERIALS AND METHODS: Sixty-eight consecutive outpatients, 37 male, with clinically suspected first episode of leg DVT were eligible and examined with CUS, DD test and venography. RESULTS: The results showed that the diagnostic procedure under examination has a high sensibility and specificity for DVT. CONCLUSIONS: It can thus be recommended as routine diagnostic procedure in symptomatic outpatients with suspected DVT reserving venography special cases only.

Ambulatory Care Facilities↗