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Biomedical subjects

P Prandoni

Publications and source records attributed to P Prandoni.

At least 37 records · Page 2Linked to original sources
PubMed2003

Incidence of cancer after a first episode of idiopathic venous thromboembolism treated with 3 months or 1 year of oral anticoagulation.

BACKGROUND: A prolonged treatment with oral anticoagulants has been claimed to reduce the incidence of newly diagnosed cancer in the long-term follow-up of patients with venous thromboembolism. OBJECTIVES: In a multicenter prospective study we assessed the incidence of newly diagnosed clinically overt cancer in patients with a first episode of idiopathic venous thromboembolism (VTE) treated with oral anticoagulants for 3 months or 1 year. PATIENTS AND METHODS: Consecutive patients with an idiopathic venous thromboembolism who had completed 3 months of oral anticoagulant therapy without having a recurrence, bleeding or newly diagnosed cancer were randomized to discontinue oral anticoagulant therapy or to continue it for nine additional months. Idiopathic venous thromboembolism was defined as thrombosis occurring in the absence of known cancer, known thrombophilia, or temporary risk factors for venous thromboembolism. All patients were followed up for at least 1 year after randomization. RESULTS: A total of 429 patients, 265 patients with DVT and 164 with PE, were followed up for an average of 43.7 months after randomization. A newly diagnosed cancer occurred in 32 patients (7.5%), 13 (6.2%) of the 210 patients treated for 3 months and 19 (8.7%) of the 219 patients treated for 1 year (RR = 0.71, 95% confidence interval 0.36-1.41). CONCLUSIONS: The incidence of newly diagnosed clinically overt cancer is not reduced in patients with idiopathic venous thromboembolism treated with 1-year anticoagulant treatment compared with patients treated for 3 months.

Administration, Oral↗
PubMed2003

[Therapeutic indications for acute venous thromboembolism. Current status and future perspectives].

Except for selected patients requiring aggressive therapies, the large majority of patients with acute venous thromboembolism are currently treated with full doses of unfractionated or low-molecular-weight heparins (LMWH) followed by oral anticoagulants for variable periods of time. LMWHs present a number of potential advantages over unfractionated heparin: a longer plasma half-life, improved subcutaneous bioavailability, and a more predictable dose-response relationship. As a result of these pharmacokinetic properties, these compounds have the potential to greatly simplify the initial treatment of venous thromboembolism, making the treatment of suitable patients feasible in an outpatient setting with considerable saving in costs and improvement in patients' quality of life. The use of unfractionated heparin is still desirable in the initial treatment of acute pulmonary embolism in non-critically ill patients. The use of heparin protocols assures that virtually all patients will promptly achieve the therapeutic range for the activated partial thromboplastin time. Although the optimal duration of anticoagulation in patients suffering an episode of venous thromboembolism is presently unknown, it seems reasonable to administer a short-term course of coumarin drugs to patients with thrombosis associated with transient risk factors, while a longer course should be considered in patients with idiopathic thrombosis and in those with permanent risk factors. At present, indefinite anticoagulant therapy remains a clinical judgment in the individual patient. The efficacy and safety of emerging drugs (pentasaccharide, ximelagatran) in the treatment and secondary prevention of venous thromboembolic disorders is currently under investigation.

Acute Disease↗
PubMed2001

Three months versus one year of oral anticoagulant therapy for idiopathic deep venous thrombosis. Warfarin Optimal Duration Italian Trial Investigators.

BACKGROUND: In patients with idiopathic deep venous thrombosis, continuing anticoagulant therapy beyond three months is associated with a reduced incidence of recurrent thrombosis during the period of therapy. Whether this benefit persists after anticoagulant therapy is discontinued is controversial. METHODS: Patients with a first episode of idiopathic proximal deep venous thrombosis who had completed three months of oral anticoagulant therapy (with warfarin, in 97 percent of the cases and acenocoumarol in 3 percent) were randomly assigned to the discontinuation of oral anticoagulants or to their continuation for nine additional months. The primary study outcome was recurrence of symptomatic, objectively confirmed venous thromboembolism during at least two years of follow-up. RESULTS: The primary intention-to-treat analysis showed that of 134 patients assigned to continued oral anticoagulant therapy, 21 had a recurrence of venous thromboembolism (15.7 percent; average follow-up, 37.8 months), as compared with 21 of 133 patients assigned to the discontinuation of oral anticoagulant therapy (15.8 percent; average follow-up, 37.2 months), resulting in a relative risk of 0.99 (95 percent confidence interval, 0.57 to 1.73). During the initial nine months after randomization (after all patients received three months of therapy), 1 patient had a recurrence while receiving oral anticoagulant therapy (0.7 percent), as compared with 11 of the patients assigned to the discontinuation of oral anticoagulant therapy (8.3 percent; P=0.003). The incidence of recurrence after the discontinuation of treatment was 5.1 percent per patient-year in patients in whom oral anticoagulant therapy was discontinued after 3 months (95 percent confidence interval, 3.2 to 7.5 percent; average interval since discontinuation, 37.2 months) and 5.0 percent per patient-year in patients who received an additional 9 months of oral anticoagulant therapy (95 percent confidence interval, 3.1 to 7.8 percent; average interval since discontinuation, 29.4 months). None of the recurrences were fatal. Four patients had non-fatal major bleeding during the extended period of anticoagulant therapy (3.0 percent). CONCLUSIONS: In patients with idiopathic deep venous thrombosis, the clinical benefit associated with extending the duration of anticoagulant therapy to one year is not maintained after the therapy is discontinued.

Acenocoumarol↗
PubMed2001

Long-term clinical course of proximal deep venous thrombosis and detection of recurrent thrombosis.

Symptomatic proximal deep vein thrombosis of lower extremities carries a high risk for recurrent venous thromboembolism that persists for many years. This risk is dependent on readily identifiable risk factors, being low after a trauma or a surgical intervention and higher in all the other patient categories. Moreover, postthrombotic sequelae will develop in one of every three patients, this risk being strongly related to the development of ipsilateral thrombosis. Although the optimal duration of anticoagulation in patients who experience an episode of proximal vein thrombosis is unknown, it seems reasonable to administer a short-term course of coumarin drugs to patients with thrombosis associated with transient risk factors, whereas a longer course (6 to 12 months) should be considered in patients with idiopathic thrombosis and in those with permanent risk factors. Indefinite anticoagulant therapy is a clinical judgement in the individual patient. The management of patients who develop clinical manifestations suggestive of recurrent ipsilateral venous thrombosis still represents a challenge for clinicians. Recent data suggest that these patients can be safely managed with the use of serial compression ultrasonography.

Clinical Trials as Topic↗
PubMed2001

Diagnosis of recurrent deep vein thrombosis.

Long-term follow-up studies demonstrated that venous thromboembolism is a chronic disease, as the rate of recurrent deep vein thrombosis (DVT) continuously increases after the primitive thrombotic episode. Objective testing is mandatory to confirm or refute the presence of recurrent DVT, as only 30% of patients with suspected recurrence have a new documented thrombotic episode. There is no consensus on the preferred diagnostic procedure; furthermore, both invasive and noninvasive methods are limited in this context. Venography, the established gold standard, is invasive, costly, inconvenient and requires high technical skills. Among noninvasive techniques, serial impedance plethysmography, alone or in combination with leg scanning and venography, and serial compression ultrasound (CUS), were adequately investigated. At present, the recommended approach is represented by a quantitative CUS method that possesses an excellent reproducibility and accuracy. The safety of withholding anticoagulants from patients with a normal quantitative CUS work-up has been recently demonstrated in a prospective management study.

Anticoagulants↗
PubMed2001

Prevention of venous thromboembolism in high-risk surgical and medical patients.

Although pharmacologic prophylaxis against venous thromboembolism has become the standard of care following total hip and knee replacement, prophylaxis among patients undergoing surgery for hip fracture and other lower extremity trauma remains underutilized. Available experience consistently supports the view that low-molecular-weight heparins are more effective than unfractionated heparin for prevention of proximal deep vein thrombosis (DVT) with no additional hemorrhagic risk and more effective than oral anticoagulants for prevention of in-hospital (mostly distal) venous thrombosis at the price of a higher surgical site bleeding and wound hematoma. The choice between low-molecular-weight heparin and warfarin should be tailored to the individual patients based on the clinical assessment of postoperative thrombosis and bleeding risk as well as the prophylaxis-specific cost and convenience. Whether thromboprophylaxis should be continued for a few additional weeks after hospital discharge is controversial. The overall incidence of postoperative DVT in patients with cancer is about twice as high as that of patients free of malignancy. Accordingly, they require prophylactic measures comparable with those usually recommended for major orthopedic surgery. In this setting, dermatan sulfate shows promise. In contrast to surgical patients, prevention of venous thromboembolism is less well studied in hospitalized medical patients. In a recent controlled randomized trial, enoxaparin in high prophylactic doses was an effective and safe measure of thromboprophylaxis in ordinary bedridden patients.

Anesthesia, Conduction↗
PubMed2001

Postthrombotic syndrome: incidence, prevention, and management.

Mild to severe postthrombotic sequelae, including chronic pain, edema, and ulceration, arise in one third of patients short after deep vein thrombosis (DVT). Recurrent DVT is closely associated with the development of postthrombotic syndrome (PTS), whereas if the extent and location of DVT might be relevant remains unclear. Chronic venous hypertension and abnormal microvessel or lymphatic function also correlates with PTS. The diagnosis of PTS is based on clinical grounds only if patients report a history of documented DVT; otherwise, objective testing is required. To abate the prevalence of PTS, the best policy is represented by prevention of recurrent thrombosis and use of stockings. Despite a plenty of surgical options, conservative treatment is preferable because half of the patients improve or remain stable during follow-up, provided they wear elastic stockings. Clinical presentation has a prognostic value, as patients with initially severe symptoms enjoy a more favorable outcome than those who progressively deteriorate over time.

Anticoagulants↗
PubMed2001

Upper extremity deep vein thrombosis: risk factors, diagnosis, and management.

Upper extremity deep vein thrombosis (UEDVT) should no longer be regarded as an uncommon and benign disease, as previously reported. It is usually associated with risk factors, as central venous lines, malignancy, and coagulation defects; however, up to 20% of UEDVTs are apparently spontaneous. The clinical picture is characterized by swelling, pain, and functional impairment, albeit UEDVT may be completely asymptomatic. Objective testing is mandatory prior to instituting anticoagulation because the prevalence of UEDVT is less than 50% in symptomatic subjects, and compression ultrasound or color Doppler represents the preferred diagnostic methods. Up to 36% of the patients develop pulmonary embolism, which may be fatal; postthrombotic sequelae and recurrent thromboembolism are also frequent complications. Unfractionated or low-molecular-weight heparin followed by oral anticoagulation should be regarded as the treatment of choice; thrombolysis and surgery may be indicated in selected cases. Prophylaxis with low-dose heparin or low-dose warfarin is necessary whenever central venous catheters are positioned.

Anticoagulants↗
PubMed2001

Venous thromboembolism as first manifestation of cancer.

Since Trousseau's time numerous studies have addressed the relationship between cancer and venous thromboembolism (VTE) providing firm evidence of the increased risk of subsequent clinically overt malignancy during the follow-up of patients with idiopathic VTE. These malignancies are not limited to certain subtypes, but involve virtually all body systems. This knowledge has led to a long-standing debate on the need to screen for occult malignancies patients with idiopathic VTE with no clinical evidence of cancer at the time of the index thrombotic event. In fact the high incidence of newly discovered cancers does not automatically imply that screening is indicated in these patients since it is unknown whether a substantial proportion of cancers can be diagnosed, whether the diagnosed cancers are treatable and what the impact on cancer-related mortality is. Proper clinical trials are being conducted to find an answer to these questions.

Cohort Studies↗
PubMed2001

The optimal treatment of venous thrombosis: current status and future perspectives.

Acute deep venous thrombosis (DVT) of the lower extremities is a serious and potentially fatal disorder, which often complicates the course of hospitalized patients but may also affect ambulatory and otherwise healthy people. Venous thrombosis is uncommon in young individuals and becomes more frequent with advancing age. The clinically important problems associated with venous thrombosis are death from pulmonary embolism, morbidity resulting from the acute event, recurrent venous thromboembolic events, the post-thrombotic syndrome, and the inconvenience and side-effects of investigations and treatment. The main objectives of treatment of DVT are prevention of (both fatal and nonfatal) pulmonary embolism and thrombus extension in the acute phase of the disease, prevention of recurrences of venous thromboembolism in the months following the acute episode, and prevention of late sequelae (post-thrombotic syndrome). These objectives are satisfactorily achieved with anticoagulant drugs (heparin and vitamin K antagonists), which therefore are the mainstays of DVT treatment. Other therapeutic options have a more limited application.

Ambulatory Care↗
PubMed2001

Fibrinolytic variables in patients with recurrent venous thrombosis: a prospective cohort study.

To determine whether fibrinolytic testing predicts recurrent venous thrombosis, we have performed a prospective cohort study in which 303 patients with a first episode of venous thromboembolism underwent comprehensive fibrinolytic testing while receiving oral anticoagulants, and after anticoagulants had been discontinued. They were then followed for up to 3 years for recurrent venous thrombosis. No systematic differences in the levels or activity of type 1 plasminogen activator inhibitor (PAI-1), tissue plasminogen activator (tPA) or euglobulin clot lysis times were detected between patients who did, or did not, suffer recurrent thrombosis. There were also no differences in these variables when patients whose initial thrombosis was idiopathic were compared to patients whose thrombosis occurred in the setting of a known thrombotic risk factor. Based on these results, neither measuring fibrinolytic parameters in patients with venous thromboembolism, nor modification of treatment based on the results of such testing, are justified. Our study also confirms that patients with idiopathic venous thromboembolism have a high risk of recurrence.

Anticoagulants↗
PubMed2001

Heparins and venous thromboembolism: current practice and future directions.

Unfractionated heparin (UFH) in adjusted doses and low-molecular-weight heparins (LMWH) in fixed doses are the chosen therapy for the initial treatment of venous thromboembolism. The use of UFH protocols ensures that virtually all patients will promptly achieve the therapeutic range for the activated partial thromboplastin time. However, proper use of UFH requires considerable expertise, can cause inconvenience and has limitations. Unmonitored therapy with subcutaneous LMWH is at least as effective and safe as adjusted-dose UFH, is associated with a considerable reduction of mortality in cancer patients, and permits the treatment of suitable patients in an outpatient setting. LMWH in high prophylactic doses is more effective than UFH and oral anticoagulants for prevention of postoperative venous thrombosis in major orthopedic surgery. Whether thromboprophylaxis should be continued for a few additional weeks after hospital discharge is controversial. LMWH and UFH are equally effective for prevention of postoperative deep-vein thrombosis in cancer patients. In a recent controlled randomized trial, enoxaparin in high prophylactic doses was an effective and safe measure of thromboprophylaxis in ordinary bedridden patients. The efficacy and safety of pentasaccharide (the smallest antithrombin binding sequence of heparin) in the treatment and prevention of venous thromboembolic disorders is currently under investigation.

Blood Loss, Surgical↗
PubMed2001

The value of ultrasound screening for proximal vein thrombosis after total hip arthroplasty--a prospective cohort study.

The role of ultrasound screening for proximal deep-vein thrombosis (DVT) following major hip surgery is controversial. 202 consecutive patients, who had received warfarin prophylaxis after total hip arthroplasty underwent a bilateral ultrasound assessment of the proximal vein system (using the criterion of vein compressibility) before hospital discharge. In the 9 patients (4.5%; 95% CI, 2.1-8.3%) with positive test anticoagulant treatment was successfully continued for three months. In all the remaining 193 patients the warfarin treatment was withdrawn. A second ultrasound test was performed 15 days later, and showed a new (asymptomatic) abnormality compatible with proximal DVT in 2 patients (1.0%; 95% CI, 0.1-3.7%). All other 191 patients remained asymptomatic until the completion of a 3-month follow-up period (rate of symptomatic thromboembolism, 0/191, 0%; 95% CI, 0-1.9%). Because of the relatively high incidence of proximal DVT in patients undergoing major orthopaedic surgery under warfarin prophylaxis, screening for proximal DVT at hospital discharge in these patients is indicated. The negativity of this test has the potential of safely preventing the extension of anticoagulation beyond hospital stay. A larger controlled study in which the value of this strategy is tested against the prolongation of oral anticoagulation in patients with a negative ultrasound screening at discharge is indicated.

Aged↗
PubMed2001

Factor V Leiden mutation and the risk of venous thromboembolism in pregnant women.

BACKGROUND AND OBJECTIVES: In this retrospective, single center, cohort study we assessed the risk of pregnancy-related venous thromboembolism (VTE) in women belonging to a large number of families identified because of a symptomatic proband with single identified factor V Leiden mutation. DESIGN AND METHODS: Female family members who had experienced at least one full-term pregnancy were enrolled in the study. Two hundred and seventy pregnancies occurred in 105 carriers and 215 pregnancies in 81 non-carriers of factor V Leiden mutation. RESULTS: The frequency of VTE was 6.4% for heterozygous, 16.7% for homozygous, 20% for double heterozygous carriers of thrombophilic defects, and 1.2% for non-carriers. The majority of VTE events related to pregnancy occurred in the post-partum period. The relative risks of developing pregnancy-related VTE in women who were carriers of heterozygous and homozygous (or combined heterozygous) factor V Leiden mutation as compared to non-carriers were 5.3 (95% CI, 0.6 to 43.9) and 15.4 (95% CI, 1.4 to 164), respectively. INTERPRETATION AND CONCLUSIONS: Factor V Leiden mutation is a risk factor for pregnancy-related VTE, especially in its homozygous form and in combination with other thrombophilic abnormalities. Screening of families with this mutation might be useful for women of fertile age, as they may take advantage from thromboprophylaxis during pregnancy and the post-partum period.

Adult↗