© 2006 Schattauer GmbH, Stuttgart
Blood Coagulation, Fibrinolysis and Cellular Haemostasis
Heparin-induced thrombocytopenia (HIT) A report of 1,478 clinical outcomes of patients treated with danaparoid (Orgaran) from 1982 to mid-2004 Harry N. Magnani1, Alex Gallus2 1
NV Organon, Oss, The Netherlands; 2Flinders University and Flinders Medical Centre, Adelaide, South Australia, Australia
Summary Clinical outcomes of 1,478 danaparoid treatment case reports for HIT (involving 1,418 patients) treated between 1982 and mid-2004 are analysed.Treatment in 1,291 episodes was for current HIT.Thromboembolism due to HIT was present in 39.4%. The patients include 33 children and 32 pregnancies. Two hundred twenty-six patients required extra-corporeal circuit use for renal failure, 241 patients had a concomitant thrombophilic disorder,and 351 major operations were performed.Clinical outcomes were assessed during danaparoid treatment (range one day to 3.5 years) plus three months of follow-up. Of the danaparoid-treated patients 83.8% survived; 63.7% had no or minor adverse events and 20.1% suffered serious non-fatal adverse events.New thromboses occurred during 9.7% of treatment episodes, and 16.4% of treatment episodes had an inadequate treatment response (i.e. developed one or more of the following: new/extended thrombosis, persistent/new platelet
count reduction, unplanned amputation during treatment and follow-up). Major bleeding was reported in 8.1% of treatment episodes.Clinical cross-reactivity of danaparoid (new/persistent platelet count reduction and/or new/extended thrombosis) was confirmed serologically in 23 of 36 patients with positive pretreatment serological danaparoid cross-reactivity and in 22 of 32 additional patients tested at the time of the new event,i.e.a total of 45 patients (3.2%). Clinical outcomes of these case reports of patients given danaparoid because of suspected or confirmed HIT appear to be comparable with those reported by others who used direct thrombin inhibitors,especially when a sufficient danaparoid dosing intensity was used in patients with isolated HIT.Post-operative bleeding limits danaparoid use for cardiopulmonary by-pass surgery. Routine clinical and platelet count monitoring are required to minimise adverse reactions due to cross-reactivity.
Keywords Heparin-induced thrombocytopenia, danaparoid, case reports
Thromb Haemost 2006; 95: 967–81
Introduction Heparin-induced thrombocytopenia (HIT) is a relatively common immunologically mediated complication of low-molecularweight heparin and unfractionated heparin [(LMW)heparin] use where a high frequency of thrombosis causes severe morbidity and mortality (1). Danaparoid is a non-heparin, parenteral antithrombotic approved for use in HIT, deep vein thrombosis (DVT) prophylaxis and disseminated intravascular coagulopathy (DIC) (Japan only). The drug is marketed in Canada, Australia, New Zealand and most of Europe but is not available in the U.S. It inhibits thrombin generation by accelerating inactivation of factor Xa by antithrombin (AT) and inhibits thrombin activity via both AT and heparin cofactor II. Danaparoid also inhibits thrombin activation of factor IX (2). Thus, danaparoid can control the rapid thrombin generation associated with HIT (3).
In 1985 a small open prospective comparison of danaparoid plus warfarin with dextran plus warfarin in patients with HIT and a thrombosis (4) showed that clinical outcomes were superior after treatment with danaparoid and warfarin. With this exception doctors have been reluctant to consider randomised prospective evaluations of unfamiliar new therapies for HIT, so that most information about HIT treatment options comes from cohort studies that are wholly retrospective (5) or where prospective treatment outcomes with newer drugs, e.g. lepirudin (Refludan®) or argatroban (Novastan®), are compared with outcomes in historic controls given drugs no longer or now infrequently used by the authors (6, 7). The results of such studies can be misleading for many different reasons (4–7). Another way to gain information on drug efficacy and safety is to review all available case reports of its use for patients with HIT. Between 1982 and 1997 the manufacturer conducted a noncomparative compassionate-use programme to supply danapa-
Correspondence to: Dr. Harry N. Magnani Schoutstraat 54 5345 MT, Oss, The Netherlands Tel.: +31 412 639512; E-mail:
[email protected]
Received July 12, 2005 Accepted after resubmission April 14, 2006 Prepublished online May 11, 2006 doi:10.1160/TH05–07–0489
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roid for named-patients with HIT and other forms of heparin-intolerance (8–13). In addition, many case reports of danaparoid treatment of HIT patients were independently published during and after this period. The aim of the present analysis is to assess the place of danaparoid in the treatment of HIT by collating case reports from 1982 (14), when the first patient was treated, until mid-2004.
Methods Included case reports were those with sufficient details for adequate data extraction (i.e. clarity of demographic data, treatment period, HIT diagnostic confirmation, danaparoid crossreactivity and events relating to clinical outcome, i.e. efficacy, safety and mortality) of unique patients or patient series treated with danaparoid. All events reported during follow-up after discontinuing danaparoid have been included for each patient. Excluded case reports were those which: – provided insufficient/inadequate data, or – duplicated an included paper (e.g. alternative language publication). Three groups of case-reports were identified: Group 1: Compassionate-use programme Apart from a reasonably well founded diagnosis of HIT and a life expectancy of more than three months if HIT was successfully treated, there was no other enrolment restriction in this namedpatient programme. Group 2: Literature search A literature search of danaparoid use in HIT patients was conducted using Medline and Current Contents databases, Internet search engines such as ‘Google’, ‘Wanadoo’ and ‘Jeeves’, as well as the manufacturer’s search facilities and in-house data bases for case reports published independently of NV Organon from 1983 to mid-2004. All papers found were included except: – presentations of interim results (e.g. preliminary meeting abstract) of the included (final) paper, or interim descriptions of the patient population enrolled in the danaparoid compassionate-use programme, – descriptions of in vivo or ex vivo testing of danaparoid for cross-reactivity without its administration to a patient with HIT. Group 3: Spontaneous serious adverse event (SAE) reports Despite sometimes fragmentary data, all SAEs of HIT patients treated with danaparoid and reported to the manufacturer to mid-2004 were entered into this data-base. Definitions used in the study Current HIT Patients with serologically demonstrable (LMW)heparininduced anti-platelet antibody or with clinical (including platelet count reduction) manifestations of HIT which developed less than three months prior to the use of danaparoid.
Past HIT Patients with negative serological status and/or whose diagnosis of HIT was documented at least three months prior to the use of danaparoid. Isolated HIT HIT presenting without a thrombotic complication. Paediatric Refers to subjects aged from birth up to and including 17 years. Serious adverse event (SAE) Is one which: – is fatal or life-threatening – prolongs or leads to renewed hospitalisation – leads to (re)operation – results in persistent or significant disability. Sero-conversion Was diagnosed if: – serological test results for danaparoid cross-reactivity changed from negative prior to its use to positive during its use, – no serological test was performed before danaparoid use but a cross-reactivity test performed because of suspected clinical cross-reactivity was positive, i.e. the test was done because of a new platelet count reduction or failure of a low count to recover and/or evidence of a thrombotic event with onset during danaparoid use. Sero-conversion Was suspected if: – clinical cross-reactivity was observed in the absence of any serological testing, i.e. a new platelet count reduction or failure of a low count to recover, and/or evidence of a thrombotic event during danaparoid use, which could not be explained by a co-morbid disorder or an inadequate dosing regimen. Diagnosis of HIT Suspicion of HIT HIT was suspected in patients if an unexplained platelet count reduction or thromboembolic event occurred during (LMW)heparin treatment (particularly if events were multiple, arterial and venous or at an unusual site). Occasionally isolated thrombopenia was associated with ‘heparin resistance’[difficulty maintaining therapeutic anticoagulation despite increasing the dose of unfractionated heparin (15)]. Serological confirmation of HIT HIT was most commonly confirmed by the platelet aggregation test (PAT, or HIPA in the USA). Other tests used include the serotonin release assay (SRA) in Canada, the heparin-induced platelet activation assay (HIPAA) in Germany and the enzyme linked immuno-assay (EIA) in France. If two or more tests were used in a single patient, then HIT was considered confirmed if at least one was positive.
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Clinical confirmation of HIT Clinical confirmation of HIT was indicated by the occurrence on rechallenge of platelet count reduction and/or white clot syndrome (WCS), and/or an acute systemic (15) or local skin (necrosis) reaction to (LMW)heparin. Occasionally one of the latter was present despite negative HIT serology. Danaparoid treatment outcome assessments Composite indicator of lack of efficacy: major efficacy outcomes (SAE’s) – fatal and non-fatal thrombotic events (new or progression) – unplanned amputations (i.e. amputations for which danaparoid was not specifically requested a priori to cover the operation) – persistent or renewed platelet count reduction – any combination of the above in one treatment episode. Composite indicator of lack of safety: major safety outcomes (SAE’s) – major bleeding (defined by any of the following: fatal or lifethreatening, led to operation or required more than two or more units of blood or other blood product transfusion if medical, or led to re-operation or more than two units of blood or other blood product transfusion if surgical or required discontinuation of danaparoid, or led to rehospitalisation or to significant or persistent disability) – all other causes of mortality (excluding deaths due to thrombotic or major bleeding events) – worsening of or new skin rash – other non-fatal adverse events leading to danaparoid discontinuation – any combination of the above in one treatment episode. Additional assessments – survival at the end of the follow-up period – minor bleeding (which did not satisfy the criteria for major bleeding and which did not require danaparoid discontinuation) – danaparoid cross-reactivity prior to treatment initiation – sero-conversion – both serological and clinical. Statistics Demographic, efficacy and safety parameters were summarised and tabulated, but no formal statistical analyses were made.
Literature search (Group 2) Two hundred twenty-two acceptable publications (1, 3, 6, 13, 16-232) and an unpublished communication from Keen RR, Durham JR, Green D (1997) were identified. They comprise 200 with individual patient(s) data, 20 papers each summarising a unique series of patients treated with danaparoid and two papers where most patients were excluded because of lack of detail, but one or two sufficiently well described patients were identified. In total, adequate data was identified in these 20 patient series on 378 individual cases and 334 cases in total, i.e. 712 treatment episodes for 699 patients in total. Thirty-six publications (5, 8–13, 233–261) were excluded because 21 appeared to duplicate cases included in other papers from the same authors (some of which were alternative language publications) and 15 mentioned danaparoid use but lacked sufficient clinical detail. Spontaneous serious adverse (SAE) event reports (Group 3) Ninety-two unsolicited reports of SAEs in HIT patients were received by the manufacturer during the review period. Four were identified with published cases and are included in Group 2, leaving 88 cases for Group 3. Number of HIT patients treated with danaparoid World-wide over 100,000 HIT patients have been treated outside the compassionate-use programme since the first approval for danaparoid use for HIT. However, because the actual number is uncertain, outcome frequencies of the various treatment endpoints are derived using the total number of reported patients (n = 1,418) or treatment episodes (n = 1,478, since 51 patients had more than one episode of treatment) as appropriate. Demographic data and HIT diagnosis Demographic data is summarised in Table 1. Current HIT was diagnosed in 1,283 of the 1,478 treatment episodes (86.8%). Laboratory confirmation of HIT (Table 2) was reported for 1,099/1,418 (77.5%) of the patients. Negative HIT serology was recorded in 8.1% of those tested. HIT was confirmed clinically in some serologically negative or untested patients by observing platelet count reduction after heparin rechallenge and/or white clot syndrome or rarely an acute anaphylactic reaction (14) to heTable 1: Demographic data.
Results In total, 1,478 case reports were found for 1,418 patients. Compassionate use programme (Group 1) Six hundred seventy-eight treatment episodes in 631 patients were identified as unique to this database. An additional 82 case reports for 80 patients from this programme were also identified in 29 independent publications and two spontaneous adverse event reports. Their data were analysed with those of the Group 2 and Group 3 patients, respectively.
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Parameter
Group 1
Group 2
Group 31
Number of – All treatment episodes – Repeat danaparoid uses – Patients
678 47 (39)4 631
712 13 (12)4 699
88 0 88
61 (90 kg. These recommendations are now mentioned in national authorisations of marketing for danaparoid. We would also recommend checking plasma anti-Xa activity at least every 1 – 2 months during chronic use, even if the patient appears problem free. Recommendations for optimal danaparoid use The collated data supports the following recommendations for optimal treatment with danaparoid in clinically suspected HIT: – the diagnosis should be serologically confirmed, and a pretreatment blood sample should be tested for danaparoid cross-reactivity. It is not necessary to wait for the result of either test before initiating danaparoid therapy (267, 293). However, if the pre-treatment danaparoid cross-reactivity test is positive, we advise switching to alternative suitable antithrombotic replacement therapy with few exceptions (see discussion). – the initial danaparoid dosing intensity should be sufficient to be effective during this early highly thrombophilic period (1, 7, 267). The patient’s high thrombotic risk in the absence of any antithrombotic therapy must be balanced against the bleeding risk and/or need for early surgery (15). – plasma anti-Xa activity monitoring should be considered if the patient is >90 kg or 30 ml/minute). In these cases and once the plasma anti-Xa activity is stable and within the target range, the monitoring interval can be extended unless the patient’s clinical status deteriorates. – we recommend platelet count monitoring daily during the first week of danaparoid administration, on alternate days during the next two weeks and then on a weekly basis while danaparoid administration continues. During chronic danaparoid use a platelet count should be performed at least once every 1 – 2 months. If the patient’s pre-treatment danaparoid cross-reactivity test was positive, then the daily platelet count should be continued for at least two weeks. – if the onset of clinical cross-reactivity is suspected during danaparoid therapy, then a test should be made for sero-conversion. Inadequate dosing and possible differential diagnoses of thrombophilia and/or thrombocytopenia (273), e.g. sepsis, concomitant drugs, DIC, APL (and related syndromes) or pseudothrombocytopenia (272) etc., some of which may also delay platelet count recovery, should be excluded. If in doubt, then danaparoid therapy should be withdrawn. – patients with confirmed clinical danaparoid cross-reactivity should carry a warning against its future use.
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Conclusions – This analysis of 1,478 reports of danaparoid treatment for HIT has found it to be safe and effective in patients of all ages with a wide range of co-morbid clinical problems and antithrombotic requirements. – Patients with isolated HIT (no thromboembolic complications at diagnosis) should receive the highest recommended prophylactic dosing intensity compatible with their risk of bleeding because of their high risk of developing thrombosis.
– Danaparoid is generally unsuitable during surgery that requires cardiopulmonary bypass. – Although danaparoid treatment has apparently successfully treated some patients with serologically proven cross-reactivity to the LMW heparin-induced anti-platelet antibody, the patient should be switched to another alternative antithrombotic if a suitable one is available. – Patients with clinical danaparoid cross-reactivity should carry a warning against its future use.
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