Antithrombin therapy to support PCI

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Unfractionated Heparin (UFH)

IV unfractionated heparin is the most common anticoagulant used in the cath lab.

Mechanism of action

Heparin is a glycosaminoglycan of 12-15 kDa that binds Anti-Thrombin 3 and facilitates its ability to inhibit coagulation factors 2a (thrombin) and 10a by a factor of 1000. Thrombin plays a central role not only in plasma coagulation (by catalyzing fibriongen to fibrin as well as activating several coagulation factors) but platelet activation as well.

Advantages

  • Physician familiarity with use
  • Level of anticoagulation can be titrated with ACT. Target ACT typically 200-250 with 2b/3a

and 250-350 without 2b/3a (these levels have been empirically derived and target ACT's have fallen in the stent era as the risk for acute vessel closure has diminished)

  • Can be reversed with protamine (1mg of protamine for 100u of heparin acutely) in case of coronary artery perforation or vascular access complication.
  • No dose adjustment needed for renal dysfunction
  • Inexpensive

Disadvantages

  • Significant protein binding
  • Monitoring required as level of anticoagulation varies widely between patients
  • Inability to inactive clot-bound thrombin
  • Does not prevent the platelet activation of thrombin
  • Risk of HIT- Heparin Induced Thrombocytopenia

Low Molecular Weight Heparinoids (LMWH)

Mechanism of Action

  • Unlike UFH or LMWH, Direct Thrombin inhibitors (Lepirudin, Argatroban and Bivalirudin), don't require the help of AT-3 to exert their anticoagulation effect. These medicines are IV only, but there is great interest in developing safe oral DTI to replace coumadin in the DVT/PE and Afib population.

Bivalirudin (Angiomax) is the only DTI used commonly in the cath lab although the others have been studied.

Advantages

  • Short Half life. This facilitates early sheath removal after PCI
  • Can inhibit fibrin-bound thrombin
  • Simplified dosing regimen. Can be adjusted for patients with renal insufficiency.
  • Fewer bleeding complications especially at access site. This advantage increases as bleeding risk increases due to age and renal insufficiency.
  • Best regimen for patients with known HIT.

Disadvantages

  • Cost (however this is offset if use of bival obviates need for 2b/3a)

Trials with BIVALIRUDIN

Replace 2-Compared Bivalirudin plus provisional 2b/3a (which ended up being given in 7.2% of pts) vs heparin with planned 2b/3a. In this study of 6010 pts ischemic events were similar but major bleeding (mostly vascular access site) was reduced by about 40%. There was no mortality difference at one year despite a .8% absolute increase in peri-procedural MI's in the bivalirudin group. Importanly 85% of pts were pre-treated with plavix or ticlid. In Replace 2 Bival strategy found to be less expensive because of savings on 2b/3a as well as less bleeding

ACUITY- Complex trial of 13,819 high risk UA or NSTEMI pts undergoing early invasive strategy comparing Bivalirudin alone vs Bivalirudin with 2b/3a vs Heparin or Lovenox with 2b/3a. Found the ischemic composite endpoint (death, MI, revasc) at 30 days to be the same in all 3 arms. However, major bleeding was significantly less with Bival alone at 3.1% vs Bival+2b3a at 5.3% and Heparin/Lovenox+2b3a at 5.7%. Again this was driven mostly by access site complications, but unlike in REPLACE 2 the bleeding endpts were significant whether one used the study definition or TIMI definition. A major caveat is also that pts who did not get plavix had increased ischemic events in the bival only arm.

CONCLUSION- Bivalirudin is an excellent choice in most NSTEMI/UA pts managed with an early invasive strategy if they have been pre-treated with clopidogrel. If this has not been done then 2b/3a will need to be used and the benefits of bivalirudin are greatly attenuated.

ACCF/AHA/SCAI 2011 Guidelines for Percutaneous Coronary Intervention (DO NOT EDIT)[1]

Use of Parenteral Anticoagulants during PCI (DO NOT EDIT)[1]

Class I
"1. An anticoagulant should be administered to patients undergoing PCI. (Level of Evidence: C)"

Unfractionated Heparin (DO NOT EDIT)[1]

Class I
"1. Administration of intravenous UFH is useful in patients undergoing PCI. (Level of Evidence: C)"

Enoxaparin (DO NOT EDIT)[1]

Class I
"1. An additional dose of 0.3 mg/kg intravenous enoxaparin should be administered at the time of PCI to patients who have received fewer than 2 therapeutic subcutaneous doses (e.g., 1 mg/kg) or received the last subcutaneousenoxaparin dose 8 to 12 hours before PCI.[2][3][4][5][6](Level of Evidence: B)"
Class III (Harm)
"1. Unfractionated heparin (UFH) should not be given to patients already receiving therapeutic subcutaneous enoxaparin.[2][7](Level of Evidence: B)"
Class IIb
"1. Performance of PCI with enoxaparin may be reasonable in patients either treated with upstream subcutaneous enoxaparin forUA/NSTEMI or who have not received prior antithrombin therapy and are administered intravenous enoxaparin at the time ofPCI.[8][9][2][10] (Level of Evidence: B)"

Bivalirudin and Argatoban (DO NOT EDIT)[1]

Class I
"1. For patients undergoing PCI, bivalirudin is useful as an anticoagulant with or without prior treatment with unfractionated heparin (UFH).[11][12][13][14][15][16][17][18][19](Level of Evidence: B)"
"2. For patients with heparin-induced thrombocytopenia, it is recommended thatbivalirudin or argatroban be used to replace unfractionated heparin (UFH).[20][21] (Level of Evidence: B)"

Fondaparinux (DO NOT EDIT)[1]

Class III (No Benefit)
"1. Fondaparinux should not be used as the sole anticoagulant to support PCI. An additional anticoagulant with anti-IIa activity should be administered because of the risk of catheter thrombosis.[22][23](Level of Evidence: C)"

References

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