Bridging Therapy in Patients at High Risk for Stent Thrombosis Undergoing Surgery
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | April 2008 |
| End Date: | April 2011 |
Patients who have undergone placement of coronary stents require dual antiplatelet therapy
with Plavix and aspirin to prevent the serious complication of in-stent thrombosis. Some of
these patients will require surgery while on dual antiplatelet therapy. This poses a
challenge because being on Plavix is associated with higher risks of perioperative bleeding,
but stopping Plavix puts patients at increased risk for in-stent thrombosis.
Currently, the ACC/AHA guidelines recommend discontinuation of Plavix five days prior to
surgery to prevent bleeding complications. However, there are no universal recommendations
for preventing in-stent thrombosis. Some experts recommend the use glycoprotein IIb/IIIa
inhibitors (short-acting antiplatelet agents) as "bridging therapy" during the high-risk
perioperative period. Although these agents should be beneficial based on theory, there is
currently no published data on their effectiveness for this purpose.
The current study proposes to evaluate the value of Aggrastat (a short-acting intravenous
platelet glycoprotein IIb/IIIa inhibitor) in decreasing the risk of in-stent thrombosis
without increasing the risk of perioperative bleeding.
with Plavix and aspirin to prevent the serious complication of in-stent thrombosis. Some of
these patients will require surgery while on dual antiplatelet therapy. This poses a
challenge because being on Plavix is associated with higher risks of perioperative bleeding,
but stopping Plavix puts patients at increased risk for in-stent thrombosis.
Currently, the ACC/AHA guidelines recommend discontinuation of Plavix five days prior to
surgery to prevent bleeding complications. However, there are no universal recommendations
for preventing in-stent thrombosis. Some experts recommend the use glycoprotein IIb/IIIa
inhibitors (short-acting antiplatelet agents) as "bridging therapy" during the high-risk
perioperative period. Although these agents should be beneficial based on theory, there is
currently no published data on their effectiveness for this purpose.
The current study proposes to evaluate the value of Aggrastat (a short-acting intravenous
platelet glycoprotein IIb/IIIa inhibitor) in decreasing the risk of in-stent thrombosis
without increasing the risk of perioperative bleeding.
A. D/C clopidogrel 5 days prior to surgery
B. Continue ASA (Increase dose to 325 mg until prohibitive bleeding risk)
C. Check baseline IIb/IIIa and P2Y12 via the Verify Now device prior to initiating tirofiban
D. Start Tirofiban 2 days prior to the procedure (Patient MUST be on a monitored bed)
- Load Tirofiban ONLY if P2Y12 (Verify Now Assay) platelet inhibition is < 20% OTHERWISE
initiate only the continuous infusion dose
- Creatinine clearance > 30mL/min: Tirofiban 0.4 mcg/kg/min for 30 minutes, followed by
continuous infusion at 0.1 mcg/kg/min
- Creatinine clearance < 30mL/min: Tirofiban 0.2 mcg/kg/min for 30 minutes, followed by
continuous infusion of 0.05 mcg/kg/min
E. Check steady state IIb/IIIa inhibitor verify now assay (>8 hour after initiation)
F. Hold Tirofiban 12 hours prior to procedure
G. Check IIb/IIIa inhibitor verify now assay (10-12 hours after Tirofiban is discontinued)
H. CBC pre and post op
I. Reload clopidogrel> 24 hours post op (300 mg X 1 then 75 mg daily) unless prohibitive
bleeding risk
J. Reduce ASA to pre-procedure dose. Restart ASA, 24 hours port-op if it was D/C prior to
procedure
K. Check P2Y12 via the Verify Now device post-loading dose of clopidogrel (test cannot be
performed w/in 48 hours of the D/C of IIb/IIIa inhibitor (tirofiban)
B. Continue ASA (Increase dose to 325 mg until prohibitive bleeding risk)
C. Check baseline IIb/IIIa and P2Y12 via the Verify Now device prior to initiating tirofiban
D. Start Tirofiban 2 days prior to the procedure (Patient MUST be on a monitored bed)
- Load Tirofiban ONLY if P2Y12 (Verify Now Assay) platelet inhibition is < 20% OTHERWISE
initiate only the continuous infusion dose
- Creatinine clearance > 30mL/min: Tirofiban 0.4 mcg/kg/min for 30 minutes, followed by
continuous infusion at 0.1 mcg/kg/min
- Creatinine clearance < 30mL/min: Tirofiban 0.2 mcg/kg/min for 30 minutes, followed by
continuous infusion of 0.05 mcg/kg/min
E. Check steady state IIb/IIIa inhibitor verify now assay (>8 hour after initiation)
F. Hold Tirofiban 12 hours prior to procedure
G. Check IIb/IIIa inhibitor verify now assay (10-12 hours after Tirofiban is discontinued)
H. CBC pre and post op
I. Reload clopidogrel> 24 hours post op (300 mg X 1 then 75 mg daily) unless prohibitive
bleeding risk
J. Reduce ASA to pre-procedure dose. Restart ASA, 24 hours port-op if it was D/C prior to
procedure
K. Check P2Y12 via the Verify Now device post-loading dose of clopidogrel (test cannot be
performed w/in 48 hours of the D/C of IIb/IIIa inhibitor (tirofiban)
Inclusion Criteria:
- Patients' with BMS/DES on plavix prior to surgery who are in need of an elective
procedures
Exclusion Criteria:
- Patients' with BMS/DES on NOT plavix prior to surgery who are in need of an elective
procedures
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