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. 2019 Jul 12;85(6):E1037–E1042. doi: 10.1093/neuros/nyz226

The Safety and Efficacy of Continuous Tirofiban as a Monoantiplatelet Therapy in the Management of Ruptured Aneurysms Treated Using Stent-Assisted Coiling or Flow Diversion and Requiring Ventricular Drainage

Kaustubh Limaye 1, Mario Zanaty 2, Joseph Hudson 2, Daichi Nakagawa 4, Sami Al Kasab 1, Carlos Alvarez 2, Sudeepta Dandapat 1, David K Kung 5, Santiago Ortega-Gutierrez 1,2,3, Pascal Jabbour 6, Edgar A Samaniego 1,2,3, David Hasan 2,✉
PMCID: PMC8133353  PMID: 31298301

Abstract

BACKGROUND

Hemorrhagic complications are a major concern for aneurysmal subarachnoid hemorrhage patients treated with stenting or stent-assisted coiling and undergoing additional procedures such as shunting, ventriculostomy placement, and craniotomies/craniectomies.

OBJECTIVE

To assess the safety and efficacy of using a continuous infusion of tirofiban as a monoantiplatelet therapy in the management of ruptured aneurysms in the setting of either stent-assisted coiling (SAC) or flow diversion devices (FDD) in patients requiring either an external ventricular drain (EVD) or ventriculoperitoneal shunt (VPS).

METHODS

Aneurysmal subarachnoid hemorrhage (aSAH) patients between July 2017 and September 2018 who were treated with SAC or FDD were started on a continuous tirofiban infusion protocol (0.10 μg/kg/min) with no preceding loading dose as a monoantiplatelet therapy. Safety analysis was performed retrospectively to assess the complication rate, hemorrhagic rate, and rate of ischemic events. There were no hemorrhages related to the VPS surgery.

RESULTS

Nineteen subjects were included in the series. The patients received a total of 25 procedures that included 19 EVDs and 6 VPSs. Two patients (8.3%) developed small asymptomatic track hemorrhages after EVD placement. One patient developed a large retroperitoneal hemorrhage due to renal artery branch injury during procedure, and another patient developed an idiosyncratic transient thrombocytopenia which resolved after stopping the medication. One patient (4%) developed a transient ischemic attack, which resolved after a bolus of tirofiban.

CONCLUSION

Our study suggests that long-term use of intravenous tirofiban monotherapy in aSAH subjects for endovascular SAC or FDD is safe in the perioperative setting.

Keywords: Aneurysm, Subarachnoid hemorrhage, Stent-assisted coiling, Flow diversion, Tirofiban, Antiplatelet therapy

Graphical Abstract

Graphical Abstract.

Graphical Abstract

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ABBREVIATIONS

aSAH

aneurysmal subarachnoid hemorrhage

CT

computed tomography

DAPT

dual antiplatelet therapy

EVD

external ventricular drain

FDD

flow diversion device

HHG

Hunt and Hess Grade

ISAT

International Subarachnoid Aneurysm Trial

IV

intravenous

PC

platelet count

SAC

stent-assisted coiling

VPS

ventriculoperitoneal shunt

In 2005, the results of the International Subarachnoid Aneurysm Trial (ISAT) revealed that aneurysmal subarachnoid hemorrhage (aSAH) subjects treated with endovascular modalities were more likely to survive independently at 1 yr, with the early survival benefit of their treatment lasting for more than 7 yr.1 The results of the trial initiated a prominent change in the practice patterns associated with ruptured aneurysm treatment.2 With rapid innovation and endovascular device development, treatment of challenging blister/pseudoaneurysms with flow diverting devices (FDD) has become possible for neuroendovascular surgeons.3,4 However, new challenges have emerged during the perioperative management while treating subjects with stent-assisted coiling (SAC) and/or FDD during the acute phase of aSAH. Up to 45% patients require placement of an external ventricular drain (EVD) or ventriculoperitoneal shunt (VPS) while receiving dual antiplatelet therapy (DAPT) to prevent in stent thrombosis, thus placing patients at risk for catheter associated intracranial hemorrhage.5,6

Prior work has suggested a low risk of symptomatic hemorrhage in aSAH patients with the use of short-term intravenous (IV) tirofiban infusion (2-4 h postprocedure) and DAPT for stent-assisted coiling.7-9 Tirofiban is an appealing alternative for platelet inhibition given its pharmacodynamics characteristics, such as short onset of action and short half-life.

In this report, we detail our single-center experience utilizing a new protocol for anticoagulation in the acute setting of aneurysmal SAH. We describe using a long-term IV tirofiban infusion as the sole antiplatelet agent in aSAH treated with SAC or FDD in patients requiring placement of an EVD/VPS.

METHODS

A retrospective review of our prospectively maintained SAH database from July 2017 to September 2018 was performed. The study was approved by the Institutional Review Board before data collection. Separate individual patient consent was not required and hence not sought. Patients were included if they met the following criteria: (1) they presented with aSAH, (2) they were treated with FDD and/or SAC, (3) they required either EVD alone or EVD and VPS placement during hospitalization, and (4) IV infusion of tirofiban (Aggrastat, Medicure, Manitoba, Canada; West Point, Pennsylvania) was used as a single monoantiplatelet therapy until the EVD was removed and/or VPS was placed. Nineteen patients met these criteria. These patients had a total of 25 procedures that included 19 EVDs and 6 VPSs.

Protocol

Pharmacology of Tirofiban

Tirofiban is a tyrosine derivative which antagonizes glycoprotein (GPIIb/IIIa) receptors. It is administered as an IV infusion. It has a short half-life (2 h), which makes it appealing in settings where hemorrhagic complications are anticipated. Greater than 90% platelet aggregation inhibition is attained by the end of a 30-min infusion. This rapid onset of action makes tirofiban appropriate when apid anticoagulation is needed, such as an anticipated need for using a stent. Thus, after carefully examining the angiogram, tirofiban makes it possible to treat the patient with SAC or FDD without the need of previous antiplatelet therapy or heparinization. Around 64% of tirofiban binds to plasma proteins, and the volume of distribution ranges from 21 to 87 L. In humans, it undergoes negligible metabolism and is excreted renally with clearance ranging from 4.8 to 25.8 L/h. It is 1 of the 3 GPIIb/IIIa antagonists approved by the FDA in the United States.10

Protocol Rationale

We follow a standard institutional protocol for all aSAH patients. An EVD is indicated if patients have hydrocephalus on admission (transependymal flow, rounded third ventricle, dilated ventricles, or visible temporal horns), altered mental status, or drowsiness. Hunt and Hess Grade (HHG) > 3 or Glascow Coma Scale < 8 are definite indication. The EVD is placed in the operating room to ensure sterile condition and meticulous hemostasis. The perforator is used to place a burr hole at Kocher's point, and the Ghajar guide is used to increase the likelihood of a single pass. The EVD is usually placed in the Neuro-IR hybrid room. The aneurysm is then preferably secured within the first 24 h, especially if the decision was made to treat the aneurysm by endovascular means. The angiogram is then performed without heparinization. If SAC or FDD were found to be the method of choice, then patients are started on an IV tirofiban maintenance dose immediately prior to SAC and FDD deployment intraoperatively (Figure 1). The tirofiban infusion protocol consists of a 0.10 μg/kg/min infusion without a loading dose bolus.7 No subjects received acetylsalicylic acid or clopidogrel before the start of tirofiban infusion. Patients remained on the IV tirofiban maintenance dose until EVD was removed or a VPS was placed. IV tirofiban was held for 4 h prior to EVD removal/VPS placement or other surgical procedure and resumed 2 h later.

FIGURE 1.

FIGURE 1.

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Summary of patients demographics and clinical charecteristics.

The resumption of infusion is followed immediately by a loading dose of DAPT consisting of 325 mg of aspirin and 600 mg of clopidogrel. Two hours after DAPT, IV tirofiban is discontinued, as there is evidence to suggest that 600 mg Plavix load, at 2 h, would produce platelet inhibition (the traditionally used 300 mg requires 6 h). The 4-h period of holding tirofiban preop is based on the half-life of Aggrastat (2 h) and that platelet aggregation returns to normal in 4 h following discontinuation of the infusion, in 90% of patients.11

Initially, we resumed the Aggrastat 4-h postsurgical procedure (VPS) or EVD removal, but to be modified to 2 h because 1 patient developed a transient ischemic attack that resolve with Aggrastat resumption (3-h postop). Thus, only 3 patients were treated with the previous protocol of waiting 4-h postop instead of 2.

Noncontrasted head-computed tomography (CT) scans were obtained at 12 to 24 h post-EVD placement and 12 to 24 h post-EVD removal and/or VPS placement. For patients who required an EVD placement after deployment of stents, IV tirofiban was held for 4 h, followed by resumption 2 h postoperatively.

Exclusion Criteria

Tirofiban is contraindicated in patients with platelet count (PC) of count < 150 000 per cubic millimeter and creatinine > 2.5 mg/dL. Prior anticoagulation and use of heparin are not required for SAC or FDD if tirofiban infusion is started. Tirofiban was not started on any patient with the above contraindications.

Monitoring and Safety

Patients were monitored on a daily basis for evidence of new symptomatic hemorrhages. Therapy with tirofiban is associated with increases in bleeding rates, particularly at the site of arterial access for femoral sheath placement. Care should be taken when attempting vascular access that only the anterior wall of the femoral artery is punctured. Furthermore, heparin is not used during the angiogram procedure if (1) patient has an EVD in place, (2) any surgery is anticipated within the next 24 h (craniotomy, EVD, etc.), or (3) antiplatelet therapy (DAPT or tirofiban) is anticipated. The following laboratory monitoring is mandatory: PC, hemoglobin, and hematocrit should be monitored prior to treatment, within 6 h following the loading infusion, and at least daily thereafter during therapy.

A noncontrast CT was obtained after the endovascular procedure and after EVD removal or VP shunt placement. EVD/VP shunt placement hemorrhages were reviewed by an independent adjudicator and graded based on our recently published scale.12 Grade I is ≤1 cc hemorrhage along the EVD track and grade II is >1 cc hemorrhage at any location along the EVD track or in the ventricle, but contiguous to the catheter tip. This new classification reflects our observation that low volume (≤1 cc) hemorrhages are often seen along the EVD/VP shunt tracks of patients on DAPT, but are rarely symptomatic. In contrast, larger hemorrhages (>1 cc) may become symptomatic.

RESULTS

A total of 19 patients were included after criteria were met (2 male and 17 females). The average age was 54.9 yr (range 39-70 yr) (Table). Subjects were maintained on an IV tirofiban infusion for an average of 9.4 d (4-18 d). A total of 25 procedures were performed on this cohort of subjects, including 19 EVDs (1 subject requiring bilateral EVDs) and 6 VPSs. HHG ranged from 1 to 5 (avg, 2.5) (Table). Two patients had a small asymptomatic track hemorrhages (<5 mm) along the EVD catheter (Figures 2 and 3). The procedure-related asymptomatic hemorrhage rate was thus 8% (2/25). One patient developed a large retroperitoneal hemorrhage due a renal artery branch injury during the procedure, where the guide wire was advanced inadvertently into the distal branch of the right renal artery resulting in a penetrating injury. This was repaired by embolization and sacrifice of this branch without affecting kidney function. One patient (4%) developed severe transient thrombocytopenia with complete quantitative recovery of platelets after tirofiban infusion was held. The platelet count trended down over 4 d until it became < 20 000. Immediately, the tirofiban was stopped, and the platelet count corrected with 24 h. One patient developed transient ischemic attack during the interval of conversion to oral dual antiplatelets. This event resolved after tirofiban bolus; no patient developed a new focal lasting deficit. One patient did not require EVD or VPS (this subject had borderline hydrocephalus on presentation, and there was anticipation that he may require placement of EVD after the procedure). At our institution, we prefer an ultra-early treatment of the aneurysm (within 24 h). In all but one patient, the EVD placement preceded endovascular treatment and the aneurysm was treated endovascularly within the next few hours. Thus, the average time to start IV tirofiban infusion was less than 24 h. In one patient who required EVD placement after being started on tirofiban infusion required a 2-h off time, with safe reinitiation, per protocol. There were no related VPS complications.

TABLE.

Series of Patients Presenting With aSAH Who Had Endovascular SAC/FDD Requiring EVD +/– VPS Treated With Continuous IV Tirofiban Infusion

No Age (years) Gender Aneurysm location Hunt and Hess Tirofiban infusion duration (days) EVD (day) VPS (day) Periprocedural hemorrhage
1 54 Female Right Pcomm 1 3 Y (1) N N
2 53 Female Left PICA 1 4 Y (1) Y (9) N
3 42 Female Right vertebral 5 11 Y (1) Y (12) N
4 50 Female Right supraclinoid ICA 3 11 Y (1) N N
5 52 Female Right PICA 2 8 Y (1) Y (8) Y (EVD)
6 57 Female Basilar artery 3 12 Y (1) N N
7 42 Male Right veretebral 3 5 Y (1) Y (15) N
8 39 Female Right Pcomm and left paraopthalmic 2 9 Y (1) N N
9 42 Female Right Pcomm 2 10 Y (1) Y (6) N
10 70 Female Acomm 3 10 Y (1) N N
11 66 Female Left PICA 5 18 Y (1) N N
12 76 Female Right PCA 2 14 Y (1) N Y (EVD B/L)
13 69 Female Acomm and right supraclinoid 1 10 Y (3) N N
14 66 Female Left ACA A1 blister aneurysm 1 10 Y (1) N N
15 61 Female Left Pcomm 2 11 Y (1) N N
16 52 Female Left ACA A1/2 3 14 Y (1) Y (15) N
17 68 Female Basilar artery 5 12 Y (1) N N
18 43 Female Right supraclinoid 2 6 N N N
19 42 Male Acomm 3 12 Y (1) N N
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ACA, anetrior cerebral artery; Acomm, anterior communicating; B/L, bilateral; N, no; NA, not applicable; PCA, posterior cerebral artery; Pcomm, posterior communicating; PICA, posterior inferior cerebellar stroke; Y, yes.

FIGURE 2.

FIGURE 2.

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Right frontal EVD with small grade I track hemorrhage (<1 cc). Arrow indicates track hemorrhage around EVD.

FIGURE 3.

FIGURE 3.

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Bilateral frontal EVD. Arrow shows asymptomatic grade 2 track hemorrhage (>1 cc).

DISCUSSION

Key Results

In this study, we report, for the first time, the safety of long-term continuous IV tirofiban infusion as a monoantiplatelet therapy in patients with ruptured intracranial aneurysm requiring EVD/VPS and treated with either SAC or FDD. Our study suggests that tirofiban has a relatively good safety profile when used in aSAH subjects. A short half-life and DDAVP (0.3 mcg/kg IV over 15 min) as a reversal agent make it an attractive alternative to other GPIIb/IIIa inhibitors.

Since publication of the ISAT, the management paradigm for ruptured intracranial aneurysms has shifted toward treatment with endovascular modalities. The addition of SAC and FDD has enabled surgeons to treat challenging aneurysm morphologies. A major drawback of using these devices in the treatment of aSAH subjects is the need for the use of DAPT in the setting of EVD and/or VPS placement. A few centers have used an IV eptifibatide (GPIIb/IIIa inhibitor) drip and observed a reduction in the rate of thromboembolic events, but the risk of intracranial hemorrhage was 6.3% in ruptured aneurysms treated endovascularly, with an accompanying mortality rate of 4.7%.13 A “no bolus” prophylactic tirofiban IV infusion has been reported to be safe and effective to reduce the rate thromboembolic events in addition to reducing the risk of hemorrhage to 1.9%, when short-term tirofiban (2-4 h) was administered simultaneously with DAPT.7

Many surgeons are cautious with the use of antiplatelet therapy in patients with aSAH because of fear of cerebral hemorrhage, and even more so in patients requiring EVD or VPS placement. Our group has recently reviewed asymptomatic and symptomatic hemorrhages associated with EVD and VPS placement in aSAH in subjects who are on DAPT. In subjects who required VPS, DAPT was associated with increased odds of catheter track associated hemorrhage.14 Likewise, subjects who had had EVD placement in the setting of DAPT had a higher risk of catheter track associated hemorrhage.15 Our group reported 8 total cases (8/80; 10%) of hemorrhagic complication after VPS, 7 out of which occurred in patients on DAPT, whereas 1 occurred in a patient who was not on any antiplatelet therapy. The rate of hemorrhage after VPS in the DAPT cohort was 21.87% (7/32) vs 2.01% (1/48). After multivariate analysis, only DAPT was significantly associated with hemorrhage (odds ratio 31.23, 95% confidence interval 2.98-327.32; P = .0001). One patient (3%) on DAPT who experienced hemorrhage required shunt revision for hemorrhage-associated proximal catheter blockage, whereas the remaining 7 hemorrhages were asymptomatic.16 In a large meta-analysis of nearly 1000 patients, Cagnazzo et al reaffirmed our results, suggesting a higher rate of EVD-associated radiographic hemorrhages in the DAPT group (125/516 vs 57/647, P < .0001).16 In another recent study, Paisan et al reported new postoperative intraventricular hemorrhage in 1/5 (20%) patients with aSAH treated with SAC.17

In our series, one patient developed transient thrombocytopenia (platelets < 20 000) with recovery to preprocedure platelet levels after stopping tirofiban. Drug-induced immune thrombocytopenia has been described with tirofiban infusion and usually recovers with stopping the infusion and treatment with platelet transfusions, glucocorticoids, or IV immunoglobulin.18,19

One patient (5.2%) developed transient ischemic attack that was treated with an additional IV bolus of tirofiban (0.4 μg/kg/min for 30 min). This was the only thromboembolic phenomenon encountered during the study protocol. Contemporary literature on aneurysm treatment with FDD or SAC estimates thromboembolic phenomenon occurs in 5.6 to 27% of endovascularly treated aneurysms.20,21 Thus, tirofiban infusion protocol appears to reduce the risk of thromboembolism without increasing the risk of hemorrhage in aSAH patients treated with FDD or SAC requiring EVD or VPS.

None of the patients in our series required additional procedures like tracheostomy or percutaneous endoscopic gastrostomy tube, and hence, we would not be able to predict the risk of hemorrhage in these procedures. However, if needed, our protocol required the tirofiban infusion be held for 4 h before the procedure and to be started after 2 h of procedure.

Limitations

Our study has some limitations such as the retrospective design, small sample size, and lack of randomization. All the endovascular procedures were done with the same exact protocol for tirofiban infusion. The choice of endovascular approach was left to the treating endovascular surgeons with different training backgrounds, which lends this study a considerable strength and generalizability in aSAH management. To address the limitations above, a prospective phase 2 study is needed.

Interpretation

This study is, to the best of our knowledge, the first report that assesses the safety of long-term use of tirofiban infusion as the sole antiplatelet agent in patients with aSAH who required SAC or FDD. Tirofiban should be considered a viable alternative antiplatelet therapy in aSAH subjects treated with SAC or FFD during the interval placement of EVDs.

Generalizability

This study provides a standardized protocol for monoantiplatelet therapy that neuroendovascular surgeons with different training backgrounds could follow when managing patients with aSAH treated with SAC or FDD, making this protocol widely generalizable.

CONCLUSION

Our study suggests that long-term use of IV tirofiban as a monoantiplatelet therapy in aSAH patients for endovascular SAC or FDD is safe in the perioperative setting. We recommend a 0.10 μg/kg/min infusion without any loading dose or concurrent use of other antiplatelet therapy in this cohort until the EVD is removed or the VPS is placed.

Disclosures

The authors have no personal, financial, or institutional interest in any of the drugs, materials, or devices described in this article.

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