The Source for Neurovascular News and Education

August 23, 2019

The study might provide impetus for a randomized clinical trial in the United States, its investigators hope.

 

 

The addition of IV alteplase, also known as tPA, to endovascular therapy for the treatment of large-vessel occlusion (LVO) stroke contributes to the cost of treatment and the risk of hemorrhage without providing any benefits in the acute setting, according to a single-center analysis published online May 18, 2019, ahead of print in the Journal of NeuroInterventional Surgery.

 

“For patients who were initially in the SWIFT PRIME study, . . . we noticed there was an increased rate of hemorrhage in the tPA arm compared with the tPA mechanical thrombectomy arm,” lead author Ameer E. Hassan, MD (University of Texas Rio Grande Valley, Harlingen, TX), told Neurovascular Exchange. “That was the first thing that piqued our interest.” Another factor, he said, was the rising price of alteplase over the years.

 

“Studies are being done around the world and now in the United States on tenecteplase, the next- generation IV thrombolytic,” Hassan continued. “Many of us want to move toward tenecteplase. For us, it would significantly improve transfer times because patient could just get a tenecteplase bolus and then be transferred to our hospital and get mechanical thrombectomy [rather than wait] 60 minutes for the [alteplase] drip to finish.”

 

For all these reasons, Hassan et al decided to evaluate the actual benefits of giving IV tPA to patients with LVO strokes undergoing endovascular therapy at their institution. They retrospectively grouped 254 patients from a prospectively collected and maintained high-volume single-center endovascular database into those who underwent endovascular therapy alone (n = 158) or combined with IV tPA pretreatment (n = 96). The two groups were compared with respect to hospital encounter charges (obtained via the hospital’s charge capture process), final patient bills (ie, negotiated final bills as per insurance/Medicare rates), demographic information, existing comorbidities, admission and discharge NIHSS score, and functional independence data (ie, mRS 0-2).

 

Median NIHSS score at admission was significantly higher among patients who received IV tPA than those who did not (19 vs 16; P < 0.006).

 

After adjusting for NIHSS admission score, final bills and hospital encounter charges were greater among patients receiving endovascular therapy plus IV tPA.

 

Costs of Endovascular Therapy With vs Without IV tPA

 

USD Difference (95% CI)

P Value

Patient Bills

+$3,861.64 ($658.84-$7,064.45)

0.02

Encounter Charges

+$158,071.29 ($134,641.50-$181,501.08)

< 0.001

 

“IV thrombolytic costs have gone up significantly over the last two decades since they were approved. That was the eye-opener for us,” said Hassan.

 

Among patients who received IV tPA, there were higher rates of hemorrhagic transformation (28.1% vs. 17.7%; P = 0.05) as well as mass effect (P = 0.04) and asymptomatic intracranial hemorrhage (P = 0.02). There were no significant differences with respect to clinical outcomes between the two treatment groups, with similar observed rates of recanalization, median discharge NIHSS, functional independence at 90 days, and average length of hospital stay.

 

US Clinical Trial Data Needed

 

According to Hassan and colleagues, a randomized controlled trial is needed in the United States in patients with LVO stroke that would compare mechanical thrombectomy alone against tPA plus mechanical thrombectomy. While similar trials are being undertaken in other countries, including Canada and the Netherlands, “we can’t wait for all these studies to come out and then start designing a US study,” Hassan commented, adding that he hopes his study will provide additional impetus for such a trial.

 

Hassan emphasized that he is very pro-tPA, even in patients with an NIHSS score of 1 or 2. “I just think that, for large-vessel occlusion, we should be doing a randomized study before giving everyone a thrombolytic and adding significantly to the cost,” he concluded.

 


 

Source:

Hassan AE, Kotta H, Garza L, et al. Pre-thrombectomy intravenous thrombolytics are associated with increased hospital bills without improved outcomes compared with mechanical thrombectomy alone. J NeuroIntervent Surg. 2019;Epub ahead of print.

 

Disclosures:

 

Hassan reports consulting for Medtronic, Microvention, Penumbra, Stryker, Genentech, and GE Healthcare.