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Evevident
Original paper
1999JAMANeurology

PROACT II

Intra-arterial prourokinase for acute ischemic stroke. The PROACT II study

RCTAcute ischemic stroke

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Overview

Intra-arterial prourokinase improved outcomes in MCA stroke but increased symptomatic ICH.

Clinical takeaway

PROACT II is a historical bridge between IV thrombolysis and modern endovascular stroke therapy, showing the promise and bleeding risk of intra-arterial reperfusion.

Key result

Functional independence at 90 days was higher with intra-arterial prourokinase.

Practice impact

Helped establish endovascular reperfusion as biologically plausible before modern thrombectomy trials.

Evidence

Study design

Randomized controlled trial.

Enrollment

180

Follow-up

90 days.

Geography

United States, Canada

Clinical question

Does intra-arterial recombinant prourokinase improve outcomes in acute MCA occlusion treated within 6 hours?

Population

  • Patients with acute ischemic stroke due to middle cerebral artery occlusion within 6 hours of symptom onset.

Intervention

Intra-arterial recombinant prourokinase plus heparin.

Comparator

Heparin alone.

Primary outcome

Modified Rankin Scale 0-2 at 90 days.

Intra-arterial prourokinase increased functional independence after acute MCA occlusion but increased symptomatic hemorrhage.

Absolute rates / p=0.04

Key results

  • Modified Rankin Scale 0-2 at 90 days was more common with prourokinase.
  • Recanalization was more frequent with prourokinase.
  • Symptomatic intracranial hemorrhage was higher with prourokinase.

Harms

  • Symptomatic intracranial hemorrhage was increased.
  • Intra-arterial thrombolysis has largely been superseded by mechanical thrombectomy for eligible large-vessel occlusion.

Clinical Use

When to cite

  • When teaching the history of endovascular acute ischemic stroke therapy.

Practice impact

  • Historical landmark for intra-arterial reperfusion and the evolution toward thrombectomy.

Applicability

  • Primarily historical; modern practice relies on IV thrombolysis and mechanical thrombectomy selection.

Limitations

  • Small trial using an agent and approach not central to current practice.
  • Superseded by stent-retriever thrombectomy trials such as MR CLEAN.

Common misinterpretations

  • Do not use PROACT II to choose intra-arterial lytics over modern thrombectomy when thrombectomy is available.

Related evidence

NINDS tPA - ContextMR CLEAN - Superseded By

Citation

Furlan A, Higashida R, Wechsler L, et al. Intra-arterial prourokinase for acute ischemic stroke. The PROACT II study: a randomized controlled trial. Prolyse in Acute Cerebral Thromboembolism. JAMA. 1999;282(21):2003-2011. doi:10.1001/jama.282.21.2003