RETAVASE® (reteplase) is a recombinant plasminogen activator which catalyzes the cleavage of endogenous plasminogen to generate plasmin. Plasmin degrades the fibrin matrix of the thrombus, exerting its thrombolytic action.

Proven efficacy in acute STEMI1‑3

More patients achieved TIMI 2 or 3 flow at 90 minutes with RETAVASE® (reteplase) in the RAPID studies compared with alteplase1-3

Two clinical studies compared patency rates 90 minutes after treatment with RETAVASE or two different regimens of alteplase in patients with acute STEMI. Partial or complete flow (TIMI grades 2 or 3) and complete flow (TIMI grade 3) were reported.

Coronary artery patency: Angiographic results1

TIMI 2 or 3 TIMI 3 90 minute patency rates RAPID 2 RETAVASE (10 + 10 unit) n=157 83% 60% P value 0.03 0.01 Alteplase (100 mg over 1.5 hours) n=146 73% 45%
TIMI 2 or 3 TIMI 3 90 minute patency rates RAPID 1 RETAVASE (10 + 10 unit) n=142 85% 63% P value* 0.08 0.02 Alteplase (100 mg over 3 hours) n=145 77% 49%

*P value represents one of multiple dose comparisons.

  • The relationship between coronary artery patency and clinical efficacy has not been established1
  • Reocclusion rates for RETAVASE and alteplase were similar in both studies1-3

RAPID 2: Percentage of patients with total patency or complete reperfusion of infarct-related artery over time2

Complete reperfusion(TIMI grade 3) At hospital discharge5 to 14 days after therapy initiationn=128 Total patency(TIMI grades 2 and 3 combined) At 30 minutesn=55 At 60 minutesn=121 At 90 minutes†n=157 At 30 minutesn=55 At 60 minutesn=121 At 90 minutes†n=157 At hospital discharge5 to 14 days after therapy initiationn=128 RAPID 2 RETAVASE 10 + 10 unit 67.3% 81.8% 83.4% 89.1% 27.3% 51.2% 59.9% 75.0%

†Only the primary endpoint, the 90-minute assessment, was mandatory according to trial protocol.

RAPID 1: Percentage of patients with partial patency or complete reperfusion of infarct-related artery over time3

Complete reperfusion(TIMI grade 3) At hospital discharge5 to 14 days after therapy initiationn=123 Partial patency(TIMI grade 2) At 30 minutesn=48 At 60 minutesn=98 At 90 minutes†n=142 At 30 minutesn=48 At 60 minutesn=98 At 90 minutes†n=142 At hospital discharge5 to 14 days after therapy initiationn=123 RAPID 1 RETAVASE 10 + 10 unit 61.2% 77.6% 85.2% 95.1% 31.3% 51.0% 62.7% 87.8%

†Only the primary endpoint, the 90-minute assessment, was mandatory according to trial protocol.

Study design

Randomized, controlled, open-label study Europe and the US Protocol Patient population Study type Study location Purpose Primary endpoint RAPID 2 1,2 RAPID 1 1,3 RAPID studies 1-3 Compare coronary artery patency after treatment with RETAVASE vs alteplase Patency, defined as TIMI 2 or 3 flow of the infarct-related artery, 90 minutes after initiation of therapy Secondary endpoint Patency by TIMI flow grade at 30 and 60 minutes and 5 to 14 days after initiation of therapy • N=303 • Patients with STEMI • N=287‡ • Patients with STEMI • Within 12 hours of the onset of symptoms, patients were randomized to open-label administration of either: – RETAVASE 10 + 10 unit or – Alteplase 100 mg over 1.5 hours • Coronary angiogram interpretation was blinded • Within 6 hours of the onset of symptoms, patients were randomized to open-label administration of either: – 1 of 3 regimens of RETAVASE (doses of 10 + 10 unit, 15 unit, or 10 + 5 unit) or – Alteplase 100 mg over 3 hours • Coronary angiogram interpretation was blinded Key inclusioncriteria Key exclusion criteria Patients >18 years old with ≥30 minutes of typical chest pain that was not relieved by nitroglycerin and ST-segment elevation of ≥0.1 mV in two of three inferior or lateral leads or ≥0.2 mV in at least two contiguous precordial leads or left bundle-branch block and presenting within ≤ 12 hours from onset of ischemic chest pain to the planned administration of treatment Patients 18 to 75 years old with at least 30 minutes of typical chest pain not relieved by nitroglycerin and ST-segment elevation of of 0.1 mV in the the inferior or lateral leads or 0.2 mV in the precordial leads and presenting <6 hours after onset of chest pain Prior coronary artery bypass graft surgery, previous stroke or known intracranial structural abnormalities, previous percutaneous transluminal coronary angioplasty within 2 weeks, previous Q-wave myocardial infarction in the same anatomic region as the qualifying infarction, or severe hypertension (>180/110 mmHg) not rapidly responding to treatment, concomitant use of oral anticoagulation therapy ECG demonstrat- ing left bundle branch block, prior coronary bypass surgery, previous Q-wave myocardial infarction in the same anatomic region, previous percutaneous transluminal cor- onary angioplasty (PTCA) within 2 weeks, previous cerebral vascular accident, or severe hyperten - sion with a systolic blood pressure >180 or diastolic blood pressure >110 mmHg at presentation to hospital

‡Represents the number of patients in the 10 + 10 RETAVASE arm plus the alteplase arm. The total number of patients enrolled in RAPID 1 was 606.

See RETAVASE safety data

Learn how to dose and administer RETAVASE