This document reports the mid-term results of the TORPEDO trial, which compared percutaneous endovenous intervention (PEVI) plus anticoagulation to anticoagulation alone for treating acute proximal deep vein thrombosis (DVT). 183 patients were randomly assigned to PEVI plus anticoagulation (n=91) or anticoagulation alone (n=92). At 30±5 month follow up, PEVI plus anticoagulation showed superior outcomes in reducing recurrent venous thromboembolic disease, post-thrombotic syndrome, hospital stay, leg edema, skin induration, duration of parenteral anticoagulants, and improved subjective perception. The study demonstrates PEV

1. Mohsen Sharifi,MD,FACC, Mahshid Mehdipour, Curt Bay, PhD, Gary Smith,MD, Jalaladdin Sharifi,MD for the "TORPEDO" investigators Arizona Cardiovascular Consultants & A.T. Still University, Mesa, AZ No Disclosures

2. TORPEDO TRIAL Thrombus Obliteration by Rapid Percutaneous Endovenous Intervention in Deep Venous Occlusion “TORPEDO” trial : Mid –Term results

3. Percutaneous Endovenous Intervention Reduces Recurrent Venous Thromboembolic Disease and Post-Thrombotic Syndrome in Acute Proximal Deep Venous Thrombosis:- Report of the “TORPEDO” trial at Mid-Term Follow-up.

4. Venous Thromboembolism (VTE) Consists of two clinical pictures: 1- Deep vein thrombosis (DVT) 2- Pulmonary embolism (PE) Intimately related to etiology, treatment and outcome 50% of proven DVT also have PE 70% of proven PE also have DVT

5. VTE Incidence: 1-2/1000 /year Up to 90% of PE originate in LE DVT,s < 2% of PE originate in UE DVT Most thrombi (80-90%) originate in the Soleal veins of the calf Majority of calf thrombi (80-70%) resolve spontaneously 20-30% of DVT,s propagate to Popliteal, femoral or iliac veins 10-20% of all DVT,s begin in proximal veins without prior calf involvement

6. Important Fact on Prox. DVT 21% of adequately anticoagulated patients develop PE Up to 50% Patients on anticoagulation develop PTS at 3-5 years Estimated cost of VTE 1.5 Billion (Plate G, Ohlin P, Eklof B. Pulmonary embolism in the acute ileofemoral venous thrombosis. Br J Surg 1985;72:912–915.)

7. No Randomized trial in Reduction of DVT Sequelae with Percutaneous Endovenous Intervention (PEVI)

8. Patients with acute symptomatic proximal DVT First Randomized Prospective Trial

9. Patients with acute symptomatic proximal DVT

11. 183 Randomized Control No=92 PEVI No=91 8 pts PEVI 88 Control 81 F/U at 30±5months

12. Primary endpoints Development of: Post- thrombotic Syndrome Recurrent Venous Thromboembolic Disease

13. Secondary Endpoints Skin Induration Leg Edema Hospital Stay Subjective Perception of Improvement Bleeding

15. Anticoagulation-Alone Group= Control Heparin 80U/kg bolus; 18U/kg/hr APTT 1.5-2 X Normal Enoxaperin 1mg/kg SQ BID Simultaneous Coumadin 5 day parenteral regimen + 24 hr overlap with warfarin Compression Stockings 20-30 mmHg

16. PEVI Same as Control Within 24 hours to Angio Suite All received retrievable IVC filters ASA 81-325 given PEVI according to venography findings Anticoagulation not withheld

17. US Guided Micropuncture Needle Popliteal Approach 5 Day Parenteral Therapy Not Required Ambulate in 1 Hour

18. PEVI MODALITIES

21. Spectrum of Venoocclusive Disease Distorted venous Architecture Acute Thrombus + Preserved Venous Anatomy

25. PTS= presence of at least 2 new symptoms: leg burning. pain, aches, discomfort, restlessness, tingling plus the following signs *= more than 1000 milliseconds of reflux on venous spectral Doppler in a segment of the deep venous system without previous reflux or more than 500 ms increase in the extent of reflux if previously present. + PTS= post-thrombotic syndrom= Finding must be present for diagnosis; - = finding must be absent for diagnosis; ± = presence or absence of finding would not affect diagnosis

30. BREAKDOWN PRIMARY ENDPOINTS

31. TOTAL OUTCOME

32. Role of ASA on PTS RR= 0.37, 95% CI: 0.19- 0.74, p=0.006.

33. Secondary Endpoints

36. ConclusionsPEVI + anticoagulation is superior to anticoagulation alone in: Reduction of recurrent VTE. Reduction of PTS Reduction of hospital stay Reduction of leg edema Reduction of skin induration Reduction in duration of parenteral anticoagulants Subjective perception of improvement