Twelve-Month Outcomes Presented From Mercator MedSystems’ TANGO Trial
November 6, 2019—VIVA Physicians announced the presentation of initial 12-month outcomes of the TANGO trial , a phase 2, dose-escalation, double-blinded trial comparing the delivery of temsirolimus versus saline in patients with severe claudication or critical limb ischemia, with the purpose of limiting neointimal hyperplastic tissue growth into the artery after endovascular below-the-knee (BTK) revascularization procedures.
Data were presented by Ehrin Armstrong, MD, in a late-breaking clinical trial session at VIVA 2019, the Vascular InterVentional Advances meeting held November 4–7 in Las Vegas, Nevada. Dr. Armstrong, a principal investigator of the trial, is with the Denver Veterans Administration Hospital in Denver, Colorado.
TANGO is the first United States trial to investigate a sirolimus analog to improve the durability of peripheral revascularization procedures, advised VIVA Physicians.
In the trial, Mercator MedSystems’ Bullfrog microinfusion device was used to deliver either low-dose temisirolimus treatment (0.1 mg/mL; n = 20) or saline control (n = 20) into the perivascular tissue around lesions after revascularization. Patients were Rutherford class 3 to 5, with ≤ 30-cm-long BTK lesions.
TANGO’s primary safety endpoint of 30-day freedom from major adverse limb events or postoperative death was met, with no observed events. The primary efficacy endpoint was improvement in 6-month transverse view vessel area loss (TVAL), an angiographic measure that uses the opacified area of the lesion to approximate the neointimal value.
As outlined in the VIVA announcement, the trial’s outcomes of the temsirolimus group compared with the saline control group at 6 months are as follows:
- Excluding patients with unstented severe dissections in their target lesion, TVAL improved to 19% versus 38%
- Freedom from target lesion failure was observed in 58% (11/19) versus 42% (8/19), favoring temsirolimus by a relative 38%
- In patients with total occlusions at baseline, 78% (7/9) versus 25% (2/8) were free from reocclusion
Additionally, in temsirolimus patients who had wounds on enrollment or developed wounds on their target limb during the study, 71% (5/7) had full healing of wounds by 12 months, without the need for clinically driven target lesion revascularization (TLR). In the control group, only 44% (4/9) had wound healing at 12 months without previous clinically driven TLR. Dr. Armstrong noted that these results warrant a phase 3 trial, and that data from the high-dose cohort are forthcoming.