Editor's Note: Dr. Zeller's slides can be downloaded as a PDF (click on PDF icon below title). AMP 2020 took place August 13-15, 2020.
On the first day of AMP 2020 Virtual, Dr. Thomas Zeller, MD, from the University Heart Center Freiburg, Bad Krozingen, Germany, shared with attendees an update on the IN.PACT BTK study, a safety and efficacy study of the paclitaxel drug-eluting balloon IN.PACT 014 versus conventional percutaneous transluminal angioplasty (PTA) for the treatment of patients with chronic total occlusions in the infrapopliteal arteries.
(Spoiler alert: the trial is done, but the data has not yet been presented.)
By way of his update, Dr. Zeller reviewed the findings of the IN.PACT DEEP trial, which presented 5-year data at last year’s AMP meeting and published in JACC: Cardiovascular Interventions in February 2020.
IN.PACT DEEP was a prospective, multicenter, randomized controlled trial that enrolled 358 subjects with CLI and randomly assigned them 2:1 to DCB angioplasty or PTA.
Freedom from clinically-driven target lesion revascularization (TLR) through 5 years was 70.9% and 76.0% for DCB angioplasty and PTA, respectively (log-rank p=0.406). Kaplan-Meier all-=cause mortality was similar to 5 years, at 60.5% with DCB and 55.1% for PTA (log-rank p-value = 0.727).
The incidence of the safety composite endpoint was 59.8% and 57.5%, respectively (log-rank p=0.309), with major amputation seen in 15.4% and 10.6%, respectively (log-rank p=0.108).
“There was no significant difference in mortality at any time point, so we can conclude that paclitaxel exposure below the knee in this trial did not expose those patients to an increase mortality risk” reported Dr. Zeller.
IN.PACT DEEP is the only trial with 5-year data available for the use of DCB below the knee, said Zeller. “Further studies with next generation devices are needed, and this is exactly what is ongoing,” he continued.
IN.PACT BTK is a prospective, multicenter, randomized, feasibility study being conducted in Italy. Fifty patients with CLI (Rutherford class 4 and 5) have been enrolled, and randomized 1:1 to either the IN.PACT 014 DCB or conventional PTA.
“There is no form of hypothesis tests specified for this feasibility study,” said Zeller, and only descriptive statistics will be reported. The effectiveness endpoint is late lumen loss 9 months after the index procedure. The safety endpoint is a composite of 30-day freedom from device- or procedure-related mortality and nine-month freedom from major target limb amputation and freedom from clinically driven TLR.
Of note, the device use in this study is different than the one used in IN.PACT DEEP, which used the Amphirion DCB.
Nine-month follow-up has been completed and the data will be published and presented soon.