An Aarhus University investigator-initiated clinical trial—Condi-2/Eric-PPCI—represented high hopes for Cellaegis Devices. However, the data presented at the European Society of Cardiology reveals that the trial failed to meet its endpoints. The net takeaway is that ischaemic conditioning offers no real clinical outcome.

Background

Cellaegis Devices’AutoRIC” medical device was to benefit well from this Denmark-based, investigator-initiated clinical trial. In fact, it was hoped that sales would take off and private funding would be triggered from positive results. The opposite has happened.

The Study

The Condi-2/Eric-PPCI study is a randomized controlled clinical trial investigating whether remote ischemic conditioning (RIC) can reduce cardiac death and hospitalization for heart failure at 12 months in 5400 patients presenting with a ST-elevation myocardial infarction (STEMI) and treated by percutaneous coronary intervention (PPCI). Targeting over 5,000 participants, the study recently concluded. With dozens of sites, the principal investigators included Derek Hausenloy of the Hatter Cardiovascular Institute, University College London, and Hans Erik Botker, Department of Clinical Medicine, Aarhus University, Denmark.

What is Remote Ischaemic Conditioning?

As reported by the European Society of Cardiology (ESC), remote ischaemic conditioning is a technique whereby blood supply to a limb is repeatedly temporarily cut off, using a device like a blood pressure cuff. Cellaegis’ AutoRIC device automatically performs four cycles of five minutes’ occlusion followed by five minutes’ reperfusion. CE marked in 2012, it is the only such device on the market or in development.

It was purposed that this device if used just prior to stent or balloon was employed to reopen a blocked blood vessel in the heart to treat heart attack, could trigger innate mechanisms guarding against the more extreme ischaemia and reperfusion injuries from the initial heart attack and the opening of the blocked blood vessel.

The Results

The investigator-initiated trial has proven the theory incorrect. The trial, an amalgamation of what were originally two independent trials in a total of 5,401 patients, showed that 239 patients treated with Cellaegis’s device (9.4%) suffered cardiac death and hospitalization for heart failure at one year. Among the control group, who underwent a sham treatment with AutoRIC, the figure was 220 (8.6%), giving a p value of 0.32. It appeared that the treatment group came out numerically worse than the control group.

Professor Botker suggests that there appears to be no benefits for remote ischaemic conditioning.

Cellaegis Faces a Challenge

Their strategy was predicated on guideline changes. Their CEO reported that they had planned on a positive Condi-2/Eric-PPCI trial followed by the European Society of Cardiology recommendation for use of the AutoRIC in its guidelines with U.S. cardiology groups to follow suit. This trial spells trouble for Cellaegis’ sales in the territory where it is already approved—Europe and Canada. The company has sold about 700 AutoRIC’s. At $3,500 outright, many customers lease the machines. The failed study may lead to a termination of some of these leases.  Moreover, the company last raised capital in 2017 and was planning on raising more funds post successful results. Those plans have been disrupted.

Lead Research/Investigator

Hans Erik Botker, Department of Clinical Medicine, Aarhus University, Denmark

Derek Hausenloy of the Hatter Cardiovascular Institute, University College London

Call to Action: For more information on this failed study we recommend contacting the principal investigators—see their links.

Source: European Society of Cardiology

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