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‘Most Promising’ Cardioprotective Strategy Ends Up a Bust

PARIS — Remote ischemic preconditioning failed as a cardioprotective strategy for patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation MI (STEMI), according to the CONDI-2/ERIC-PPCI trial presented here.

The rate of 12-month cardiac death or hospitalization for heart failure was similar between groups randomized to PCI with or without preconditioning (9.4% vs 8.6%, HR 1.10, 95% CI 0.91-1.32), reported investigator Hans Erik Bøtker, MD, PhD, of Aarhus University Hospital in Denmark. In total, there were 5,401 patients randomized in the multicenter study.

“Our trial provides definitive evidence that remote ischemic conditioning offers no benefit on clinical outcome in STEMI patients treated by contemporary optimal [primary] PCI,” he told the audience at the European Society of Cardiology (ESC) congress.

Thus, preconditioning has never been and will not be part of clinical practice, commented Patrick Meybohm, MD, of University Hospital Frankfurt in Germany, who said he agreed with Bøtker’s conclusions.

Remote ischemic preconditioning was performed in the trial using an automatic device set to inflate and deflate an arm cuff over four 5-minute cycles. The idea being that this increases myocardial salvage by activating the body’s inherent cardioprotective system against subsequent ischemia-reperfusion injury, said Bøtker.

“It’s unfortunate because until now, remote ischemic conditioning had been the most promising cardioprotective strategy for improving clinical outcomes following STEMI,” he said during a press briefing. Exenatide (Byetta) and cyclosporine A had similarly succeeded in proof-of-concept studies before succumbing to clinical investigation, the former just recently in the COMBAT-MI trial also presented at ESC.

Hans Erik Bøtker, MD, PhD, presenting the data during a press briefing at ESC

Novel cardioprotective targets and innovative approaches, including combination multi-target therapy, are needed for cardioprotection of these patients, he said.

Researchers have tried various ways to salvage heart cells by targeting cell death pathways and activation of endogenous cardioprotective signaling pathways. Another option is to target the inflammation that contributes to post-MI injury.

If nothing works, it may be that STEMI patients “fare so well nowadays” after PCI that the magnitude of benefit associated with cardioprotection, if such a benefit exists, is too small to translate into clinical benefit, Bøtker suggested.

Preconditioning and control groups shared similar baseline and procedural characteristics in the trial.

Participants were just over 63 years old on average and approximately 23% were women. The cohort spent nearly 3 hours between symptom onset and balloon time.

The neutral results of CONDI-2/ERIC-PPCI were maintained across pre-specified subgroup analyses that included age, diabetes status, TIMI flow, and time to ballooning. Findings were robust across participating countries and hospitals, too.

“It is what it is,” said disappointed session discussant Bernard Gersh, MBChB, DPhil, of the Mayo Clinic in Rochester, Minnesota.

But even though there is no role for routine remote ischemic preconditioning in the management of most STEMI patients undergoing primary PCI, Gersh said he still held out hope for a subgroup out there that might benefit — perhaps patients with cardiogenic shock and no cardiac arrest, he suggested.

Other groups are testing remote ischemic preconditioning as a neuroprotective strategy in carotid endarterectomy and other settings.

Trial funding came from the British Heart Foundation, University College London, Danish Innovation Foundation, Novo Nordisk Foundation, and TrygFonden.

Bøtker holds shares in CellAegis.

2019-02-09T00:00:00-0500

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Source: MedicalNewsToday.com