The RECOVER IV randomized trial has been stopped early for ethical reasons. The trial’s data safety monitoring board (DSMB) recommended that the trial be stopped based on the recently released DanGer Shock trial, which showed that patients who experienced cardiogenic shock and were treated with the Impella CP microaxial flow pump had significantly higher survival at 6 months compared to those receiving standard care. The decision, first reported by TCTmd, turned heads among interventional cardiologists posting on X, formerly known as Twitter. Gregg W. Stone, MD, the study chair of RECOVER IV, announced on X that the trial’s DSMB “strongly recommended that the trial be discontinued because of lack of equipoise” based on the DanGer Shock trial findings. He added: “We are actively exploring other randomized investigations of Impella in AMI [acute myocardial infarction]-cardiogenic shock. Possibilities include examining best practices to reduce complications, selected multivessel intervention, early escalation to Impella 5.5, Impella in chronic HF [heart failure]-shock, and more.” Mirvat Alasnag, MD, wrote on X that she was “unsure why the DSMB finds” continuing RECOVER IV to be unethical. “DanGer Shock was designed well before @SCAI shock classification & we don’t know at which stage any MCS is futile ..s imply answering that would’ve been valuable .. escalation/de-escalation .. combination,” she said. William Suh, MD, said, “RECOVER IV would have never completed enrollment. All equipoise is gone in US. They had no choice but to stop.” RECOVER IV randomized patients experiencing cardiogenic shock to receive Impella support before percutaneous coronary intervention or to standard of care, including intra-aortic balloon pump (IABP) support if needed. Patients in the Impella arm were not allowed to be given IABP. Image Credit: Thipphaphone – stock.adobe.com