Patient enrollment was challenging
Even independent of the COVID-19 pandemic, enrolling patients proved to be difficult. The 35 patients enrolled represented about 10% of the 333 patients screened at the participating centers. Unwitnessed out-of-hospital cardiac arrest, cardiogenic shock from a cause other than MI, and recovery from cardiogenic shock after the PCI was performed were among reasons for the high rate of exclusions.
The difficulty of identifying and engaging appropriate candidates for VA-ECMO, along with a substantial crossover rate, should be among lessons for investigators planning the next trial, said Dr. Sabate, who pointed out that 5 of the 17 patients assigned to VA-ECMO were never treated due to complications or patient refusal.
Dr. Sabate said.
Davide Capodanno, MD, PhD, a professor of cardiology and interventional cardiologist at the University of Catania (Italy), agreed.
“It was a good decision to publish these results,” he said. Noting that there were challenges in conducting the trial unrelated to COVID-19, Dr. Capodanno acknowledged the promise of mechanical ventilatory support for a relatively common and life-threatening complication.
“This study must be read for the lessons it will provide for future trials,” he said.
Dr. Sabate reported he has no potential conflicts of interest. Dr. Capodanno reported financial relationships with Amgen, Daiichi Sankyo, and Sanofi.