New hemodynamic device improved outcomes for high-risk PCI patients

Issue: June 2011

Society for Cardiovascular Angiography and Interventions 2011 Scientific Sessions

BALTIMORE — An analysis of data showed that the Abiomed Impella 2.5 device offered better hemodynamic support than the intra-aortic balloon pump traditionally used in high-risk percutaneous coronary intervention patients.

William O’Neill, MD, executive dean for clinical affairs at the University of Miami Miller School of Medicine, presented data from the aborted PROTECT II trial during the Society for Cardiovascular Angiography and Interventions 2011 Scientific Sessions. After the trial was halted, investigators continued to follow the population for 90 days. They determined that in the Impella arm (n=213), 21.6% experienced major adverse events compared with 31% in the balloon device arm (n=210).

Between November 2007 and November 2010, 452 of an intended 654 patients were prospectively enrolled in a multicenter, randomized trial to determine the type of hemodynamic support that provides the best clinical outcomes during high-risk PCI. Patients with three-vessel disease and left ventricular ejection fraction <30% or with unprotected left main or last patent conduit and LVEF <35% during PCI were included. Prophylactic support was initiated before the intervention and halted as soon as it was efficacious after the procedure. The revascularization procedure was at the discretion of the clinician. The primary endpoint was a composite of major adverse events at 30 days; the primary endpoint follow-up was assessed at 90 days.

Due to futility on the primary analysis at the first interim mark, the Data Safety Monitoring Board recommended the study be terminated. The patient population (n=452) at interim was 66 ± 10 years of age and included those with diabetes (52%), active angina (66%) and renal insufficiency (25%). Class NYHA III/IV patients numbered 56%; 67% were not candidates for surgery. Patients had syntax scores of 31 ± 14 and their LVEF was 24 ± 6%.

O’Neill also presented data on the effect of operator learning curve: 90-day outcomes in the intent-to-treat population (n=447) saw a major adverse event rate for the Impella device of 47.8% in 2008; 39.1% in 2009; and 37.3% in 2010. “I can’t fault the Data Safety Monitoring Board for halting the trial,” O’Neill said. “The thing we didn’t take into full consideration was the learning curve of the trial.”

For more information:

O’Neill W. LBCT 3. Presented at: Society for Cardiovascular Angiography and Interventions 2011 Scientific Sessions; May 4-May 7, 2011; Baltimore.

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