Table 4: Clinical outcome at longest follow-up.

ADVERSE EVENTPresent Study  
N=86 (%)
PROTECT II  
N=225 (%)°
EUROpella  
N=144 (%)°
USpella  
N=175 (%)°

MACCE21 (24)90 (41) §17 (12)
 Re-PCI12 (14)8 (4)/1 (1)
 CABG1 (1)2 (1)0
 AMI6 (7)27 (12)02 (1)
 Stroke02 (1)1 (1)1 (1)
All-cause death 9 (10)27 (12)8 (6)7 (4)

Randomized Impella arm
° Data at longest follow up available in the intention-to-treat population
§ Composite rate of intra- and postprocedural major adverse events (MAEs) at discharge or 30-day follow-up, whichever was longer. The composite primary end point components included all-cause death, Q-wave or non–Q wave
MI, stroke, or transient ischemic attack, any repeat revascularization procedure, need for a cardiac or a vascular operation, acute renal insufficiency, severe intraprocedural hypotension requiring therapy, cardiopulmonary resuscitation or ventricular tachycardia requiring cardioversion, aortic insufficiency, and angiographic failure of PCI.
Includes PCI or CABG revascularization.
MACCE=major adverse cardiac and cerebrovascular events; PCI= percutaneous coronary intervention; CABG=coronary artery bypass grafting; AMI=acute myocardial infarction