The AiMI Trial Arshad Ali, MD, David Cox, MD, Nabil Dib, MD, Bruce Brodie, MD, Daniel Berman, MD, Navin Gupta, MD, Kevin Browne, MD, Robert Iwaoka, MD, Michael Azrin, MD, Dwight Stapleton, MD, Cindy Setum, PHD, Jeffrey Popma, MD, for the AIMI Investigators The Journal of The American College of Cardiology AngioJet in Acute Myocardial Infarction Trial

www. Clinical trial results.org AiMI Trial: Background AiMI was a multicenter, prospective randomized two- arm trial comparing AngioJet thrombectomy followed by definitive treatment (angioplasty, stent and eptifibatide), versus immediate definitive treatment only, in patients undergoing intervention for acute myocardial infarction.AiMI was a multicenter, prospective randomized two- arm trial comparing AngioJet thrombectomy followed by definitive treatment (angioplasty, stent and eptifibatide), versus immediate definitive treatment only, in patients undergoing intervention for acute myocardial infarction. The hypothesis was that rheolytic thrombectomy with the Possis Angiojet catheter prior to definitive therapy for acute myocardial infarction would reduce infarct size compared with immediate definitive therapy.The hypothesis was that rheolytic thrombectomy with the Possis Angiojet catheter prior to definitive therapy for acute myocardial infarction would reduce infarct size compared with immediate definitive therapy. AiMI was a multicenter, prospective randomized two- arm trial comparing AngioJet thrombectomy followed by definitive treatment (angioplasty, stent and eptifibatide), versus immediate definitive treatment only, in patients undergoing intervention for acute myocardial infarction.AiMI was a multicenter, prospective randomized two- arm trial comparing AngioJet thrombectomy followed by definitive treatment (angioplasty, stent and eptifibatide), versus immediate definitive treatment only, in patients undergoing intervention for acute myocardial infarction. The hypothesis was that rheolytic thrombectomy with the Possis Angiojet catheter prior to definitive therapy for acute myocardial infarction would reduce infarct size compared with immediate definitive therapy.The hypothesis was that rheolytic thrombectomy with the Possis Angiojet catheter prior to definitive therapy for acute myocardial infarction would reduce infarct size compared with immediate definitive therapy. J Am Coll Cardiol 2006;48:244–52

www. Clinical trial results.org AiMI Trial: Study Design J Am Coll Cardiol 2006;48:244–52  Primary Endpoint: Final infarct size at days, as measured by Tc-99m sestamibi SPECT imaging  Secondary Endpoint: ST segment resolution, post-procedure TIMI flow, corrected TIMI frame count, TIMI myocardial perfusion grade, MACE (death, new Q wave MI, stroke, target lesion revascularization), ejection fraction and procedural complications  Primary Endpoint: Final infarct size at days, as measured by Tc-99m sestamibi SPECT imaging  Secondary Endpoint: ST segment resolution, post-procedure TIMI flow, corrected TIMI frame count, TIMI myocardial perfusion grade, MACE (death, new Q wave MI, stroke, target lesion revascularization), ejection fraction and procedural complications Rheolytic Thrombectomy using the Possis Angiojet XMI device n=240 n=240 Primary PCI Control n=240 n=240 Transmural anterior MI or large inferior MI, with definitive treatment being initiated within 12 hours of symptom onset. Treated vessels were native coronary arteries ≥ 2mm in diameter. Angiographic evidence of thrombus was not required for patient enrollment. Randomized. 25% female, mean age 60 years, mean follow-up 30 days 95% received Eptifibatide Transmural anterior MI or large inferior MI, with definitive treatment being initiated within 12 hours of symptom onset. Treated vessels were native coronary arteries ≥ 2mm in diameter. Angiographic evidence of thrombus was not required for patient enrollment. Randomized. 25% female, mean age 60 years, mean follow-up 30 days 95% received Eptifibatide

www. Clinical trial results.org AiMI Trial: Primary Endpoint Primary Endpoint of Infarct Size p= %9.8% 12.5%12.5% As measured by nuclear scan, the 197 intent-to-treat patients in the AngioJet arm had a larger final infarct size than the 205 patients in the control arm (12.5% +/ v. 9.8% +/- 10.9; p=0.03).As measured by nuclear scan, the 197 intent-to-treat patients in the AngioJet arm had a larger final infarct size than the 205 patients in the control arm (12.5% +/ v. 9.8% +/- 10.9; p=0.03). J Am Coll Cardiol 2006;48:244–52 Angiojet n=197 Primary PCI n=205

www. Clinical trial results.org AiMI Trial: Secondary Endpoint The rate of MACE was higher in patients undergoing thrombectomy (6.7% v. 1.7%; p=0.01).The rate of MACE was higher in patients undergoing thrombectomy (6.7% v. 1.7%; p=0.01). Rate of MACE in Patients Undergoing Throbectomy p=0.01 J Am Coll Cardiol 2006;48:244–52

www. Clinical trial results.org AiMI Trial: Mortality Mortality rates at 30 days were higher in those undergoing thrombectomy (4.6% (n=11) v. 0.8% (n=2); p=0.01).Mortality rates at 30 days were higher in those undergoing thrombectomy (4.6% (n=11) v. 0.8% (n=2); p=0.01). Rate of Mortality in Patients Undergoing Throbectomy p=0.01 J Am Coll Cardiol 2006;48:244–52

www. Clinical trial results.org AiMI Trial: Secondary Endpoint The rates of TIMI 3 flow after completion of the procedure was lower in those randomized to thrombectomy (92% thrombectomy v. 97% control, p<0.02).The rates of TIMI 3 flow after completion of the procedure was lower in those randomized to thrombectomy (92% thrombectomy v. 97% control, p<0.02). For all of the remaining secondary endpoints, there were no statistically significant difference between the two treatment arms.For all of the remaining secondary endpoints, there were no statistically significant difference between the two treatment arms. Rate of TIMI 3 Flow p<0.02 J Am Coll Cardiol 2006;48:244–52

www. Clinical trial results.org AiMI Trial: Limitations “Randomization that occurred after angiography may have introduced selection bias against enrolling high-risk patients with a large amount of angiographically apparent thrombus. No data is available to confirm such bias in enrollment.”“Randomization that occurred after angiography may have introduced selection bias against enrolling high-risk patients with a large amount of angiographically apparent thrombus. No data is available to confirm such bias in enrollment.” “Another limitation is that MI size rather than myocardial salvage was measured. As a result, the effect of a lower baseline TIMI flow grade in patients treated with adjunct RT cannot be determined.”“Another limitation is that MI size rather than myocardial salvage was measured. As a result, the effect of a lower baseline TIMI flow grade in patients treated with adjunct RT cannot be determined.” “It is difficult to ascertain whether the higher baseline TIMI flow grades contributed to the very favorable outcomes in patients treated with PCI alone.”“It is difficult to ascertain whether the higher baseline TIMI flow grades contributed to the very favorable outcomes in patients treated with PCI alone.” “Randomization that occurred after angiography may have introduced selection bias against enrolling high-risk patients with a large amount of angiographically apparent thrombus. No data is available to confirm such bias in enrollment.”“Randomization that occurred after angiography may have introduced selection bias against enrolling high-risk patients with a large amount of angiographically apparent thrombus. No data is available to confirm such bias in enrollment.” “Another limitation is that MI size rather than myocardial salvage was measured. As a result, the effect of a lower baseline TIMI flow grade in patients treated with adjunct RT cannot be determined.”“Another limitation is that MI size rather than myocardial salvage was measured. As a result, the effect of a lower baseline TIMI flow grade in patients treated with adjunct RT cannot be determined.” “It is difficult to ascertain whether the higher baseline TIMI flow grades contributed to the very favorable outcomes in patients treated with PCI alone.”“It is difficult to ascertain whether the higher baseline TIMI flow grades contributed to the very favorable outcomes in patients treated with PCI alone.” J Am Coll Cardiol 2006;48:244–52

www. Clinical trial results.org AiMI Trial: Summary Among patients with ST elevation MI, infarct size and mortality rates significantly increased among patients treated with rheolytic thrombectomy compared with the primary PCI control arm.Among patients with ST elevation MI, infarct size and mortality rates significantly increased among patients treated with rheolytic thrombectomy compared with the primary PCI control arm. These results do not support the routine use of rheolytic thrombectomy in ST segment elevation MI. These results do not support the routine use of rheolytic thrombectomy in ST segment elevation MI. Among patients with ST elevation MI, infarct size and mortality rates significantly increased among patients treated with rheolytic thrombectomy compared with the primary PCI control arm.Among patients with ST elevation MI, infarct size and mortality rates significantly increased among patients treated with rheolytic thrombectomy compared with the primary PCI control arm. These results do not support the routine use of rheolytic thrombectomy in ST segment elevation MI. These results do not support the routine use of rheolytic thrombectomy in ST segment elevation MI. J Am Coll Cardiol 2006;48:244–52