Coronary Artery DiseaseImpact of Hemodynamic Support With Impella 2.5 Versus Intra-Aortic Balloon Pump on Prognostically Important Clinical Outcomes in Patients Undergoing High-Risk Percutaneous Coronary Intervention (from the PROTECT II Randomized Trial)
Section snippets
Methods
PROTECT II was a prospective multicenter randomized trial conducted in 112 sites in the United States, Canada, and Europe, and its methods have been previously reported in detail.4 In brief, patients who underwent high-risk PCI requiring circulatory support and were randomized to the Impella 2.5 device versus IABP. Inclusion criteria were a nonemergent PCI on an unprotected left main or last patent coronary vessel with a left ventricular ejection fraction ≤35% or PCI in patients with 3-vessel
Results
The baseline features and procedural outcomes of the ITT groups have been previously reported,4 and thus the PP data are shown here. Baseline characteristics in the per protocol population were similar between groups, apart from higher rates of congestive heart failure, current smokers, and previous aortocoronary bypass surgery and a trend toward a lower rate of chronic renal failure in the Impella arm (Table 1). The overall patient population was anatomically complex and very high risk, with
Discussion
The principal results of the present study are that in a high-risk population that underwent PCI, use of Impella compared with IABP resulted in significantly lower MAE and MACCE rates at 90 days by both multivariable analyses performed when using a more clinically relevant definition of pMI. These results are new since the primary article of the PROTECT II trial (4).
The PROTECT II trial was terminated when only 69% of the planned enrollment was achieved because of a Data and Safety Monitoring
Disclosures
Drs. George Dangas, Annapoorna S. Kini, Samin K. Sharma, Neal Kleiman, Simon Dixon, and William O'Neill have no conflict of interest to report for this study. Dr. Henriques reported that his institution has received research funding from Abiomed as an investigator site for other Impella trials. Dr. Henriques received modest speaker honoraria from Abiomed. Dr. Claessen reported that his institution has received research funding from Abiomed as investigator site for other Impella trials. Dr.
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2022, Journal of Cardiothoracic and Vascular AnesthesiaCitation Excerpt :The Impella devices include: Impella 2.5 (percutaneous through the femoral artery, up to 2.5 L/min flow), Impella Cardiac Power (CP) (percutaneous through the femoral artery, up to 3.5 L/min flow), Impella 5.0 (surgical cutdown through the femoral artery or the axillary artery, up to 5 L/min flow), Impella 5.5 (surgical cutdown through the axillary artery or direct aortic, up to 5 L/min flow), and Impella LD (direct aortic placement).58,59 The Protect II trial demonstrated the safety, efficacy, and superiority of these devices as compared with intraaortic balloon pumps in high-risk percutaneous coronary interventions and postcardiac arrest shock.60,61 Imaging Considerations: The presence of (1) aortic pathology, such as aortic dissection or severe atherosclerotic disease, (2) AV abnormalities, such as severe aortic regurgitation or presence of mechanical AV prostheses, (3) LV clots and VSDs58,62-66 are contraindications to the placement of the device.
The PROTECT-II clinical study was funded by Abiomed (Danvers, Massachusetts).
Clinical trial registration: http://clinicaltrials.gov/ct2/show/NCT00562016 (identifier NCT00562016).
See page 227 for disclosure information.