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STAPLE-2: The Pivotal Study of the Aptus Endovascular AAA Repair System - 24-Months Results
Manish Mehta, MD MPH1, Ronald M. Fairman, MD2, David H. Deaton, MD FACS3, William D. Jordan, MD4.
1Albany Medical College/Albany Medical Center Hospital, Albany, NY, USA, 2Hospital of the University of Pennsylvania, Philadelphia, PA, USA, 3Georgetown University Hospital, Washington DC, DC, USA, 4University of Alabama, Birmingham, AL, USA.
OBJECTIVES:
Aptus is the first endograft with EndoStaples for proximal fixation. A study evaluated standard EVAR safety and efficacy endpoints.
METHODS:
A prospective single-arm IDE study was performed. The Aptus System includes a modular endograft and stapling system. MAEs were defined as death, MI, stroke, renal failure, respiratory failure or paralysis at 30d. Composite success was defined as delivery success and absence of Type I/III endoleak, migration>10mm, rupture and open conversion at 1yr.
RESULTS:
155 patients were enrolled. 147 and 121 pts completed 1 and 2yr f/u respectively. 153 (99%) were successfully implanted. 2 pts were acutely converted due to cannulation failure and misdeployment. 810 total staples were implanted (median 5/pt). Primary safety and efficacy endpoints were achieved in 98% (goals>87% and >80% respectively), though thrombus-related events (TRE) occurred in 34.8%, adjudicated by CEC as device related. Shear stress induced platelet aggregation in out-of-spec docking area caused TRE. TRE resulted in 52 interventions in 49 pts (31.6%) thru 2 yrs, with no related amputation or death. There was 1 Type I leak in a patient that did not meet proximal neck inclusion criteria and 1 Type III leak with an aortic cuff that was not stapled. There were no late Type I/III leaks. 2 cases of migration were seen at 2yr f/u, both due to neck elongation and no evidence of graft or staple dislocation, Type I leak or need for re-intervention. Type II leak at 2yrs was 12%. AAA size decreased in 72.5%, was stable in 22% and increased in 3% at 2yrs; all patients with increased AAA had Type II leaks. Through 2yr f/u there are no ruptures, AAA-related deaths, stent fracture, staple displacement, or late Type I/III endoleaks. CONCLUSIONS:
The STAPLE-2 trial met safety and efficacy endpoints. An abnormally high rate of TREs occurred due to a manufacturing discrepancy. Excluding TRE, results thru 2 yrs demonstrate device fixation and seal integrity, a high rate of sac regression and few re-interventions.
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