Amsterdam Investigator–initiateD Absorb strategy all-comers trial (AIDA trial)

Selected in American Heart Journal by R. El Mahmoud

References

Authors

Pier Woudstra, MD, a Maik J. Grundeken, MD, a Robin P. Kraak, MD, a Mariëlla E. C. J. Hassell, MD, E. Karin Arkenbout, PhD, MD, Jan Baan Jr, PhD, MD, Marije M. Vis, PhD, MD, Karel T. Koch, MD, PhD, Jan G. P. Tijssen, PhD, Jan J. Piek, MD, PhD, Robbert J. de Winter, MD, PhD, José P. S. Henriques, MD, PhD, and Joanna J. Wykrzykowska, MD, PhD Amsterdam, The Netherland

Reference

Am Heart J 2014;167:133-40

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My Comment

A clinical evaluation comparing the efficacy and performance of ABSORB everolimus-eluting bioresorbable vascular scaffold strategy vs the XIENCE family (XIENCE PRIME or XIENCE Xpedition) everolimus-eluting coronary stent strategy in the treatment of coronary lesions in consecutive all-comers: Rationale and study design

Background

The metallic stent causes a rigid permanent caging of coronary artery, limiting remodeling of the vessel and impairing vasomotion. The Absorb everolimus-eluting bioresorbable vascular scaffold (AbsorbBVS) is a completely resorbable device developped to provide temporary scaffolding and antiproliferative drug delivery. The AIDA trial is a randomized all-comer trial using the AbsorbBVS strategy in a real-world population.

Major Findings

  • The AIDA trial is a prospective, randomized, all-comer, noninferiority trial to evaluate the efficacy and performance of the ABSORB everolimus-eluting BVS revision 1.1 strategy vs the Xience family everolimus-eluting stent (Xience Prime or Xpedition) in the treatment of coronary lesions
  • Consecutive patients from all-comer population with 1 or more target lesions suitable for DES implantation are candidates for enrollment
  • The trial enrolled the first patient in August 2013 and will randomize 2,690 subjects who meet all eligibility criteria
  • Patients will be followed up by phone contact at 30 days, 6 months, 1, 2, 3, 4, and 5 years following the procedure to acquire information about angina status, medication, and clinical events
  • The primary end point is target vessel failure, defined as the composite of cardiac death, myocardial infarction, and target vessel revascularization at 2 years.

My comments

  • The AIDA trial is the first trial performing a randomized direct comparison between the everolimus-eluting BVS second generation and the everolimus-eluting metallic stent in a real-world population
  • Currently, 2 large studies are ongoing. The ABSORB-II randomized,active-controlled, comparing the AbsorbBVS strategy vs the XIENCE-strategy in stable lesions in noncomplex, native coronary arteries in 40 sites and the ABSORB-EXTEND-SAS which is a, prospective, single-arm, observational study enrolling 1,000 subjects with a maximum of 2 de novo short lesions (< 28 mm).
  • For the record, ABSORB Cohort B trial conducted with second generation AbsorbBVS in 101 patients showed a 6.8% MACE rate at 2 years without any thrombosis and with a late loss at 6 and 12 months lower than first generation and comparable with DES late loss.
  • The AIDA trial will provide important data on the safety and efficacy of the AbsorbBVS in daily practice and will add informations expanding the inclusion of patients with ACS and complex lesions (long lesions, small vessels).

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