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Two-year clinical outcomes of patients treated with overlapping absorb scaffolds: An analysis of the ABSORB EXTEND single-arm study

Catheterization and Cardiovascular Interventions Oct 13, 2017

Costa JR, et al. - This study entailed a comparison of immediate and 2-year clinical outcomes in patients treated with overlapping (OVP) scaffolds versus patients treated with nonOVP scaffolds. Higher incidence of periprocedure myocardial infarction (MI) with no immediate or long-term increase in cardiac death, target lesion revascularization [TLR] or scaffold thrombosis (ST) were the reported consequences of treatment with OVP scaffolds in a low-to-moderate complex population treated with the ABSORB scaffold.

Methods

  • ABSORB EXTEND is a prospective, single-arm, open-label clinical study in which 812 patients were enrolled at 56 sites.
  • This study compared patients with OVP scaffolds (n = 115) to those of patients with nonOVP scaffolds (n = 697) in terms of the immediate and 2-year clinical outcomes, mainly focusing on major adverse cardiac event (MACE) (cardiac death, MI and ischemic-driven target lesion revascularization [TLR]) and scaffold thrombosis (ST) rates up to 2 years

Results

  • Findings demonstrated comparable baseline clinical and angiographic characteristics between cohorts except for longer lesions in the OVP patients as expected (16.7 ± 7.3 vs. 11.6 ± 4.4 mm, P < 0.0001), higher lesion complexity (B2) and numerically smaller vessel size.
  • Data also reported a marked increase in in-hospital MACE in the OVP cohort (7.0 vs. 0.9%, P = 0.002), exclusively driven by a higher rate of periprocedure MI (7.0 vs. 0.9%, P = 0.002).
  • Researchers observed no significant difference in the long-term MACE between groups (10.4% in the OVP cohort vs. 6.6% in the no-OVP group, P = 0.1) with comparable rates of cardiac death (0.9 vs. 1.2%, P = 1.0) and ischemia-driven TLR (1.7 vs. 2.5%, P = 1.0).
  • They noted that cumulative incidence of MI was higher in the OVP cohort (7.8 vs. 3.0%, P = 0.02).
  • Essentially, the OVP cohort had lower rate of MI between hospital discharge and 2-year follow-up (0.8 vs. 2.1%, P = 0.04).
  • It was also reported that cumulative incidence of definite/probable ST was relatively low and comparable between groups (1.8 vs. 1.5%, P = 0.7).

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