AIDA
Trial question
What is the role of bioresorbable vascular scaffold in patients undergoing PCI?
Study design
Multi-center
Single blinded
RCT
Population
Characteristics of study participants
26.0% female
74.0% male
N = 1845
1845 patients (475 female, 1370 male)
Inclusion criteria: patients with coronary artery disease who were undergoing PCI
Key exclusion criteria: target lesions > 70 mm in length, a reference vessel diameter < 2.5 mm or > 4.0 mm, bifurcation lesions for which the use of two stents or scaffolds was planned, and in-stent restenosis
Interventions
N=924 bioresorbable vascular scaffold stents (everolimus-eluting)
N=921 metallic stents (everolimus-eluting)
Primary outcome
Target-vessel failure
11.7
10.7
11.7 %
8.8 %
5.8 %
2.9 %
0.0 %
Bioresorbable vascular scaffold stents
Metallic stents
Difference not exceeding
nonferiority margin ✓
Difference not exceeding nonferiority margin in target-vessel failure (11.7% vs. 10.7%; HR 1.12, 95% CI 0.85 to 1.48)
Secondary outcomes
Significant increase in definite or probable device thrombosis (3.5% vs. 0.9%; HR 3.87, 95% CI 1.78 to 8.42)
No significant difference in the rate of cardiac death by 2 years (2% vs. 2.7%; HR 0.78, 95% CI 0.42 to 1.44)
Significant increase in target-vessel myocardial infarction (5.5% vs. 3.2%; HR 1.6, 95% CI 1.01 to 2.53)
Conclusion
In patients with coronary artery disease who were undergoing PCI, bioresorbable vascular scaffold stents were noninferior to metallic stents with respect to a target-vessel failure.
Reference
Wykrzykowska JJ, Kraak RP, Hofma SH et al. Bioresorbable Scaffolds versus Metallic Stents in Routine PCI. N Engl J Med. 2017 Jun 15;376(24):2319-2328.
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