AGENT IDE
Trial question
What is the role of paclitaxel-coated balloon in patients with coronary in-stent restenosis?
Study design
Multi-center
Single blinded
RCT
Population
Characteristics of study participants
26.0% female
74.0% male
N = 600
600 patients (157 female, 443 male)
Inclusion criteria: patients with in-stent restenosis undergoing PCI
Key exclusion criteria: recent ST-elevation or Q-wave myocardial infarction; unprotected left main disease; saphenous vein or arterial graft disease; LVEF < 25%; thrombus in the target vessel
Interventions
N=406 paclitaxel-coated balloon (coronary angioplasty with a paclitaxel-coated balloon)
N=194 uncoated balloon (coronary angioplasty with an uncoated balloon)
Primary outcome
Target lesion failure at 1 year
17.9
28.6
28.6 %
21.5 %
14.3 %
7.2 %
0.0 %
Paclitaxel-coated balloon
Uncoated balloon
Significant decrease ▼
NNT = 9
Significant decrease in target lesion failure at 1 year (17.9% vs. 28.6%; HR 0.59, 95% CI 0.42 to 0.84)
Secondary outcomes
Significant decrease in target lesion revascularization (13% vs. 24.7%; HR 0.5, 95% CI 0.34 to 0.74)
Significant decrease in target vessel-related myocardial infarction (5.8% vs. 11.1%; HR 0.51, 95% CI 0.28 to 0.92)
No significant difference in cardiac death (2.9% vs. 1.6%; HR 1.75, 95% CI 0.49 to 6.28)
Conclusion
In patients with in-stent restenosis undergoing PCI, paclitaxel-coated balloon was superior to uncoated balloon with respect to target lesion failure at 1 year.
Reference
Robert W Yeh, Richard Shlofmitz, Jeffrey Moses et al. Paclitaxel-Coated Balloon vs Uncoated Balloon for Coronary In-Stent Restenosis: The AGENT IDE Randomized Clinical Trial. JAMA. 2024 Mar 9:e241361.
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