Paclitaxel-Coated Balloon vs Uncoated Balloon for Coronary In-Stent Restenosis: The AGENT IDE Randomized Clinical Trial
Primary result · Target lesion failureResult — go to the resultHazard ratio 0.59 95% CI 0.42–0.84Authors' conclusion
Among patients undergoing coronary angioplasty for in-stent restenosis, a paclitaxel-coated balloon was superior to an uncoated balloon with respect to the composite end point of target lesion failure.
Study context
- Population
- Patients with coronary in-stent restenosis (lesion length <26 mm, reference vessel diameter >2.0 mm to ≤4.0 mm) undergoing PCI, 40 US centres, May 2021–August 2022574 (95.7%) completed 1-year follow-up
- Participants
- 600 patients
- Comparison
- Paclitaxel-coated balloon vs uncoated balloon
- Paclitaxel-coatedn = 406
- Uncoatedn = 194reference
- Primary endpoint
- Target lesion failure:
- Ischemia-driven target lesion revascularization
- Target vessel-related MI
- Cardiac death
- Follow-up
- 1 year
Methodological detailsmulticentre, 2:1 allocation, superiority
- Multicentre
- 2:1 allocation
- Superiority
Primary result
Target lesion failure
Hazard ratio
0.59
95% CI 0.42–0.84
P = 0.003
By group
Paclitaxel-coated vs Uncoated
HR 0.59 (95% CI 0.42–0.84); P = 0.003
As reported in the abstract
Further findings
| Outcome | Paclitaxel-coated | Uncoated | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Target lesion revascularization | 13.0% | 24.7% | 0.50 (0.34–0.74) | P = 0.001 | |
| Target vessel-related MI | 5.8% | 11.1% | 0.51 (0.28–0.92) | P = 0.02 | |
| Cardiac death | 2.9% | 1.6% | 1.75 (0.49–6.28) | P = 0.38 | |
| 0.10.31310Hazard ratio (log scale) |
Original publication
Paclitaxel-Coated Balloon vs Uncoated Balloon for Coronary In-Stent Restenosis: The AGENT IDE Randomized Clinical Trial. JAMA. Published 26 March 2024. doi:10.
Summarised from the published abstract; every number is checked against it