Key result
Modified balloon lesion preparation fails to reduce major cardiovascular events vs control in severely calcified coronary lesions.
Why the study?
The performance of modified balloons, such as cutting or scoring balloons, to prepare severely calcified lesions in patients undergoing PCI remains controversial.
Does modified balloon therapy improve clinical or imaging outcomes compared with control therapy in patients undergoing PCI for severely calcified coronary lesions?
Meta-Analysis (n=648)
Open-label
Randomized
Yes
Does modified balloon therapy improve clinical or imaging outcomes compared with control therapy in patients undergoing PCI for severely calcified coronary lesions?
In patients undergoing PCI for severely calcified lesions, lesion preparation with a modified balloon before stenting does not improve clinical or imaging outcomes compared with control therapy.
Answers are grounded in this paper and cite their sources.
No benefit from modified balloon preparation in calcified PCI; challenges assumptions of routine use and leaves open subtype-specific efficacy.
BACKGROUND: The performance of modified balloons (namely cutting or scoring balloons) to prepare severely calcified lesions in patients undergoing percutaneous coronary intervention (PCI) remains controversial. We investigated the clinical and imaging outcomes of patients undergoing PCI assigned to modified balloon therapy to prepare severely calcified coronary lesions before stent implantation. METHODS: In this meta-analysis, we aggregated the study-level data from trials enrolling invasively treated patients who were randomly assigned to modified balloon or control therapy to prepare severely calcified lesions before stenting. The primary outcome was major adverse cardiac events (MACE), including death, myocardial infarction (MI), and repeat revascularization. The secondary outcomes included the individual components of the primary outcome, coronary perforation and final minimal stent area (MSA) as measured by intracoronary imaging. Patients treated with a modified balloon compared with control therapy showed neither a significant difference for the other clinical outcomes nor for final MSA [standardized mean difference = 0.67 (- 0.71, 2.06); P = 0.26]. CONCLUSIONS: In patients treated with PCI for severely calcific coronary artery disease a strategy of lesion preparation with a modified balloon before stenting does not improve clinical or imaging outcomes compared with control therapy. The different performance of cutting and scoring balloons warrants further investigation.
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Scalamogna et al. (2023) conducted a meta-analysis in Severely calcified coronary lesions (n=648). Modified balloon therapy (cutting or scoring balloons) vs. Control therapy (semi-compliant, non-compliant, or super high-pressure balloon) was evaluated on Major adverse cardiac events (MACE) (RR 0.70, 95% CI 0.35-1.39, p=0.24). Lesion preparation with a modified balloon before stenting did not significantly reduce the risk of major adverse cardiac events compared with control therapy in patients with severely calcified coronary lesions.
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