Effectiveness of spherical tip noncompliant balloon for stent postdilatation: the REPIC02-RECONQUISTHA study

ABSTRACT Introduction and objectives: Noncompliant balloon postdilatation of coronary stents improves clinical results. Regular noncompliant balloons (RegNC) have less crossability and a tapered-tip that can complicate successful stent postdilatation. The mechanical conditions of a new spherical tip non-compliant balloon (SphNC) could facilitate stent postdilatation. We tried to evaluate the effectiveness of a new SphNC in the routine percutaneous coronary intervention (PCI) practice. Methods: Prospective multicenter technical registry to assess the effectiveness of a new SphNC for stent postdilatation with 2 study arms: use of SphNC as the first choice or as the secondary choice after RegNC failure. The primary endpoint was technical success defined as advancing the SphNC across the stent segment. Secondary endpoints were angiographic success defined as technical success and residual stenosis < 30% with final TIMI grade-3 flow, and procedural success defined as angiographic success without mechanical stent complications or any perioperative major adverse cardiovascular events. Results: The SphNC was used in 263 lesions (177 lesions as first choice, and 86 after RegNC failure) in 250 procedures. The use of the complex technique to advance the SphNC was low (9.9%). Technical, angiographic, and procedural success rates were 98.9%, 98.3%, and 98.3%, respectively, as the first choice, and 98.8%, 97.7%, and 96.5%, respectively, after RegNC failure. SphNC had similar size (3.39 mm ± 0.6 mm vs 3.34 mm ± 0.6 mm; P = nonsignificant), and shorter lengths (11 mm ± 2 mm vs 12 mm ± 3 mm; P = .005) compared to RegNC. No stent-related mechanical complications were reported. Conclusions: SphNC for coronary stent postdilatation in the routine PCI clinical practice has a very high technical success rate as the first choice (98.9%), as well as in cases of RegNC failure (98.8% with low complex technique requirements, and a safe profile).