Greater stent expansion at the maximally calcified segment with cutting balloon versus noncompliant balloon preparation: the randomized PREDICTION trial

Coronary calcification can limit stent expansion during percutaneous coronary intervention. Cutting balloons concentrate mechanical stress at the blade-plaque interface, but randomized in vivo evidence comparing cutting balloon with conventional noncompliant balloon preparation is limited. To compare cutting balloon (CB) preparation with conventional noncompliant balloon angioplasty (BA) for lesion preparation in calcified coronary lesions. PREDICTION was a prospective, multicenter, open-label randomized trial at eight Japanese centers. Patients with de novo coronary lesions and angiographically significant calcification were randomized 1:1 to CB preparation or BA. PCI was NIRS-IVUS-guided. The primary endpoint was post-PCI minimum stent area at the preintervention maximally calcified segment. The trial was registered in the Japan Registry of Clinical Trials (jRCTs052200044). Of 170 randomized patients, 152 had evaluable primary endpoint data and were analyzed according to randomized treatment assignment (CB, n = 77; BA, n = 75). Mean predilatation pressure was lower with CB than BA (10.7 ± 3.3 vs. 16.1 ± 4.2 atm; p < 0.001). MSA at the maximally calcified segment was greater in the CB group (6.4 [5.8-7.5] vs. 5.9 [4.8-7.3] mm²; p = 0.013), as was MSA (6.1 [5.2-6.8] vs. 5.2 [4.2-6.7] mm²; p = 0.03). Clinically driven 9-month TLR occurred in 1 CB patient and no BA patients. One coronary perforation occurred during postdilatation in the CB group. In this multicenter randomized trial, CB preparation resulted in greater IVUS-derived stent expansion at the maximally calcified segment than conventional BA. The trial was not powered to assess differences in clinical outcomes or infrequent procedural complications.