Gradual inflation at optimum pressure versus stent implantation trial: Final report

Abstract

Purpose: To evaluate whether or not Gradual Prolonged Balloon Angioplasty (GPBA) at optimized pressure provides similar clinical benefit as stent implantation (SI). Method: 417 patients with type A, B1, B2 lesions were randomly assigned to either the GPBA or Stent group. In all stent patients, slotted tube stents were used. For the GPBA, the perfusion balloon cumulative inflation time was required to exceed 10 minutes. QCA analysis was performed for both the acute and 6 month follow-up (f/u) results. Results: Among the 210 GPBA patients and the 207 SI patients in this randomized multi-center trial, 185 GPBA and 180 SI patients were available for QCA and clinical analysis. Reference diameter was similar between the GPBA group and the SI group. Acute and f/u results of minimum lumen diameter (mm) in the SI group were better than in the GPBA group: (0.94±0.5 vs. 0.97±0.48 for pre; NS, 2.7±0.5 vs. 2.25±0.42 for post; p< 0. 0001, 2.10±0.55 vs 1.87±0.64 for f/u; p<0.0003). Mid-grade restenosis (50∼70%) occurred in 36 patients in the GPBA group and in 15 patients in the SI group, and high-grade restenosis (>70%) occurred in 7 of the GPBA patients and in 5 of the SI patients. The binary restenosis rate in the SI group was lower than in the GPBA group (11.0 vs. 23.3%, respectively, p=0.03), however, there were no differences in TLR rates between the two groups (9.3% vs. 14.0%) Conclusion: Gradual prolonged balloon angioplasty may provide similar clinical benefits as stent implantation.