Impact of non-compliant balloons on long-term clinical outcomes in coronary bifurcation lesions: results from the COBIS (COronary Bifurcation Stent) II registry

Abstract

Aims: Non-compliant balloons provide uniform radial force along the vessel wall at any inflation pressure. As a result, the use of non-compliant balloons may reduce side branch complications and optimise stent deployment. We sought to investigate the impact of non-compliant balloons on the long-term clinical outcomes of patients undergoing a coronary bifurcation intervention. Methods and results: A total of 2,897 patients treated with drug-eluting stents for bifurcation lesions were enrolled. Non-compliant balloons were used in 752 patients (26%). During a median three-year follow-up, major adverse cardiac events (MACE: cardiac death, myocardial infarction, or target lesion revascularisation) occurred less frequently in the non-compliant balloon group than in the compliant balloon group (8.2% versus 10.9%; p=0.03). After propensity score matching (710 pairs), the use of non-compliant balloons resulted in a lower rate of side branch dissection (0.1% versus 1.1%; p=0.046) and a higher rate of procedural success (79.0% versus 73.9%; p=0.01). The use of non-compliant balloons was associated with a lower risk of MACE (HR 0.64, 95% CI: 0.46-0.91; p=0.01) and cardiac death (HR 0.14, 95% CI: 0.03-0.64; p=0.01). Conclusions: The use of non-compliant balloons was associated with favourable procedural and long-term clinical outcomes in patients receiving coronary bifurcation intervention. ClinicalTrials.gov number: NCT01642992