1Universitätsklinikum Ulm Klinik für Innere Medizin II Ulm, Deutschland
Aims: Modified balloon (MB) treatment prior to stent implantation in severely calcified coronary artery lesions is an established technique. However, in some lesions Rotablation (RA) is required as bailout strategy. This study aimed to assess predictors of switch from MB to RA and its impact on long-term outcomes.
Methods: This retrospective study included 483 consecutive patients undergoing RA (n=279) or MB (n=204) with a scoring or cutting balloon at our University Heart Center. Strategy switch from MB to RA was performed in 19 of 204 patients (9.3%). Procedure success was defined as successful stent implantation. Predictors of strategy switch were calculated using logistic regression and 1-year target lesion revascularization (TLR) using Kaplan-Meier analysis.
Results: In the MB cohort, diabetes (53% vs. 27%; p=0.020), Troponin T (38 [23 – 940] vs. 16 [9 - 53] ng/l; p=0.013), chronic kidney disease (CKD) stage 4 or 5 (26% vs. 5%; p<0.001) and diameter stenosis (90% [90 - 99] vs. 75% [75 - 90]; p<0.001) were significantly higher in patients with strategy switch to RA compared to MB only. Procedure time (81 [53 – 110] vs. 123 [91 – 201] minutes) and radiation dose (150 [126 – 252] vs. 59 [30 – 100] Gycm2) were significantly higher in MB patients with switch to RA (p<0.001 both). Procedure success was achieved in 98.4% in the MB only group vs. 89.4% in the switch group (p<0.001) and 96.4% in the RA cohort. In the switch group, periprocedural coronary artery dissection (21% in the switch vs. 4% in the MB only group vs. 4% in the RA cohort; p=0.003) and relevant arrhythmia (16% vs. 2% vs. 5%; p=0.015) were significantly higher compared to MB and RA only. Additionally, in-hospital death was significantly higher in the switch group (11% vs. 2% vs. 2%; p=0.030). Multivariate logistic regression revealed Diabetes [OR 3.8 (95%-CI 1.1 – 13.9) p=0.042], CKD stage 4 or 5 [OR 14.0 (95%-CI 1.2 – 167.2) p=0.037) and angiographic diameter stenosis [OR 1.13 (95%-CI 1.1 – 1.2) p=0.001] to independently predict strategy switch. 1-year TLR rates did not differ between each treatment (86% vs. 89% vs. 89%; log-rank p=0.95).
Conclusion
Modified balloon treatment achieves high procedural success rates in patients with severely calcified coronary artery lesions, however, procedure failure and switch to RA is required in 9%. Switch is associated with higher periprocedural complication rates and increased in-hospital mortality compared to MB only as well as to RA first strategy. In patients with impaired renal function, diabetes mellitus or angiographic high diameter stenosis, Rotablation might be considered as primary treatment strategy.