Impact of post-procedural peripheral fractional flow reserve after drug-coated balloon angioplasty in femoropopliteal lesions.

PURPOSE: The aim of this study was to determine if postprocedural peripheral fractional flow reserve (pFFR) is associated with patency one year after drug-coated balloon (DCB) angioplasty for femoropopliteal (FP) lesions. MATERIALS AND METHODS: Forty-five consecutive patients having 49 de novo FP lesions were enrolled in this prospective, observational study conducted from April 2022 to Aug 2023. The pFFR was measured under hyperemic conditions after the administration of 30 mg of papaverine. The relationship between pFFR and restenosis 12 months after the procedure was determined using receiver operating characteristic (ROC) curve analysis. RESULTS: The one-year follow-up was completed for 47 lesions (95.9 %). Restenosis was detected in 7 lesions (14.9 %). Postprocedural pFFR was significantly higher in the nonrestenosis group compared with the pFFR in the stenosis group (0.95 ± 0.054 vs. 0.88 ± 0.090, p = 0.010). The optimal pFFR cutoff value for predicting restenosis was 0.92 (sensitivity, 0.824; specificity, 0.600). The area under the curve for pFFR was numerically higher than the area under the curve for minimum lumen area (0.73 vs. 0.64, p = 0.22). Rates of freedom from restenosis at one year were significantly higher in the pFFR >0.92 group compared with the pFFR ≤0.92 group (p = 0.0042). CONCLUSION: Postprocedural pFFR was associated with patency at one year after DCB angioplasty for FP lesions.

Comprehensive clinical outcomes of drug-coated balloon treatment for coronary artery disease. Insights from a single-center experience.

BACKGROUND: Some clinical trials have verified the efficacy and safety of paclitaxel drug-coated balloon (DCB) for small vessel coronary artery disease. However, nonsmall vessel and calcified lesions received less attention. AIMS: This study aimed to investigate the efficacy of DCB treatment for various types of coronary artery lesions, including not only small vessel disease but also nonsmall vessel disease and calcified lesions. In this real-world clinical practice study, in-stent restenosis was excluded. METHODS: This study consecutively included 934 patients with 1751 nonstented lesions who received DCB at a cardiovascular center in Kyoto Katsura Hospital in Japan between 2009 and 2012 and 2014 to 2019. This study enrolled and retrospectively analyzed all of the patients. Eligible patients routinely underwent follow-up angiography at 6-8 months after percutaneous coronary intervention. The primary endpoint includes target lesion revascularization (TLR) during follow-up. Further, this study calculated the predictor of TLR using multivariate analysis. RESULTS: This study included the lesions involving 46.4% of type B2/C, 26.9% with severe calcification, and 6.0% with DCB restenosis. Mean DCB diameter and length were 2.75 ± 0.51 mm and 24.2 ± 9.6 mm, respectively. The median follow-up duration was 18 months. Follow-up angiography revealed a TLR rate of 9% and a restenosis rate of 9%. This study identified hemodialysis and current smoking as independent TLR predictors. CONCLUSION: In routine clinical practice, the effectiveness of DCB was observed consistently across various types of coronary artery disease.

Correlation between physiological assessment and imaging findings during drug-coated balloon treatment for femoropopliteal diseases.

BACKGROUND: This prospective cross-sectional study evaluated the correlation between physiological assessment (PA) and minimum lumen area (MLA) by intravascular ultrasound (IVUS) during drug-coated balloon (DCB) treatment for femoropopliteal (FP) diseases. METHODS: A total of 51 limbs of 44 patients undergoing endovascular treatment with DCB for de novo FP disease were examined from April 2022 to February 2023. PA was conducted at baseline, after balloon dilatation, and after DCB treatment. PA was measured before (pressure ratio; PR) and after vasodilation (peripheral flow fractional flow reserve; pFFR) with the administration of 30 mg papaverine through a guiding catheter. The correlation of PA with percent diameter stenosis (%DS) and MLA was examined, and factors correlated with higher pFFR after balloon dilatation were evaluated in a multivariate analysis. RESULTS: At baseline, there were correlations between pressure ratio (PR) and %DS (coefficients: 0.641 [p < 0.001]) and between pFFR and %DS (0.666 [p < 0.001]). After balloon dilatation, there was no correlation between PR and %DS (coefficients: 0.33 [p = 0.27]) or between pFFR and %DS (0.41 [p = 0.71]). At baseline, PR and MLA were correlated (coefficients: 0.757 [p < 0.001]) as were pFFR and MLA (0.762 [p < 0.001]). After balloon dilatation, PR and MLA were correlated (coefficients: 0.524 [p < 0.001]) as were pFFR and MLA (0.601 [p < 0.001]). Balloon/EEM ratio, calcification >270°, and chronic total occlusion were associated with pFFR after balloon dilatation. CONCLUSION: After balloon dilatation, PA was correlated with MLA by IVUS but not with %DS based on angiography.

Acute and mid-term results of percutaneous coronary intervention for severely calcified coronary artery lesions with orbital atherectomy system.

OBJECTIVES: Severely calcified lesions present many challenges for percutaneous coronary intervention (PCI). This study aimed to assess the safety and efficacy of the orbital atherectomy system (OAS) in treating calcified coronary lesions. METHODS: The present study included 422 consecutive cases (546 lesions) who underwent PCI with OAS in Kyoto Katsura Hospital from February 2018 to December 2021. We assessed the following clinical outcomes after OAS was used for severely calcified lesions: procedure success, angiographic complications, in-hospital Major Adverse Cardiovascular Events (MACE), and mid-term results. The primary endpoint was the combination of incidence of MACE at 12 months, cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR). RESULTS: Of all the cases, 74% patients were men and the mean age was 76.5 years. In total, 81% of lesions were treated with drug-coated balloon, and 14% were implanted with stents. Procedural success rate was 96.3%. Coronary perforation occurred in 0.5% and persistent slow flow in 2% lesions. There was 1 cardiac death (0.5%), 43 periprocedural MIs (10.2%), and no TLR as in-hospital MACE. The incidence of MACE at 12 months was 8.4%, including 2.1% cardiac death and 6.9% TLR. In multivariate analysis, CKD, hemodialysis, and restenosis lesions were independently associated with MACE at 12 months. Periprocedural MI was not an independent predictor of MACE. CONCLUSIONS: This study suggested that OAS is a safe and effective treatment option for calcified coronary lesions with acceptable acute and mid-term results; thus, it can be an alternate for reducing calcified plaque.

Comparison of drug-eluting stents vs. drug-coated balloon after rotational atherectomy for severely calcified lesions of nonsmall vessels.

Calcified lesion is a risk factor for adverse events, even in the drug-eluting stent (DES) era. Recently, drug-coated balloon (DCB) has been shown to have favourable results for in-stent restenosis and small vessels, but its results for calcified lesions are unknown. This study aimed to clarify the rotational atherectomy (RA) and DCB results for calcified lesions of nonsmall vessels. A total of 194 consecutive de novo lesions from 165 cases underwent RA for calcified lesions of nonsmall vessels between January 2016 and August 2018 in a single centre. Overall, 8 cases/10 lesions were excluded because of RA followed plain old balloon angioplasty (POBA). Remaining lesions were grouped into the DES (88 cases/104 lesions) and DCB (69 cases/80 lesions) groups and then compared retrospectively. The primary endpoint was post-discharge major adverse cardiovascular events (MACE) at 1 year, and it was defined as cardiac death, noncardiac death, target-vessel-related myocardial infarction, target lesion revascularization (TLR), and major bleeding (BARC ≥ type 3). There was no difference in the clinical follow-up rate between RA + DES (96/104 lesions) and RA + DCB (78/80 lesions). The post-discharge MACE values after 1 year of RA + DES and RA + DCB were 8% and 11% (P = 0.30), respectively, in terms of cardiac death (0% vs. 0%, respectively), noncardiac death (4% vs. 3%, respectively, P = 0.36), target-vessel-related myocardial infarction (0% vs. 0%, respectively), TLR (4% vs. 8%, respectively, P = 0.30), and major bleeding (1% vs. 0%, respectively). For calcified lesions of nonsmall vessels, RA + DCB showed good results as well as RA + DES. RA + DCB is a potential new strategy for these lesions.