De-novo Lesions Research Articles

Usage patterns and outcomes of drug coated ballons at a tertiary care center - a cohort analysis in 462 patients

Abstract Background The usage of drug coated ballons (DCB) in percutaneous coronary interventions (PCI) is rising. Initially applied in in-stent restenosis (ISR), wider clinical applications especially in de novo lesions (DNL) are discussed. Here we aim to assess the pattern of usage as well as the clinical and angiographic outcomes associated with DCB. Methods For this analysis we included all patients treated with DCB during PCI, at a tertiary care centre between 01/2015 and 12/2021. Cath lab results of all patients were screened to assess the DCB indication. Patients were followed up until 09/2022 to assess clinical as well as angiographic complications. Results A total of 7608 interventions were carried out between 2015 and 2021, in 462 (6.1%) a DCB was used. The median follow-up time were 3.1 years (IQR 1.6 to 4.4 years), the median age of our patient population was 66 (IQR 58-75) and 24.7% (n=114) were female. There were 92 of 462 (19.9%) cases including a DNL preparation, 335 (72.5%) cases treating an ISR, in 6 (1.3%) cases both, DNL and ISR were treated, and in 29 (6.3%) cases DCB were used for other reasons (e.g. pre-/ postdilatation in coronary stenting). The mean DCB inflation diameter was significantly higher in ISR with 3.50mm (IQR 3.0-3.5mm) compared to DNL with 2.50mm (2.00-2.50mm, p-value <0.001 ) While the number of DCBs used is rising over time (179 cases [38.7%] in 2015-2018, 283 cases [61.3%] in 2019-2021), the proportion of de novo lesions showed no significant difference (37/179 [20.7%] in 2015-2018, 61/282 [21.6%] in 2019-2021, p-value 0.806, Figure 1). Patients with DCB for ISR had significantly higher rates of arterial hypertension (ISR: 255 [76.1%], DNL: 57 [62.0%], both: 3 [50.0%], other: 20 [69.0%] p value 0.029), hyperlipidaemia (ISR: 228 [68.1%], DNL: 56 [60.9%], both: 2 [33.3%], other: 14 [48.3%], p value 0.041) and previous myocardial infarction (ISR: 231 [69.0%], DNL: 33 [35.9%], both: 2 [33.3%], other: 8 [27.6%], p-value <0.001). When analysing the outcomes, patients with DNL showed lower rates of acute myocardial infarction (8 [8.2%] vs 51 [15.0%]) as well as target lesion (6 [6.1%] vs 56 [16.5%]) and any revascularization (27 [27.6%] vs 122 [35.9%])%]), yet a higher rate of cardiovascular mortality (19 [5.6] vs 9 [9.2%]) during the follow up period compared to patients treated for ISR (Figure 2). Both groups showed a very low rate of target lesion thrombosis within 30 days after PCI (1 [1.0%] vs 1 [0.3%], p-value 0.745). Conclusions The use of DCB in PCIs is increasing, yet as we were able to emphasize with our data, they are primarily used in ISR as well as lesions with a small vessel diameter with favourable outcomes indicated by low event rates. Research should expand beyond small-vessel disease and ISR to assess safety and outcomes of DCB in DNL, larger vessels and bifurcation interventions with one stent to further assess its potential benefits in a wider field of indications.

Percutaneous coronary intervention of in-stent restenosis: A three-arm analysis from SWEDEHEART

Abstract Background During the last decades, there have been substantial improvements in treatment techniques for percutaneous coronary intervention (PCI). Yet, in-stent restenosis (ISR) continues to pose significant challenges as they account for 10% of all PCI cases and are associated with worse outcome compared to de-novo lesions. When assessing ISR with PCI, balloon angioplasty with drug-coated balloons (DCB) is frequently used. Purpose Despite frequent use of DCB, there is a lack of long-term data ensuring the safety of DCB for ISR as no randomized trial has extended beyond a 3-year follow-up. We aimed to study the long-term outcome and conducted a nationwide three-arm investigation on the outcome of ISR, comparing DCB with drug-eluting stents (DES) or plain old balloon angioplasty (POBA) within a 5-year follow-up. Methods We conducted a nationwide analysis using the SWEDEHEART (Swedish Web System for Enhancement of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies) registry. The SWEDEHEART registry was used to include any ISR undergoing coronary angiography between June 11, 2013, and December 31, 2020. Target lesion revascularization (TLR) was the primary outcome. Secondary outcomes included all-cause mortality, myocardial infarction, and any PCI. The outcomes were analysed using a multivariable Cox regression model. Results A total of 9304 segments from 7987 patients were eligible. Compared to POBA, the use of DCB was associated with lower rates of TLR, hazard ratio (HR) 0.62 (95% confidence interval [CI]: 0.50-0.78), all-cause mortality, HR 0.60 (95% CI: 0.50-0.72), and any PCI, HR 0.78 (95% CI: 0.66-0.93). No difference was observed for myocardial infarction. Compared to DES, the use of DCB was associated with higher rates of TLR, HR 1.24 (95% CI: 1.08-1.42). No difference was observed for all-cause mortality, cardiovascular mortality, myocardial infarction, or any PCI. Conclusions In this nationwide analysis including any ISR undergoing PCI, the use of DCB showed superior outcomes compared to POBA within 5 years but higher rates of repeat revascularizations compared to DES. While DES demonstrated lower TLR rates than DCB, the lack of mortality differences indicates that DCB is a viable option, particularly for patients where DES might not be suitable, but that DES should be considered as the first line strategy.Table 1.5-year outcomeFigure 1.Kaplan-Meier curves

Use of sirolimus-coated balloon in de novo coronary lesions; long-term clinical outcomes from a multi-center real-world population.

Sirolimus-coated balloon (SCB), a relatively novel technology appears attractive due to the drug properties (safety and efficacy) and sirolimus remains the drug of choice in stents. However, there is limited data long-term data on SCB. In this study, we have explored the clinical outcomes following the use of SCB in de-novo lesions from a real-world practice. To report long-term clinical outcomes following the use of Siroliumus coated balloon in de novo lesions. We analyzed all patients treated with an SCB in de novo lesions between 2016 and 2023 at four high-volume centers in UK and Italy. The outcomes measured included cardiac death, target vessel myocardial infarction (TVMI), target lesion revascularization (TLR) and major adverse cardiac events (MACE). During the study period, 771 patients had SCB in de novo lesions. Diabetes mellitus was noted in 36% of patients (n = 280), of which 14% (n = 108) were insulin dependent. Fifteen percent (n = 117) had chronic kidney disease, Fifty-two percent (n = 398) of cases were in the setting acute coronary syndrome (ACS) and of which 51 cases (7%) were ST-segment elevation myocardial infarction. Small vessels (<3.0 mm) accounted for 78% (n = 601) of cases and 76% (n = 584) were long lesions ( 20 mm). The mean diameter of SCB was 2.6 ± 0.4 mm and the mean length was 25 ± 10.39 mm. Bailout stenting following SCB was required in 9% lesions (n = 67). During the median follow-up 640 days, total death occurred in 39 (5%) patients and of which, cardiac death occurred in 10 patients (1.3%). TVMI occurred in 20 patients (2.6%). TLR and TVR were 5.6% and 5.8% respectively. The overall MACE rate was 8%. We had no documented case of acute vessel closure. The results from this long-term follow-up in a real-world population are encouraging with low rates of hard endpoints and acceptable rates of TLR and MACE despite a complex group of patients. Our data suggest that SCBs are safe in coronary intervention with good clinical outcomes in the long term.

TCT-453 Comparison of “Predicted” Versus “Calculated” Flow Ratio (μFR) Acquired With Single-Angiographic View to Guide Drug-Coated Balloon Angioplasty in Coronary De-Novo Lesions

TCT-453 Comparison of “Predicted” Versus “Calculated” Flow Ratio (μFR) Acquired With Single-Angiographic View to Guide Drug-Coated Balloon Angioplasty in Coronary De-Novo Lesions

Angiographic and clinical impact of balloon inflation time in percutaneous coronary interventions with sirolimus-coated balloon: A subanalysis of the EASTBOURNE study

IntroductionPercutaneous coronary intervention (PCI) with drug-coated balloon (DCB) is an attractive strategy for the treatment of obstructive coronary artery disease (CAD). The implantation technique strongly influences the outcome of DCB PCI: accurate and adequate lesion preparation, short delivery time and sufficient DCB inflation time are deemed crucial to warrant adequate drug transfer and mitigate the risk of immediate vessel recoil and flow-limiting dissections. However, the optimal DCB inflation time is unclear, current consensus documents suggesting 30–60 s based on Experts' opinion. However, clinical studies comparing the prognostic role of different inflation times are scarce and mainly involve paclitaxel-coated balloons. In this study we aimed to assess the impact of different inflation times in patients undergoing PCI with a sirolimus-coated balloon (SCB). MethodsWe conducted a post-hoc analysis of the prospective, multicenter, EASTBOURNE study, classified into two study groups according to balloon inflation time: long (>30 s) versus short (≤30 s). The primary endpoint was target lesion revascularization (TLR) at 24-month follow-up. Secondary clinical endpoints were major adverse clinical events (MACE), death, non-fatal myocardial infarction (MI), and BARC 2–5 bleedings. Furthermore, angiographic endpoints (the rate of bailout stenting and post-procedural TIMI flow <3) were also addressed. ResultsA total of 2289 lesions (2092 in the long inflation group, 197 in the short inflation group) were included in the analysis. Median balloon inflation time was 60 s in the long inflation and 30 s in the short inflation group. The two study groups experienced a similar rate of TLR [6.2 % in the short versus 6.3 % in the long inflation group, p = 1.00] as well MACE (p = 0.683), death (p = 0.102), non-fatal MI (p = 0.822), and BARC 2–5 bleedings (p = 0.252). These results were consistent when considering subpopulations with different target lesion phenotypes (in-stent restenosis, de-novo lesions, large and small vessels). Interesting, the rate of bailout stent implantation and post-procedural TIMI flow <3 was higher in the short SCB inflation time, as compared to the standard strategy. ConclusionsShort vs. long SCB inflation time is associated with a higher need of bailout stenting after PCI with SCB, with similar clinical outcomes at 24-month follow-up.

One-Year Outcome of Drug-Coated Balloon vs. Drug-Eluting Stent in Patients Undergoing Initial Percutaneous Coronary Intervention (PCI) for De Novo Lesion.

Drug-eluting stents (DES) are the major treatment option in percutaneous coronary intervention (PCI). Recently, drug-coated balloon (DCB) utilization has been increasing globally, leading to the expected new strategy of "stent-less PCI." This study aimed to evaluate the one-year outcome of DCB compared to DES. Patients who underwent initial PCI for de novo lesions in our institution from January 2018 to December 2021 (n=337) were subjected to retrospective analysis. Among them, 75 patients were treated with DCB, while 262 patients were treated with DES. Target lesion failure (TLF) was evaluated during the follow-up period. The proportion of PCIs for ACS was significantly lower in the DCB group (DCB, n=23, 30.7% vs. DES, n=143, 54.6%; p=0.001). The median device diameter and length in the DES group were larger than those in the DCB group (DCB, 2.60 mm vs. DES, 2.98 mm; p<0.001; DCB, 19.1 mm vs. DES, 25.2 mm; p<0.001). There was no significant difference between the DCB and DES groups in lesion calcification. The proportion of ostial lesions was significantly higher in the DCB group (DCB, n=13, 17.3% vs. DES, n=21, 8.0%; p=0.018). The cumulative rate of TLF (DCB, n=5, 6.7% vs. DES, n=18, 6.9%; p=0.951) did not significantly differ between the DCB and DES groups. DCB may be as effective a strategy as DES in the patient who underwent initial PCI for a de novo lesion.

The role of drug-coated balloons for coronary bifurcation management: results from the prospective EASTBOURNE-BIF study.

Coronary bifurcation lesions are associated with less favourable outcome as compared to other lesion subsets. The role of drug-coated balloons (DCB) for bifurcation lesions has been only investigated in small studies so far, which reported encouraging results. We here describe the results of EASTBOURNE-BIF prospective registry, in which a sirolimus-DCB was used for the treatment of bifurcation lesions. Overall, 194 patients with bifurcations lesions identified in the EASTBOURNE study (Medina 1.1.1/1.1.0/1.0.1/0.1.1/0.1.0) were compared with 1049 patients with de-novo lesions from the same registry. Both a blended-strategy using a drug-eluting stent in the main branch and a DCB in the side branch as well as a full-DCB approach were used in the treatment of bifurcation lesions. At one year of follow-up the study primary endpoint, target-lesion revascularization occurred at a similar rate in the bifurcation group versus the de-novo group (4.2 vs. 2%, P=0.28). Similar outcomes were observed in terms of all-cause death (3.3 vs. 1.4%, P=0.138), major adverse cardiovascular events (8.8 vs. 5.2%, P=0.081) and the rate of spontaneous myocardial infarction (2.8 vs. 1.0%, P=0.117). The results of EASTBOURNE-BIF study show how the use of this DCB alone or in combination with drug eluting stents could represent a safe and effective alternative to stents for the treatment of bifurcations.

Sirolimus-coated balloon in all-comer population of coronary artery disease patients: the EASTBOURNE DIABETES prospective registry

BackgroundThe outcomes of percutaneous coronary intervention (PCI) in diabetic patients are still suboptimal, and it is unclear if diabetic patients might derive a benefit from the use of drug-coated balloons.AimsTo evaluate the impact of diabetes mellitus on the outcomes of patients undergoing PCI with sirolimus-coated balloon (SCB) MagicTouch (Concept Medical, India).MethodsWe conducted a subgroup analysis of the prospective, multicenter, investigator-initiated EASTBOURNE registry, evaluating the performance of MagicTouch SCB in patients with and without diabetes. The study primary endpoint was target lesion revascularization (TLR) at 12-month follow-up. Secondary clinical endpoints were major adverse clinical events (MACE), death, myocardial infarction (MI), and BARC 2–5 bleedings.ResultsAmong 2,083 enrolled patients, a total of 864 suffered from diabetes (41.5%). Patients with diabetes had a numerically higher occurrence of TLR (6.5% vs. 4.7% HR 1.38, 95%CI 0.91–2.08), all-cause death (3.8% vs. 2.6%, HR 1.81, 95%CI 0.95–3.46), and MACE (12.2% vs. 8.9%; HR 1.26 95%CI 0.92–1.74). The incidence of spontaneous MI was significantly higher among diabetic patients (3.4% vs. 1.5%, HR 2.15 95%CI 1.09–4.25); bleeding events did not significantly differ. The overall incidence of TLR was higher among in-stent restenosis (ISR) as compared to de-novo coronary lesions, irrespectively from diabetes status.ConclusionsIn the EASTBOURNE DIABETES registry, diabetic patients treated with the MagicTouch SCB did not have a significant increase in TLR when compared to non-diabetic patients; moreover, diabetic status did not affect the study device performance in terms of TLR, in both de-novo lesions and ISR.

Angiography-Based Computational Modeling for In Vivo Assessment of Endothelial Dynamic Strain in Coronary Arteries with De Novo Lesions: Comparison of Treatment Effects of Drug-Coated Balloons Between Small and Large Arteries

Acute morphological changes in de novo coronary lesions after drug-coated balloon (DCB) angioplasty can affect endothelial mechanics and consequently clinical outcomes. Angiography-based computational modeling has been validated to assess endothelial dynamic strain (EDS) in coronary arteries in vivo. The EDS was calculated on the basis of pre- and post-DCB angiography. Parameters of quantitative coronary angiography and EDS were quantified at cross-sections in the treated segments. A total of 336 and 348 lesion cross-sections were included in the small/large vessel groups, respectively. The acute lumen gain after DCB was significantly higher in large than small vessels (relative changes: 21.3% [17.4%, 25.1%] vs. 7.4% [4.8%, 10.1%], P &lt; 0.001). Before treatment, three indices of EDS were significantly higher in small than large vessels (for ED-EDS: 29.2% [19.8%, 44.8%] vs. 20.4% [14.3%, 30.2%]; for ES-EDS: 26.8% [18.9%, 37.7%] vs. 18.3% [13.9%, 25.4%]; for TA-EDS: 19.1% [13.9%, 27.8%] vs. 14.3% [10.5%, 20.1%], P &lt; 0.001). After treatment, the EDS in small vessels significantly decreased (P &lt; 0.001). ED-EDS showed the highest correlation with pre-DCB DSP (r = 0.43, P &lt; 0.001) and post-DCB MLD (r = 0.35, P &lt; 0.001). The levels of EDS parameters for small or large vessel lesions significantly differed. Further study is required to examine the clinical value of EDS in predicting cardiac events after DCB treatment.

The relation between fractional flow reserve and vascular dilation ration in predicting myocardial ischemia

Abstract Introduction Fractional flow reserve (FFR) is the gold standard for evaluation of myocardial ischemia but requires invasive pressure wire. Laplace’s Law states that the tension in the wall if a vessel is proportional to the pressure inside the vessel and its radius. The vascular dilation ratio (VDR) is the degree of dilation in the vessel proximal to the stenosis. Our aim was to test VDR using routine angiographic images and its correlation with FFR. Method Patients who performed coronary angiography with FFR were enrolled. After the images were reconstructed using ciunterpint and binarization analysis, VDR was calculated using the ratio of the maximal diameter minus the minimal diameter divided by the minimal diameter after contrast injection. Lesion’s characteristics, including adenosine dose and FFR were collected. The lesions were divided into two groups based on their FFR values: FFR≤ 0.8 and FFR &amp;gt;0.8. Result A total of 31 patients were enrolled, with a mean age 62.0 ± 13.3 years, and 19 of them were male). Of the 31 de-novo lesions analyzed, 23 were located in the left anterior descending artery, 4 in left circumflex artery, and 4 in right coronary artery. VDR was significantly higher in the group of lesions with FFR≤ 0.8, compared to the group with FFR &amp;gt;0.8 (P&amp;lt;0.01) (Table 1). The negative correlation coefficient between VDR and FFR was -0.92 (Figure 1). Conclusion The high negative correlation between VDR and FFR suggests that VDR could be a useful pre-FFR test for evaluating the severity of myocardial ischemia. Further studies with larger sample sized are warranted to confirm these finding.Table 1Figure 1

ISR vs De Novo Lesion Treatment During OCT-Guided PCI: Insights From the LightLab Initiative.

Long-term outcomes after percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) are poor, yet limited granular procedural data exist evaluating lesion assessment, vessel treatment, and acute procedural outcomes. The LightLab Initiative was a multicenter, prospective, observational study with contemporaneous procedural data collection during PCI procedures. Data were collected during PCIs performed by 48 interventional cardiologists at 17 US hospitals (2019-2021). Optical coherence tomography (OCT) was performed pre-PCI for lesion assessment and post-PCI for stent optimization, and results were compared between ISR and de novo lesion PCI. In total, 2592 OCT-guided PCIs involving 2944 lesions were included, of which 458 procedures (17.7%) were ISR PCI. Compared with de novo lesion PCI, ISR lesions were more commonly type C (64.8% vs 52.9%) and performed via femoral artery access (46.4% vs 37.7%). Use of OCT changed operator assessment and treatment decisions more frequently in ISR PCI (94.2% vs 85.2%; P = .002). Scoring balloons (21.8% vs 2.5%), cutting balloons (16.4% vs 3.4%), and atherectomy (26.3% vs 9.9%) were used more commonly in ISR PCI (all P < .0001), and ISR PCI procedures were longer (62 vs 51 min). Moreover, the final achieved minimum stent area and percent expansion (4.4 vs 5.1 mm2 and 80% vs 83%, respectively; both P < .0001) were lower in ISR PCI. In this real-world cohort of patients who underwent OCT-guided PCI, ISR procedures were longer and final minimum stent area and percent expansion were lower despite greater use of advanced lesion modification. OCT frequently altered physician decision making, emphasizing its utility in potentially reducing recurrent stent failure in this high-risk population.

Drug-Coated Balloon Angioplasty for De Novo Lesions on the Left Anterior Descending Artery.

Drug-coated balloons (DCB) are an emerging tool for modern percutaneous coronary intervention (PCI), but evidence on their use for de novo lesions on large vessels is limited. Consecutive patients undergoing DCB-based PCI on the left anterior descending artery in 2 Italian centers from 2018 to 2022 were retrospectively enrolled and compared with patients who received left anterior descending PCI with contemporary drug-eluting stents (DES). In-stent restenosis was excluded. The DCB group included both patients undergoing DCB-only PCI and those receiving hybrid PCI with DCB and DES combined. The primary end point was target lesion failure at 2 years, defined as the composite of target lesion revascularization, cardiac death, and target vessel myocardial infarction. We included 147 consecutive patients undergoing DCB-based treatment on the left anterior descending artery and compared them to 701 patients who received conventional PCI with DES. In the DCB group, 43 patients (29.2%) were treated with DCB only and 104 (70.8%) with a hybrid approach; DCB length was greater than stent length in 55.1% of cases. Total treated length was higher in the DCB group (65 [40-82] versus 56 [46-66] mm; P=0.002), while longer DESs were implanted (38 [24-62] versus 56 [46-66] mm; P<0.001) and a higher rate of large vessels were treated (76.2% versus 83.5%; P=0.036) in the DES cohort. The cumulative 2-year target lesion failure incidence was not significantly different between the 2 groups (DCB, 4.1% versus DES, 9.8%; hazard ratio, 0.51 [95% CI, 0.20-1.27]; P=0.15). After a 1:1 propensity score matching resulting in 139 matched pairs, the DCB-based treatment was associated with a lower risk for target lesion failure at 2 years compared with DES-only PCI (hazard ratio, 0.2 [95% CI, 0.07-0.58]; P=0.003), mainly driven by less target lesion revascularization. A DCB-based treatment approach for left anterior descending revascularization allows a significantly reduced stent burden, thereby potentially limiting target lesion failure risk at midterm follow-up.

TCT-433 Clinical and Procedural Outcomes of Percutaneous Coronary Intervention for De Novo Lesions involving the Ostial Left Circumflex Coronary Artery

TCT-433 Clinical and Procedural Outcomes of Percutaneous Coronary Intervention for De Novo Lesions involving the Ostial Left Circumflex Coronary Artery

Diffuse coronary artery disease management with drug-coated balloons

Drug-coated balloons (DCB) have emerged as a valid alternative for drug-eluting stents in the treatment of in-stent restenosis and de-novo lesions in small vessels. In the past years, a significant effort has been made to investigate the role of this strategy in larger vessel disease, with promising preliminary results being reported for several clinical scenarios, including complex lesions, such as bifurcations, chronic total occlusions and diffuse, long lesions. A DCB strategy appears to be of significant interest in diffuse coronary disease, as the total stent length represents an independent predictor for target-vessel failure and a surgical approach does not seem to improve mid- and long-term results compared to optimal medical treatment. Several studies have investigated the safety and efficacy of a non-stent-based approach in this complex setting, and as promising results have been reported, it is fair to assume that reducing the amount of implanted metal in diffusely affected vessels could become the standard of care for these patients if a full or blended therapy with DCB is adopted. However, long-term results from large-scale studies are awaited to confirm these preliminary and intriguing results.

Hybrid and open repair for patients with acute limb ischemia of the lower extremities.

Hybrid revascularization procedures for acute limb ischemia (ALI) are becoming increasingly common, bibliographic data on outcomes is however sparse. Single-center, retrospective study of consecutive patients with ALI that underwent either surgical treatment (ST) or hybrid treatment (HT) between January 2015 and December 2021. The composite outcome of amputation-free survival (AFS) was the primary endpoint. Technical success, overall survival, amputation, and re-intervention rates were the secondary endpoints. During the study period 266 patients (mean age 70.2±14.5 years; 49.6% males) were treated for ALI, 67.3% undergoing ST and 32.7% HT. HT was more frequently used in patients with a previous vascular intervention in the index limb (38/87; 43.7% HT vs. 40/179; 22.3% ST, P=0.001), a stent- or stent graft-occlusion (16/87; 18.4% HT vs. 10/179; 5.6% ST, P=0.002) and/or a bypass occlusion (16/87; 18.4% HT vs. 16/179; 8.9% ST, P=0.043). Technical success was higher in the OR group (75/87; 86.2% HT vs. 173/179; 96.6% ST, P=0.003). Amputation-free survival rate during follow-up (43/87; 49.4% HT vs. 94/179; 52.5% ST, HR 0.76, 95% CI: 0.49 to 1.18, P=0.22) and overall survival (32/87; 36.8% HT vs. 84/179; 46.9% ST, HR 0.81, 95% CI: 0.49 to 1.34, P=0.41) were comparable between the two groups. No statistical differences were observed between the groups regarding major amputation (19/87; 21.8% HT vs. 15/179; 8.4% ST, HR 0.85, 95% CI: 0.33 to 2.23, P=0.74) or reintervention during follow-up (45/87; 51.7% HT vs. 65/179; 36.3% ST, HR 0.92, 95% CI: 0.56 to 1.51, P=0.73). Hybrid and open surgical treatments showed comparable results in our cohort, even though significantly more patients undergoing HT presented with stent and bypass occlusions rather than de-novo lesions.

Establishment of a Nomogram for Predicting the Suboptimal Angiographic Outcomes of Coronary De Novo Lesions Treated with Drug-Coated Balloons.

Factors affecting the angiographic outcomes of coronary de novo lesions treated with drug-coated balloons (DCBs) have not been well illustrated. The aim of the study is to establish a nomogram for predicting the risk of suboptimal diameter stenosis (DS) at angiographic follow-up. A retrospective analysis was performed on a cohort of patients who underwent DCB intervention for coronary de novo lesions with angiographic follow-up data. Multivariable logistic regression analysis was applied to determine the independent predictors of DS ≥ 30% at follow-up, and then a nomogram model was established and validated. A total of 196 patients (313 lesions) were divided into the suboptimal (DS ≥ 30%) and optimal (DS < 30%) DS groups according to quantitative coronary angiography (QCA) measurements of the target lesions at follow-up. Seven independent factors including calcified lesions, true bifurcation lesions, immediate lumen gain rate (iLG%) < 20%, immediate diameter stenosis (iDS) ≥ 30%, DCB diameter/reference vessel diameter ratio (DCB/RVD) < 1.0, DCB length and mild dissection wereidentified. The area under the curve (AUC) (95% CI) of the receiver-operating characteristic (ROC) curve of the nomogram was 0.738 (0.683, 0.794). After the internal validation, the AUC (95% CI) was 0.740 (0.685, 0.795). The Hosmer-Lemeshow goodness of fit (GOF) test (χ2 = 6.57, P = 0.766) and the calibration curve suggested a good predictive consistency of the nomogram. The well-calibrated nomogram could efficiently predict the suboptimal angiographic outcomes at follow-up.This model may be helpful to optimize lesion preparation to achieve optimal outcomes.

Progress and prospect of excimer laser ablation in the treatment of therosclerotic obliterans

In the past few years, the occurrence of atherosclerotic obliterans (ASO) has increased obviously. Although the percutaneous transluminal angioplasty and stenting have been the main treatment methods of ASO, 50% of these patients need re-intervention within 2 years due to restenosis. As the emerging debulking device, excimer laser ablation (ELA) could decrease the deployment of stent and increase the vessel patency. However, the application time of ELA in China is short. Although the effectiveness of ELA in in-stent restenosis has been reported in previous studies, its value in de-novo lesions of lower extremity arteries is still unclear. By reviewing the latest literature and the clinical experience, this article aims to summarize the application of ELA in the lower extremity arterial disease, the factors affecting the vessel patency, the prevention and treatment of device-related complications, and the developing trend of ELA, in order to improve the vessel patency and the patient's prognosis.

Long-Term Outcomes With Drug-Eluting Balloon for the Treatment of In-Stent Restenosis and De Novo Lesions: The Novara-Biella-Trento (NOBITRE) Registry.

Drug-coated balloons (DCBs) have emerged for percutaneous coronary interventions (PCI) of in-stent restenosis or particular anatomical subsets. We provide a real-world analysis of the prognostic determinants and long-term outcomes of patients treated with DCB for any lesion in a comprehensive multicenter registry. The primary study endpoint was the occurrence of major cardiovascular events (MACE: composite of all-cause death, myocardial infarction, and target vessel revascularization) at the longest available follow-up. We included 267 patients (196 treated for in-stent restenosis and 71 for de novo lesions), with a median follow-up of 616 [368-1025] days. MACE occurred in 70 (26.2%) of the patients and related with higher rates of in-stent restenosis (P = .04), longer and more type C lesions (P = .05 and P = .04). At multivariate Cox-regression, type C lesions emerged as the only independent predictor of MACE (adjusted OR [95% CI] = 1.83[1.13-2.97], P = .014), mainly driven by target vessel revascularization (adjusted OR[95% CI] = 1.78[1.05-2.95], P = .03) not conditioning survival. In-stent restenosis emerged as major determinant of TLF (adjusted OR[95% CI] = 2.59[1.17-5.75], P = .02). DCBs represent a treatment option for any lesion; however, type C and restenotic lesions are associated with an increased risk of MACE and target lesion failure, where the optimal strategies for patients' selection and lesion preparation are still undefined.

Mid-term results of stent-less coronary intervention using rotational atherectomy and drug-coated balloon for de-novo lesions in hemodialysis patients.

Although drug-coated balloon (DCB)-based stent-less percutaneous coronary intervention (PCI) for de-novo lesions has attracted more attention, outcomes of the DCB procedure for hemodialysis (HD) patients are reported to be inferior to those for non-HD patients, similarly to drug-eluting stent (DES). Recent several reports have shown that rotational atherectomy (RA) followed by DCB treatment (RA/DCB) could be an option of revascularization strategy particularly for calcified de-novo lesions even in the new-generation DES era; however, efficacy of the RA/DCB procedure for HD patients remains unclear. A total of 47 consecutive cases (53 lesions) undergoing RA/DCB for de-novo lesions were enrolled. According to the presence/absence of HD at baseline, the 47 cases were divided into the HD cases (N.=16) and the non-HD cases (N.=31), and the 53 lesions were divided into the HD lesions (N.=20) and the non-HD lesions (N.=33). The HD cases had a significantly lower prevalence of dyslipidemia and smoking than the non-HD cases. Final RA burr size, DCB diameter used, and angiographic success rate of PCI did not significantly differ between the 2 groups. Preprocedural, post-procedural, and follow-up QCA parameters were also similar between the 2 groups. Twelve-month clinical outcomes were comparable between the 2 groups. Mid-term outcomes of stent-less PCI using RA/DCB for de-novo lesions in HD patients might be comparable to those in non-HD patients, suggesting efficacy of pretreatment of RA prior to DCB treatment in HD patients.

Which predilatation balloons provide the best lesion preparation prior to use of drug coated balloons in de-novo lesions? Results from the PREPARE study.

There is a lack of data on the clinical outcomes following the use of different strategies for lesion preparation prior to the use of drug-coated balloons (DCB). In this study, we have explored the clinical outcomes between different types of predilatation balloons: semi-compliant (SB), non-compliant (NB) and scoring balloons (ScB) used when preparing de-novo lesions prior to the use of DCB. We retrospectively evaluated all patients who underwent treatment with DCB for de-novo lesions between 2011-2019 at 4 high-volume European centres. The measured study endpoints were cardiac-death, TV-MI, TLR and MACE. During the study period, 553 patients were treated with DCB for de-novo lesions, 327 with SB only, 172 with NB and 54 with ScB. There were some differences in the procedural characteristics between the 3 groups. Predilatation balloons were significantly larger in the ScB, and NB groups as compared to the SB (2.7 mm and 2.6 mm vs. 2.3 mm; P<0.001). The reference vessel diameter was significantly larger in the NB group as compared to the ScB and SB (2.6 mm vs. 2.2 mm and 2.3 mm; P<0.001). During the median follow-up duration of 547-days, there were no differences in the hard-clinical endpoints, however, TLR was significantly higher in the ScB as compared to SB and NB group (11% vs. 3.4% and 4.7%; P=0.02). The PREPARE study results do not suggest routine use of ScB prior to DCB in de-novo lesions.