Drug-Coated Balloons in the Management of Coronary Artery Disease.

Drug-coated balloons (DCBs) are specialized coronary devices comprised of a semicompliant balloon catheter with an engineered coating that allows the delivery of antiproliferative agents locally to the vessel wall during percutaneous coronary intervention. Although DCBs were initially developed more than a decade ago, their potential in coronary interventions has recently sparked renewed interest, especially in the United States. Originally designed to overcome the limitations of conventional balloon angioplasty and stenting, they aim to match or even improve upon the outcomes of drug-eluting stents without leaving a permanent implant. Presently, in-stent restenosis is the condition with the most robust evidence supporting the use of DCBs. DCBs provide improved long-term vessel patency compared with conventional balloon angioplasty and may be comparable to drug-eluting stents without the need for an additional stent layer, supporting their use as a first-line therapy for in-stent restenosis. Beyond the treatment of in-stent restenosis, DCBs provide an additional tool for de novo lesions for a strategy that avoids a permanent metal scaffold, which may be especially useful for the management of technically challenging anatomies such as small vessels and bifurcations. DCBs might also be advantageous for patients with high bleeding risk due to the decreased necessity for extended antiplatelet therapy, and in patients with diabetes and patients with diffuse disease to minimize long-stented segments. Further studies are crucial to confirm these broader applications for DCBs and to further validate safety and efficacy.

Jailed high-pressure balloon technique is superior to jailed wire technique in protecting side branch of coronary bifurcation lesions.

Objectives. This study investigated the influence of higher pressure protection with a small diameter balloon of side branch (SB) on bifurcation lesions. Background. Of the different coronary stent implantation techniques, the modified jailed balloon technique has become a viable option for bifurcation lesions. However, there was no detailed study on the relationship between the balloon inflation pressure of the main vessel (MV) and SB. Methods. In this study, we collected information of patients who underwent percutaneous coronary intervention (PCI) for bifurcated lesions between March 2019 and December 2022. They were divided into two groups according to the operation way: active jailed balloon technique (A-JBT) group and jailed wire technique (JWT) group. Results. A total of 216 patients were enrolled. The A-JBT group had a larger SB stenosis diameter (1.53 ± 0.69 vs. 0.95 ± 0.52, p < .001), the lower degree of stenosis (44.34 ± 18.30 vs. 63.69 ± 17.34, p < .001) compared to the JWT group. However, the JWT group had a higher incidence of SB occlusion (18.0% vs. 1.9%, p < .001) compared to the A-JBT group. Nevertheless, the success rate for both groups was 100%. Conclusions. This novel high inflation pressure and small diameter balloon approach we propose has significant advantages. There is a lower rate of SB occlusion and SB dissection, which is more cost-effective and provides better clinical outcomes for the patient. This method should be considered in the future for treating bifurcation lesions.

Predictors of late lumen enlargement after drug-coated balloon angioplasty for de novo coronary lesions.

BACKGROUND: Late lumen enlargement (LLE) - a positive remodelling phenomenon - after drug-coated balloon (DCB) angioplasty for stable coronary disease contributes to a lower restenosis rate. However, lesion characteristics promoting LLE remain unclear. AIMS: This study aimed to investigate predictive lesion characteristics for LLE using serial optical frequency domain imaging (OFDI) following DCB angioplasty for de novo coronary artery lesions. METHODS: This retrospective, single-centre observational study included patients with angina pectoris who underwent paclitaxel-coated balloon angioplasty without stenting under OFDI guidance as well as follow-up OFDI. OFDI endpoints were lumen volume, plaque phenotype, and procedure-associated dissection. LLE was defined as a ≥10% increase in the lumen volume of the treated lesion at follow-up. RESULTS: Between August 2016 and December 2019, among patients with successful DCB angioplasty, 108 lesions (83 patients) had available follow-up imaging after a median of 6.1 months. LLE was detected in 44 (40.7%) lesions. Fibrous/fibrocalcific and layered plaques had significantly larger lumen volumes at follow-up than immediately after the index procedure, whereas lipid plaques exhibited no significant difference. Medial dissection with an arc >90° revealed an increased lumen volume. Multivariate analysis showed that layered plaques (odds ratio [OR] 8.73, 95% confidence interval [CI]: 1.92-39.7; p=0.005) and medial dissection with an arc >90° (OR 4.65, 95% CI: 1.63-13.3; p=0.004) were independent LLE predictors. CONCLUSIONS: Layered plaques and extensive medial dissection after DCB angioplasty were associated with higher LLE occurrence in de novo coronary lesions. These findings may be clinically applicable to DCB therapeutic strategies based on plaque features.

Drug-coated balloon in the treatment of coronary artery de-novo large lesions angiography.

The superiority of drug-coated balloon (DCB) in treating small vessels, branching lesions, and high-risk bleeding lesions in coronary heart disease patients has been confirmed. However, its safety and efficacy in large vessels are still unclear. We aimed to investigate whether the efficacy of DCB in large vessels is not inferior to that of drug-eluting stent (DES). From November 2019 to April 2022, a total of 88 patients in our hospital who underwent coronary angiography for the first time and decided to receive DCB or DES treatment were selected. Indicators including late lumen loss (LLL), major adverse cardiovascular event (MACE) rate, major bleeding and all-cause mortality were evaluated at 9 months and 1-year post percutaneous coronary intervention (PCI) therapy. The primary endpoint of 9-month LLL was -0.07 in the DCB group and 0.19 mm in the DES group (p value＜0.001). 1-year cumulative MACE rates were similar in the DCB and DES groups (3.03% vs. 7.23%, P=0.519), TLR rates were similar (3.03% vs. 7.23%, P=0.519), Major bleeding was similar (3.03% vs. 5.45%, P=0.580), and 1 case of Cardiac death in DES group. For LLL, the DCB-only strategy was non-inferior to DES in treating de novo large lesions in the coronary arteries. Furthermore, the efficacy of DCB was comparable to DES at 1 year of follow-up for secondary clinical endpoints.

Two stents' dislodgement in the left main coronary artery: a case report.

BACKGROUND: Stent dislodgement is a life-threatening complication that can result in coronary artery embolization, stent thrombosis, acute myocardial infarction, and even death. Severely angulated, heavily calcified, and previously stented coronary arteries are associated risk factors. With the development of different lesion preparation techniques and the drug eluting stent era, the reported incidence of stent dislodgement has decreased to < 1% in the last few years. CASE PRESENTATION: We report a case of a 64-year-old Moroccan man complicated during percutaneous intervention in the left main artery by the loss of two stents. This complication was successfully managed by passing the stent's balloon into the stent and then fully expanding it. In our case, the device's characteristics were involved and could play a role in such complications, but it is still not well understood. CONCLUSIONS: The main treatment option is stent retrieval with different available techniques. If retrieval of the stent is impossible, crushing it against the blood vessel wall could be considered.

Comparison of long-term outcomes of double kissing crush versus T and minimal protrusion techniques in complex bifurcation lesions: The EVOLUTE-CRUSH II registry.

BACKGROUND: Double kissing (DK)-crush and T-stenting and small protrusion (TAP) techniques are gaining popularity, but the comparison for both techniques is still lacking. This study sought to retrospectively evaluate the long-term outcomes of DK-crush and TAP techniques in patients with complex bifurcation lesions. METHODS: A total of 255 (male: 205 [80.3%], mean age: 59.56 ± 10.13 years) patients who underwent coronary bifurcation intervention at a single-center between January 2014 and May 2021 were included. Angiographic features, procedure details, and in-hospital or long-term outcomes were assessed. The primary endpoint was target lesion failure (TLF), defined as the combination of cardiac death, target vessel myocardial infarction, or clinically driven-target lesion revascularization (TLR). The regression models were adjusted applying by the inverse probability weighted (IPW) approach to reduce treatment selection bias. RESULTS: The initial management strategy was DK-crush in 152 (59.6%) patients and TAP in 103 (40.4%) cases. The SYNTAX scores (24.58 ± 7.4 vs. 24.26 ± 6.39, p = 0.846) were similar in both groups. The number of balloon (6.32 ± 1.82 vs. 3.92 ± 1.19, p < 0.001) usage was significantly higher in the DK-crush group than in the TAP group. The rates of TLF (11.8 vs. 22.3%, p = 0.025) and clinically driven TLR (6.6 vs. 15.5%, p = 0.020) were significantly lower in the DK-crush group compared to the TAP group. The long-term TLF was significantly higher in the TAP group compared to the DK-crush group (unadjusted HR: 1.974, [95% CI: 1.044-3.732], p = 0.035 and adjusted HR [IPW]: 2.498 [95% CI: 1.232-5.061], p = 0.011). CONCLUSION: The present study showed that the DK-crush technique of bifurcation treatment was associated with lower long-term TLF and TLR rates compared to the TAP technique.

Drug-coated balloon therapy for in-stent restenosis in patients with iliofemoral deep vein thrombosis: A single-arm observational study.

BACKGROUND: Iliofemoral deep vein thrombosis (IFDVT) causes severe symptoms and affect the quality of life to a great extent. Endovascular thrombectomy and stent implantation have been a feasible strategie to alleviate the signs and symptoms of IFDVT. However, venous in-stent restenosis (ISR) has become an emerging non-negligible problem. METHODS: To evaluate the histological characteristics of venous ISR, neointima of arterial and venous ISR patients were collected and examed. To explore the effect of drug-coated balloon (DCB) on venous ISR lesions, we conducted a single-center retrospective case series study involving IFDVT patients with ISR after venous stenting who were treated with paclitaxel-coated balloon dilatation. RESULTS: We found a collagen-rich matrix but not elastin, as well as fewer cells and less neovascularization in venous intimal hyperplasia compared with neointima in arteries. Thirteen IFDVT patients were involved in the study, with average preoperative stenosis degree of 87.69% ± 13.48%. After intervention, the stenosis degree was significantly reduced to 14.6% ± 14.36% immediately (p < 0.0001) and to 16.54% ± 15.73% during follow-up (p < 0.0001). During follow-up, the VEINES-QOL scores (p < 0.0001), VEINES-Sym scores (p < 0.0001), and Villalta scores (p = 0.04) of patients was improved significantly compared with those before intervention. No major adverse events were observed. CONCLUSIONS: The use of DCB may have a positive effect in the treatment of venous ISR by targeting intimal hyperplasia. Moreover, the application of DCB dilatation in IFDVT stenting patients with ISR is deemed safe and effective.

Procedural characteristics and cardiovascular outcomes in patients undergoing drug-coated balloon angioplasty for de novo lesions in large coronary arteries: an observational study.

Limited data exist regarding drug-coated balloon (DCB) treatment in de novo large coronary arteries. We sought to demonstrate procedural characteristics, residual stenosis, and clinical outcomes following DCB angioplasty for de novo lesions in large versus small coronary arteries. The study included 184 consecutive patients with 223 de novo coronary lesions undergoing paclitaxel DCB angioplasty between January 2019 and August 2020, who were divided according to whether the DCB diameter was ≥ 3.0 mm (large group, n = 58) or < 3.0 mm (small group, n = 125). The large group had a higher proportion of acute coronary syndrome more commonly with ostial, bifurcation, and calcified lesions in large vessels and received lesion preparation with more frequent use of scoring or cutting balloons and atherectomy devices compared to the small group. Postprocedural angiographic diameter stenosis was smaller in the large group compared to the small group (31% [22-37] vs. 35% [26-42], p = 0.032), and intravascular ultrasound revealed no significant difference in postprocedural area stenosis between the groups (66.2 ± 7.7% vs. 67.9 ± 7.8%; p = 0.26). The median follow-up duration was 995 days. The incidence of a composite of all-cause death, myocardial infarction, stroke, or target lesion revascularization was similar between the groups (log-rank p = 0.41) and was influenced by the presence of acute coronary syndrome and anemia but not by DCB diameter. The rate of cardiovascular outcomes after DCB treatment was comparable in de novo large and small coronary arteries. Notably, well-planned lesion preparation with intravascular imaging guidance was prevalent in large vessels.

Comparison of Drug-Coated Balloon and Drug-Eluting Stent for the Treatment of Small Vessel Disease (from the Dissolve SVD Randomized Trial).

The Dissolve drug-coated balloons (DCBs) is a new-generation DCB coated with paclitaxel of balloon surface, with midchain triglyceride excipient. Although the use of DCBs is a promising technique, little is known about the the clinical efficacy of the novel Dissolve DCB in coronary small vessel disease. This study was a prospective, randomized, multicenter, noninferiority trial comparing the Dissolve DCB with the Resolute drug-eluting stent (DES) in patients with a reference vessel diameter ≥2.25 and ≤2.75 mm. Patients with a reference vessel diameter ≥2.00 and <2.25 mm were enrolled in the very small vessel registry. The angiographic and clinical follow-up were planned at 9 months and 1 year in all patients, respectively. The primary end point was 9-month in-segment percentage diameter stenosis. A total of 247 patients with small vessel disease from 10 Chinese sites were included (Dissolve DCB, n = 118; Resolute DES, n = 129); 30 patients were treated with the DCB in the very small vessel cohort. The 9-month in-segment percentage diameter stenosis was 31.2 ± 2.0% with Dissolve DCB versus 26.1 ± 2.1% with Resolute DES; the 1-sided 97.5% upper confidence limit of the difference was 10.3% (p for noninferiority = 0.0002). At 12 months, the DCB and DES groups were associated with similar rates of target lesion failure (8.5% vs 6.1%, p = 0.28) and major adverse cardiac and cerebrovascular events (20.9% vs 13.6%, p = 0.12). In conclusion, the Dissolve DCB was noninferior to the Resolute DES for the primary end point of 9-month in-segment percentage diameter stenosis in this multicenter, head-to-head, randomized trial (a safety and efficacy study of Dissolve In Treatment Of Coronary Small Vessel Disease; NCT03376646).

Procedural and one-year outcomes following drug-eluting stent and drug-coated balloon combination for the treatment of de novo diffuse coronary artery disease: the HYPER Study.

BACKGROUND: De novo diffuse coronary artery disease (CAD) is a challenging scenario in interventional cardiology with limited treatment option, beside stent implantation. In this context, a hybrid approach, combining the use of drug-eluting stent (DES) and drug-coated balloon (DCB) to treat different segments of the same lesion (e.g. long lesion and/or true bifurcation), might be an interesting and alternative strategy to limit the metal amount. The aim of this study was to evaluate the safety and efficacy of a hybrid approach in addressing percutaneous treatment of de novo diffuse CAD. METHODS: This was a prospective, multicenter study including patients affected by de novo diffuse CAD treated with a hybrid approach from April 2019 to December 2020. Angiographic and clinical data were collected. The primary endpoint was the one-year device-oriented composite endpoint (DOCE, cardiac death, target vessel myocardial infarction and ischemia-driven target lesion revascularization [ID-TLR]). Periprocedural myocardial infarctions and periprocedural success were included among secondary endpoints. RESULTS: One hundred six patients were included, mean age was 68.2±10.2 years and 78.3% were male. De novo diffuse CAD consisted of 52.8% long lesions and 47.2% true bifurcation lesions. Significant increase in the final minimal lumen diameters and significant decrease in the final diameter stenosis were observed when compared to the baseline values in both DES- and DCB-target segments. Procedural success was 96.2%. DOCE at one-year was 3.7%, with all the adverse events characterized by ID-TLR. CONCLUSIONS: Combination of DES and DCB could be a safe and effective treatment option for the treatment of de novo diffuse CAD (NCT03939468).

Optical Coherence Tomography Predictors of SIde Branch REstenosis after unprotected Left Main bifurcation angioplasty using double kissing crush technique (OP-SIBRE LM Study).

BACKGROUND: Among the two stent strategies, contemporary evidence favors double kissing crush technique (DKC) for complex unprotected distal left main bifurcation (UdLMB) lesions. However one of the major challenges to these lesions is side branch (SB) restenosis. AIMS: Our aim was to identify optical coherence tomographic (OCT) characteristics that may predict SB restenosis (SBR) after UdLMB angioplasty using DKC technique. METHODS: This was a single-center, retrospective study that included 60 patients with complex UdLMB disease, who underwent OCT-guided angioplasty using DKC technique. Angiographic follow-up was performed in all patients at 1 year to identify patients with SBR. Patients with SBR group were compared with patients without SBR (NSBR group) for OCT parameters during index procedure. RESULTS: Twelve (20%) patients developed SBR at 1-year follow-up. The SBR group had longer SB lesion (18.8 ± 3.2 vs. 15.3 ± 3.7 mm, p = 0.004) and neo-metallic carinal length (2.1 vs. 0.1 mm, p < 0.001) when compared to the NSBR group. Longer neo-metallic carinal length was associated with the absence of the dumbbell sign, presence of hanging stent struts across the SB ostium on OCT of final MB pullback. On multivariate regression analysis, SB distal reference diameter (DRD) and SB stent expansion were identified as independent predictors of SBR with SB-DRD of ≤2.8 mm (area under curve-0.73, sensitivity-83.3%, and specificity-62.5%) and SB stent expansion of ≤89% (area under curve-0.88, sensitivity-83.3%, and specificity- 81.2%) as the best cut off values to predict SBR. CONCLUSIONS: SB DRD and SB stent expansion are the OCT predictors of future SBR after UdLMB angioplasty using DKC technique.

Residence time in complex left main bifurcation disease after stenting.

BACKGROUND: Data regarding the mean resident time (RT) after left main (LM) bifurcation stenting are scant. In the present study we performed a patient-specific computational fluid dynamic (CFD) analysis to investigate the different post-stenting mean RT values in LM patients treated with single-or double stenting techniques. METHODS: Patients were identified after reviewing the local Optical Coherence Tomography (OCT) scans database. Overall, 27 patients (mean age 65.5 ± 12.4, 21 males) [10 patients treated with provisional cross-over stenting, 7 with the double kissing crush (DK crush) and 10 with the nano-inverted T (NIT) technique, respectively] with isolated and significant LM bifurcation disease were analyzed. RESULTS: After LM bifurcation stenting, the NIT showed a higher averages WSS values at all bifurcation sites compared to DK crush and provisional cross-over stenting. Moreover, the mean RT resulted lower after NIT compared to provisional or DK crush. During the diastolic phase, the average RT of the entire LM bifurcation was 0.46 s, 0.38 s and 0.33 s after using the provisional stenting, DK crush and NIT, respectively. Moreover, the average RT in the LM bifurcation decreased by 17.1 % using the DK crush and by 28.2 % using the NIT compared to the Provisional. CONCLUSION: The present OCT-derived CFD analysis revealed that, in patients with complex bifurcation LM disease, the provisional approach resulted in lower WSS values, while double stenting techniques, especially the NIT technique, resulted in a marked reduction of average RT compared to the provisional approach. CONDENSED ABSTRACT: In the present study we performed a patient-specific Optical coherence tomography (OCT)-based computational fluid dynamic (CFD) analysis to investigate the different post-stenting mean RT values in 27 patients treated with provisional cross-over stenting, DK crush and Nano-inverted-T (NIT) stenting. The NIT showed a higher averages WSS values at all bifurcation sites compared to DK crush and Provisional. The mean RT resulted lower in NIT compared to Provisional or DK crush. During the entire diastolic phase, the average RT of the entire LM bifurcation was 0.46 s, 0.38 s and 0.33 s after using the provisional stenting, DK crush and NIT, respectively. Moreover, the average RT in the entire LM bifurcation decreased by 17.1 % using the DK crush and by 28.2 % using the NIT compared to the Provisional.

Cost effectiveness analysis of drug coated balloon only angioplasty for de novo coronary artery disease.

AIMS: We aimed to perform a cost analysis of drug coated balloon (DCB)-only angioplasty versus drug eluting stent (DES), for de novo disease of all vessel sizes and all clinical indications. BACKGROUND: DCB angioplasty is an emergent technology for the treatment of coronary artery disease. There is lack of data regarding the cost-effectiveness of DCB-only angioplasty for treatment of de novo coronary artery disease as compared with second generation DES. METHODS: We compared total costs of patients treated with DCB or DES for first presentation of ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, or stable angina due to de novo disease between January 1, 2018 and November 15, 2019. We defined total cost as the sum of (1) procedural devices-cost, (2) procedural staff-cost, (3) post-percutaneous coronary intervention hospital stay cost, and (4) antiplatelet regime cost. A cost minimization analysis was performed to compare the costs of DCB and DES. RESULTS: We present 1952 all-comer, consecutive patients; 902 (1064 lesions) treated with DCB and 1050 (1236 lesions) treated with DES for de novo coronary artery disease. The cost per patient was estimated to be £9.02 more expensive in the DCB group (£3153.00 vs. £3143.98). However, the cost per lesion treated was calculated to be £15.51 cheaper in the DCB group (£3007.56 vs. £3023.07). The results were consistent irrespective of duration of long-term antiplatelet medications. CONCLUSION: We have compared the cost-effectiveness of DCB-only angioplasty to DES-angioplasty and showed that the per patient and per lesion results were not different and hence cost should not be implicated in the decision to choose DCB or DES.