Drug-coated Balloon Research Articles

Efficacy and safety of drug-coated balloons in the treatment of de novo coronary lesions in very small vessels: a prospective, multicenter, single-arm trial.

BackgroundEvidence of the use of drug-coated balloons (DCB) in de novo large or small coronary lesions and in-stent restenosis has accumulated over the past years. Due to their anatomical peculiarity, the treatment of very small vessels (VSV) (lumen diameter <2 mm) is still a controversial issue. Studies that examine the use of DCB in VSV are limited. We investigated the efficacy and safety of using DCBs for the de novo coronary lesions in VSV undergoing percutaneous coronary intervention (PCI).MethodsIn this prospective, single-arm study, we enrolled adult patients with coronary artery disease from six centers in China. A total of 29 patients had VSV with a target lesion stenosis ≥70% were included. All patients were treated with DCB. The primary endpoint was late lumen loss (LLL) at 9 months of follow-up. The secondary endpoints were major adverse cardiac events including target lesion revascularization, death, or myocardial infarction at 9 months of follow-up.ResultsTwenty-nine eligible patients with VSV were enrolled between November 2019 to May 2020. Angiographic and clinical follow-up were completed at 9 months in 18 (56.25%) patients (7 patients refused to final angiography; 2 failed to finish DCB angioplasty; 1 patient request; 1 other causes of death). The mean diameter of the reference vessel of the target lesion was 1.71±0.27 mm, the minimum lumen diameter (MLD) of the target lesion before operation was 0.31±0.24 mm, the average LLL of the target lesion was 0.13±0.28 mm, and the MLD of the target vessel immediately after operation was (1.19±0.20 mm) and at the 9-month follow-up (1.06±0.31 mm) were significantly higher than those before operation (P=0.043). One patient (5.56%) underwent revascularization. No myocardial infarction or death occurred during follow-up after treatment with DCBs.ConclusionsDCB can be a safe and effective alternative in the treatment of de novo coronary lesions in VSV.

Retrospective study of treatment with a drug-coated balloon alone is beneficial for ostial coronary lesions.

BackgroundThe effects of ostial coronary lesion (OCL) treatment with a drug-coated balloon (DCB) alone remain controversial. This retrospective study assessed the effectiveness and safety with DCB only strategy for OCL and the factors associated with target lesion revascularization (TLR) in these patients.MethodsThe study retrospectively included patients whom had OCLs treated with a paclitaxel-eluting DCB only strategy from 1 May 2014 to 1 May 2017. Patients were divided into in-stent restenosis (ISR) and de novo (primary) groups. And all patients came back to hospital, and underwent clinical and also angiographic follow-up.ResultsAmong the 44 patients with 55 OCLs, 12 (27.3%) were assigned to the ISR group and 32 (72.7%) to the de novo group. The outcomes included TLR, post-interventional lumen gain, and late lumen loss (LLL). Only 8 TLRs (7 ISR and 1 de novo) were observed after a mean follow-up of 16 months. The TLR rate in the de novo group was significantly lower than the ISR group (2.4% vs. 50%, P<0.001). The LLL was 0.07±0.63 mm. Logistic regression analysis showed that the TLR incidence was independently associated with the type of stenosis (ISR vs. de novo) after adjusting for sex [odds ratio (OR), 58.72; 95% confidence interval (CI): 4.42–779.94, P=0.002].ConclusionsTreatment with DCB alone was beneficial to patients with OCLs, particularly those with de novo lesions.

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.

TCTAP A-042 Comparison Between Drug-Coated Balloon and Drug-Eluting Stent in Very Small Coronary Artery Intervention

TCTAP A-042 Comparison Between Drug-Coated Balloon and Drug-Eluting Stent in Very Small Coronary Artery Intervention

Treatment of Coronary De Novo Lesions by a Sirolimus- or Paclitaxel-Coated Balloon

The aim of this randomized controlled trial was to investigate a novel sirolimus-coated balloon (SCB) compared with the best investigated paclitaxel-coated balloon (PCB). There is increasing clinical evidence for the treatment of coronary de novo disease using drug-coated balloons. However, it is unclear whether paclitaxel remains the drug of choice or if sirolimus is an alternative, in analogy to drug-eluting stents. Seventy patients with coronary de novo lesions were enrolled in a randomized, multicenter trial to compare a novel SCB (SeQuent SCB, B. Braun Melsungen; 4μg/mm2) with a PCB (SeQuent Please, B. Braun Melsungen; 3μg/mm2). The primary endpoint was angiographic late lumen loss (LLL) at 6months. Secondary endpoints included major adverse cardiovascular events and individual clinical endpoints such as cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis. Quantitative coronary angiography revealed no differences in baseline parameters. After 6months, in-segment LLL was 0.01 ± 0.33mm in the PCB group versus 0.10 ± 0.32mm in the SCB group. The mean difference between SCB and PCB was 0.08 (95%CI:-0.07 to 0.24). Noninferiority at a predefined margin of 0.35 was shown. However, negative LLL was more frequent in the PCB group (60% of lesions vs 32% in the SCB group; P=0.019). Major adverse cardiovascular events up to 12months also did not differ between the groups. This first-in-human comparison of a novel SCB with a crystalline coating showed similar angiographic outcomes in the treatment of coronary de novo disease compared with a clinically proven PCB. However, late luminal enlargement was more frequently observed after PCB treatment. (Treatment of Coronary De-Novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter Malaysia [SCBDNMAL]; NCT04017364).

TCTAP C-118 A Case of Small Vessel Chronic Total Occlusion Treated With Drug-Coated Balloon

TCTAP C-118 A Case of Small Vessel Chronic Total Occlusion Treated With Drug-Coated Balloon

A Propensity Score-Matched Comparison of Midterm Outcomes Between Drug-Coated Balloons and Drug-Eluting Stents for Patients with Acute Coronary Syndrome.

We conducted a single-center, retrospective, lesion-based study to examine the safety and efficacy of drug-coated balloons (DCBs) for de novo coronary stenosis in patients with acute coronary syndrome (ACS) by comparing them with those of drug-eluting stents (DESs).A total of 309 consecutive lesions in patients with ACS who were successfully treated by emergent procedures using either a DCB (n = 107) or a DES between January 2016 and December 2019 were included in the study. The primary endpoint was the incidence of target lesion failure (TLF), defined as cardiac death without mortality due to ACS, non-fatal myocardial infarction, and any target lesion revascularization, including acute occlusion, after DCB use and definite stent thrombosis after DES placement. A propensity score-matched analysis was used to adjust the 36 baseline variables. Retrospective investigations were conducted in January 2021.Baseline adjustment yielded 91 lesions in each group, with a mean balloon size of 3.02 ± 0.22 mm and a mean length of 20.9 ± 6.2 mm in the DCB group. The frequency of TLF in the DCB group (9.9% during the mean observational interval of 671 ± 508 days) was not significantly different from that in the DES group (13.2% during a period of 626 ± 543 days, P = 0.467). The cumulative TLF-free ratio in the DCB group was not significantly different from that in the DES group (P = 0.475, log-rank test).The present propensity score-matched comparison showed statistically equivalent midterm clinical outcomes after DCB use to those of DES placement for de novo lesions in patients with ACS treated by emergent procedures.

Mid-Term Clinical Outcomes Following Drug-Coated Balloons in Coronary Artery Disease.

Objective: The aim of this study was to evaluate the mid-term efficacy of drug-coated balloons (DCB) in percutaneous coronary intervention (PCI) in two different pathophysiologic scenarios. Background: There are different underlying pathological processes in coronary artery disease. Mid-term safety and efficacy of DCB approach is still limited. Methods: Medical records of all consecutive patients undergoing DCB were evaluated. The primary endpoint was the rate of clinically driven target lesion revascularization (TLR) after 24 months. Results: Between January 2011 and December 2017, 442 patients were included, representing 4.4% of all PCIs in our institution. A total of 460 DCB lesions were treated, of which 328 (71.3%) were de novo and 132 (28.7%) were combined bare metal or drug-eluting stents with in-stent restenosis (ISR). The patients’ mean age was 66.2 ± 11.7 years with a diabetes prevalence of 45.3%. The TLR rate was lower in the de novo group (5.3%) compared to the ISR group (9.4%) (p = 0.04). No differences were observed in major adverse cardiovascular events (MACE) between the de novo group (38.9%) and ISR group (42.5%) (p = 0.47). No significant differences were detected in the TLR occurrence in the subgroup analysis. Conclusion: Our extended experience demonstrates that the mid-term DCB approach in these two pathophysiologic settings represent a reasonable option, with low TLR rate.

Changes to Drug-Coated Balloon Reimbursement Affect Peripheral Arterial Disease Patient Care: A Single-Center Experience.

Introduction: Balloon angioplasty (BA) and stenting have long been the mainstays of endovascular therapy in peripheral arterial disease (PAD). However, the rise of drug-coated balloons (DCBs) has revolutionized care in recent years, with multiple clinical trials showing superiority over BA in maintaining primary patency and freedom from target lesion revascularization (TLR). With the recent drop of the add-on payment for DCBs, a barrier for their use and consequently reduced therapy adoption in PAD might arise. We assessed if this affected physicians' behavior and hospital administration towards stocking and using DCBs.Methods: This single-center, retrospective study evaluated DCB utilization in 2017 versus 2018. Data were collected in two groups: 1) July 1, 2017, to December 31, 2017 - with pass-through code (PTC) - prior medical billing reimbursement - and 2) January 1, 2018, to June 30, 2018 - without PTC - markedly reduced reimbursement. Patients treated for superficial femoral artery (SFA) or popliteal artery (POP) disease were included. The study aimed to determine changes in DCB utilization between the years with and without PTC, and we investigated the treatments that have replaced DCBs. Additionally, we aimed to collect data on readmissions and procedure costs compared to national data.Results: From July through December 2017, 350 DCBs were used in 209 patients (1.675 DCBs per patient), while from January through June 2018, 256 DCBs were used in 180 patients (1.422 DCBs per patient) - a 15.07% reduction in DCBs per patient. The detailed numbers of DCB-treated patients were presented as fractions of total interventions in the groups with and without PTC.Conclusion: The findings of this study show a statistically significant reduction in DCB usage following PTC withdrawal. There are several ethical implications to these findings, primarily highlighting patient beneficence and justice. Moving forward, it will be important to determine if this shift in treatment is owed to other treatment strategies such as BA, BA and atherectomy, BA and bare-metal stents (BMS), or BA and drug-eluting-stents (DES). The next steps should also include determining procedure costs and comparing readmission rates.

New Ultrasound-Controlled Paclitaxel Releasing Balloon vs. Asymmetric Drug-Eluting Stent in Primary ST-Segment Elevation Myocardial Infarction - A Prospective Randomized Trial.

Application of drug-coated balloons (DCBs) is popular for the treatment of percutaneous coronary intervention (PCI). A new DCB has been designed as ultrasound-controlled paclitaxel releasing. This study was conducted to determine whether a DCB-only strategy has a similar safety profile and equal angiographic and clinical outcomes to DES implantation in primary ST-elevation myocardial infarction (STEMI) patients, as well as determine the efficiency and safety of this new DCB. Overall, 184 pretreated STEMI patients were randomized into DCB and DES groups with a 1:1 allocation. The main study end-point was late lumen loss (LLL) during the 9 months after PCI. Late lumen loss was reported to be 0.24±0.39 mm in the DCB group and 0.31±0.38 mm in the DES group (P=0.215). Diameter stenosis was 28.27±15.35% in the DCB group and 25.73±15.41% in the DES group (P=0.312). Major adverse cardiovascular events (MACEs) were reported in 3 patients (3.4%) in the DCB group and 4 patients (4.7%) in the DES group (P=0.718). TLR and TVR in the DCB group was 2.3%, 3.4% and 2.4%, 3.5% in the DES group (P=1.000), respectively. No cardiac death and stent thrombosis (ST) was found in the DCB group at 12 months clinical follow up. The DCB-only strategy showed good angiographic and clinical outcomes in the 9- and 12-month follow-up periods, respectively. The VasoguardTM DCB is safe and feasible to treat STEMI patients.

Below-the-Ankle Orbital Atherectomy in Chronic Limb-Threatening Ischemia Patients as a Bailout Strategy for Limb Salvage: Early Clinical Experience

PurposeTo evaluate the feasibility and early outcomes of below the ankle orbital atherectomy in chronic limb-threatening ischemia in patients with calcified foot arteries. Methods12 patients (mean age 69.4 ± 14.7; range 57 to 85 years) who were affected by diabetes underwent orbital atherectomy below the knee and ankle arterial segments. Technical success was defined as orbital atherectomy passage and debulked the calcified lesion, delivery of adjunctive therapy, and < 30% residual stenosis at final angiogram. The procedural outcome included complications, amputation-free survival, and freedom from clinically-driven target lesion revascularization at 30-days and 6-months of follow-up. ResultsOrbital atherectomy was performed in 3 cases in Anterior tibial (AT) and dorsalis pedis (Ped) arteries + Posterior tibial (PT) and Lateral Plantar (Lat Plan), 5 cases in PT and Lat Plan arteries, 1 case of PT and Medial Plantar, 1 case of Peroneal and Plan Lat, and 2 cases of AT and Ped. After atherectomy, we used a drug-coated balloon (DCB) angioplasty.Technical success was achieved in 11 (91.6%) cases. No deaths were registered during the follow-up. The limb salvage rate was 100%, and no major amputations were registered. Amputation-free survival was 50%. Freedom from CD-TLR was 100% at 30 days and 91.7% at 6-months. One patient underwent a TLR at three months. No major cardiovascular events, limb events, or significant procedure-related complications were registered. ConclusionsCSI orbital atherectomy and DCB angioplasty appear a feasible and promissor treatment options in diabetic CLTI patients.

DCB combined with provisional DES implantation in the treatment of De Novo Medina 0,1,0 or 0,0,1 left main coronary bifurcation lesions: A proof-of-concept study.

ObjectiveTo investigate the safety and efficacy of a percutaneous revascularization strategy that is based on the use of drug-coated balloon for the treatment of patients with acute coronary syndrome and de novo Medina type 0,1,0 or 0,0,1 left main stem bifurcation lesions.Methods: In this multicenter, prospective, proof-of-concept study, patients fulfilling the above criteria were enrolled and received treatment with drug-coated balloon combined with provisional drug-eluting stent implantation in the proximal major branches of the left main stem. Patients who declined this revascularization approach were treated with drug-eluting stent implantation 1-2 mm distally to the left anterior descending or left circumflex artery ostium followed by drug-coated balloon therapy for the ostial disease. The primary endpoint of the study was the calculation of percent diameter stenosis on quantitative coronary angiography post-procedure as well as event rate at 8 months follow-up.ResultsA total of 30 patients were enrolled in the study; their mean age was 60.3 ± 7.8 years, while 22 (73.3%) were male. Twenty-two patients were treated only with drug-coated balloon and provisional drug-eluting stent implantation and 8 had drug-eluting stent implantation followed by drug-coated balloon therapy of the ostium of the left main stem major branch. All the procedures were successful with no immediate complications. The percent diameter stenosis of lesion decreased significantly post-procedure from 87.5% (80.0-90.0) to 20% (17.5-30.0), P < .001. During the follow-up period, no major adverse cardiac events were reported.ConclusionsThis proof-of-concept study indicates that ostial drug-coated balloon therapy of the left main stem major branches is safe and effective. Larger clinical data and longer follow-up are needed before advocating its regular use in clinical practice.

Femoropopliteal Drug-coated Balloon Angioplasty: Long-term Results of the Randomized EffPac Trial

HomeRadiologyVol. 304, No. 1 PreviousNext Original ResearchVascular and Interventional RadiologyFemoropopliteal Drug-coated Balloon Angioplasty: Long-term Results of the Randomized EffPac TrialUlf Teichgräber , Thomas Lehmann, René Aschenbach, Markus Thieme, Thomas Zeller, Ulrich Beschorner, Dierk ScheinertUlf Teichgräber , Thomas Lehmann, René Aschenbach, Markus Thieme, Thomas Zeller, Ulrich Beschorner, Dierk ScheinertAuthor AffiliationsFrom the Department of Radiology, Friedrich-Schiller University, Jena University Hospital, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); Department of Angiology, Cardiology, Diabetology, Regiomed-Vascular Center, Sonneberg, Germany (M.T); University Heart Center Freiburg Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); and Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.).Address correspondence to U.T. (e-mail: [email protected]).Ulf Teichgräber Thomas LehmannRené AschenbachMarkus ThiemeThomas ZellerUlrich BeschornerDierk ScheinertPublished Online:Mar 22 2022https://doi.org/10.1148/radiol.212622MoreSectionsFull textPDF ToolsImage ViewerAdd to favoritesCiteTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinked In AbstractDownload as PowerPoint

Atherectomy With Drug-Eluting Balloon for Common Femoral Artery Occlusive Disease: Early Experience

Previously, the reference standard treatment of occlusive lesions of the common femoral artery was endarterectomy. In recent years, interest in endovascular treatment of the common femoral artery has been increasing. Stenting of the common femoral artery is possible; however, we believe it is better to avoid it. Calcified arterial lesions cannot be treated well with drug-coated balloons alone. Vessel preparation with rotational atherectomy, followed by drug-eluting balloon usage, could be a good option.

A retrospective study of drug-coated balloon angioplasty for vertebral artery origin stenosis.

Angioplasty using drug-coated balloon (DCB) for treatment of symptomatic vertebral artery origin stenosis (VAOS) is promising, but of uncertain benefit. This study aimed to evaluate the feasibility, safety, and effectiveness of using DCB in the treatment of severe VAOS. This study included 20 patients with severe VAOS treated with DCB alone between April 2018 and December 2019. Vascular death, transient ischemic attack (TIA), and stroke related to the responsible artery within 30days after procedure were recorded as primary endpoints. Restenosis, late TIA, and stroke related to VAOS and satisfied clinical outcome [modified Rankin Scale (mRS) ≤ 2] were documented at follow-up visit as secondary endpoints. Of 20 patients, 16 were performed DCB dilation successfully, and 4 were excluded due to further bailout stenting. After the procedure, no adverse event occurred within 30days. Ten of 16 patients achieved residual VAOS (rVAOS) < 50% (lower rVAOS group), and the remaining 6 patients achieved rVAOS ≥ 50% but < 70% (higher rVAOS group). During follow-up, vertebral artery origin restenosis was detected in 3 (18.8%) of 16 patients by ultrasound. Among the 3 patients with restenosis, 2 were belonged to the higher rVAOS group, which might indicate a tendency that the more severe the residual stenosis, the higher the restenosis rate. All patients had no complaint in the whole follow-up period (median, 7months; InterQuartile Range, 1-18months). Angioplasty using DCB for VAOS may be feasible, safe, and effective. The degree of residual stenosis after using DCB alone may affect the restenosis rate.

Clinical Impact of the Size of Drug-Coated Balloon Therapy on Restenosis Rate in Femoropopliteal Lesions

Purpose: Although the size of drug-coated balloons (DCBs) is determined according to the vessel diameter during femoropopliteal (FP)-endovascular therapy (EVT), the measurements of the vessel diameter vary among modalities and its definitions. The aim of this study was to reveal whether the DCB size fitting (1) angiographically-measured lumen diameter (Angio-lumen size), (2) intravascular ultrasound (IVUS)-measured lumen diameter (IVUS-lumen size), or (3) IVUS-measured external elastic membrane (EEM) diameter (IVUS-EEM size) would be beneficial in restenosis occurrence. Materials and Methods: This retrospective, single-center study included 231 de novo FP lesions in 165 patients with peripheral artery disease treated with IN.PACT Admiral DCB under IVUS evaluation. The reference vessel diameter was evaluated as the lumen or EEM diameter at the healthy site distal to the lesion. We retrospectively determined whether the DCB size was close to (ie, equal to or different by <0.5 mm from) Angio-lumen size, IVUS-lumen size, and IVUS-EEM size. The association of the size of DCB with restenosis risk was investigated. Results: The mean lesion length was 13 ± 9 cm and the prevalence of chronic total occlusion was 18%. During a mean follow-up period of 17 ± 9 months, restenosis occurred in 26% of lesions. Lesions treated with a DCB of IVUS-EEM size had a lower 2 year restenosis rate than those treated with a DCB over/under IVUS-EEM size (19.7 ± 5.7% vs 34.5 ± 4.7%, p=0.02 by the log-rank test), while the restenosis rate was not significantly different between DCBs of Angio-lumen size or IVUS-lumen size and those over/under the size (both p>0.05). The multivariate Cox regression analysis revealed that DCBs of IVUS-EEM size were independently associated with a reduced risk of restenosis (adjusted hazard ratio 0.50; 95% confidence interval 0.27–0.95; p=0.03). Conclusion: The DCBs of IVUS-EEM size, but not of Angio-lumen size or IVUS-lumen size, were associated with a reduced risk of restenosis after FP-EVT. Determining the DCB size according to IVUS-evaluated EEM diameter would be potentially beneficial in restenosis occurrence.

Long-term outcomes of paclitaxel-coated balloons for non-malignant ureteral strictures.

To evaluate the clinical efficacy and safety of drug-coated balloon (DCB) ureteroplasty for the management of non-malignant ureteral strictures. A prospective "off-label" monocentric single-arm pilot study investigating the safety and efficacy of drug-coated balloon (DCB) (Lutonix®; BD, USA) was performed. Twenty-five patients with benign ureteral strictures related to uretero-enteric anastomosis (n = 13); lithiasis (n = 5), post-surgical complications (iatrogenic n = 5), transplanted kidney (n = 1) and post-radiotherapy (n = 1) were included. Following lesion crossing, predilatation was performed using 4-7mm high-pressure balloon catheter (5-6Fr) with a balloon pressure of 6-7atm based on the manufacturer's recommendation. In the absence of rupture of the ureteral wall, the DCB was dilated for 4min. across the lesion. The process was repeated if deemed necessary to a maximum of three stricture dilatations. We analysed both clinical and radiological primary patency (no signs of ipsilateral hydronephrosis or improvement of the existing residual dilatation at the follow-up examinations) and secondarily safety endpoints. Mean lesion length was 40 ± 28.5mm. Mean time follow up was 36months ± 10.46months. Strictures were located at upper ureteric (12%), lower ureteric (32%), ureterovesical anastomosis (4%) and uretero-enteric anastomosis (52%) levels. The overall radiological success at 1-year follow-up was 88% (22/25 patients). In 56% patients (14/25 patients with primary patency) the nephrostomy catheter was removed 21days following a single DCB procedure. In 32% (8/25 patients) an additional dilatation sessions were required for maintaining the ureteral patency. The overall failure rate at 1-year follow-up was 12% (3/25 patients). Only one case of febrile urinary tract infection in a female patient (acute pyelonephritis) was encountered after the first dilatation. Paclitaxel-coated balloon ureteroplasty proved to be safe and effective for the treatment of non-malignant ureteral strictures. Larger studies are warranted to validate these promising initial results.

The Impact of Intravascular Ultrasound onFemoropopliteal Artery EndovascularInterventions: A Randomized Controlled Trial.

The aim of this study was to investigate whether the addition of intravascular ultrasound (IVUS) guidance during femoropopliteal artery interventions reduced the rate of binary restenosis within 12months compared with angiographic guidance alone. IVUS is more accurate than angiography for assessment of vessel size and disease severity. Low-level studies suggest that the use of IVUS in femoropopliteal endovascular interventions improves outcomes, but currently, no level 1 evidence exists. This was a prospective single-center trial of 150 patients undergoing femoropopliteal endovascular intervention, randomized (1:1) to guidance by angiography or angiography and IVUS. The primary outcome measure was freedom from binary restenosis, on duplex ultrasound, within 12months. Secondary outcomes included clinically driven target lesion revascularization, disagreements in imaging findings between modalities, and changes in treatment caused by IVUS. Freedom from binary restenosis at 12months was significantly higher in the IVUS group (72.4% vs 55.4%; P = 0.008). There was no significant difference between groups for clinically directed target lesion revascularization (84.2% and 82.4%; P = 0.776). Mean vessel diameter was significantly larger with IVUS (5.60mm vs 5.10mm; P< 0.001). A change in treatment occurred caused by IVUS in 79% of cases. Binary restenosis was lower in the IVUS group for cases treated with drug-coated balloons (9.1% vs 37.5%; P = 0.001). The use of IVUS resulted in a significant reduction in the rate of restenosis after endovascular intervention. This is the first randomized controlled trial to demonstrate that IVUS improves outcomes in femoropopliteal interventions. This benefit may primarily relate to cases treated with drug-coated balloons. (Does the use of intravascular ultrasound improve outcomes of endovascular interventional procedures for peripheral vascular disease of the superficial femoral artery or popliteal artery?; ACTRN12614000006640).

Rationale and design for comparison of non-compliant balloon with drug-coating balloon angioplasty for side branch after provisional stenting for patients with true coronary bifurcation lesions: a prospective, multicentre and randomised DCB-BIF trial

IntroductionProvisional stenting using drug-eluting stent is effective for simple coronary bifurcation lesions. Kissing balloon inflation using conventional non-compliant balloon is the primary treatment of side branch (SB) after main vessel...

Safety and efficacy of systematic lesion preparation with a novel generation scoring balloon in complex percutaneous interventions: results from a prospective registry.

Coronary lesions predilatation with semicompliant (SC) or non-compliant balloons (NC) may be insufficient to obtain an optimal stent expansion, which can lead to in-stent restenosis or thrombosis. Moreover, increasing evidence supporting an optimal lesion preparation is mandatory when drug coated balloons (DCB) are used. To this extent, more "aggressive tools" such as cutting/scoring balloons, atherectomy or lithotripsy may play an important role and improve outcomes. We enrolled 78 consecutive patients from March 2020 to October 2020 with calcific/fibrotic or ostially-located lesions, which were prepared using scoring balloons, in addition to SC/NC balloons and other plaque modification strategies. The final treatment consisted in either stent or DCB usage. The primary endpoint was the rate of clinically-driven target lesion revascularization. Secondary endpoints entailed the procedural success and the individual rates of major adverse cardiac events (MACE) at 12 months. Most of the patients had left main (LM) or ostial lesions, 65% of them being moderate/severely calcified, with further debulking strategies being required in 15 (19.2%) patients (rotational atherectomy, 3.8% or coronary intravascular lithotripsy, 15.3%). A high-rate of DCB usage was reported. Angiographic and procedural success was obtained in 77 and 76 patients, respectively. We encountered one vessel perforation, which was sealed with a covered stent, without consequence. During follo- up, we observed only 6 MACE, 6 target lesion revascularizations (TLR) and 2 cardiovascular deaths. Among patients with high complexity and calcific lesions, an optimal lesion preparation using a dedicated scoring balloon was associated with low clinical events at mid-term follow-up and may be considered to improve immediate procedural success rate.