Drug-eluting Balloons In Patients Research Articles

Prevention of in-stent restenosis with drug-eluting balloons in patients with postirradiated carotid stenosis accepting percutaneous angioplasty and stenting

ObjectiveTo investigate the technical safety and outcome of in-stent restenosis (ISR) prevention with drug-eluting balloon (DEB) in patients with postirradiated carotid stenosis (PIRCS) undergoing percutaneous angioplasty and stenting (PTAS).MethodsBetween 2017...

Below Knee Angioplasty Using Drug-Eluting Balloons in Patients with Critical Limb Ischemia with Six Months Follow-Up: Single-Center Experience at Tertiary Care Hospital

Abstract Purpose The aim of this study was to evaluate 6 monthly safety and primary patency rates of drug-eluting balloons (DEB) angioplasty in below-the-knee (BTK) arteries in critical limb ischemia (CLI) patients. Methods A prospective observational study was conducted over 2 years in a tertiary care center. A total of 25 patients with CLI were enrolled in this study. Inclusion criteria were patients presenting with CLI (Rutherford class 4 or greater), equal to or more than 50% luminal stenosis or occlusion of at least one tibial artery, and agreement to 6-month evaluation. Exclusion criteria were life expectancy less than 1 year, allergy to paclitaxel, and contraindication to antiplatelet treatment.Follow-up was performed by clinical and Doppler assessment. The primary endpoint was a 6-month primary patency rate, and secondary endpoints were changes in the Rutherford class and incidence of major amputation. Restenosis rate is defined as a reduction in the luminal diameter by 50% or greater by duplex ultrasound. Results Six-month primary patency was achieved in 19 (76%) patients. Both Rutherford category improvement and reduction in the percentage of stenosis after angioplasty were statistically significant (p-value <0.0001). At 6 months, better patency rates were seen among diabetics (88.8%) than smokers (69.2%). Limb salvage was observed in 24 (96%) patients with one major amputation (above the ankle). Conclusion DEBs have shown safe and promising clinical outcomes with successful performance in infrapopliteal arteries in the short-term follow-up. DEB had a substantial 6-month primary patency rate. DEB angioplasty is a safe and effective treatment option for CLI patients with BTK vascular disease.

Usefulness of Drug-Eluting Balloons for Bare-Metal and Drug-Eluting In-Stent Restenosis (from the RIBS IV and V Randomized Trials)

Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) is particularly challenging. We sought to compare results of drug-eluting balloons in patients with DES-ISR with those in patients with bare-metal stent (BMS) ISR. A pooled analysis of the Restenosis Intra-Stent: Drug-Eluting Balloon versus Everolimus-Eluting Stent IV and V randomized trials was performed. Both trials had identical inclusion and exclusion criteria. Results of drug-eluting balloons in 95 patients with BMS-ISR and 154 patients with DES-ISR were compared. Patients with DES-ISR were more frequently diabetics, presented more often as an acute coronary syndrome and had more severe lesions and more frequently a focal pattern, including edge-ISR. Late angiographic findings (92% of eligible patients), including minimal lumen diameter (1.80 ± 0.6 vs 2.01 ±0.6mm, p= 0.001; absolute mean difference 0.21mm; 95% confidence interval 0.04 to 0.38; p= 0.014) and restenosis rate (19% vs 9.5%, p <0.05) were poorer in DES-ISR. Results were consistent across 10 prespecified subgroups. Moreover, on multiple linear regression analysis, minimal lumen diameter at follow-up remained significantly smaller in patients with DES-ISR after adjusting for potential confounders (adjusted absolute mean difference 0.17mm; 95% confidence interval 0.04 to 0.41; p= 0.019). Finally, at 1-year clinical follow-up (100% of patients), rates of target vessel revascularization (16% vs 6%, p= 0.02) and of the main combined clinical end point (18% vs 8%, p= 0.03) were significantly higher in patients treated for DES-ISR. In conclusion, this study confirms the efficacy of DEB for patients with ISR. However, the long-term clinical and angiographic results of DEB are poorer in patients with DES-ISR than in those with BMS-ISR. (ClinicalTrials.govIdentifier:NCT01239953&NCT01239940).

The Mid-Term Clinical Follow-Up Using Drug-Eluting Balloons on Tibial Artery "De Novo" Lesions in Patients With Critical Limb Ischemia: A Cohort Study.

Restenosis due to intimal hyperplasia (IH) is a major clinical issue that affects the success of lower limb endovascular surgery. After 1 year, restenosis occurs in 40% to 60% of the treated vessels. The possibility to reduce IH using local antiproliferative drugs, such as taxols, has been the rationale for the clinical applications of drug-eluting stents and drug-eluting balloons (DEBs). The purpose of this study was to evaluate the clinical and instrumental efficacy of DEBs versus simple percutaneous transluminal angioplasty (PTA) in patients affected by chronic limb ischemia (CLI) with tibial artery "de novo" lesions. A retrospective analysis was performed and included all consecutive patients who underwent endovascular treatment for CLI in our centers between January 2011 and March 2013. Inclusion criteria were (1) "de novo" tibial artery stenosis and (2) Rutherford class >4. Lesions were further divided by TransAtlantic Inter-Societal Consensus (TASC) classification into groups A, B, C, and D. Between January 2010 and March 2013, a total of 138 patients underwent simple PTA or DEB for CLI, and the groups were clinically and demographically homogenous. We decided to use DEBs in 70 cases. An improvement in the Rutherford Scale in cumulative and single TASC lesions classification was better in the DEB group (74% vs 51%; P = .024) at 24 months than in the PTA group. In the DEB group, the increase in ankle-brachial index was significantly higher than in the PTA group (P = .039). Our experience in addition to the existing literature supports the use of DEB in patients with CLI Rutherford class >3.

Comparison of the Efficacy of Everolimus-Eluting Stents Versus Drug-Eluting Balloons in Patients With In-Stent Restenosis (from the RIBS IV and V Randomized Clinical Trials)

Treatment of patients with in-stent restenosis (ISR) remains a challenge. This study sought to compare the efficacy of everolimus-eluting stents (EESs) and drug-eluting balloons (DEBs) with paclitaxel in patients with ISR. A pooled analysis of the Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent (RIBS IV) and Restenosis Intra-Stent of Bare-Metal Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent (RIBS V) randomized trials was performed using patient-level data. In both trials, EESs were compared with DEBs in patients with ISR (RIBS V included 189 patients with bare-metal ISR; RIBS IV included 309 patients with drug-eluting ISR). Inclusion and exclusion criteria were identical in both trials. A total of 249 patients were allocated to EES and 249 to DEB. Clinical follow-up at 1 year was obtained in all (100%) patients and late angiography (median 249 days) in 91% of eligible patients. Compared with patients treated with DEBs, patients treated with EESs obtained better short-term results (postprocedural minimal lumen diameter 2.28 ± 0.5 vs 2.12 ± 0.4 mm, p <0.0001). At follow-up, patients treated with EESs had larger in-segment minimal lumen diameter (primary end point 2.16 ± 0.7 vs 1.88 ± 0.6 mm, p <0.0001; absolute mean difference 0.28 mm; 95% confidence interval [CI] 0.16 to 0.40) and net lumen gain (1.33 ± 0.6 vs 1.00 ± 0.7 mm, p <0.0001) and had lower %diameter stenosis (19 ± 21% vs 28 ± 22%, p <0.0001) and binary restenosis rate (8.7% vs 15.7%, p = 0.02). Consistent results were observed in the in-lesion analysis. No interactions were found between the underlying stent type and treatment effects. At 1-year clinical follow-up, the composite of cardiac death, myocardial infarction, and target vessel revascularization was significantly reduced in the EES arm (8.8% vs 14.5%, p = 0.03; hazard ratio 0.59, 95% CI 0.31 to 0.94) mainly driven by a lower need for target vessel revascularization (6% vs 12.4%, p = 0.01, hazard ratio 0.46, 95% CI 0.25 to 0.86). This pooled analysis of the RIBS IV and RIBS V randomized trials demonstrates the superiority of EES over DEB in the treatment of patients with ISR.

GW26-e1581 A Meta-Analysis of Randomized Controlled Trials of Plain Old Balloon Angioplasty Versus Drug-Eluting Balloon in Patients with In-Stent Restenosis

The aim of this study was to compare the 30-day safety and efficacy of plain old balloon angioplasty (POBA) versus drug-eluting balloon (DEB) for treatment in patients with in-stent restenosis (ISR). Data were combined across 11 trials comprising 1,989 patients. Major adverse cardiovascular events(

Rationale and design of the RIBS IV randomised clinical trial (drug-eluting balloons versus everolimus-eluting stents for patients with drug-eluting stent restenosis).

This study will compare the efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients with drug-eluting stent (DES) in-stent restenosis (ISR). This is a prospective, multicentre, randomised clinical trial comparing DEB and EES in patients with DES-ISR. The study is an investigator-driven initiative generated within the RIBS study programme. A total of 310 patients with DES-ISR will be included and randomised (1:1) to DEB or EES. Angiographic follow-up has been scheduled at six to nine months. Quantitative coronary analyses will be performed in a centralised core lab by blinded personnel. The primary endpoint of the study is minimal lumen diameter at angiographic follow-up. Other secondary angiographic endpoints include % diameter stenosis, late loss, net gain and binary restenosis rate. An independent clinical events committee will adjudicate clinical events after reviewing source documents. The main clinical outcome measure is a combined endpoint of cardiac death, myocardial infarction and target vessel revascularisation at one year. Individual components of the combined clinical endpoint and rates of target lesion revascularisation and stent thrombosis will also be compared. This randomised clinical trial will determine the relative efficacy of EES versus DEB in patients presenting with DES-ISR. (ClinicalTrials.gov Identifier: NCT01239940).

Drug-eluting balloons in patients with non-ST elevation acute coronary syndrome

BackgroundWe compared efficacy of bare-metal stent (BMS) and drug-eluting balloon (DEB) combination vs BMS alone, in patients with non-ST elevation acute coronary syndrome treated with percutaneous coronary intervention (PCI). MethodsPatients with non-ST elevation myocardial infarction (NSTEMI) or unstable angina (UA) were randomized to BMS only or BMS+DEB group. Angiographic follow-up was performed after 6 months. The primary endpoints were binary in-stent restenosis (ISR) and late lumen loss (LLL) and the secondary endpoints were target lesion revascularization (TLR), stent thrombosis (ST), and new acute coronary syndrome (ACS). ResultsA total of 85 patients were enrolled, 44 (BMS) and 41 (BMS+DEB). The median age was 67 (36–84) years and 68 (80%) were male. Fifty-two patients (61.2%) had NSTEMI and 33 patients (38.8%) UA. There was no difference in patient demographics, risk factors, and clinical characteristics, except for more smokers in the BMS+DEB group 18/41 (43.9%) vs 9/44 (20.5%). At follow-up, no significant difference in binary ISR was found; p=0.593, but LLL was significantly lower in the BMS+DEB group 0.68 (0.00–2.15) mm vs 0.22 (0.00–2.35) mm; p=0.002. The difference in major adverse cardiac events (MACE) rate combining TLR, ST, and ACS, between the groups was also non-significant, 29.5% (BMS) vs 24.4% (BMS+DEB); p=0.835. One patient had a subacute ST (BMS+DEB) due to clopidogrel resistance. ConclusionPatients treated with BMS+DEB combination for non-ST elevation acute coronary syndrome had significantly less LLL in comparison to patients treated with BMS alone but without an impact on patient clinical outcomes.

Drug-eluting balloons for coronary artery disease: an updated meta-analysis of randomized controlled trials

Drug-eluting balloons (DEB) continue to present as a promising percutaneous intervention for the treatment of coronary artery disease (CAD) [ [1] Cortese B. Bertoletti A. Paclitaxel coated balloons for coronary artery interventions: a comprehensive review of preclinical and clinical data. Int J Cardiol. 2012; 161: 4-12 Abstract Full Text Full Text PDF PubMed Scopus (74) Google Scholar ]. Since we performed our meta-analysis of five randomized trials enrolling 349 patients [ [2] Yu C.M. Kwong J.S. Sanderson J.E. Drug-eluting balloons for coronary artery disease: a meta-analysis of randomized controlled trials. Int J Cardiol. Sept 20 2013; 168: 197-206 Abstract Full Text Full Text PDF PubMed Scopus (8) Google Scholar ], several other studies evaluating DEB in CAD have been completed [ 3 Byrne R.A. Neumann F.J. Mehilli J. et al. Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3): a randomised, open-label trial. Lancet. 2013; 381: 461-467 Abstract Full Text Full Text PDF PubMed Scopus (317) Google Scholar , 4 Rittger H. Brachmann J. Sinha A.M. et al. A randomized, multicenter, single-blinded trial comparing paclitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis: the PEPCAD-DES study. J Am Coll Cardiol. 2012; 59: 1377-1382 Crossref PubMed Scopus (273) Google Scholar ]. Therefore, we incorporated the new evidence into an updated meta-analysis to extend the current knowledge on the efficacy and safety of DEB in patients with CAD.

Comparison of efficacy and safety between sirolimus, paclitaxel, everolimus-eluting stent and drug-eluting balloon on the outcome of patients with diffuse in-stent restenosis after BMS implantation

Purpose: The aim of this study is to compare the safety and efficacy of Sirolimus (SES), Paclitaxel (PES), Everolimus-eluting stent (EES) and SeQuent™ Please, a drug-eluting balloon (DEB) on the outcome of patients with diffuse in-stent restenosis (D-ISR) after bare metal stent (BMS) implantation. Methods: A prospective analysis of 1078 patients with 1251 D-ISR lesions (427 SES, 363 PES, 232 EES and 229 DEB) in six high volume Asian centers after successful stent implantation (SES: LAD 45.7%, LCX 27.9%, RCA 26.4%) (PES: LAD 46.0%, LCX 22.9%, RCA 31.1%) (EES: LAD 50.0%, LCX 21.0%, RCA 29.0%) (DEB: LAD 54.0%, LCX 23.0%, RCA 23.0%) was performed. The study endpoints were major adverse cardiac events (MACE) and target lesion revascularization (TLR) at 12 and 24 months. Results: See table for clinical results. View this table: Conclusion: (1) The use of SES, PES, EES and DEB in patients with D-ISR seems to be favorable in terms of in-hospital clinical outcome. (2) Patients treated with DEB showed higher restenosis rate and TLR compared with DES.

TCT-70 Comparison of Efficacy and Safety between Sirolimus, Paclitaxel, Everolimus-Eluting Stent and SeQuent™ Please, a Drug-Eluting Balloon on the Outcome of Patients with Diffuse In-Stent Restenosis after Bare Metal Stent Implantation

Purpose: The aim of this study is to compare the safety and efficacy of Sirolimus (SES), Paclitaxel (PES), Everolimus-eluting stent (EES) and SeQuent™ Please, a drug-eluting balloon (DEB) on the outcome of patients with diffuse in-stent restenosis (D-ISR) after bare metal stent (BMS) implantation. Methods: A prospective analysis of 1078 patients with 1251 D-ISR lesions (427 SES, 363 PES, 232 EES and 229 DEB) in six high volume Asian centers after successful stent implantation (SES: LAD 45.7%, LCX 27.9%, RCA 26.4%) (PES: LAD 46.0%, LCX 22.9%, RCA 31.1%) (EES: LAD 50.0%, LCX 21.0%, RCA 29.0%) (DEB: LAD 54.0%, LCX 23.0%, RCA 23.0%) was performed. The study endpoints were major adverse cardiac events (MACE) and target lesion revascularization (TLR) at 12 and 24 months. Results: See table for clinical results. Conclusion: (1) The use of SES, PES, EES and DEB in patients with D-ISR seems to be favorable in terms of in-hospital clinical outcome. (2) Patients treated with DEB showed higher restenosis rate and TLR compared with DES.

Asocjacja interwencji sercowo-naczyniowych PTK Stanowisko grupy ekspertów dotyczące zastosowania stentów oraz balonów uwalniających leki antyproliferacyjne u pacjentów z chorobą wieńcową przyjęte przez Asocjację Interwencji Sercowo-Naczyniowych i Polskie Towarzystwo Kardiologiczne

Asocjacja interwencji sercowo-naczyniowych PTK Stanowisko grupy ekspertów dotyczące zastosowania stentów oraz balonów uwalniających leki antyproliferacyjne u pacjentów z chorobą wieńcową przyjęte przez Asocjację Interwencji Sercowo-Naczyniowych i Polskie Towarzystwo Kardiologiczne

Safety and efficacy of drug‐eluting balloons in percutaneous treatment of bifurcation lesions the DEBIUT (drug‐eluting balloon in bifurcaton utrecht) registry

To evaluate outcomes after percutaneous coronary intervention (PCI) with a drug-eluting balloon catheter (paclitaxel-coated) in patients with coronary artery bifurcation lesions. The current practice of provisional stenting of the main branch (MB) is reasonable; however, long-term results of side-branch (SB) treatment are suboptimal. The use of drug-eluting stents has not improved these results, regardless of the implantation technique, and could potentially lead to a significant increase in (late) thrombotic events. To evaluate short-term safety and efficacy of a drug-eluting balloon (DEB) in patients with bifurcation lesions followed by provisional stenting of the main branch, we set up the DEBIUT Registry. This registry enrolled 20 eligible patients with coronary artery bifurcation lesions. Patients received a PCI with a paclitaxel-coated balloon catheter, followed by provisional stenting of the MB with a bare-metal stent. Acute angiographic and clinical follow-up were performed after 1 and 4 months. The procedure was successful in all patients. The use of sequential predilatation with DEB was safe and well tolerated. No acute or subacute closure of side branches occurred after treating with DEB. All patients were treated according to the provisional stenting technique; no stents were placed in the SB. At 4-month follow-up no major acute coronary events and no subacute vessel closure were reported. The use of a drug-eluting balloon in patients with bifurcation lesions was effective and safe up to 4 months following PCI in patients with coronary artery bifurcation lesions.