Balloon Versus Research Articles

3-Year Clinical Follow-Up of the RIBS IV Clinical Trial: A Prospective Randomized Study of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis in Coronary Arteries Previously Treated With Drug-Eluting Stents

ObjectivesThis study sought to compare the long-term safety and efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients with in-stent restenosis (ISR) of drug-eluting stents (DES). BackgroundTreatment of patients with DES-ISR remains a challenge. MethodsThe RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents) trial is a prospective multicenter randomized clinical trial comparing DEB and EES in patients with DES-ISR. The pre-specified comparison of the 3-year clinical outcomes obtained with these interventions is the main objective of the present study. ResultsA total of 309 patients with DES-ISR were randomized to DEB (n = 154) or EES (n = 155). At angiographic follow-up, the in-segment minimal lumen diameter was larger in the EES arm (2.03 ± 0.7 mm vs. 1.80 ± 0.6 mm; p < 0.01). Three-year clinical follow-up was obtained in all enrolled patients (100%). The combined clinical outcome measure of cardiac death, myocardial infarction and target lesion revascularization was significantly reduced in the EES arm (19 [12.3%] vs. 31 [20.1%]; p = 0.04; hazard ratio: 0.57 [95% confidence interval: 0.34 to 0.96]), driven by a lower need for target lesion revascularization (11 [7.1%] vs. 24 [15.6%]; p = 0.015; hazard ratio: 0.43 [95% confidence interval: 0.21 to 0.87]). The need for “late” (>1 year) target lesion revascularization (2.6% vs. 4%) and target vessel revascularization (4% vs. 6.6%) was similar in the 2 arms. Rates of cardiac death (3.9% vs. 3.2%), myocardial infarction (2.6% vs. 4.5%), and stent thrombosis (1.3% vs. 2.6%) at 3 years were also similar in both arms. ConclusionsThe 3-year clinical follow-up of this randomized clinical trial demonstrates that in patients with DES-ISR, EES reduce the need for repeat interventions compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents [RIBS IV]; NCT01239940)

LBT-5 A Multicenter Randomized Clinical Trial to Evaluate the Efficiency of Small-Vessel Coronary Treatment Using Paclitaxel Drug-Coated Balloon Versus Zotarolimus-Eluting Stent: RAMSES trial

LBT-5 A Multicenter Randomized Clinical Trial to Evaluate the Efficiency of Small-Vessel Coronary Treatment Using Paclitaxel Drug-Coated Balloon Versus Zotarolimus-Eluting Stent: RAMSES trial

GW28-e0314 Drug-Eluting Balloon Versus Bare-Mental Stent and Drug-Eluting Stent for De Novo Coronary Artery Disease: a Systematic Review and Meta-Analysis

Drug-eluting balloon (DEB) has become an alternative option to drug-eluting stent (DES) for the treatment of in-stent restenosis (ISR). However, the effect of drug-eluting balloon with regular bare-mental stent (BMS) in de novo coronary artery disease (CAD) is unclear. This meta-analysis aimed to

Drug-Coated Balloon Versus Drug-Eluting Stent in Primary Percutaneous Coronary Intervention: A Feasibility Study

BackgroundDrug-eluting stents (DES) represent a significant evolution in the treatment of patients with acute myocardial infarction with ST elevation. However, stent-related adverse events have led to an introduction of drug-coated balloons (DCB) applied particularly to bifurcation lesions, in-stent restenosis and small vessel disease. The aim of this study was to determine whether a DCB-only strategy has a similar safety profile and equal angiographic and clinical outcomes to DES implantation in primary percutaneous coronary intervention (pPCI). Materials and MethodsSeventy-five patients with acute myocardial infarction with ST elevation were randomized into DES and DCB groups of 37 and 38 patients, respectively. The study end-points were major adverse cardiac events and late lumen loss during the 6 months following the pPCI. ResultsReinfarction occurred in 5.4% of patients in the DES and 5.3% of patients in the DCB group after 1 month (risk ratio = 1.03, 95% CI [0.15-6.91], P = 0.98). After 6 months, major adverse cardiac events were reported in 5.4% of patients in the DES group and none in the DCB group (risk ratio = 5.13, 95% CI [0.25-103.42], P = 0.29). Late lumen loss in the DES group was 0.10 ± 0.19mm and −0.09 ± 0.09mm in the DCB group (P < 0.05). ConclusionsA DCB-only strategy is safe and feasible in the pPCI setting and showed good clinical and angiographic outcomes in a 6-month follow-up period.

Medical Therapy Versus Balloon Angioplasty for CTEPH: A Systematic Review and Meta-Analysis

A significant number of chronic thromboembolic pulmonary hypertension (CTEPH) patients will have an inoperable disease. Medical therapy and balloon pulmonary angioplasty (BPA) have provided alternate therapeutic options for patients with inoperable CTEPH, although there are a limited number of published studies examining the outcomes. Thus, our study aims to evaluate and compare the efficacy of medical therapy and BPA in patients with inoperable CTEPH. An electronic search of six databases was performed and the search results were screened against established criteria for inclusion into this study. Data was extracted and meta-analytical techniques were used to analyse the data. Pooled data from RCTs revealed that medical therapy, compared with a placebo, was associated with a significant improvement of at least one functional class (p=0.038). With regards to pulmonary haemodynamics, medical therapy also resulted in a significant reduction in both mean pulmonary arterial pressure (mPAP) (p=0.002) and pulmonary vascular resistance (PVR) (p<0.001). From the included observational studies, the 6-minute walk distance (6MWD) significantly increased following medical therapy by an average of 22.8% (p<0.001). The pooled improvement in 6MWD was found to be significantly higher in the BPA group when compared to medical therapy for CTEPH (p=0.001). Pooled data from available observational studies of medical therapy or BPA all demonstrated significant improvements in mPAP and PVR for pre versus post intervention comparisons. The improvement in mPAP (p=0.002) and PVR (p=0.002) were significantly greater for BPA intervention when compared to medical therapy. High-quality evidence supports the use of targeted medical therapy in improving haemodynamics in patients with inoperable CTEPH. There is only moderate-quality evidence from observational studies supporting the efficacy of BPA in improving both haemodynamics and exercise capacity. Further RCTs and prospective observational studies comparing medical therapy and BPA in patients with inoperable CTEPH are required.

Emergency Transcatheter Aortic Valve Replacement Versus Balloon Aortic Valvuloplasty for the Management of Decompensated Aortic Stenosis

Emergency Transcatheter Aortic Valve Replacement Versus Balloon Aortic Valvuloplasty for the Management of Decompensated Aortic Stenosis

Drug-Coated Balloon Versus Standard Balloon for Superficial Femoral Artery In-Stent Restenosis: The Randomized Femoral Artery In-Stent Restenosis (FAIR) Trial

Drug-Coated Balloon Versus Standard Balloon for Superficial Femoral Artery In-Stent Restenosis: The Randomized Femoral Artery In-Stent Restenosis (FAIR) Trial

Drug-Coated Balloon Versus Plain BalloonAngioplasty for the Treatment ofFemoropopliteal Artery Disease: An Updated Systematic Review and Meta-Analysis of Randomized Clinical Trials.

This study sought to assess the risk of target lesion revascularization (TLR) and all-cause death at 12months andat the maximum available follow-up. Secondary objectives included the identification of factors which could have influenced general findings. Recently several randomized trials comparing drug-coated balloon (DCB) with conventional plain balloon (PB) for the treatment of femoropopliteal artery disease have been reported, but no updated meta-analyses are available and questions remain surrounding the long-term antirestenotic effectiveness of the 2 therapies. We searched main electronic databases for randomized trials comparing DCB and PB for femoropopliteal artery disease. Random effects models were used to estimate the risk of TLR and all-cause death at 12 months, whereas long-term TLR and death risk were assessed by mixed effects Poisson regression models and incident rates of each outcome per patient-year. Main analyses were supplemented by sensitivity analyses, Bayesian estimates, and trial sequential analysis. A total of 8 eligible trials were identified. DCB was associated with a marked 12-month TLR risk reduction as compared with PB (risk ratio: 0.33; 95% confidence interval [CI]: 0.19 to 0.57). The risk of death was similar between groups (risk ratio: 0.96; 95% CI: 0.47 to 1.95). Long-term outcomes assessment showed a reduced incidence of TLR with DCB (0.35; 95% CI: 0.24 to 0.51) and a similar incidence of all-cause death (incidence rate ratio: 1.13; 95% CI: 0.60 to 2.15). Similar findings were observed in Bayesian analyses. Significant heterogeneity was present with evidence of differential efficacy across devices. Trial sequential analysis indicated that available evidence is sufficient to prove superior antirestenotic efficacy of DCB over PB. DCB significantly reduces the risk of TLR as compared with PB without any effect on all-cause death.Evidence exists for differential efficacy according to the type of device used. Future trials investigating DCB angioplasty should include potentially more effective comparator therapies.

Drug-eluting Balloon Versus Second Generation Drug Eluting Stents in the Treatment of In-stent Restenosis: A Systematic Review and Meta-analysis

In-stent restenosis (ISR) remains a significant mode of stent failure following PCI. The optimal treatment strategy, however, remains undefined and the role of drug-eluting balloons (DEB) in the management of ISR is also unclear. A meta-analysis was performed to compare the efficacy of DEB in the treatment of ISR against second generation drug eluting stents (DES). Seven studies comprised of 1,065 patients were included for analysis. The follow-up period ranged from 12-25 months. The use of DEB was associated with an inferior acute gain in minimal luminal diameter (MLD) (0.36, 95% CI: 0.16-0.57mm), higher late loss in MLD (0.11, 0.02-0.19mm) and a higher binary restenosis rate at follow-up (risk ratio: 2.24, 1.49-3.37). No significant differences were noted in the overall incidence of the analysed clinical parameters between the two groups. When only the randomised controlled trials (RCT) were considered however, there was a strong trend towards higher target lesion revascularisation (TLR; 9.9% vs. 3.6%; RR: 2.5, p=0.07) and a significantly higher major adverse cardiovascular event (MACE) rate (15.7% vs. 8.8%; RR 1.78; p=0.02) with DEB. While equipoise has been demonstrated in selected clinical outcomes between DEB and second generation DES in the treatment of ISR, the suboptimal angiographic outcome at follow-up and the higher TLR and MACE rates associated with DEB observed in the RCT are concerning. The results of the present analysis should be regarded as preliminary, although the generalised adoption of DEB in the treatment of ISR currently cannot be recommended.

TCTAP A-148 One Year Clinical Outcome in Patients with Small Vessel Disease Treated with Bare-Metal Stenting Plus Drug-Eluting Balloon Versus Drug-Eluting Stenting

TCTAP A-148 One Year Clinical Outcome in Patients with Small Vessel Disease Treated with Bare-Metal Stenting Plus Drug-Eluting Balloon Versus Drug-Eluting Stenting

Drug-Coated Balloon Versus Standard Balloon for Superficial Femoral Artery In-Stent Restenosis: The Randomized Femoral Artery In-Stent Restenosis (FAIR) Trial

Drug-Coated Balloon Versus Standard Balloon for Superficial Femoral Artery In-Stent Restenosis: The Randomized Femoral Artery In-Stent Restenosis (FAIR) Trial

A Controlled, Randomized Clinical Study on the Impact of Treatment on Antral Mucociliary Clearance: Uncinectomy Versus Balloon Sinuplasty.

To find out the effect of minimal invasive sinus surgery and balloon sinuplasty on mucociliary clearance and compare different methods of measuring mucociliary clearance. Twenty-nine patients with chronic rhinosinusitis were randomized in 2 operative groups (uncinectomy or balloon sinuplasty). Before and 6 months after the treatment, patients filled out a quality of life questionnaire (Sino Nasal Outcome Test-22 [SNOT-22]), and mucociliary clearance was measured with endoscope and gamma camera after 0.03 ml of saccharine, methylene-blue dye, and human albumin labeled with Tc99m was introduced to the bottom of maxillary sinuses. In uncinectomy group, SNOT-22 score decreased, but treatment had no effect on mucociliary clearance. Based on saccharine test, smoking was associated with worse mucociliary clearance (r = 0.618, P < .05). Methylene blue test results associated with saccharine test (r = 0.434, P < .05) and Tc99m-labeled tracer technique (r = 0.261, P = .039) separately. Treatment positively affects patients' quality of life; however, it has no effect on mucociliary clearance. There was a statistically significant correlation between the Tc99m-labeled tracer technique and the methylene blue technique. The saccharine technique was even less accurate, but it can be useful in clinical practice because it is a quick, easy, and safe technique.

Cost Effectiveness of Drug Coated Balloon Versus Percutaneous Transluminal Balloon Angioplasty In The Treatment of Peripheral Arterial Disease In Lower Limbs In Brazil

Cost Effectiveness of Drug Coated Balloon Versus Percutaneous Transluminal Balloon Angioplasty In The Treatment of Peripheral Arterial Disease In Lower Limbs In Brazil

Drug-Coated Balloons Versus Second-Generation Drug-Eluting Stents for the Management of Recurrent Multimetal-Layered In-Stent Restenosis

This study aimed to investigate the clinical outcomes of patients presenting with recurrent drug-eluting stent (DES) in-stent restenosis (ISR) treated with a second-generation DES or with a drug-coated balloon (DCB). To date, there are no reports of DCB treatment and limited data with regard to the efficacy of further DES implantation for recurrent ISR. Between January 2008 and December 2013, 171 lesions were assessed for eligibility (82 lesions in the second-generation DES group and 89 lesions in the DCB group). Acute gain was greater in the second-generation DES group (second-generation DES, 2.09 ± 0.53 mm vs. DCBs, 1.60 ± 0.62 mm, p< 0.001). The rates of major adverse cardiac events were comparable (at 1 year, DES 14.0% vs. DCBs 12.3%; at 2 years, DES 28.8% vs. DCBs 43.5%, p= 0.21). Major adverse cardiac event rates were mainly driven by target lesion revascularization (at 1 year, DES 12.5% vs. DCBs 10.9%; at 2 years, DES 27.7% vs. DCBs 38.3%; p= 0.40). Definite scaffold thrombosis occurred in 2 patients (1 patient in each group). Multivariable analysis revealed ISR recurrence within 1 year (hazard ratio: 2.43, 95% confidence interval: 1.14 to 5.18, p= 0.02) and lesion length (per 10-mm increase) (hazard ratio: 1.15, 95% confidence interval: 1.00 to 1.32, p= 0.049) to be independent predictors of TLR. The results after both treatments were equivalent. ISR recurrence within 1 year of the first reintervention and lesion length were independent predictors of future target lesion revascularization. Larger studies are required to confirm the late (>1 year) differences with regard to clinical outcomes.

A Prospective Randomized Trial of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis of Drug-Eluting Stents: The RIBS IV Randomized Clinical Trial

BackgroundTreatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) remains a major challenge. ObjectivesThis study evaluated the comparative efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients presenting with DES-ISR. MethodsThe study design of this multicenter randomized clinical trial assumed superiority of EES for the primary endpoint, in-segment minimal lumen diameter at the 6- to 9-month angiographic follow-up. ResultsA total of 309 patients with DES-ISR from 23 Spanish university hospitals were randomly allocated to DEB (n = 154) or EES (n = 155). At late angiography (median 247 days; 90% of eligible patients), patients in the EES arm had a significantly larger minimal lumen diameter (2.03 ± 0.7 mm vs. 1.80 ± 0.6 mm; p < 0.01) (absolute mean difference: 0.23 mm; 95% CI: 0.07 to 0.38), net lumen gain (1.28 ± 0.7 mm vs. 1.01 ± 0.7 mm; p < 0.01), and lower percent diameter stenosis (23 ± 22% vs. 30 ± 22%; p < 0.01) and binary restenosis rate (11% vs. 19%; p = 0.06), compared with patients in the DEB arm. Consistent results were observed in the in-lesion analysis. At the 1-year clinical follow-up (100% of patients), the main clinical outcome measure (composite of cardiac death, myocardial infarction, and target vessel revascularization) was significantly reduced in the EES arm (10% vs. 18%; p = 0.04; hazard ratio: 0.58; 95% CI: 0.35 to 0.98), mainly driven by a lower need for target vessel revascularization (8% vs. 16%; p = 0.035). ConclusionsIn patients with DES-ISR, EES provided superior long-term clinical and angiographic results compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent [RIBS IV]; NCT01239940)

Functional Endoscopic Sinus Surgery Versus Balloon Sinuplasty with Ethmoidectomy: A 2-year Analysis in Pediatric Chronic Rhinosinusitis.

To evaluate the 2-year post-operative outcomes of pediatric patients with chronic rhinosinusitis (CRS) treated with balloon catheter sinuplasty (BCS) and ethmoidectomy compared to functional endoscopic sinus surgery (FESS). Two-group, retrospective cohort study of 28 children with CRS was performed. Of these 28 participants, 15 were treated with traditional FESS (53.6%) and 13 (46.4%) underwent traditional ethmoidectomy with balloon sinuplasty. Pre-operative and 2-year postoperative total symptom scores and medications were compared. To examine the potential long-term differences in surgical outcomes and surgical procedure on symptom outcome, one-tailed Chi square analyses were employed. The mean age of the children examined was 9.3 (SD=SD=4.1; range 3-18) and 61.9% were male. Pre-operative symptomatology, medication and Lund Mackay scores were evaluated for both groups and no significant differences were identified. Overall, 73.3% of children that underwent traditional FESS and 76.9% of those who had BCS with ethmoidectomy reported significant long-term improvement in at least one of their pre-operative sinus complaints. Our data suggests that both BCS with ethmoidectomy and traditional FESS are effective treatment options for uncomplicated CRS and result in long-term alleviation of core sinus complaints, as well as decreased sinus related medication use. Larger prospective studies are needed to further evaluate these procedures.

Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis).

The purpose of this study was to evaluate the safety and efficacy of excimer laser atherectomy (ELA) with adjunctive percutaneous transluminal angioplasty (PTA) versus PTA alone for treating patients with chronic peripheral artery disease with femoropopliteal bare nitinol in-stent restenosis (ISR). Femoropopliteal stenting has shown superiority to PTA for lifestyle-limiting claudication and critical limb ischemia, although treating post-stenting artery reobstruction, or ISR, remains challenging. The multicenter, prospective, randomized, controlled EXCITE ISR (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis) trial was conducted across 40 U.S. centers. Patients with Rutherford Class 1 to 4 and lesions of target lesion length ≥4 cm, vessel diameter 5 to 7 mm were enrolled and randomly divided into ELA + PTA and PTA groups by a 2:1 ratio. The primary efficacy endpoint was target lesion revascularization (TLR) at 6-month follow up. The primary safety endpoint was major adverse event (death, amputation, or TLR) at 30 days post-procedure. Study enrollment was stopped at 250 patients due to early efficacy demonstrated at a prospectively-specified interim analysis. A total of 169 ELA + PTA subjects (62.7% male; mean age 68.5 ± 9.8 years) and 81 PTA patients (61.7% male; mean age 67.8 ± 10.3 years) were enrolled. Mean lesion length was 19.6 ± 12.0 cm versus 19.3 ± 11.9 cm, and 30.5% versus 36.8% of patients exhibited total occlusion. ELA + PTA subjects demonstrated superior procedural success (93.5% vs. 82.7%; p = 0.01) with significantly fewer procedural complications. ELA + PTA and PTA subject 6-month freedom from TLR was 73.5% versus 51.8% (p < 0.005), and 30-day major adverse event rates were 5.8% versus 20.5% (p < 0.001), respectively. ELA + PTA was associated with a 52% reduction in TLR (hazard ratio: 0.48; 95% confidence interval: 0.31 to 0.74). The EXCITE ISR trial is the first large, prospective, randomized study to demonstrate superiority of ELA + PTA versus PTA alone for treating femoropopliteal ISR. (Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis [EXCITE ISR]; NCT01330628).

ELA Useful in Treatment of Femoropopliteal ISR

Use of excimer laser atherectomy (ELA) as an adjunct to percutaneous transluminal angioplasty (PTA, also known as balloon angioplasty) is superior to PTA alone in patients with peripheral artery disease who experience artery narrowing following stent implantation (in-stent restinosis [ISR]). This article discusses the results from the Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-Stent Restenosis [EXCITE ISR; NCT01330628].

TCTAP A-112 Comparison of 12-month Clinical Outcomes of Infrapopliteal Balloon Angioplasty Alone Versus Balloon Angioplasty with Provisional Stenting in Patients with Critical Limb Ischemia

TCTAP A-112 Comparison of 12-month Clinical Outcomes of Infrapopliteal Balloon Angioplasty Alone Versus Balloon Angioplasty with Provisional Stenting in Patients with Critical Limb Ischemia

The LEVANT I (Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis) Trial for Femoropopliteal Revascularization: First-in-Human Randomized Trial of Low-Dose Drug-Coated Balloon Versus Uncoated Balloon Angioplasty

This study sought to evaluate the safety and efficacy of the Lutonix drug-coated balloon (DCB) coated with 2 μg/mm(2)paclitaxel and a polysorbate/sorbitol carrier for treatment of femoropopliteal lesions. Percutaneous treatment of peripheral vascular disease is associated with a high recurrence. Paclitaxel-coated balloons at 3 μg/mm(2) formulated differently have shown promising results with reduced restenosis. Methods Subjects at 9 centers with Rutherford class 2 to 5 femoropopliteal lesions were randomized between June 2009 and December 2009 to treatment with Lutonix DCB (n = 49) versus uncoated balloons (control group [n = 52]), stratified by whether balloon-only treatment (n = 75) or stenting (n = 26) was intended. The primary endpoint was angiographic late lumen loss at 6 months. Secondary outcomes included adjudicated major adverse events (death, amputation, target lesion thrombosis, reintervention), functional outcomes, and pharmacokinetics. Demographic, peripheral vascular disease, and lesion characteristics were matched, with mean lesion length of 8.1 3.8 cm and 42% total occlusions. At 6 months, late lumen loss was 58% lower for the Lutonix DCB group (0.46 1.13 mm) than for the control group (1.09 1.07 mm; p = 0.016). Composite 24-month major adverse events were 39% for the DCB group, including 15 target lesion revascularizations, 1 amputation, and 4 deaths versus 46% for uncoated balloon group, with 20 target lesion revascularizations, 1 thrombosis, and 5 deaths. Pharmacokinetics showed biexponential decay with peak concentration (Cmax) of 59 ng/ml and total observed exposure (AUC(all)) of 73 ng h/ml. For successful DCB deployment excluding 8 malfunctions, 6-month late lumen loss was 0.39 mm and the 24-month target lesion revascularization rate was 24%. Treatment of femoropopliteal lesions with the low-dose Lutonix DCB reduced late lumen loss with safety comparable to that of control angioplasty. (LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis; NCT00930813)