Outcomes Of Drug-eluting Balloon Research Articles

Outcomes of Drug Eluting Balloons in a Tertiary Care Hospital in South India

Outcomes of Drug Eluting Balloons in a Tertiary Care Hospital in South India

The Contemporary Indications, Safety, and Outcomes of Drug-Eluting Balloons in Queensland Public Hospitals

The Contemporary Indications, Safety, and Outcomes of Drug-Eluting Balloons in Queensland Public Hospitals

Abstract 16656: Drug Eluting Balloon Versus Percutaneous Transluminal Angioplasty Below the Knee Intervention for Critical Limb Ischemia: A Meta-analysis of Randomized Controlled Trials

Introduction: Studies have shown decrease rates of restenosis and target lesion revascularization (TLR) with drug eluting balloon (DEB) in diabetic patients with critical limb ischemia (CLI). Hypothesis: The aim of this meta-analysis to compare the efficacy of DEB versus Percutaneous transluminal angioplasty (PTA) below the knee peripheral intervention. Methods: Electronic databases including MEDLINE, ClinicalTrials.gov and the Cochrane Library were searched for all randomized controlled trials (RCTs) published until April 2020 comparing outcomes of DEB vs PTA in patients with CLI below the knee. End points were major amputation, major adverse events (MAEs), all-cause mortality, target lesion revascularization (TLR), myocardial infarction, and cerebrovascular accidents (CVA). The risk ratio (RR) with 95% confidence interval (CI) were computed and p <0.05 was considered as a level of significance. Results: A total of 4 RCTs (n=655) were included in the final analysis. There were no differences of major amputation (RR: 1.30; CI: 0.68-2.46; p=0.43), MAEs (RR: 0.86; CI: 0.60-1.23; p=0.41), all-cause mortality (RR: 0.91; CI: 0.69-1.19; p=0.48), TLR (RR: 0.65; CI: 0.30-1.44; p=0.29), MI (RR: 1.71; CI: 0.57-5.14; p=0.34) and CVA (RR: 0.66; CI: 0.19-2.26; p=0.50) between the 2 groups [Figure 1]. Conclusions: There were no significant differences of major amputation and TLR for DEB versus PTA . Major adverse cardiac, cerebrovascular events and all-cause mortality were not statistically different for drug coated balloon versus PTA in the management of below knee critical limb ischemia. Further studies needed to confirm these findings.

Assessment of a Drug-Eluting Balloon for the Treatment of de novo Coronary Lesions Guided by Optical Coherence Tomography: Study Protocol for a Randomized Controlled Trial

Background: The drug-eluting balloon (DEB) is a promising tool to prevent restenosis after coronary angioplasty. However, data on the outcomes of DEB in de novo lesions are scarce. Vessel recoil and constrictive remodeling are the dominant causes of restenosis after angioplasty. The use of cutting balloons (CB) may effectively reduce elastic recoil after balloon dilation. In this study, we evaluate the efficacy and safety of DEB in treating de novo coronary artery lesions, using a predilation strategy with cutting balloon (CB) dilation before DEB angioplasty. Methods/Design: We present the design of a prospective, single-center, open-label, randomized, 2-arm clinical trial aiming to assess whether or not the strategy of CB dilation before DEB angioplasty reduces the primary end point of late lumen loss (LLL) compared with drug-eluting stent (DES) implantation alone for de novo coronary artery lesions. A total of 120 patients will be randomly enrolled into the DEB or DES group (1:1 ratio). The primary end point is insegment LLL at 12 months as measured by optical coherence tomography (OCT). Secondary end points include procedural success, such as angiographic success and device success, and clinical outcomes including all-cause death, myocardial infarction, target vessel revascularization, target lesion revascularization, and stent thrombosis. Discussion: The study will evaluate the clinical efficacy, angiographic outcomes, and safety of DEB after CB dilation compared with DES for the treatment of de novo coronary artery lesions guided by OCT.

The Leipzig Prospective Drug-Eluting Balloon-Registry – Outcome of 484 Consecutive Patients Treated for Coronary In-Stent Restenosis and De Novo Lesions Using Paclitaxel-Coated Balloons –

Drug-eluting balloons (DEB) are an alternative treatment of in-stent restenosis (ISR), but data regarding outcomes of DEB in de novo lesions are lacking. We investigated the effect of DEB on target lesion revascularization (TLR), procedural complications (coronary dissection/rupture, pericardial effusion, stent thrombosis, peri-interventional NSTEMI, stroke), major adverse cardiac and cerebrovascular events (all-cause mortality, myocardial infarction, TLR, stroke) in patients with ISR and de novo lesions in an all-comers setting. Between April 2009 and October 2013, 484 consecutive patients (mean age 68.4 years; 77.9% male) were enrolled in a prospective registry. TLR rate was 4.9% at 12 months and 8.7% at long-term follow-up of 2.3 years. Subgroup analysis confirmed a TLR rate of 8.9% after DEB treatment of ISR in bare-metal stents (21/235 lesions), 13.0% in drug-eluting stents (21/161 lesions) and 0% for de novo lesions (0/76 lesions). At long-term follow-up, all-cause mortality/cardiac mortality was 8.7% (42/484)/3.3% (16/484) and MACCE rate was 18.4% (89/484 patients), with no differences between DEB for ISR compared with de novo lesions. DEB for ISR resulted in a low rate of TLR. Our data support DEB in ISR as an effective treatment option. DEB in small coronary vessels in our limited cohort appeared to be safe. Larger, randomized trials in small coronary vessels should be undertaken to verify the long-term results of the current trial.

Outcomes of drug eluting balloons in coronary revascularisation

Backgound: Small randomised trials and registry data suggest a role for drug-eluting balloons (DEB) in percutaneous coronary intervention (PCI). This single-centre, observational study investigated PCI outcomes when using the Sequent Please, paclitaxel-eluting DEB (B. Braun, Germany). Methods: A total of 122 unselected patients had PCI using DEB at Liverpool Hospital, Sydney (Oct 2011-Dec 2014). Patients were categorised into 2 PCI groups: de novo lesions (DNL) and in-stent restenosis (IRS), comprising bare-metal stent (BMS) and drug-eluting stent (DES). Procedural and outcome data were retrieved from a computer database. The primary outcome was clinically driven, target lesion revascularisation (TLR), and MACE (all-cause death, major bleeding, re-infarction, and stroke). Results: Cohort age was 66±11 years, 74% were male, and 36% presented with acute coronary syndrome. There were no differences between groups for target lesion complexity (55% type B2/C), target lesion length (22±14mm), and DEB length (20±5mm). DEB calibre used to treat DNL was significantly less than for ISR (2.3±0.3 vs 2.8±0.6mm; p<0.001). For DNL, there was a non-significant trend toward extensive (Grade C-F) target vessel dissection (11 vs 7%; p=0.63). DEB-related TLR rates were low (3% for DNL), with no significant differences between groups. MACE event rates were 33% vs 34% for DNL and all ISR, respectively (p=0.60); and 37% vs 30% for DES and BMS ISR, respectively (p=0.42). Conclusions: This study shows similar clinical outcomes for DEB used to treat DNL and (DES and BMS) ISR. DEB may be used for PCI when stent-sparing revascularisation is desirable.

Outcomes of drug eluting balloon in native coronaries & venous graft instent restenosis

Outcomes of drug eluting balloon in native coronaries & venous graft instent restenosis

Clinical Outcomes of Drug Eluting Balloon (DEB) in Treatment of Coronary In-Stent Restenosis (ISR) Compared to Plain Old Balloon Angioplasty (POBA) and Drug Eluting Stent (DES)

Background: Treatment of coronary in-stent restenosis (ISR) is still high incidence of recurrence of ISR. We aimed to compare the efficacy and safety of a paclitaxel drug eluting balloon (DEB) in treatment of ISR to POBA and DES. Methods: We reviewed 179 patients (190 lesions, male 70.4%, mean age 64.1 11.7 years) who treated ISR with DEB or POBA or DES from January 2006 to May 2012. The primary end point was major adverse cardiac events (cardiac death, myocardial infarction, target lesion revascularization). Results: We reviewed 179 patients, 190 ISR lesions (LAD/LCX/RCA/ LM; 46.8/16.8/33.7/2.2%, ISR type Ia/Ib/Ic/Id/II/III/IV; 0.5/24.2/23.2/ 22.1/6.3/10.5%). Sixty seven patients treated with POBA and 54 patients with DES. And 58 patients were treated with the DEB (mean diameter/length/pressure/time; 3.0 0.3mm/ 21.7 4.4mm/ 10.4 2.4atm/ 45.6 23.6sec).Meanclinical followupwas 16.3 11.2months.During the follow up, overall, total major adverse cardiac events were 20 (11.2%). There were 6 cardiac deaths (3.3%), one myocardial infaction (0.6%), and 13 target lesion revascularization (7.3%) and 3 stent thrombosis (1.7%).But there was no difference between 3 groups (Table). Conclusion: Treatment of coronary in-stent restenosis with DEB showed feasible and relatively low MACE compared to POBA and DES in small and short-term of this study. But large and long term clinical and angiographic follow up will be needed.