Plain Balloon Research Articles

Drug-Coated Balloon Angioplasty for Femoropopliteal In-Stent Restenosis

The optimal revascularization therapy for in-stent restenosis (ISR) of femoropopliteal arteries represents a matter of debate. We investigated the outcomes of patients treated with drug-coated balloon (DCB) angioplasty for ISR of femoropopliteal arteries. Patient-level data from 3 randomized trials of DCB angioplasty for ISR of femoropopliteal arteries were pooled. The primary outcome was target lesion revascularization. The main secondary outcome was recurrent ISR. Other outcomes of interest were ipsilateral amputation, death, Rutherford class improvement, and ankle-brachial index at follow-up. A total of 263 patients randomly assigned to DCB (n=133) or plain balloon angioplasty (n=130) were included in the analysis. After a follow-up of 12 months, patients treated with DCB angioplasty displayed a lower risk for target lesion revascularization (hazard ratio [95% CIs]: 0.25 [0.14-0.46]; P<0.001) and recurrent ISR (0.19 [0.10-0.35]; P<0.001) as compared with those treated with plain balloon angioplasty. There was no significant interaction between the treatment effect for target lesion revascularization and high-risk subgroups of patients such as those with diabetes mellitus, longer lesions, small vessels, moderate to severe underlying calcification, and occlusive pattern of ISR. DCB and plain balloon angioplasty were comparable with respect to other secondary outcomes. In case of femoropopliteal ISR, the percutaneous treatment with DCB angioplasty is associated with superior clinical and antirestenotic efficacy as compared with plain balloon angioplasty at 1-year follow-up, without attrition of efficacy in high-risk subgroups of patients. The long-term durability of DCB angioplasty in this setting remains to be further investigated.

HDA 3. A Prospective Randomized Study Comparing the Use of Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheters With Plain Balloon Angioplasty Catheters to Treat Stenotic Segments at the Venous Anastomotic Site After Thrombectomy for Thrombosed Prosthetic Vascular Grafts for Dialysis

HDA 3. A Prospective Randomized Study Comparing the Use of Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheters With Plain Balloon Angioplasty Catheters to Treat Stenotic Segments at the Venous Anastomotic Site After Thrombectomy for Thrombosed Prosthetic Vascular Grafts for Dialysis

Commentary: Getting Back to Basics: Optimization of Plain Balloon Angioplasty

Commentary: Getting Back to Basics: Optimization of Plain Balloon Angioplasty

Impact of Prolonged Inflation Times During Plain Balloon Angioplasty on Angiographic Dissection in Femoropopliteal Lesions

Purpose: To investigate if balloon angioplasty with a prolonged inflation time (>3 minutes) can prevent postdilation dissection in femoropopliteal lesions. Methods: A retrospective single-center analysis examined 294 consecutive patients (mean age 74.1±8.7 years; 215 men) with de novo femoropopliteal lesions treated with balloon angioplasty between 2013 and 2018. The patients were classified into 2 groups to compare angiographic dissection patterns: 175 patients treated with balloon angioplasty for 3 minutes (3-minute group) and 119 treated for >3 minutes (>3-minute group). Results: Mean balloon inflation time was 7.8±2.7 minutes in the >3-minute group. Severe dissections (type C or higher) were observed less frequently after balloon dilation in the >3-minute group (22.7% vs 50.9%, p<0.001); therefore, significantly more patients in the >3-minute group had successful endovascular treatment after initial balloon angioplasty (57.1% vs 38.3%, p=0.001). Additional balloon dilation was attempted more frequently in the 3-minute group (30.9% vs 14.3%, p=0.001); as a result, there were more patients in whom additional balloon dilation repaired severe dissection that occurred after the initial dilation (25.1% vs 10.9%, p=0.001). Multivariate analysis revealed that chronic total occlusion (p<0.001) and longer lesion (p<0.001) were independent predictors of severe dissection, and prolonged dilation time was independently related to preventing severe dissection (p<0.001). Among 171 patients undergoing successful balloon angioplasty without stent implantation, the Kaplan-Meier estimates of primary patency within 1 year did not differ significantly according to inflation time. Conclusion: Balloon dilation with prolonged inflation time (>3 minutes) may be effective as an initial strategy to prevent severe dissection in femoropopliteal lesions compared to inflation for 3 minutes.

Acute- and Long-term Outcomes of Rotational Atherectomy followed by Cutting Balloon versus Plain Balloon before Drug-Eluting Stent Implantation for Calcified Coronary Lesions.

Background:Coronary calcification is a major determinant of stent underexpansion and subsequent adverse events. This study aimed to evaluate the acute- and long-term outcomes of rotational atherectomy (RA) followed by cutting balloon (CB) versus plain balloon before drug-eluting stent implantation for calcified coronary lesions.Methods:From June April 2013 to March 2016, a total of 127 patients with moderately or severely calcified coronary lesions were treated with RA. Patients were divided into two groups according to the balloon type after RA: RA+CB group (n = 75) and RA+plain balloon group (n = 52). Minimal lumen diameter and acute lumen gain were analyzed by quantitative coronary angiography. In-hospital and long-term (>1 year) outcomes were recorded. Multivariate Cox regression analysis was performed to determine the independent predictors of in-stent restenosis.Results:The mean age of the patients was 65.5 years, and 76.4% were men. Total lesion length and minimal lumen diameter at baseline were similar in the two groups. After RA and balloon dilation, the lumen diameter was significantly larger in the RA+CB group than in the RA+plain balloon group (1.57 ± 0.46 mm vs. 1.10 ± 0.40 mm, t = 4.123, P < 0.001). The final lumen diameter was also larger in the RA+CB group compared to that in the RA group (2.81 ± 0.41 mm vs. 2.60 ± 0.25 mm, t = 2.111, P = 0.039). Moreover, patients receiving RA and CB tended to have larger final lumen gain (2.15 ± 0.48 mm vs. 1.95 ± 0.47 mm, t = 1.542, P = 0.132). Multivariate Cox regression analysis indicated that the strategy of RA+CB was a significant protective factor against long-term (>1 year) in-stent restenosis (hazard ratio: 0.136, 95% confidence interval: 0.020–0.936, P = 0.043).Conclusions:In patients with moderately or severely calcified lesions, a strategy of RA followed by CB before stent implantation can increase lumen diameter and acute lumen gain. This strategy is safe with lower risk of long-term in-stent restenosis.

MD2 - Economic Analysis of Urea-Excipient Drug-Coated Balloon Therapy for Treatment of Femoropopliteal Artery Disease in Japan

In recent years, numerous studies have reported favorable outcomes using drug-coated balloons (DCBs) for treatment of symptomatic peripheral artery disease (PAD) of the upper leg. Our objective was to study the cost-effectiveness of DCB therapy vs. plain balloon angioplasty (PTA), bare metal stents (BMS), and drug-eluting stents (DES) for femoropopliteal artery disease in the Japanese healthcare system. Target lesion revascularization (TLR) rates post PTA, BMS, DES, and DCB, as the relevant clinical effectiveness measure, were pooled from studies published through 2017 that were identified through systematic search. Only urea-excipient DCB TLR rates were utilized based on regulatory approval in Japan and improved performance compared to non-urea excipient DCB devices. Costs were based on detailed resource-based accounting and current reimbursement tariffs (JPY 170,000 per DCB device). A Markov model computed strategy-specific costs and comparative cost-effectiveness, considering a 3-year time horizon and up to one reintervention. QALY computations were based on an estimated TLR-associated QALY decrement of 0.06. Costs and effects were discounted at 2% per annum, and extensive sensitivity analyses performed. Pooled 36-month probabilities of TLR were 16.3%, 25.5%, 36.9%, and 48.4% for DCB, DES, BMS, and PTA, based on evidence of n= 358, 1,959, 3,009, and 892 lesions treated, respectively. Over three years, DCB added 0.0047, 0.0107, and 0.0167 QALYs compared to DES, BMS, and PTA, at concurrent cost savings of JPY 135,067, 167,210, and 118,914, respectively. These savings are primarily a result of reduced TLR costs, and of lower DCB index procedure cost compared to DES and BMS (JPY 1,008,740 vs. 1,076,640, and 1,015,140). Across a wide range of assumptions, DCB was found dominant or cost-effective. Urea-excipient drug-coated balloon therapy for femoropopliteal disease is associated with improved patient outcomes and overall cost-savings to payers in the Japanese healthcare system, rendering it a dominant treatment strategy.

Drug-Coated versus Plain Balloon Angioplasty in Bypass Vein Grafts (the DRECOREST I-Study)

Stenosis is a known complication in bypass vein grafts for peripheral arterial disease. The aim of this study was to evaluate the effect of drug-coated balloons (DCBs) in the treatment of vein graft stenoses. DCBs may prevent restenosis in arterial lesions. One small prospective and larger retrospective and registry studies have failed to show benefit from DCBs in vein grafts. Prospective data are scarce. Sixty patients treated for primary or recurrent stenosis in venous bypass grafts were randomized to DCB (n=30) or standard balloon angioplasty (BA) (n=30). Follow-up was 1year. The primary outcome measure was target lesion revascularization (TLR). Secondary outcome measures were assisted primary patency and secondary patency and graft occlusion. Fifty-seven patients were analyzed. Three patients were excluded due to primary technical failure (2 DCB, 1 BA). Overall TLR rate was 34.5% and 46.4% in the DCB and BA groups, respectively (P=0.33). Five (8.8%) grafts occluded during follow-up (1 DCB, 4 BA). Assisted primary patency was 93.1% (DCB) versus 85.7% (BA) (P=0.362) and secondary patency was 100% (DCB) versus 89.3% (BA) (P=0.076). Subgroup analysis showed a significant benefit from DCB in the treatment of primary stenosis (TLR rate 15.0% vs. 18.9%, P=0.03). There was no significant benefit from DCBs for treatment of vein graft stenosis compared to BA, although a trend in favor of DCBs could be seen. ClinicalTrials.govNCT03023098.

Are Endovascular Interventions for Central Vein Obstructions due to Cardiac Implanted Electronic Devices Effective?

Objective: One of the late-onset complications of cardiac implanted electronic devices (CIEDs) is central venous obstruction (CVO). The aim of this study was to investigate the feasibility, efficacy, and safety of endovascular treatment of CIED-related CVOs.Methods:Eighteen patients who underwent endovascular management of their device-related CVO were reviewed. Patients were classified into three groups: Group I patients were asymptomatic and needed lead replacement; Group II patients presented with symptomatic CVO without lead dysfunction, and Group III patients were referred with both symptomatic CVO and lead dysfunction. A treatment strategy involved recanalization and balloon angioplasty for Group I and angioplasty/stents for Groups II and III. Technical success, clinical success, complications, and long-term follow-up were assessed.Results: Thirteen patients were in Group I, four in Group II, and one in Group III. Technical and clinical success was achieved in 17 patients (94%). No major complications were reported. Restenosis was observed in two patients at 40 and 42 weeks of follow-up, and these patients were successfully treated with angioplasty.Conclusion: Endovascular management of CVO due to CIED is a safe and efficient technique. Plain balloon angioplasty is sufficient for lead replacement purposes, while stenting is needed for symptomatic CVO to achieve good long-term patency.

Safety and effectiveness of combined scoring balloon and paclitaxel-coated balloon angioplasty for stenosis in the hemodialysis access circuit.

To evaluate the safety and effectiveness of combined scoring balloon (SB) and paclitaxel-coated balloon (PCB) angioplasty for stenosis in the dysfunctional hemodialysis access circuit. Patients were referred from outpatient dialysis centers by their nephrologists because of dysfunctional dialysis access circuit. Fistulogram/graftogram was performed by experienced interventional radiologists. Those with in-stent stenosis, stent edge stenosis or vessel diameter at the culprit segment larger than 6mm were excluded. Angioplasty of the stenotic segment was performed with SB and followed by PCB. All study outcomes were defined according to the Society of Interventional Radiology technology assessment committee reporting standards for percutaneous interventional procedures in dialysis access circuit. A total of 23 patients received combined SB/PCB angioplasty for stenosis of hemodialysis access circuit which included 15 fistulas and 8 grafts. There were 10 men and 13 women with a mean age of 63.3±2.7 (SD) years (range: 37-85years). The technical success and clinical success rates were both 100%. There were no complications during or after the procedures. The target lesion primary patency rates at 3, 6 and 12months were 91.3%, 69.6%, and 45.2%, respectively and the estimated median target lesion restenosis (TLR) free duration was 11.0months (95% confidence interval [CI]: 5.1-16.9months). In patients with a recurrent stenosis, the median TLR-free duration of combined angioplasty was significantly higher than that of prior angioplasty with plain balloon (10.2months [95% CI: 6.4-14.0months] vs. 4.2months [95%CI: 2.1-6.4months]) (P=0.047). The mean TLR-free duration was significantly higher in patients with a juxta-anastomotic stenosis than those with non-juxta-anastomotic lesion (21.3months [95% CI: 14.7-28.0months] vs. 8.2months [95% CI: 5.1-11.4months]) (P=0.004). Combined SB/PCB angioplasty is safe and effective for the hemodialysis access stenosis.

Incidence and Endovascular Treatment of Isolated Atherosclerotic Popliteal Artery Disease: Outcomes from the IPAD Multicenter Study.

To report the incidence and long-term outcomes following endovascular treatment of symptomatic, atherosclerotic isolated popliteal artery disease (IPAD). This retrospective, multicenter study included all patients who underwent endovascular treatment of IPAD between January 2010 and December 2016 because of intermittent claudication or critical limb ischemia (CLI), in three tertiary University Hospitals. In total, 4717 peripheral arterial disease (PAD) procedures were analyzed. The study's primary outcome measures were: IPAD incidence, binary restenosis rate and freedom from target lesion revascularization (TLR). Secondary outcome measures included technical success, limb salvage rate and the identification of predictors of outcomes. The incidence of IPAD was 0.98% (46/4717 PAD procedures). In total, 46 patients (38 male; mean age 73 ± 12years) underwent plain balloon (69.5%) or bail-out stenting (30.5%) procedures. Most patients suffered from CLI (65.2%). Mean lesion length was 52.5 ± 32.0mm and 45.6% of the cases were occlusions. Severe calcifications were noted in 26.1%. Technical success was 100%. Mean time follow-up was 32.6 ± 25.6months. According to Kaplan-Meier analysis, restenosis was 15.8, 40.9, 45.8% and TLR-free rate was 90.5, 79.0, 74.1%, at 1, 2 and 3years, respectively. Survival and limb salvage rates were 73.6 and 88.1%, at 5years, respectively. The major amputation rate for CLI patients was 10.0% (3/29 limbs), while no major amputations occurred in the claudication subgroup. Cox multivariable analysis detected baseline occlusion as an independent predictor of increased restenosis (HR 5.3; 95% CI 0.21-0.66, p = 0.02). Isolated popliteal lesions requiring treatment appear in nearly 1% of patients with PAD. Balloon angioplasty and bail-out stenting resulted in acceptable long-term clinical outcomes. Treatment of occlusions was correlated with increased restenosis rate.

FT02. Drug-Coated Balloon Versus Plain Balloon Angioplasty for Below-Knee Revascularization in Critical Ischemia: Primary Patency and Clinical Outcomes at 6 Months

FT02. Drug-Coated Balloon Versus Plain Balloon Angioplasty for Below-Knee Revascularization in Critical Ischemia: Primary Patency and Clinical Outcomes at 6 Months

The use of scoring balloons in the superficial femoral artery.

Percutaneous transluminal angioplasty and stenting is becoming increasingly the first-line treatment for patients with both claudication and critical limb ischemia instead of surgery, with the aim of returning the patient's quality of life in the former and preventing amputation. Drug-eluting technologies have seen a large surge in popularity in recent years, and significant patient benefits have been seen with the use of drug-eluting stents and balloons over the use of plain balloon angioplasty. Unfortunately, in many patients with arterial disease there is significant vessel wall calcification - this can theoretically be a barrier to drug delivery and can also be a contributing factor to flow limiting dissection and the subsequent need for bail out stenting. Several studies have looked at the efficacy of scoring balloons to minimize these problems in patients with severe calcification. With increasing use of vascular stents over the last 5-10 years, more cases of in stent stenosis are being seen, and scoring balloons have been postulated to improve outcomes here also. Scoring balloons have been available for many years, having seen first use in the coronary system, but are now being studied in the peripheral arterial landscape, both above and below the popliteal segment. This article will review their use in the superficial femoral artery.

A Comparison of Clinical Outcomes Between Primary Bypass and Secondary Bypass After Failed Plain Balloon Angioplasty in the Bypass versus Angioplasty for Severe Ischaemia of the Limb (BASIL) Trial

A Comparison of Clinical Outcomes Between Primary Bypass and Secondary Bypass After Failed Plain Balloon Angioplasty in the Bypass versus Angioplasty for Severe Ischaemia of the Limb (BASIL) Trial

Two-Year Clinical Outcomes of the CONSEQUENT Trial: Can Femoropopliteal Lesions be Treated with Sustainable Clinical Results that are Economically Sound?

The previously reported 6-month angiographic and 12-month clinical outcomes of the CONSEQUENT trial demonstrated the safety and efficacy of a novel paclitaxel-resveratrol-coated balloon for the treatment of lesions in the femoropopliteal segment. The purpose of this report is to present the 2-year results including a cost-benefit analysis for Germany. Patients with symptomatic peripheral artery occlusive disease in femoropopliteal lesions were randomized either to drug-coated balloon (DCB, n = 78) or plain old balloon angioplasty (POBA, n = 75). As secondary endpoints, the 2-year clinical results consisting of target lesion revascularization (TLR), patency and increase in walking distance were recorded. Based on the Kaplan-Meier analyses for TLR and other adverse events, a cost-benefit analysis was conducted for the German DRG system. There were no additional TLRs in both groups between 14 and 24months so that the corresponding rates remained significantly different between the treatment groups (DCB: 19.1 vs. POBA 40.6%, p = 0.007). At 2years, the patency rate was significantly higher in the DCB group (72.3 vs. 48.4%, p = 0.006). The walking distance increase was also significantly higher after DCB angioplasty (172 ± 103 vs. 52 ± 136m, p = 0.001). We estimated 2-year cost savings of € 1111.97 per patient treated with DCB instead of POBA. The use of paclitaxel-resveratrol matrix-coated peripheral balloons compared to POBA was associated with a significantly reduced TLR rate, superior patency and substantial cost savings at 2years. ClinicalTrials.gov Identifier NCT01970579.

Editor's Choice – A Comparison of Clinical Outcomes Between Primary Bypass and Secondary Bypass After Failed Plain Balloon Angioplasty in the Bypass versus Angioplasty for Severe Ischaemia of the Limb (BASIL) Trial

Chronic limb threatening ischaemia (CLTI) is a growing global health problem. The UK NIHR HTA funded BASIL trial is still the only randomised controlled trial to have compared a "bypass surgery first" with a "plain balloon angioplasty (PBA) first" strategy for the management of CLTI. In patients who were likely to survive for 2 years and had a suitable vein, primary bypass (PB) was associated with better clinical outcomes. Furthermore, PBA was associated with a high technical and clinical failure rate and many went on to have secondary bypass (SB). This study aimed at comparing clinical outcomes following PB and SB in the BASIL trial. Demographic, procedural, and outcome data were obtained from the BASIL case report forms. Outcomes were amputation free survival (AFS), limb salvage (LS), overall survival (OS), and freedom from revascularisation (FFR). The SB cohort comprises patients whose first trial intervention was PBA and who subsequently underwent bypass during follow up. The PB cohort comprises those patients whose first trial intervention was bypass. The 190 PB and 49 SB patients were well matched except that the SB patients were more likely to be current smokers. At a median of 7 years, PB was associated with better AFS (PB 60% vs. SB 40%; HR 1.58, p=.04), LS (PB 85% vs. SB 73%, p=.06), and OS (PB 68% vs. 51%, p=.06). FFR was equivalent (PB 53% vs. 53%, p=.3). In the BASIL trial, clinical outcomes following PB were significantly better than in patients undergoing SB after failed PBA. Prior to treating patients with CLTI with primary PBA, clinicians should consider that if this should fail, the outcome of attempted subsequent bypass is likely to be significantly worse than if PB were attempted.

Endovascular Treatment of Haemodialysis Arteriovenous Fistula with Drug-Coated Balloon Angioplasty: A Single-Centre Study.

To evaluate the effect of percutaneous transluminal angioplasty (PTA) on haemodialysis fistulas utilising drug-coated balloons with plain balloon vessel preparation (DCB). In the study group, 31 patients (16 men; mean age 62.8 ± 17.2years) with failing arteriovenous fistulas were treated, with DCB, and compared with a control group (31 patients; 15 men; mean age 67.0 ± 8.44years), in which only plain balloon PTA was performed. All stenoses were dilated with regular PTA balloons. After achieving haemodynamic success (< 30% residual stenosis), drug-coated balloons were used for drug administration in the study group. The follow-up intervals were 6, 12 and 24months. Target lesion primary patency, primary assisted patency and secondary patency were compared. The statistical significance was set at 0.05. Target lesion primary patency was compared in both groups and was significantly higher in the study group (DCB) at 6months (90.3 vs. 61.3%; p = 0.016), 12months (77.4 vs. 29%; p = 0.0004) as well as 24months (45.2 vs. 16.1%; p = 0.026). Kaplan-Meier survival curves also showed a significant difference for target lesion primary patency (534.2 vs. 315.7days; p = 0.0004). There were no significant differences in target lesion primary assisted patency and in secondary patency. However, only 38.7% of patients in the study group were treated twice or more versus 80.6% in the control group (p = 0.002). DCB increases target lesion primary patency during the first 24months and decreases the rate of reinterventions.

Comparison of the safety and efficacy of two types of drug-eluting balloons (RESTORE DEB and SeQuent® Please) in the treatment of coronary in-stent restenosis: study protocol for a randomized controlled trial (RESTORE ISR China).

In-stent restenosis (ISR), characterized by neointimal proliferation and/or neoatherosclerosis in the vessel of the stent, can cause a reduction in lumen diameter after stent implantation, which can directly induce the recurrence of angina symptoms or an acute coronary syndrome in patients and is usually life-threatening.[1]–[3] ISR has also been considered as formidable clinical problem for the interventional cardiologists. In recent years, many remarkable improvements in medical technology of percutaneous coronary intervention (PCI), such as first-generation bare metal stents (BMS) and newer-generation drug-eluting stents (DES) have been achieved, which significantly reduce ISR occurrence in patients with PCI.[4],[5] For example, growing evidence has suggested that the safety and efficacy of revascularization procedures of newer-generation DES was greatly superior to those of first generation DES and BMS.[6]–[10] However, ISR rate remains as high as 5% to 10% for patients treated with newer-generation DES at two years.[11] More recently, a newly developed drug-eluting balloon (DEB) coated with paclitaxel, an antiproliferative drug that could inhibit neointimal hyperplasia, had emerged as an alternative therapeutic tool for ISR disease.[12],[13] DEB plays the anti-restenosis efficacy through a high-concentration, rapid local delivery of paclitaxel without the use of polymers on a stent. To date, there are numerous randomized trials performed to compare the safety and efficacy among plain old balloon angioplasty (POBA), DES and DEB for the treatment of ISR.[14] One recent meta-analysis enrolled eight randomized controlled trials and indicated that DEB was a better option for treatment of ISR when compared to POBA.[15] Another meta-analysis showed that DEB and DES have similar efficacy and safety for the treatment of ISR.[16] SeQuent® Please DEB is the only approved product utilized for ISR treatment in China.[17] Currently, a novel paclitaxel-coated balloon (RESTORE DEB) has been invented for the treatment of ISR. However, clinical information on the two different types of DEB in treatment of ISR is limited. This trial aims to compare the safety and efficacy of the RESTOREDEB versus SeQuent® Please DEB for the treatment of coronary ISR in Chinese patients.

Treatment of coronary in-stent restenosis: a systematic review.

Coronary stent implantation has significantly improved percutaneous coronary intervention and enabled the management of early complications of plain balloon angioplasty. However, a new complication has accompanied these improvements: in-stent restenosis (ISR) arising from neointimal hyperplasia. ISR after coronary angioplasty is currently one of the main limitations of this method, leading to the recurrence of exertional angina pectoris or acute coronary syndromes. The clinical incidence of ISR after bare-metal stent (BMS) implantation is approximately 20%–35%. The use of drug-eluting stents (DES) has led to a further decrease in the occurrence of ISR to 5%–10%. Evidence resulting from controlled clinical studies suggests that DES and drug-eluting balloon catheters (DEB) provide the best clinical and angiographic results in the treatment of ISR. We undertook a systematic review of the pathophysiology, diagnostics and treatment options for BMS- and DES-ISR. We discuss recent randomised studies, comparing different DES or DEB used for BMS or DES-ISR treatment, as well as the use of new biovascular scafolds and the topic of scafold restenosis.

Therapeutic efficacy of paclitaxel-coated balloon for de novo coronary lesions with diameters larger than 2.8 mm

Objective: To evaluate the efficacy of paclitaxel-coated balloon for de novo coronary lesions with diameters ≥ 2.8 mm. Methods: This prospective study included 215 consecutive patients with 238 de novo lesions, who received paclitaxel-coated balloon angioplasty in Beijing Hospital from May 2014 to June 2016. According to the reference vessel diameter, the patients were divided into large vessel disease (LVD) group (reference vessel diameter≥2.8 mm, 85 patients and 90 lesions) and small vessel disease (SVD) group (reference vessel diameter<2.8 mm, 130 patients and 148 lesions). Clinical characteristics, interventional procedures and major adverse cardiovascular events (includingall-cause mortality, non-fatal myocardial infarction and target lesion revascularization) after procedure were compared between the 2 groups. Results: (1)Patients in LVD group were younger than SVD group ((60.1±11.1) years old vs. (65.0±10.6) years old, P<0.01), and less patients had diabetes (24.7% (21/85) vs. 43.1%(56/130), P<0.01).(2)Prevalence of three-vessel disease (35.5%(30/85) vs. 53.6%(67/130), P<0.05) and complex lesions (type B2/C,34.4% (31/90) vs. 50.0%(74/148), P<0.05) were significantly lower in LVD group than in SVD group.(3) During pre-dilation, the rate with plain balloons use was significantly higher in SVD group than in LVD group(76.4%(113/148) vs. 58.9%(53/90), P<0.01), while the proportion of additional use of non-compliant balloons was significantly higher in LVD groupthan in SVD group(20.0% (18/90) vs. 3.4% (5/148) , P<0.01). The ratio of paclitaxel-coated balloon diameter/RVD was significantly lower (0.87±0.12 vs. 0.96±0.15, P<0.01) and the duration of dilationwas significantly shorter ((41.5±9.5) seconds vs. (45.1±9.1) seconds, P<0.01) in LVD group than those in SVD group. Each group had 1 failure case that was bailout stented with drug-eluting stents. The success rate of paclitaxel-coated balloon treatment was similar in LVD group and SVD group (98.9% (89/90) vs. 99.3%(147/148), P>0.05).(4) At the fourth day of procedure, there was 1 acute myocardial infarction requiring emergent target lesion revascularization in SVD group. No major adverse cardiovascular event was observed in LVD group during hospitalization. Forty-two patients with 53 lesions, including 27 LVD lesions and 26 SVD lesions,underwent coronary angiography at (9.4±4.6) months after paclitaxel-coated balloon intervention. The quantitative coronary angiography analysis showed that minimal lumen diameter significantlyincreased during follow-up than that of post-procedurein SVD group ((1.71±0.36)mm vs. (1.52±0.30)mm, P<0.05) , while in LVD group the minimal lumen diameter was similar between during follow-up and post-procedure ((2.35±0.48)mm vs. (2.19±0.34)mm, P>0.05). Major adverse cardiovascular event rate was 0 in LVD group and 2.3%(3/130) in SVD group (P>0.05) during follow up. No death was observed in this patient cohort. Conclusion: Treatment with paclitaxel-coated balloon for de novo coronary lesions with diameters≥2.8 mm is safe and effective.

Treating complex femoropopliteal lesions.

Peripheral artery disease affects 202 million patients worldwide and may cause disabling intermittent claudication and critical limb ischemia. Next to life style changes, best medical treatment and supervised exercise therapy, it can be necessary to re-vascularize the limb. Treatment of femoropopliteal lesions poses a challenge and a surgical bypass remains recommended in the guidelines for longer and more complex lesions. Bypass surgery is associated with substantial morbidity and even mortality. Endovascular alternatives are quickly evolving from plain balloon angioplasty to drug-eluting stents, drug-coated balloons, polytetrafluoroethylene-covered stents and atherectomy. These developments might challenge the gold standard in the near future. This article focuses on which technique can be used for which femoropopliteal lesion, particularly complex lesions, and summarizes the most recent and important literature on this topic.