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Cil: Cilem teto studie je srovnani dlouhodobých klinických výsledků lecby restenoz v holých kovových stentech (BMS-ISR) pomoci seal-wing a iopromidových lekových balonkových katetrů s paclitaxelem (PEB). Metodika: Celkem bylo po dobu tři let roky klinicky sledovano 132 pacientů s BMS-ISR, z nichž 64 bylo leceno pomoci seal-wing PEB; kontrolni skupinu tvořilo 68 pacientů z iopromidove PEB větve předchozi studie TIS. Primarnim cilovým ukazatelem byla cetnost výskytu zavažných nežadoucich kardiovaskularnich přihod (MACE; umrti z kardiovaskularnich přicin, infarkt myokardu [IM] nebo nutnost opakovane revaskularizace cilove tepny [TVR]) Výsledky: Výskyt MACE byl po třech letech signifikantně vyssi ve skupině pacientů lecených seal-wing PEB oproti skupině iopromidových PEB (40,6 % vs. 19,1%; p = 0,008); obdobneho rozdilu bylo dosaženo ve srovnani nutnosti TVR (26,9 % vs. 8,8 %; p = 0,011). Doba přežiti bez klinicke přihody byla ve skupině iopromidových PEB signifikantně delsi (p = 0,021). Mezi oběma skupinami nebyly zaznamenany rozdily v mortalitě z kardiovaskularnich přicin (4,7 % vs. 5,9 %; p = 1,000), výskytu IM (6,3 % vs. 4,4 %; p = 0,712), potvrzene trombozy stentů (0 % vs. 2,9 %; p = 0,497) nebo opakovaných MACE (4,7 % vs. 1,5 %; p = 0,354). Zavěr: Ve srovnani s iopromidovými PEB je použiti seal-wing PEB v lecbě BMS-ISR spojeno se signifikantně vyssim třiletým výskytem MACE a TVR (ClinicalTrials.gov; https://clinicaltrials.gov; NCT01735825). © 2021, CKS.

Aims Drug-eluting stent (DES) implantation is an effective treatment of in-stent restenosis (ISR). However, literature data indicate that drug-coated balloons (DCBs) may be a valid alternative, particularly for recurrent ISR. We sought to evaluate clinical results on the long-term efficacy of a new DCB for ISR treatment. Methods One hundred and ninety-nine patients were treated with paclitaxel drug-coated balloons (Pantera Lux, Biotronik, Switzerland) in the Italian REGistry of Paclitaxel Eluting Balloon in ISR (REGPEB study). Clinical follow-up was scheduled at 1 and 12 months. A subgroup of patients received adjunctive 5-year follow-up. Primary end point was Major Adverse Cardiac Events (MACE) at 1 year. Results A total of 214 ISR coronary lesions were treated (75.4% DES-ISR). Mean time between stent implantation and DCB treatment is 41 months. DCBs were successfully delivered in 99% of the cases; crossover to a DES occurred in 3% of cases. Procedural success rate was 98.5%. Clinical success rate was 98.5%. First-month follow-up compliance was 98% and freedom from MACE was 96.9%. Twelve-month follow-up compliance was 89.3% with a freedom from MACE rate of 87.3% (CI: 81.3-91.5%). Five-year long-term follow-up showed 65.2% of freedom from MACE. Conclusion Our study confirms that Pantera Lux treatment is effective and well tolerated in ISR, showing good acute and long/very long-term results in the treatment of complex lesions (DES and late ISR).

Aneurysmal degeneration after peripheral angioplasty is a potentially serious complication. In this case, the patient underwent repeated angioplasty of a prior vein bypass graft utilizing a paclitaxel-coated balloon. He subsequently developed a progressive aneurysmal degeneration, threatening his bypass, which ultimately required an urgent exclusion with a covered stent. This case represents a rare complication of peripheral bypass graft related to percutaneous intervention as well as paclitaxel-coated devices and warns other practitioners of the increased scrutiny and caution one should exercise in the use of such interventions.

Percutaneous coronary intervention with a drug-eluting stent is the most common mode of revascularization for coronary artery disease. However, restenosis rates remain high. Non-stent-base...

Amaç: Periferik arter hastalığı insidansının artması ve periferik vasküler cerrahi sonrası istenmeyen sonuçları azaltmak için endovasküler girişimlerin sıklığı ve çeşitliliği artmıştır. Yaygın kalsifik stenotik lezyonlar, endovasküler prosedürlerin açık kalma oranlarını etkilemekte ve komplikasyon sıklığını artırmaktadır. Bu çalışmada direksiyonel aterektomi (DA) ile kombine edilmiş paklitaksel salınımlı balon anjioplasti (PEBA) ve kendiliğinden açılan nitinol stent (SENS) uygulamalarının açık kalma oranları bakımından karşılaştırılması amaçlandı.Gereç ve Yöntemler: Namık Kemal Üniversitesi Hastanesi Kalp Damar Cerrahisi kliniğinde Mart 2013 ile Mayıs 2014 tarihleri arasında kalsifik stenotik süperfisyal femoral arter lezyonları sebebiyle endovasküler prosedür uygulanmış 56 hasta (her grupta 28 olgu) çalışmaya alındı. Olguların yaş ortalaması 65,4±7,6 olup, 10’u kadın 46’sı erkek idi. Olgular işlem öncesi ve işlem sonrası 6. aya kadar Ayak bileği-kol indeksi (ABI), Rutherford skoru (RS) ve Doppler ultrasonografi (DUSG) ile takip edildi.Bulgular: DA ve PEBA grubunda ortalama lezyon uzunluğu 66,4±24,8 mm olup SENS grubunda ise 65,0±20,6 mm olarak tespit edildi. Olguların 6 aylık takibinde primer ve sekonder açık kalma oranları DA ve PEBA grubunda %85,7 ve %92,9 olarak saptanırken SENS grubunda ise %57,1 ve %71,4 olarak saptandı. Gruplar arasında istatistiksel olarak anlamlı bir fark mevcuttu. Her iki grupta da ABI ve RS açısından anlamlı derecede düzelme olduğu gözlendi.Sonuç: Bu çalışmadan elde edilen sonuçlardan, DA ile kombine edilmiş PEBA’nın, başarılı erken dönem sonuçları olması, intravasküler yabancı cisim içermemesi ve cerrahi şansını anastomoz sahasını etkilemeden devam ettirmesi sebepleriyle SENS uygulamasına göre daha üstün olduğunu düşünmekteyiz., Aim: The frequency and variety of endovascular interventions have increased with the rise in peripheral arterial occlusive disease incidence and to lessen undesirable outcomes after peripheral vascular surgery. Extensive calcific stenotic lesions affect patency rates of endovascular interventions and enhance complication rates. In this study we aimed to compare paclitaxel eluting balloon angioplasty (PEBA) combined with directional atherectomy (DA) with self expandable nitinol stent (SENS) implantation in terms of patency rates.Material and Methods: Fifty-six patients (28 patients in each group) underwent endovascular interventions for calcific stenotic superficial femoral artery lesions between March 2013 and May 2014 at Cardiovascular Surgery clinic in Namık Kemal University Hospital were included in the study. Mean age was 65.4±7.6 and male to female ratio was 46/10. Patients were followed up with ankle brachial index (ABI), Rutherford score (RS) and Doppler ultrasonography (DUSG) from the pre-intervention period to sixth month after intervention.Results: Mean lesion length in DA and PEBA group was 66.4±24.8 mm and 65.0±20.6 mm in SENS group. Primary and secondary patency rates were 85.7% and 92.9% in DA and PEBA group, and 57.1% and 71.4% in SENS group in six months follow up. There was a statistically significant difference between groups. Significant improvement was detected in terms of ABI and RS in both groups.Conclusion: We conclude from this study results that PEBA combined with DA is better than SENS implantation, because of its successful early-term results, no intravascular foreign bodies, and continues the chance of surgery without affecting the anastomosis field.

Cil: Cilem nasi studie bylo srovnani ucinnosti seal-wing balonkových katetrů s paclitaxelem (PEB) v lecbě restenoz v lekových(DES-ISR) a holých kovových stentech (BMS-ISR).Metodika: Do studie bylo zahrnuto 17 pacientů s 19 DES-ISR lezemi. Kontrolni skupinu představovalo 64 pacientů s BMS-ISR zeseal-wing PEB větve předchozi studie TIS. Primarnim end-pointem byl 12měsicni late lumen loss (LLL). Sekundarni end-pointyzahrnovaly výskyt opakovaných in-stent restenoz, hlavnich nežadoucich kardiovaskularnich přihod (MACE) a nutnosti opakovanerevaskularizace cilove tepny (TVR) po 12 měsicich.Výsledky: Ve srovnani s BMS-ISR, byla lecba DES-ISR pomoci seal-wing PEB spojena se signifikantně vyssim LLL (1,12 ± 0,83 mmvs. 0,47 ± 0,57 mm; p = 0,008), procentualnim diametrem stenozy (% DS; 62,6 ± 29,2 % vs. 42,4 ± 27,9 %; p = 0,020) a výskytemopakovaných binarnich restenoz (64,3 % vs. 28,1%; p=0,014). Rozdily ve 12měsicnich klinických výsledcich (MACE a TVR) nedosahlystatisticke významnosti (50 % vs. 30 %; p = 0,077 a 43,7 % vs. 20,6 %; p = 0,103).Zavěr: Lecba DES-ISR pomoci seal-wing PEB je spojena se signifikantně horsimi 12měsicnimi angiografickými výsledky. Rozdily ve 12měsicnim klinickem sledovani (MACE a TVR) nedosahly statisticke významnosti. (ClinicalTrials.gov; https://clinicaltrials.gov; NCT01735825.)

Background: The efficacy of paclitaxel-eluting balloon catheters (PEB) is affected by the method of binding paclitaxel to the balloon catheter surface. The aim of this study was to compare the long-term efficacy of seal-wing and iopromide-coated PEB for bare-metal stent restenosis (BMS-ISR) treatment. Methods:We analyzed 3-year clinical follow-up data of 132 patients with BMS-ISR. 64 of them were treated with seal-wing PEB, the control group comprised 68 patients from the iopromide-coated PEB arm of the previous TIS clinical study. Primary end-points included the occurrence of major adverse cardiac events (MACE; cardiovascular [CV] death, myocardial infarction [MI], or target vessel revascularization [TVR]) Results:At 3 year clinical follow-up, the incidence of MACE was significantly higher in the seal-wing PEB than in the iopromide-coated PEB group (40.6 % vs. 19.1%; p=0.008); the same can be said about TVR (26.9% vs. 8.8%; p=0.011). Similarly, the event-free survival was significantly longer in the iopromide-coated PEB than in the seal-wing PEB group (p=0.021). No significant differences were found between the groups where CV mortality (4.7% vs. 5.9%; p=1.000), MI (6.3% vs. 4.4%; p=0.712), definite stent thrombosis (0% vs. 2.9%; p=0.497) or the second MACE (4.7% vs. 1.5%; p=0.354) are concerned.Conclusions: Compared to iopromide-coated PEB, the use of seal-wing PEB for BMS-ISR treatment led to a significantly higher 3-year occurrence of MACE and TVR. Trial registartion: ClinicalTrials.gov; https://clinicaltrials.gov; NCT01735825 (Registered 7 Nov 2012).

Objectives: The authors sought to evaluate the relative performance of a drug-eluting balloon (DEB) and a drug-eluting stent (DES) in patients with any (bare-metal or drug-eluting stent) in...

Percutaneous coronary intervention (PCI) is often performed with implantation of a drug-eluting stent (DES)

To report a randomized trial comparing the Legflow paclitaxel-eluting balloon (PEB) + Supera stenting to Supera stenting alone in patients with intermediate to long superficial femoral artery (SFA) lesions.The multicenter RAPID trial ( controlled-trials.com ; identifier ISRCTN47846578) randomized (1:1) 160 patients (mean age 67 years; 102 men) with Rutherford category 2-6 ischemia to treatment with Legflow PEB + Supera stent or Supera stent alone in intermediate to long SFA lesions (mean lesion length 15.8±7.4 vs 15.8±7.6 cm, respectively). The efficacy outcome was primary patency, defined as freedom from restenosis on duplex ultrasound or angiography.Baseline characteristics including the percentage of occlusions were similar between groups. In the intention-to-treat analysis, the estimated primary patency at 1 year was 68.3% (95% CI 56.7% to 79.9%) in the PEB + Supera group vs 62.0% (95% CI 49.1% to 74.9%) in the Supera group (p=0.900). Per-protocol analysis showed a 12-month primary patency estimate of 74.7% (95% CI 63.1% to 86.3%) in the PEB + Supera group vs 62.0% (95% CI 49.1% to 74.9%) in the control group (p=0.273). Secondary patency estimates at 12 months (per-protocol analysis) were 89.0% (95% CI 80.6% to 97.4%) vs 98.0% (95% CI 94.1% to 100%; p=0.484); the estimates for freedom from clinically driven target lesion revascularization (CD-TLR) were 83.0% (95% CI 72.8% to 93.2%) and 77.8% (95% CI 66.6% to 89.0%; p=0.277), respectively.The short-term results from the multicenter RAPID randomized controlled trial indicate that the Legflow PEB is safe and feasible for the treatment of intermediate to long SFA lesions. In this trial, at least 70% of the patients suffered an occlusion. The PEB group had higher rates of primary patency and freedom from CD-TLR, although there were no statistically significant differences vs controls.

Background Our study aimed to compare the efficacy of seal-wing paclitaxel-eluting balloon catheters (PEB) with iopromide-coated PEB and everolimus-eluting stents (EES) for treating bare metal stent restenosis (BMS-ISR). Methods We enrolled 64 patients with 69 BMS-ISR. The control group comprised patients from the iopromide-PEB and EES arms of a previous TIS study. The primary end-point was 12-month in-segment late lumen loss (LLL). Secondary end-points included incidence of binary in-stent restenosis and 12-month major adverse cardiac events (MACE). Results Compared to iopromide-coated PEB, seal-wing PEB was associated with significantly higher 12-month LLL (0.30 vs. 0.02 mm; p

Background Albeit DES might be considered as a breakthrough against neointimal hyperplasia, concerns on stent thrombosis and increase incidence of in-stent restenosis after multiple DES implantations in complex, long lesions still exist. Hereby, we tried to test efficacy and safety of using PEB in long lesions followed by focal BMS implantation in a pilot multicenter study. Methods This study enrolled 16 patients with long lesions (> 30 mm) that were treated with PEB angioplasty followed by focal stenting with BMS. IVUS was performed before, after PEB and post stenting. Clinical and angiographic follow-up was done at 6 months. The primary end-point was angiographic late lumen loss. Results Patient age was 64.6 ± 8.1 years, 15 (93.7%) were males, and 7 (43.7%) diabetics. Target vessels were most commonly the left anterior descending (6 [31.6%]) and the right coronary artery (6 [31.6%]). PEB diameter was 2.8 ± 0.4 mm with a 31.3 ± 8.9 mm length. Stents per patient were 2.1 ± 0.8. No overlapping stents were deployed. Angiographic success was achieved in 100% of patients. Peri-procedural myocardial infarction occurred in 4 patients (25%). At 6 months follow-up angiography, MLD was 1.55 ± 0.53 mm with a late loss of 0.48 ± 0.52 mm, a binary re-stenosis rate of 2 (12.5%). Conclusion Using PEB with focal stenting by BMS proved to be a feasible, safe, and promising strategy in long coronary lesions. However larger study are needed to confirm these data.

We report about a 12-year-old girl who presented with a blood pressure difference between the extremities with the suspicion of an aortic coarctation. After imaging and laboratory tests, the diagnosis of Takayasu arteritis was made. Owing to persistent arterial hypertension despite medical treatment, we initiated a treatment with a balloon angioplasty of the renal arteries with an eluting balloon.

Background: Atherosclerosis in the superficial femoral artery is common in patients suffering from peripheral artery disease. Paclitaxel-eluting balloon (PEB) angioplasty, stenting, and directional atherectomy (DA) have provided new options for the treatment of superficial femoral artery disease; however, the comparative efficacy of these interventional strategies remains uncertain. Methods: One hundred and fifty-five patients with symptomatic peripheral artery disease due to de novo superficial femoral artery stenotic or occlusive lesions were randomized to treatment with plain balloon angioplasty (BA) followed by PEB angioplasty and stenting (n=48), BA and stenting (n=52), or DA with distal protection and bailout stenting (n=55). The primary end point of the study was percentage diameter stenosis after 6 months measured by angiography. Other end points included target lesion revascularization, thrombosis, ipsilateral amputation, binary restenosis, and all-cause mortality at 6 and 24 months. Results: Baseline and lesion characteristics were comparable in all groups with a mean lesion length of 65.9±46.8 mm and 56% total occlusions. At 6 months angiography, the percent diameter stenosis was significantly lower in patients treated by PEB angioplasty and stenting (34±31%) as compared with BA angioplasty and stenting (56±29%, P =0.009) or DA (55±29%, P =0.007). Similarly, binary restenosis was significantly lower after treatment with PEB and stenting as compared with BA and stenting or DA. Clinical follow-up at 24 months revealed a lower risk for target lesion revascularization after PEB angioplasty and stenting as compared with BA and stenting or DA. We found no difference in terms of target lesion thrombosis and mortality among groups, and no patient underwent amputation. Conclusions: Treatment of de novo superficial femoral artery lesions with PEB angioplasty and stenting is superior to BA angioplasty and stenting or DA in terms of angiographic diameter stenosis at 6 months and target lesion revascularization at 24 months. Clinical Trial Registration: URL: http://www.clinicaltrials.gov . Unique identifier: NCT00986752.

We read with great interest the study of Pleva et al1 comparing paclitaxel-eluting balloons (PEBs) with everolimus-eluting stents (EES) in patients with bare-metal in-stent restenosis. The results of this randomized trial suggest that PEBs reduce angiographic late lumen loss compared with EES in this scenario. However, other relevant late angiographic findings, including minimal lumen diameter and percent diameter stenosis, were similar in the 2 arms. Clinical outcome was also similar. Because these findings are of potential clinical value, but differ from the results of the RIBS V randomized trial …

Plain balloon angioplasty in femoropopliteal and below-the-knee arteries is currently associated with unacceptably high restenosis rates. Drug-eluting balloons are a promising novel technology for endovascular treatment of lower limb atherosclerotic disease. Among a variety of current commercially available devices, the Cotavance® Paclitaxel-coated Balloon Angioplasty Catheter is the device with the most extensive published clinical science. The purpose of this manuscript is to review preclinical and clinical data, as well as specificities of the Cotavance drug-eluting balloon.

Paclitaxel coated balloons (PCB) currently constitute one of the therapeutic tools used in percutaneous coronary interventions (PCI). Sequent Please® (SPB) and In-Pact Falcon® (IFB) are PCB widely used that differ in several features such as the drug carrier. Their results at a long-term follow-up

Our purpose was to confirm the local drug delivery of a paclitaxel-eluting balloon by percutaneous intervention of single arterial segments or bifurcations of porcine coronary arteries.Eight domestic pigs were subjected to 2 x 30 s Dior balloon dilatation of the mid left anterior descending, left circumflex and proximal right coronary arteries. Bifurcation intervention was performed in six arteries. The dilated, and the distal and proximal reference segments were prepared for tissue paclitaxel concentration measurement. Tissue samples were harvested at mean 1.5, 12, 24 and 48 h after balloon dilatation and plasma samples were taken at various time points.The tissue paclitaxel concentration of the single dilated segment was at 1.5 h postdilatation 1.82+/-1.60 micromol/l, which decreased significantly to 0.73+/-0.27 (P=0.032), 0.62+/-0.34 and 0.44+/-0.31 micromol/l at 12, 24 and 48 h. The bifurcation intervention resulted in 5.10+/-1.80 micromol/l tissue paclitaxel amount in the main branch, which at 12 h had diminished to 1.41+/-1.23 micromol/l (P=0.004). The bifurcation side contained 7.00+/-4.80 micromol/l paclitaxel at 1.5 h postdilatation, which lowered to 2.72+/-0.40 micromol/l (P=0.034). The mean paclitaxel concentration of the reference segments decreased gradually from 0.84+/-0.99 to 0.34+/-0.36 micromol/l (P=0.09), 0.28+/-0.16 and 0.19+/-0.18 micromol/l tissue at 1.5, 12, 24 and 48 h postdilatation, respectively. No paclitaxel was found in the peripheral blood at any time point.Short exposure of the coronary artery to paclitaxel with a coated balloon is sufficient for the attainment of an adequate tissue concentration of paclitaxel, which is known to be efficient in inhibiting neointimal growth.

Drug eluting stents decrease the rate of restenosis, however, concerns still remains about their safety, especially in ST-segment elevation myocardial infarction (STEMI). The quest for new devices and procedures, aiming for an improved safety/efficacy balance, in STEMI is still warranted. The aim of

Drug eluting balloons currently constitute one of the therapeutic tools used in percutaneous coronary intervention (PCI) of de novo coronary lesions, mainly in bifurcations and small vessels. Nowadays, their results at a very long-term follow up are unclear. The main objective of this study was to

We report the first case of coronary aneurysm formation after paclitaxel-eluting balloon angioplasty (PEBA) used to treat a coronary restenosis following previous balloon angioplasty.

Previous studies of drug-eluting stent (DES) restenosis have shown that the morphologic pattern of in-stent restenosis (ISR) was an important predictor of outcomes after plain balloon angioplasty or repeat DES placement. However, there is no data available on the relationship between the restenosis

Coronary artery bypass graft (CABG) intervention, particularly anastomosis site intervention, is challenging for interventional cardiologists. A paclitaxel-eluting balloon catheter (SeQuent Please) is a recently-introduced device capable of delivering paclitaxel homogeneously into the targeted vessel wall. We herein report our experience with two cases. In the first case, coronary angiography showed significant stenosis at the site of anastomosis between the saphenous vein graft and the left anterior descending artery (LAD). In the second case, coronary angiography showed significant stenosis at the site of anastomosis between the left internal mammary artery and the LAD. We performed percutaneous intervention of these CABG anastomoses using paclitaxel-eluting balloon catheters, and obtained favorable angiographic and clinical outcomes.

Clinical Efficacy and Safety of Sequent Please Paclitaxel-eluting Balloon in a Real-world Multi-center Registry of South-east Asian Patients. Loon Yee Louis Teo, Rohit Khurana, Fahim Haider Jafary, Yau Wei Ooi, Julian Ko Beng Tan, Khung Keong Yeo, Tian Hai Koh, Soo Teik Lim, Than Htike Aung, Paul Ong, Hee Hwa Ho. National Heart Centre Singapore, Singapore, Singapore; Tan Tock Seng Hospital, Singapore, Singapore.

Safety concerns regarding use of drug eluting coronary stents are related to late stent thrombosis, which is facilitated by incomplete endothelial stent coverage. Optical coherence tomography (OCT) is the new gold standard for intravascular imaging, enabling precise assessment of neointimal