Dierk Scheinert

Park-Krankenhaus, Leipzig, Leipzig, Saxony, Germany

Are you Dierk Scheinert?

Claim your profile

Publications (194)1081.97 Total impact

  • [Show abstract] [Hide abstract]
    ABSTRACT: Purpose: To describe and compare primary patency rates in patients undergoing endovascular femoropopliteal interventions with standard or interwoven nitinol stents or drug-coated balloons. Methods: A cohort of 1292 patients was treated for symptomatic femoropopliteal occlusive disease classified as Rutherford category ≥1 at a large vascular center between June 2006 and August 2013 using either standard nitinol stents (SNS; n=432), interwoven nitinol stents (INS; n=470), or drug-coated balloons (DCB; n=390). Primary patency rates were assessed by ultrasound or angiographic readings for over 3 years of follow-up. Propensity score-matched pairs were formed to compare each treatment with another using survival analysis. Results: Survival curves of primary patency favored INS compared with SNS in 368 propensity score-matched pairs (p<0.001). Kaplan-Meier estimates at 1, 2, and 3 years were 86.6%, 76.4%, and 68.9%, respectively, in the INS group vs 60.5%, 46.1%, and 42.1%, respectively, in the SNS group. No significant difference (p=0.232) was seen for the comparison of SNS vs DCB in 284 matched pairs over long-term follow-up (primary patency estimates at 1, 2, and 3 years were 79.8%, 53.8%, and 32.9%, respectively, in the DCB group vs 60.5%, 44.8%, and 40.3%, respectively, in the SNS group). Survival curves of primary patency favored INS over DCB in 254 matched pairs (p<0.001). Kaplan-Meier estimates at 1, 2, and 3 years were 79.0%, 51.2%, and 30.1%, respectively, in the DCB group vs 89.0%, 76.9%, and 66.2%, respectively, in the INS group. Conclusion: Propensity score-based analysis of primary patency suggests profound differences in restenosis rates between various treatment modalities for femoropopliteal disease for over 3 years of follow-up.
    No preview · Article · Feb 2016 · Journal of Endovascular Therapy
  • [Show abstract] [Hide abstract]
    ABSTRACT: Objective: Recent small single-center data indicate that the current hemodynamic parameters used to diagnose critical limb ischemia are insensitive. We investigated the validity of the societal guidelines-recommended hemodynamic parameters against core laboratory-adjudicated angiographic data from the multicenter IN.PACT DEEP (RandomIzed AmPhirion DEEP DEB vs StAndard PTA for the treatment of below the knee Critical limb ischemia) Trial. Methods: Of the 358 patients in the IN.PACT DEEP Trial to assess drug-eluting balloon vs standard balloon angioplasty for infrapopliteal disease, 237 had isolated infrapopliteal disease with an available ankle-brachial index (ABI), and only 40 of the latter had available toe pressure measurements. The associations between ABI, ankle pressure, and toe pressure with tibial runoff, Rutherford category, and plantar arch were examined according to the cutoff points recommended by the societal guidelines. Abnormal tibial runoff was defined as severely stenotic (≥70%) or occluded and scored as one-, two-, or three-vessel disease. A stenotic or occluded plantar arch was considered abnormal. Results: Only 14 of 237 patients (6%) had an ABI <0.4. Abnormal ankle pressure, defined as <50 mm Hg if Rutherford category 4 and <70 mm Hg if Rutherford category 5 or 6, was found only in 37 patients (16%). Abnormal toe pressure, defined as <30 mm Hg if Rutherford category 4 and <50 mm Hg if Rutherford category 5 or 6, was found in 24 of 40 patients (60%) with available measurements. Importantly, 29% of these 24 patients had an ABI within normal reference ranges. A univariate multinomial logistic regression found no association between the above hemodynamic parameters and the number of diseased infrapopliteal vessels. However, there was a significant paradoxic association where patients with Rutherford category 6 had higher ABI and ankle pressure than those with Rutherford category 5. Similarly, there was no association between ABI and pedal arch patency. Conclusions: The current recommended hemodynamic parameters fail to identify a significant portion of patients with lower extremity ulcers and angiographically proven severe disease. Toe pressure has better sensitivity and should be considered in all patients with critical limb ischemia.
    No preview · Article · Feb 2016 · Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter
  • [Show abstract] [Hide abstract]
    ABSTRACT: The authors sought to report the wound healing outcomes, health-related quality-of-life changes and quality-adjusted life-years (QALYs) gain in the 2 treatment arms of the ACHILLES (Comparing Angioplasty and DES in the Treatment of Subjects With Ischemic Infrapopliteal Arterial Disease) multicenter randomized trial.
    No preview · Article · Jan 2016
  • [Show abstract] [Hide abstract]
    ABSTRACT: Purpose: To evaluate the safety and efficacy of the Igaki-Tamai biodegradable scaffold after drug-eluting balloon (DEB) angioplasty in patients with occlusive superficial femoral artery (SFA) disease. Methods: A prospective, single-center, nonrandomized study enrolled 20 patients (mean age 66.7±11.6 years; 14 men) with symptomatic de novo SFA lesions undergoing angioplasty with the In.Pact Admiral paclitaxel-coated balloon and subsequent implantation of the Igaki-Tamai bioresorbable scaffold. All patients were claudicants. The average diameter stenosis was 89.7%, and the mean length was 43.6 mm. Clinical examinations with duplex sonography were performed after 1, 6, 9, and 12 months. The main study outcomes were technical success, restenosis, target lesion revascularization (TLR), ankle-brachial index (ABI) improvement, and changes in quality of life evaluated with the walking impairment questionnaire. Safety was assessed by monitoring the occurrence of adverse events. Results: Angioplasty with a paclitaxel-coated balloon was performed in all patients, resulting in an average diameter stenosis of 24%. Subsequent implantation of the Igaki-Tamai scaffold reduced the average diameter stenosis to 3.5%. In the first 6 months, 2 cases of restenosis were reported, with no TLRs within that period. However, by the 12-month follow-up in 19 patients, 11 patients had lost in-stent patency. Among these patients, 8 had TLRs, which were the only adverse events recorded that were referable to the procedure. Quality-of-life assessments showed improvement in the majority of patients. Conclusion: The GAIA-DEB study shows that DEB treatment of the femoral artery prior to the implantation of the biodegradable Igaki-Tamai scaffold is safe. However, the antiproliferative actions of paclitaxel in the vessel wall were not effective in preventing restenosis. In-stent restenosis occurred predominantly after 6 months.
    No preview · Article · Dec 2015 · Journal of Endovascular Therapy

  • No preview · Article · Oct 2015 · New England Journal of Medicine
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Background: Evidence from large, randomized, controlled peripheral artery disease trials reporting long-term outcomes using drug-coated balloons (DCBs) is limited. Previously, the DCB showed favorable 1-year outcomes compared with conventional percutaneous transluminal angioplasty (PTA), yet durability of the treatment effect with DCBs remains unknown. Objectives: This study sought to investigate the longer-term outcomes of a paclitaxel-eluting DCB compared to PTA for femoropopliteal lesions. Methods: We enrolled 331 patients with symptomatic (Rutherford 2 to 4) femoropopliteal lesions up to 18 cm in length. Patients were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The 24-month assessments included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), major adverse events, and quality of life and functional outcomes as assessed by the EuroQOL-5D quality-of-life questionnaire, walking impairment questionnaire, and 6-min walk test. Results: At 24 months, patients treated with DCB showed significantly higher primary patency when compared with PTA (78.9% vs. 50.1%; p < 0.001). The rates of CD-TLR were 9.1% and 28.3% (p < 0.001) for the DCB and PTA groups, respectively. The overall mortality rate in the DCB group was 8.1% versus 0.9% in the PTA group (p = 0.008). There were no device- or procedure-related deaths and no major amputations in either group through 24-month follow-up. The rate of vessel thrombosis was low (1.5% DCB vs. 3.8% PTA; p = 0.243), with no new events reported between 1 and 2 years. Both groups showed similar functional improvement at 2 years, although DCB patients achieved this level of function with 58% fewer reinterventions. Conclusions: The 24-month outcomes from the trial demonstrate a durable and superior treatment effect of DCB versus PTA with significantly higher primary patency, lower CD-TLR, and similar functional status improvement with fewer repeat interventions. (Randomized Trial of IN.PACT Admiral Drug Eluting Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [INPACT SFA I]; NCT01175850; and IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA] [INPACT SFA II]; NCT01566461).
    Preview · Article · Oct 2015 · Journal of the American College of Cardiology
  • [Show abstract] [Hide abstract]
    ABSTRACT: Background: -Drug-coated balloon angioplasty (DCBA) was shown to be superior to standard balloon angioplasty (POBA) with regard to restenosis prevention for de-novo superficial femoral artery (SFA) disease. For in-stent restenosis (ISR), the benefit of DCBA over POBA remains uncertain. Methods and results: -One-hundred-nineteen patients with SFA ISR and chronic limb ischemia were recruited over 34 months at 5 German clinical sites and prospectively randomized to either DCBA (n = 62) or POBA (n = 57). Mean lesion length was 82.2 ± 68.4 mm. Thirty four (28.6%) lesions were totally occluded, 30 (25.2%) were moderately or heavily calcified. Clinical and duplex ultrasound follow-up was conducted at 6 and 12 months. The primary endpoint of recurrent ISR assessed by ultrasound at 6 months was 15.4% (8/52) in the DCBA and 44.7% (21/47) in the POBA group (P = 0.002). Freedom from target lesion revascularization (TLR) was 96.4 % vs. 81.0% (P = 0.0117) at 6 months and 90.8% vs. 52.6% (P < 0.0001) at 12 months, respectively. At 12 months, clinical improvement by ≥ 1 Rutherford category without the need of TLR was observed in 35/45 DCBA patients (77.8%) and 23/44 POBA patients (52.3%, P = 0.015). No major amputation was needed. Two patients in the DCBA and 3 patients in the POBA group died. No death was procedure-related. Conclusions: -DCBA for SFA ISR is associated with less recurrent restenosis and a better clinical outcome than POBA, without an apparent difference in safety. Clinical Trial Registration Information-www.clinicaltrials.gov. Identifier: NCT01305070.
    No preview · Article · Oct 2015 · Circulation

  • No preview · Article · Oct 2015 · Journal of the American College of Cardiology
  • [Show abstract] [Hide abstract]
    ABSTRACT: The aim of BIOLUX P-II (BIOTRONIK'S–First in Man study of the Passeo-18 LUX drug releasing PTA Balloon Catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries) trial was to compare the safety and efficacy of a novel paclitaxel-coated drug-eluting balloon (DEB) versus an uncoated balloon (percutaneous transluminal angioplasty [PTA]) in de novo or native restenotic lesions of the infrapopliteal arteries in patients with claudication and critical limb ischemia.
    No preview · Article · Oct 2015
  • [Show abstract] [Hide abstract]
    ABSTRACT: Background: The treatment of peripheral artery disease with percutaneous transluminal angioplasty is limited by the occurrence of vessel recoil and restenosis. Drug-coated angioplasty balloons deliver antiproliferative agents directly to the artery, potentially improving vessel patency by reducing restenosis. Methods: In this single-blind, randomized trial conducted at 54 sites, we assigned, in a 2:1 ratio, 476 patients with symptomatic intermittent claudication or ischemic pain while at rest and angiographically significant atherosclerotic lesions to angioplasty with a paclitaxel-coated balloon or to standard angioplasty. The primary efficacy end point was primary patency of the target lesion at 12 months (defined as freedom from binary restenosis or from the need for target-lesion revascularization). The primary safety end point was a composite of freedom from perioperative death from any cause and freedom at 12 months from limb-related death (i.e., death from a medical complication related to a limb), amputation, and reintervention. Results: The two groups were well matched at baseline; 42.9% of the patients had diabetes, and 34.7% were current smokers. At 12 months, the rate of primary patency among patients who had undergone angioplasty with the drug-coated balloon was superior to that among patients who had undergone conventional angioplasty (65.2% vs. 52.6%, P=0.02). The proportion of patients free from primary safety events was 83.9% with the drug-coated balloon and 79.0% with standard angioplasty (P=0.005 for noninferiority). There were no significant between-group differences in functional outcomes or in the rates of death, amputation, thrombosis, or reintervention. Conclusions: Among patients with symptomatic femoropopliteal peripheral artery disease, percutaneous transluminal angioplasty with a paclitaxel-coated balloon resulted in a rate of primary patency at 12 months that was higher than the rate with angioplasty with a standard balloon. The drug-coated balloon was noninferior to the standard balloon with respect to safety. (Funded by Lutonix-Bard; LEVANT 2 ClinicalTrials.gov number, NCT01412541.).
    No preview · Article · Jun 2015 · New England Journal of Medicine

  • No preview · Article · May 2015 · European Heart Journal
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: To evaluate the short- and midterm outcomes of the Viabahn endoprosthesis with Propaten Bioactive Surface vs. standard balloon angioplasty for treatment of in-stent restenosis in the superficial femoral artery. Between June 2010 and February 2012, 83 patients with superficial femoral artery in-stent and Rutherford category 2 to 5 ischemia were enrolled at 7 sites participating in this prospective randomized controlled study (RELINE; ClinicalTrials.gov; identifier NCT01108861). The patients were randomized to treatment with either the heparin-bonded Viabahn endoprosthesis (n=39: 29 men; mean age 67.7±9.8 years) or a standard angioplasty balloon (n=44: 32 men; mean age 69.0±9.7 years). The primary effectiveness outcome was primary patency at 12 months, defined as no restenosis/occlusion within the target lesion based on duplex ultrasound and no target lesion revascularization. The primary safety endpoint was the incidence of serious device-related adverse events within 30 days of the procedure. All patients randomized to receive dilation or the Viabahn stent-graft were treated according to their assignment. The technical success was 100% for the Viabahn group and 81.8% for the angioplasty group (p=0.002) owing to 9 patients requiring a bailout procedure after unsuccessful angioplasty. The 12-month primary patency rates were 74.8% for the Viabahn group and 28.0% for the angioplasty group (p<0.001). Excluding the 9 angioplasty patients who received bailout stenting, the primary patency for optimal balloon angioplasty was 37.0% (p<0.001). Three patients experienced device-related adverse events within 30 days: occlusion of the target lesion (Viabahn group), peripheral embolization (angioplasty group), and reocclusion of the target lesion (angioplasty group). In this study, the treatment of femoropopliteal in-stent restenosis with a Viabahn endoprosthesis showed significantly better results than treatment with a standard balloon at 1 year. © The Author(s) 2015.
    Full-text · Article · Feb 2015 · Journal of Endovascular Therapy
  • [Show abstract] [Hide abstract]
    ABSTRACT: To evaluate the safety and efficacy of the novel Passeo-18 Lux paclitaxel-coated balloon compared with the Passeo-18 uncoated balloon in patients with symptomatic de novo or restenotic femoropopliteal lesions. Sixty patients (34 men; mean age 70.7±10.1 years) in 5 European centers were enrolled in the BIOLUX P-I trial (ClinicalTrials.gov identifier NCT01056120) and randomized 1:1 to either the paclitaxel-coated balloon or the uncoated balloon. The primary endpoint was late lumen loss at 6 months. Secondary endpoints were binary restenosis at 6 months, clinically driven target lesion revascularization (TLR), change in ankle-brachial index and Rutherford classification, and major adverse events at 6 and 12 months. At 6 months, patients treated with paclitaxel-coated balloons had a significantly lower late lumen loss (0.51±0.72 vs. 1.04±1.00 mm, p=0.033) and binary restenosis (11.5% vs. 34.6%, p=0.048) than the control group. Correspondingly, clinically driven TLR was lower in the paclitaxel-coated balloon group at 12 months [15.4% vs. 41.7% (p=0.064) for the intention-to-treat population and 16.0% vs. 52.9%, (p=0.020) for the as-treated population]. No death and one minor amputation were observed compared with two deaths and two minor amputations in the control group. No major amputations or thrombosis were reported. The Passeo-18 Lux paclitaxel-coated balloon has been proven to be safe and effective in patients with femoropopliteal lesions, with superior performance outcomes compared with treatment with an uncoated balloon. © The Author(s) 2015.
    No preview · Article · Feb 2015 · Journal of Endovascular Therapy
  • [Show abstract] [Hide abstract]
    ABSTRACT: To investigate the 2-year technical and clinical results of primary nitinol stent placement in comparison with percutaneous transluminal angioplasty (PTA) in the treatment of de novo lesions of the popliteal artery. The ETAP study (Endovascular Treatment of Atherosclerotic Popliteal Artery Lesions: balloon angioplasty vs. primary stenting; www.ClinicalTrials.gov identifier NCT00712309) is a prospective, randomized trial that enrolled 246 patients (158 men; mean age 72 years) who were randomly assigned to receive a nitinol stent (n=119) or PTA (n=127) for lesions averaging 42.3 mm in length. The results of the primary study endpoint were published. Secondary outcome measures and endpoints included primary patency (freedom from duplex-detected target lesion restenosis), target lesion revascularization (TLR), secondary patency, changes in ankle-brachial index and Rutherford class, and event-free survival (freedom from target limb amputation, TLR, myocardial infarction, and death). In total, 183 patients (89 stent and 94 PTA) were available for the 2-year analysis. The primary patency rate was significantly higher in the stent group (64.2%) than in the PTA group (31.3%, p=0.0001). TLR rates were 22.4% and 59.5%, respectively (p=0.0001). When provisional stent placement in the PTA arm was not considered as TLR and loss in patency, the differences prevailed between the study groups but were not significant (64.2% vs. 56.1% for primary patency, respectively; p=0.44). A significant improvement in ABI and Rutherford category was observed at 2 years in both groups. In treatment of obstructive popliteal artery lesions, provisional stenting reveals equivalent patency in comparison to primary stenting. However, the 2-year results of this trial suggest the possibility of a shift toward higher patency rates in favor of primary stenting. © The Author(s) 2015.
    No preview · Article · Feb 2015 · Journal of Endovascular Therapy

  • No preview · Article · Feb 2015 · JACC Cardiovascular Interventions
  • [Show abstract] [Hide abstract]
    ABSTRACT: The occurrence of early post-procedural complications after carotid artery stenting (CAS) can be attributed to embolization of thrombus or plaque particles released from the stented segment. Vascular emboli can be non-invasively detected by transcranial Doppler ultrasound as microembolic signals (MES). We performed this study to discover factors predicting MES detected by transcranial Doppler (TCD)-monitoring within the early post-interventional phase. In 134 consecutive patients undergoing CAS, transcranial Doppler monitoring of the ipsilateral middle cerebral artery was performed for MES detection during the first post-interventional hour. To identify clinical, morphologic, and procedure-related parameters likely to predict the occurrence of post-interventional MES a logistic regression analysis was performed. In 134 patients (111 male, mean age 69.7 years) relevant MES were detected in 51 patients (38 %) with a median of 4 MES/h and a maximum of 62 MES/h. Three factors were observed to be associated with increased post-interventional MES-counts. These included symptomatic lesion (p < 0.05), elevated total cholesterol (p < 0.05), and aspirin monotherapy (p < 0.0005). In a binary logistic regression model, dual antiplatelet therapy (OR 5.6, p < 0.0005) and asymptomatic lesions (OR 2.6, p < 0.05) were revealed as independent predictors for the absence of post-interventional MES. Post-interventional MES were most likely in symptomatic lesions and patients with elevated cholesterol. The absence of an effective dual antiplatelet therapy and symptomatic lesions were revealed as independent predictors for post-interventional MES. An effective pre-interventional dual antiplatelet and lipid lowering therapy might improve the safety of CAS.
    No preview · Article · Jan 2015 · VASA.: Zeitschrift für Gefässkrankheiten. Journal for vascular diseases
  • Andrej Schmidt · Dierk Scheinert

    No preview · Article · Dec 2014
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: -Drug-coated balloons (DCB) have shown promise in improving outcomes for patients with peripheral artery disease. We compared a paclitaxel-coated balloon with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic superficial femoral and/or popliteal artery disease. -The IN.PACT SFA Trial is a prospective, multicentre, single-blinded, randomized trial in which 331 patients with intermittent claudication or ischemic rest pain due to superficial femoral and/or popliteal peripheral artery disease (PAD) were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The primary efficacy endpoint was primary patency, defined as freedom from restenosis or clinically-driven target lesion revascularization at 12 months. Baseline characteristics were similar between the 2 groups. Mean lesion length and percent of total occlusions for the DCB and PTA arms were 8.94±4.89 and 8.81±5.12 cm (P=.82) and 25.8% and 19.5% (P=.22), respectively. DCB resulted in higher primary patency vs. PTA (82.2% vs. 52.4%; P<.001). The rate of clinically-driven target lesion revascularization was 2.4% in the DCB arm compared with 20.6% in the PTA arm (P<.001). There was a low rate of vessel thrombosis in both arms (1.4% after DCB and 3.7% after PTA (P=.10)). There were no device- or procedure-related deaths and no major amputations. -In this prospective, multicenter, randomized trial, DCB was superior to PTA and had a favorable safety profile for the treatment of patients with symptomatic femoropopliteal PAD. Clinical Trial Registration Information-ClinicalTrials.gov. Identifiers: NCT01175850 and NCT01566461.
    Full-text · Article · Dec 2014 · Circulation
  • [Show abstract] [Hide abstract]
    ABSTRACT: Atherosclerotic peripheral artery disease (PAD) is common and results in limitations in quality of life and potential progression to limb loss. Options for therapy include medical therapy, supervised exercise, surgical revascularization, and, more recently, endovascular therapies to restore arterial perfusion to the limb. Endovascular revascularization has evolved over the past 2 decades, from percutaneous transluminal angioplasty (PTA) to self-expanding stents, atherectomy, laser angioplasty, and drug-eluting stents. Despite impressive technologic advances, PTA remains the standard of care at many institutions and is the recommended primary treatment modality for femoral-popliteal PAD according to current American College of Cardiology Foundation/American Heart Association guidelines. However, restenosis after PTA is common. Therefore, a significant clinical need remains for a device that is able to achieve more durable patency than PTA but does not require a permanent implant. Drug-coated balloons (DCBs) have the potential to address this need. Several randomized controlled clinical trials of PTA balloons coated with different formulations of paclitaxel have been conducted in Europe (N Engl J Med 2008;358:689-699) (Circulation 2008;118:1358-1365) (Circ Cardiovasc Interv 2012;5:831-840) (JACC Cardiovas Interv 2014;7:10-19) and demonstrated more durable efficacy than PTA with comparable safety. These studies were limited by small sample sizes and powered solely for an angiographic primary end point. The pivotal LEVANT 2 trial was designed in collaboration with the US Food and Drug Administration to demonstrate safety and efficacy in a large population and to obtain US Food and Drug Administration approval. A prospective, multicenter, single-blind trial comparing the Lutonix DCB (Bard Lutonix; New Hope, MN) versus PTA for treatment of femoropopliteal PAD (LEVANT 2) is the first US-based 2:1 randomized controlled trial of 476 patients with femoral-popliteal PAD designed to demonstrate superior efficacy and noninferior safety of a novel paclitaxel DCB compared with PTA. The primary efficacy end point is primary patency at 12 months. The primary safety end point is composite freedom at 12 months from perioperative death, index limb amputation, reintervention, and limb-related mortality. A series of important secondary end points include physical functioning, quality of life, revascularizations, and alternative measures of patency. To minimize bias potential for confounding variables, LEVANT 2 (1) excluded patients stented after predilation before randomization, (2) incorporated very stringent criteria for bailout stenting, (3) did not count bailout stenting as a target lesion revascularization or failure of any end point, (4) required a blinded clinician to perform clinical evaluations at follow-up, and (5) required clinical assessment before review of duplex ultrasound results. LEVANT 2 represents the first US-inclusive multicenter, randomized controlled trial to assess the safety and efficacy of a novel DCB compared with PTA as primary therapy for symptomatic PAD on the background of standard medical therapy. Copyright © 2014 Elsevier Inc. All rights reserved.
    No preview · Article · Dec 2014 · American Heart Journal
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Purpose: To confirm the performance and safety of the 25-cm Viabahn endoprosthesis with Propaten bioactive surface when used in the treatment of de novo and/or restenotic TransAtlantic Inter-Society Consensus II C and D lesions of the superficial femoral artery and proximal popliteal artery. Methods: The 25-cm Gore Viabahn Endoprosthesis study (ClinicalTrials.gov identifier NCT01263665) is a prospective, multicenter, single-arm study that enrolled 71 patients (50 men; mean age 66.7 +/- 8.34 years) with lifestyle-limiting claudication (Rutherford class 2 to 4) and lesions longer than 20 cm (mean length 26.5 +/- 5.31 cm, range 20-40). The majority of lesions (92.9%) were total occlusions. The primary performance outcome was post-deployment stent length within 610% of the pre-deployment stent length determined angiographically by quantitative vascular analysis. The primary safety outcome was device- and procedure-related serious adverse events occurring within 30 days of the procedure. The patients underwent follow-up examinations at 1 month and 1 year. Results: The median follow-up was 12.3 months (mean 12.3 +/- 0.6). Nine (12.7%) patients discontinued the study due to different reasons including 2 bypass surgeries. Angiography was available in 60 patients to determine the primary performance outcome, which was met in all cases. Two (2.8%) patients experienced a procedure-/ device-related adverse event (dissection) during the 30-day follow-up. Kaplan-Meier estimates for 1-year primary and secondary patency were 67.0% [95% confidence interval (CI) 53.5% to 77.3%] and 96.9% (95% CI 88.0% to 99.2%), respectively. Changes in ankle-brachial index and Rutherford category at 1 and 12 months each showed sustained improvement. Conclusion: This study confirms that the 25-cm Viabahn endoprosthesis acutely performs as intended and is safe when used as indicated in complex femoropopliteal lesions. Oneyear primary and secondary patency rates are satisfying and comparable to historical prosthetic bypass graft outcomes.
    Full-text · Article · Dec 2014 · Journal of Endovascular Therapy

Publication Stats

6k Citations
1,081.97 Total Impact Points


  • 2009-2016
    • Park-Krankenhaus, Leipzig
      Leipzig, Saxony, Germany
    • Universität Witten/Herdecke
      Witten, North Rhine-Westphalia, Germany
  • 2006-2015
    • Kunststoff-Zentrum in Leipzig
      Leipzig, Saxony, Germany
  • 2003-2015
    • University of Leipzig
      • • Klinik und Poliklinik für Diagnostische und Interventionelle Radiologie
      • • Department of Cardiac Surgery
      • • Institute for Social Medicine, Occupational Health and Public Health
      Leipzig, Saxony, Germany
    • University of Hamburg
      Hamburg, Hamburg, Germany
    • Montreal Heart Institute
      Montréal, Quebec, Canada
  • 2011-2014
    • Heart & Vascular Center
      Göttingen, Lower Saxony, Germany
  • 2013
    • Universitäts-Herzzentrum Freiburg - Bad Krozingen
      باد کروزینگن, Baden-Württemberg, Germany
    • University of Antwerp
      Antwerpen, Flemish, Belgium
  • 2005-2011
    • Isar Heart Center
      Münchenbernsdorf, Thuringia, Germany
    • Jagiellonian University
      Cracovia, Lesser Poland Voivodeship, Poland
    • University of Tuebingen
      • Department of Radiology
      Tübingen, Baden-Württemberg, Germany
  • 2000-2006
    • Universitätsklinikum Erlangen
      Erlangen, Bavaria, Germany
  • 2004
    • Humboldt-Universität zu Berlin
      • Department of Biology
      Berlín, Berlin, Germany
  • 2000-2003
    • Friedrich-Alexander-University of Erlangen-Nürnberg
      Erlangen, Bavaria, Germany