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• W2167826036 abstract "The Percutaneous transluminal Angioplasty and Drug eluting stents for Infrapopliteal lesions in critical limb ischemia (PADI) trial is a prospective, multicenter, randomized, controlled, double-arm study investigating the safety and efficacy of primary paclitaxel-eluting stent implantation vs primary percutaneous transluminal angioplasty (PTA) in infrapopliteal lesions in critical limb ischemia (CLI). PTA with provisional “bailout” stent implantation is currently an accepted treatment for arterial obstructions in CLI, including those in below-the-knee arteries. A drawback compared to open bypass surgery is the relatively high restenosis rate. One proposed method to reduce restenosis is the use of drug-eluting stents (DES), as these have shown good results in the coronary bed. Primary DES implantation for focal obstructions in infrapopliteal arteries in CLI potentially reduces restenosis compared to PTA alone and may subsequently prolong effect of treatment, allowing for better wound healing, and preventing recurrence of symptoms. In this article, we report on rationale, design, and progress of the PADI trial, which investigates the safety and efficacy of a paclitaxel-eluting stent system compared to PTA with provisional bare metal stent implantation (Clinicaltrials.gov number NCT00471289). The Percutaneous transluminal Angioplasty and Drug eluting stents for Infrapopliteal lesions in critical limb ischemia (PADI) trial is a prospective, multicenter, randomized, controlled, double-arm study investigating the safety and efficacy of primary paclitaxel-eluting stent implantation vs primary percutaneous transluminal angioplasty (PTA) in infrapopliteal lesions in critical limb ischemia (CLI). PTA with provisional “bailout” stent implantation is currently an accepted treatment for arterial obstructions in CLI, including those in below-the-knee arteries. A drawback compared to open bypass surgery is the relatively high restenosis rate. One proposed method to reduce restenosis is the use of drug-eluting stents (DES), as these have shown good results in the coronary bed. Primary DES implantation for focal obstructions in infrapopliteal arteries in CLI potentially reduces restenosis compared to PTA alone and may subsequently prolong effect of treatment, allowing for better wound healing, and preventing recurrence of symptoms. In this article, we report on rationale, design, and progress of the PADI trial, which investigates the safety and efficacy of a paclitaxel-eluting stent system compared to PTA with provisional bare metal stent implantation (Clinicaltrials.gov number NCT00471289). In patients with critical limb ischemia (CLI) restoration of pulsatile blood flow to the distal limb is imperative for relief of symptoms and prevention of (further) tissue loss. Revascularization can be achieved by open surgical bypass or endovascular techniques, percutaneous transluminal angioplasty (PTA) with bailout stent implantation being the most widely used technique.1Norgren L. Hiatt W.R. Dormandy J.A. Nehler M.R. Harris K.A. Fowkes F.G. TASC II Working GroupInter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II).J Vasc Surg. 2007; 45: S5-S67Abstract Full Text Full Text PDF PubMed Scopus (3975) Google Scholar Possible advantages of endovascular approach are lower periprocedural morbidity and mortality, and lower cost. Short-term data from the bypass versus angioplasty in severe ischemia of the leg (BASIL) trial has confirmed this, with similar clinical outcome for surgical and endovascular approach.2Adam D.J. Beard J.D. Cleveland T. Bell J. Bradbury A.W. Forbes J.F. et al.Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial.Lancet. 2005; 366: 1925-1934Abstract Full Text Full Text PDF PubMed Scopus (1493) Google Scholar Long-term results are not yet available. The main disadvantage of PTA is the relatively high rate of restenosis, reported to be around 50% after 1 year.3Rand T. Basile A. Cejna M. Fleischmann D. Funovics M. Gschwendtner M. et al.PTA versus carbofilm-coated stents in infrapopliteal arteries: pilot study.Cardiovasc Intervent Radiol. 2006; 29: 29-38Crossref PubMed Scopus (123) Google Scholar, 4Bosiers M. Hart J.P. Deloose K. Verbist J. Peeters P. Endovascular therapy as the primary approach for limb salvage in patients with critical limb ischemia: experience with 443 infrapopliteal procedures.Vascular. 2006; 14: 63-69Crossref PubMed Scopus (162) Google Scholar, 5Gargiulo M. Maioli F. Ceccacci T. Morselli-Labate A.M. Faggioli G. Freyrie A. et al.What's next after optimal infrapopliteal angioplasty? Clinical and ultrasonographic results of a prospective single-center study.J Endovasc Ther. 2008; 15: 363-369Crossref PubMed Scopus (33) Google Scholar, 6Giles K.A. Pomposelli F.B. Hamdan A.D. Blattman S.B. Panossian H. Schermerhorn M.L. Infrapopliteal angioplasty for critical limb ischemia: relation of TransAtlantic InterSociety Consensus class to outcome in 176 limbs.J Vasc Surg. 2008; 48: 128-136Abstract Full Text Full Text PDF PubMed Scopus (199) Google Scholar Severe comorbidities and advanced age, typical of this population, pose increased surgical risk. By reducing restenosis rates, endovascular revascularization can become a better alternative to bypass surgery. One proposed method is the use of drug-eluting stents (DES), which have proven their worth in treatment of coronary artery disease (CAD). Because of similar vessel diameter, several investigators have used coronary DES in infrapopliteal arteries. These studies show very promising results, but all have considerable limitations due to study design and small numbers of patients.7Siablis D. Karnabatidis D. Katsanos K. Diamantopoulos A. Christeas N. Kagadis G.C. Infrapopliteal application of paclitaxel-eluting stents for critical limb ischemia: midterm angiographic and clinical results.J Vasc Interv Radiol. 2007; 18: 1351-1361Abstract Full Text Full Text PDF PubMed Scopus (78) Google Scholar, 8Siablis D. Karnabatidis D. Katsanos K. Kagadis G.C. Kraniotis P. Diamantopoulos A. Tsolakis J. Sirolimus-eluting versus bare stents after suboptimal infrapopliteal angioplasty for critical limb ischemia: enduring 1-year angiographic and clinical benefit.J Endovasc Ther. 2007; 14: 241-250Crossref PubMed Scopus (123) Google Scholar, 9Siablis D. Kraniotis P. Karnabatidis D. Kagadis G.C. Katsanos K. Tsolakis J. Sirolimus-eluting versus bare stents for bailout after suboptimal infrapopliteal angioplasty for critical limb ischemia: 6-month angiographic results from a nonrandomized prospective single-center study.J Endovasc Ther. 2005; 12: 685-695Crossref PubMed Scopus (112) Google Scholar, 10Rosales O.R. Mathewkutty S. Gnaim C. Drug eluting stents for below the knee lesions in patients with critical limb ischemia: long-term follow-up.Catheter Cardiovasc Interv. 2008; 72: 112-115PubMed Google Scholar, 11Commeau P. Barragan P. Roquebert P.O. Sirolimus for below the knee lesions: mid-term results of SiroBTK study.Catheter Cardiovasc Interv. 2006; 68: 793-798Crossref PubMed Scopus (103) Google Scholar The Percutaneous transluminal Angioplasty and Drug eluting stents for Infrapopliteal lesions in critical limb ischemia (PADI) trial is designed to further investigate the safety and efficacy of primary implantation of DES vs standard endovascular therapy (PTA and bailout stent implantation), using a paclitaxel-eluting stainless steel coronary stent system (TAXUS Liberté; Boston Scientific, Natick, Mass). This system was chosen because of its availability in participating centers. The PADI trial is a multicenter, prospective, randomized, controlled, nonblinded, double-arm study conducted in major vascular centers in The Netherlands. Eligible subjects are adults with CLI of the lower limb, defined as Rutherford categories 4 to 6, with obstruction or occlusion below the level of the knee joint (ie, infragenicular popliteal artery, trifurcation, and tibial and peroneal arteries) and who are considered for endovascular revascularization. Inflow proximal to target lesion(s) should be uninterrupted, possibly after treatment during the same session. Outflow distal to target lesion(s) should be unimpeded at least until the level of the ankle joint. Because of available stent sizes, reference vessel diameter for target lesions is 2-6 mm and maximum lesion length is 90 mm with a maximum of three stents overlapping. Screening of these criteria is by pretreatment imaging, ie, duplex ultrasound (DUS) scan, digital subtraction angiography (DSA), magnetic resonance angiography (MRA), or computed tomography angiography (CTA). Further inclusion criteria and exclusion criteria are detailed in Table I. Patients unwilling to participate or not meeting all criteria receive standard PTA treatment. In participating patients, clinical data is recorded (Rutherford class, ulcer size, extent of gangrene, medical history/comorbidities, cardiovascular risk factors, and concomitant medication); along with ankle-brachial index (ABI) and toe pressure (TP), if available. All patients in both arms are informed about the risks and (potential) benefits of DES stenting, the investigational nature of this procedure prior to the procedure itself, and informed consent is mandatory for randomization. Lesion criteria are re-evaluated with DSA during treatment. After the target lesions are passed with a guidewire, subjects are randomized on a 1:1 basis to receive either primary paclitaxel-eluting stent implantation or PTA with optional bailout stenting using bare metal stents (BMS). Randomization is per limb and is stratified by center in blocks, the size of which is known only to the statistician to prevent investigator bias. If both limbs are treated, each limb is randomized separately. Subjects in both arms receive 100 mg of carbasalate calcium daily indefinitely and 75 mg of clopidogrel daily for at least 6 months.Table IInclusion and exclusion criteriaInclusion criteria: •Age >18 years. •If female patient with child-bearing potential, patient may not be pregnant at the study entry and must utilize reliable birth control for the duration of her participation in the study. •Patient is willing and able to comply with the specified follow-up evaluation. •Critical limb ischemia, this is Fontaine stage III (ischemic rest pain) and IV (ischemic ulcers or gangrene) or Rutherford category 4 (ischemic rest pain), 5 (minor tissue loss), or 6 (major tissue loss). •Stenosis (>50% luminal loss) or occlusion of infrapopliteal artery, including the tibiofibular trunk, the anterior tibial artery, the posterior tibial artery, and the peroneal artery. •Target lesion length ≤90 mm. •Artery to be treated with a diameter ≥2 mm and ≤6 mm. •Patent common iliac, external iliac, superficial femoral and popliteal artery on the ipsilateral side prior to randomization, possibly after treatment during the same session. •At least 1 patent crural (anterior tibial, posterior tibial, or peroneal) artery with expected unobstructed runoff to ankle level after treatment.Exclusion criteria: •Acute limb ischemia. •Previous amputation of affected limb at or above ankle level. •Subacute limb ischemia which requires thrombolysis as first treatment modality. •Active bleeding or bleeding diathesis. •Recent (≤3 months) hemorrhagic stroke or any other CNS abnormality with increased risk of hemorrhage, such as intracranial neoplasm, arteriovenous malformation, intracranial aneurysm, or aneurysm repair. •Gastrointestinal or genitourinary bleeding of clinical significance within the previous 6 weeks before treatment. •Aneurysm in common femoral, superficial femoral, or popliteal artery on the ipsilateral side. •Surgical revascularization involving the same limb within 30 days prior to the index procedure or planned surgical revascularization of the same limb within 30 days of the index procedure. •Previous implanted stent at the index site. •Life expectancy of less than 6 months or other factors making clinical follow-up difficult. •Known allergy to acetylsalicylic acid (aspirin), clopidogrel, heparin, or paclitaxel. •Known allergy to contrast media. •Known heparin-induced thrombocytopenia (HIT type 2). •Patient unable or unwilling to tolerate anticoagulant, anti-platelet therapy or contrast media. •Creatinine clearance <20 mL/minute (as derived from Cockroft-Gault formula). •Severely calcified lesions with expected resistance to stenting. •Poor inflow due to ipsilateral stenoses or occlusions of the iliac or femoropopliteal arteries that cannot be treated during the same session. •Significant vessel tortuosity or other parameters prohibiting access to the lesions and/or delivery of the stent. •Patients without (expected) distal runoff to the index site. •Previous implanted stent at the index site.CNS, Central nervous system. Open table in a new tab CNS, Central nervous system. Follow-up consists of clinical evaluation, ABI, TP if available, and DUS of treated vessel(s) 3, 6, and 12 months post-treatment. After 6 months, a CTA of the treated limb is performed. CTA is far less invasive and less burdening to the patient than the gold standard DSA, better at evaluating stent patency than DUS and MRA, and is an adequate tool for assessment of arterial obstructions.12Schernthaner R. Stadler A. Lomoschitz F. Weber M. Fleischmann D. Lammer J. Loewe Ch Multidetector CT angiography in the assessment of peripheral arterial occlusive disease: accuracy in detecting the severity, number, and length of stenoses.Eur Radiol. 2008; 18: 665-671Crossref PubMed Scopus (83) Google Scholar Primary endpoint of the study is primary binary in segment patency, defined as less than 50% loss of luminal diameter on CTA without re-intervention in the interim. All endpoints are listed in Table II. More preferable clinical endpoints or long-term patency would require very large patient populations of more than 300, statistical sample size calculation showed. Statistical analysis is based on the null hypothesis that primary patency rates after 6 months are equal for both study-arms, with an expected patency rate of 50%, based on available literature. Rejection of the null hypothesis signifies either superior or inferior primary patency for DES. The primary endpoint will be tested by χ2 test, the secondary endpoints by χ2 test, combined logistic regression analysis, Kaplan-Meier curves, and log-rank test. Sample size was calculated to 136 patients in total, 68 for each arm.Table IIEndpointsPrimary •Primary patency (defined as ≤50% loss of luminal diameter at the treated site on CTA without re-intervention in the interim) of the treated infra-popliteal artery at 6 months.Secondary •Primary patency on duplex sonography scan of the treated sites at 3 months. •Primary patency on duplex sonography scan of the treated sites at 6 months. •Primary patency on duplex sonography scan of the treated sites at 12 months. •Clinical categorization of the treated ischemic leg by means of the Rutherford classification at 3, 6, and 12 months. •Major amputation (at or above the ankle) of the trial leg at 3, 6, and 12 months. •Minor amputation (below the ankle excluding the toes) of the trial leg at 3, 6, and 12 months. •Infrapopliteal surgical bypass of the trial leg at 3, 6, and 12 months. •Infrapopliteal endovascular re-intervention of the trial leg at 3, 6, and 12 months. •Patency of treated femoropopliteal sites, if applicable. •Peri-procedural (within 30 days) complications. •Death.CTA, Computed tomography angiography. Open table in a new tab CTA, Computed tomography angiography. The PADI trial has been approved by the medical ethical board of each of the participating centers. It is an investigator-initiated trial, receiving a grant from The Netherlands Society for Interventional Radiology. Currently, four major vascular centers in The Netherlands are recruiting patients. We expect two more to receive approval from the ethical board and to start recruiting within a few weeks. Due to discussion between local medical ethics boards and the Central Committee involving Human Subjects (Dutch: CCMO) on whether research involving DES should follow guidelines on medical device research or clinical drug research, rollout to centers other than the principle site (Haga Teaching Hospital) was delayed by almost 2 years (initial approval April 2007, final approval December 2008). A total of 19 patients have been included in 15 months, but centers other than the principal site have only just started recruiting. The relatively strict angiographic criteria prohibit inclusion of most screened subjects, since many of them have diffuse arterial disease over long segments. Reducing restenosis rates for endovascular revascularization can make it a better alternative to bypass surgery. DES have this potential. The PADI trial studies the safety and efficacy of primary paclitaxel-eluting stent implantation for infrapopliteal lesions in CLI compared to standard PTA with optional bailout bare metal stent implantation." @default.
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• W2167826036 title "Update on PADI trial: Percutaneous transluminal angioplasty and drug-eluting stents for infrapopliteal lesions in critical limb ischemia" @default.
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