4-French-compatible endovascular material is safe and effective in the treatment of femoropopliteal occlusive disease: Results of the 4-EVER trial

Journal of Endovascular Therapy

Volumn 20, Issue 6, 2013, Pages 746-756

  Bosiers, Marc ^a   Deloose, Koen ^a   Callaert, Joren ^a   Keirse, Koen ^b   Verbist, Jur̈gen ^b   Hendriks, Jeroen ^c   Lauwers, Patrick ^c   D'Archambeau, Olivier ^c   Scheinert, Dierk ^d   Torsello, Giovanni ^e   Peeters, Patrick ^b  

^a AZ Sint Blasius ^*  (Belgium)

^b IMELDA HOSPITAL   (Belgium)

^c ANTWERP UNIVERSITY HOSPITAL   (Belgium)

^d Park Hospital Leipzig   (Germany)

^e St Franziskus Hospital   (Germany)

Author keywords

4 French devices; Access site complications; Endovascular therapy; Femoropopliteal segment; Low profile; Manual compression; Nitinol stent; Occlusion; Patency; Peripheral artery disease; Puncture site complications; Stenosis; Superficial femoral artery

Indexed keywords

ACETYLSALICYLIC ACID; BIOMATERIAL; CLOPIDOGREL; WARFARIN;

ADULT; AGED; ANGIOCARDIOGRAPHY; ARTICLE; COMPRESSION; DIABETES MELLITUS; DISSECTION; ECHOGRAPHY; ENDOVASCULAR SURGERY; EVALUATION; FEMALE; FEMOROPOPLITEAL OCCLUSIVE DISEASE; FLUOROSCOPY; FOLLOW UP; HEART ATRIUM FIBRILLATION; HEMATOMA; HUMAN; MAJOR CLINICAL STUDY; MALE; MEDICAL DEVICE COMPLICATION; MULTICENTER STUDY; NITINOL STENT; OUTCOME ASSESSMENT; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY; PRIORITY JOURNAL; PROSPECTIVE STUDY; PUNCTURE; RESTENOSIS; REVASCULARIZATION; RISK FACTOR; SAFETY; SELF EXPANDING STENT; SUPERFICIAL FEMORAL ARTERY; SURVIVAL RATE; VASCULAR ACCESS; VASCULAR DISEASE; VASCULAR PATENCY;

AGED; AGED, 80 AND OVER; ALLOYS; ANGIOPLASTY, BALLOON; BELGIUM; EQUIPMENT DESIGN; FEMALE; FEMORAL ARTERY; GERMANY; HUMANS; MALE; MIDDLE AGED; PERIPHERAL ARTERIAL DISEASE; POPLITEAL ARTERY; PROSPECTIVE STUDIES; STENTS; TIME FACTORS; TREATMENT OUTCOME; ULTRASONOGRAPHY, DOPPLER, DUPLEX; VASCULAR ACCESS DEVICES; VASCULAR PATENCY;

EID: 84890078179     PISSN: 15266028     EISSN: 15451550     Source Type: Journal    
DOI: 10.1583/13-4437MR.1     Document Type: Article

References (46)

1. Nowygrod R, Egorova N, Greco G, et al. Trends, complications, and mortality in peripheral vascular surgery. J Vasc Surg. 2006;43:205-216.
2. Anderson PL, Gelijns A, Moskowitz A, et al. Understanding trends in inpatient surgical volume: vascular interventions, 1980-2000. J Vasc Surg. 2004;39:1200-1208.
3. Adam DJ, Beard JD, Cleveland T, et al. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet. 2005;366:1925-1934.
4. Schillinger M, Sabeti S, Dick P, et al. Sustained benefit at 2 years of primary femoropopliteal stenting compared with balloon angioplasty with optional stenting. Circulation. 2007;1158:2745-2749.
5. Norgren L, Hiatt WR, Dormandy JA, et al. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007;45 Suppl S:S5-67.
6. Conrad MF, Cambria RP, Stone DH, et al. Intermediate results of percutaneous endovascular therapy of femoropopliteal occlusive disease: a contemporary series. J Vasc Surg. 2006;44:762-769.
7. Scott EC, Biuckians A, Light RE, et al. Subintimal angioplasty for the treatment of claudication and critical limb ischemia: 3-year results. J Vasc Surg. 2007;46:959-964.
8. Mousa A, Rhee JY, Trocciola SM, et al. Percutaneous endovascular treatment for chronic limb ischemia. Ann Vasc Surg. 2005;19:186-191.
9. Dick P, Wallner H, Sabeti S, et al. Balloon angioplasty versus stenting with nitinol stents in intermediate length superficial femoral artery lesions. Catheter Cardiovasc Interv. 2009;74:1090-1095.
10. Laird JR, Katzen BT, Scheinert D, et al. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery. Circ Cardiovasc Interv. 2010;3:267-276.
11. Tavris DR, Gallauresi BA, Lin B, et al. Risk of local adverse events following cardiac catheterization by hemostasis device use and gender. J Invasive Cardiol. 2004;16:459-464.
12. Durst R, Lotan C, Nassar H, et al. Comparison of 4 and 6 French catheters for coronary angiography: real-world modeling. Isr Med Assoc J. 2007;9:290-293.
13. Bosiers M, Torsello G, Gissler HM, et al. Nitinol stent implantation in long superficial femoral artery lesions: 12-month results of the DURABILITY I study. J Endovasc Ther. 2009;16:261-269.
14. Rutherford RB, Baker JD, Ernst C, et al. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997;26:517-538.
15. Leiner T, Kessels AG, Nelemans PJ, et al. Peripheral arterial disease: comparison of color duplex US and contrast-enhanced MR angiography for diagnosis. Radiology. 2005;235:699-708.
16. Rocha-Singh KJ, Jaff MR, Crabtree TR, et al. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Catheter Cardiovasc Interv. 2007;69:910-919.
17. Krankenberg H, Schluter M, Steinkamp HJ, et al. Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the femoral artery stenting trial (FAST). Circulation. 2007;116:285-292.
18. Schillinger M, Sabeti S, Loewe C, et al. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006;354:1879-1888.
19. Dake MD, Ansel GM, Jaff MR, et al. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease. Circ Cardiovasc Interv. 2011;4:495-504.
20. Matsumara JS, Yamanouchi D, Goldstein JA, et al. The United States study for evaluating endovascular treatments of lesions in the superficial femoral artery and proximal popliteal by using the Protégé EverFlex nitinol stent system II (DURABILITY II). J Vasc Surg. 2013;5214:115-118.
21. Scheinert D, Werner M, Scheinert S, et al. Treatment of complex atherosclerotic popliteal artery disease with a new self-expanding interwoven nitinol stent: 12-month results of the Leipzig SUPERA popliteal artery stent registry. JACC Cardiovasc Interv. 2013;6:65-71.
22. Schulte KL, Kralj I, Gissler HM, et al. MISAGO 2: one-year outcomes after implantation of the Misago self-expanding nitinol stent in the superficial femoral and popliteal arteries of 744 patients. J Endovasc Ther. 2012;19:774-784.
23. Rzany A, Schaldach M. Smart material silicon carbide: reduced activation of cells and proteins on a-SiC:H-coated stainless steel. Prog Biom Res. 2001;6:182-194.
24. Schwartz BG, Burstein S, Economides C, et al. Review of vascular closure devices. J Invasive Cardiol. 2010;22:599-607.
25. Semler HJ. Transfemoral catheterization: mechanical versus manual control of bleeding. Radiology. 1985;154:234-235.
26. Beyer-Enke SA, Söldner J, Zeitler E. Immediate sealing of arterial puncture site following femoropopliteal angioplasty: a prospective randomized trial. Cardiovasc Intervent Radiol. 1996;19:406-410.
27. Dehghani P, Mohammad A, Marcuzzi D, et al. Efficacy and long-term safety of StarClose for hemostasis of arterial puncture sites distal to common femoral artery bifurcation after percutaneous coronary interventions. J Invasive Cardiol. 2010;22:505-510.
28. Carere RG, Webb JG, Ahmed T, et al. Initial experience using Prostar: a new device for percutaneous suture-mediated closure of arterial puncture sites. Cathet Cardiovasc Diagn. 1996;37:367-372.
29. Hon LQ, Ganeshan A, Thomas SM, et al. An overview of vascular closure devices: what every radiologist should know. Eur J Radiol. 2010;73:181-190.
30. Applegate RJ, Sacrinty MT, Kutcher MA, et al. Trends in vascular complications after diagnostic cardiac catheterization and percutaneous coronary intervention via the femoral artery, 1998-2007. JACC Cardiovasc Interv. 2008;1:317-326.
31. Ahmed B, Piper WD, Malenka D, et al. Significantly improved vascular complications among women undergoing percutaneous coronary intervention: a report from the Northern New England Percutaneous Coronary Intervention Registry. Circ Cardiovasc Interv. 2009;2:423-429.
32. Koreny M, Riedmüller E, Nikfardjam M, et al. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: systematic review and meta-analysis. JAMA. 2004;291:350-357.
33. Van den Berg JC. A close look at closure devices. J Cardiovasc Surg. 2006;47:285-295.
34. Bogart MA. Time to hemostasis: a comparison of manual versus mechanical compression of the femoral artery. Am J Crit Care. 1995;4:149- 156.
35. Simon A, Bumgarner B, Clark K, et al. Manual versus mechanical compression for femoral artery hemostasis after cardiac catheterization. Am J Crit Care. 1998;7:308-313.
36. Baim DS, Knopf WD, Hinohara T, et al. Suture-mediated closure of the femoral access site after cardiac catheterization: results of the suture to ambulate and discharge (STAND I and STAND II) trials. Am J Cardiol. 2000;85:864-869.
37. Gutzeit A, Van Schie B, Schoch E, et al. Feasibility and safety of vascular closure devices in an antegrade approach to either the common femoral artery or the superficial femoral artery. Cardiovasc Intervent Radiol. 2012;35:1036-1040.
38. Sanborn TA, Gibbs HH, Brinker JA, et al. A multicenter randomized trial comparing a percutaneous collagen hemostasis device with conventional manual compression after diagnostic angiography and angioplasty. J Am Coll Cardiol. 1993;22:1273-1279.
39. Brueck M, Bandorski D, Rauber K, et al. Percutaneous transluminal dilatation of inadvertent partial or complete occlusion of the femoral artery caused by Angio-Seal deployment for puncture site closure after cardiac catheterization. J Invasive Cardiol. 2010;22:353-357.
40. Applegate RJ. Unintended consequences of femoral artery closure devices. J Invasive Cardiol. 2010;22:358-359.
41. Biancari F, D'Andrea V, Di Marco C, et al. Meta-analysis of randomized trials on the efficacy of vascular closure devices after diagnostic angiography and angioplasty. Am Heart J. 2010;159:518-531.
42. Dangas G, Mehran R, Kokolis S, et al. Vascular complications after percutaneous coronary interventions following hemostasis with manual compression versus arteriotomy closure devices. J Am Coll Cardiol. 2001;38:638-641.
43. Applegate RJ, Sacrinty MT, Kutcher MA, et al. Propensity score analysis of vascular complications after diagnostic cardiac catheterization and percutaneous coronary intervention 1998-2003. Catheter Cardiovasc Interv. 2006;67:556-562.
44. Exaire JE, Dauerman HL, Topol EJ, et al. Triple antiplatelet therapy does not increase femoral access bleeding with vascular closure devices. Am Heart J. 2004;147:31-34.
45. Tron C, Koning R, Eltchaninoff H, et al. A randomized comparison of a percutaneous suture device versus manual compression for femoral artery hemostasis after PTCA. J Interv Cardiol. 2003;16:217-221.
46. Cura FA, Kapadia SR, L'Allier PL, et al. Safety of femoral closure devices after percutaneous coronary interventions in the era of glycoprotein IIb/IIIa platelet blockade. Am J Cardiol. 2000;86:780-782.