Skip to main content
Erschienen in: CardioVascular and Interventional Radiology 4/2014

01.08.2014 | Clinical Investigation

Calcium Burden Assessment and Impact on Drug-Eluting Balloons in Peripheral Arterial Disease

verfasst von: F. Fanelli, A. Cannavale, M. Gazzetti, P. Lucatelli, A. Wlderk, C. Cirelli, A. d’Adamo, F. M. Salvatori

Erschienen in: CardioVascular and Interventional Radiology | Ausgabe 4/2014

Einloggen, um Zugang zu erhalten

Abstract

Purpose

This study was designed to assess the effect of calcium on the efficacy of DEB during revascularization of steno-obstructive SFA lesions.

Methods

Sixty patients with de novo lesions of the superficial femoral artery underwent endovascular treatment with drug eluting balloons (DEB). DEB was selected according to vessel reference diameter (1:1). In case of residual stenosis > 50 % or flow-limiting dissection, postdilatation with conventional balloon or provisional stenting was done. Patients were classified into eight groups according to circumferential distribution of calcium on CT-angiography axial images (from 0° to 360°) and to its length (length < or > 3 cm) evaluated with digital-subtraction-angiography. Ankle-brachial index (ABI), late lumen loss (LLL), target lesion revascularization (TLR), primary (PP) and secondary (SP) patency, major adverse events (MAE), and Rutherford shift were evaluated at 1-year follow-up and correlated with the amount of calcium.

Results

Revascularization was successful in all cases. Flow-limiting dissection occurred in five cases (8.3 %) with a higher circumferential degree of calcium and solved in three cases with postdilatation and in the other two with provisional stenting. DEB effect was lower in patients with higher degree of calcium (>270° vs. <90°): ABI 0.71 ± 0.07 versus 0.92 ± 0.07; LLL 0.75 ± 0.21 versus 0.45 ± 0.1; PP 50 versus 100 %; SP 50 versus 100 %; TLR 25 versus 0 %; MAE 25 versus 0 %.

Conclusions

Calcium represents a barrier to optimal drug absorption. Circumferential distribution seems to be the most influencing factor with the worst effect noticed in 360° calcium presence.
Literatur
1.
Zurück zum Zitat Schillinger M, Minar E (2012) Percutaneous treatment of peripheral artery disease: novel techniques. Circulation 126(20):2433–2440PubMedCrossRef Schillinger M, Minar E (2012) Percutaneous treatment of peripheral artery disease: novel techniques. Circulation 126(20):2433–2440PubMedCrossRef
2.
Zurück zum Zitat European Stroke Organisation, Tendera M, Aboyans V, Bartelink ML, Baumgartner I, Clément D, Collet JP, Cremonesi A, De Carlo M, Erbel R, Fowkes FG, Heras M, Kownator S, Minar E, Ostergren J, Poldermans D, Riambau V, Roffi M, Röther J, Sievert H, van Sambeek M, Zeller T (2011) ESC Committee for Practice Guidelines. ESC Guidelines on the diagnosis and treatment of peripheral artery diseases: Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology (ESC). Eur Heart J 32(22):2851–2906PubMedCrossRef European Stroke Organisation, Tendera M, Aboyans V, Bartelink ML, Baumgartner I, Clément D, Collet JP, Cremonesi A, De Carlo M, Erbel R, Fowkes FG, Heras M, Kownator S, Minar E, Ostergren J, Poldermans D, Riambau V, Roffi M, Röther J, Sievert H, van Sambeek M, Zeller T (2011) ESC Committee for Practice Guidelines. ESC Guidelines on the diagnosis and treatment of peripheral artery diseases: Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology (ESC). Eur Heart J 32(22):2851–2906PubMedCrossRef
3.
Zurück zum Zitat Rooke TW, Hirsch AT, Misra S, Sidawy AN, Beckman JA, Findeiss LK, Golzarian J, Gornik HL, Halperin JL, Jaff MR, Moneta GL, Olin JW, Stanley JC, White CJ, White JV, Zierler RE (2012) American College of Cardiology Foundation; American Heart Association; Society for Cardiovascular Angiography and Interventions; Society of Interventional Radiology; Society for Vascular Medicine; Society for Vascular Surgery. 2011 ACCF/AHA focused update of the guideline for the management of patients with peripheral artery disease (updating the 2005 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society for Vascular Medicine, and Society for Vascular Surgery. Catheter Cardiovasc Interv 79(4):501–531PubMedCrossRef Rooke TW, Hirsch AT, Misra S, Sidawy AN, Beckman JA, Findeiss LK, Golzarian J, Gornik HL, Halperin JL, Jaff MR, Moneta GL, Olin JW, Stanley JC, White CJ, White JV, Zierler RE (2012) American College of Cardiology Foundation; American Heart Association; Society for Cardiovascular Angiography and Interventions; Society of Interventional Radiology; Society for Vascular Medicine; Society for Vascular Surgery. 2011 ACCF/AHA focused update of the guideline for the management of patients with peripheral artery disease (updating the 2005 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society for Vascular Medicine, and Society for Vascular Surgery. Catheter Cardiovasc Interv 79(4):501–531PubMedCrossRef
4.
Zurück zum Zitat Kashyap VS, Pavkov ML, Bishop PD, Nassoiy SP, Eagleton MJ, Clair DG, Ouriel K (2008) Angiography underestimates peripheral atherosclerosis: lumenography revisited. J Endovasc Ther 15(1):117–125PubMedCentralPubMedCrossRef Kashyap VS, Pavkov ML, Bishop PD, Nassoiy SP, Eagleton MJ, Clair DG, Ouriel K (2008) Angiography underestimates peripheral atherosclerosis: lumenography revisited. J Endovasc Ther 15(1):117–125PubMedCentralPubMedCrossRef
5.
Zurück zum Zitat Halwani DO, Anderson PG, Brott BC, Anayiotos AS, Lemons JE (2012) The role of vascular calcification in inducing fatigue and fracture of coronary stents. J Biomed Mater Res B Appl Biomater 100(1):292–304PubMedCrossRef Halwani DO, Anderson PG, Brott BC, Anayiotos AS, Lemons JE (2012) The role of vascular calcification in inducing fatigue and fracture of coronary stents. J Biomed Mater Res B Appl Biomater 100(1):292–304PubMedCrossRef
6.
Zurück zum Zitat Adlakha S, Sheikh M, Wu J, Burket MW, Pandya U, Colyer W, Eltahawy E, Cooper CJ (2010) Stent fracture in the coronary and peripheral arteries. J Interv Cardiol 23(4):411–419PubMedCrossRef Adlakha S, Sheikh M, Wu J, Burket MW, Pandya U, Colyer W, Eltahawy E, Cooper CJ (2010) Stent fracture in the coronary and peripheral arteries. J Interv Cardiol 23(4):411–419PubMedCrossRef
7.
Zurück zum Zitat Shammas NW, Lam R, Mustapha J, Ellichman J, Aggarwala G, Rivera E, Niazi K, Balar N (2012) Comparison of orbital atherectomy plus balloon angioplasty vs. balloon angioplasty alone in patients with critical limb ischemia: results of the CALCIUM 360 randomized pilot trial. J Endovasc Ther 19(4):480–488PubMedCrossRef Shammas NW, Lam R, Mustapha J, Ellichman J, Aggarwala G, Rivera E, Niazi K, Balar N (2012) Comparison of orbital atherectomy plus balloon angioplasty vs. balloon angioplasty alone in patients with critical limb ischemia: results of the CALCIUM 360 randomized pilot trial. J Endovasc Ther 19(4):480–488PubMedCrossRef
8.
Zurück zum Zitat Fitzgerald PJ, Ports TA, Yock PG (1992) Contribution of localized calcium deposits to dissection after angioplasty. Circulation 86(1):64–70PubMedCrossRef Fitzgerald PJ, Ports TA, Yock PG (1992) Contribution of localized calcium deposits to dissection after angioplasty. Circulation 86(1):64–70PubMedCrossRef
9.
Zurück zum Zitat Cioppa A, Stabile E, Popusoi G, Salemme L, Cota L, Pucciarelli A, Ambrosini V, Sorropago G, Tesorio T, Agresta A, Biamino G, Rubino P (2012) Combined treatment of heavy calcified femoro-popliteal lesions using directional atherectomy and a paclitaxel coated balloon: one-year single centre clinical results. Cardiovasc Revasc Med 13(4):219–223PubMedCrossRef Cioppa A, Stabile E, Popusoi G, Salemme L, Cota L, Pucciarelli A, Ambrosini V, Sorropago G, Tesorio T, Agresta A, Biamino G, Rubino P (2012) Combined treatment of heavy calcified femoro-popliteal lesions using directional atherectomy and a paclitaxel coated balloon: one-year single centre clinical results. Cardiovasc Revasc Med 13(4):219–223PubMedCrossRef
10.
Zurück zum Zitat Amighi J, Schillinger M, Dick P, Schlager O, Sabeti S, Mlekusch W, Haumer M, Mathies R, Heinzle G, Schuster A, Loewe C, Koppensteiner R, Lammer J, Minar E, Cejna M (2008) De novo superficial femoropopliteal artery lesions: peripheral cutting balloon angioplasty and restenosis rates–randomized controlled trial. Radiology 247(1):267–272PubMedCrossRef Amighi J, Schillinger M, Dick P, Schlager O, Sabeti S, Mlekusch W, Haumer M, Mathies R, Heinzle G, Schuster A, Loewe C, Koppensteiner R, Lammer J, Minar E, Cejna M (2008) De novo superficial femoropopliteal artery lesions: peripheral cutting balloon angioplasty and restenosis rates–randomized controlled trial. Radiology 247(1):267–272PubMedCrossRef
11.
Zurück zum Zitat Banerjee S, Das TS, Abu-Fadel MS, Dippel EJ, Shammas NW, Tran DL, Zankar A, Varghese C, Kelly KC, Weideman RA, Little BB, Reilly RF, Addo T, Brilakis ES (2012) Pilot trial of cryoplasty or conventional balloon post-dilation of nitinol stents for revascularization of peripheral arterial segments: the COBRA trial. J Am Coll Cardiol 60(15):1352–1359PubMedCrossRef Banerjee S, Das TS, Abu-Fadel MS, Dippel EJ, Shammas NW, Tran DL, Zankar A, Varghese C, Kelly KC, Weideman RA, Little BB, Reilly RF, Addo T, Brilakis ES (2012) Pilot trial of cryoplasty or conventional balloon post-dilation of nitinol stents for revascularization of peripheral arterial segments: the COBRA trial. J Am Coll Cardiol 60(15):1352–1359PubMedCrossRef
12.
Zurück zum Zitat Scheinert D, Peeters P, Bosiers M, O’Sullivan G, Sultan S, Gershony G (2007) Results of the multicenter first-in-man study of a novel scoring balloon catheter for the treatment of infra-popliteal peripheral arterial disease. Catheter Cardiovasc Interv 70(7):1034–1039PubMedCrossRef Scheinert D, Peeters P, Bosiers M, O’Sullivan G, Sultan S, Gershony G (2007) Results of the multicenter first-in-man study of a novel scoring balloon catheter for the treatment of infra-popliteal peripheral arterial disease. Catheter Cardiovasc Interv 70(7):1034–1039PubMedCrossRef
13.
Zurück zum Zitat Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J (2008) Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation 118(13):1358–1365PubMedCrossRef Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J (2008) Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation 118(13):1358–1365PubMedCrossRef
14.
Zurück zum Zitat Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U (2008) Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med 358(7):689–699PubMedCrossRef Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U (2008) Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med 358(7):689–699PubMedCrossRef
15.
Zurück zum Zitat Fanelli F, Cannavale A, Corona M, Lucatelli P, Wlderk A, Salvatori FM (2014) The “debellum”—lower limb multilevel treatment with drug eluting balloon—randomized trial: 1-year results. J Cardiovasc Surg (Torino) 55(2):207–216 Fanelli F, Cannavale A, Corona M, Lucatelli P, Wlderk A, Salvatori FM (2014) The “debellum”—lower limb multilevel treatment with drug eluting balloon—randomized trial: 1-year results. J Cardiovasc Surg (Torino) 55(2):207–216
16.
Zurück zum Zitat Micari A, Cioppa AMD, Vadalà G, Castriota F, Liso A, Marchese A, Grattoni C, Pantaleo P, Cremonesi A, Rubino P, Biamino G (2012) Clinical evaluation of a paclitaxel-eluting balloon for treatment of femoropopliteal arterial disease: 12-month results from a multicenter Italian registry. JACC Cardiovasc Interv 5(3):331–338PubMedCrossRef Micari A, Cioppa AMD, Vadalà G, Castriota F, Liso A, Marchese A, Grattoni C, Pantaleo P, Cremonesi A, Rubino P, Biamino G (2012) Clinical evaluation of a paclitaxel-eluting balloon for treatment of femoropopliteal arterial disease: 12-month results from a multicenter Italian registry. JACC Cardiovasc Interv 5(3):331–338PubMedCrossRef
17.
Zurück zum Zitat Stabile E, Virga V, Salemme L, Cioppa A, Ambrosini V, Sorropago G, Tesorio T, Cota L, Popusoi G, Pucciarelli A, Biamino G, Rubino P (2012) Drug-eluting balloon for treatment of superficial femoral artery in-stent restenosis. J Am Coll Cardiol 60(18):1739–1742PubMedCrossRef Stabile E, Virga V, Salemme L, Cioppa A, Ambrosini V, Sorropago G, Tesorio T, Cota L, Popusoi G, Pucciarelli A, Biamino G, Rubino P (2012) Drug-eluting balloon for treatment of superficial femoral artery in-stent restenosis. J Am Coll Cardiol 60(18):1739–1742PubMedCrossRef
18.
Zurück zum Zitat Werk M, Albrecht T, Meyer DR, Ahmed MN, Behne A, Dietz U, Eschenbach G, Hartmann H, Lange C, Schnorr B, Stiepani H, Zoccai GB, Hänninen EL (2012) Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial. Circ Cardiovasc Interv 5(6):831–840PubMedCrossRef Werk M, Albrecht T, Meyer DR, Ahmed MN, Behne A, Dietz U, Eschenbach G, Hartmann H, Lange C, Schnorr B, Stiepani H, Zoccai GB, Hänninen EL (2012) Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial. Circ Cardiovasc Interv 5(6):831–840PubMedCrossRef
19.
Zurück zum Zitat Schmidt A, Piorkowski M, Werner M, Ulrich M, Bausback Y, Ick H, Schuster J, Botsios S, Kruse HJ, Varcoe RL, Scheinert D (2011) First experience with drug-eluting balloons in infrapopliteal arteries: restenosis rate and clinical outcome. J Am Coll Cardiol 58(11):1105–1109PubMedCrossRef Schmidt A, Piorkowski M, Werner M, Ulrich M, Bausback Y, Ick H, Schuster J, Botsios S, Kruse HJ, Varcoe RL, Scheinert D (2011) First experience with drug-eluting balloons in infrapopliteal arteries: restenosis rate and clinical outcome. J Am Coll Cardiol 58(11):1105–1109PubMedCrossRef
20.
Zurück zum Zitat Liistro F, Porto I, Angioli P, Grotti S, Ricci L, Ducci K, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L (2013) Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation 128(6):615–621PubMedCrossRef Liistro F, Porto I, Angioli P, Grotti S, Ricci L, Ducci K, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L (2013) Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation 128(6):615–621PubMedCrossRef
21.
Zurück zum Zitat Scheller B, Speck U, Abramjuk C, Bernhardt U, Bohm M, Nickenig G (2004) Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation 110(7):810–814PubMedCrossRef Scheller B, Speck U, Abramjuk C, Bernhardt U, Bohm M, Nickenig G (2004) Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation 110(7):810–814PubMedCrossRef
22.
Zurück zum Zitat Gertz ZM, Wilensky RL (2011) Local drug delivery for treatment of coronary and peripheral artery disease. Cardiovasc Ther 29(6):e54–e66PubMedCrossRef Gertz ZM, Wilensky RL (2011) Local drug delivery for treatment of coronary and peripheral artery disease. Cardiovasc Ther 29(6):e54–e66PubMedCrossRef
23.
Zurück zum Zitat Scheller B (2011) Opportunities and limitations of drug-coated balloons in interventional therapies. Herz 36(3):232–239PubMedCrossRef Scheller B (2011) Opportunities and limitations of drug-coated balloons in interventional therapies. Herz 36(3):232–239PubMedCrossRef
24.
Zurück zum Zitat Rocha-Singh KJ, Zeller T, Jaff MR (2014) Peripheral arterial calcification: prevalence, mechanism, detection, and clinical implications. Catheter Cardiovasc Interv. doi:10.1002/ccd.25387 PubMed Rocha-Singh KJ, Zeller T, Jaff MR (2014) Peripheral arterial calcification: prevalence, mechanism, detection, and clinical implications. Catheter Cardiovasc Interv. doi:10.​1002/​ccd.​25387 PubMed
25.
Zurück zum Zitat Heijenbrok-Kal MH, Kock MC, Hunink MG (2007) Lower extremity arterial disease: multidetector CT angiography meta-analysis. Radiology 245(2):433–439PubMedCrossRef Heijenbrok-Kal MH, Kock MC, Hunink MG (2007) Lower extremity arterial disease: multidetector CT angiography meta-analysis. Radiology 245(2):433–439PubMedCrossRef
26.
Zurück zum Zitat Raman R, Raman B, Napel S, Rubin GD (2008) Semiautomated quantification of the mass and distribution of vascular calcification with multidetector CT: method and evaluation. Radiology 247(1):241–250PubMedCrossRef Raman R, Raman B, Napel S, Rubin GD (2008) Semiautomated quantification of the mass and distribution of vascular calcification with multidetector CT: method and evaluation. Radiology 247(1):241–250PubMedCrossRef
27.
Zurück zum Zitat Garcìa-Garcìa HM, Gogas BD, Serruys PW, Bruining N (2011) IVUS-based imaging modalities for tissue characterization: similarities and differences. Int J Cardiovasc Imaging 27(2):215–224PubMedCentralPubMedCrossRef Garcìa-Garcìa HM, Gogas BD, Serruys PW, Bruining N (2011) IVUS-based imaging modalities for tissue characterization: similarities and differences. Int J Cardiovasc Imaging 27(2):215–224PubMedCentralPubMedCrossRef
28.
Zurück zum Zitat Mintz GS, Nissen SE, Anderson WD, Bailey SR, Erbel R, Fitzgerald PJ, Pinto FJ, Rosenfield K, Siegel RJ, Tuzcu EM, Yock PG (2001) American College of Cardiology Clinical Expert Consensus Document on Standards for Acquisition, Measurement and Reporting of Intravascular Ultrasound Studies (IVUS). A report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. J Am Coll Cardiol 37(5):1478–1492PubMedCrossRef Mintz GS, Nissen SE, Anderson WD, Bailey SR, Erbel R, Fitzgerald PJ, Pinto FJ, Rosenfield K, Siegel RJ, Tuzcu EM, Yock PG (2001) American College of Cardiology Clinical Expert Consensus Document on Standards for Acquisition, Measurement and Reporting of Intravascular Ultrasound Studies (IVUS). A report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. J Am Coll Cardiol 37(5):1478–1492PubMedCrossRef
Metadaten
Titel
Calcium Burden Assessment and Impact on Drug-Eluting Balloons in Peripheral Arterial Disease
verfasst von
F. Fanelli
A. Cannavale
M. Gazzetti
P. Lucatelli
A. Wlderk
C. Cirelli
A. d’Adamo
F. M. Salvatori
Publikationsdatum
01.08.2014
Verlag
Springer US
Erschienen in
CardioVascular and Interventional Radiology / Ausgabe 4/2014
Print ISSN: 0174-1551
Elektronische ISSN: 1432-086X
DOI
https://doi.org/10.1007/s00270-014-0904-3

Weitere Artikel der Ausgabe 4/2014

CardioVascular and Interventional Radiology 4/2014 Zur Ausgabe

„Übersichtlicher Wegweiser“: Lauterbachs umstrittener Klinik-Atlas ist online

17.05.2024 Klinik aktuell Nachrichten

Sie sei „ethisch geboten“, meint Gesundheitsminister Karl Lauterbach: mehr Transparenz über die Qualität von Klinikbehandlungen. Um sie abzubilden, lässt er gegen den Widerstand vieler Länder einen virtuellen Klinik-Atlas freischalten.

Klinikreform soll zehntausende Menschenleben retten

15.05.2024 Klinik aktuell Nachrichten

Gesundheitsminister Lauterbach hat die vom Bundeskabinett beschlossene Klinikreform verteidigt. Kritik an den Plänen kommt vom Marburger Bund. Und in den Ländern wird über den Gang zum Vermittlungsausschuss spekuliert.

Darf man die Behandlung eines Neonazis ablehnen?

08.05.2024 Gesellschaft Nachrichten

In einer Leseranfrage in der Zeitschrift Journal of the American Academy of Dermatology möchte ein anonymer Dermatologe bzw. eine anonyme Dermatologin wissen, ob er oder sie einen Patienten behandeln muss, der eine rassistische Tätowierung trägt.

Ein Drittel der jungen Ärztinnen und Ärzte erwägt abzuwandern

07.05.2024 Klinik aktuell Nachrichten

Extreme Arbeitsverdichtung und kaum Supervision: Dr. Andrea Martini, Sprecherin des Bündnisses Junge Ärztinnen und Ärzte (BJÄ) über den Frust des ärztlichen Nachwuchses und die Vorteile des Rucksack-Modells.

Update Radiologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.