nach oben

Erschienen in:

01.03.2015 | Original Paper

Local paclitaxel induces late lumen enlargement in coronary arteries after balloon angioplasty

verfasst von: Franz X. Kleber, Antonia Schulz, Matthias Waliszewski, Telse Hauschild, Michael Böhm, Ulrich Dietz, Bodo Cremers, Bruno Scheller, Yvonne P. Clever

Erschienen in: Clinical Research in Cardiology | Ausgabe 3/2015

Einloggen, um Zugang zu erhalten

Abstract

Background

This study investigated p aclitaxel-induced luminal changes following drug-coated balloon (DCB) angioplasty to treat coronary de novo lesions without additional stenting. DCB-mediated local drug delivery reduces late lumen loss in de novo coronary artery lesions. We performed a retrospective clinical assessment based on a pre-specified quantitative coronary angiography (QCA) protocol.

Methods

QCA was performed for each centre to assess the primary endpoint late lumen changes, i.e. the difference between in-lesion minimal lumen diameter (MLD) at the routine angiographic follow-up as compared to post-procedural in-lesion MLDs. These MLD changes were compared to corresponding reference vessel diameter changes as an intra-patient control.

Results

We evaluated 58 consecutive native coronary artery lesions directly after DCB angioplasty and at a routine target follow-up angiography of 4 months by QCA. Target lesion MLD increased significantly within the 4.1 ± 2.1 month observation period (1.75 ± 0.55 vs. 1.91 ± 0.55 mm, p < 0.001, diameter stenosis 33.8 ± 12.3 vs. 26.9 ± 13.8 %, p < 0.001), while there were no changes in non-target reference vessel diameters (2.33 ± 0.60 vs. 2.34 ± 0.61 mm, p = ns). A total of 69 % of patients showed luminal enlargement whereas 29 % had minor luminal loss.

Conclusion

Local application of paclitaxel by DCB angioplasty to native coronary arteries after pre-dilatation without major dissection and recoil leads to late lumen increase.

Smith SC Jr, Feldman TE, Hirshfeld JW Jr et al (2006) American College of Cardiology/American Heart Association Task Force on Practice Guidelines; ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention. ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention). J Am Coll Cardiol 47:e1–e121CrossRefPubMed

Wijns W, Kolh P, Danchin N et al (2010) Guidelines on myocardial revascularization. Eur Heart J 31:2501–2555CrossRefPubMed

Brophy JM, Belisle P, Joseph L (2003) Evidence for use of coronary stents. A hierarchical bayesian meta-analysis. Ann Intern Med 138:777–786CrossRefPubMed

Al Suwaidi J, Holmes DR Jr, Salam AM et al (2004) Impact of coronary artery stents on mortality and nonfatal myocardial infarction: meta-analysis of randomized trials comparing a strategy of routine stenting with that of balloon angioplasty. Am Heart J 147:815–822CrossRefPubMed

Holmes DR Jr, Vlietstra RE, Smith HC et al (1984) Restenosis after percutaneous transluminal coronary angioplasty (PTCA): a report from the PTCA Registry of the National Heart, Lung, and Blood Institute. Am J Cardiol 53:77C–81CCrossRefPubMed

Cremers B, Toner JL, Schwartz LB et al (2012) Inhibition of neointimal hyperplasia with a novel zotarolimus coated balloon catheter. Clin Res Cardiol 101(6):469–476CrossRefPubMed

Cremers B, Kelsch B, Clever YP et al (2012) Inhibition of neointimal proliferation after bare metal stent implantation with low-pressure drug delivery using a paclitaxel-coated balloon in porcine coronary arteries. Clin Res Cardiol 101(5):385–391CrossRefPubMed

Scheller B, Hehrlein C, Bocksch W et al (2006) Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med 355:2113–2124CrossRefPubMed

Unverdorben M, Vallbracht C, Cremers B et al (2009) Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation 119:2986–2994CrossRefPubMed

10.

Navarese EP, Austin D, Gurbel PA et al (2013) Drug-coated balloons in treatment of in-stent restenosis: a meta-analysis of randomised controlled trials. Clin Res Cardiol 102(4):279–287CrossRefPubMedCentralPubMed

11.

Bonaventura K, Leber AW, Sohns C et al (2012) Cost-effectiveness of paclitaxel-coated balloon angioplasty and paclitaxel-eluting stent implantation for treatment of coronary in-stent restenosis in patients with stable coronary artery disease. Clin Res Cardiol 101(7):573–584CrossRefPubMed

12.

Wöhrle J, Zadura M, Möbius-Winkler S et al (2012) SeQuentPlease World Wide Registry: clinical results of SeQuent please paclitaxel-coated balloon angioplasty in a large-scale, prospective registry study. J Am Coll Cardiol 60:1733–1738CrossRefPubMed

13.

Scheller B, Fischer D, Clever YP et al (2013) Treatment of a coronary bifurcation lesion with drug-coated balloons: lumen enlargement and plaque modification after 6 months. Clin Res Cardiol 102(6):469–472CrossRefPubMed

14.

Kleber FX, Mathey DG, Rittger H et al (2011) How to use the drug-eluting balloon: recommendations by the German consensus group. EuroIntervention 7(Suppl K):K125–K128CrossRefPubMed

15.

Kleber FX, Rittger H, Bonaventura K et al (2013) Drug-coated balloons for treatment of coronary artery disease: updated recommendations from a consensus group. Clin Res Cardiol 102(11):785–797CrossRefPubMed

16.

Huber MS, Mooney JF, Madison J et al (1991) Use of a morphologic classification to predict clinical outcome after dissection from coronary angioplasty. Am J Cardiol 68:467–471CrossRefPubMed

17.

Hausleiter J, Jost S, Nolte CW et al (1997) Comparative in vitro validation of eight first- and second-generation quantitative coronary angiography systems. Coron Artery Dis 8:83–90CrossRefPubMed

18.

Dietz U, Rupprecht HJ, Brennecke R et al (1997) Comparison of QCA systems. Int J Card Imaging 13:271–280CrossRefPubMed

19.

Herrington D, Walford G (1993) Optimal frame selection for QCA. In: Reiber JHC, Serruys PW (eds) Advances in quantitative coronary arteriography. Kluwer Academic Publishers, Dordrecht, pp 125–135CrossRef

20.

Reiber JH, van Eldik-Helleman P, Visser-Akkerman N et al (1988) Variabilities in measurement of coronary arterial dimensions resulting from variations in cineframe selection. Cathet Cardiovasc Diagn 14:221–228CrossRefPubMed

21.

Haude M, Erbel R, Issa H et al (1993) Quantitative analysis of elastic recoil after balloon angioplasty and after intracoronary implantation of balloon-expandable Palmaz-Schatz stents. J Am Coll Cardiol 21:26–34CrossRefPubMed

22.

Sigwart U, Puel J, Mirkovitch V et al (1987) Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med 316:701–706CrossRefPubMed

23.

Serruys PW, de Jaegere P, Kiemeneij F et al (1994) A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med 331:489–495CrossRefPubMed

24.

Brener SJ, Prasad AJ, Khan Z et al (2011) The relationship between late lumen loss and restenosis among various drug-eluting stents: a systematic review and meta-regression analysis of randomized clinical trials. Atherosclerosis 214:158–162CrossRefPubMed

25.

Chevalier B, Silber S, Park SJ, NOBORI 1 Clinical Investigators et al (2009) Randomized comparison of the Nobori Biolimus A9-eluting coronary stent with the Taxus Liberte paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries: the NOBORI 1 trial–Phase 2. Circ Cardiovasc Interv 2:188–195CrossRefPubMed

26.

Bondesson P, Lagerqvist B, James SK et al (2012) Comparison of two drug-eluting balloons: a report from the SCAAR registry. EuroIntervention 8:444–449CrossRefPubMed

27.

Glagov S, Weisenberg E, Zarins CK et al (1987) Compensatory enlargement of human atherosclerotic coronary arteries. N Engl J Med 316:1371–1375CrossRefPubMed

28.

Kakuta T, Currier JW, Haudenschild CC et al (1994) Differences in compensatory vessel enlargement, not intimal formation, account for restenosis after angioplasty in the hypercholesterolemic rabbit model. Circulation 89:2809–2815CrossRefPubMed

29.

Heldman AW, Cheng L, Jenkins GM et al (2001) Paclitaxel stent coating inhibits neointimal hyperplasia at 4 weeks in a porcine model of coronary restenosis. Circulation 103:2289–2295CrossRefPubMed

30.

Habara S, Mitsudo K, Kadota K et al (2011) Effectiveness of paclitaxel-eluting balloon catheter in patients with sirolimus-eluting stent restenosis. JACC Cardiovasc Interv 4:149–154CrossRefPubMed

31.

Byrne RA, Neumann FJ, Mehilli J, ISAR-DESIRE 3 investigators et al (2013) Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3): a randomised, open-label trial. Lancet 381:461–467CrossRefPubMed

32.

Latib A, Colombo A, Castriota F et al (2012) A randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels: the BELLO (Balloon Elution and Late Loss Optimization) study. J Am Coll Cardiol 60:2473–2480CrossRefPubMed

33.

Rittger H, Brachmann J, Sinha AM et al (2012) A randomized, multicenter, single-blinded trial comparing paclitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis: the PEPCAD-DES study. J Am Coll Cardiol 59:1377–1382CrossRefPubMed

34.

Clever YP, Cremers B, von Scheidt W et al (2014) Compassionate use of a paclitaxel coated balloon in patients with refractory recurrent coronary in-stent restenosis. Clin Res Cardiol 103(1):21–27CrossRefPubMed

35.

Werk M, Albrecht T, Meyer DR et al (2012) Paclitaxel-coated balloons reduce Restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial. Circ Cardiovasc Interv 5:831–840CrossRefPubMed

36.

Tepe G, Zeller T, Albrecht T et al (2008) Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med 358:689–699CrossRefPubMed

37.

Werk M, Langner S, Reinkensmeier B et al (2008) Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation 118:1358–1365CrossRefPubMed

38.

Pires NM, Eefting D, de Vries MR et al (2007) Sirolimus and paclitaxel provoke different vascular pathological responses after local delivery in a murine model for restenosis on underlying atherosclerotic arteries. Heart 93:922–927CrossRefPubMedCentralPubMed

39.

Vogt F, Stein A, Rettemeier G et al (2004) Long-term assessment of a novel biodegradable paclitaxel-eluting coronary polylactide stent. Eur Heart J 25:1330–1340CrossRefPubMed

40.

Speck U, Cremers B, Kelsch B et al (2012) Do pharmacokinetics explain persistent restenosis inhibition by a single dose of paclitaxel? Circ Cardiovasc Interv 5:392–400CrossRefPubMed

41.

Axel DI, Kunert W, Göggelmann C et al (1997) Paclitaxel inhibits arterial smooth muscle cell proliferation and migration in vitro and in vivo using local drug delivery. Circulation 96:636–645CrossRefPubMed

42.

Ako J, Morino Y, Honda Y et al (2005) Late incomplete stent apposition after sirolimus-eluting stent implantation: a serial intravascular ultrasound analysis. J Am Coll Cardiol 46:1002–1005CrossRefPubMed

43.

Hou D, Rogers PI, Toleikis PM et al (2000) Intrapericardial paclitaxel delivery inhibits neointimal proliferation and promotes arterial enlargement after porcine coronary overstretch. Circulation 102:1575–1581CrossRefPubMed

44.

Diletti R, Serruys PW, Farooq V et al (2012) ABSORB II randomized controlled trial: a clinical evaluation to compare the safety, efficacy, and performance of the Absorb everolimus-eluting bioresorbable vascular scaffold system against the XIENCE everolimus-eluting coronary stent system in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions: rationale and study design. Am Heart J 164:654–663CrossRefPubMed

45.

Hirshfeld JW Jr, Schwartz JS, Jugo R et al (1991) Clinical and angiographic determinants of primary coronary angioplasty success. M-HEART Investigators. J Am Coll Cardiol 17:22–28CrossRefPubMed

46.

Lam JY, Chesebro JH, Steele PM et al (1986) Deep arterial injury during experimental angioplasty: relation to a positive indium-111-labeled platelet scintigram, quantitative platelet deposition and mural thrombosis. J Am Coll Cardiol 8:1380–1386CrossRefPubMed

47.

Chesebro JH, Lam JY, Badimon L et al (1987) Restenosis after arterial angioplasty: a hemorrheologic response to injury. Am J Cardiol 60:10B–16BCrossRefPubMed

48.

Serruys PW, Luijten HE, Beatt KJ et al (1988) Incidence of restenosis after successful coronary angioplasty: a time-related phenomenon. A quantitative angiographic study in 342 consecutive patients at 1, 2, 3, and 4 months. Circulation 77:361–371CrossRefPubMed

49.

Zeymer U, Waliszewski M, Spiecker M et al (2014) Prospective ‘real world’ registry for the use of the ‘PCB only’ strategy in small vessel de novo lesions. Heart 100(4):311–316CrossRefPubMed

50.

Currier JW, Faxon DP (1995) Restenosis after percutaneous transluminal coronary angioplasty: have we been aiming at the wrong target? J Am Coll Cardiol 25:516–520CrossRefPubMed

51.

Leimgruber PP, Roubin GS, Anderson HV et al (1985) Influence of intimal dissection on restenosis after successful coronary angioplasty. Circulation 72:530–535CrossRefPubMed

52.

Poerner TC, Otto S, Gassdorf J et al (2011) A prospective randomised study using optical coherence tomography to assess endothelial coverage and neointimal proliferation at 6-months after implantation of a coronary everolimus-eluting stent compared with a bare metal stent postdilated with a paclitaxel-eluting balloon (OCTOPUS Trial): rationale, design and methods. EuroIntervention 7(Suppl K):K93–K99CrossRefPubMed

Titel: Local paclitaxel induces late lumen enlargement in coronary arteries after balloon angioplasty
verfasst von: Franz X. Kleber
Antonia Schulz
Matthias Waliszewski
Telse Hauschild
Michael Böhm
Ulrich Dietz
Bodo Cremers
Bruno Scheller
Yvonne P. Clever
Publikationsdatum: 01.03.2015
Verlag: Springer Berlin Heidelberg
Erschienen in: Clinical Research in Cardiology / Ausgabe 3/2015
Print ISSN: 1861-0684
Elektronische ISSN: 1861-0692
DOI: https://doi.org/10.1007/s00392-014-0775-2

Neu im Fachgebiet Kardiologie

23.04.2024 | Ablationstherapie | Nachrichten

Update Kardiologie

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

Newsletter bestellen

Live-Webinar: Aktuelle Leitlinien bei Herz-Kreislauf-Erkrankungen

Springer Medizin

Local paclitaxel induces late lumen enlargement in coronary arteries after balloon angioplasty

Abstract

Background

Methods

Results

Conclusion

Neu im Fachgebiet Kardiologie

Wie erfolgreich ist eine Re-Ablation nach Rezidiv?

Europäische Ernährungsgewohnheiten: Das sind die häufigsten Fehler

Parodontalbehandlung verbessert Prognose bei Katheterablation

Antihypertensiva schützen auch alte Menschen noch vor Demenz

Update Kardiologie

Live-Webinar: Aktuelle Leitlinien bei Herz-Kreislauf-Erkrankungen

Springer Medizin

Abstract

Background

Methods

Results

Conclusion

Bitte loggen Sie sich ein, um Zugang zu diesem Inhalt zu erhalten

Weitere Artikel der Ausgabe 3/2015

Resolution of aortic root thrombosis in a patient treated with veno-arterial extracorporeal membrane oxygenation

Impact of sleep-disordered breathing and efficacy of positive airway pressure on mortality in patients with chronic heart failure and sleep-disordered breathing: a meta-analysis

Effects of β-blocker therapy on electrocardiographic and echocardiographic characteristics of left ventricular noncompaction

Detection of coronary artery disease in postmenopausal women: the significance of integrated stress imaging tests in a 4-year prognostic study

Successful single-sided renal denervation in drug-resistant hypertension and ventricular tachycardia

Neuropsychological impact of cerebral microemboli in ablation of atrial fibrillation

Neu im Fachgebiet Kardiologie

Wie erfolgreich ist eine Re-Ablation nach Rezidiv?

Europäische Ernährungsgewohnheiten: Das sind die häufigsten Fehler

Parodontalbehandlung verbessert Prognose bei Katheterablation

Antihypertensiva schützen auch alte Menschen noch vor Demenz

Update Kardiologie