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Clinical Research in Cardiology
Published in: Clinical Research in Cardiology 4/2013

Open Access 01-04-2013 | Original Paper

Drug-coated balloons in treatment of in-stent restenosis: a meta-analysis of randomised controlled trials

Authors: Eliano Pio Navarese, David Austin, Paul A. Gurbel, Felicita Andreotti, Udaya Tantry, Stefan James, Antonino Buffon, Marek Kozinski, Karolina Obonska, Kevin Bliden, Young-Hoon Jeong, Jacek Kubica, Vijay Kunadian

Published in: Clinical Research in Cardiology | Issue 4/2013

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Abstract

Background

Drug-coated balloons (DCBs) have been developed for the percutaneous treatment of coronary artery disease. An initial focus has been the management of in-stent restenosis (ISR) but randomised controlled trials (RCTs) have been small and powered only for angiographic endpoints.

Objective

The aim of the work was to assess the clinical and angiographic outcomes of patients treated for ISR with DCB versus control (balloon angioplasty or drug-eluting stents) by a meta-analysis of RCTs.

Methods

A comprehensive search was performed of RCTs where patients with ISR were randomly assigned to either DCB or alternative coronary intervention. Outcome measurements were death, myocardial infarction (MI), target lesion revascularisation (TLR), binary definition of restenosis and in-lesion late luminal loss (LLL).

Results

Four studies were identified that fulfilled the inclusion criteria. Pooled odds ratios (ORs) were calculated for patients treated for ISR (n = 399). Mean follow-up duration was 14.5 months. DCBs were associated with lower rates of TLR [8.8 vs. 29.7 % OR (95 % confidence interval, CI) 0.20 (0.11–0.36), p < 0.0001], binary restenosis [10.3 vs. 41.3 % OR (95 % CI) 0.13 (0.07–0.24), p < 0.00001] and MI [0.5 vs. 3.8 %, OR (95 % CI) 0.21 (0.04–1.00), p = 0.05]. No significant heterogeneity was identified.

Conclusion

Drug-coated balloons appear to be effective versus control in reducing TLR and possibly MI versus balloon angioplasty or drug-eluting stents in the management of ISR.
Literature
1.
Cortese B, Bertoletti A (2011) Paclitaxel coated balloons for coronary artery interventions: A comprehensive review of preclinical and clinical data. Int J Cardiol 161(1):4–12PubMedCrossRef
2.
Waksman R, Pakala R (2009) Drug-eluting balloon: the comeback kid? Circ Cardiovasc Interv 2(4):352–358PubMedCrossRef
3.
Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS et al (2007) Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet 370(9591):937–948PubMedCrossRef
4.
Scheller B, Speck U, Bohm M (2007) Prevention of restenosis: is angioplasty the answer? Heart 93(5):539–541PubMedCrossRef
5.
Higgins J, Green S (eds) (2011) Cochrane handbook for systematic reviews of intervention. Wiley, London
6.
Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gotzsche PC, Ioannidis JP, Clarke M, Devereaux PJ, Kleijnen J, Moher D (2009) The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. J Clin Epidemiol 62(10):e1–e34PubMedCrossRef
7.
Cremers B, Clever Y, Schaffner S, Speck U, Bohm M, Scheller B (2010) Treatment of coronary in-stent restenosis with a novel paclitaxel urea coated balloon. Minerva Cardioangiol 58(5):583–588PubMed
8.
Fanggiday JC, Stella PR, Guyomi SH, Doevendans PA (2008) Safety and efficacy of drug-eluting balloons in percutaneous treatment of bifurcation lesions: the DEBIUT (drug-eluting balloon in bifurcation Utrecht) registry. Catheter Cardiovasc Interv 71(5):629–635PubMedCrossRef
9.
Ahmed W, Shah MA, Thaver AM, Mirza J (2011) Drug-eluting balloon (DEB) for de novo coronary artery disease and in-stent restenosis: immediate and intermediate term results from a prospective registry. J Pak Med Assoc 61(2):157–160PubMed
10.
Nakamura S, Ogawa H, Bae J-H, Cahyadi YH, Udayachalerm W, Tresukosol D (2011) Comparison of efficacy and safety between sirolimus paclitaxel everolimus-eluting stent and sequent please a drug-eluting balloon on the outcome of patients with diffuse in-stent restenosis after bare metal stent implantation. J Am Coll Cardiol 57(14 Suppl S):E1638CrossRef
11.
Sgueglia GA, Todaro D, Bisciglia A, Conte M, Stipo A, Pucci E (2011) Kissing inflation is feasible with all second-generation drug-eluting balloons. Cardiovasc Revasc Med 12(5):280–285PubMedCrossRef
12.
Unverdorben M, Kleber FX, Heuer H, Figulla HR, Vallbracht C, Leschke M, Cremers B, Hardt S, Buerke M, Ackermann H et al (2010) Treatment of small coronary arteries with a paclitaxel-coated balloon catheter. Clin Res Cardiol 99(3):165–174PubMedCrossRef
13.
Vaquerizo B, Serra A, Miranda-Guardiola F, Martinez V, Antoni Gomez-Hospital J, Iniguez A, Fernandez E, Ramon Rumoroso J, Bosa F, Otaegui I (2011) One-year outcomes with angiographic follow-up of paclitaxel-eluting balloon for the treatment of in-stent restenosis: insights from Spanish multicenter registry. J Interv Cardiol 24(6):518–528PubMedCrossRef
14.
Stella PR, Belkacemi A, Waksman R, Stahnke S, Torguson R, von Strandmann RP, Agostoni P, Sangiorgi G, Silber S (2011) The valentines trial: results of the first one week worldwide multicentre enrolment trial, evaluating the real world usage of the second generation DIOR paclitaxel drug-eluting balloon for in-stent restenosis treatment. EuroIntervention 7(6):705–710PubMedCrossRef
15.
Wohrle J, Birkemeyer R, Markovic S, Nguyen TV, Sinha A, Miljak T, Spiess J, Rottbauer W, Rittger H (2011) Prospective randomised trial evaluating a paclitaxel-coated balloon in patients treated with endothelial progenitor cell capturing stents for de novo coronary artery disease. Heart 97(16):1338–1342PubMedCrossRef
16.
Cortese B, Micheli A, Picchi A, Coppolaro A, Bandinelli L, Severi S, Limbruno U (2010) Paclitaxel-coated balloon versus drug-eluting stent during PCI of small coronary vessels, a prospective randomised clinical trial. The PICCOLETO study. Heart 96(16):1291–1296PubMedCrossRef
17.
Stella P (2011) Drug eluting balloon in acute myocardial infarction. In: TCT, San Francisco, 2011
18.
Belkacemi A (2011) A multicenter randomized comparison of drug-eluting balloon plus bare metal stent versus bare metal stent versus drug-eluting stent in bifurcation lesions: 6-month angiographic and 12-month clinical results of DEBUIT. EuroPCR, In
19.
Mathey DG, Wendig I, Boxberger M, Bonaventura K, Kleber FX (2011) Treatment of bifurcation lesions with a drug-eluting balloon: the PEPCAD V (paclitaxel eluting PTCA balloon in coronary artery disease) trial. EuroIntervention 7(Suppl K):K61–K65PubMedCrossRef
20.
Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U (2006) Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med 355(20):2113–2124PubMedCrossRef
21.
Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U (2008) Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. Clin Res Cardiol 97(10):773–781PubMedCrossRef
22.
Habara S, Mitsudo K, Kadota K, Goto T, Fujii S, Yamamoto H, Katoh H, Oka N, Fuku Y, Hosogi S et al (2011) Effectiveness of paclitaxel-eluting balloon catheter in patients with sirolimus-eluting stent restenosis. JACC Cardiovasc Interv 4(2):149–154PubMedCrossRef
23.
Unverdorben M, Vallbracht C, Cremers B, Heuer H, Hengstenberg C, Maikowski C, Werner GS, Antoni D, Kleber FX, Bocksch W et al (2009) Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation 119(23):2986–2994PubMedCrossRef
24.
Rittger H, Brachmann J, Sinha AM, Waliszewski M, Ohlow M, Brugger A, Thiele H, Birkemeyer R, Kurowski V, Breithardt OA 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(15):1377–1382PubMedCrossRef
25.
Mehilli J, Byrne RA, Tiroch K, Pinieck S, Schulz S, Kufner S, Massberg S, Laugwitz KL, Schomig A, Kastrati A (2010) Randomized trial of paclitaxel- versus sirolimus-eluting stents for treatment of coronary restenosis in sirolimus-eluting stents: the ISAR-DESIRE 2 (intracoronary stenting and angiographic results: drug eluting stents for in-stent restenosis 2) study. J Am Coll Cardiol 55(24):2710–2716PubMedCrossRef
26.
Scheller B, Clever YP, Kelsch B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Speck U, Bohm M et al (2012) Long-term follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. JACC Cardiovasc Interv 5(3):323–330PubMedCrossRef
27.
Stone GW, Ellis SG, Colombo A, Dawkins KD, Grube E, Cutlip DE, Friedman M, Baim DS, Koglin J (2007) Offsetting impact of thrombosis and restenosis on the occurrence of death and myocardial infarction after paclitaxel-eluting and bare metal stent implantation. Circulation 115(22):2842–2847PubMedCrossRef
28.
Chen MS, John JM, Chew DP, Lee DS, Ellis SG, Bhatt DL (2006) Bare metal stent restenosis is not a benign clinical entity. Am Heart J 151(6):1260–1264PubMedCrossRef
29.
Hamm C (2009) PEPCAD III: A randomized trial comparing a paclitaxel-eluting PTCA-balloon in combination with the coroflex blue stent versus the sirolimus coated Cypher stent in the treatment of coronary artery disease. In: American Heart Association, Scientific Sessions, 2009
Metadata
Title
Drug-coated balloons in treatment of in-stent restenosis: a meta-analysis of randomised controlled trials
Authors
Eliano Pio Navarese
David Austin
Paul A. Gurbel
Felicita Andreotti
Udaya Tantry
Stefan James
Antonino Buffon
Marek Kozinski
Karolina Obonska
Kevin Bliden
Young-Hoon Jeong
Jacek Kubica
Vijay Kunadian
Publication date
01-04-2013
Publisher
Springer-Verlag
Published in
Clinical Research in Cardiology / Issue 4/2013
Print ISSN: 1861-0684
Electronic ISSN: 1861-0692
DOI
https://doi.org/10.1007/s00392-012-0532-3

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