Efficacy of a seal-wing paclitaxel-eluting balloon catheters in the treatment of bare metal stent restenosis
Language English Country Great Britain, England Media electronic
Document type Journal Article, Research Support, Non-U.S. Gov't
PubMed
28651572
PubMed Central
PMC5485564
DOI
10.1186/s12872-017-0602-6
PII: 10.1186/s12872-017-0602-6
Knihovny.cz E-resources
- Keywords
- Drug-eluting stent, In-stent restenosis, Paclitaxel-elution balloon,
- MeSH
- Angioplasty, Balloon, Coronary adverse effects instrumentation MeSH
- Coated Materials, Biocompatible * MeSH
- Time Factors MeSH
- Kaplan-Meier Estimate MeSH
- Cardiovascular Agents administration & dosage adverse effects MeSH
- Coronary Angiography MeSH
- Percutaneous Coronary Intervention adverse effects instrumentation MeSH
- Coronary Restenosis diagnostic imaging etiology therapy MeSH
- Metals * MeSH
- Middle Aged MeSH
- Humans MeSH
- Logistic Models MeSH
- Coronary Artery Disease diagnostic imaging therapy MeSH
- Odds Ratio MeSH
- Paclitaxel administration & dosage adverse effects MeSH
- Disease-Free Survival MeSH
- Prospective Studies MeSH
- Prosthesis Design MeSH
- Randomized Controlled Trials as Topic MeSH
- Recurrence MeSH
- Risk Factors MeSH
- Aged MeSH
- Cardiac Catheters * MeSH
- Drug-Eluting Stents MeSH
- Stents * MeSH
- Case-Control Studies MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Names of Substances
- Coated Materials, Biocompatible * MeSH
- Cardiovascular Agents MeSH
- Metals * MeSH
- Paclitaxel MeSH
BACKGROUND: Our study aimed to compare the efficacy of seal-wing paclitaxel-eluting balloon catheters (PEB) with iopromide-coated PEB and everolimus-eluting stents (EES) for treating bare metal stent restenosis (BMS-ISR). METHODS: We enrolled 64 patients with 69 BMS-ISR. The control group comprised patients from the iopromide-PEB and EES arms of a previous TIS study. The primary end-point was 12-month in-segment late lumen loss (LLL). Secondary end-points included incidence of binary in-stent restenosis and 12-month major adverse cardiac events (MACE). RESULTS: Compared to iopromide-coated PEB, seal-wing PEB was associated with significantly higher 12-month LLL (0.30 vs. 0.02 mm; p < 0.0001), repeated binary restenosis (28.12% vs. 8.7%; p = 0.012), 12-month MACE (26.98% vs. 10.29%; p = 0.003), and target vessel revascularization (TVR; 20.63% vs. 7.35%; p = 0.009). Compared to EES, no significant differences were found in the 12-month LLL (0.30 vs. 0.19 mm; p = 1.000), repeated binary restenosis (28.12% vs. 19.12%; p = 0.666), 12-month MACE (26.98% vs. 19.12%; p = 0.102) or TVR (20.63% vs. 16.18%; p = 0.360). CONCLUSION: BMS-ISR treatment using seal-wing PEB led to significantly higher 12-month LLL, repeated binary restenosis, MACE, and TVR compared to iopromide-coated PEB. However, no significant differences were found in comparison with EES. TRIAL REGISTRATION: ClinicalTrials.gov; NCT01735825.
Department of Medical Biophysics Palacky University Hněvotínská 3 775 15 Olomouc Czech Republic
International Clinical Research Center St Anne's University Hospital Brno Czech Republic
See more in PubMed
Kim MS, Dean LS. In-Stent Restenosis. Cardiovascular Therapeutic. 2011;29:190–198. doi: 10.1111/j.1755-5922.2010.00155.x. PubMed DOI
Alfonso F, Byrne RA, Rivero F, Kastrati A. Current treatment of in-stent restenosis. JACC. 2014;63:2659–2673. doi: 10.1016/j.jacc.2014.02.545. PubMed DOI
Speck U, Scheller B, Abramjuk C, Grossmann S, Mahnkopf D, Simon O. Inhibition of restenosis in stented porcine coronary arteries: uptake of paclitaxel from angiographic contrast media. Investig Radiol. 2004;39(3):182–186. doi: 10.1097/01.rli.0000116125.96544.64. PubMed DOI
Pleva L, Kukla P, Kusnierova P, Zapletalova J, Hlinomaz O. Comparison of the efficacy of paclitaxel-eluting balloon catheters and Everolimus-eluting stents in the treatment of coronary in-stent restenosis. The Treatment of In-Stent Restenosis Study Circ Cardiovasc Interv. 2016;9 doi: 10.1161/CIRCINTERVENTIONS.115.003316. PubMed DOI
Pocock SJ, Lansky AJ, Mehran R, Popma JJ, Fahy MP, Na Y, et al. Angiogaphic surrogate end points in drug-eluting stent trials. JACC. 2008;51:23–32. doi: 10.1016/j.jacc.2007.07.084. PubMed DOI
Vaquerizo B, Aizpurua DA, Cuscullida JC, Peñaranda AS. Update on drug-eluting balloons for percutaneous coronary interventions. EMJ Int Cardiol. 2013;1:80–90.
van Driel A, Ijsselmuiden S, Polad J, Scholte M, Vries A, Weevers A. Interim results of a new paclitaxel-coated DEB in real-world PCI indications. [Abstract].In: Abstracts of EuroPCR 2016, Paris, France, Euro 16A–POS0885. http://www.pcronline.com/eurointervention/AbstractsEuroPCR2016_issue/abstracts-europcr-2016/. Accessed on October 28, 2016.
Thygesen K, Albert JS, Jafe AS, Simoons ML, Chaitman BR, White HD. Third universal definition of myocardial infarction. EHJ. 2012;33:2551–2567. doi: 10.1093/eurheartj/ehs184. PubMed DOI
Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, et al. Clinical end points in coronary stent trials. A case for standardized definitions. Circulation. 2007;115:2344–2351. doi: 10.1161/CIRCULATIONAHA.106.685313. PubMed DOI
Ryan TJ, Faxon DP, Gunnar RM, Kennedy JW, King SB, Loop FD, et al. Guidelines for percutaneous transluminal coronary angioplasty: a report of the American College of Cardiology/American Heart Association task force on the Assesment of diagnostic and therapeutic cardiovascular procedures. Circulation. 1988;78:486–502. doi: 10.1161/01.CIR.78.2.486. PubMed DOI
Mehran R, Dangas G, Abizaid AS, Mintz GS, Lansky AJ, Satler LF, et al. Angiographic patterns of in-stent restenosis classification and implications for long-term outcome. Circulation. 1999;100:1872–1878. doi: 10.1161/01.CIR.100.18.1872. PubMed DOI
Scheller B, Speck U, Abramjuk C, Bernhardt U, Böhm M, Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004;110:810–814. doi: 10.1161/01.CIR.0000138929.71660.E0. PubMed DOI
Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, et al. Treatment of coronary in-stent restenosis with a paclitaxel-coated ballon catheter. NEJM. 2006;355:2113–2124. doi: 10.1056/NEJMoa061254. PubMed DOI
Unverdorben M, Vallbracht C, Cremers B, Heuer H, Hengstenberg C, Maikowski C, et al. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation. 2009;119:2986–2994. doi: 10.1161/CIRCULATIONAHA.108.839282. PubMed DOI
Alfonso F, Pérez-Vizcayno MJ, Cárdenas A, del Blanco BG, Seidelberger B, Ińiguez A, et al. A randomized comparison of drug-eluting balloon versus everolimus-eluting stent in patients with bare-metal stent in-stent restenosis. JACC. 2014;63:1378–1386. doi: 10.1016/j.jacc.2013.12.006. PubMed DOI
Bondesson P, Lagerqvist B, James SK, Olivecrona GK, Venetsanos D, Harnek J. Comparison of two drug-eluting balloons: a report from the SCAAR registry. EuroInterv. 2012;8:444–449. doi: 10.4244/EIJV8I4A70. PubMed DOI
Nijhoff F, Stella PR, Troost MS, Belkacemi A, Nathoe HM, Voskuil M, et al. Comparative assessment of the antirestenotic efficacy of two paclitaxel drug-eluting balloons with different coatings in the treatment of in-stent restenosis. Clin Res Cardiol 2015;11p.doi:10.1007/s00392-015-0934-0. PubMed PMC
Campo G, Tebaldi M, Vranckx P, Biscaglia S, Tumscitz C, Ferrari R, et al. Short- Versus Long-Term Duration of Dual Antiplatelet Therapy in Patients Treated for In-Stent Restenosis A PRODIGY Trial Substudy (Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia) JACC. 2014;63(6):506–512. doi: 10.1016/j.jacc.2013.09.043. PubMed DOI
Valgimigli M, Campo G, Monti M, Vranckx P, Percoco G, Tumscitz C, et al. Short- Versus Long-Term Duration of Dual-Antiplatelet Therapy After Coronary Stenting A Randomized Multicenter Trial. Circulation. 2012;125:2015–2026. doi: 10.1161/CIRCULATIONAHA.111.071589. PubMed DOI
Campo G, Punzetti S, Malagu M, Ferrari R, Valgimigli M. Two-year outcomes after first- or second-generation drug-eluting stent implantation in patients with in-stent restenosis. A PRODIGY trial substudy. Int Journal of Cardiol. 2014;173(2):343–345. doi: 10.1016/j.ijcard.2014.03.028. PubMed DOI
Valgimigli M, Campo G, Percoco G, Monti M, Ferrari F, Tumscitz C, et al. Randomized comparison of 6- versus 24-month clopidogrel therapy after balancing anti-intimal hyperplasia stent potency in all-comer patients undergoing percutaneous coronary intervention: design and rationale for the PROlonging dual-antiplatelet treatment after Grading stent-induced intimal hyperplasia study (PRODIGY) Am Heart J. 2010;160:804–811. doi: 10.1016/j.ahj.2010.07.034. PubMed DOI
Valgimigli M, Tebaldi M, Borghesi M, Vranckx P, Campo G, Tumscitz C, et al. Two-year outcomes after first- or second-generation drug-eluting or bare-metal stent implantation in all-comer patients undergoing percutaneous coronary intervention a pre-specified analysis from the PRODIGY study (PROlonging dual antiplatelet treatment after Grading stent-induced intimal hyperplasia studY) JACC: Cardiovasc Interv. 2014;7(1):20–28. PubMed
Treatment of coronary in-stent restenosis: a systematic review
ClinicalTrials.gov
NCT01735825
