eISSN: 1897-4295
ISSN: 1734-9338
Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej
Current issue Archive Manuscripts accepted About the journal Abstracting and indexing Subscription Contact Instructions for authors
SCImago Journal & Country Rank
4/2016
vol. 12
 
Share:
Share:
more
 
 
abstract:
Original paper

First-generation paclitaxel- vs. second-generation zotarolimus-eluting stents in small coronary arteries: the BASKET-SMALL Pilot Study

Raban Jeger, Matthias Pfisterer, Otmar Pfister, Peter Rickenbacher, Michael Handke, Nicole Gilgen, Michael Coslovsky, Christoph Kaiser

Adv Interv Cardiol 2016; 12, 4 (46): 314–320
Online publish date: 2016/11/17
View full text
Get citation
ENW
EndNote
BIB
JabRef, Mendeley
RIS
Papers, Reference Manager, RefWorks, Zotero
AMA
APA
Chicago
Harvard
MLA
Vancouver
 
Introduction: Event rates after percutaneous coronary interventions (PCI) are higher in small than large coronary vessels but may vary between different drug-eluting stent (DES) types.

Aim: To assess the efficacy of two different DES in small vessel disease.

Material and methods: Patients with small vessel PCI were randomised 1 : 1 to a first-generation paclitaxel- vs. a second-generation zotarolimus-eluting stent. The primary endpoint was a composite of cardiac death, non-fatal myocardial infarction, and target vessel revascularisation after 2 years.

Results: Overall, 191 patients were enrolled: 100 with a paclitaxel- and 91 with a zotarolimus-eluting stent. Baseline characteristics were similar in both groups. After 2 years, rates of the primary endpoint were numerically higher for zotarolimus- than paclitaxel-eluting stents (9.9% vs. 5.0%, hazard ratio 2.09, 95% confidence interval (CI) 0.7–6.2, p = 0.19), which was mainly driven by higher rates of target vessel revascularisation (6.6% vs. 2.0%, hazard ratio 3.39, 95% CI: 0.68–16.78, p = 0.14). Based on this, a total of 1,019 patients would be necessary to demonstrate at least non-inferiority between the DES used.

Conclusions: In this pilot study, paclitaxel-eluting stents had a favourable efficacy profile in small vessel disease, although the numbers were too small to draw final conclusions. Based on the prohibitively high sample size for a randomized controlled trial between DES, other treatment options should be considered.
keywords:

small vessel disease, drug-eluting stent, paclitaxel, zotarolimus

references:
Brunner-La Rocca H, Kaiser C, Pfisterer M. Targeted stent use in clinical practice based on evidence from the Basel Stent Cost Effectiveness Trial (BASKET). Eur Heart J 2007; 28: 719-25.
Ardissino D, Cavallini C, Bramucci E, et al. Sirolimus-eluting vs uncoated stents for prevention of restenosis in small coronary arteries: a randomized trial. JAMA 2004; 292: 2727-34.
Stone G, Ellis S, Cannon L, et al. Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: a randomized controlled trial. JAMA 2005; 294: 1215-23.
Siontis GC, Piccolo R, Praz F, et al. Percutaneous coronary interventions for the treatment of stenoses in small coronary arteries: a network meta-analysis. JACC Cardiovasc Interv 2016; 9: 1324-34.
Mehilli J, Dibra A, Kastrati A, et al. Randomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels. Eur Heart J 2006; 27: 260-6.
Morice M, Colombo A, Meier B, et al. Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions: the REALITY trial: a randomized controlled trial. JAMA 2006; 295: 895-904.
Gershlick A, Kandzari DE, Leon MB, et al. Zotarolimus-eluting stents in patients with native coronary artery disease: clinical and angiographic outcomes in 1,317 patients. Am J Cardiol 2007; 100: 45M-55M.
Tanimoto S, Daemen J, Tsuchida K, et al. Two-year clinical outcome after coronary stenting of small vessels using 2.25-mm sirolimus- and paclitaxel-eluting stents: insight into the RESEARCH and T-SEARCH registries. Catheter Cardiovasc Interv 2007; 69: 94-103.
Daemen J, Garcia-Garcia HM, Kukreja N, et al. The long-term value of sirolimus- and paclitaxel-eluting stents over bare metal stents in patients with diabetes mellitus. Eur Heart J 2007; 28: 26-32.
Ong AT, Aoki J, van Mieghem CA, et al. Comparison of short- (one month) and long- (twelve months) term outcomes of sirolimus- versus paclitaxel-eluting stents in 293 consecutive patients with diabetes mellitus (from the RESEARCH and T-SEARCH registries). Am J Cardiol 2005; 96: 358-62.
Stankovic G, Cosgrave J, Chieffo A, et al. Impact of sirolimus-eluting and paclitaxel-eluting stents on outcome in patients with diabetes mellitus and stenting in more than one coronary artery. Am J Cardiol 2006; 98: 362-6.
Kaul U, Bangalore S, Seth A, et al. Paclitaxel-eluting versus everolimus-eluting coronary stents in diabetes. N Engl J Med 2015; 373: 1709-19.
Tanimoto S, Serruys P, Thuesen L, et al. Comparison of in vivo acute stent recoil between the bioabsorbable everolimus-eluting coronary stent and the everolimus-eluting cobalt chromium coronary stent: insights from the ABSORB and SPIRIT trials. Catheter Cardiovasc Interv 2007; 70: 515-23.
Cannon LA, Kereiakes DJ, Mann T, et al. A prospective evaluation of the safety and efficacy of TAXUS Element paclitaxel-eluting coronary stent implantation for the treatment of de novo coronary artery lesions in small vessels: the PERSEUS Small Vessel trial. EuroIntervention 2011; 6: 920-7, 1-2.
Alfonso F, García-Guimaraes M. Optimal coronary interventions in small vessels: is size all that matters? JACC Cardiovasc Interv 2016; 9: 1335-7.
Kaiser C, Galatius S, Erne P, et al.; Group tBPS. Drug-eluting versus bare-metal stents in large coronary arteries. N Engl J Med 2010; 363: 2310-2319.
COSTAR II Presentation EuroPCR 2007 (http://www.pcronline.com/Lectures/2007/COSTAR-II-primary-outcome-results).
Mehran R, Rao SV, Bhatt DL, et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation 2011; 123: 2736-47.
Silber S, Albertsson P, Avilés F, et al.; Cardiology TFfPCIotESo. Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Eur Heart J 2005; 26: 804-47.
Firth D. Bias reduction of maximum likelihood estimates. Biometrika 1993; 80: 27-38.
Heinze G, Schemper M. A solution to the problem of monotone likelihood in Cox regression. Biometrics 2001; 57: 114-9.
Leon M, Kandzari D, Eisenstein E, et al. Late safety, efficacy, and cost-effectiveness of a zotarolimus-eluting stent compared with a paclitaxel-eluting stent in patients with de novo coronary lesions: 2-year follow-up from the ENDEAVOR IV trial (Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions). JACC Cardiovasc Interv 2009; 2: 1208-18.
Park DW, Kim YH, Yun SC, et al. Comparison of zotarolimus-eluting stents with sirolimus- and paclitaxel-eluting stents for coronary revascularization: the ZEST (comparison of the efficacy and safety of zotarolimus-eluting stent with sirolimus-eluting and paclitaxel-eluting stent for coronary lesions) randomized trial. J Am Coll Cardiol 2010; 56: 1187-95.
Palmerini T, Benedetto U, Biondi-Zoccai G, et al. Long-term safety of drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. J Am Coll Cardiol 2015; 65: 2496-507.
Wessely R, Schomig A, Kastrati A. Sirolimus and paclitaxel on polymer-based drug-eluting stents: similar but different. J Am Coll Cardiol 2006; 47: 708-14.
Byrne RA, Joner M, Alfonso F, Kastrati A. Drug-coated balloon therapy in coronary and peripheral artery disease. Nat Rev Cardiol 2014; 11: 13-23.
Cortese B, Micheli A, Picchi A, et al. Paclitaxel-coated balloon versus drug-eluting stent during PCI of small coronary vessels, a prospective randomised clinical trial. The PICCOLETO study. Heart 2010; 96: 1291-6.
Latib A, Colombo A, Castriota F, et al. 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 2012; 60: 2473-80.
Byrne RA, Joner M. Drug-coated balloon angioplasty for de novo stenosis: the balloon is back…reloaded! JACC Cardiovasc Interv 2015; 8: 2010-2.
Quick links
© 2018 Termedia Sp. z o.o. All rights reserved.
Developed by Bentus.
PayU - płatności internetowe