Efficacy of Drug-eluting Balloon for Coronary Artery In-stent Restenosis: A Meta-analysis and Trial Sequential Analysis_Chinese Journal of Evidence-Based Medicine

Authors：

 ZHANGChen , XUYuan-ning , LIAOYan-biao , HUANGBao-tao , CHAIHua , HUANGFang-yang , LIUWei , HUANGKai-sen ,  HUANGDe-jia

West China School of Medicine/West China Hospital, Sichuan University, Chengdu 610041, China;

Corresponding author：

HUANGDe-jia, Email: huangdjhx@sina.com

Keywords：

Drug-eluting balloon; Coronary artery in-stent restenosis; Meta-analysis; Trial sequential analysis; Randomized controlled trial

DOI：

10.7507/1672-2531.20160082

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Objective To systematically evaluate the outcomes of drug-eluting balloon (DEB) in treating coronary artery in-stent restenosis (ISR) by using meta-analysis and trial sequential analysis (TSA). Methods We searched PubMed, EMbase, The Cochrane Library（Issue 4, 2016）, CNKI, CBM, VIP and WanFang Data to collect randomized controlled trials (RCTs) regarding the treatment of ISR by DEB from inception to April 2016. After two reviewers independently screened citations, extracted data and assessed the bias risk of included studies, we carried out meta-analysis and TSA analysis by using RevMan 5.3 version and TSA v0.9 respectively. Results A total of 10 RCTs involving 1909 patients were included. Seven-hundred and forty-seven patients were included with regard to the comparison between DEB and POBA, 1162 patients were recruited to compare DEB and drug-eluting stents (DES). The results of meta-analysis revealed that DEB was associated with decreased mortality (OR=0.36, 95%CI 0.14 to 0.93, P=0.04), compared with that of plain old balloon angioplasty (POBA). And TSA showed that cumulative Z-curve strode the conventional threshold value but not the TSA threshold value which suggested a false positive result of meta-analysis. In comparison with that of POBA, DEB had a lower incidence of target lesion revascularization (TLR) (OR=0.16, 95%CI 0.07 to 0.38, P＜0.01). And the result of TSA displayed that the cumulative Z-curve strode both the conventional and TSA threshold value which validated the result of meta-analysis. Besides, the results of meta-analysis showed that there were no significant differences in mortality (OR=0.84, 95%CI 0.41 to 1.72, P=0.63) and TLR (OR=1.55, 95%CI 0.76 to 3.16, P=0.22) between DEB and DES. However, the result of TSA revealed that the cumulative Z-curve did not strode both the conventional and TSA threshold value, and the included sample size less was than required information size which suggested that the reliability of the meta-analysis needed more studies to confirm. While the subgroup analysis of EES revealed that DEB had a higher incidence of TLR than that of DEB (OR=3.37, 95%CI 1.59 to 7.15, P＜0.01). And the result of TSA displayed that the cumulative Z-curve strode both the conventional and TSA threshold value which validated the result of meta-analysis. Conclusion Current evidence shows, EES is superior to DEB in decreasing the incidence of TLR in patients with ISR, while DEB is superior to POBA. However, the comparison of DEB and other strategies on reducing of mortality in patients with ISR still needed more studies to prove.

Citation： ZHANGChen, XUYuan-ning, LIAOYan-biao, HUANGBao-tao, CHAIHua, HUANGFang-yang, LIUWei, HUANGKai-sen, HUANGDe-jia. Efficacy of Drug-eluting Balloon for Coronary Artery In-stent Restenosis: A Meta-analysis and Trial Sequential Analysis. Chinese Journal of Evidence-Based Medicine, 2016, 16(5): 523-531. doi: 10.7507/1672-2531.20160082 Copy

1.	Taniwaki M, Stefanini GG, Silber S, et al. 4-year clinical outcomes and predictors of repeat revascularization in patients treated with new-generation drug-eluting stents: a report from the RESOLUTE All-Comers trial (A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention). J Am Coll Cardiol, 2014, 63(16): 1617-1625.
2.	Cassese S, Byrne RA, Tada T, et al. Incidence and predictors of restenosis after coronary stenting in 10 004 patients with surveillance angiography. Heart, 2014, 100(2): 153-159.
3.	Go AS, Mozaff arian D, Roger VL, et al, for the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2014 update: a report from the American Heart Association. Circulation, 2014, 129(3): e28-e292.
4.	Cremers B, Toner JL, Schwartz LB, et al. Inhibition of neointimal hyperplasia with a novel zotarolimus coated balloon catheter. Clin Res Cardiol, 2012, 101(6): 469-476.
5.	Scheller B, Speck U, Abramjuk C, et al. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation, 2004, 110(7): 810-814.
6.	Windecker S, Kolh P, Alfonso F, et al. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for CardioThoracic Surgery (EACTS) Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions ( EAPCI). Eur Heart J, 2014, 35(37): 2541-2619.
7.	王权, 田金徽, 李伦, 等. 试验序贯分析简介. 中国循证医学杂志, 2013, 13(10): 1265-1268.
8.	Thorlund K, Engstrøm J, Wetterslev J, et al. User manual for trial sequential analysis (TSA). Copenhagen Trial Unit. Available at: http://wwwctudk/tsa/files/tsa_manualpdf. Accessed 2011.
9.	Higgins JPT, Green S. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0[updated March 2011]. The Cochrane Collaboration, 2011. Available at: http://handbook.Cochrane.org/.
10.	Scheller B, Speck U, Abramjuk C, et al. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation, 2004, 110: 810-814.
11.	Scheller B, Hehrlein C, Bocksch W, et al. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med, 2006, 355(20): 2113-2124.
12.	Kleber FX, Mathey DG, Rittger H, et al. for the German DrugEluting Balloon Consensus Group. How to use the drug-eluting balloon: recommendations by the German consensus group. EuroIntervention, 2011, 7 Suppl K: K125-128.
13.	Mathey DG, Wendig I, Boxberger M, et al. Treatment of bifurcation lesions with a drug-eluting balloon: the PEPCAD V (Paclitaxel Eluting PTCA Balloon in Coronary Artery Disease) trial. EuroIntervention, 2011, 7 Suppl K: K61-65.
14.	Fanggiday JC, Stella PR, Guyomi SH, et al. 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, 2008, 71(5): 629-635.
15.	Zeymer U, Waliszewski M, Spiecker M, et al. Prospective ‘real world’ registry for the use of the ‘PCB only’ strategy in small vessel de novo lesions. Heart, 2014, 100(4): 311-316.
16.	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(24): 2473-2480.
17.	崔孔勇, 吕树铮, 柳弘,等. 药物洗脱球囊治疗支架内再狭窄的研究进展. 心肺血管病杂志, 2016, 35(3): 246-250.
18.	Lee JM, Park J, Kang J, et al. Comparison among drug-eluting balloon, drug-eluting stent, and plain balloon angioplasty for the treatment of in-stent restenosis: a network meta-analysis of 11 randomized, controlled trials. JACC Cardiovasc Interv, 2015, 8(3): 382-394.
19.	Siontis GC, Stefanini GG, Mavridis D, et al. Percutaneous coronary interventional strategies for treatment of in-stent restenosis: a network meta-analysis. Lancet, 2015, 386(9994): 655-664.
20.	Tada T, Kadota K, Hosogi S, et al. Association between tissue characteristics evaluated with optical coherence tomography and mid-term results after paclitaxel-coated balloon dilatation for in-stent restenosis lesions: a comparison with plain old balloon angioplasty. Eur Heart J Cardiovasc Imaging, 2014, 15(3): 307-315.
21.	Almalla M, Schroder J, Pross V, et al. Paclitaxel-eluting balloon versus everolimus-eluting stent for treatment of drug-eluting stent restenosis. Catheter Cardiovasc Interv, 2014, 83(6): 881-887.
22.	Vaquerizo B, Serra A, Miranda-Guardiola F, et al. 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, 2011, 24(6): 518-528.
23.	Hehrlein C, Dietz U, Kubica J, et al. Twelve-month results of a paclitaxel releasing balloon in patients presenting with in-stent restenosis First-in-Man (PEPPER) trial. Cardiovasc Revasc Med, 2012, 13(5): 260-264.
24.	Wohrle J, Zadura M, Mobius-Winkler S, et al. SeQuentPlease World Wide Registry: clinical results of SeQuent please paclitaxel-coated balloon angioplasty in a large-scale, prospective registry study. J Am Coll Cardiol, 2012, 60(18): 1733-1738.
25.	Clever YP, Cremers B, von Scheidt W, et al. Compassionate use of a paclitaxel coated balloon in patients with refractory recurrent coronary in-stent restenosis. Clin Res Cardiol, 2014, 103(1): 21-27.
26.	Stella PR, Belkacemi A, Waksman R, et al. 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, 2011, 7(6): 705-710.

1. Taniwaki M, Stefanini GG, Silber S, et al. 4-year clinical outcomes and predictors of repeat revascularization in patients treated with new-generation drug-eluting stents: a report from the RESOLUTE All-Comers trial (A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention). J Am Coll Cardiol, 2014, 63(16): 1617-1625.
2. Cassese S, Byrne RA, Tada T, et al. Incidence and predictors of restenosis after coronary stenting in 10 004 patients with surveillance angiography. Heart, 2014, 100(2): 153-159.
3. Go AS, Mozaff arian D, Roger VL, et al, for the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2014 update: a report from the American Heart Association. Circulation, 2014, 129(3): e28-e292.
4. Cremers B, Toner JL, Schwartz LB, et al. Inhibition of neointimal hyperplasia with a novel zotarolimus coated balloon catheter. Clin Res Cardiol, 2012, 101(6): 469-476.
5. Scheller B, Speck U, Abramjuk C, et al. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation, 2004, 110(7): 810-814.
6. Windecker S, Kolh P, Alfonso F, et al. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for CardioThoracic Surgery (EACTS) Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions ( EAPCI). Eur Heart J, 2014, 35(37): 2541-2619.
7. 王权, 田金徽, 李伦, 等. 试验序贯分析简介. 中国循证医学杂志, 2013, 13(10): 1265-1268.
8. Thorlund K, Engstrøm J, Wetterslev J, et al. User manual for trial sequential analysis (TSA). Copenhagen Trial Unit. Available at: http://wwwctudk/tsa/files/tsa_manualpdf. Accessed 2011.
9. Higgins JPT, Green S. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0[updated March 2011]. The Cochrane Collaboration, 2011. Available at: http://handbook.Cochrane.org/.
10. Scheller B, Speck U, Abramjuk C, et al. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation, 2004, 110: 810-814.
11. Scheller B, Hehrlein C, Bocksch W, et al. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med, 2006, 355(20): 2113-2124.
12. Kleber FX, Mathey DG, Rittger H, et al. for the German DrugEluting Balloon Consensus Group. How to use the drug-eluting balloon: recommendations by the German consensus group. EuroIntervention, 2011, 7 Suppl K: K125-128.
13. Mathey DG, Wendig I, Boxberger M, et al. Treatment of bifurcation lesions with a drug-eluting balloon: the PEPCAD V (Paclitaxel Eluting PTCA Balloon in Coronary Artery Disease) trial. EuroIntervention, 2011, 7 Suppl K: K61-65.
14. Fanggiday JC, Stella PR, Guyomi SH, et al. 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, 2008, 71(5): 629-635.
15. Zeymer U, Waliszewski M, Spiecker M, et al. Prospective ‘real world’ registry for the use of the ‘PCB only’ strategy in small vessel de novo lesions. Heart, 2014, 100(4): 311-316.
16. 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(24): 2473-2480.
17. 崔孔勇, 吕树铮, 柳弘,等. 药物洗脱球囊治疗支架内再狭窄的研究进展. 心肺血管病杂志, 2016, 35(3): 246-250.
18. Lee JM, Park J, Kang J, et al. Comparison among drug-eluting balloon, drug-eluting stent, and plain balloon angioplasty for the treatment of in-stent restenosis: a network meta-analysis of 11 randomized, controlled trials. JACC Cardiovasc Interv, 2015, 8(3): 382-394.
19. Siontis GC, Stefanini GG, Mavridis D, et al. Percutaneous coronary interventional strategies for treatment of in-stent restenosis: a network meta-analysis. Lancet, 2015, 386(9994): 655-664.
20. Tada T, Kadota K, Hosogi S, et al. Association between tissue characteristics evaluated with optical coherence tomography and mid-term results after paclitaxel-coated balloon dilatation for in-stent restenosis lesions: a comparison with plain old balloon angioplasty. Eur Heart J Cardiovasc Imaging, 2014, 15(3): 307-315.
21. Almalla M, Schroder J, Pross V, et al. Paclitaxel-eluting balloon versus everolimus-eluting stent for treatment of drug-eluting stent restenosis. Catheter Cardiovasc Interv, 2014, 83(6): 881-887.
22. Vaquerizo B, Serra A, Miranda-Guardiola F, et al. 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, 2011, 24(6): 518-528.
23. Hehrlein C, Dietz U, Kubica J, et al. Twelve-month results of a paclitaxel releasing balloon in patients presenting with in-stent restenosis First-in-Man (PEPPER) trial. Cardiovasc Revasc Med, 2012, 13(5): 260-264.
24. Wohrle J, Zadura M, Mobius-Winkler S, et al. SeQuentPlease World Wide Registry: clinical results of SeQuent please paclitaxel-coated balloon angioplasty in a large-scale, prospective registry study. J Am Coll Cardiol, 2012, 60(18): 1733-1738.
25. Clever YP, Cremers B, von Scheidt W, et al. Compassionate use of a paclitaxel coated balloon in patients with refractory recurrent coronary in-stent restenosis. Clin Res Cardiol, 2014, 103(1): 21-27.
26. Stella PR, Belkacemi A, Waksman R, et al. 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, 2011, 7(6): 705-710.

Chinese Journal of Evidence-Based Medicine

Efficacy of Drug-eluting Balloon for Coronary Artery In-stent Restenosis: A Meta-analysis and Trial Sequential Analysis

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