Comparison of dedicated BIOSS bifurcation stents with regular drug-eluting stents for coronary artery bifurcated lesions: Pooled analysis from two randomized studies
Abstract
Background: Coronary bifurcation treatment poses a therapeutic challenge. The aim of this study was to analyze pooled data of two randomized clinical trials, POLBOS I and POLBOS II, to compare 1-year follow-up results and identify possible prognostic factors.
Methods: In POLBOS trials dedicated bifurcation BiOSS® stents were compared with regular drug eluting stents (rDES) in patients with stable coronary artery disease or non ST-segment elevation acute coronary syndrome (POLBOS I: paclitaxel eluting BiOSS® Expert vs. rDES; POLBOS II: sirolimus eluting BiOSS® LIM vs. rDES). Provisional T-stenting was the default strategy. Angiographic control was performed at 12 months. The primary endpoint was major adverse cardiovascular events (MACE) rate defined as the rate of cardiac death, myocardial infarction (MI) or target lesion revascularization (TLR).
Results: 445 patients, with 222 patients in the BiOSS group and 223 patients in the rDES group, were analyzed. In 26.7% cases procedures were performed within distal left main, and true bifurcations which accounted for 81.6% of treated lesions. At 12 months the whole population exhibited no statistical differences in terms of MACE, TLR, MI or cardiac death between rDES and BiOSS groups. In multivariate analysis odds for MACE decreased with female sex (OR 0.433, 95% CI 0.178–0.942, p = 0.047) and with proximal optimization technique use (OR 0.208, 95% CI 0.097–0.419, p < 0.001), whereas the odds for MACE increased with main vessel predilatation (OR 2.191, 95% CI 1.042–5.066, p = 0.049) and diabetes mellitus treated with insulin (OR 2.779, 95% CI 1.1–6.593, p = 0.024).
Conclusions: Pooled data showed no significant difference between MACE and TLR rates for BiOSS® group vs. rDES group.
Keywords: coronary bifurcationdrug eluting stentproximal optimization techniqueleft maindiabetes mellitus
References
- Lassen JF, Holm NR, Stankovic G, et al. Percutaneous coronary intervention for coronary bifurcation disease: consensus from the first 10 years of the European Bifurcation Club meetings. EuroIntervention. 2014; 10(5): 545–560.
- Diletti R, Garcia-Garcia HM, Bourantas CV, et al. Clinical outcomes after zotarolimus and everolimus drug eluting stent implantation in coronary artery bifurcation lesions: insights from the RESOLUTE All Comers Trial. Heart. 2013; 99(17): 1267–1274.
- Ferenc M, Kornowski R, Belardi J, et al. Three-year outcomes of percutaneous coronary intervention with next-generation zotarolimus-eluting stents for de novo coronary bifurcation lesions. J Invasive Cardiol. 2014; 26(12): 630–638.
- Kern A, Gil RJ, Bojko K, et al. The approach to coronary bifurcation treatment and its outcomes in Poland: The single center experience. Cardiol J. 2017; 24(6): 589–596.
- Gil RJ, Bil J, Grundeken MJ, et al. Regular drug-eluting stents versus the dedicated coronary bifurcation sirolimus-eluting BiOSS LIM® stent: the randomised, multicentre, open-label, controlled POLBOS II trial. EuroIntervention. 2016; 12(11): e1404–e1412.
- Gil RJ, Bil J, Džavík V, et al. Regular Drug-Eluting Stent vs Dedicated Coronary Bifurcation BiOSS Expert Stent: Multicenter Open-Label Randomized Controlled POLBOS I Trial. Can J Cardiol. 2015; 31(5): 671–678.
- Gil RJ, Bil J, Vassilev D. Vassilev D. The BiOSS stent EuroIntervention. 2015; 11(Suppl V): V153–V154.
- Bil J, Gil RJ, Kern A, et al. Novel sirolimus-eluting stent Prolim® with a biodegradable polymer in the all-comers population: one year clinical results with quantitative coronary angiography and optical coherence tomography analysis. BMC Cardiovasc Disord. 2015; 15: 150.
- Gil RJ, Vassilev D, Michalek A, et al. Dedicated paclitaxel-eluting bifurcation stent BiOSS® (bifurcation optimisation stent system): 12-month results from a prospective registry of consecutive all-comers population. EuroIntervention. 2012; 8(3): 316–324.
- Bil J, Gil RJ, Vassilev D, et al. Dedicated bifurcation paclitaxel-eluting stent BiOSS Expert® in the treatment of distal left main stem stenosis. J Interv Cardiol. 2014; 27(3): 242–251.
- Gil RJ, Bil J, Vassiliev D, et al. First-in-man study of dedicated bifurcation sirolimus-eluting stent: 12-month results of BiOSS LIM® Registry. J Interv Cardiol. 2015; 28(1): 51–60.
- Gil RJ, Bil J, Legutko J, et al. Comparative assessment of three drug eluting stents with different platforms but with the same biodegradable polymer and the drug based on quantitative coronary angiography and optical coherence tomography at 12-month follow-up. Int J Cardiovasc Imaging. 2018; 34(3): 353–365.
- Chen SL, Mintz G, Santoso T, et al. Comparison of paclitaxal vs. sirolimus eluting stents with bio-degradable polymer for the treatment of coronary bifurcation lesions: subgroup analysis from DKCRUSH-I and DKCRUSH-II studies. Chin Med J (Engl). 2012; 125(19): 3382–3387.
- Qian J, Chen Z, Ma J, et al. Sirolimus- versus paclitaxel-eluting stents for coronary bifurcations intervention: a meta-analysis of five clinical trials. Catheter Cardiovasc Interv. 2012; 80(4): 507–513.
- Costopoulos C, Latib A, Ferrarello S, et al. First- versus second-generation drug-eluting stents for the treatment of coronary bifurcations. Cardiovasc Revasc Med. 2013; 14(6): 311–315.
- Pan M, Medina A, Suárez de Lezo J, et al. Randomized study comparing everolimus- and sirolimus-eluting stents in patients with bifurcation lesions treated by provisional side-branch stenting. Catheter Cardiovasc Interv. 2012; 80(7): 1165–1170.
- Sgueglia GA, Burzotta F, Trani C, et al. Comparative assessment of mammalian target of rapamycin inhibitor-eluting stents in the treatment of coronary artery bifurcation lesions: the CASTOR-Bifurcation registry. Catheter Cardiovasc Interv. 2011; 77(4): 503–509.
- Llano R, Winsor-Hines D, Patel DB, et al. Vascular responses to drug-eluting and bare metal stents in diabetic/hypercholesterolemic and nonatherosclerotic porcine coronary arteries. Circ Cardiovasc Interv. 2011; 4(5): 438–446.
- Sakata K, Waseda K, Kume T, et al. Impact of diabetes mellitus on vessel response in the drug-eluting stent era: pooled volumetric intravascular ultrasound analyses. Circ Cardiovasc Interv. 2012; 5(6): 763–771.
- Zhang Qi, Lu L, Pu L, et al. Neointimal hyperplasia persists at six months after sirolimus-eluting stent implantation in diabetic porcine. Cardiovasc Diabetol. 2007; 6: 16.
- Liu Z, Jin G, Qi Y, et al. Efficacy of one- vs. two-stent implantation for coronary bifurcation lesions in diabetic patients utilizing AIR2 as an endpoint. Int J Clin Exp Med. 2015; 8(7): 11831–11842.
- Meelu OA, Tomey MI, Sartori S, et al. Comparison of provisional 1-stent and 2-stent strategies in diabetic patients with true bifurcation lesions: the EES bifurcation study. J Invasive Cardiol. 2014; 26(12): 619–623.
- Sibbald M, Chan W, Daly P, et al. Long-term outcome of unprotected left main stenting: a Canadian tertiary care experience. Can J Cardiol. 2014; 30(11): 1407–1414.
- Stone G, Sabik J, Serruys P, et al. Everolimus-Eluting stents or bypass surgery for left main coronary artery disease. N Engl J Med. 2016; 375(23): 2223–2235.
- Mäkikallio T, Holm NR, Lindsay M, et al. Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial. Lancet. 2016; 388(10061): 2743–2752.
- Takagi K, Ielasi A, Basavarajaiah S, et al. The impact of main branch restenosis on long term mortality following drug-eluting stent implantation in patients with de novo unprotected distal left main bifurcation coronary lesions: the Milan and New-Tokyo (MITO) Registry. Catheter Cardiovasc Interv. 2014; 84(3): 341–348.
- Wihanda D, Alwi I, Yamin M, et al. Factors associated with in-stent restenosis in patients following percutaneous coronary intervention. Acta Med Indones. 2015; 47(3): 209–215.
- Lassen JF, Holm NR, Banning A, et al. Percutaneous coronary intervention for coronary bifurcation disease: 11th consensus document from the European Bifurcation Club. EuroIntervention. 2016; 12(1): 38–46.
