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

Jacek Bil, Robert J Gil, Adam Kern, Tomasz Pawłowski, Piotr Seweryniak, Zbigniew Śliwiński, Jacek Bil, Robert J Gil, Adam Kern, Tomasz Pawłowski, Piotr Seweryniak, Zbigniew Śliwiński

Abstract

Background: The aim of this study was to assess the safety and the efficacy of the novel sirolimus-eluting Prolim® stent with a biodegradable polymer in the all-comers population.

Methods: We prospectively enrolled all patients with stable coronary artery disease or acute coronary syndrome treated with Prolim® stent between January and December 2013 in two interventional cardiology centers in Poland. Angiographic control was planned at 12 months, in which 15 % of patients (randomly chosen) underwent optical coherence tomography imaging. The primary end-point was the cumulative rate of cardiac death, myocardial infarction, and target lesion revascularization at 12 months.

Results: There were 204 patients enrolled, in whom 238 Prolim® stents were deployed (1.17 stent per patient). The mean age was 68 ± 10 years and 32.8 % were females. The examined stent was implanted in 5.9 % in STEMI patients, in 21.6 % - in NSTE-ACS and in 72.5 % - in patients with stable coronary artery disease. The Prolim® stent was most frequently implanted in right coronary artery (38.2 %) followed by left anterior descending artery (34.0 %). The cumulative major adverse cardiovascular events rate at 12 months was 6.9 %, and the clinically-driven target lesion revascularization rate - 5.4 %. At 12 months in quantitative coronary angiography the late lumen loss was 0.21 ± 0.18 mm, and in optical coherence tomography the mean neointima burden was 24.6 ± 8.6 %.

Conclusions: Sirolimus-eluting Prolim® stent with a biodegradable polymer is a feasible device with a very good safety profile and long-term clinical effectiveness.

Trial registration number: ClinicalTrials.gov NCT02545985 .

Figures

Fig. 1
Fig. 1
The Prolim® stent. a Lesion in LAD before stent implantation, b LAD directly after Prolim® 3.5 × 15 mm deployment, c LAD at 12 months after stent implantation, d OCT analysis of Prolim® stent at 12 months

References

    1. Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, et al. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007;9591:937–48. doi: 10.1016/S0140-6736(07)61444-5.
    1. Buszman P, Trznadel S, Milewski K, Rzezniczak J, Przewlocki T, Kosmider M, et al. Novel paclitaxel-eluting, biodegradable polymer coated stent in the treatment of de novo coronary lesions: a prospective multicenter registry. Catheter Cardiovasc Interv. 2008;1:51–7. doi: 10.1002/ccd.21392.
    1. Kandzari DE, Leon MB, Meredith I, Fajadet J, Wijns W, Mauri L. Final 5-year outcomes from the Endeavor zotarolimus-eluting stent clinical trial program: comparison of safety and efficacy with first-generation drug-eluting and bare-metal stents. J Am Coll Cardiol Intv. 2013;5:504–12. doi: 10.1016/j.jcin.2012.12.125.
    1. Shahar L, Džavík V. Biodegradable Stent Platforms: Are We Heading in the Right Direction? Can J Cardiol. 2015;8:957–9.
    1. Milewski K, Gorycki B, Buszman PP, Jelonek M, Beaudry D, Lapointe JM, et al. Vascular response and mechanical integrity of the new biodegradable polymer coated sirolimus-eluting PROLIM stent implanted in porcine coronary arteries. Kardiol Pol. 2012;7:703–11.
    1. Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD, et al. Third universal definition of myocardial infarction. Circulation. 2012;16:2020–35. doi: 10.1161/CIR.0b013e31826e1058.
    1. Vranckx P, Kint PP, Morel MA, Van Es GA, Serruys PW, Cutlip DE. Identifying stent thrombosis, a critical appraisal of the academic research consortium (ARC) consensus definitions: a lighthouse and as a toe in the water. EuroIntervention. 2008;4(Suppl C):C39-44.
    1. Bil J, Gil RJ, Vassilev D, Rzezak J, Kulawik T, Pawlowski T. Dedicated bifurcation paclitaxel-eluting stent BiOSS Expert(R) in the treatment of distal left main stem stenosis. J Interv Cardiol. 2014;3:242–51. doi: 10.1111/joic.12119.
    1. Pawlowski T, Prati F, Kulawik T, Ficarra E, Bil J, Gil R. Optical coherence tomography criteria for defining functional severity of intermediate lesions: a comparative study with FFR. Int J Cardiovasc Imaging. 2013;8:1685–91. doi: 10.1007/s10554-013-0283-x.
    1. Ali ZA, Roleder T, Narula J, Mohanty BD, Baber U, Kovacic JC, et al. Increased thin-cap neoatheroma and periprocedural myocardial infarction in drug-eluting stent restenosis: multimodality intravascular imaging of drug-eluting and bare-metal stents. Circ Cardiovasc Interv. 2013;5:507–17. doi: 10.1161/CIRCINTERVENTIONS.112.000248.
    1. Nagoshi R, Shinke T, Otake H, Shite J, Matsumoto D, Kawamori H, et al. Qualitative and quantitative assessment of stent restenosis by optical coherence tomography: comparison between drug-eluting and bare-metal stents. Circ J. 2013;3:652–60. doi: 10.1253/circj.CJ-12-0610.
    1. Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, et al. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial. Lancet. 2008;9644:1163–73. doi: 10.1016/S0140-6736(08)61244-1.
    1. Zhang Q, Qiu JP, Kirtane AJ, Zhu TQ, Zhang RY, Yang ZK, et al. Comparison of biodegradable polymer versus durable polymer sirolimus-eluting stenting in patients with acute st-elevation myocardial infarction undergoing primary percutaneous coronary intervention: results of the RESOLVE study. J Interv Cardiol. 2014;2:131–41. doi: 10.1111/joic.12102.
    1. Dani S, Kukreja N, Parikh P, Joshi H, Prajapati J, Jain S, et al. Biodegradable-polymer-based, sirolimus-eluting Supralimus stent: 6-month angiographic and 30-month clinical follow-up results from the series I prospective study. EuroIntervention. 2008;1:59–63. doi: 10.4244/EIJV4I1A11.
    1. Han Y, Jing Q, Chen X, Wang S, Ma Y, Liu H, et al. Long-term clinical, angiographic, and intravascular ultrasound outcomes of biodegradable polymer-coated sirolimus-eluting stents. Catheter Cardiovasc Interv. 2008;2:177–83. doi: 10.1002/ccd.21600.
    1. Waltenberger J, Brachmann J, van der Heyden J, Richardt G, Frobert O, Seige M, et al.: Real-world experience with a novel biodegradable polymer sirolimus-eluting stent: twelve-month results of the BIOFLOW-III registry. In PubMed there is: EuroIntervention. 2015 Mar 17;10(11). pii: 20140318-06. doi: 10.4244/EIJY15M03_08.
    1. Windecker S, Haude M, Neumann FJ, Stangl K, Witzenbichler B, Slagboom T, et al. Comparison of a novel biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: results of the randomized BIOFLOW-II trial. Circ Cardiovasc Interv. 2015;2 doi: 10.1161/CIRCINTERVENTIONS.114.001441.
    1. Byrne RA, Kastrati A, Kufner S, Massberg S, Birkmeier KA, Laugwitz KL, et al. Randomized, non-inferiority trial of three limus agent-eluting stents with different polymer coatings: the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST-4) Trial. Eur Heart J. 2009;20:2441–9. doi: 10.1093/eurheartj/ehp352.
    1. Mehilli J, Byrne RA, Wieczorek A, Iijima R, Schulz S, Bruskina O, et al. Randomized trial of three rapamycin-eluting stents with different coating strategies for the reduction of coronary restenosis. Eur Heart J. 2008;16:1975–82. doi: 10.1093/eurheartj/ehn253.
    1. Pache J, Kastrati A, Mehilli J, Schuhlen H, Dotzer F, Hausleiter J, et al. Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO-2) trial. J Am Coll Cardiol. 2003;8:1283–8. doi: 10.1016/S0735-1097(03)00119-0.
    1. Rittersma SZ, de Winter RJ, Koch KT, Bax M, Schotborgh CE, Mulder KJ, et al. Impact of strut thickness on late luminal loss after coronary artery stent placement. Am J Cardiol. 2004;4:477–80. doi: 10.1016/j.amjcard.2003.10.049.
    1. Colmenarez H, Fernandez C, Escaned J. Impact of technological developments in drug-eluting stents on patient-focused outcomes: a pooled direct and indirect comparison of randomised trials comparing first- and second-generation drug-eluting stents. EuroIntervention. 2014;8:942–52. doi: 10.4244/EIJV10I8A161.
    1. Naidu SS, Krucoff MW, Rutledge DR, Mao VW, Zhao W, Zheng Q, et al. Contemporary incidence and predictors of stent thrombosis and other major adverse cardiac events in the year after XIENCE V implantation: results from the 8,061-patient XIENCE V United States study. J Am Coll Cardiol Intv. 2012;6:626–35. doi: 10.1016/j.jcin.2012.02.014.
    1. Zhu L, Lv YN, Wang LY. Stent thrombosis with biodegradable polymer drug-eluting stents versus durable polymer sirolimus-eluting stents: an update meta-analysis. Cardiology. 2015;2:96–105.
    1. Lv J, Wu Y, Zhang X, Jing T, Zhang L, Tong S, et al. Comparison of the safety and efficacy of biodegradable polymer drug-eluting stents versus durable polymer drug-eluting stents: a meta-analysis. Eur J Med Res. 2015;1:21. doi: 10.1186/s40001-015-0110-z.
    1. Commandeur S, van Beusekom HM, van der Giessen WJ. Polymers, drug release, and drug-eluting stents. J Interv Cardiol. 2006;6:500–6. doi: 10.1111/j.1540-8183.2006.00198.x.
    1. Gutierrez-Chico JL, Juni P, Garcia-Garcia HM, Regar E, Nuesch E, Borgia F, et al. Long-term tissue coverage of a biodegradable polylactide polymer-coated biolimus-eluting stent: comparative sequential assessment with optical coherence tomography until complete resorption of the polymer. Am Heart J. 2011;5:922–31. doi: 10.1016/j.ahj.2011.09.005.
    1. Gutierrez-Chico JL, van Geuns RJ, Regar E, van der Giessen WJ, Kelbaek H, Saunamaki K, et al. Tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent vs. a fluoropolymer-coated everolimus-eluting stent at 13-month follow-up: an optical coherence tomography substudy from the RESOLUTE All Comers trial. Eur Heart J. 2011;19:2454–63. doi: 10.1093/eurheartj/ehr182.
    1. Barlis P, Regar E, Serruys PW, Dimopoulos K, van der Giessen WJ, van Geuns RJ, et al. An optical coherence tomography study of a biodegradable vs. durable polymer-coated limus-eluting stent: a LEADERS trial sub-study. Eur Heart J. 2010;2:165–76. doi: 10.1093/eurheartj/ehp480.
    1. Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, et al. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation. 2007;18:2435–41. doi: 10.1161/CIRCULATIONAHA.107.693739.
    1. Kim BK, Ha J, Mintz GS, Kim JS, Shin DH, Ko YG, et al. Randomised comparison of strut coverage between Nobori biolimus-eluting and sirolimus-eluting stents: an optical coherence tomography analysis. EuroIntervention. 2014;12:1389–97. doi: 10.4244/EIJV9I12A236.
    1. Davlouros PA, Mavronasiou E, Xanthopoulou I, Karantalis V, Tsigkas G, Hahalis G, et al. An optical coherence tomography study of two new generation stents with biodegradable polymer carrier, eluting paclitaxel vs. biolimus-A9. Int J Cardiol. 2012;3:341–6. doi: 10.1016/j.ijcard.2010.12.072.
    1. Adriaenssens T, Ughi GJ, Dubois C, De Cock D, Onsea K, Bennett J, et al. STACCATO (Assessment of Stent sTrut Apposition and Coverage in Coronary ArTeries with Optical coherence tomography in patients with STEMI, NSTEMI and stable/unstable angina undergoing everolimus vs. biolimus A9-eluting stent implantation): a randomised controlled trial. EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2014;20130911–03. doi: 10.4244/EIJY14M11_11.
    1. Kim JS, Lee JH, Shin DH, Kim BK, Ko YG, Choi D, et al. Long-term outcomes of neointimal hyperplasia without neoatherosclerosis after drug-eluting stent implantation. JACC Cardiovasc Imaging. 2014;8:788–95. doi: 10.1016/j.jcmg.2014.05.004.
    1. Kim JS, Afari ME, Ha J, Tellez A, Milewski K, Conditt G, et al. Neointimal patterns obtained by optical coherence tomography correlate with specific histological components and neointimal proliferation in a swine model of restenosis. Eur Heart J Cardiovasc Imaging. 2014;3:292–8. doi: 10.1093/ehjci/jet162.
    1. D’Ascenzo F, Barbero U, Cerrato E, Lipinski MJ, Omede P, Montefusco A, et al. Accuracy of intravascular ultrasound and optical coherence tomography in identifying functionally significant coronary stenosis according to vessel diameter: A meta-analysis of 2,581 patients and 2,807 lesions. Am Heart J. 2015;5:663–73. doi: 10.1016/j.ahj.2015.01.013.
    1. Zhang L, Li Y, Jing QM, Wang XZ, Ma YY, Wang G, et al. Dual antiplatelet therapy over 6 months increases the risk of bleeding after biodegradable polymer-coated sirolimus eluting stents implantation: insights from the CREATE study. J Interv Cardiol. 2014;2:119–26. doi: 10.1111/joic.12104.

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel