Vol 25, No 4 (2018)
Original articles — Interventional cardiology
Published online: 2017-11-14
Evaluation of bioresorbable vascular scaffolds in acute coronary syndrome: A two-center, one-year follow-up analysis
Abstract
Background: Bioresorbable vascular scaffolds (BVS) have emerged as a new treatment option in cardiovascular medicine. Nonetheless, there is still limited data on the use of these novel devices in patients with acute coronary syndromes (ACS). The purpose of this study was to evaluate the feasibility and efficacy of BVS implantation in patients with ACS.
Methods: The present report is a prospective, two-center registry that involved 165 consecutive patients hospitalized with the diagnosis of ACS and treated with the Absorb BVS (Abbot Vascular, Santa Clara, USA). During 1-year, all patients were monitored for the following endpoints: death, myocardial infarction (MI), scaffold thrombosis (ST), target lesion revascularization (TLR), target vessel revascularization (TVR) and target vessel failure (TVF), defined as cardiac death, target vessel MI, and TVR.
Results: A total of 165 patients underwent 179 BVS implantations. 94 patients were diagnosed with unstable angina (UA; 57.6%), 45 with non-ST-segment elevation myocardial infarction (NSTEMI; 27.3%) and 26 with ST-segment elevation myocardial infarction (STEMI; 15.7%). Procedural success was achieved in all patients with thrombolysis in myocardial infarction flow 3. During a follow-up of 14.1 ± 8.5 months (median 12.4 months, IQR 8.7 [8.4 to 12.1] months) death occurred in 4 (2.4%) patients, including 2 (1.3%) cardiac deaths. There was only 1 case of subacute ST (0.66%), without late ST. The incidence of MI, TLR, TVR and TVF were: 2.65%, 2.65%, 7.95%, 9.3%, respectively.
Conclusions: The present results suggest that BVS implantation in ACS patients is feasible and safe in
highly experienced centers. One-year clinical results are encouraging with a low rate of stent thrombosis.
Keywords: acute coronary syndromeacute myocardial infarctionSTEMINSTEMIangiographycoronarybioresorbable devices/polymers
References
- Stefanini GG, Holmes DR. Drug-eluting coronary-artery stents. N Engl J Med. 2013; 368(3): 254–265.
- Lüscher TF, Steffel J, Eberli FR, et al. Drug-eluting stent and coronary thrombosis: biological mechanisms and clinical implications. Circulation. 2007; 115(8): 1051–1058.
- Nakazawa G, Otsuka F, Nakano M, et al. The pathology of neoatherosclerosis in human coronary implants bare-metal and drug-eluting stents. J Am Coll Cardiol. 2011; 57(11): 1314–1322.
- Spaulding C, Henry P, Teiger E, et al. TYPHOON Investigators. Sirolimus-eluting versus uncoated stents in acute myocardial infarction. N Engl J Med. 2006; 355(11): 1093–1104.
- Stone GW, Lansky AJ, Pocock SJ, et al. HORIZONS-AMI Trial Investigators. Paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction. N Engl J Med. 2009; 360(19): 1946–1959.
- Brar SS, Leon MB, Stone GW, et al. Use of drug-eluting stents in acute myocardial infarction: a systematic review and meta-analysis. J Am Coll Cardiol. 2009; 53(18): 1677–1689.
- Serruys PW, Garcia-Garcia HM, Onuma Y. From metallic cages to transient bioresorbable scaffolds: change in paradigm of coronary revascularization in the upcoming decade? Eur Heart J. 2012; 33(1): 16–25.
- Ormiston JA, Serruys PW, Onuma Y, et al. First serial assessment at 6 months and 2 years of the second generation of absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study. Circ Cardiovasc Interv. 2012; 5(5): 620–632.
- Dudek D, Onuma Y, Ormiston JA, et al. Four-year clinical follow-up of the ABSORB everolimus-eluting bioresorbable vascular scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention. 2012; 7(9): 1060–1061.
- Serruys PW, Onuma Y, Dudek D, et al. Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes. J Am Coll Cardiol. 2011; 58(15): 1578–1588.
- Onuma Y, Serruys PW, Ormiston JA, et al. Three-year results of clinical follow-up after a bioresorbable everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention. 2010; 6(4): 447–453.
- Diletti R, Farooq V, Girasis C, et al. Clinical and intravascular imaging outcomes at 1 and 2 years after implantation of absorb everolimus eluting bioresorbable vascular scaffolds in small vessels. Late lumen enlargement: does bioresorption matter with small vessel size? Insight from the ABSORB cohort B trial. Heart. 2013; 99(2): 98–105.
- Serruys PW, Onuma Y, Garcia-Garcia HM, et al. Dynamics of vessel wall changes following the implantation of the absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study at 6, 12, 24 and 36 months. EuroIntervention. 2014; 9(11): 1271–1284.
- Kolandaivelu K, Swaminathan R, Gibson WJ, et al. Stent thrombogenicity early in high-risk interventional settings is driven by stent design and deployment and protected by polymer-drug coatings. Circulation. 2011; 123(13): 1400–1409.
- Pan M, Romero M, Ojeda S, et al. Fracture of bioresorbable vascular scaffold after side-branch balloon dilation in bifurcation coronary narrowings. Am J Cardiol. 2015; 116(7): 1045–1049.
- Lesiak M, Araszkiewicz A. "Leaving nothing behind": is the bioresorbable vascular scaffold a new hope for patients with coronary artery disease? Post Kardiol Interw. 2014; 10(4): 283–288.
- Onuma Y, Serruys PW, Perkins LEL, et al. Intracoronary optical coherence tomography and histology at 1 month and 2, 3, and 4 years after implantation of everolimus-eluting bioresorbable vascular scaffolds in a porcine coronary artery model: an attempt to decipher the human optical coherence tomography images in the ABSORB trial. Circulation. 2010; 122(22): 2288–2300.
- Thygesen K, Alpert JS, Jaffe AS, et al. Third Universal Definition of Myocardial Infarction. Circulation. 2012; 126(16): 2020–2035.
- Laskey WK, Yancy CW, Maisel WH. Thrombosis in coronary drug-eluting stents: report from the meeting of the Circulatory System Medical Devices Advisory Panel of the Food and Drug Administration Center for Devices and Radiologic Health, December 7-8, 2006. Circulation. 2007; 115(17): 2352–2357.
- Cutlip DE, Windecker S, Mehran R, et al. Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007; 115(17): 2344–2351.
- Hong MK, Mintz GS, Lee CW, et al. Late stent malapposition after drug-eluting stent implantation: an intravascular ultrasound analysis with long-term follow-up. Circulation. 2006; 113(3): 414–419.
- Tamburino C, Latib A, van Geuns RJ, et al. Contemporary practice and technical aspects in coronary intervention with bioresorbable scaffolds: a European perspective. EuroIntervention. 2015; 11(1): 45–52.
- Diletti R, Karanasos A, Muramatsu T, et al. Everolimus-eluting bioresorbable vascular scaffolds for treatment of patients presenting with ST-segment elevation myocardial infarction: BVS STEMI first study. Eur Heart J. 2014; 35(12): 777–786.
- Kočka V, Malý M, Toušek P, et al. Bioresorbable vascular scaffolds in acute ST-segment elevation myocardial infarction: a prospective multicentre study 'Prague 19'. Eur Heart J. 2014; 35(12): 787–794.
- Serruys PW, Ormiston JA, Onuma Y, et al. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet. 2009; 373(9667): 897–910.
- Onuma Y, Dudek D, Thuesen L, et al. Five-year clinical and functional multislice computed tomography angiographic results after coronary implantation of the fully resorbable polymeric everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB cohort A trial. JACC Cardiovasc Interv. 2013; 6(10): 999–1009.
- Serruys PW, Chevalier B, Dudek D, et al. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial. Lancet. 2015; 385(9962): 43–54.
- Serruys PW, Chevalier B, Sotomi Y, et al. Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): a 3 year, randomised, controlled, single-blind, multicentre clinical trial. Lancet. 2016; 388(10059): 2479–2491.
- Wykrzykowska J, Kraak R, Hofma S, et al. Bioresorbable scaffolds versus metallic stents in routine PCI. N Engl J Med. 2017; 376(24): 2319–2328.
- Capodanno D, Gori T, Nef H, et al. Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: early and midterm outcomes from the European multicentre GHOST-EU registry. EuroIntervention. 2015; 10(10): 1144–1153.
- Puricel S, Cuculi F, Weissner M, et al. Bioresorbable coronary scaffold thrombosis: multicenter comprehensive analysis of clinical presentation, mechanisms, and predictors. J Am Coll Cardiol. 2016; 67(8): 921–931.
- Kolandaivelu K, Swaminathan R, Gibson WJ, et al. Stent thrombogenicity early in high-risk interventional settings is driven by stent design and deployment and protected by polymer-drug coatings. Circulation. 2011; 123(13): 1400–1409.
- Rzeszutko Ł, Siudak Z, Włodarczak A, et al. Use of bioresorbable vascular scaffolds in patients with stable angina and acute coronary syndromes. Polish National Registry. Kardiol Pol. 2014; 72(12): 1394–1399.
- Dudek D, Rzeszutko Ł, Zasada W, et al. Bioresorbable vascular scaffolds in patients with acute coronary syndromes: the POLAR ACS study. Pol Arch Med Wewn. 2014; 124(12): 669–677.
- Räber L, Kelbæk H, Ostojic M, et al. Effect of biolimus-eluting stents with biodegradable polymer vs bare-metal stents on cardiovascular events among patients with acute myocardial infarction: the COMFORTABLE AMI randomized trial. JAMA. 2012; 308(8): 777–787.
- Kang WC, Ahn T, Lee K, et al. Comparison of zotarolimus-eluting stents versus sirolimus-eluting stents versus paclitaxel-eluting stents for primary percutaneous coronary intervention in patients with ST-elevation myocardial infarction: results from the Korean Multicentre Endeavor (KOMER) acute myocardial infarction (AMI) trial. EuroIntervention. 2011; 7(8): 936–943.
- Palmerini T, Genereux P, Caixeta A, et al. Prognostic value of the SYNTAX score in patients with acute coronary syndromes undergoing percutaneous coronary intervention: analysis from the ACUITY (Acute Catheterization and Urgent Intervention Triage StrategY) trial. J Am Coll Cardiol. 2011; 57(24): 2389–2397.
- Dvir D, Barbash IM, Torguson R, et al. Clinical outcomes after treating acute coronary syndrome patients with a drug-eluting stent: results from REWARDS-EMI (Endeavor for Myocardial Infarction Registry). Cardiovasc Revasc Med. 2013; 14(3): 128–133.
- Sabate M, Cequier A, Iñiguez A, et al. Everolimus-eluting stent versus bare-metal stent in ST-segment elevation myocardial infarction (EXAMINATION): 1 year results of a randomised controlled trial. Lancet. 2012; 380(9852): 1482–1490.
- Gori T, Schulz E, Hink U, et al. Clinical, angiographic, functional, and imaging outcomes 12 months after implantation of drug-eluting bioresorbable vascular scaffolds in acute coronary syndromes. JACC Cardiovasc Interv. 2015; 8(6): 770–777.
- Imori Y, D'Ascenzo F, Gori T, et al. Impact of postdilatation on performance of bioresorbable vascular scaffolds in patients with acute coronary syndrome compared with everolimus-eluting stents: A propensity score-matched analysis from a multicenter "real-world" registry. Cardiol J. 2016; 23(4): 374–383.
