Long-term clinical results of biodegradable vascular scaffold ABSORB BVS™ using the PSP-technique in patients with acute coronary syndrome
Abstract
Background: The PSP (predilatation, sizing, post-dilatation)-technique was developed to improve the prognosis of patients after bioresorbable vascular scaffold (BVS) implantation. In acute coronary syndrome (ACS) the use of BVS is particularly demanding and carries some potential risk regarding aggressive lesion preparation, proper vessel sizing due to spasm and thrombus inside the artery. The aim herein, was to determine the long-term results of BVS stenting in ACS patients depending on the scaffold implantation technique.
Methods: The present study is a prospective, two-center study, which consisted of 182 patients who underwent percutaneous coronary intervention (PCI) with BVS (Absorb, Abbott Vascular, Santa Clara, California, USA) implantation for the ACS. All patients were divided into two groups. The first consisted of 52 patients treated with the PSP-technique (PSP group). The second group enrolled 130 patients treated with a non-PSP procedure (non-PSP group).
Results: The procedure was successful in all patients. The mean observation time was 28.8 ± 16.5 months (median 28.3 months, interquartile range 24.0 [17.0–41.0] months). It was found that target vessel failure (TVF) was consistently reduced in patients using the PSP-technique as compared with the non-PSP group (5.8% vs. 17.7%, p = 0.03). Moreover, PSP-technique was superior to non-PSP-technique concerning major adverse cardiac events (MACE) (3.7% vs. 22.3%, p = 0.02). Logistic regression analysis revealed that the use of PSP technique significantly decreased the risk of target vessel revascularization (odds ratio [OR] 0.11, p = 0.01), TVF (OR 0.28, p = 0.03) and MACE (OR 0.29, p = 0.02).
Conclusions: The PSP-technique for BVS implantation improves long-term results and should also be recommended for newer generations of the bioresorbable scaffold.
Keywords: acute coronary syndromeacute myocardial infarctionSTEMINSTEMIangiographycoronarybioresorbable devices/polymers
References
- Giacchi G, Ortega-Paz L, Brugaletta S, et al. Bioresorbable vascular scaffold implantation in acute coronary syndromes: clinical evidence, tips and tricks. Postepy Kardiol Interwencyjnej. 2015; 11(3): 161–169.
- Gomez-Lara J, Brugaletta S, Jacobi F, et al. Five-Year optical coherence tomography in patients with ST-segment-elevation myocardial infarction treated with bare-metal versus everolimus-eluting stents. Circ Cardiovasc Interv. 2016; 9(10).
- 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 JJ, Kraak RP, Hofma SH, et al. Bioresorbable Scaffolds versus Metallic Stents in Routine PCI. N Engl J Med. 2017; 376(24): 2319–2328.
- Kereiakes DJ, Ellis SG, Metzger C, et al. 3-year clinical outcomes with everolimus-eluting bioresorbable coronary scaffolds: the absorb III trial. J Am Coll Cardiol. 2017; 70(23): 2852–2862.
- Ali ZA, Serruys PW, Kimura T, et al. 2-year outcomes with the Absorb bioresorbable scaffold for treatment of coronary artery disease: a systematic review and meta-analysis of seven randomised trials with an individual patient data substudy. Lancet. 2017; 390(10096): 760–772.
- 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.
- Ortega-Paz L, Brugaletta S, Sabaté M. Impact of PSP technique on clinical outcomes following bioresorbable scaffolds implantation. J Clin Med. 2018; 7(2).
- De Ribamar Costa J, Abizaid A, Bartorelli AL, et al. Impact of post-dilation on the acute and one-year clinical outcomes of a large cohort of patients treated solely with the Absorb Bioresorbable Vascular Scaffold. EuroIntervention. 2015; 11(2): 141–148.
- Ormiston JA, Serruys PW, Regar E, et al. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet. 2008; 371(9616): 899–907.
- 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. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007; 115(17): 2344–2351.
- Onuma Y, Sotomi Y, Shiomi H, et al. Two-year clinical, angiographic, and serial optical coherence tomographic follow-up after implantation of an everolimus-eluting bioresorbable scaffold and an everolimus-eluting metallic stent: insights from the randomised ABSORB Japan trial. EuroIntervention. 2016; 12(9): 1090–1101.
- 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.
- 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.
- Ortega-Paz L, Capodanno D, Gori T, et al. Predilation, sizing and post-dilation scoring in patients undergoing everolimus-eluting bioresorbable scaffold implantation for prediction of cardiac adverse events: development and internal validation of the PSP score. EuroIntervention. 2017; 12(17): 2110–2117.
- Stone GW, Abizaid A, Onuma Y, et al. Effect of technique on outcomes following bioresorbable vascular scaffold implantation: analysis from the ABSORB trials. J Am Coll Cardiol. 2017; 70(23): 2863–2874.
- 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.
- Absorb Bioresorbable Vascular Scaffold System [Internet]. https://www.vascular.abbott:80/us/products/coronary-intervention/absorb-bioresorbable-scaffold-dissolving-stent.html (cited 2018 Jun 12).
- Everaert B, Felix C, Koolen J, et al. Appropriate use of bioresorbable vascular scaffolds in percutaneous coronary interventions: a recommendation from experienced users : A position statement on the use of bioresorbable vascular scaffolds in the Netherlands. Neth Heart J. 2015; 23(3): 161–165.
- Iwańczyk S, Hiczkiewicz J, Araszkiewicz A, et al. Evaluation of bioresorbable vascular scaffolds in acute coronary syndrome: A two-center, one-year follow-up analysis. Cardiol J. 2018; 25(4): 479–486.
- Ellis SG, Steffenino G, Kereiakes DJ, et al. Clinical, angiographic, and procedural correlates of acute, subacute, and late absorb scaffold thrombosis. JACC Cardiovasc Interv. 2017; 10(18): 1809–1815.
- 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.
- Spaulding C, Henry P, Teiger E, et al. 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. Paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction. N Engl J Med. 2009; 360(19): 1946–1959.
- Tanaka A, Latib A, Kawamoto H, et al. Clinical outcomes of a real-world cohort following bioresorbable vascular scaffold implantation utilising an optimised implantation strategy. EuroIntervention. 2017; 12(14): 1730–1737.
- Wöhrle J, Naber C, Schmitz T, et al. Beyond the early stages: insights from the ASSURE registry on bioresorbable vascular scaffolds. EuroIntervention. 2015; 11(2): 149–156.
- Cortese B, Ielasi A, Moscarella E, et al. Thirty-Day outcomes after unrestricted implantation of bioresorbable vascular scaffold (from the prospective RAI registry). Am J Cardiol. 2017; 119(12): 1924–1930.
- Felix CM, Onuma Y, Fam JM, et al. Are BVS suitable for ACS patients? Support from a large single center real live registry. Int J Cardiol. 2016; 218: 89–97.
- Farag M, Spinthakis N, Gorog DA, et al. Use of bioresorbable vascular scaffold: a meta-analysis of patients with coronary artery disease. Open Heart. 2016; 3(2): e000462.
- Fam JM, Felix C, van Geuns RJ, et al. Initial experience with everolimus-eluting bioresorbable vascular scaffolds for treatment of patients presenting with acute myocardial infarction: a propensity-matched comparison to metallic drug eluting stents 18-month follow-up of the BVS STEMI first study. Eurointervention. 2016; 12(1): 30–37.