A Prospective, observational, Italian multi-center registry of self-aPposing® cOronary Stents in patients presenting with ST-segment Elevation Myocardial InfarcTION: The iPOSITION registry
, 3, 1, 4, 5, 3, 4, 6, 2, 12, 7, 1
Abstract
Background: Primary percutaneous coronary intervention (pPCI) in ST-segment elevation myocardial infarction (STEMI) can be challenging for high thrombus burden and catecholamine-induced vasoconstriction. The Xposition-S stent was designed to prevent stent undersizing and minimize strut malapposition. We evaluated 1-year clinical outcomes of a nitinol, self-apposing®, sirolimus-eluting stent, pre-mounted on a novel balloon delivery system, in de novo lesions of patients presenting with STEMI undergoing pPCI.
Methods: The iPOSITION is a prospective, multicenter, post-market, observational study. The primary endpoint, target lesion failure (TLF), was defined as the composite of cardiac death, recurrent target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR).
Results: The study enrolled 247 STEMI patients from 7 Italian centers. Both device and procedural success occurred in 99.2% of patients, without any death, TV-MI, TLR, or stent thrombosis during the hospital stay and at 30-day follow-up. At 1 year, TLF occurred in 2.6%, cardiac death occurred in 1.7%, TV-MI occurred in 0.4%, and TLR in 0.4% of patients. The 1-year stent thrombosis rate was 0.4%.
Conclusions: The use of an X-position S self-apposing® stent is feasible in STEMI pPCI, with excellent post-procedural results and 1-year outcomes.
Keywords: acute myocardial infarctionST-segment elevation myocardial infarctionclinical trialsself-apposing stentnitinol stentinterventional device/innovationpercutaneous coronary intervention (PCI)complexprimary PCIdrug-eluting stent
References
- Widimsky P, Wijns W, Fajadet J, et al. Reperfusion therapy for ST elevation acute myocardial infarction in Europe: description of the current situation in 30 countries. Eur Heart J. 2010; 31(8): 943–957.
- Neumann FJ, Sousa-Uva M, Ahlsson A, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019; 40(2): 87–165.
- Ibanez B, James S, Agewall S, et al. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST -segment elevation. Eur Hear J. 2018; 39: 119–177.
- Cook S, Windecker S. Early stent thrombosis: past, present, and future. Circulation. 2009; 119(5): 657–659.
- van Werkum JW, Heestermans AA, Zomer AC, et al. Predictors of coronary stent thrombosis: the Dutch Stent Thrombosis Registry. J Am Coll Cardiol. 2009; 53(16): 1399–1409.
- van der Hoeven BL, Liem SS, Jukema JW, et al. Sirolimus-eluting stents versus bare-metal stents in patients with ST-segment elevation myocardial infarction: 9-month angiographic and intravascular ultrasound results and 12-month clinical outcome results from the MISSION! Intervention Study. J Am Coll Cardiol. 2008; 51(6): 618–626.
- Spaulding C, Amoroso G, Verheye S, et al. Assessment of the safety and performance of the stentys self-expanding coronary stent system in acute myocardial infarction. J Am Coll Cardiol. 2010; 55(10): A105.E977.
- van Geuns RJ, Tamburino C, Fajadet J, et al. Self-expanding versus balloon-expandable stents in acute myocardial infarction: results from the APPOSITION II study: self-expanding stents in ST-segment elevation myocardial infarction. JACC Cardiovasc Interv. 2012; 5(12): 1209–1219.
- Lu H, Grundeken MJ, Vos NS, et al. Clinical outcomes with the STENTYS self-apposing coronary stent in patients presenting with ST-segment elevation myocardial infarction: Two-year insights from the APPOSITION III registry. EuroIntervention. 2017; 13: e572–e577.
- Koch KT, Grundeken MJ, Vos NS, et al. One-year clinical outcomes of the STENTYS Self-Apposing¨ coronary stent in patients presenting with ST-segment elevation myocardial infarction: results from the APPOSITION III registry. EuroIntervention. 2015; 11(3): 264–271.
- Hofma SH, Brouwer J, Velders MA, et al. Second-generation everolimus-eluting stents versus first-generation sirolimus-eluting stents in acute myocardial infarction. 1-year results of the randomized XAMI (XienceV Stent vs. Cypher Stent in Primary PCI for Acute Myocardial Infarction) trial. J Am Coll Cardiol. 2012; 60(5): 381–387.
- Tu D, Lu TF, Matter CM, et al. Effect of biolimus-eluting stents with biodegradable polymer vs bare-metal stents. JAMA. 2012; 308: 777–787.
- 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.
- Valgimigli M, Bueno H, Byrne RA, et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS. Eur J Cardio-Thoracic Surg. 2017: 213–254.
- Kimura M, Mintz GS, Carlier S, et al. Outcome after acute incomplete sirolimus-eluting stent apposition as assessed by serial intravascular ultrasound. Am J Cardiol. 2006; 98(4): 436–442.
- Fujii K, Carlier SG, Mintz GS, et al. Stent underexpansion and residual reference segment stenosis are related to stent thrombosis after sirolimus-eluting stent implantation: an intravascular ultrasound study. J Am Coll Cardiol. 2005; 45(7): 995–998.
- Hong MK, Mintz GS, Lee CW, et al. Intravascular ultrasound predictors of angiographic restenosis after sirolimus-eluting stent implantation. Eur Heart J. 2006; 27(11): 1305–1310.
- Cheneau E, Leborgne L, Mintz GS, et al. Predictors of subacute stent thrombosis: results of a systematic intravascular ultrasound study. Circulation. 2003; 108(1): 43–47.
- Corpataux N, Spirito A, Gragnano F, et al. Validation of high bleeding risk criteria and definition as proposed by the academic research consortium for high bleeding risk. Eur Heart J. 2020; 41(38): 3743–3749.
- Svilaas T, Vlaar PJ, van der Horst IC, et al. Thrombus aspiration during primary percutaneous coronary intervention. N Engl J Med. 2008; 358(6): 557–567.
- Fröbert O, Lagerqvist Bo, Olivecrona GK, et al. Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med. 2013; 369(17): 1587–1597.
- Jolly SS, Cairns JA, Yusuf S, et al. TOTAL Investigators. Randomized trial of primary PCI with or without routine manual thrombectomy. N Engl J Med. 2015; 372(15): 1389–1398.
- Dziewierz A, Siudak Z, Rakowski T, et al. Impact of direct stenting on outcome of patients with ST-elevation myocardial infarction transferred for primary percutaneous coronary intervention (from the EUROTRANSFER registry). Catheter Cardiovasc Interv. 2014; 84(6): 925–931.
- Bessonov I, Zyrianov I, Kuznetsov V, et al. TCTAP A-024 comparison of direct stenting versus pre-dilation in ST-elevation myocardial infarction. J Am Coll Cardiol. 2016; 67(16): S10.
- Azzalini L, Millán X, Ly HQ, et al. Direct stenting versus pre-dilation in ST-elevation myocardial infarction: a systematic review and meta-analysis. J Interv Cardiol. 2015; 28(2): 119–131.
- Mahmoud KD, Jolly SS, James S, et al. Clinical impact of direct stenting and interaction with thrombus aspiration in patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention: Thrombectomy Trialists Collaboration. Eur Heart J. 2018; 39(26): 2472–2479.
- Zimarino M, Curzen N, Cicchitti V, et al. The adequacy of myocardial revascularization in patients with multivessel coronary artery disease. Int J Cardiol. 2013; 168(3): 1748–1757.
- Thygesen K, Alpert JS, Jaffe AS, et al. Fourth universal definition of myocardial infarction (2018). Eur Heart J. 2018: 1–33.
- 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.
