Safety and effectiveness of the self-aPposing, bAlloon-delivered, siRolimus-eluting stent for the Treatment of the coronary Artery disease: SPARTA, a multicenter experience.


Journal

Coronary artery disease
ISSN: 1473-5830
Titre abrégé: Coron Artery Dis
Pays: England
ID NLM: 9011445

Informations de publication

Date de publication:
01 2020
Historique:
pubmed: 29 10 2019
medline: 25 6 2021
entrez: 29 10 2019
Statut: ppublish

Résumé

To assess the long-term outcomes of patients treated with sirolimus-eluting Stentys stent in a real-life setting. Few data regarding the safety and effectiveness of self-apposing sirolimus-eluting Stentys stent are available. 278 patients (30% stable coronary artery disease, 70% acute coronary syndromes, and 54% on unprotected left main) treated with sirolimus eluting Stentys stent were retrospectively included in the self-aPposing, bAlloon-delivered, siRolimus-eluting stent for the Treatment of the coronary Artery disease multicenter registry. Major adverse cardiovascular events (MACE, a composite of cardiac death, myocardial infarction, target lesion revascularization, stent thrombosis) were the primary end-point, single components of MACE were the secondary ones. After 13 months (interquartile range 5-32), MACE was 14%. Stent thrombosis occurred in 3.9% of the patients (2.5% definite stent thrombosis and 1.4% probable stent thrombosis), 66% of them presenting with ST-segment elevation myocardial infarction (STEMI) at admission. Cardiovascular death, target lesion revascularization and myocardial infarction was 4.7%, 8.3%, and 7.2%, respectively. At multivariate analysis, risk of MACE was increased by diabetes (hazard ratios 4.76; P = 0.002) but was not affected by the indication leading to sirolimus-eluting Stentys stent implantation (marked vessel tapering vs. coronary ecstasies, hazard ratios 0.74, P = 0.71). Sirolimus-eluting Stentys stent may represent a potential solution for specific coronary anatomies such as bifurcation, ectasic, or tapered vessels. Risk of stent thrombosis appears related to clinical presentation with STEMI and to anatomic features, stressing the importance of the use of intracoronary imaging for self-expandable stents implantation.

Sections du résumé

AIMS
To assess the long-term outcomes of patients treated with sirolimus-eluting Stentys stent in a real-life setting.
BACKGROUND
Few data regarding the safety and effectiveness of self-apposing sirolimus-eluting Stentys stent are available.
METHODS
278 patients (30% stable coronary artery disease, 70% acute coronary syndromes, and 54% on unprotected left main) treated with sirolimus eluting Stentys stent were retrospectively included in the self-aPposing, bAlloon-delivered, siRolimus-eluting stent for the Treatment of the coronary Artery disease multicenter registry. Major adverse cardiovascular events (MACE, a composite of cardiac death, myocardial infarction, target lesion revascularization, stent thrombosis) were the primary end-point, single components of MACE were the secondary ones.
RESULTS
After 13 months (interquartile range 5-32), MACE was 14%. Stent thrombosis occurred in 3.9% of the patients (2.5% definite stent thrombosis and 1.4% probable stent thrombosis), 66% of them presenting with ST-segment elevation myocardial infarction (STEMI) at admission. Cardiovascular death, target lesion revascularization and myocardial infarction was 4.7%, 8.3%, and 7.2%, respectively. At multivariate analysis, risk of MACE was increased by diabetes (hazard ratios 4.76; P = 0.002) but was not affected by the indication leading to sirolimus-eluting Stentys stent implantation (marked vessel tapering vs. coronary ecstasies, hazard ratios 0.74, P = 0.71).
CONCLUSION
Sirolimus-eluting Stentys stent may represent a potential solution for specific coronary anatomies such as bifurcation, ectasic, or tapered vessels. Risk of stent thrombosis appears related to clinical presentation with STEMI and to anatomic features, stressing the importance of the use of intracoronary imaging for self-expandable stents implantation.

Identifiants

pubmed: 31658146
doi: 10.1097/MCA.0000000000000790
pii: 00019501-202001000-00005
doi:

Substances chimiques

Antibiotics, Antineoplastic 0
Sirolimus W36ZG6FT64

Types de publication

Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

27-34

Références

Wijns W, Kolh P, Danchin N, Di Mario C, Falk V, Folliguet T, et al. Task force on myocardial revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS), European Association for Percutaneous Cardiovascular Interventions (EAPCI). Guidelines on myocardial revascularization. Eur Heart J. 2010; 31:2501–2555
Iannaccone M, Barbero U, D’ascenzo F, Latib A, Pennacchi M, Rossi ML, et al. Rotational atherectomy in very long lesions: results for the ROTATE registry. Catheter Cardiovasc Interv. 2016; 88:E164–E172
D’Ascenzo F, Chieffo A, Cerrato E, Ugo F, Pavani M, Kawamoto H, et al. Incidence and management of restenosis after treatment of unprotected left main disease with second-generation drug-eluting stents (from failure in left main study with 2nd generation stents-cardiogroup III study). Am J Cardiol. 2017; 119:978–982
van der Hoeven BL, Liem SS, Jukema JW, Suraphakdee N, Putter H, Dijkstra J, 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; 51:618–626
Cook S, Eshtehardi P, Kalesan B, Räber L, Wenaweser P, Togni M, et al. Impact of incomplete stent apposition on long-term clinical outcome after drug-eluting stent implantation. Eur Heart J. 2012; 33:1334–1343
D’Ascenzo F, Bollati M, Clementi F, Castagno D, Lagerqvist B, de la Torre Hernandez JM, et al. Incidence and predictors of coronary stent thrombosis: evidence from an international collaborative meta-analysis including 30 studies, 221,066 patients, and 4276 thromboses. Int J Cardiol. 2013; 167:575–584
Kim YS, Koo BK, Seo JB, Park KW, Suh JW, Lee HY, et al. The incidence and predictors of postprocedural incomplete stent apposition after angiographically successful drug-eluting stent implantation. Catheter Cardiovasc Interv. 2009; 74:58–63
van Werkum JW, Heestermans AA, Zomer AC, Kelder JC, Suttorp MJ, Rensing BJ, et al. Predictors of coronary stent thrombosis: the Dutch stent thrombosis registry. J Am Coll Cardiol. 2009; 53:1399–1409
Cheneau E, Leborgne L, Mintz GS, Kotani J, Pichard AD, Satler LF, et al. Predictors of subacute stent thrombosis: results of a systematic intravascular ultrasound study. Circulation. 2003; 108:43–47
Pyxaras SA, Schmitz T, Naber CK. The STENTYS self-apposing® stent. Eurointervention. 2015; 11Suppl VV147–V148
Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, et al.; ESC Scientific Document Group. 2015 ESC guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: task force for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016; 37:267–315
Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, et al. 2014 ESC/EACTS guidelines on myocardial revascularization. Eur Heart J. 2014; 35:2541–2619
Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD, et al.; Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction. Third universal definition of myocardial infarction. Circulation. 2012; 126:2020–2035
Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, et al.; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007; 115:2344–2351
Montefusco A, Scacciatella P, Omedè P, D’Ascenzo F, Gaita F, Moretti C. Never underestimate the comeback kid; a case report of very early side branch occlusion after Stentys exposition implantation without kissing balloon. Int J Cardiol. 2016; 215:502–503
Williams DO, Abbott JD, Kip KE; DEScover Investigators. Outcomes of 6906 patients undergoing percutaneous coronary intervention in the era of drug-eluting stents: report of the descover registry. Circulation. 2006; 114:2154–2162
Saia F, Piovaccari G, Manari A, Santarelli A, Benassi A, Aurier E, et al. Clinical outcomes for sirolimus-eluting stents and polymer-coated paclitaxel-eluting stents in daily practice: results from a large multicenter registry. J Am Coll Cardiol. 2006; 48:1312–1318
Amoroso G, van Geuns RJ, Spaulding C, Manzo-Silberman S, Hauptmann KE, Spaargaren R, et al. Assessment of the safety and performance of the STENTYS self-expanding coronary stent in acute myocardial infarction: results from the APPOSITION I study. Eurointervention. 2011; 7:428–436
van Geuns RJ, Tamburino C, Fajadet J, Vrolix M, Witzenbichler B, Eeckhout E, 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; 5:1209–1219
Koch KT, Grundeken MJ, Vos NS, IJsselmuiden AJ, van Geuns RJ, Wessely R, 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; 11:264–271
van Geuns RJ, Yetgin T, La Manna A, Tamburino C, Souteyrand G, Motreff P, et al. STENTYS self-apposing sirolimus-eluting stent in ST-segment elevation myocardial infarction: results from the randomised APPOSITION IV trial. Eurointervention. 2016; 11:e1267–e1274
Gaede L, Liebetrau C, Dörr O, Blumenstein J, Elsässer A, Hamm CW, et al. Long-term clinical outcome after implantation of the self-expandable STENTYS stent in a large, multicenter cohort. Coron Artery Dis. 2017; 28:588–596
Buccheri S, Franchina G, Romano S, Puglisi S, Venuti G, D’Arrigo P, et al. Clinical outcomes following intravascular imaging-guided versus coronary angiography-guided percutaneous coronary intervention with stent implantation: a systematic review and bayesian network meta-analysis of 31 studies and 17,882 patients. JACC Cardiovasc Interv. 2017; 10:2488–2498
D’Ascenzo F, Barbero U, Cerrato E, Lipinski MJ, Omedè 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; 169:663–673
Pastormerlo LE, Ciardetti M, Coceani M, Trianni G, Ravani M, Vaghetti M, et al. Self-expanding stent for complex percutaneous coronary interventions: a real life experience. Cardiovasc Revasc Med. 2016; 17:186–189
Briguori C, Visconti G, Donahue M, Focaccio A, Mitomo S, Kawamoto H, Nakamura S. The STENTYS® paclitaxel-eluting stent in the treatment of unprotected distal left main. Catheter Cardiovasc Interv. 2015; 86:E131–E139
Naber CK, Pyxaras SA, Nef H, IJsselmuiden AJ, Briguori C, Schlundt C, et al. Final results of a self-apposing paclitaxel-eluting stent for the percutaneous treatment of de novo lesions in native bifurcated coronary arteries study. Eurointervention. 2016; 12:356–358

Auteurs

Antonio Montefusco (A)

Department of Medical Sciences, Division of Cardiology, AOU Città della Salute e della Scienza, University of Turin, Turin.

Ovidio De Filippo (O)

Department of Medical Sciences, Division of Cardiology, AOU Città della Salute e della Scienza, University of Turin, Turin.

Sebastiano Gili (S)

Department of Medical Sciences, Division of Cardiology, AOU Città della Salute e della Scienza, University of Turin, Turin.

Massimo Mancone (M)

Department of Cardiovascular, Respiratory, Nephrologic, Anesthesiological and Geriatric Sciences, Sapienza University of Rome, Policlinico Umberto I, Rome.

Simone Calcagno (S)

Department of Cardiovascular, Respiratory, Nephrologic, Anesthesiological and Geriatric Sciences, Sapienza University of Rome, Policlinico Umberto I, Rome.

Plinio Cirillo (P)

Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples.

Giovanni Esposito (G)

Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples.

Arnaldo Poli (A)

Division of Cardiology, Ospedale Civile di Legnano - ASST Ovest Mi, Legnano, Italy.

Erika Ferrara (E)

Division of Cardiology, Ospedale Civile di Legnano - ASST Ovest Mi, Legnano, Italy.

Grzegorz Smolka (G)

Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.

Wojciech Wanha (W)

Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.

Cataldo Palmieri (C)

Fondazione Monasterio CNR-Regione Toscana, Massa, Italy.

Luigi Emilio Pastormerlo (LE)

Fondazione Monasterio CNR-Regione Toscana, Massa, Italy.

Andreas Baumbach (A)

Queen Mary University London and Barts Heart Centre, London, UK.

Paolo Sganzerla (P)

Division of Cardiology, AO Ospedale Treviglio-Caravaggio, Treviglio.

Corrado Tamburino (C)

Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania.

Francesco Bruno (F)

Department of Medical Sciences, Division of Cardiology, AOU Città della Salute e della Scienza, University of Turin, Turin.

Gioel Gabrio Secco (GG)

Interventional Cardiology, Santi Antonio, Biagio e Cesare Arrigo Hospital, Alessandria.

Annamaria Nicolino (A)

Division of Cardiology, Santa Corona Hospital, Pietra Ligure, Italy.

Kuang Leon Yew (KL)

Cardiology Department, Manipal Hospital, Klang, Selangor, Malaysia.

Gaetano di Palma (G)

Department of Interventional Cardiology, ASST Fatebenefratelli-Sacco, Milano, Italy.

Wojciech Wojakowski (W)

Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.

Gennaro Sardella (G)

Department of Cardiovascular, Respiratory, Nephrologic, Anesthesiological and Geriatric Sciences, Sapienza University of Rome, Policlinico Umberto I, Rome.

Mauro Rinaldi (M)

Department of Medical Sciences, Division of Cardiology, AOU Città della Salute e della Scienza, University of Turin, Turin.

Bernardo Cortese (B)

Fondazione Monasterio CNR-Regione Toscana, Massa, Italy.
Department of Interventional Cardiology, ASST Fatebenefratelli-Sacco, Milano, Italy.

Fabrizio D'Ascenzo (F)

Department of Medical Sciences, Division of Cardiology, AOU Città della Salute e della Scienza, University of Turin, Turin.

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