Stent Selection for Primary Angioplasty and Outcomes in the Era of Potent Antiplatelets. Data from the Multicenter Randomized Prague-18 Trial

. 2021 Oct 30 ; 10 (21) : . [epub] 20211030

Status PubMed-not-MEDLINE Jazyk angličtina Země Švýcarsko Médium electronic

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/pmid34768623

Grantová podpora
Progress Q 38 Charles University

Drug-eluting stents (DES) are the recommended stents for primary percutaneous coronary intervention (PCI). This study aimed to determine why interventional cardiologists used non-DES and how it influenced patient prognoses. The efficacy and safety outcomes of the different stents were also compared in patients treated with either prasugrel or ticagrelor. Of the PRAGUE-18 study patients, 749 (67.4%) were treated with DES, 296 (26.6%) with bare-metal stents (BMS), and 66 (5.9%) with bioabsorbable vascular scaffold/stents (BVS) between 2013 and 2016. Cardiogenic shock at presentation, left main coronary artery disease, especially as the culprit lesion, and right coronary artery stenosis were the reasons for selecting a BMS. The incidence of the primary composite net-clinical endpoint (EP) (death, nonfatal myocardial infarction, stroke, serious bleeding, or revascularization) at seven days was 2.5% vs. 6.3% and 3.0% in the DES, vs. with BMS and BVS, respectively (HR 2.7; 95% CI 1.419-5.15, p = 0.002 for BMS vs. DES and 1.25 (0.29-5.39) p = 0.76 for BVS vs. DES). Patients with BMS were at higher risk of death at 30 days (HR 2.20; 95% CI 1.01-4.76; for BMS vs. DES, p = 0.045) and at one year (HR 2.1; 95% CI 1.19-3.69; p = 0.01); they also had a higher composite of cardiac death, reinfarction, and stroke (HR 1.66; 95% CI 1.0-2.74; p = 0.047) at one year. BMS were associated with a significantly higher rate of primary EP whether treated with prasugrel or ticagrelor. In conclusion, patients with the highest initial risk profile were preferably treated with BMS over BVS. BMS were associated with a significantly higher rate of cardiovascular events whether treated with prasugrel or ticagrelor.

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Sabate M., Cequier A., Iniguez A., Serra A., Hernandez-Antolin R., Mainar V., Valgimigli M., Tespili M., den Heijer P., Bethencourt 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;380:1482–1490. doi: 10.1016/S0140-6736(12)61223-9. PubMed DOI

Palmerini T., Biondi-Zoccai G., Della Riva D., Mariani A., Sabate M., Valgimigli M., Frati G., Kedhi E., Smits P.C., Kaiser C., et al. Clinical outcomes with drug-eluting and bare-metal stents in patients with ST-segment elevation myocardial infarction: Evidence from a comprehensive network meta-analysis. J. Am. Coll. Cardiol. 2013;62:496–504. doi: 10.1016/j.jacc.2013.05.022. PubMed DOI

Ibanez B., James S., Agewall S., Antunes M.J., Bucciarelli-Ducci C., Bueno H., Caforio A.L.P., Crea F., Goudevenos J.A., Halvorsen S., et al. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC) Eur. Heart J. 2018;39:119–177. PubMed

Neumann F.J., Sousa-Uva M., Ahlsson A., Alfonso F., Banning A.P., Benedetto U., Byrne R.A., Collet J.P., Falk V., Head S.J., et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur. Heart J. 2019;40:87–165. doi: 10.1093/eurheartj/ehy394. PubMed DOI

Byrne R.A., Alfonso F., Schneider S., Maeng M., Wiebe J., Kretov E., Bradaric C., Rai H., Cuesta J., Rivero F., et al. Prospective, randomized trial of bioresorbable scaffolds vs. everolimus-eluting stents in patients undergoing coronary stenting for myocardial infarction: The Intracoronary Scaffold Assessment a Randomized evaluation of Absorb in Myocardial Infarction (ISAR-Absorb MI) trial. Eur. Heart J. 2019;40:167–176. PubMed

Serruys P.W., Chevalier B., Dudek D., Cequier A., Carrie D., Iniguez A., Dominici M., van der Schaaf R.J., Haude M., Wasungu L., 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;385:43–54. PubMed

Ali Z.A., Serruys P.W., Kimura T., Gao R., Ellis S.G., Kereiakes D.J., Onuma Y., Simonton C., Zhang Z., Stone G.W. 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;390:760–772. doi: 10.1016/S0140-6736(17)31470-8. PubMed DOI

Motovska Z., Hlinomaz O., Miklik R., Hromadka M., Varvarovsky I., Dusek J., Knot J., Jarkovsky J., Kala P., Rokyta R., et al. Prasugrel Versus Ticagrelor in Patients With Acute Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention: Multicenter Randomized PRAGUE-18 Study. Circulation. 2016;134:1603–1612. doi: 10.1161/CIRCULATIONAHA.116.024823. PubMed DOI

Motovska Z., Hlinomaz O., Kala P., Hromadka M., Knot J., Varvarovsky I., Dusek J., Jarkovsky J., Miklik R., Rokyta R., et al. 1-Year Outcomes of Patients Undergoing Primary Angioplasty for Myocardial Infarction Treated With Prasugrel Versus Ticagrelor. J. Am. Coll. Cardiol. 2018;71:371–381. doi: 10.1016/j.jacc.2017.11.008. PubMed DOI

Pache J., Kastrati A., Mehilli J., Schühlen H., Dotzer F., Hausleiter J., Fleckenstein M., Neumann F.J., Sattelberger U., Schmitt C., et al. Intracoronary stenting and angiographic results: Strut thickness effect on restenosis outcome (ISAR-STEREO-2) trial. J. Am. Coll. Cardiol. 2003;41:1283–1288. doi: 10.1016/S0735-1097(03)00119-0. PubMed DOI

Wijns W., Kolh P., Danchin N., Di Mario C., Falk V., Folliguet T., Garg S., Huber K., James S., Knuuti J., et al. Guidelines on myocardial revascularization. Eur. Heart J. 2010;31:2501–2555. doi: 10.1016/j.repce.2011.11.010. PubMed DOI

Windecker S., Kolh P., Alfonso F., Collet J.P., Cremer J., Falk V., Filippatos G., Hamm C., Head S.J., Jüni P., et al. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Eur. Heart J. 2014;35:2541–2619. PubMed

Pilgrim T., Muller O., Heg D., Roffi M., Kurz D.J., Moarof I., Weilenmann D., Kaiser C., Tapponnier M., Losdat S., et al. Biodegradable- Versus Durable-Polymer Drug-Eluting Stents for STEMI: Final 2-Year Outcomes of the BIOSTEMI Trial. JACC Cardiovasc. Interv. 2021;14:639–648. doi: 10.1016/j.jcin.2020.12.011. PubMed DOI

Smits P.C., Hofma S., Togni M., Vázquez N., Valdés M., Voudris V., Slagboom T., Goy J.J., Vuillomenet A., Serra A., et al. Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent (COMPARE II): A randomised, controlled, non-inferiority trial. Lancet. 2013;381:651–660. doi: 10.1016/S0140-6736(12)61852-2. PubMed DOI

Dworeck C., Redfors B., Völz S., Haraldsson I., Angerås O., Råmunddal T., Ioanes D., Myredal A., Odenstedt J., Hirlekar G., et al. Radial artery access is associated with lower mortality in patients undergoing primary PCI: A report from the SWEDEHEART registry. Eur. Heart J. Acute Cardiovasc. Care. 2020;9:323–332. doi: 10.1177/2048872620908032. PubMed DOI PMC

Madhavan M.V., Kirtane A.J., Redfors B., Généreux P., Ben-Yehuda O., Palmerini T., Benedetto U., Biondi-Zoccai G., Smits P.C., von Birgelen C., et al. Stent-Related Adverse Events >1 Year After Percutaneous Coronary Intervention. J. Am. Coll. Cardiol. 2020;75:590–604. doi: 10.1016/j.jacc.2019.11.058. PubMed DOI

Sakamoto A., Torii S., Jinnouchi H., Guo L., Cornelissen A., Kuntz S., Cheng Q., Fernandez R., Paek K.H., Harris K., et al. Comparison of endothelial barrier functional recovery after implantation of a novel biodegradable polymer sirolimus-eluting stent in comparison to durable and biodegradable polymer everolimus-eluting stents. Cardiovasc. Revasc. Med. 2020;24:1–10. doi: 10.1016/j.carrev.2020.08.012. PubMed DOI

Rymer J.A., Harrison R.W., Dai D., Roe M.T., Messenger J.C., Anderson H.V., Peterson E.D., Wang T.Y. Trends in Bare-Metal Stent Use in the United States in Patients Aged ≥65 Years (from the CathPCI Registry) Am. J. Cardiol. 2016;118:959–966. doi: 10.1016/j.amjcard.2016.06.061. PubMed DOI

Morice M.C., Urban P., Greene S., Schuler G., Chevalier B. Why are we still using coronary bare-metal stents? J. Am. Coll. Cardiol. 2013;61:1122–1123. doi: 10.1016/j.jacc.2012.11.049. PubMed DOI

Biswas S., Duffy S.J., Lefkovits J., Andrianopoulos N., Brennan A., Walton A., Chan W., Noaman S., Shaw J.A., Dawson L., et al. Australian Trends in Procedural Characteristics and Outcomes in Patients Undergoing Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction. Am. J. Cardiol. 2018;121:279–288. doi: 10.1016/j.amjcard.2017.10.025. PubMed DOI

Sakamoto K., Sato R., Tabata N., Ishii M., Yamashita T., Nagamatsu S., Motozato K., Yamanaga K., Hokimoto S., Sueta D., et al. Temporal trends in coronary intervention strategies and the impact on one-year clinical events: Data from a Japanese multi-center real-world cohort study. Cardiovasc. Interv. Ther. 2021 doi: 10.1007/s12928-020-00752-5. PubMed DOI

Costa F., Brugaletta S., Pernigotti A., Flores-Ulmanzor E., Ortega-Paz L., Cequier A., Iniguez A., Serra A., Jiménez-Quevedo P., Mainar V., et al. Does Large Vessel Size Justify Use of Bare-Metal Stents in Primary Percutaneous Coronary Intervention? Circ. Cardiovasc. Interv. 2019;12:e007705. doi: 10.1161/CIRCINTERVENTIONS.118.007705. PubMed DOI

Bønaa K.H., Mannsverk J., Wiseth R., Aaberge L., Myreng Y., Nygård O., Nilsen D.W., Kløw N.E., Uchto M., Trovik T., et al. Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease. N. Engl. J. Med. 2016;375:1242–1252. doi: 10.1056/NEJMoa1607991. PubMed DOI

Raj L., Upadyhay R., Clavijo L.C., Tun H., Mehra A., Hindoyan A., Matthews R.V., Shavelle D.M. Factors Associated With the Use of Bare Metal Stents in Patients With ST Elevation Myocardial Infarction. Cardiovasc. Revasc. Med. 2020;21:1489–1492. doi: 10.1016/j.carrev.2020.05.008. PubMed DOI

Goel S., Pasam R.T., Chava S., Sharma A., Malik B.A., Ayzenberg S., Frankel R., Shani J., Gidwani U. Three to four years outcomes of the absorb bioresorbable vascular scaffold versus second-generation drug-eluting stent: A meta-analysis. Catheter. Cardiovasc. Interv. 2020;95:216–223. doi: 10.1002/ccd.28290. PubMed DOI

Ke J., Zhang H., Huang J., Lv P., Chen Y., Xu K., Yang W., Tu B. Three-year outcomes of bioresorbable vascular scaffolds versus second-generation drug-eluting stents: Meta-analysis of randomized trials. Medicine. 2020;99:e21554. doi: 10.1097/MD.0000000000021554. PubMed DOI PMC

Ke J., Zhang H., Huang J., Lv P., Yan J. Mid-term outcomes of bioresorbable vascular scaffolds vs second-generation drug-eluting stents in patients with acute coronary syndromes: A systematic review and meta-analysis. Medicine. 2020;99:e19458. doi: 10.1097/MD.0000000000019458. PubMed DOI PMC

Verdoia M., Kedhi E., Suryapranata H., Galasso G., Dudek D., De Luca G. Poly (l-lactic acid) bioresorbable scaffolds versus metallic drug-eluting stents for the treatment of coronary artery disease: A meta-analysis of 11 randomized trials. Catheter. Cardiovasc. Interv. 2020;96:813–824. doi: 10.1002/ccd.28594. PubMed DOI

Serruys P.W., Chevalier B., Sotomi Y., Cequier A., Carrié D., Piek J.J., Van Boven A.J., Dominici M., Dudek D., McClean D., 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;388:2479–2491. doi: 10.1016/S0140-6736(16)32050-5. PubMed DOI

Lipinski M.J., Escarcega R.O., Baker N.C., Benn H.A., Gaglia M.A., Torguson R., Waksman R. Scaffold Thrombosis After Percutaneous Coronary Intervention With ABSORB Bioresorbable Vascular Scaffold: A Systematic Review and Meta-Analysis. JACC Cardiovasc. Interv. 2016;9:12–24. doi: 10.1016/j.jcin.2015.09.024. PubMed DOI

Onuma Y., Sotomi Y., Shiomi H., Ozaki Y., Namiki A., Yasuda S., Ueno T., Ando K., Furuya J., Igarashi K., 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;12:1090–1101. doi: 10.4244/EIJY16M09_01. PubMed DOI

Tamburino C., Latib A., van Geuns R.J., Sabate M., Mehilli J., Gori T., Achenbach S., Alvarez M.P., Nef H., Lesiak M., et al. Contemporary practice and technical aspects in coronary intervention with bioresorbable scaffolds: A European perspective. EuroIntervention. 2015;11:45–52. doi: 10.4244/EIJY15M01_05. PubMed DOI

Byrne R.A., Kastrati A., Kufner S., Massberg S., Birkmeier K.A., Laugwitz K.L., Schulz S., Pache J., Fusaro M., Seyfarth M., 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;30:2441–2449. doi: 10.1093/eurheartj/ehp352. PubMed DOI

Räber L., Kelbæk H., Taniwaki M., Ostojic M., Heg D., Baumbach A., von Birgelen C., Roffi M., Tüller D., Engstrøm T., et al. Biolimus-eluting stents with biodegradable polymer versus bare-metal stents in acute myocardial infarction: Two-year clinical results of the COMFORTABLE AMI trial. Circ. Cardiovasc. Interv. 2014;7:355–364. doi: 10.1161/CIRCINTERVENTIONS.113.001440. PubMed DOI

De Luca G., Dirksen M.T., Spaulding C., Kelbaek H., Schalij M., Thuesen L., van der Hoeven B., Vink M.A., Kaiser C., Musto C., et al. Drug-eluting vs bare-metal stents in primary angioplasty: A pooled patient-level meta-analysis of randomized trials. Arch. Intern. Med. 2012;172 doi: 10.1001/archinternmed.2012.758. PubMed DOI

Chichareon P., Modolo R., Collet C., Tenekecioglu E., Vink M.A., Oh P.C., Ahn J.M., Musto C., Díaz de la Llera L.S., Cho Y.S., et al. Efficacy and Safety of Stents in ST-Segment Elevation Myocardial Infarction. J. Am. Coll. Cardiol. 2019;74:2572–2584. doi: 10.1016/j.jacc.2019.09.038. PubMed DOI

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