Velocidad de desinflado del sistema de liberación del stent en la angioplastia primaria: estudio aleatorizado

  1. Berta Vega Hernández 1
  2. Armando Pérez de Prado 2
  3. Juan Rondán 1
  4. Carlos Cuellas Ramón 2
  5. Jose Miguel Vegas Valle 1
  6. María López Benito 2
  7. Tomás Benito González 2
  8. Eduardo Segovia 1
  9. Felipe Fernández Vázquez 2
  10. Iñigo Lozano 1
  1. 1 Servicio de Cardiología, Hospital Universitario de Cabueñes, Gijón, Asturias, España
  2. 2 Servicio de Cardiología, Hospital Universitario de León, León, España
Journal:
REC: Interventional Cardiology

ISSN: 2604-7276,  2604-7306

Year of publication: 2022

Volume: 4

Issue: 2

Pages: 91-98

Type: Article

DOI: 10.24875/RECIC.M21000230 DIALNET GOOGLE SCHOLAR lock_openDialnet editor

More publications in: REC: Interventional Cardiology

Abstract

Introduction and objectives: Distal embolization and no-reflow are common complications in primary angioplasty and the information available on the role played by the deflation speed of the stent delivery system is scarce. Our aim is to analyze how the deflation speed of the stent delivery system impacts the results of primary angioplasty. Methods: From December 2016 through February 2019, all consecutive patients with ST-segment elevation myocardial infarction undergoing urgent coronary angiography at our institution and who were eligible for thrombectomy, IIB-IIIA inhibitors, and direct stenting were randomized in a 1:1 ratio to rapid (group 1, n = 103) or slow deflation of the stent delivery system, at 1 atm/second, (group 2, n = 107). Pre- and postdilatation was not allowed per protocol. The primary outcomes were myocardial blush ≥ 2 and ST-segment resolution ≥ 70% while the size of myocardial damage, the ejection fraction both at discharge and at the 12-month follow-up, and the overall and 12-month cardiovascular mortality rates were the secondary outcomes. Results: The study was stopped prematurely with 50% of the estimated sample size due to futility. Myocardial blush ≥ 2 occurred in 77 (74.7%) vs 79 (75.2%) of the patients, P = .93, and ST-segment resolution ≥ 70% occurred in 54 (53.9%) vs 59 (55.5%) of the patients, P = .75 in groups 1 and 2, respectively without any differences being reported in any of the secondary endpoints. Conclusions: In our series, the deflation speed of the stent delivery system in primary angioplasty did not modify the myocardial blush ≥ 2, the ST-segment resolution ≥ 70% or impacted the clinical outcomes, the size of myocardial infarction according to the biomarkers or the ejection fraction.

Bibliographic References

  • 1. Ito H, Tomooka T, Sakai N, et al. Lack of myocardial perfusion immediately after successful thrombolysis. A predictor of poor recovery of left ventricular function in anterior myocardial infarction. Circulation. 1992;85:1699-1705.
  • 2. 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;39:2472-2479.
  • 3. Frobert O, Lagerqvist B, Olivecrona GK, et al. Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med. 2013;369:1587-1597.
  • 4. Jolly SS, Cairns JA, Yusuf S, et al. Outcomes after thrombus aspiration for ST elevation myocardial infarction:1-year follow-up of the prospective randomised TOTAL trial. Lancet. 2016;387:127-135.
  • 5. Roolvink V, Ibanez B, Ottervanger JP, et al. Early Intravenous Beta-Blockers in Patients With ST-Segment Elevation Myocardial Infarction Before Primary Percutaneous Coronary Intervention. J Am Coll Cardiol. 2016;67:2705-2715.
  • 6. Ellis SG, Tendera M, de Belder MA, et al. Facilitated PCI in patients with ST-elevation myocardial infarction. N Engl J Med. 2008;358:2205-2217.
  • 7. Konijnenberg LSF, Damman P, Duncker DJ, et al. Pathophysiology and diagnosis of coronary microvascular dysfunction in ST-elevation myocardial infarction. Cardiovasc Res. 2020;116:787-805.
  • 8. Dong M, Mu N, Guo F, et al. The beneficial effects of postconditioning on no-reflow phenomenon after percutaneous coronary intervention in patients with ST-elevation acute myocardial infarction. J Thromb Thrombolysis. 2014;38:208-214.
  • 9. Li R, Zijlstra JG, Kamps JA, van Meurs M, Molema G. Abrupt reflow enhances cytokine-induced proinflammatory activation of endothelial cells during simulated shock and resuscitation. Shock. 2014;42:356-364.
  • 10. Perez de Prado A, Fernandez-Vazquez F, Cuellas-Ramon JC, Iglesias-Garriz I. Coronary clearance frame count:a new index of microvascular perfusion. J Thromb Thrombolysis. 2005;19:97-100.
  • 11. Sianos G, Papafaklis MI, Daemen J, et al. Angiographic stent thrombosis after routine use of drug-eluting stents in ST-segment elevation myocardial infarction:the importance of thrombus burden. J Am Coll Cardiol. 2007;50:573-583.
  • 12. Rentrop KP, Cohen M, Blanke H, Phillips RA. Changes in collateral channel filling immediately after controlled coronary artery occlusion by an angioplasty balloon in human subjects. J Am Coll Cardiol. 1985;5:587-592.
  • 13. Suzuki N, Asano T, Nakazawa G, et al. Clinical expert consensus document on quantitative coronary angiography from the Japanese Association of Cardiovascular Intervention and Therapeutics. Cardiovasc Interv Ther. 2020;35:105-116.
  • 14. Farkouh ME, Reiffel J, Dressler O, et al. Relationship between ST-segment recovery and clinical outcomes after primary percutaneous coronary intervention:the HORIZONS-AMI ECG substudy report. Circ Cardiovasc Interv. 2013;6:216-223.
  • 15. Fabris E, van 't Hof A, Hamm CW, et al. Clinical impact and predictors of complete ST segment resolution after primary percutaneous coronary intervention:A subanalysis of the ATLANTIC Trial. Eur Heart J Acute Cardiovasc Care. 2019;8:208-217.
  • 16. Fregni F. Sample Size Calculation. Clinical Thinking in Clinical Research:Applied Theory and Practice Using Case Studies. New York:Oxford University Press. 2018:225-242.
  • 17. Gu J, Zhuo Y, Liu TJ, et al. Balloon Deflation Strategy during Primary Percutaneous Coronary Intervention in Acute ST-Segment Elevation Myocardial Infarction:A Randomized Controlled Clinical Trial and Numerical Simulation-Based Analysis. Cardiol Res Pract. 2020;2020:4826073.
  • 18. Loubeyre C, Morice MC, Lefevre T, Piechaud JF, Louvard Y, Dumas P. A randomized comparison of direct stenting with conventional stent implantation in selected patients with acute myocardial infarction. J Am Coll Cardiol. 2002;39:15-21.
  • 19. Lemesle G, Sudre A, Bouallal R, et al. Impact of thrombus aspiration use and direct stenting on final myocardial blush score in patients presenting with ST-elevation myocardial infarction. Cardiovasc Revasc Med. 2010;11:149-154.
  • 20. Sardella G, Mancone M, Nguyen BL, et al. The effect of thrombectomy on myocardial blush in primary angioplasty:the Randomized Evaluation of Thrombus Aspiration by two thrombectomy devices in acute Myocardial Infarction (RETAMI) trial. Catheter Cardiovasc Interv. 2008;71:84-91.
  • 21. G DEL, Bellandi F, Huber K, et al. Early glycoprotein IIb-IIIa inhibitors in primary angioplasty-abciximab long-term results (EGYPT-ALT) cooperation:individual patient's data meta-analysis. J Thromb Haemost. 2011;9:2361-2370.
  • 22. Marra MP, Corbetti F, Cacciavillani L, et al. Relationship between myocardial blush grades, staining, and severe microvascular damage after primary percutaneous coronary intervention a study performed with contrast-enhanced magnetic resonance in a large consecutive series of patients. Am Heart J. 2010;159:1124-1132.
  • 23. Bajaj NS, Singh A, Zhou W, et al. Coronary Microvascular Dysfunction, Left Ventricular Remodeling, and Clinical Outcomes in Patients With Chronic Kidney Impairment. Circulation. 2020;141:21-33.
  • 24. De Luca G, van 't Hof AW, de Boer MJ, et al. Time-to-treatment significantly affects the extent of ST-segment resolution and myocardial blush in patients with acute myocardial infarction treated by primary angioplasty. Eur Heart J. 2004;25:1009-1013.
  • 25. Ng VG, Lansky AJ, Toro S, et al. Prognostic utility of myocardial blush grade after PCI in patients with NSTE-ACS:Analysis from the ACUITY trial. Catheter Cardiovasc Interv. 2016;88:215-224.
  • 26. Bottner RK, Morea CJ, Green CR, Renzi RH, Kent KM, Krucoff MW. Quantitation of ischemia during total coronary occlusion with computer-assisted high resolution ST-segment monitoring:effect of collateral flow. J Electrocardiol. 1987;20 Suppl:104-106.
  • 27. Brodie BR, Stuckey TD, Hansen C, et al. Relation between electrocardiographic ST-segment resolution and early and late outcomes after primary percutaneous coronary intervention for acute myocardial infarction. Am J Cardiol. 2005;95:343-348.
  • 28. Verouden NJ, Haeck JD, Kuijt WJ, et al. Clinical and angiographic predictors of ST-segment recovery after primary percutaneous coronary intervention. Am J Cardiol. 2010;105:1692-1697.
  • 29. Lefevre T, Garcia E, Reimers B, et al. X-sizer for thrombectomy in acute myocardial infarction improves ST-segment resolution:results of the X-sizer in AMI for negligible embolization and optimal ST resolution (X AMINE ST) trial. J Am Coll Cardiol. 2005;46:246-252.
  • 30. De Luca G, Ernst N, van 't Hof AW, et al. Preprocedural Thrombolysis in Myocardial Infarction (TIMI) flow significantly affects the extent of ST-segment resolution and myocardial blush in patients with acute anterior myocardial infarction treated by primary angioplasty. Am Heart J. 2005;150:827-831.
  • 31. Brener SJ, Dizon JM, Mehran R, et al. Complementary prognostic utility of myocardial blush grade and ST-segment resolution after primary percutaneous coronary intervention:analysis from the HORIZONS-AMI trial. Am Heart J. 2013;166:676-683.
Data source: Dialnet