Impact of Bioresorbable Scaffold Use on Procedural Features Compared with New-Generation Drug-Eluting Stents

Yıl 2020, Cilt: 23 Sayı: 1, 38 - 45, 01.04.2020

Beytullah Çakal

Öz

Introduction: Although bioresorbable scaffolds (BRS) are considered a new paradigm in stent technology, operators are often discouraged from implanting BRS because of increased strut thickness, reduced radial force, requirement for pre- and postdilatation of the lesions, and concerns about the risk of stent thrombosis. We compared procedure and fluoroscopy duration, cumulative radiation dose, and contrast agent volume among patients undergoing BRS or drug-eluting stent (DES) implantation.

Patients and Methods: One hundred thirty-four patients with a total of 165 coronary lesions, including 64 patients (78 lesions) with BRS and 70 patients (87 lesions) with DES, were selected. Clinical and procedural characteristics and angiographic features were calculated. Procedure and fluoroscopy time, volume of contrast medium, and cumulative radiation dose (Gy) were compared.

Results: The number of predilated and postdilated lesions was higher in the BRS group than in the DES group, although baseline lesion morphologies were similar. Stent diameters were comparable between the two groups. Larger postdilatation balloon sizes were chosen in the BRS group. Mean procedure time (45.4 ± 16.1 minutes vs. 38.3 ± 15.1 minutes; p= 0.010), volume of contrast medium (207.7 ± 80.7 mL vs. 154.7 ± 74.6 mL; p= 0.001), fluoroscopy duration (15.9 ± 6.6 minutes vs. 13.1 ± 6.6 minutes; p= 0.014), and radiation dose (1.80 ± 1.08 Gy vs. 1.44 ± 0.91 Gy, p= 0.037) were significantly higher in the BRS group than in the DES group.

Conclusion: BRS implantation leads to prolonged fluoroscopy, longer procedure duration, greater contrast volume, and higher radiation exposure compared with DES procedures.

Anahtar Kelimeler

Coronary artery disease, percutaneous, coronary intervention

Eriyebilen Stentlerin Prosedür Üzerine Olan Etkilerinin İlaç Kaplı Stentlerle Karşılaştırılması

Öz

Giriş: Artmış strut kalınlığı, azalmış stentin açılma kuvveti, stent takılmadan önce ve sonrasında balon yapma ihtiyacı, stent trombozu riskinde artış gibi birçok faktör operatörleri yenilikçi bir teknoloji olarak sunulan eriyebilen stentlerin (ES) kullanılmasında endişeye itmiştir. Bu çalışmada ES ile ilaç salınımlı stent (İSS) kullanılan hastalardaki işlem süresi ve floroskopi zamanı, opak miktarı ve radyasyon dozu karşılaştırılması hedeflenmiştir.

Hastalar ve Yöntem: Çalışmada koroner arter hastalığı tanısı alan 134 hastadaki 165 lezyon ele alınmış olup, bunlardan ES takılan 64 hastadaki 78 lezyon ile İSS takılan 70 hastadaki 87 lezyon dahil edilmiştir. İşlemle ilgili, klinik ve anjiyografik özellikler her grup için hesaplanmıştır. Her iki gruptaki prosedür ve floroskopi zamanı, kontrast miktarı ve toplam radyasyon dozu (Gy) karşılaştırılmıştır.

Bulgular: Başlangıç lezyon özellikleri her iki grupta benzer saptanmasına rağmen balon ile pre- ve postdilatasyon anlamlı olarak ES takılanlarda daha yüksek saptandı. Stent çapları iki grupta da benzer iken ES grubunda postdilatasyon için daha yüksek çaplı balonlar tercih edildi. Ortalama işlem süresi (sırasıyla 45.4 ± 16.1 dakika ve 38.3 ± 15.1 dakika, p= 0.01), kontrast volümü (sırasıyla 207.7 ± 80.7 mL ve 154.7 ± 74.6 mL; p= 0.001), floroskopi zamanı (sırasıyla 15.9 ± 6.6 dakika ve 13.1 ± 6.6 dakika, p= 0.014), radyasyon dozu (sırasıyla 1.8 ± 1.08 Gy ve 1.44 ± 0.91 Gy, p= 0.037) ES grubunda İSS grubuna kıyasla anlamlı olarak daha yüksek bulunmuştur.

Sonuç: ES kullanımı İSS ile karşılaştırıldığında uzamış floro ve işlem süresi, artmış opak yükü ve radyasyon dozu ile ilişkilidir.

Anahtar Kelimeler

Koroner arter hastalığı, perkütan koroner girişim

Kaynakça

• 1. Sousa J, A Costa M, Abizaid AS, Feres F, Pinto I, C Seixas A, et al. Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries: A quantitative coronary angiography and three-dimensional intravascular ultrasound study. Circulation 2001;103(2):192-5.
• 2. Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, et al. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol 2006;48(1):193-202.
• 3. Serruys PW, Garcia-Garcia HM, Onuma Y. From metallic cages to transient bioresorbable scaffolds: change in paradigm of coronary revascularization in the upcoming decade? Eur Heart J 2012;33(1):16-25b.
• 4. Ormiston JA, Serruys PW, Regar E, Dudek D, Thuesen L, Webster MW, 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.
• 5. Sotomi Y, Onuma Y, Collet C, Tenekecioglu E, Virmani R, Kleiman NS, et al. Bioresorbable scaffold: the emerging reality and future directions. Circulation Research 2017;120(8):1341-52.
• 6. Capodanno D. Bioresorbable scaffolds in coronary intervention: unmet needs and evolution. Korean Circulation Journal 2018;48(1):24-35.
• 7. Jinnouchi H, Torii S, Sakamoto A, Kolodgie FD, Virmani R, Finn AV. Fully bioresorbable vascular scaffolds: lessons learned and future directions. Nat Rev Cardiol 2019;16(5):286-304.
• 8. Ortega-Paz L, Capodanno D, Gori T, Nef H, Latib A, Caramanno G, 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):2110-7.
• 9. Bonow RO, Masoudi FA, Rumsfeld JS, Delong E, Estes NA 3rd, Goff DC Jr, et al. ACC/AHA classification of care metrics: performance measures and quality metrics: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures. J Am Coll Cardiol 2008;52(24):2113-7.
• 10. Tan HC, Ananthakrishna R. Bioresorbable vascular scaffolds in routine clinical practice: should we wait longer? JACC Cardiovasc Interv 2016;9(16):1664-6.
• 11. Ellis SG, Kereiakes DJ, Metzger DC, Caputo RP, Rizik DG, Teirstein PS, et al. Everolimus-eluting bioresorbable scaffolds for coronary artery disease. N Engl J Med 2015;373(20):1905-15.
• 12. Kereiakes DJ, Ellis SG, Metzger C, Caputo RP, Rizik DG, Teirstein PS, et al. 3-year clinical outcomes with everolimus-eluting bioresorbable coronary scaffolds: The ABSORB III Trial. J Am Coll Cardiol 2017;70(23):2852-62.
• 13. Verheye S, Ormiston JA, Stewart J, Webster M, Sanidas E, Costa R, et al. A next-generation bioresorbable coronary scaffold system: from bench to first clinical evaluation: 6- and 12-month clinical and multimodality imaging results. JACC Cardiovasc Interv 2014;7(1):89-99.
• 14. Rizik DG, Hermiller JB, Kereiakes DJ. The ABSORB bioresorbable vascular scaffold: A novel, fully resorbable drug-eluting stent: Current concepts and overview of clinical evidence. Catheter Cardiovasc Interv 2015;86(4):664-77.
• 15. Tamburino C, Latib A, van Geuns RJ, Sabate M, Mehilli J, Gori T, et al. Contemporary practice and technical aspects in coronary intervention with bioresorbable scaffolds: a European perspective. EuroIntervent 2015;11(1):45-52.
• 16. Stone GW, Abizaid A, Onuma Y, Seth A, Gao R, Ormiston J, et al. Effect of technique on outcomes following bioresorbable vascular scaffold implantation: analysis from the ABSORB trials. J Am Coll Cardiol 2017;70(23):2863-74.
• 17. Ali ZA, Serruys PW, Kimura T, Gao R, Ellis SG, Kereiakes DJ, 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):760-72.
• 18. Yamaji K, Raber L, Windecker S. What determines long-term outcomes using fully bioresorbable scaffolds-the device, the operator or the lesion? EuroIntervent 2017;12(14):1684-7.
• 19. Sato K, Latib A, Panoulas VF, Kawamoto H, Naganuma T, Miyazaki T, et al. Procedural feasibility and clinical outcomes in propensity-matched patients treated with bioresorbable scaffolds vs new-generation drug-eluting stents. Can J Cardiol 2015;31(3):328-34.
• 20. Wiebe J, Liebetrau C, Dorr O, Most A, Weipert K, Rixe J, et al. Feasibility of everolimus-eluting bioresorbable vascular scaffolds in patients with chronic total occlusion. Int J Cardiol 2015;179:90-4.
• 21. Ozel E, Tastan A, Ozturk A, Ozcan EE, Kilicaslan B, Ozdogan O. Procedural and one-year clinical outcomes of bioresorbable vascular scaffolds for the treatment of chronic total occlusions: a single-centre experience. Cardiovasc J Afr 2016;27(6):345-9.