Bioresorbable Vascular Scaffold Compared With Minimally Invasive Bypass Surgery for the Left Anterior Descending Coronary Artery Disease: 12-Month Follow up

The aim. Evaluates long­term clinical outcomes of percutaneous coronary intervention (PCI) with bioresorbable vascular scaffold (BVS) versus minimally invasive direct coronary artery bypass (MIDCAB) surgery for the treatment of left anterior descending (LAD) lesions.

Methods and Results. In this single­center study were included 130 patients with stable angina and significant (≥ 70 %) LAD disease. Patients were randomly assigned in a 1:1 ratio to PCI with everolimus­eluting BVS (n=65) or MIDCAB (n=65). The primary end­point was major adverse cerebro­cardiovascular events (MACCE) and secondary was scaffold (graft) thrombosis at 1 year. The groups of patients were comparable for all baseline demographic, clinical and angiographic parameters. MACCE at 12 month occurred in 9.2 % of patients in the BVS group and in 4.6 % of patients in the MIDCAB group (p=0.3). There was no significant difference between the groups in rates of all cause death (1.5 % vs 1.5 %, p=1.0), myocardial infarction (3.1 % vs. 6.1 %, p=0.4), any revascularization (1.5 % vs. 6.1 %, p=0.1) and scaffold (graft) thrombosis (1.5 % vs. 1.5 %, p=1.00).

Conclusion. At 12­month follow up, there was no significant difference in the rate of MACCE between PCI by BVS and MIDCAB in patients with isolated LAD lesions.

1. Serruys P., Chevalier B., Dudek D. et al. A bioresorbable everoli-mus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by denovo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomized controlled trial. Lancet 2015;385:43-54. DOI:10.1016/S0140-6736(14)61455-0.

2. Kimura T., Kozuma K., Tanabe K. et al.; ABSORB Japan Investigators. A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan. Eur Heart J 2015;36:3332-3342. DOI: 10.1093/eurheartj/ehv435

3. Gao R., Yang Y., Han Y. et al.; ABSORB China Investigators. Bioresorbable vascular scaffolds versus metallic stentsin patients with coronary artery disease: ABSORB China Trial. J Am Coll Cardiol 2015;66:2298-2309. DOI:10.1016/j.jacc.2015.09.054.

4. Puricel S., Arroyo D., Corpataux N. et al. Comparison of everoli-mus- and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds. J Am Coll Cardiol 2015;65:791-801. DOI:10.1016/j.jacc.2014.12.017.

5. Sabate' M., Windecker S., In'iguez A. et al. Everolimus-eluting bioresorbable stent vs. durable polymer everolimus-eluting metallic stent in patients with STsegment elevation myocardial infarction: results of the randomized ABSORB ST-segment elevation myocardial infarction-TROFI II trial. Eur Heart J 2016;37:229-240. DOI: 10.1093/eurheartj/ehv500.

6. Cassese S., Byrne R., Ndrepepa G. et al. Everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: a meta-analysis of randomized controlled trials. Lancet 2016;387:537-544. DOI:10.1016/S0140-6736(15)00979-4.

7. Zhang X., Zhu L., Wei Z. et al. Comparative efficacy and safety of everolimus-eluting bioresorbable scaffold versus everolimus-eluting metallic stents: a systematic review and meta-analysis. Ann Intern Med 2016;164:752-763. DOI:10.7326/M16-0006.

8. Wykrzykowska J., Kraak R., Hofma S. et al. Bioresorbable scaffolds versus metallic stents in routine PCI. N Engl J Med 2017;376 (24):2319-2328. DOI: 10.1056/NEJMoa1614954.

9. Kereiakes D., Ellis S., Metzger C. et al. ABSORB III Investigators. 3-Year Clinical Outcomes With Everolimus-Eluting Bioresorbable Coronary Scaffolds: The ABSORB III Trial. J Am Coll Cardiol 2017;70 (23):2852-2862. DOI: 10.1016/j.jacc.2017.10.010.

10. William M. FDA Investigating Increased Rate of Major Adverse Cardiac Events Observed in Patients Receiving Abbott Vascular's Absorb GT1 Bioresorbable Vascular Scaffold (BVS) - Letter to Health Care Providers. https://www.fda.gov/medicaldevices/safety/letterstohealthcareproviders/ucm546808. htm (02.02.2018).

11. Wang X., Qu C., Huang C. et al. Minimally invasive direct coronary bypass compared with percutaneous coronary intervention for left anterior descending artery disease: a meta-analysis. J Cardiothorac Surg 2016;11 (1):125. DOI: 10.1186/s13019-016-0512-1.

12. Cutlip D., Windecker S., Mehran R. et al. Clinical endpoints in coronary stent trials: a case for standardized definitions. Circulation 2007;115:2344-2351. DOI: 10.1161/CIRCULATIONAHA. 106.685313

13. Ellis S., Kereiakes D., Metzger D. et al. ABSORB III Investigators. Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease. N Engl J Med 2015;373 (20):1905-1915. DOI: 10.1056/NEJMoa1509038.

14. Moscarella E., Ielasi A., De Angelis M. et al. Are acute coronary syndromes an ideal scenario for bioresorbable vascular scaffold implantation? J Thorac Dis 2017;9 (9):S969 - S978. DOI: 10.21037/jtd.2017.06.136.

15. Samak M., Fatullayev J., Sabashnikov A. et al: Total arterial revascularization: bypassing antiquated notions to better alternatives for coronary artery disease. Med Sci Monit Basic Res 2016;22:107-14.

16. Mourad F., Duncan A. Tissue stabilizer reverse mounting in minimally invasive direct coronary artery bypass, a simple tool in difficult times. Innovations (Phila) 2009;4:117.

17. Shilov A., Kochergin N., Ganyukov V. et al. Hybrid strategy of revascularization compared with coronary artery bypass grafting in patients with multivessel coronary disease with stable coronary artery disease, thirty results. Complex Issues of Cardiovascular Diseases 2016;5 (3):16-20. Russian

18. Birla R., Patel P., Aresu G., Asimakopoulos G. Minimally invasive direct coronary artery bypass versus off-pump coronary surgery through sternotomy. Ann R Coll Surg Engl 2013;95 (7):481-485. DOI: 10.1308/003588413X13629960047119.

19. Deppe C., Liakopoulos J., Kuhn W. et al. Minimally invasive direct coronary bypass grafting versus percutaneous coronary intervention for single-vessel disease: a meta-analysis of 2885 patients. Eur J Cardiothorac Surg 2015;47 (3):397-406. DOI: 10.1093/ejcts/ezu285.

20. Reser D., Hemelrijck Mv., Pavicevic J. et al. Mid-term outcomes of minimally invasive direct coronary artery bypass grafting. Thorac Cardiovasc Surg 2015;63 (4):313-318. DOI: 10.1055/s-0034-1389085.