TCT-428 Bioresorbable Coronary Devices in Clinical Practice: 6-month Results of the Prospective REPARA Registry

  • Hernandez F
  • Bermudez E
  • Molina E
  • et al.
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Abstract

BACKGROUND Regular use of bioresorbable coronary devices in daily clinical practice is not fully established yet. Few data exist about clinical outcomes in specific lesions or clinical scenarios. METHODS REPARA is a multicentre, prospective registry, designed to evaluate the efficacy and safety of the bioresorbable coronary device Absorb in native coronary arteries in daily clinical practice. Primary objective is a combined of MACE at 12 months, including cardiac death, myocardial infarction, target lesion revascularization and stent thrombosis. We report the 6‐month results of the whole population. RESULTS 2448 patients were included (81% male, mean age 57+/‐11 years), 24% diabetics, whose clinical indication for PCI was ACS in 59.1% (32.4% STEMI, 26.7% non‐STEMI), unstable angina in 15.4% and stable angina/silent ischemia in 25.5%. Radial access was achieved in 84% of the patients. A total of 3370 lesions were treated (1.38+/‐0.7 per patient, 53% in LAD, 21% in Cx and 26% in RCA), with a mean length of 18.3+/‐9.4 mm, and 18.4% of them were bifurcations. Predilatation was performed in 78% of lesions, and 1.2+/‐0.5 devices per lesion were implanted, with a mean length of 23.8+/‐13 mm and a mean diameter of 3+/‐0.4 mm. Overlapping devices were required in 16.5%. Postdilatation was performed in 46% of the lesions (mean balloon diameter 3.3+/‐0.4 mm, mean pressure 17.7+/‐5 atm). Intracoronary imaging was used in 11.1% of cases (IVUS in 2.5%, OCT in 8.6%). Procedural success was obtained in 98.9% of the lesions. At discharge all patients were on DAPT (ASA 100%, clopidogrel 52%, ticagrelor 31.7%, prasugrel 16.3%). At 30 days and 6 months respectively events were: cardiac death 0.3% and 0.6%, myocardial infarction 1.5% and 2.1%, need for TLR 0.8% and 1.4% and device thrombosis 0.9% and 1.4%. Overlapping devices and bifurcations were significantly related with device thrombosis in univariant analysis at 30 days and 6 months, but there were no differences in STEMI and diabetes patients. CONCLUSION Bioresorbable coronary devices in daily clinical practice show a high procedural success rate and low MACE at 30‐day and 6‐month follow‐up. Device thrombosis rates are higher in overlapping devices and bifurcated lesions.

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APA

Hernandez, F., Bermudez, E. P., Molina, E., Diaz, J., Salvatella, N., Fernández, J. C., … Lozano, I. (2016). TCT-428 Bioresorbable Coronary Devices in Clinical Practice: 6-month Results of the Prospective REPARA Registry. Journal of the American College of Cardiology, 68(18), B173. https://doi.org/10.1016/j.jacc.2016.09.563

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