Simone Biscaglia1, Fabrizio Ugo2, Alfonso Ielasi3, Gioel Gabrio Secco4, Alessandro Durante5, Fabrizio D'Ascenzo6, Enrico Cerrato7, Mohammed Balghith8, Giampaolo Pasquetto9, Carlo Penzo10, Massimo Fineschi11, Francesco Bonechi12, Christian Templin13, Mila Menozzi14, Matteo Aquilina15, Andrea Rognoni16, Piera Capasso17, Carlo Di Mario18, Salvatore Brugaletta19, Gianluca Campo20. 1. Cardiovascular Section, Medical Sciences Department, Azienda Ospedaliera Universitaria S.Anna, Ferrara, Italy. Electronic address: bscsmn@unife.it. 2. Interventional Cardiology, San Giovanni Bosco Hospital, Turin, Italy. 3. Cardiology Division, , Bolognini Hospital, Seriate, Italy. 4. Interventional Cardiology, Santi Antonio e Biagio e Cesare Arrigo Hospital, Alessandria, Italy. 5. Cardiologia, Ospedale Valduce, Como, Italy. 6. Dipartimento di Scienze Mediche, Divisione di Cardiologia, Città della Salute e della Scienza, Turin, Italy. 7. Division of Cardiology, Infermi Hospital, Rivoli, Italy. 8. King Saud Bin Abdulaziz University for Health Sciences, KACC, National Guard, Riyadh, ,Saudi Arabia. 9. Ospedali Riuniti Padova Sud, Monselice, Italy. 10. Divisione di Cardiologia, Ospedale Civile, Mirano, Italy. 11. U.O. Emodinamica, Azienda Ospedaliera Universitaria Senese, Siena, Italy. 12. UOS Emodinamica, Ospedale San Giuseppe, Azienda USL 11, Empoli, Italy. 13. Department of Cardiology, University Heart Center, University Hospital Zürich, Zürich, Switzerland. 14. Department of Cardiovascular Disease, Infermi Hospital, Rimini, Italy. 15. U.O. Cardiologia, Ospedale S. Maria delle Croci, Ravenna, Italy. 16. Cardiologia 2, A.O.U. Maggiore della Carità, Novara, Italy. 17. Division of Cardiology, San Giovanni Bosco Hospital, Turin, Italy. 18. NIHR Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, London, United Kingdom. 19. Cardiology Department; Thorax Institute; IDIBAPS, University of Barcelona, Hospital Clinic, Barcelona, Spain. 20. LTTA Center, Ferrara, Italy.
Abstract
BACKGROUND: Randomized clinical trials on bioresorbable scaffolds (BRS) enrolled patients with simple coronary lesions. The present study was sought to give preliminary findings about safety of BRS implantation in overlap in long coronary lesions. METHODS: From June 2012 to January 2015, we prospectively collected data from 162 consecutive patients receiving overlapping BRS implantation in the 16 participating institutions. We applied a propensity-score to match BRS-treated patients with 162 patients receiving second generation drug eluting stents (DES) in overlap. The primary endpoint was a device-oriented endpoint (DOCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization. RESULTS: DOCE rate did not significantly differ between the two groups (5.6% in BRS group vs. 7.4% in DES group, HR 0.79, 95%CI 0.37-3.55, p=0.6). Also stent/scaffold thrombosis did not differ between groups (1.2% in BRS group vs. 1.9% in DES group, p=0.6). Occurrence of procedural-related myocardial injury was significantly higher in the BRS group (25% vs. 12%, p=0.001), although it was not related to DOCE (HR 1.1, 95%CI 0.97-1.2, p=0.2). Imaging techniques and enhanced stent visualization systems were significantly more employed in the BRS group (p=0.0001 for both). Procedure length, fluoroscopy time and contrast dye amount were significantly higher in the BRS group (p=0.001, p=0.001 and p=0.01, respectively). CONCLUSIONS: Overlapping BRS utilization in long coronary lesions showed a comparable DOCE rate at 1year if compared to second generation DES. Further and larger studies are on demand to confirm our findings.
BACKGROUND: Randomized clinical trials on bioresorbable scaffolds (BRS) enrolled patients with simple coronary lesions. The present study was sought to give preliminary findings about safety of BRS implantation in overlap in long coronary lesions. METHODS: From June 2012 to January 2015, we prospectively collected data from 162 consecutive patients receiving overlapping BRS implantation in the 16 participating institutions. We applied a propensity-score to match BRS-treated patients with 162 patients receiving second generation drug eluting stents (DES) in overlap. The primary endpoint was a device-oriented endpoint (DOCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization. RESULTS: DOCE rate did not significantly differ between the two groups (5.6% in BRS group vs. 7.4% in DES group, HR 0.79, 95%CI 0.37-3.55, p=0.6). Also stent/scaffold thrombosis did not differ between groups (1.2% in BRS group vs. 1.9% in DES group, p=0.6). Occurrence of procedural-related myocardial injury was significantly higher in the BRS group (25% vs. 12%, p=0.001), although it was not related to DOCE (HR 1.1, 95%CI 0.97-1.2, p=0.2). Imaging techniques and enhanced stent visualization systems were significantly more employed in the BRS group (p=0.0001 for both). Procedure length, fluoroscopy time and contrast dye amount were significantly higher in the BRS group (p=0.001, p=0.001 and p=0.01, respectively). CONCLUSIONS: Overlapping BRS utilization in long coronary lesions showed a comparable DOCE rate at 1year if compared to second generation DES. Further and larger studies are on demand to confirm our findings.
Authors: Gioel Gabrio Secco; Monica Verdoia; Gianfranco Pistis; Giuseppe De Luca; Matteo Vercellino; Andrea Audo; Rosario Parisi; Maurizio Reale; Giorgio Ballestrero; Paolo Nicola Marino; Carlo Di Mario Journal: J Thorac Dis Date: 2017-08 Impact factor: 2.895
Authors: Daniel Dalos; Clemens Gangl; Christian Roth; Lisa Krenn; Sabine Scherzer; Markus Vertesich; Irene Lang; Gerald Maurer; Thomas Neunteufl; Rudolf Berger; Georg Delle-Karth Journal: BMC Cardiovasc Disord Date: 2016-05-25 Impact factor: 2.298