Author + information
- Received September 9, 2018
- Revision received September 18, 2018
- Accepted September 18, 2018
- Published online September 23, 2018.
- David E. Kandzari, M.D.a,∗ (, )@Kandzari@PiedmontHealth,
- Jacques J. Koolen, M.D., Ph.D.b,
- Gheorghe Doros, Ph.D.c,
- Joseph J. Massaro, Ph.D.d,
- Hector M. Garcia-Garcia, MD, Ph.D.e,
- Johan Bennett, M.D., Ph.D.f,
- Ariel Roguin, M.D., Ph.D.g,
- Elie G. Gharib, M.D.h,
- Donald E. Cutlip, M.D.i,
- Ron Waksman, M.D.e,
- for the BIOFLOW V Investigators
- aPiedmont Heart Institute, Atlanta, GA, USA
- bCatharina Hospital, Eindhoven, Netherlands
- cDepartment of Biostatistics and Epidemiology, Boston University School of Public Health, Baim Institute for Clinical Research, Boston, MA, USA
- dDepartment of Biostatistics and Epidemiology, Boston University School of Public Health, Boston, MA, USA
- eDivision of Interventional Cardiology, MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Washington, DC, USA
- fDepartment of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium
- gDepartment of Cardiology, Rambam Medical Center, Haifa, Israel
- hCharleston Area Medical Center, Charleston, WV, USA
- iBeth Israel Deaconess Medical Center, Baim Institute for Clinical Research, Boston, MA, USA
- ↵∗Address for correspondence: David E. Kandzari, MD Piedmont Heart Institute Suite 2065, 95 Collier Road Atlanta, GA 30309, USA Telephone: +1 404 605 5526 Fax: +1 404 720 0911.
Background Coronary drug-eluting stent development has introduced new metal alloys, changes in stent architecture and bioresorbable polymers. Whether these advancements improve long-term clinical safety and efficacy has been inconsistent in prior studies.
Objectives To compare late-term clinical outcomes among patients treated with an ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stent (BP SES) and a thin strut (81 μm) durable polymer everolimus-eluting stent (DP EES) in a large randomized trial.
Methods BIOFLOW V was an international randomized trial comparing coronary revascularization with BP SES and DP EES regarding the primary endpoint of 12-month target lesion failure (TLF). Analysis of pre-specified 2-year clinical outcomes was performed.
Results Among 1,334 patients randomized to treatment with BP SES (884 patients) or DP EES (450 patients), the two-year TLF rate was 7.5% for BP SES and 11.9% for DP EES (-4.33% treatment difference, 95% CI -8.16% to -0.91%, P=0.015), driven by differences in target vessel myocardial infarction (MI; 5.3% versus 9.5%, P=0.01) and ischemia-driven target lesion revascularization (TLR; 2.6% versus 4.9%, P=0.04). Rates of cardiac death or MI were 7.0% versus 10.4% for BP SES and DP EES, respectively (P=0.047). Late/very late definite stent thrombosis was statistically lower for BP SES compared with DP EES (0.1% versus 1.0%, P=0.045).
Conclusions In a large randomized trial, significant differences in both TLF and target vessel-related MI persisted through 2 years favoring treatment with BP SES over DP EES. Significantly lower cumulative TLR and late/very late stent thrombosis were also observed with BP SES.
Funding Source: Biotronik AG, Bülach, Switzerland
Disclosures: Dr. Kandzari reports institutional research/grant support from Biotronik, Boston Scientific, Medinol, Medtronic, and Orbus Neich; and personal consulting honoraria from Boston Scientific, Cardiovascular Systems, Inc. and Medtronic. Dr. Koolen reports lecturer and consultant fees from Medtronic, and proctoring for Biotronik. Dr. Massaro reports compensation from Biotronik through the Baim Institute for Clinical Research, for aid with the design of the study. Dr. Doros reports consultancy from Pfizer, Sarepta, Novartis, Softworld, and Lipocine. Dr. Cutlip reports contracted research to institution from Medtronic and Boston Scientific. Dr. Waksman reports consultant fees from Abbott Vascular, Amgen, Biosensors, Biotronik, Boston Scientific, Corindus, Lifetech Medical, Medtronic, and Philips Volcano; advisory board for Abbott Vascular, Amgen, Boston Scientific, Medtronic, and Philips Volcano; grant support from Abbott Vascular, Biosensors, Biotronik, Boston Scientific, and Edwards Lifesciences; and speakers bureau from AstraZeneca. Dr. Garcia, Dr. Bennett has received research grants from Abbott Vascular and Biotronik AG and speaking fees from Abbott Vascular, Biotronik AG, Boston Scientific and Terumo. Drs. Gharib and Roguin report no relevant conflicts of interest.
Tweet: 2-year BIOFLOW-V results show significantly lower TLF, TV-MI, and TLR events favoring ultrathin strut BP SES Orsiro vs. thin strut DP EES Xience. New DES standard?
Clinical Trial Registration: NCT02389946
- Received September 9, 2018.
- Revision received September 18, 2018.
- Accepted September 18, 2018.
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