Clinical Outcomes Before and After Complete Everolimus-Eluting Bioresorbable Scaffold Resorption: Five-Year Follow-Up From the ABSORB III Trial
BACKGROUND:The Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) provides early drug delivery and mechanical support similar to those of metallic drug-eluting stents, followed by complete resorption in ≈3 years with recovery of vascular structure and function. The ABSORB III trial demo...
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| Published in | Circulation (New York, N.Y.) Vol. 140; no. 23; pp. 1895 - 1903 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
by the American College of Cardiology Foundation and the American Heart Association, Inc
03.12.2019
|
| Online Access | Get full text |
| ISSN | 0009-7322 1524-4539 1524-4539 |
| DOI | 10.1161/CIRCULATIONAHA.119.042584 |
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| Abstract | BACKGROUND:The Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) provides early drug delivery and mechanical support similar to those of metallic drug-eluting stents, followed by complete resorption in ≈3 years with recovery of vascular structure and function. The ABSORB III trial demonstrated noninferior rates of target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year with BVS compared with cobalt chromium everolimus-eluting stents. Between 1 and 3 years and cumulative to 3 years, adverse event rates (particularly target vessel myocardial infarction and scaffold thrombosis) were increased after BVS. We sought to assess clinical outcomes after BVS through 5 years, including beyond the 3-year time point of complete scaffold resorption.
METHODS:Clinical outcomes from ABSORB III were analyzed by randomized device (intention to treat) cumulative to 5 years and between 3 and 5 years.
RESULTS:Rates of target lesion failure, target vessel myocardial infarction, and scaffold thrombosis were increased through the 5-year follow-up with BVS compared with everolimus-eluting stents. However, between 3 and 5 years, reductions in the relative hazards of the BVS compared with everolimus-eluting stents were observed, particularly for target lesion failure (hazard ratio, 0.83 [95% CI, 0.55–1.24] versus 1.35 [95% CI, 1.02–1.78]; P=0.052) and scaffold thrombosis (hazard ratio, 0.26 [95% CI, 0.02–2.87] versus 3.23 [95% CI, 1.25–8.30]; P=0.056) compared with the 0- to 3-year time period.
CONCLUSIONS:In the ABSORB III trial, cumulative 5-year adverse event rates were increased after BVS compared with everolimus-eluting stents. However, the period of excess risk for BVS ended at 3 years, coincident with complete scaffold resorption.
CLINICAL TRIAL REGISTRATION:URLhttps://clinicaltrials.gov. Unique identifierNCT01751906. |
|---|---|
| AbstractList | BACKGROUND:The Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) provides early drug delivery and mechanical support similar to those of metallic drug-eluting stents, followed by complete resorption in ≈3 years with recovery of vascular structure and function. The ABSORB III trial demonstrated noninferior rates of target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year with BVS compared with cobalt chromium everolimus-eluting stents. Between 1 and 3 years and cumulative to 3 years, adverse event rates (particularly target vessel myocardial infarction and scaffold thrombosis) were increased after BVS. We sought to assess clinical outcomes after BVS through 5 years, including beyond the 3-year time point of complete scaffold resorption.
METHODS:Clinical outcomes from ABSORB III were analyzed by randomized device (intention to treat) cumulative to 5 years and between 3 and 5 years.
RESULTS:Rates of target lesion failure, target vessel myocardial infarction, and scaffold thrombosis were increased through the 5-year follow-up with BVS compared with everolimus-eluting stents. However, between 3 and 5 years, reductions in the relative hazards of the BVS compared with everolimus-eluting stents were observed, particularly for target lesion failure (hazard ratio, 0.83 [95% CI, 0.55–1.24] versus 1.35 [95% CI, 1.02–1.78]; P=0.052) and scaffold thrombosis (hazard ratio, 0.26 [95% CI, 0.02–2.87] versus 3.23 [95% CI, 1.25–8.30]; P=0.056) compared with the 0- to 3-year time period.
CONCLUSIONS:In the ABSORB III trial, cumulative 5-year adverse event rates were increased after BVS compared with everolimus-eluting stents. However, the period of excess risk for BVS ended at 3 years, coincident with complete scaffold resorption.
CLINICAL TRIAL REGISTRATION:URLhttps://clinicaltrials.gov. Unique identifierNCT01751906. The Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) provides early drug delivery and mechanical support similar to those of metallic drug-eluting stents, followed by complete resorption in ≈3 years with recovery of vascular structure and function. The ABSORB III trial demonstrated noninferior rates of target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year with BVS compared with cobalt chromium everolimus-eluting stents. Between 1 and 3 years and cumulative to 3 years, adverse event rates (particularly target vessel myocardial infarction and scaffold thrombosis) were increased after BVS. We sought to assess clinical outcomes after BVS through 5 years, including beyond the 3-year time point of complete scaffold resorption.BACKGROUNDThe Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) provides early drug delivery and mechanical support similar to those of metallic drug-eluting stents, followed by complete resorption in ≈3 years with recovery of vascular structure and function. The ABSORB III trial demonstrated noninferior rates of target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year with BVS compared with cobalt chromium everolimus-eluting stents. Between 1 and 3 years and cumulative to 3 years, adverse event rates (particularly target vessel myocardial infarction and scaffold thrombosis) were increased after BVS. We sought to assess clinical outcomes after BVS through 5 years, including beyond the 3-year time point of complete scaffold resorption.Clinical outcomes from ABSORB III were analyzed by randomized device (intention to treat) cumulative to 5 years and between 3 and 5 years.METHODSClinical outcomes from ABSORB III were analyzed by randomized device (intention to treat) cumulative to 5 years and between 3 and 5 years.Rates of target lesion failure, target vessel myocardial infarction, and scaffold thrombosis were increased through the 5-year follow-up with BVS compared with everolimus-eluting stents. However, between 3 and 5 years, reductions in the relative hazards of the BVS compared with everolimus-eluting stents were observed, particularly for target lesion failure (hazard ratio, 0.83 [95% CI, 0.55-1.24] versus 1.35 [95% CI, 1.02-1.78]; Pint=0.052) and scaffold thrombosis (hazard ratio, 0.26 [95% CI, 0.02-2.87] versus 3.23 [95% CI, 1.25-8.30]; Pint=0.056) compared with the 0- to 3-year time period.RESULTSRates of target lesion failure, target vessel myocardial infarction, and scaffold thrombosis were increased through the 5-year follow-up with BVS compared with everolimus-eluting stents. However, between 3 and 5 years, reductions in the relative hazards of the BVS compared with everolimus-eluting stents were observed, particularly for target lesion failure (hazard ratio, 0.83 [95% CI, 0.55-1.24] versus 1.35 [95% CI, 1.02-1.78]; Pint=0.052) and scaffold thrombosis (hazard ratio, 0.26 [95% CI, 0.02-2.87] versus 3.23 [95% CI, 1.25-8.30]; Pint=0.056) compared with the 0- to 3-year time period.In the ABSORB III trial, cumulative 5-year adverse event rates were increased after BVS compared with everolimus-eluting stents. However, the period of excess risk for BVS ended at 3 years, coincident with complete scaffold resorption.CONCLUSIONSIn the ABSORB III trial, cumulative 5-year adverse event rates were increased after BVS compared with everolimus-eluting stents. However, the period of excess risk for BVS ended at 3 years, coincident with complete scaffold resorption.URL: https://clinicaltrials.gov. Unique identifier: NCT01751906.CLINICAL TRIAL REGISTRATIONURL: https://clinicaltrials.gov. Unique identifier: NCT01751906. |
| Author | Rizik, David G. Simonton, Charles Kabour, Ameer Litt, Marc R. Stone, Gregg W. Ediebah, Divine E. Metzger, D. Christopher Tan, Siok Hwee Popma, Jeffrey J. Teirstein, Paul S. Ellis, Stephen G. Marx, Steven O. Caputo, Ronald P. Kereiakes, Dean J. Kini, Annapoorna |
| AuthorAffiliation | The Christ Hospital Heart and Vascular Center, Lindner Research Center, Cincinnati, OH (D.J.K.). Cleveland Clinic, OH (S.G.E.). Wellmont Holston Valley Medical Center, Kingsport, TN (D.C.M.). St. Joseph’s Hospital Health Center, Liverpool, NY (R.P.C.). Scottsdale Healthcare, AZ (D.G.R.). Scripps Clinic, La Jolla, CA (P.S.T.). Baptist Medical Center, Jacksonville, FL (M.R.L.). Mount Sinai Medical Center, New York (A. Kini). Mercy St. Vincent’s Medical Center, Toledo, OH (A. Kabour). New York Presbyterian Hospital, Columbia University Medical Center and the Cardiovascular Research Foundation (S.O.M., G.W.S.). Beth Israel Deaconess Medical Center, Boston, MA (J.J.P.). Abbott Vascular, Santa Clara, CA (S.H.T., D.E.E., C.S.) |
| AuthorAffiliation_xml | – name: The Christ Hospital Heart and Vascular Center, Lindner Research Center, Cincinnati, OH (D.J.K.). Cleveland Clinic, OH (S.G.E.). Wellmont Holston Valley Medical Center, Kingsport, TN (D.C.M.). St. Joseph’s Hospital Health Center, Liverpool, NY (R.P.C.). Scottsdale Healthcare, AZ (D.G.R.). Scripps Clinic, La Jolla, CA (P.S.T.). Baptist Medical Center, Jacksonville, FL (M.R.L.). Mount Sinai Medical Center, New York (A. Kini). Mercy St. Vincent’s Medical Center, Toledo, OH (A. Kabour). New York Presbyterian Hospital, Columbia University Medical Center and the Cardiovascular Research Foundation (S.O.M., G.W.S.). Beth Israel Deaconess Medical Center, Boston, MA (J.J.P.). Abbott Vascular, Santa Clara, CA (S.H.T., D.E.E., C.S.) |
| Author_xml | – sequence: 1 givenname: Dean surname: Kereiakes middlename: J. fullname: Kereiakes, Dean J. organization: The Christ Hospital Heart and Vascular Center, Lindner Research Center, Cincinnati, OH (D.J.K.). Cleveland Clinic, OH (S.G.E.). Wellmont Holston Valley Medical Center, Kingsport, TN (D.C.M.). St. Joseph’s Hospital Health Center, Liverpool, NY (R.P.C.). Scottsdale Healthcare, AZ (D.G.R.). Scripps Clinic, La Jolla, CA (P.S.T.). Baptist Medical Center, Jacksonville, FL (M.R.L.). Mount Sinai Medical Center, New York (A. Kini). Mercy St. Vincent’s Medical Center, Toledo, OH (A. Kabour). New York Presbyterian Hospital, Columbia University Medical Center and the Cardiovascular Research Foundation (S.O.M., G.W.S.). Beth Israel Deaconess Medical Center, Boston, MA (J.J.P.). Abbott Vascular, Santa Clara, CA (S.H.T., D.E.E., C.S.) – sequence: 2 givenname: Stephen surname: Ellis middlename: G. fullname: Ellis, Stephen G. – sequence: 3 givenname: D. surname: Metzger middlename: Christopher fullname: Metzger, D. Christopher – sequence: 4 givenname: Ronald surname: Caputo middlename: P. fullname: Caputo, Ronald P. – sequence: 5 givenname: David surname: Rizik middlename: G. fullname: Rizik, David G. – sequence: 6 givenname: Paul surname: Teirstein middlename: S. fullname: Teirstein, Paul S. – sequence: 7 givenname: Marc surname: Litt middlename: R. fullname: Litt, Marc R. – sequence: 8 givenname: Annapoorna surname: Kini fullname: Kini, Annapoorna – sequence: 9 givenname: Ameer surname: Kabour fullname: Kabour, Ameer – sequence: 10 givenname: Steven surname: Marx middlename: O. fullname: Marx, Steven O. – sequence: 11 givenname: Jeffrey surname: Popma middlename: J. fullname: Popma, Jeffrey J. – sequence: 12 givenname: Siok surname: Tan middlename: Hwee fullname: Tan, Siok Hwee – sequence: 13 givenname: Divine surname: Ediebah middlename: E. fullname: Ediebah, Divine E. – sequence: 14 givenname: Charles surname: Simonton fullname: Simonton, Charles – sequence: 15 givenname: Gregg surname: Stone middlename: W. fullname: Stone, Gregg W. |
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| Cites_doi | 10.1016/j.jacc.2011.01.011 10.1016/S0140-6736(16)32050-5 10.1016/j.jacc.2017.10.010 10.1016/j.jacc.2015.11.060 10.1161/CIRCINTERVENTIONS.119.008152 10.1016/j.ahj.2015.07.013 10.1016/j.jacc.2014.09.029 10.1056/NEJMsr1203730 10.1016/j.jacc.2015.04.017 10.1007/978-1-4419-6646-9 10.1016/j.jcin.2019.04.054 10.1161/CIRCULATIONAHA.117.031843 10.1016/j.jacc.2015.08.853 10.1056/NEJMoa1509038 10.1001/jamacardio.2016.5208 10.1161/CIRCULATIONAHA.116.021539 10.1161/CIRCULATIONAHA.113.001790 10.1016/j.jacc.2018.02.051 10.1161/CIRCINTERVENTIONS.110.958249 10.1161/CIRCULATIONAHA.112.097014 10.1016/j.jcin.2016.01.008 |
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| Snippet | BACKGROUND:The Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) provides early drug delivery and mechanical support similar to those of metallic... The Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) provides early drug delivery and mechanical support similar to those of metallic... |
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| Title | Clinical Outcomes Before and After Complete Everolimus-Eluting Bioresorbable Scaffold Resorption: Five-Year Follow-Up From the ABSORB III Trial |
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