Relation Between Bioresorbable Scaffold Sizing Using QCA-Dmax and Clinical Outcomes at 1 Year in 1,232 Patients From 3 Study Cohorts (ABSORB Cohort B,ABSORB EXTEND,and ABSORB II) |
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Institution: | 1. Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands;2. Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands;3. Northern Region Heart Center, Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand;4. Centro Cardiologico Monzino, IRCCS, University of Milan, Milan, Italy;6. St. Vincent’s Hospital, Fitzroy, Victoria, Australia;5. Institut Cardiovasculaire Paris Sud, Massy, France;7. Auckland City Hospital, Auckland, New Zealand;11. Abbott Vascular, Santa Clara, California;12. Abbott Vascular, Diegem, Belgium;8. International Centre for Cardiovascular Health, Imperial College, London, United Kingdom |
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Abstract: | ObjectivesThis study sought to investigate the clinical outcomes based on the assessment of quantitative coronary angiography–maximal lumen diameter (Dmax).BackgroundAssessment of pre-procedural Dmax of proximal and distal sites has been used for Absorb scaffold size selection in the ABSORB studies.MethodsA total of 1,248 patients received Absorb scaffolds in the ABSORB Cohort B (ABSORB Clinical Investigation, Cohort B) study (N = 101), ABSORB EXTEND (ABSORB EXTEND Clinical Investigation) study (N = 812), and ABSORB II (ABSORB II Randomized Controlled Trial) trial (N = 335). The incidence of major adverse cardiac events (MACE) (a composite of cardiac death, any myocardial infarction MI], and ischemia-driven target lesion revascularization) was analyzed according to the Dmax subclassification of scaffold oversize group versus scaffold nonoversize group.ResultsOf 1,248 patients, pre-procedural Dmax was assessed in 1,232 patients (98.7%). In 649 (52.7%) patients, both proximal and distal Dmax values were smaller than the nominal size of the implanted scaffold (scaffold oversize group), whereas in 583 (47.3%) of patients, the proximal and/or distal Dmax were larger than the implanted scaffold (scaffold nonoversize group). The rates of MACE and MI at 1 year were significantly higher in the scaffold oversize group than in the scaffold nonoversize group (MACE 6.6% vs. 3.3%; log-rank p < 0.01, all MI: 4.6% vs. 2.4%; log-rank p = 0.04), mainly driven by a higher MI rate within 1 month post-procedure (3.5% vs. 1.9%; p = 0.08). The independent MACE determinants were both Dmax smaller than the scaffold nominal size (odds ratio OR]: 2.13, 95% confidence interval CI]: 1.22 to 3.70; p < 0.01) and the implantation of overlapping scaffolds (OR: 2.10, 95% CI: 1.17 to 3.80; p = 0.01).ConclusionsImplantation of an oversized Absorb scaffold in a relatively small vessel appears to be associated with a higher 1-year MACE rate driven by more frequent early MI. (ABSORB Clinical Investigation, Cohort B ABSORB Cohort B], NCT00856856; ABSORB EXTEND Clinical Investigation ABSORB EXTEND], NCT01023789; ABSORB II Randomized Controlled Trial ABSORB II], NCT01425281) |
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Keywords: | bioresorbable scaffold major adverse cardiac event(s) maximal lumen diameter CI"} {"#name":"keyword" "$":{"id":"kwrd0030"} "$$":[{"#name":"text" "_":"confidence interval Dmax"} {"#name":"keyword" "$":{"id":"kwrd0040"} "$$":[{"#name":"text" "_":"maximal lumen diameter ID"} {"#name":"keyword" "$":{"id":"kwrd0050"} "$$":[{"#name":"text" "_":"ischemia-driven MACE"} {"#name":"keyword" "$":{"id":"kwrd0060"} "$$":[{"#name":"text" "_":"major adverse cardiac event(s) MI"} {"#name":"keyword" "$":{"id":"kwrd0070"} "$$":[{"#name":"text" "_":"myocardial infarction MLD"} {"#name":"keyword" "$":{"id":"kwrd0080"} "$$":[{"#name":"text" "_":"minimal lumen diameter OCT"} {"#name":"keyword" "$":{"id":"kwrd0090"} "$$":[{"#name":"text" "_":"optical coherence tomography PMI"} {"#name":"keyword" "$":{"id":"kwrd0100"} "$$":[{"#name":"text" "_":"periprocedural myocardial infarction QCA"} {"#name":"keyword" "$":{"id":"kwrd0110"} "$$":[{"#name":"text" "_":"quantitative coronary angiography OR"} {"#name":"keyword" "$":{"id":"kwrd0120"} "$$":[{"#name":"text" "_":"odds ratio ST"} {"#name":"keyword" "$":{"id":"kwrd0130"} "$$":[{"#name":"text" "_":"scaffold thrombosis TLR"} {"#name":"keyword" "$":{"id":"kwrd0140"} "$$":[{"#name":"text" "_":"target lesion revascularization TVMI"} {"#name":"keyword" "$":{"id":"kwrd0150"} "$$":[{"#name":"text" "_":"target vessel myocardial infarction |
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