Yuki Ishibashi1, Shimpei Nakatani1, Yohei Sotomi2, Pannipa Suwannasom3, Maik J Grundeken2, Hector M Garcia-Garcia1, Antonio L Bartorelli4, Robert Whitbourn5, Bernard Chevalier6, Alexandre Abizaid7, John A Ormiston8, Richard J Rapoza9, Susan Veldhof10, Yoshinobu Onuma11, Patrick W Serruys12. 1. Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands. 2. Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands. 3. Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands; Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; 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. 5. St. Vincent's Hospital, Fitzroy, Victoria, Australia. 6. Institut Cardiovasculaire Paris Sud, Massy, France. 7. Instituto de Cardiologia Dante Pazzanese, São Paulo, Brazil. 8. Auckland City Hospital, Auckland, New Zealand. 9. Abbott Vascular, Santa Clara, California. 10. Abbott Vascular, Diegem, Belgium. 11. Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands. Electronic address: yoshinobuonuma@gmail.com. 12. International Centre for Cardiovascular Health, Imperial College, London, United Kingdom.
Abstract
OBJECTIVES: This study sought to investigate the clinical outcomes based on the assessment of quantitative coronary angiography-maximal lumen diameter (Dmax). BACKGROUND: Assessment of pre-procedural Dmax of proximal and distal sites has been used for Absorb scaffold size selection in the ABSORB studies. METHODS: A 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. RESULTS: Of 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). CONCLUSIONS: Implantation 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).
RCT Entities:
OBJECTIVES: This study sought to investigate the clinical outcomes based on the assessment of quantitative coronary angiography-maximal lumen diameter (Dmax). BACKGROUND: Assessment of pre-procedural Dmax of proximal and distal sites has been used for Absorb scaffold size selection in the ABSORB studies. METHODS: A 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. RESULTS: Of 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). CONCLUSIONS: Implantation 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).
Authors: Łukasz Rzeszutko; Zbigniew Siudak; Tomasz Tokarek; Krzysztof Plens; Adrian Włodarczak; Andrzej Lekston; Andrzej Ochała; Robert J Gil; Wojciech Balak; Dariusz Dudek Journal: Postepy Kardiol Interwencyjnej Date: 2016-05-11 Impact factor: 1.426
Authors: Jung Min Ahn; Duk Woo Park; Sung Jin Hong; Young Keun Ahn; Joo Yong Hahn; Won Jang Kim; Soon Jun Hong; Chang Wook Nam; Do Yoon Kang; Seung Yul Lee; Woo Jung Chun; Jung Ho Heo; Deok Kyu Cho; Jin Won Kim; Sung Ho Her; Sang Wook Kim; Sang Yong Yoo; Myeong Ki Hong; Seung Jea Tahk; Kee Sik Kim; Moo Hyun Kim; Yangsoo Jang; Seung Jung Park Journal: Korean Circ J Date: 2017-11-06 Impact factor: 3.243