Sex differences in 1-year clinical outcomes after percutaneous coronary intervention with COMBO stents: From the COMBO collaboration.
anti-CD34 antibodies
dual therapy stent
endothelial progenitor cell capture
percutaneous coronary intervention
sex differences
Journal
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139
Informations de publication
Date de publication:
01 04 2021
01 04 2021
Historique:
received:
03
03
2020
accepted:
09
03
2020
pubmed:
22
3
2020
medline:
25
9
2021
entrez:
22
3
2020
Statut:
ppublish
Résumé
The COMBO drug eluting stent is a novel device with luminal endothelial progenitor cell capture technology for rapid homogeneous endothelialization. We examined for sex differences in 1-year outcomes after COMBO stenting from the COMBO collaboration, a pooled patient-level dataset from the MASCOT and REMEDEE multicenter registries. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel-myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR). Secondary outcomes included stent thrombosis (ST). Adjusted outcomes were assessed using Cox regression methods. The study included 861 (23.8%) women and 2,753 (76.2%) men. Women were older with higher prevalence of several comorbidities including diabetes mellitus. Risk of 1-year TLF was similar in both sexes (3.8% vs. 3.9%, HR 0.92, 95% CI 0.59-1.42, p = .70), without sex differences in the incidence of cardiac death (1.6% vs. 1.5%, p = .78), TV-MI (1.5% vs. 1.1%, p = .32), or CD-TLR (2.0% vs. 2.2%, p = .67). Definite or probable ST occurred in 0.4% women and 1.0% men (HR 0.26, 95% CI 0.06-1.11, p = .069). Despite greater clinical risks at baseline, women treated with COMBO stents had similarly low 1-year TLF and other ischemic outcomes compared to men.
Sections du résumé
BACKGROUND
The COMBO drug eluting stent is a novel device with luminal endothelial progenitor cell capture technology for rapid homogeneous endothelialization.
METHODS AND RESULTS
We examined for sex differences in 1-year outcomes after COMBO stenting from the COMBO collaboration, a pooled patient-level dataset from the MASCOT and REMEDEE multicenter registries. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel-myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR). Secondary outcomes included stent thrombosis (ST). Adjusted outcomes were assessed using Cox regression methods. The study included 861 (23.8%) women and 2,753 (76.2%) men. Women were older with higher prevalence of several comorbidities including diabetes mellitus. Risk of 1-year TLF was similar in both sexes (3.8% vs. 3.9%, HR 0.92, 95% CI 0.59-1.42, p = .70), without sex differences in the incidence of cardiac death (1.6% vs. 1.5%, p = .78), TV-MI (1.5% vs. 1.1%, p = .32), or CD-TLR (2.0% vs. 2.2%, p = .67). Definite or probable ST occurred in 0.4% women and 1.0% men (HR 0.26, 95% CI 0.06-1.11, p = .069).
CONCLUSIONS
Despite greater clinical risks at baseline, women treated with COMBO stents had similarly low 1-year TLF and other ischemic outcomes compared to men.
Banques de données
ClinicalTrials.gov
['NCT01874002', 'NCT02183454']
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
797-804Subventions
Organisme : OrbusNeich Medical; OrbusNeich Medical BV
Organisme : OrbusNeich Medical
Organisme : OrbusNeich Medical BV
Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2020 Wiley Periodicals, Inc.
Références
Hess CN, McCoy LA, Duggirala HJ, et al. Sex-based differences in outcomes after percutaneous coronary intervention for acute myocardial infarction: a report from TRANSLATE-ACS. J Am Heart Assoc. 2014;3:e000523.
Farhan S, Baber U, Vogel B, et al. Impact of diabetes mellitus on ischemic events in men and women after percutaneous coronary intervention. Am J Cardiol. 2017;119:1166-1172.
Baber U, Giustino G, Sartori S, et al. Effect of chronic kidney disease in women undergoing percutaneous coronary intervention with drug-eluting stents: a patient-level pooled analysis of randomized controlled trials. JACC Cardiovasc Interv. 2016;9:28-38.
Giustino G, Harari R, Baber U, et al. Long-term safety and efficacy of new-generation drug-eluting stents in women with acute myocardial infarction: from the women in innovation and drug-eluting stents (WIN-DES) collaboration. JAMA Cardiol. 2017;2:855-862.
Giustino G, Baber U, Aquino M, et al. Safety and efficacy of new-generation drug-eluting stents in women undergoing complex percutaneous coronary artery revascularization: from the WIN-DES collaborative patient-level pooled analysis. JACC Cardiovasc Interv. 2016;9:674-684.
Fadini GP, de Kreutzenberg S, Albiero M, et al. Gender differences in endothelial progenitor cells and cardiovascular risk profile: the role of female estrogens. Arterioscler Thromb Vasc Biol. 2008;28:997-1004.
Topel ML, Hayek SS, Ko YA, et al. Sex differences in circulating progenitor cells. J Am Heart Assoc. 2017;6:e006245.
de Winter RJ, Chandrasekhar J, Kalkman DN, et al. 1-Year clinical outcomes of all-comer patients treated with the dual-therapy COMBO stent: primary results of the COMBO collaboration. JACC Cardiovasc Interv. 2018;11:1969-1978.
Woudstra P, Kalkman DN, den Heijer P, et al. 1-Year results of the REMEDEE registry: clinical outcomes after deployment of the abluminal sirolimus-coated bioengineered (Combo) stent in a multicenter, prospective all-comers registry. JACC Cardiovasc Interv. 2016;9:1127-1134.
Colombo A, Chandrasekhar J, Aquino M, et al. Safety and efficacy of the COMBO bio-engineered stent in an all-comer PCI cohort: 1-year final clinical outcomes from the MASCOT post-marketing registry. Int J Cardiol. 2019;283:67-72.
Nakazawa G, Granada JF, Alviar CL, et al. Anti-CD34 antibodies immobilized on the surface of sirolimus-eluting stents enhance stent endothelialization. JACC Cardiovasc Interv. 2010;3:68-75.
Granada JF, Inami S, Aboodi MS, et al. Development of a novel prohealing stent designed to deliver sirolimus from a biodegradable abluminal matrix. Circ Cardiovasc Interv. 2010;3:257-266.
Cutlip DE, Windecker S, Mehran R, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115:2344-2351.
Thygesen K, Alpert JS, Jaffe AS, et al. Third universal definition of myocardial infarction. J Am Coll Cardiol. 2012;60:1581-1598.
Rao SV, Hess CN, Barham B, et al. A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention: the SAFE-PCI for women (study of access site for enhancement of PCI for women) trial. JACC Cardiovasc Interv. 2014;7:857-867.
Zanchin C, Ueki Y, Zanchin T, et al. Everolimus-eluting biodegradable polymer versus everolimus-eluting durable polymer stent for coronary revascularization in routine clinical practice. JACC Cardiovasc Interv. 2019;12:1665-1675.
von Birgelen C, Zocca P, Buiten RA, et al. Thin composite wire strut, durable polymer-coated (resolute onyx) versus ultrathin cobalt-chromium strut, bioresorbable polymer-coated (Orsiro) drug-eluting stents in allcomers with coronary artery disease (BIONYX): an international, single-blind, randomised non-inferiority trial. Lancet. 2018;392:1235-1245.
Hoetzer GL, MacEneaney OJ, Irmiger HM, et al. Gender differences in circulating endothelial progenitor cell colony-forming capacity and migratory activity in middle-aged adults. Am J Cardiol. 2007;99:46-48.
Mehran R, Chandrasekhar J, Urban P, et al. Sex-based outcomes in patients at high bleeding risk: results from the LEADERS FREE randomized controlled trial. JAMA Cardiol. 2020; 5(8):1-10.
Shreenivas S, Kereiakes DJ, Ellis SG, et al. Efficacy and safety of the absorb bioresorbable vascular scaffold in females and males: results of an individual patient-level pooled meta-analysis of randomized controlled trials. JACC Cardiovasc Interv. 2017;10:1881-1890.
Kerkmeijer LSM, Tijssen RYG, Hofma SH, et al. A paradox in sex-specific clinical outcomes after bioresorbable scaffold implantation: 2-year results from the AIDA trial. Int J Cardiol. 2019;300:93-98. https://doi.org/10.1016/j.ijcard.2019.08.045.
De Luca G, Damen SA, Camaro C, et al. Final results of the Randomised Evaluation of short-term DUal antiplatelet therapy in patients with acute Coronary syndromE treated with a new generation stent (REDUCE) trial. EuroIntervention. 2019;15(11):e990-e998. https://doi.org/10.4244/EIJ-D-19-00539.