TY - JOUR
T1 - Impact of Coronary Calcification on Clinical Outcomes After Implantation of Newer-Generation Drug-Eluting Stents
AU - Hemetsberger, Rayyan
AU - Abdelghani, Mohammad
AU - Toelg, Ralph
AU - Mankerious, Nader
AU - Allali, Abdelhakim
AU - Garcia-Garcia, Hector M.
AU - Windecker, Stephan
AU - Lefèvre, Thierry
AU - Saito, Shigeru
AU - Slagboom, Ton
AU - Kandzari, David
AU - Koolen, Jacques
AU - Waksman, Ron
AU - Richardt, Gert
N1 - Funding Information: The trials complied with the provisions of the Declaration of Helsinki and were approved by the institutional review board or ethics committee at each enrolling site. Eligible patients signed written informed consent. An independent clinical events committee adjudicated all clinical end points. An independent core laboratory (MedStar Cardiovascular Research Network, Angiographic Core Laboratory, Washington, DC) analyzed all angiographic data. The trials were funded by Biotronik. The authors (R.H., R.T., G.R.) had unrestricted access to the data and are responsible for the analyses and drafting of the article. The data that support the findings of this study are available from the corresponding author upon reasonable request after obtaining the approval of the study sponsor. Funding Information: This study was sponsored by Biotronik. Publisher Copyright: © 2021 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/6/15
Y1 - 2021/6/15
N2 - Background Percutaneous coronary intervention of calcified lesions was associated with worse outcomes in the era of bare-metal and first-generation drug-eluting stents. Data on percutaneous coronary intervention of calcified lesions with newer-generation drug-eluting stents are scarce. Therefore, we investigated the impact of lesion calcification on clinical outcomes in patients undergoing percutaneous coronary intervention with a bioresorbable-polymer sirolimus-eluting stent or a durable-polymer everolimus-eluting stent. Methods and Results Patients (n=2361) from BIOFLOW II, IV, and V trials were categorized into moderate/severe versus none/mild lesion calcification by a core laboratory. End points were target-lesion failure (TLF) (cardiac death, target-vessel myocardial infarction, or target-lesion revascularization) and probable/definite stent thrombosis at 2 years. The agreement in calcification assessment between the operator and the core laboratory was weak (weighted κ, 0.23). Patients with moderate/severe calcification (n=303; 16%) had higher TLF (13.5% versus 8.4%; P=0.003) and stent thrombosis rates (2.1% versus 0.2%; P<0.0001), whereas target-lesion revascularization was not different between the groups (5.0% versus 3.9%; P=0.302). After adjustment, calcification did not emerge as an independent predictor of TLF (adjusted hazard ratio [aHR], 1.37; 95% CI, 0.89-2.08; P=0.148) but did for target-vessel myocardial infarction (aHR, 1.66; 95% CI, 1.03-2.68; P=0.037). TLF rates were similar between bioresorbable-polymer sirolimus-eluting stent and durable-polymer everolimus-eluting stent (12.6% versus 15.4%, P=0.482) in moderate/severe calcification. In none/mild calcification, the bioresorbable-polymer sirolimus-eluting stent showed lower TLF (7.5% versus 10.3%, P=0.045). Conclusions With newer-generation drug-eluting stents, moderate/severe lesion calcification was not associated with more TLF after adjustment for the higher risk of patients with coronary calcification, whereas the rate of target-vessel myocardial infarction was higher. The bioresorbable-polymer sirolimus-eluting stent and durable-polymer everolimus-eluting stent were equally effective and safe in calcified lesions. Registration URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01356888, NCT01939249, NCT02389946.
AB - Background Percutaneous coronary intervention of calcified lesions was associated with worse outcomes in the era of bare-metal and first-generation drug-eluting stents. Data on percutaneous coronary intervention of calcified lesions with newer-generation drug-eluting stents are scarce. Therefore, we investigated the impact of lesion calcification on clinical outcomes in patients undergoing percutaneous coronary intervention with a bioresorbable-polymer sirolimus-eluting stent or a durable-polymer everolimus-eluting stent. Methods and Results Patients (n=2361) from BIOFLOW II, IV, and V trials were categorized into moderate/severe versus none/mild lesion calcification by a core laboratory. End points were target-lesion failure (TLF) (cardiac death, target-vessel myocardial infarction, or target-lesion revascularization) and probable/definite stent thrombosis at 2 years. The agreement in calcification assessment between the operator and the core laboratory was weak (weighted κ, 0.23). Patients with moderate/severe calcification (n=303; 16%) had higher TLF (13.5% versus 8.4%; P=0.003) and stent thrombosis rates (2.1% versus 0.2%; P<0.0001), whereas target-lesion revascularization was not different between the groups (5.0% versus 3.9%; P=0.302). After adjustment, calcification did not emerge as an independent predictor of TLF (adjusted hazard ratio [aHR], 1.37; 95% CI, 0.89-2.08; P=0.148) but did for target-vessel myocardial infarction (aHR, 1.66; 95% CI, 1.03-2.68; P=0.037). TLF rates were similar between bioresorbable-polymer sirolimus-eluting stent and durable-polymer everolimus-eluting stent (12.6% versus 15.4%, P=0.482) in moderate/severe calcification. In none/mild calcification, the bioresorbable-polymer sirolimus-eluting stent showed lower TLF (7.5% versus 10.3%, P=0.045). Conclusions With newer-generation drug-eluting stents, moderate/severe lesion calcification was not associated with more TLF after adjustment for the higher risk of patients with coronary calcification, whereas the rate of target-vessel myocardial infarction was higher. The bioresorbable-polymer sirolimus-eluting stent and durable-polymer everolimus-eluting stent were equally effective and safe in calcified lesions. Registration URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01356888, NCT01939249, NCT02389946.
KW - BIOFLOW
KW - Calcified coronary lesion
KW - Newer-generation drug eluting stent
KW - Orsiro
KW - Xience
UR - http://www.scopus.com/inward/record.url?scp=85108303686&partnerID=8YFLogxK
U2 - https://doi.org/10.1161/JAHA.120.019815
DO - https://doi.org/10.1161/JAHA.120.019815
M3 - Article
C2 - 34056911
SN - 2047-9980
VL - 10
SP - e019815
JO - Journal of the American Heart Association
JF - Journal of the American Heart Association
IS - 12
M1 - e019815
ER -