Safety and efficacy of polymer-free biolimus-eluting stents versus ultrathin stents in unprotected left main or coronary bifurcation: A propensity score analysis from the RAIN and CHANCE registries: Catheterization and Cardiovascular Interventions

F. D'Ascenzo; L. Gaido; A. Bernardi; A. Saglietto; A. Franzé; A. Ielasi; D. Trabattoni; M. Di Biasi; V. Infantino; A. Rognoni; G. Helft; A. Gangor; R.A. Latini; L. De Luca; S. Mitomo; F. Ugo; G. Smolka; Z. Huczek; B. Cortese; D. Capodanno; A. Chieffo; F. Piazza; C. di Mario; A. Poli; M. D'Urbano; F. Romeo; M. Giammaria; F. Varbella; I. Sheiban; J. Escaned; G.M. De Ferrari

doi:10.1002/ccd.28413

Safety and efficacy of polymer-free biolimus-eluting stents versus ultrathin stents in unprotected left main or coronary bifurcation: A propensity score analysis from the RAIN and CHANCE registries: Catheterization and Cardiovascular Interventions

F. D'Ascenzo, L. Gaido, A. Bernardi, A. Saglietto, A. Franzé, A. Ielasi, D. Trabattoni, M. Di Biasi, V. Infantino, A. Rognoni, G. Helft, A. Gangor, R.A. Latini, L. De Luca, S. Mitomo, F. Ugo, G. Smolka, Z. Huczek, B. Cortese, D. CapodannoA. Chieffo, F. Piazza, C. di Mario, A. Poli, M. D'Urbano, F. Romeo, M. Giammaria, F. Varbella, I. Sheiban, J. Escaned, G.M. De Ferrari

Research output: Contribution to journal › Article › peer-review

Abstract

Objectives: Evaluate safety and efficacy of polymer-free biolimus-eluting stents (PF-BESs) versus ultrathin stents in unprotected left main (ULM) or bifurcation. Background: PF-BESs due to reduced length of dual antiplatelet therapy (DAPT) are increasingly used. However, there are limited data about safety and efficacy for ULM or bifurcation. Methods: We selected all-patients treated for ULM or bifurcation from two multicenter real life registries (RAIN [NCT03544294] evaluating ultrathin stents, CHANCE [NCT03622203] appraising PF-BES). After propensity score with matching, the primary endpoint was major adverse cardiac events (MACE; a composite of all-cause death, myocardial infarction, target lesion revascularization [TLR], and stent thrombosis [ST]), while its components along with target vessel revascularization (TVR) secondary endpoints. Results: Three thousand and three patients treated with ultrathin stents and 446 with PF-BESs, resulting respectively in 562 and 281 after propensity score with matching (33 and 22%, respectively, with ULM disease). After 12 (8–20) months, rates of MACE were similar (9 vs. 8%, p = 0.56) without difference in TLR and ST (3.0 vs. 1.7%, p =.19 and 1.8 vs. 1.1%, p =.42). These results were consistent for ULM group (3 vs. 1.7% and 1.8 vs. 1.1%, p =.49 and.76), for non-ULM group (2.1 vs. 3.4%, p =.56 and 1.2 vs. 1.7%, p =.78) and for two-stent strategy (8.7 vs. 4.5% and 4.3 vs. 3.2%, p =.75 and.91). Among patients treated with 1 month of DAPT in both groups, those with ultrathin stents experienced higher rates of MACE related to all-cause death (22 vs. 12%, p =.04) with higher although not significant rates of ST (3 vs. 0%, p =.45). Conclusions: PF-BES implanted on ULM or BiF offered freedom from TLR and ST comparable to ultrathin stents. PF-BESs patients assuming DAPT for 1 month experienced a lower despite not significant incidence of ST. © 2019 Wiley Periodicals, Inc.

Original language	English
Pages (from-to)	522-529
Number of pages	8
Journal	Catheter. Cardiovasc. Interventions
Volume	95
Issue number	3
DOIs	https://doi.org/10.1002/ccd.28413
Publication status	Published - 2020

Keywords

coronary artery disease
drug eluting stent
percutaneous coronary intervention
percutaneous coronary intervention complex
stent restenosis
stent thrombosis
aged
all cause mortality
Article
controlled study
coronary bifurcation lesion
dual antiplatelet therapy
female
human
left anterior descending coronary artery
left coronary artery
major adverse cardiac event
major clinical study
male
non ST segment elevation myocardial infarction
propensity score
ST segment elevation myocardial infarction
stable angina pectoris
target lesion revascularization
unprotected left main coronary artery
unstable angina pectoris
adverse event
clinical protocol
clinical trial
comparative study
devices
diagnostic imaging
middle aged
mortality
multicenter study
pathophysiology
prosthesis design
register
retrospective study
risk assessment
risk factor
time factor
very elderly
cardiovascular agent
rapamycin
umirolimus
Aged
Aged, 80 and over
Cardiovascular Agents
Clinical Protocols
Coronary Artery Disease
Drug-Eluting Stents
Female
Humans
Male
Middle Aged
Percutaneous Coronary Intervention
Propensity Score
Prosthesis Design
Registries
Retrospective Studies
Risk Assessment
Risk Factors
Sirolimus
Time Factors

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D'Ascenzo, F., Gaido, L., Bernardi, A., Saglietto, A., Franzé, A., Ielasi, A., Trabattoni, D., Di Biasi, M., Infantino, V., Rognoni, A., Helft, G., Gangor, A., Latini, R. A., De Luca, L., Mitomo, S., Ugo, F., Smolka, G., Huczek, Z., Cortese, B., ... De Ferrari, G. M. (2020). Safety and efficacy of polymer-free biolimus-eluting stents versus ultrathin stents in unprotected left main or coronary bifurcation: A propensity score analysis from the RAIN and CHANCE registries: Catheterization and Cardiovascular Interventions. Catheter. Cardiovasc. Interventions, 95(3), 522-529. https://doi.org/10.1002/ccd.28413

Safety and efficacy of polymer-free biolimus-eluting stents versus ultrathin stents in unprotected left main or coronary bifurcation: A propensity score analysis from the RAIN and CHANCE registries : Catheterization and Cardiovascular Interventions. / D'Ascenzo, F.; Gaido, L.; Bernardi, A.; Saglietto, A.; Franzé, A.; Ielasi, A.; Trabattoni, D.; Di Biasi, M.; Infantino, V.; Rognoni, A.; Helft, G.; Gangor, A.; Latini, R.A.; De Luca, L.; Mitomo, S.; Ugo, F.; Smolka, G.; Huczek, Z.; Cortese, B.; Capodanno, D.; Chieffo, A.; Piazza, F.; di Mario, C.; Poli, A.; D'Urbano, M.; Romeo, F.; Giammaria, M.; Varbella, F.; Sheiban, I.; Escaned, J.; De Ferrari, G.M.

In: Catheter. Cardiovasc. Interventions, Vol. 95, No. 3, 2020, p. 522-529.

Research output: Contribution to journal › Article › peer-review

D'Ascenzo, F, Gaido, L, Bernardi, A, Saglietto, A, Franzé, A, Ielasi, A, Trabattoni, D, Di Biasi, M, Infantino, V, Rognoni, A, Helft, G, Gangor, A, Latini, RA , De Luca, L, Mitomo, S, Ugo, F, Smolka, G, Huczek, Z, Cortese, B, Capodanno, D, Chieffo, A, Piazza, F, di Mario, C, Poli, A, D'Urbano, M, Romeo, F, Giammaria, M, Varbella, F, Sheiban, I, Escaned, J & De Ferrari, GM 2020, 'Safety and efficacy of polymer-free biolimus-eluting stents versus ultrathin stents in unprotected left main or coronary bifurcation: A propensity score analysis from the RAIN and CHANCE registries: Catheterization and Cardiovascular Interventions', Catheter. Cardiovasc. Interventions, vol. 95, no. 3, pp. 522-529. https://doi.org/10.1002/ccd.28413

D'Ascenzo F, Gaido L, Bernardi A, Saglietto A, Franzé A, Ielasi A et al. Safety and efficacy of polymer-free biolimus-eluting stents versus ultrathin stents in unprotected left main or coronary bifurcation: A propensity score analysis from the RAIN and CHANCE registries: Catheterization and Cardiovascular Interventions. Catheter. Cardiovasc. Interventions. 2020;95(3):522-529. https://doi.org/10.1002/ccd.28413

D'Ascenzo, F. ; Gaido, L. ; Bernardi, A. ; Saglietto, A. ; Franzé, A. ; Ielasi, A. ; Trabattoni, D. ; Di Biasi, M. ; Infantino, V. ; Rognoni, A. ; Helft, G. ; Gangor, A. ; Latini, R.A. ; De Luca, L. ; Mitomo, S. ; Ugo, F. ; Smolka, G. ; Huczek, Z. ; Cortese, B. ; Capodanno, D. ; Chieffo, A. ; Piazza, F. ; di Mario, C. ; Poli, A. ; D'Urbano, M. ; Romeo, F. ; Giammaria, M. ; Varbella, F. ; Sheiban, I. ; Escaned, J. ; De Ferrari, G.M. / Safety and efficacy of polymer-free biolimus-eluting stents versus ultrathin stents in unprotected left main or coronary bifurcation: A propensity score analysis from the RAIN and CHANCE registries : Catheterization and Cardiovascular Interventions. In: Catheter. Cardiovasc. Interventions. 2020 ; Vol. 95, No. 3. pp. 522-529.

@article{58e443d6b2a54d64ad74016d1027c1c9,

title = "Safety and efficacy of polymer-free biolimus-eluting stents versus ultrathin stents in unprotected left main or coronary bifurcation: A propensity score analysis from the RAIN and CHANCE registries: Catheterization and Cardiovascular Interventions",

abstract = "Objectives: Evaluate safety and efficacy of polymer-free biolimus-eluting stents (PF-BESs) versus ultrathin stents in unprotected left main (ULM) or bifurcation. Background: PF-BESs due to reduced length of dual antiplatelet therapy (DAPT) are increasingly used. However, there are limited data about safety and efficacy for ULM or bifurcation. Methods: We selected all-patients treated for ULM or bifurcation from two multicenter real life registries (RAIN [NCT03544294] evaluating ultrathin stents, CHANCE [NCT03622203] appraising PF-BES). After propensity score with matching, the primary endpoint was major adverse cardiac events (MACE; a composite of all-cause death, myocardial infarction, target lesion revascularization [TLR], and stent thrombosis [ST]), while its components along with target vessel revascularization (TVR) secondary endpoints. Results: Three thousand and three patients treated with ultrathin stents and 446 with PF-BESs, resulting respectively in 562 and 281 after propensity score with matching (33 and 22%, respectively, with ULM disease). After 12 (8–20) months, rates of MACE were similar (9 vs. 8%, p = 0.56) without difference in TLR and ST (3.0 vs. 1.7%, p =.19 and 1.8 vs. 1.1%, p =.42). These results were consistent for ULM group (3 vs. 1.7% and 1.8 vs. 1.1%, p =.49 and.76), for non-ULM group (2.1 vs. 3.4%, p =.56 and 1.2 vs. 1.7%, p =.78) and for two-stent strategy (8.7 vs. 4.5% and 4.3 vs. 3.2%, p =.75 and.91). Among patients treated with 1 month of DAPT in both groups, those with ultrathin stents experienced higher rates of MACE related to all-cause death (22 vs. 12%, p =.04) with higher although not significant rates of ST (3 vs. 0%, p =.45). Conclusions: PF-BES implanted on ULM or BiF offered freedom from TLR and ST comparable to ultrathin stents. PF-BESs patients assuming DAPT for 1 month experienced a lower despite not significant incidence of ST. {\textcopyright} 2019 Wiley Periodicals, Inc.",

keywords = "coronary artery disease, drug eluting stent, percutaneous coronary intervention, percutaneous coronary intervention complex, stent restenosis, stent thrombosis, aged, all cause mortality, Article, controlled study, coronary bifurcation lesion, dual antiplatelet therapy, female, human, left anterior descending coronary artery, left coronary artery, major adverse cardiac event, major clinical study, male, non ST segment elevation myocardial infarction, propensity score, ST segment elevation myocardial infarction, stable angina pectoris, target lesion revascularization, unprotected left main coronary artery, unstable angina pectoris, adverse event, clinical protocol, clinical trial, comparative study, devices, diagnostic imaging, middle aged, mortality, multicenter study, pathophysiology, prosthesis design, register, retrospective study, risk assessment, risk factor, time factor, very elderly, cardiovascular agent, rapamycin, umirolimus, Aged, Aged, 80 and over, Cardiovascular Agents, Clinical Protocols, Coronary Artery Disease, Drug-Eluting Stents, Female, Humans, Male, Middle Aged, Percutaneous Coronary Intervention, Propensity Score, Prosthesis Design, Registries, Retrospective Studies, Risk Assessment, Risk Factors, Sirolimus, Time Factors",

author = "F. D'Ascenzo and L. Gaido and A. Bernardi and A. Saglietto and A. Franz{\'e} and A. Ielasi and D. Trabattoni and {Di Biasi}, M. and V. Infantino and A. Rognoni and G. Helft and A. Gangor and R.A. Latini and {De Luca}, L. and S. Mitomo and F. Ugo and G. Smolka and Z. Huczek and B. Cortese and D. Capodanno and A. Chieffo and F. Piazza and {di Mario}, C. and A. Poli and M. D'Urbano and F. Romeo and M. Giammaria and F. Varbella and I. Sheiban and J. Escaned and {De Ferrari}, G.M.",

note = "Cited By :1 Export Date: 11 March 2021 CODEN: CARIF Correspondence Address: D'Ascenzo, F.; Division of Cardiology, Italy; email: fabrizio.dascenzo@gmail.com Chemicals/CAS: rapamycin, 53123-88-9; umirolimus, 851536-75-9; Cardiovascular Agents; Sirolimus; umirolimus Tradenames: Promus Element; Resolute Onyx; Synergy; Ultimaster; Xience Alpine Manufacturers: Biosensors",

year = "2020",

doi = "10.1002/ccd.28413",

language = "English",

volume = "95",

pages = "522--529",

journal = "Catheter. Cardiovasc. Interventions",

issn = "1522-1946",

publisher = "John Wiley and Sons Inc.",

number = "3",

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TY - JOUR

T1 - Safety and efficacy of polymer-free biolimus-eluting stents versus ultrathin stents in unprotected left main or coronary bifurcation: A propensity score analysis from the RAIN and CHANCE registries

T2 - Catheterization and Cardiovascular Interventions

AU - D'Ascenzo, F.

AU - Gaido, L.

AU - Bernardi, A.

AU - Saglietto, A.

AU - Franzé, A.

AU - Ielasi, A.

AU - Trabattoni, D.

AU - Di Biasi, M.

AU - Infantino, V.

AU - Rognoni, A.

AU - Helft, G.

AU - Gangor, A.

AU - Latini, R.A.

AU - De Luca, L.

AU - Mitomo, S.

AU - Ugo, F.

AU - Smolka, G.

AU - Huczek, Z.

AU - Cortese, B.

AU - Capodanno, D.

AU - Chieffo, A.

AU - Piazza, F.

AU - di Mario, C.

AU - Poli, A.

AU - D'Urbano, M.

AU - Romeo, F.

AU - Giammaria, M.

AU - Varbella, F.

AU - Sheiban, I.

AU - Escaned, J.

AU - De Ferrari, G.M.

N1 - Cited By :1 Export Date: 11 March 2021 CODEN: CARIF Correspondence Address: D'Ascenzo, F.; Division of Cardiology, Italy; email: fabrizio.dascenzo@gmail.com Chemicals/CAS: rapamycin, 53123-88-9; umirolimus, 851536-75-9; Cardiovascular Agents; Sirolimus; umirolimus Tradenames: Promus Element; Resolute Onyx; Synergy; Ultimaster; Xience Alpine Manufacturers: Biosensors

PY - 2020

Y1 - 2020

N2 - Objectives: Evaluate safety and efficacy of polymer-free biolimus-eluting stents (PF-BESs) versus ultrathin stents in unprotected left main (ULM) or bifurcation. Background: PF-BESs due to reduced length of dual antiplatelet therapy (DAPT) are increasingly used. However, there are limited data about safety and efficacy for ULM or bifurcation. Methods: We selected all-patients treated for ULM or bifurcation from two multicenter real life registries (RAIN [NCT03544294] evaluating ultrathin stents, CHANCE [NCT03622203] appraising PF-BES). After propensity score with matching, the primary endpoint was major adverse cardiac events (MACE; a composite of all-cause death, myocardial infarction, target lesion revascularization [TLR], and stent thrombosis [ST]), while its components along with target vessel revascularization (TVR) secondary endpoints. Results: Three thousand and three patients treated with ultrathin stents and 446 with PF-BESs, resulting respectively in 562 and 281 after propensity score with matching (33 and 22%, respectively, with ULM disease). After 12 (8–20) months, rates of MACE were similar (9 vs. 8%, p = 0.56) without difference in TLR and ST (3.0 vs. 1.7%, p =.19 and 1.8 vs. 1.1%, p =.42). These results were consistent for ULM group (3 vs. 1.7% and 1.8 vs. 1.1%, p =.49 and.76), for non-ULM group (2.1 vs. 3.4%, p =.56 and 1.2 vs. 1.7%, p =.78) and for two-stent strategy (8.7 vs. 4.5% and 4.3 vs. 3.2%, p =.75 and.91). Among patients treated with 1 month of DAPT in both groups, those with ultrathin stents experienced higher rates of MACE related to all-cause death (22 vs. 12%, p =.04) with higher although not significant rates of ST (3 vs. 0%, p =.45). Conclusions: PF-BES implanted on ULM or BiF offered freedom from TLR and ST comparable to ultrathin stents. PF-BESs patients assuming DAPT for 1 month experienced a lower despite not significant incidence of ST. © 2019 Wiley Periodicals, Inc.

AB - Objectives: Evaluate safety and efficacy of polymer-free biolimus-eluting stents (PF-BESs) versus ultrathin stents in unprotected left main (ULM) or bifurcation. Background: PF-BESs due to reduced length of dual antiplatelet therapy (DAPT) are increasingly used. However, there are limited data about safety and efficacy for ULM or bifurcation. Methods: We selected all-patients treated for ULM or bifurcation from two multicenter real life registries (RAIN [NCT03544294] evaluating ultrathin stents, CHANCE [NCT03622203] appraising PF-BES). After propensity score with matching, the primary endpoint was major adverse cardiac events (MACE; a composite of all-cause death, myocardial infarction, target lesion revascularization [TLR], and stent thrombosis [ST]), while its components along with target vessel revascularization (TVR) secondary endpoints. Results: Three thousand and three patients treated with ultrathin stents and 446 with PF-BESs, resulting respectively in 562 and 281 after propensity score with matching (33 and 22%, respectively, with ULM disease). After 12 (8–20) months, rates of MACE were similar (9 vs. 8%, p = 0.56) without difference in TLR and ST (3.0 vs. 1.7%, p =.19 and 1.8 vs. 1.1%, p =.42). These results were consistent for ULM group (3 vs. 1.7% and 1.8 vs. 1.1%, p =.49 and.76), for non-ULM group (2.1 vs. 3.4%, p =.56 and 1.2 vs. 1.7%, p =.78) and for two-stent strategy (8.7 vs. 4.5% and 4.3 vs. 3.2%, p =.75 and.91). Among patients treated with 1 month of DAPT in both groups, those with ultrathin stents experienced higher rates of MACE related to all-cause death (22 vs. 12%, p =.04) with higher although not significant rates of ST (3 vs. 0%, p =.45). Conclusions: PF-BES implanted on ULM or BiF offered freedom from TLR and ST comparable to ultrathin stents. PF-BESs patients assuming DAPT for 1 month experienced a lower despite not significant incidence of ST. © 2019 Wiley Periodicals, Inc.

KW - coronary artery disease

KW - drug eluting stent

KW - percutaneous coronary intervention

KW - percutaneous coronary intervention complex

KW - stent restenosis

KW - stent thrombosis

KW - aged

KW - all cause mortality

KW - Article

KW - controlled study

KW - coronary bifurcation lesion

KW - dual antiplatelet therapy

KW - female

KW - human

KW - left anterior descending coronary artery

KW - left coronary artery

KW - major adverse cardiac event

KW - major clinical study

KW - male

KW - non ST segment elevation myocardial infarction

KW - propensity score

KW - ST segment elevation myocardial infarction

KW - stable angina pectoris

KW - target lesion revascularization

KW - unprotected left main coronary artery

KW - unstable angina pectoris

KW - adverse event

KW - clinical protocol

KW - clinical trial

KW - comparative study

KW - devices

KW - diagnostic imaging

KW - middle aged

KW - mortality

KW - multicenter study

KW - pathophysiology

KW - prosthesis design

KW - register

KW - retrospective study

KW - risk assessment

KW - risk factor

KW - time factor

KW - very elderly

KW - cardiovascular agent

KW - rapamycin

KW - umirolimus

KW - Aged

KW - Aged, 80 and over

KW - Cardiovascular Agents

KW - Clinical Protocols

KW - Coronary Artery Disease

KW - Drug-Eluting Stents

KW - Female

KW - Humans

KW - Male

KW - Middle Aged

KW - Percutaneous Coronary Intervention

KW - Propensity Score

KW - Prosthesis Design

KW - Registries

KW - Retrospective Studies

KW - Risk Assessment

KW - Risk Factors

KW - Sirolimus

KW - Time Factors

U2 - 10.1002/ccd.28413

DO - 10.1002/ccd.28413

M3 - Article

VL - 95

SP - 522

EP - 529

JO - Catheter. Cardiovasc. Interventions

JF - Catheter. Cardiovasc. Interventions

SN - 1522-1946

IS - 3

ER -