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 journalArticlepeer-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 languageEnglish
Pages (from-to)522-529
Number of pages8
JournalCatheter. Cardiovasc. Interventions
Volume95
Issue number3
DOIs
Publication statusPublished - 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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