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 |
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Pages (from-to) | 522-529 |
Number of pages | 8 |
Journal | Catheter. Cardiovasc. Interventions |
Volume | 95 |
Issue number | 3 |
DOIs | |
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