Impact of Coronary Stent Architecture on Clinical Outcomes: Do Minor Changes in Stent Architecture Really Matter?
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ORIGINAL RESEARCH
Impact of Coronary Stent Architecture on Clinical Outcomes: Do Minor Changes in Stent Architecture Really Matter? Amin Ariff Bin Nuruddin . Wan Azman Wan Ahmad . Matthias Waliszewski . Tay Mok Heang . Liew Houng Bang . Ahmad Khairuddin Mohamed Yusof . Imran Zainal Abidin . Ahmad Syadi Zuhdi . Florian Krackhardt Received: September 30, 2020 Ó The Author(s) 2020
ABSTRACT Introduction: The objective of this study was to compare the accumulated clinical outcomes of two Malaysian all-comers populations, each treated with different polymer-free sirolimuseluting stents (PF-SES) of similar stent design. Methods: The Malaysian subpopulation of two all-comers observational studies based on the A. A. B. Nuruddin (&) A. K. M. Yusof National Heart Institute Cardiology Department, Kuala Lumpur, Malaysia e-mail: [email protected] W. A. W. Ahmad University Malaya Medical Centre, Kuala Lumpur, Malaysia M. Waliszewski Medical Scientific Affairs, B. Braun Melsungen AG, Berlin, Germany M. Waliszewski F. Krackhardt Department of Internal Medicine and Cardiology, Charite´–Universita¨tsmedizin Berlin, Campus Virchow, Berlin, Germany T. M. Heang Pantai Hospital Ayer Keroh, Ayer Keroh, Melaka, Malaysia L. H. Bang Hospital Queen Elizabeth II, Kota Kinabalu, Sabah, Malaysia I. Z. Abidin A. S. Zuhdi University Malaya Medical Center, Kuala Lumpur, Malaysia
same protocol (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were combined and compared to a Malaysian-only cohort which was treated with a later-generation PFSES. The PF-SES’s used differed only in their bare-metal backbone architecture, with otherwise identical sirolimus coating. The primary endpoint was the accumulated target lesion revascularization (TLR) rate at 12 months. The rates of major adverse cardiac events (MACE), stent thrombosis (ST) and myocardial infarction (MI) were part of the secondary endpoints. Results: A total of 643 patients were treated with either the first-generation PF-SES (413 patients) or second-generation PF-SES (230 patients). Patient demographics were similar in terms of age (p = 0.744), male gender (0.987), diabetes mellitus (p = 0.293), hypertension (p = 0.905) and acute coronary syndrome (ACS, 44.8% vs. 46.1%, p = 0.752) between groups. There were no differences between treatment groups in terms of lesion length (20.8 ± 7.3 mm vs. 22.9 ± 7.9, p = 0.111) or vessel diameter (2.87 ± 0.39 vs. 2.93 ± 0.40, p = 0.052) despite numerically smaller diameters in the first-generation PF-SES group. The second-generation PF-SES tended to have more complex lesions as characterized by calcification (10.3% vs. 16.2%, p = 0.022), severe tortuosity (3.5% vs. 6.9%, p = 0.041) and B2/C lesions (49.2% vs. 62.8%, p \ 0.001). The accumulated TLR rates did not differ significantly between the first- and second-generation PF-SES (0.8% vs. 0.9%,
Cardiol Ther
p = 0.891). The accumulated MACE rates were not significantly different (p = 0.561), at 1.5% (6/413) and 2.2% (5/230), respectively. Conclusions: Modifications in coronary stent arch
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