Author + information
- Markus Florian Krackhardt1,
- Matt Waliszewski2,
- Christian Sperling3,
- Tay Mok Heang4,
- Mohd Ali Rosli5,
- Behrouz Kherad6,
- Pedro Sousa7 and
- Andre Schneider8
- 1Charite University Hospital Berlin, Augustenburger Platz, Germany
- 2B.Braun Vascular Systems, Berlin, Germany
- 3B.Braun Melsungen AG, Berlin, Germany
- 4Universitätsklinikum Jena, Germany, Ayer Keroh, Malaysia
- 5National Heart Institute, Kuala Lumpur, Malaysia
- 6charite, berlin, Germany
- 7Hospital de Santa Cruz, Lisbon, Portugal
- 8Klinikum Esslingen, Esslingen, Germany
Recently published randomized trials comparing BMS to DES with a focus on shortened dual-antiplatelet therapy reported incidences of stent thrombosis and bleeding complications (LEADERS FREE) in favor of drug eluting stents (DES). This study compares the safety and efficacy of a polymer-free sirolimus coated, ultrathin strut drug eluting stent (PF-SES) to its uncoated bare-metal stent (BMS) platform of identical stent architecture.
PS matching was conducted on published large-sale, international, single-armed, multicenter, observational studies which investigated the use of ultra-thin PF-SES and BMS. Target lesion revascularization (TLR), myocardial infarction (MI), cardiac death, major adverse cardiac events (MACE), bleeding complications and stent thrombosis (ST) rates were compared whereas the primary endpoint in both studies was TLR at 9 months.
At 9 months the rates of TLR was significantly lower in the PF-SES group as compared to patients treated with the BMS analogue of identical stent design (1.4% vs. 4.6%, p=0.005). Likewise the 9-month MACE rates were lower in the PF-SES group (3.2% vs. 8.7%, p=0.001). There were no differences in the accumulated ST rates (0.5% vs. 1.5%, p=0.109) and the overall accumulated bleeding incidences (BARC 1-5) were not significantly different between PF-SES and BMS patients (1.8% vs. 2.7%, p=0.388).
PF-SES are superior over analogue BMS of identical stent architecture in daily clinical routine with lower rates of TLR and MACE in a PS-matched, unselected patient population without differences in accumulated ST rates and bleeding frequencies (ClinicalTrials.gov Identifier NCT02629575).
CORONARY: Stents: Bare Metal