Author + information
- Deborah Kalkman1,
- Ruben Tijssen2,
- Joelle Elias3,
- Ivo M. van Dongen4,
- Robin Kraak5,
- Pier Woudstra6,
- M. Beijk7,
- Jan Tijssen8,
- Jan Piek9,
- Jose PS. Henriques4,
- Robbert de Winter4 and
- Joanna Wykrzykowska10
- 1Academic Medical Center, Amsterdam, Netherlands
- 2AMC Amsterdam, Amsterdam, Netherlands
- 3Academic Medical Centre (AMC) - University of Amsterdam, Amsterdam, Netherlands
- 4Academic Medical Center - University of Amsterdam, Amsterdam, Netherlands
- 5AMC Heartcentre, Academic Medical Centre - Un, Amsterdam, Netherlands
- 6AMC, Amsterdam, Netherlands
- 7Academic Medical hospital - University of Amsterdam, Amsterdam, Netherlands
- 8AMC, Naarden, Netherlands
- 9Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands
- 10Academic Medical Center Amsterdam, Amsterdam, Netherland
The Xience stent (Abbott Vascular, USA) shows good clinical performance. The novel COMBO stent (OrbusNeich BV, The Netherlands) is a new device that combines a drug-eluting layer with an unique pro-healing layer. This device has not been compared to the well-established Xience stent in all-comers patients.
The REMEDEE Registry is a 1000 patient registry, evaluating patients treated with COMBO. The randomized AIDA trial compares Xience and Absorb BVS. Both trials are investigator-initiated, prospective, multicentre all-comers studies. A propensity-matched analysis is performed for COMBO versus Xience, using 13 baseline variables: age, gender, insulin treated-Diabetes Mellitus, hypertension, previous MI/PCI/bypass, acute coronary syndrome (ACS), number of treated lesions, target vessel location, stent length and diameter and ACC/AHA classification. Target lesion failure (TLF, a composite of cardiac death, target vessel myocardial infarction and any target lesion revascularization) is the primary focus of this analysis. Definite and probable stent thrombosis (ST) is evaluated.
The analysis yields 674 true all-comers patients-pairs, with a high number of ACS and B2/C lesions. All baseline characteristics are well-balanced between both groups. TLF was observed in 5.5% of COMBO and 5.3% in Xience, HR 1.05, p=0.82. Definite and probable ST occurred in 0.7% of patients treated with both Xience and Combo, HR 1.00, p=1.00.
This is the first study to compare clinical performance between COMBO and Xience stent in all-comers patients. No significant differences were found.
CORONARY: Stents: Drug-Eluting