The aim of this study is to determine whether biodegradable polymer based rapamycin-eluting stent performs equal to permanent polymer based everolimus- and rapamycin-eluting stents regarding reduction of adverse cardiac events at one year.
Drug-eluting stents significantly reduce in-stent restenosis and the subsequent need for target vessel revascularisation compared with bare metal stents. Although this applies to the vast majority of patients, intimal hyperplasia and in-stent restenosis have not been completely eliminated and remain to occur in certain high risk subgroups. Thus there is ongoing research for new, potentially more effective and safe drug-eluting stent systems. One direction of extensive research is the search of new polymers such as biodegradable polymers which allow a controlled drug-release and disappear with time, reducing the probability of polymer-induced chronic inflammation on the vessel wall. Another direction is finding new drugs to suppress neointimal hyperplasia. Promising preclinical and clinical results suggest that the Everolimus eluting stent platform might provide potential improvements over prior generations of drug-eluting stents.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,600
due to randomization, rapamycin-eluting stent with biodegradable polymer will be implanted
due to randomization, rapamycin-eluting stent with permanent polymer will be implanted
due to randomization, everolimus-eluting stent with permanent polymer will be implanted
Deutsches Herzzentrum Muenchen
Munich, Germany
Medizinische Klinik, Klinikum rechts der Isar
München, Germany
The primary end point of the study is a combined endpoint of cardiac death, myocardial infarction related to the target vessel or revascularization related to the target lesion.
Time frame: 12 months
In-segment binary restenosis at follow-up angiography
Time frame: 6-8 months
Late Lumen Loss at follow-up angiography
Time frame: 6-8 months
All cause mortality.
Time frame: 12 months
Incidence of stent thrombosis (by ARC definition)
Time frame: 12 months
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