Treatment of in-stent restenosis with sirolimus-eluting-stents: results from the prospective German Cypher stent registry.
OBJECTIVE
Drug-eluting stents have been reported to effectively reduce in-stent restenosis (ISR). However, the effectiveness and safety have yet been investigated only in small trials or case series. The aim of this prospective large scale registry was to show that treatment of ISR with sirolimus eluting stents (SES) is safe, effective and feasible in daily routine.


RESULTS
The German Cypher registry prospectively enrolled 6,555 patients undergoing implantation with SES for various indications, including 1,533 patients treated for ISR. Follow-up data (median 6.6 months) of this cohort was available for 1,531 patients (99.8%). Of these patients 75.8% were male. Of these patients 36.5% (n = 552) presented with acute coronary syndromes. In total, 1,932 SES were used with successful implantation in 98.9%. MI during hospitalization was observed in 0.7% (n = 11) while in-hospital mortality was only 0.1% (n = 2). MACE-rate at follow-up was 13.8% (n = 211) including a mortality of 1.3% (n = 20) and MI in 1.9% (n = 29). Total revascularization procedures including CABG (1.7%) were necessary in 12.3% (n = 186). Target vessel revascularization (TVR) rate was 9.3% (n = 139) and thus similar to patients with de novo lesions (8.1%, P = 0.69). Ten patients (0.65%) suffered from subacute stent thrombosis Vs. 0.24% observed in patients with de novo lesions (P = 0.03).


CONCLUSIONS
This large registry confirms that treatment of ISR with sirolimus-eluting-stents is effective and save with good clinical results at index procedure and follow-up. TVR was not different from de novo lesions.
Möllmann
Helge
H
Department of Cardiology, Kerckhoff Heart Centre, Bad Nauheim, Germany. h.moellmann@kerckhoff-klinik.de
Elsässer
Albrecht
A
Nef
Holger
H
Schneider
Steffen
S
Nienaber
Christoph A
CA
Richardt
Gert
G
Weber
Michael
M
Kelm
Malte
M
Levenson
Benny
B
Bonzel
Tassilo
T
Tebbe
Ulrich
U
Sabin
Georg
G
Pfannebecker
Thomas
T
Senges
Jochen
J
Hamm
Christian W
CW
D000368:Aged; D054855:Drug-Eluting Stents; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D005858:Germany / Q000453:epidemiology; D006083:Graft Occlusion, Vascular / Q000453:epidemiology / Q000401:mortality / Q000628:therapy*; D017052:Hospital Mortality; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012042:Registries; D020123:Sirolimus / Q000627:therapeutic use*
D007166:Immunosuppressive Agents; D020123:Sirolimus