Six- and twelve-month results from first human experience using everolimus-eluting stents with bioabsorbable polymer.
BACKGROUND
Everolimus, an active immunosuppressive and antiproliferative agent of the same family as sirolimus (rapamycin), has demonstrated significant reduction of neointimal proliferation in animal studies. The First Use To Underscore restenosis Reduction with Everolimus (FUTURE) I trial was the first in-human experience to evaluate the safety and efficacy of everolimus-eluting stents (EES), coated with a bioabsorbable polymer, compared with bare metal stents (BMS).


RESULTS
FUTURE I was a prospective, single-blind, randomized trial that enrolled 42 patients with de novo coronary lesions (EES 27, BMS 15). Patient and lesion characteristics were comparable between the groups. Major adverse cardiac event rates were low at 30 days and 6 months, without any early or late stent thrombosis for either group (P=NS). Between 6 and 12 months, there were no additional reports of major adverse cardiac events. The 6-month angiographic in-stent restenosis rate was 0% versus 9.1% (1 patient) (P=NS), with an associated late loss of 0.11 mm versus 0.85 mm (P<0.001), and the in-segment restenosis rate was 4% (1 patient) and 9.1% (1 patient) (P=NS) for EES and BMS, respectively. Intravascular ultrasound analysis revealed a significant reduction of percent neointimal volume in EES compared with BMS (2.9+/-1.9 mm3/mm versus 22.4+/-9.4 mm3/mm, P<0.001). There was no late stent malapposition in either group. The safety and efficacy of the EES appeared to be sustained at 12 months.


CONCLUSIONS
In this initial clinical experience, EES with bioabsorbable polymer demonstrated a safe and efficacious method to reduce in-stent neointimal hyperplasia and restenosis.
Grube
Eberhard
E
Heart Center Siegburg, Siegburg, Germany.
Sonoda
Shinjo
S
Ikeno
Fumiaki
F
Honda
Yasuhiro
Y
Kar
Saibal
S
Chan
Charles
C
Gerckens
Ulrich
U
Lansky
Alexandra J
AJ
Fitzgerald
Peter J
PJ
D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use; D002404:Catheterization; D002932:Cineangiography; D020099:Coated Materials, Biocompatible; D015897:Comorbidity; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000517:prevention & control*; D023921:Coronary Stenosis / Q000188:drug therapy / Q000628:therapy*; D004343:Drug Implants; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006131:Growth Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D006965:Hyperplasia; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D019344:Lactic Acid; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology / Q000517:prevention & control; D011091:Polyesters; D011108:Polymers; D011446:Prospective Studies; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000627:therapeutic use*; D013193:Stainless Steel; D015607:Stents; D016896:Treatment Outcome; D017539:Tunica Intima / Q000473:pathology; D018084:Ultrasonography, Interventional
D000925:Anticoagulants; D020099:Coated Materials, Biocompatible; D004343:Drug Implants; D006131:Growth Inhibitors; D007166:Immunosuppressive Agents; D011091:Polyesters; D011108:Polymers; D013193:Stainless Steel; D019344:Lactic Acid; C033616:poly(lactide); D000068338:Everolimus; D020123:Sirolimus