A novel bioresorbable polymer paclitaxel-eluting stent for the treatment of single and multivessel coronary disease: primary results of the COSTAR (Cobalt Chromium Stent With Antiproliferative for Restenosis) II study.
OBJECTIVE
The aim was to compare safety and effectiveness of the CoStar drug-eluting stent (DES) (Conor MedSystems, Menlo Park, California) with those of the Taxus DES (Boston Scientific, Maple Grove, Minnesota) in de novo single- and multivessel percutaneous coronary intervention (PCI).


BACKGROUND
Paclitaxel elution from a stent coated with biostable polymer (Taxus) reduces restenosis after PCI. The CoStar DES is a novel stent with laser-cut reservoirs containing bioresorbable polymer loaded to elute 10 microg paclitaxel/30 days.


METHODS
Patients undergoing PCI for a single target lesion per vessel in up to 3 native epicardial vessels were randomly assigned 3:2 to CoStar or Taxus. Primary end point was 8-month major adverse cardiac events (MACE), defined as adjudicated death, myocardial infarction (MI), or clinically driven target vessel revascularization (TVR). Protocol-specified 9-month angiographic follow-up included 457 vessels in 286 patients.


RESULTS
Of the 1,700 patients enrolled, 1,675 (98.5%) were evaluable (CoStar = 989; Taxus = 686), including 1,330 (79%) single-vessel and 345 (21%) multivessel PCI. The MACE rate at 8 months was 11.0% for CoStar versus 6.9% for Taxus (p < 0.005), including adjudicated death (0.5% vs. 0.7%, respectively), MI (3.4% vs. 2.4%, respectively), and TVR (8.1% vs. 4.3%, respectively). Per-vessel 9-month in-segment late loss was 0.49 mm with CoStar and 0.18 mm with Taxus (p < 0.0001). Findings were consistent across pre-specified subgroups.


CONCLUSIONS
The CoStar DES is not noninferior to the Taxus DES based on per-patient clinical and per-vessel angiographic analyses. The relative benefit of Taxus is primarily attributable to reduction in TVR. Follow-up to 9 months showed no apparent difference in death, MI, or stent thrombosis rates.
Krucoff
Mitchell W
MW
Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina 27705, USA. kruco001@mc.duke.edu
Kereiakes
Dean J
DJ
Petersen
John L
JL
Mehran
Roxana
R
Hasselblad
Vic
V
Lansky
Alexandra J
AJ
Fitzgerald
Peter J
PJ
Garg
Jyotsna
J
Turco
Mark A
MA
Simonton
Charles A
CA
Verheye
Stefan
S
Dubois
Christophe L
CL
Gammon
Roger
R
Batchelor
Wayne B
WB
O'Shaughnessy
Charles D
CD
Hermiller
James B
JB
Schofer
Joachim
J
Buchbinder
Maurice
M
Wijns
William
W
D020341:Absorbable Implants; D015906:Angioplasty, Balloon, Coronary; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000627:therapeutic use; D002858:Chromium Alloys; D000077144:Clopidogrel; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D023903:Coronary Restenosis / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D003920:Diabetes Mellitus; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000627:therapeutic use; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D011108:Polymers; D012306:Risk; D013923:Thromboembolism / Q000517:prevention & control; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D013997:Time Factors
D000972:Antineoplastic Agents, Phytogenic; D002858:Chromium Alloys; D010975:Platelet Aggregation Inhibitors; D011108:Polymers; D000077144:Clopidogrel; D013988:Ticlopidine; D017239:Paclitaxel