Increased late mortality after sirolimus-eluting stents versus bare-metal stents in diseased saphenous vein grafts: results from the randomized DELAYED RRISC Trial.
OBJECTIVE
We sought to provide long-term follow-up data of sirolimus-eluting stents (SES) versus bare-metal stents (BMS) in saphenous vein grafts (SVG) from the RRISC (Reduction of Restenosis In Saphenous vein grafts with Cypher) trial.


BACKGROUND
We have previously shown that, in SVG, the use of SES reduces 6-month restenosis and repeated revascularization procedures versus the use of BMS. These data are consistent with trials in native coronary arteries. However, recently published long-term follow-up data of these trials have revealed an increased risk of adverse events (particularly very late stent thrombosis) after SES.


METHODS
A total of 75 patients with 96 SVG lesions were randomized to SES versus BMS. All patients underwent clinical follow-up up to 3 years. Specific outcomes assessed in this secondary post-hoc analysis were all-cause mortality, myocardial infarction, and target vessel revascularization.


RESULTS
Thirty-eight patients received 60 SES for 47 lesions, whereas 37 patients received 54 BMS for 49 lesions. At a median follow-up time of 32 months (interquartile range 26.5 to 36 months), 11 deaths (7 cardiac, of which 1 was caused by very late stent thrombosis and, 3 were sudden) occurred after SES (29% [95% confidence interval (CI) 17% to 45%]) versus 0 after BMS (0% [95% CI 0% to 9%]) with an absolute difference of 29% ([95% CI 14% to 45%], p < 0.001). The rates of myocardial infarction and target vessel revascularization were not different: 18% and 34% after SES, respectively, versus 5% and 38% after BMS, respectively (p = 0.15 and p = 0.74, respectively).


CONCLUSIONS
In this secondary post-hoc analysis, BMS were associated with lower long-term mortality than SES for SVG disease. Also, the 6-month reduction in repeated revascularization procedures with SES was lost at longer-term follow-up. (RRISC Study: Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent; http://clinicaltrials.gov/ct/show/NCT00263263?order=1; NCT00263263).
Vermeersch
Paul
P
Antwerp Cardiovascular Institute Middelheim, AZ Middelheim, Antwerp, Belgium.
Agostoni
Pierfrancesco
P
Verheye
Stefan
S
Van den Heuvel
Paul
P
Convens
Carl
C
Van den Branden
Frank
F
Van Langenhove
Glenn
G
D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000379:methods; D016001:Confidence Intervals; D017023:Coronary Angiography; D001026:Coronary Artery Bypass / Q000009:adverse effects / Q000379:methods; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000401:mortality* / Q000628:therapy*; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery; D004311:Double-Blind Method; D016503:Drug Delivery Systems; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection; D006801:Humans; D008297:Male; D008670:Metals; D011336:Probability; D011474:Prosthesis Design; D019233:Retreatment; D018570:Risk Assessment; D012501:Saphenous Vein / Q000473:pathology / Q000637:transplantation*; D020123:Sirolimus / Q000008:administration & dosage*; D018709:Statistics, Nonparametric; D015607:Stents; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome
D008670:Metals; D020123:Sirolimus