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EXPEDITED REVIEW

Increased Late Mortality After Sirolimus-Eluting Stents Versus Bare-Metal Stents in Diseased Saphenous Vein Grafts

Results From the Randomized DELAYED RRISC Trial

Antwerp Cardiovascular Institute Middelheim, AZ Middelheim, Antwerp, Belgium

Manuscript received April 2, 2007; revised manuscript received May 18, 2007, accepted May 21, 2007.

^_* Reprint requests and correspondence: Dr. Pierfrancesco Agostoni, Antwerp Cardiovascular Institute Middelheim, AZ Middelheim, Lindendreef 1, 2020 Antwerp, Belgium (Email: agostonipf{at}gmail.com).

Objectives: 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 [ClinicalTrials.gov] )

Abbreviations and Acronyms   BMS = bare-metal stent(s)   CI = confidence interval   MI = myocardial infarction   SES = sirolimus-eluting stent(s)   SVG = saphenous vein graft(s)   TLR = target lesion revascularization   TVR = target vessel revascularization

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