Maintenance of long-term clinical benefit with sirolimus-eluting coronary stents: three-year results of the RAVEL trial.

BACKGROUND: The use of sirolimus-eluting coronary stents has been associated with a nearly complete elimination of restenosis at 6 months and with a very low 1-year incidence of major adverse cardiac events (MACE). This analysis examined whether these beneficial effects persist over the longer term. METHODS AND RESULTS: This multicenter trial randomly assigned 238 patients to revascularization of single, de novo, native coronary artery lesions with sirolimus-eluting versus conventional bare-metal stents. Survival free from target lesion revascularization (TLR), target vessel failure (TVF), and MACE up to 3 years of follow-up was compared between the 2 treatment groups. Complete data sets were available in 94.2% of patients treated with sirolimus-eluting stents and in 94.1% of patients randomized to the control group. The cumulative 1-, 2-, and 3-year event-free survival rates were 99.2%, 96.5%, and 93.7% for TLR and 95.8%, 92.3%, and 87.9% for TVF, respectively, in the sirolimus-eluting stent group, versus 75.9%, 75.9%, and 75.0% for TLR and 71.2%, 69.4%, and 67.3% for TVF in the control group (P<0.001 for both comparisons at 3 years). Rates of MACE at 3 years were 15.8% in patients randomly assigned to sirolimus-eluting stents versus 33.1% in patients assigned to bare-metal stents (P=0.002). One patient treated with a sirolimus-eluting stent died of a cardiac cause between 12 and 36 months. CONCLUSIONS: Treatment of de novo coronary stenosis with sirolimus-eluting stents was associated with a sustained clinical benefit and very low rates of TLR and of other MACE up to 3 years after device implantation.

Fate of Side Branches After Coronary Arterial Sirolimus-Eluting Stent Implantation

The sirolimus-eluting stent (SES) is emerging as a potential solution for the prevention of restenosis. Although the outcome of side branches after stenting with an uncoated metal stent (UMS) has been reported, the fateof side branches after SES implantation is unknown.Furthermore, the absence of spontaneous recanalizationof occluded side branches following intracoronarybrachytherapy has been previously described and hasbeen related to a delayed healing process. We assessedthe procedural and 6-month follow-up angiograms of238 patients enrolled in the RAVEL study, a double-blindcontrolled trial of the SES versus the UMS. Any sidebranch seen on the preprocedure angiogram and subsequentlycovered by the stent was evaluated. The side branch Thrombolysis In Myocardial Infarction (TIMI) flow grade was assessed at baseline and at follow-up by 2 observers. One hundred twenty-eight patients with >1 side branches were identified (63 patients in the SES group with 118 side branches, 65 patients in the UMS group with 124 side branches). Side branch occlusion occurred after stenting in 12 branches (10%) in the SES group and in 9 branches (7%) in the UMS group (p NS). Of these occluded branches, spontaneous recanalization was observed in 11 branches (92%) in the SES group and in 6 branches (67%) in the UMS group at follow-up angiography (p NS). Thus, the fate of side branches after SES implantation is favorable and at least as good as after UMS implantation.

Fate of side branches after coronary arterial sirolimus-eluting stent implantation.

The sirolimus-eluting stent (SES) is emerging as a potential solution for the prevention of restenosis. Although the outcome of side branches after stenting with an uncoated metal stent (UMS) has been reported, the fate of side branches after SES implantation is unknown. Furthermore, the absence of spontaneous recanalization of occluded side branches following intracoronary brachytherapy has been previously described and has been related to a delayed healing process. We assessed the procedural and 6-month follow-up angiograms of 238 patients enrolled in the RAVEL study, a double-blind controlled trial of the SES versus the UMS. Any side branch seen on the preprocedure angiogram and subsequently covered by the stent was evaluated. The side branch Thrombolysis In Myocardial Infarction (TIMI) flow grade was assessed at baseline and at follow-up by 2 observers. One hundred twenty-eight patients with > or =1 side branches were identified (63 patients in the SES group with 118 side branches, 65 patients in the UMS group with 124 side branches). Side branch occlusion occurred after stenting in 12 branches (10%) in the SES group and in 9 branches (7%) in the UMS group (p = NS). Of these occluded branches, spontaneous recanalization was observed in 11 branches (92%) in the SES group and in 6 branches (67%) in the UMS group at follow-up angiography (p = NS). Thus, the fate of side branches after SES implantation is favorable and at least as good as after UMS implantation.