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Despite encouraging results from randomized trials, concerns exist about long-term results of sirolimus-eluting stent implantation. We sought to determine whether in-stent restenosis occurring >1 year ("late") after sirolimus-eluting stent implantation is a real clinical entity. We analyzed data on all sirolimus-eluting stents implanted in our institution before March 2003. During the study period 928 lesions in 433 patients were treated. Angiographic follow-up was performed in 306 patients (70.6%) with 679 lesions (73.2%). Angiography after 1 year was performed only in symptomatic patients. We considered restenosis "early" if it occurred during the first year and late if after 1 year. Late restenosis required demonstration of a widely patent stent at 6 to 9 months, with repeat angiography after 1 year demonstrating restenosis. Restenosis occurred in 160 lesions overall (23.5%). Of the 31 (4.6%) that were documented after 1 year, 13 were excluded from analysis due to absence of 6- to 9-month angiography; the remaining 18 (2.6%, 1.7 to 4.2) fulfilled our criteria for late restenosis (median time of documentation 607 days, interquartile range 511 to 923). In conclusion, late restenosis is an infrequent but real entity; its existence implies we should not discount the possibility of restenosis as the cause of symptoms that develop >1 year after sirolimus-eluting stent implantation.

Objectives: This study was designed to compare the outcomes of paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) in a contemporaneous cohort of real-world patients., Background: A number of randomized comparisons of PES and SES have shown unequivocal advantages for SES in angiographic end points such as late loss. However, the data on clinical outcomes are less consistent., Methods: All consecutive patients successfully treated with only SES or PES in de novo native vessel lesions between March 2003 and March 2005 were analyzed. Our end points were major adverse cardiac events (MACE), a composite of death, myocardial infarction (MI), target vessel revascularization (TVR), and target lesion revascularization (TLR). We also analyzed late loss and angiographic restenosis., Results: There were 609 patients (1,064 lesions) treated with PES and 674 patients (1,205 lesions) treated with SES. Diabetes mellitus was present in 26.8% of patients and multivessel disease in 75% of patients. Bifurcations made up 16.3% of lesions, chronic occlusions 9.5%, left main 4.8%, and American Heart Association/American College of Cardiology type B2/C 75.4%. Despite a higher late loss in the PES group (p = 0.0001), there were no differences in angiographic restenosis (PES 18% vs. SES 17.8%, p = 0.95), TLR (PES 11.9% vs. SES 11%, p = 0.47), or MACE (PES 21.3% vs. SES 21.1%, p = 0.95). The relative risk of MACE for the PES group was 1.02 (95% confidence interval [CI] 0.78 to 1.33). Multivariable analysis confirmed the lack of association of stent type with MACE (odds ratio 1.03 [95% CI 0.77 to 1.38], p = 0.83) and TLR (odds ratio 1.08 [95% CI 0.81 to 1.44], p = 0.61)., Conclusions: In this complex cohort, both stent platforms demonstrated similar clinical outcomes despite different late loss.

Late loss is becoming an important end point to compare drug-eluting stents; however, little is known about its pattern of distribution. We analyzed the pattern of late loss distribution in sirolimus-eluting stents (SESs) and paclitaxel-eluting stents (PESs) in a consecutive cohort of patients. From a cohort of 529 patients treated with drug-eluting stents in 1 year, we selected all patients who underwent angiographic follow-up. Three hundred fifty-nine patients with 592 de novo lesions received SESs (286 lesions) or PESs (306 lesions). Late loss and binary angiographic restenosis were analyzed. Binary restenosis occurred in 56 lesions (19.6%) treated with SESs compared with 53 (17.3%) treated with PESs (p = 0.48). The 2 late loss distributions were skewed to the right and were not normally distributed (p <0.001 for SES, p = 0.003 for PES). Late loss was significantly lower in the SES group (p = 0.03), with a median value of 0.29 mm (interquartile range -0.09 to 0.66) versus 0.41 mm (-0.02 to 0.85) in the PES group. When analyzing only restenotic lesions, late loss had a normal distribution in the SES and PES groups (p = 0.96 and 0.44, respectively) and was similar in the 2 groups (1.75 +/- 0.51 vs 1.82 +/- 0.62, p = 0.48). When evaluating nonrestenotic lesions, late loss was also normally distributed in the 2 groups (p = 0.75 for SES, p = 0.73 for PES) but was significantly lower (p = 0.002) after SES implantation (0.14 +/- 0.39) than after PES implantation (0.27 +/- 0.44). In conclusion, SESs and PESs have a bimodal pattern of late loss distribution. The observed difference in late loss between SES and PES seems to be partly explained by the decrease in late loss after SES implantation in nonrestenotic lesions (where SES approaches "zero late loss"). Thus, late loss may not be a reliable marker of the true efficacy of these devices due to its complex and nongaussian distribution.

Background: Currently, little data are available on the management of drug-eluting stent (DES) restenosis. Drug resistance may play a role in its etiology., Methods: We identified all cases of either sirolimus-eluting or paclitaxel-eluting stent restenosis treated with repeated DES implantation. The lesions were divided into those receiving the same DES as the one that restenosed and those treated with the alternative DES. The end points analyzed were target lesion revascularization (TLR) and angiographic restenosis., Results: We included 201 lesions (174 patients); the same DES was implanted in 107 lesions and a different DES in 94 lesions. Angiographic follow-up of the retreatment was available in 69.7% of the lesions. Angiographic restenosis occurred in 26.4% (19) of cases treated with the same DES and 25.8% (17) of those treated with a different DES (P = 1.0). Target lesion revascularization occurred in 15.9% (17) and 16% (15) of lesions, respectively (P = 1.0). A multivariate analysis confirmed the lack of association between the treatment selected and TLR (OR 0.7, 95% CIs [0.29-1.67]; P = .42). A nonfocal pattern of restenosis remained associated with TLR and restenosis (OR 2.99, 95% CIs [1.24-7.24]; P = .015 and OR 3.6, 95% CIs [1.5-8.8]; P = .004, respectively)., Conclusions: Repeated DES implantation for DES restenosis is feasible and safe. The TLR rate is acceptable, with no differences between implantation of the same or a different DES. The pattern of restenosis treated is an important predictor of outcomes.

Aim: To evaluate patterns of restenosis following implantation of sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) in comparable unselected lesions., Methods and Results: We have identified all episodes of restenosis after SES or PES implantation in our institutions between March 2003 and March 2005. Restenosis pattern was classified as focal, diffuse, proliferative, or occlusive. The position of focal restenosis was also categorized as proximal, in-stent, distal, or multi-focal. We have characterized 150 and 149 restenotic lesions in SES and PES groups, respectively. The incidence of diffuse and occlusive restenosis was significantly higher in PES than in SES (47.6 vs. 27.0%, P < 0.001). Multivariable (OR 2.693, 95% CI 1.425-5.089, P = 0.002) and propensity (OR 3.00, 95% CI 1.584-5.672, P < 0.001) analyses confirmed the positive association of PES with non-focal restenosis. For both stents, focal-edge restenosis was significantly more likely to occur proximally than distally (61.0 vs. 16.9%, P < 0.001 for PES and 45.8 vs. 16.8%, P < 0.001 for SES)., Conclusion: Focal restenosis remains the most common pattern with SES. In contrast, just under half of restenosis in PES is the more severe non-focal pattern. Paradoxically, the majority of focal restenosis occurs at the proximal stent margin for both platforms.

We investigated early and mid-term clinical and angiographic outcomes of patients who had de novo ostial left anterior descending coronary artery (LAD) lesions that were treated with drug-eluting stents (DESs) or bare metal stents (BMSs). We identified 43 consecutive patients who underwent percutaneous intervention for isolated de novo ostial LAD lesions with implantation of DESs and compared them with 43 patients who had similar lesions that were treated with BMSs. All stents were successfully implanted. There were no significant differences with respect to major in-hospital complications between the 2 groups. One patient in the BMS group died during hospitalization. Non-Q-wave myocardial infarction occurred in 2 patients (4.7%) in the DES and in 1 patient (2.3%) in the BMS group. At 9-month follow-up, 3 patients (7%) in the DES group and 11 (25.6%) in the BMS group underwent target lesion revascularization (p = 0.038); major adverse cardiac events were less frequent in the DES than in the BMS group (9.3% vs 32.6%, p = 0.015). Angiographic follow-up was available in 82% of patients in the DES group and 75% of those in the BMS group (p = 0.6) and showed lower binary restenotic rates (5.7% vs 31.3%, p = 0.01) and smaller late loss (0.30 +/- 0.81 vs 1.23 +/- 0.93 mm, p = 0.0001) in the DES group. In conclusion, DES implantation in de novo ostial LAD lesions appears safe and effective and is associated with a significant decrease in restenotic rates compared with historical experience with BMSs.

Aims: To evaluate the outcomes of sirolimus-eluting stent (SES) implantation for the treatment of chronic total occlusion (CTO)., Methods and Results: We identified 122 patients who underwent revascularization in CTO lesions with SES from April 2002 to April 2004 (SES group). A control group was composed of 259 consecutive patients with CTO lesions treated with bare metal stents (BMS) in the 24 months immediately before the introduction of SES (BMS group). At 6-month follow-up, the cumulative rate of major adverse cardiac events (MACE) was 16.4% in the SES group and 35.1% in the BMS group (P<0.001). The incidence of restenosis was 9.2% in the SES group and 33.3% in the BMS group (P<0.001). The need for revascularization in the SES group was significantly lower, both target lesion revascularization (7.4 vs. 26.3%, P<0.001) and target vessel revascularization (9.0 vs. 29.0%, P<0.001). BMS implantation (HR: 2.97; 95% CI: 1.80-4.89; P<0.001), lesion length (>20 mm) (HR: 2.02; 95% CI: 1.37-2.99; P=0.0004), and baseline reference vessel diameter (>2.8 mm) (HR: 0.62; 95% CI: 0.42-0.92; P=0.02) were identified as predictors of MACE during 6-month follow-up., Conclusion: Compared with BMS, SES implantation in CTO lesions appears to be effective in reducing the incidence of restenosis and the need for revascularization at 6 months.