Impact of sirolimus-eluting stents on outcomes of patients treated for acute myocardial infarction by primary angioplasty.

Sirolimus-eluting stents (SESs) are currently being used in patients undergoing percutaneous coronary intervention (PCI). SESs have not been evaluated in the treatment of acute myocardial infarction by primary angioplasty. We report our initial experience with SESs implanted during primary angioplasty. One hundred and three patients were treated within 12 hr after onset of acute myocardial infarction (AMI) with primary angioplasty and SES implantation. Those patients were compared to 504 patients treated with bare metal stents (BMSs). Angiographic success (TIMI flow grade 3 and residual stenosis < 50%) was completed in 98% of patients with SESs and no subacute stent thrombosis was reported. In-hospital outcomes were similar in the SES and BMS groups. At 6 months, major cardiac events were less frequent in the SES group than in the BMS group (9% vs. 24%, respectively; P < 0.001), driven by a lesser need for repeat revascularization with SESs (1% vs. 10.3% with BMSs; P = 0.014). Mortality at 6 months was 7% with SESs and 11% with BMSs (P = 0.14). SESs are safe and effective for the treatment of AMI by primary angioplasty. As compared to BMSs, SESs improve long-term outcome after AMI, mainly by reducing the need for repeat revascularization.     

Comparison of safety and efficacy of sirolimus-eluting stents versus bare metal stents in patients with ST-segment elevation myocardial infarction

Sirolimus-eluting stents (SESs) are superior to bare metal stents (BMSs) for percutaneous coronary intervention, but data regarding SESs in ST-segment elevation myocardial infarction (STEMI) are limited. We investigated the clinical outcomes of patients with STEMI who were treated with SESs. We measured clinical characteristics and acute and long-term outcomes in 306 consecutive patients with STEMI who received a SES (n = 156) or a BMS (n = 150). Patients were followed for death, nonfatal reinfarction, and target vessel revascularization. Patients with SESs had a 0.6% in-hospital mortality rate versus 5.3% in patients with BMSs (p = 0.015). Six-month mortality rates were 1.9% (SES) and 10.1% (BMS, p = 0.003). At 6 months, patients with SESs were less likely to have target vessel revascularization (1.3% vs 8.1%, p = 0.005) and achieve the composite end point (3.2% vs 16.1%, p = 0.0001). No subacute thrombosis or clinical restenosis occurred in the SES group. Patients who received BMSs were older, received more stents, and had more myocardial damage, worse renal function, and lower ejection fractions than did those in the SES group. By multivariate discriminant analysis, stent type (SES vs BMS) was the most significant determinant of the 6-month composite end point (p = 0.01) and the need for target vessel revascularization (p = 0.02). In conclusion, SESs are safe and effective in STEMI at 6 months.     

Comparison of three-year clinical outcome of sirolimus- and paclitaxel-eluting stents versus bare metal stents in patients with ST-segment elevation myocardial infarction (from the RESEARCH and T-SEARCH Registries)

Sirolimus-eluting stents (SESs) recently proved to be superior to bare metal stents (BMSs) in decreasing the need for repeat revascularization in patients with ST-segment elevation myocardial infarction (STEMI) at 1 year. Whether this also holds for paclitaxel-eluting stents (PESs) is currently unclear and the long-term relatively efficacy of the 2 drug-eluting stents is currently unknown. We investigated the 3-year efficacy of SESs and PESs versus BMSs in patients with STEMI. Primary angioplasty was performed in a consecutive group of 505 patients (BMSs in 183, SESs in 186, PESs in 136). At 3 years, the cumulative mortality rate was comparable in the 3 groups: 13.3% in the BMS group, 11.5% in the SES group, and 12.4% in the PES group (nonsignificant for all). The rate of target vessel revascularization (TVR) was 12.0% in the BMS group compared with 8.0% and 7.7% in the SES and PES groups, respectively (p = 0.12 for BMS vs SES, 0.30 for BMS vs PES, 0.62 for SES vs PES). The cumulative incidence of death, MI, or TVR was 25.5% in the BMS group compared with 17.9% and 20.6% in the SES and PES groups, respectively (p = 0.06 for BMS vs SES, 0.32 for BMS vs PES, 0.45 for SES vs PES). Angiographic stent thrombosis occurred in 2.4% of all patients (BMS 1.6%, SES 2.7%, PES 2.9%). In conclusion, in this relatively small consecutive patient cohort, the use of SESs and PESs was no longer associated with significantly lower rates of TVR and major adverse cardiace events in patients with STEMI after 3 years of follow-up. A high frequency of stent thrombosis was observed in the 2 drug-eluting stent groups.     

Comparison of neointimal coverage by optical coherence tomography of a sirolimus-eluting stent versus a bare-metal stent three months after implantation

No detailed data regarding neointimal coverage of bare-metal stents (BMSs) at 3 months after implantation was reported to date. This investigation was designed to evaluate the neointimal coverage of BMSs compared with sirolimus-eluting stents (SESs) using optical coherence tomography. A prospective optical coherence tomographic follow-up examination was performed 3 months after stent implantation for patients who underwent BMS (n = 16) or SES implantation (n = 24). Neointimal hyperplasia (NIH) thickness on each stent strut and percentage of NIH area in each cross section were measured. Malapposition of stent struts to the vessel wall and the existence of in-stent thrombi were also evaluated. There were 5,076 struts of SESs and 2,875 struts of BMSs identified. NIH thickness and percentage of NIH area in the BMS group were higher than in the SES group (351 +/- 248 vs 31 +/- 39 mum; p <0.0001; 45.0 +/- 14% vs 10.0 +/- 4%; p <0.0001, respectively). The frequency of uncovered struts was higher in the SES group than the BMS group (15% vs 0.1%; p <0.0001). Malapposed struts were observed more frequently in the SES group than the BMS group (15% vs 1.1%; p <0.0001). In conclusion, there was no difference in incidence of in-stent thrombus between the 2 groups (14% vs 0%; p = 0.23). The present study showed almost all BMS struts to be well covered at a 3-month follow-up, suggesting that patients receiving BMS stents may not require dual-antiplatelet therapy >3 months after implantation.     

Comparison of effectiveness of sirolimus-eluting stents versus bare metal stents for percutaneous coronary intervention in patients at high risk for coronary restenosis or clinical adverse events

We evaluated the clinical effect of selective use of sirolimus-eluting stents (SESs) in real-world, high-risk patients. A total of 4,237 consecutive patients who underwent percutaneous coronary intervention (SES, n = 872, bare metal stents [BMSs], n = 3,365) was enrolled in a prospective regional survey. A prespecified high-risk subset of patients was selected on the basis of clinical and angiographic characteristics. A propensity score analysis was performed to compare patients who received SESs with those who received BMSs. Patients in the SES group more often had diabetes and more frequently had previous myocardial infarction or coronary revascularization, type C lesions, and multivessel procedures. Patients who presented with acute myocardial infarction were treated more often with BMSs. At 9 months, the use of SESs was associated with fewer major adverse cardiac events (death, myocardial infarction, or target lesion revascularization; hazard ratio 0.56, 95% confidence interval 0.37 to 0.85) and target lesion revascularizations (hazard ratio 0.43, 95% confidence interval 0.20 to 0.91). This decrease was more evident in a prespecified high-risk subgroup of patients (major adverse cardiac events, 8.0% SES vs 15.6% BMS, hazard ratio 0.45, 95% confidence interval 0.29 to 0.72). We conclude that selective SES use in real-world patients who have high-risk clinical and angiographic characteristics is associated with significant decreases in major adverse cardiac events and repeat revascularizations compared with BMS use.     

Clinical and angiographic outcome after sirolimus-eluting stent implantation in aorto-ostial lesions.

OBJECTIVES: This observational study evaluated the clinical and angiographic outcomes of patients with aorto-ostial coronary artery disease treated with sirolimus-eluting stents (SESs) or with bare metal stents (BMSs). BACKGROUND: The safety and effectiveness of SESs for the treatment of aorto-ostial lesions have not been demonstrated. METHODS: We identified 82 consecutive patients who underwent percutaneous coronary interventions in 82 aorto-ostial lesions using the SES (32 patients) or BMS (50 patients) and compared the two groups of patients. The incidence of major adverse cardiac events (MACE), including death or Q-wave myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularization (TVR), were recorded in-hospital and at a 10-month follow-up. RESULTS: All stents were implanted successfully. There were no statistically significant differences regarding major in-hospital complications between the two groups. At 10-month follow-up, two (6.3%) patients in the SES group and 14 (28%) patients in the BMS group underwent TLR (p = 0.01); MACE were less frequent in the SES group compared to the BMS group (19% vs. 44%, p = 0.02). Angiographic follow-up showed lower binary restenosis rates (11% vs. 51%, p = 0.001) and smaller late loss (0.21 +/- 0.31 mm vs. 2.06 +/- 1.37 mm, p < 0.0001) in the SES group. CONCLUSIONS: The main finding of our study is that, compared to the BMS, implantation of the SES in aorto-ostial lesions appears safe and effective, with no increase in major in-hospital complications and a significant improvement in restenosis and late event rates at 10-month follow-up.     

Comparison of angioscopic findings and three-year cardiac events between sirolimus-eluting stent and bare-metal stent in acute myocardial infarction

The safety of sirolimus-eluting stents (SESs) in acute myocardial infarction (AMI) remains controversial. We compared long-term neointimal coverage after stent implantation for AMI evaluated by coronary angioscopy and 3-year clinical events between SESs and bare-metal stents (BMSs). Eighty-seven consecutive patients who received SESs or BMSs for AMI were enrolled. At 8 months after AMI coronary angiography with angioscopy was performed. Using angioscopy we evaluated maximum and minimum grades of neointimal coverage using an angioscopic score (0 to 3). We calculated the heterogeneity score as the maximum grade minus the minimum grade. We compared angioscopic parameters including minimum grade and heterogeneity score of neointimal coverage, thrombi and plaque color, serum parameters, and major adverse cardiac events for 3 years between the 2 groups. The restenosis rate of the SES group (n = 56) was significantly lower than that of the BMS group (n = 31, 9% vs 31%, p = 0.015). The SES group had a lower minimum grade of neointimal coverage and higher heterogeneity score and prevalence of thrombi than the BMS group, but from 8 months to 3 years after stent implantation there were no significant differences in major adverse cardiac events between the 2 groups. In conclusion, a lower minimum grade and greater heterogeneity of neointimal coverage and thrombi were shown for SESs compared to BMSs at 8 months after AMI. However, these findings did not correlate with cardiac events over a period of 3 years in our patients.     

Comparison of effectiveness and safety of sirolimus-eluting stents versus bare-metal stents in patients with diabetes mellitus (from the Italian Multicenter Randomized DESSERT Study)

Few studies directly compared drug-eluting stents and bare-metal stents (BMSs) in diabetic patients. DESSERT was an Italian multicenter randomized trial to show the efficacy of sirolimus-eluting stents (SESs) compared with BMSs in de novo lesions of diabetic patients treated with insulin and/or oral antidiabetics for > or =3 months on top of glycoprotein IIb/IIIa inhibitors. The primary end point was in-stent late lumen loss, assessed using centralized quantitative coronary angiography at 8-month follow-up. Centrally adjudicated composite major adverse cardiac events (MACEs) and target-vessel failure (TVF; death, treated vessel-related acute myocardial infarction, and target-vessel revascularization) at 30 days and 9 and 12 months were secondary end points. Seventy-five patients were randomly assigned to an SES (109 lesions), and 75 (109 lesions), to a BMS. The 2 groups were well balanced for clinical, anatomic, and procedural characteristics. In-stent late lumen loss decreased from 0.96 +/- 0.61 mm for BMSs to 0.14 +/- 0.33 for SESs (p <0.001), and in-segment binary restenosis was 38.8% versus 3.6%, respectively (p <0.001). Twelve-month clinical events were significantly lower in the sirolimus group: MACEs 22.1% versus 40% (p = 0.023), target-lesion revascularization 5.9% versus 30% (p <0.001), and TVF 14.7% versus 34.3% (p = 0.008). At multivariate analysis, stent type was confirmed as an independent predictor of in-segment late loss (p <0.001), binary restenosis (p <0.001), 12-month TVF (p = 0.010), and 12-month MACEs (p = 0.037). In conclusion, the randomized DESSERT showed SESs to be safe and effective in decreasing both angiographic parameters of restenosis and incidence of MACEs compared with BMSs in diabetic patients with de novo 1- or 2-vessel coronary stenoses.     

RESTEM: a percutaneous coronary intervention 'real world' registry in the drug-eluting stent era

Sirolimus-eluting stents (SESs) reduce the rate of in-stent restenosis in selected cases. Their performance in more complex patients and their impact on the final clinical outcome of these patients, however, remains uncertain. RESTEM Registry (REgistro delle PCI in era di STEnt Medicati), a prospective multicenter registry collecting all percutaneous coronary interventions (PCIs) performed over 20 months and monitored up to 2 years, includes 5524 consecutive patients treated with bare metal stent (BMS) (72%), sirolimus-eluting stent (SES) (15%), combined BMS+SES (4%), or other techniques (9%). The combination of death, acute myocardial infarction (AMI), unstable angina and revascularizations had been chosen as primary endpoint. One-year multivariate analysis shows no significant advantage of SES in combined clinical events, a slight benefit in primary endpoint [18.5 vs. 25.0% BMS=odds ratio (OR) 0.78) and revascularizations (13.6 vs. 20.4% BMS=OR 0.74], a consistent advantage when only target vessel revascularizations (TVRs) are considered (5.5 vs. 10.5% BMS=OR 0.52). The two-year adjusted results confirm a significant advantage of SES in TVR (8.3 vs. 13.7% BMS=OR 0.65), a slight benefit for revascularizations (18.3 vs. 25.6% BMS=OR 0.76), without reducing mortality and other clinical events; these data refute the benefit on primary endpoint observed at 12 months (25.8 vs. 32.4% BMS=OR 0.84). After analyzing events recorded during the first and second year follow-up periods separately, the incidence of many of them favors SES in the first year, yet appear independent of the technique utilized in the second. RESTEM results confirming SES's capacity to reduce TVR without reduction of other clinical events, suggest that this advantage is limited to the first year after PCI, and show no evidence of excess of deaths, AMIs and late thrombosis following SES implantation described in recent meta-analyses.     

Efficacy of sirolimus-eluting stents compared with bare metal stents for saphenous vein graft intervention

Saphenous vein graft (SVG) intervention is associated with a significantly increased rate of periprocedural complications and late clinical and angiographic restenosis. We examined the efficacy and safety of sirolimus-eluting stents (SESs; Cypher) compared with bare metal stents (BMSs) in SVG intervention. Forty-eight patients who had 50 SVG lesions and underwent standard percutaneous coronary intervention with SESs (SES group) were compared with 57 patients who had 64 SVG lesions and underwent intervention with BMSs (BMS group). All patients received distal protection devices during SVG intervention. In-hospital, 30-day, 6-month, and 1-year clinical outcomes in the 2 groups were compared. Baseline clinical and procedural characteristics were balanced between groups. There were no deaths or Q-wave myocardial infarctions during the index hospitalization, but compared with the BMS group, patients in the SES group had significantly fewer non-Q-wave myocardial infarctions (4% vs 21%, p = 0.01), which was mainly attributed to increased periprocedural creatine kinase-MB levels. At 30-day, 6-month, and 1-year follow-ups, all clinical outcomes were similar between groups. Event-free survival at 1 year was also similar between groups (p = 0.84). In conclusion, the use of SESs in patients who undergo SVG intervention with a distal protection device is clinically safe and feasible but is not associated with decreased clinical events up to 1 year compared with BMSs.     

Impact of sirolimus-eluting stent on the outcome of patients with chronic total occlusions

Several randomized trials have demonstrated that stent implantation after successful recanalization of long-term total occlusions decreases restenosis and reocclusion rates. The sirolimus-eluting stent (SES) has recently proved its efficacy to decrease restenosis in selected patients. However, the efficacy of SES implantation in patients who have chronic total occlusions is currently unknown. Therefore, we investigated procedural and 6- and 12-month angiographic outcomes (analyzed by quantitative coronary angiography) and left ventricular function in 60 patients who received SESs and 120 patients who received bare metal stents (BMSs). Minimum luminal diameter did not differ immediately after recanalization (SES group 3.04 +/- 0.50 mm vs BMS group 3.12 +/- 0.48 mm). After 6 months, the SES group still had significantly larger luminal diameters (3.04 +/- 0.44 mm vs 1.94 +/- 0.98 mm) and significantly lower restenosis and reocclusion rates (2% and 0%, respectively) than did the BMS group (32% and 6%, respectively). Late loss was significantly smaller in the SES group than in the BMS group. At follow-up, the SES group had fewer cardiac events, including target lesion revascularization (p <0.001), than did the BMS group. In conclusion, SES implantation after recanalization of chronic total occlusion provides a better clinical outcome with less restenosis and target lesion revascularization after 6 months than does BMSs.     

Comparison of five-year outcome of octogenarians undergoing percutaneous coronary intervention with drug-eluting versus bare-metal stents (from the RESEARCH and T-SEARCH Registries)

Although octogenarians are increasingly referred for percutaneous coronary intervention (PCI), data are lacking on long-term safety and efficacy of drug-eluting stents in this high-risk subpopulation. The aim of this study was to evaluate 5-year clinical outcome of octogenarians who underwent PCI using sirolimus-eluting stents (SESs) or paclitaxel-eluting stents (PESs) compared to bare-metal stents (BMSs). From January 2000 to December 2005, 319 consecutive octogenarian patients who underwent PCI with BMSs (n = 93, January 2000 to April 2002), SESs (n = 52, April 2002 to February 2003), or PESs (n = 174, February 2003 to December 2005) were included prospectively. Primary study end points were all-cause mortality and major adverse cardiac events (MACEs), defined as all-cause death, any myocardial infarction, or any revascularization. Mean age of the study population was 83 ± 2 years and 51% of patients were men. Median follow-up duration was 5.4 years (range 3 to 9). Five-year mortality rates in the BMS, SES, and PES cohorts were similar (41%, 42%, and 41%, respectively). Cumulative 5-year MACE-free survival in the BMS, SES, and PES cohorts were 44%, 52%, and 48%, respectively. Compared to the BMS cohort, adjusted hazard ratios for MACEs in the SES and PES cohorts were 0.5 (95% confidence interval [CI] 0.3 to 0.9, p <0.05) and 0.5 (95% CI 0.2 to 1.4, p = 0.2), respectively. Overall, use of drug-eluting stents was associated with fewer MACEs (adjusted hazard ratio 0.5, 95% CI 0.3 to 0.9, p <0.05) and a trend toward less target vessel revascularization (adjusted hazard ratio 0.5, 95% CI 0.2 to 1.2, p = 0.1). In conclusion, PCI with drug-eluting stents in octogenarians was found to be safe and more effective compared to PCI with BMSs.     

One-year clinical outcomes of dialysis patients after implantation with sirolimus-eluting coronary stents

Background The efficacy of sirolimus-eluting stents (SESs) has not been established in dialysis patients. Methods and Results This study was a non-randomized observational single-center registry in a community hospital: data for 80 consecutive dialysis patients who underwent percutaneous coronary intervention (PCI) with SES were compared with those of a historical group of consecutive 124 dialysis patients treated with bare-metal stents (BMS). After 1 year, the cumulative incidence of major adverse cardiac events (MACE), comprising cardiac death, nonfatal myocardial infarction, stent thrombosis, or target lesion revascularization (TLR), was 25.2% in the SES group and 38.2% in the BMS group (p=0.048). In multivariate analysis, use of SES remained an independent predictor of MACE at 1 year after PCI (risk ratio 0.70, 95% confidence interval 0.52-0.93, p=0.015). Rates of TLR were 21.7% in the SES group and 30.9% in the BMS group and (p=0.15). Subgroup analysis showed that use of SES was effective in patients with small vessels, non-diabetic patients, and patients without highly calcified lesions. Conclusions In dialysis patients, the implantation of SES was moderately effective in reducing MACE at 1 year after PCI as compared with BMS. However, the TLR rate at 1 year was relatively higher than previously reported. (Circ J 2008; 72: 1430 - 1435).     

Selective versus exclusive use of sirolimus-eluting stent implantation in multivessel coronary artery disease.

Sirolimus-eluting stents (SESs; Cypher) have demonstrated a significant reduction in restenosis rates when compared to bare metal stents (BMSs). The purpose of this study was to evaluate the strategy of exclusive use of two SESs versus the combination of one BMS and one SES for two-vessel coronary artery disease (CAD). It was found that the selective use of one SES combined with one BMS in patients undergoing percutaneous coronary intervention that requires more than one stent is safe, feasible, and associated with favorable procedural, 30-day, and 6-month clinical outcomes when compared to the exclusive use of SESs.     

Outcome of overlapping heterogenous drug-eluting stents and of overlapping drug-eluting and bare metal stents

Overlapping homogenous drug-eluting stents (DESs) may be used instead of overlapping bare metal stents (BMSs) to treat coronary lesions longer than available stents. Yet, no data are available on patients treated with overlapping heterogenous DESs or DESs and BMSs. We prospectively assessed 9-month clinical outcome and 6-month angiographic late loss (evaluated at 5 different lesion segments) in a consecutive series of 40 patients who received overlapping homogenous DESs (sirolimus-eluting stent [SES] or paclitaxel-eluting stent [PES]), heterogenous DESs (SES + PES), or overlapping DESs and BMSs. In 8 patients (7 with angiographic follow-up) with overlapping heterogenous DESs, no angiographic or clinical adverse event was observed. Moreover, in-segment late loss was similar to that of patients who received homogenous DESs. In 8 patients (7 with angiographic follow-up) with overlapping DESs and BMSs, there was a higher incidence of major adverse events (3 repeat percutaneous coronary interventions and 1 death, 50% adverse event rate) and worse in-segment binary restenosis rate compared with patients treated with homogenous or heterogenous DESs (p = 0.02 and 0.012, respectively). Late lumen loss at the site of stent overlap showed significant differences according to type of overlapped stent (1.00 +/- 0.76 mm in DES-BMS overlap, 0.32 +/- 0.55 mm in PES-PES overlap, 0.13 +/- 0.11 in SES-PES overlap, and 0.08 +/- 0.10 mm in SES-SES overlap, p = 0.005). In conclusion, the present study suggests that overlap of DESs and BMSs should be avoided because the antirestenotic effect of DESs is skewed by contiguous BMS implantation. Overlap between SESs and PESs in this very preliminary report was associated with no specific adverse event.     

Drug-eluting stents are associated with similar cardiovascular outcomes when compared to bare metal stents in the setting of acute myocardial infarction

BACKGROUND: Recent randomized trials have demonstrated conflicting results regarding the use of drug-eluting stents (DESs) as compared to bare metal stents (BMSs) in primary percutaneous coronary intervention (PCI). We compared outcomes among patients presenting with acute ST-elevation myocardial infarction (STEMI) who received DES with those who received BMS. METHODS: In-hospital, 30-day, 6-month, and 1-year outcomes of a cohort of 122 patients who underwent primary or facilitated PCI and received a BMS were compared to 122 propensity-matched patients who received a DES. Seventy-two patients received sirolimus-eluting stents, and 50 received paclitaxel-eluting stents. RESULTS: Baseline demographics were similar among groups. One-, 6-, and 12-month outcomes, including reinfarction, death, stent thrombosis, and target vessel revascularization (TVR), were similar among groups. At 1 year, all-cause mortality was 13.3% in the BMS group and 9.2% in the DES group [P=not significant (ns)], recurrent MI was 5.3% in the BMS group vs. 4.4% in the DES group (P=ns), and TVR was 7% in the BMS group vs. 8.7% in the DES group (P=ns). CONCLUSIONS: Our data do not support the general use of DES in the setting of STEMI given similar cardiovascular outcomes among patients receiving BMS or DES, the need for long-term dual antiplatelet therapy with DES, and the possible repercussions of very late stent thrombosis.     

Long-Term Clinical Follow-up after Sirolimus-Eluting Stent versus Bare Metal Stent Implantation in Patients with Acute Coronary Syndrome

Background and Objective: Drug-eluting stents have been shown to reduce the incidence of restenosis and target vessel revascularization (TVR) compared with bare metal stents (BMSs); however, the long-term efficacy of sirolimus-eluting stent (SES) implantation in patients with acute coronary syndrome (ACS) has not been well established. We have investigated the long-term clinical outcome of SES in patients with ACS.
Methods: Consecutive 245 patients with ACS treated by primary stenting within 24 hours after onset were enrolled. There were 128 patients treated with SES and 117 patients were treated with BMS. We evaluated the incidence of major cardiac events (MACE; total death, nonfatal myocardial infarction, TVR) at 3 years, comparing with 8-month clinical outcome.
Results: Eight-month clinical follow-up shows a significantly lower incidence of TVR in the SES group, 3.1% in the SES group versus 9.4% in the BMS group (P = 0.04). At 3-year clinical follow-up, there was no significant difference in the rate of TVR between the two groups, 8.4% versus 12.4% (P = 0.37). Cumulative incidence of total MACE was 9.2% in the SES group compared with 15.9% in the BMS group (P = 0.18). Only one case of stent thrombosis was observed in the SES (late thrombosis), while two cases of stent thrombosis occurred in the BMS group (late and very late thrombosis; P = 0.55).
Conclusion: SES implantation in patients with ACS is associated with favorable long-term clinical outcome with no excess of late stent thrombosis. Further long-term clinical follow-up will be warranted to confirm the safety and efficacy of SES.     

Effect of sirolimus-eluting stent in diabetic patients with small coronary arteries (a SES-SMART substudy)

Randomized clinical trials have shown that sirolimus-eluting stents (SESs) decrease restenosis rates compared with bare metal stents (BMSs), but their efficacy among patients who have diabetes mellitus remains to be established. This study investigated the effect of SES implantation in a high-risk population (i.e., patients who had diabetes and small coronary vessel disease). For this purpose, we analyzed outcomes of the subset of patients who had diabetes and were enrolled in the SES-SMART, a randomized trial that compared the results of implantation of SESs and BMSs in small coronary arteries. Twenty-nine patients who had diabetes were originally randomized to receive SESs and 45 patients received BMSs. The use of SESs was associated with approximately 60% decreases in the relative incidence of in-segment angiographic restenosis (63% vs 25%, p = 0.003) and in-segment late loss (0.76 vs 0.28 mm, p <0.002). Angiographic patterns of restenosis were more favorable in the SES group. SES implantation was associated with a 15% absolute decrease in adverse clinical events. In patients who had insulin-dependent diabetes mellitus, SESs showed a high in-segment restenosis rate (40%) that was principally due to persistent restenosis. In conclusion, in diabetics with small coronary arteries, SES implantation significantly reduces the incidence of the 8-month angiographic restenosis rate compared with BMSs.     

Sirolimus-eluting stents for percutaneous coronary intervention in acute myocardial infarction Lesson from a case-controlled comparison of bare metal versus drug-eluting stents in thrombus-laden lesions

BACKGROUND: Given the encouraging results on early restenosis rate with drug-eluting coronary stents, both safety and 6 months outcomes of PCI with sirolimus-eluting stents (SES) in acute myocardial infarction are scarce. METHODS AND RESULTS: Fifty consecutive patients with acute myocardial infarction were subjected to acute PCI with SES and compared to 50 matched control patients who received a bare metal stent (BMS). All patients were followed over 6 months; in addition repeat angiography was obtained in 88.0% of SES and 92.0% of BMS patients. As a result of matching both groups were similar with regard to demographic, clinical, and infarction characteristics, as well as procedural data and adjunctive medication. SES diameter was 3.0 +/- 0.1 versus 3.3 +/- 0.5 mm with BMS, while the length of stented segment was 24 +/- 11 mm with SES versus 16 +/- 8 mm with BMS (p<0.05). No subacute stent thrombosis occurred in either group. At 6 months, all-cause mortality was 2.0% with SES, and 4.0% with BMS (n. s.); reinfarction rate was 2.0% in both groups, but binary restenosis rate (4.0 versus 18.0%; p<0.05) and target vessel revascularization (TVR) were improved with SES (2.0 versus 16.0%; p<0.05) resulting in lower MACE rate of 6.0 versus 22.0% with BMS (p<0.05). CONCLUSION: Placement of SES with PCI for myocardial infarction is feasible and as safe as BMS; 6-month outcome is superior with SES due to the lower rate of both angiographic restenosis and TVR.     

Intravascular ultrasound comparison of sirolimus-eluting stent versus bare metal stent implantation in diseased saphenous vein grafts (from the RRISC [Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent] trial)

The randomized Reduction of Restenosis In Saphenous Vein Grafts with Cypher Sirolimus-Eluting Stent trial compared angiographic outcomes of sirolimus-eluting stents (SESs) versus bare metal stents (BMSs) in saphenous vein grafts (SVG). Using intravascular ultrasound (IVUS) performed during 6-month follow-up angiography, we compared the vascular effects of the 2 types of stent on SVGs. Of 75 patients (96 lesions) included, 59 patients underwent IVUS in 61 SVGs; 29 patients received 40 SESs for 34 lesions, and 30 patients received 42 BMSs for 39 lesions. IVUS parameters (diameters, areas, and volumes) were compared in the 2 groups. A specific analysis was performed for overlapping SESs. Median neointimal volume was 1.3 mm(3) (interquartile range 0 to 13.1) in SESs versus 24.5 (7.8 to 39.5) in BMSs (p <0.001). Minimal incomplete stent apposition was detected at only 3 stent edges (2 BMSs, 1 SES) next to ectatic regions of the SVG. Compared with single SESs, overlapping SESs showed significant increases in neointimal reaction, with a neointimal volume of 0.6 mm(3)/mm of stent (0.1 to 1.8) versus 0 (0 to 0.4) in single SESs (p = 0.03), and this phenomenon was mainly localized in overlapping SES segments, where neointimal volume per millimeter of stent was 1.1 mm(3)/mm (0.6 to 4.4) versus 0 (0 to 1.3) in nonoverlapping segments (p = 0.05). In conclusion, SESs effectively inhibit neointimal hyperplasia volume compared with BMSs in diseased vein grafts, without evidence of increased incomplete apposition risk. The neointimal response to overlapping SES layers seems higher than to a single SES layer.