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.     

Three-year clinical follow-up of the unrestricted use of sirolimus-eluting stents as part of the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) registry

Sirolimus-eluting stents (SESs) have been shown to decrease restenosis compared with bare metal stents (BMSs). Currently, there are limited data on the long-term efficacy of these devices in a real-world patient population. Furthermore, the potential of a late restenotic phenomenon has not yet been excluded. From April to October 2002, 508 consecutive patients with de novo lesions exclusively treated with SESs were enrolled and compared with 450 patients treated with BMSs in the preceding 6 months (control group). Patients in the SES group more frequently had multivessel disease and type C lesions, received more stents, and had more bifurcation stenting. After 3 years, the cumulative incidence of major adverse cardiac events (comprising death, myocardial infarction, and target vessel revascularization) was significantly lower in the SES group compared with the pre-SES group (18.9% vs 24.7%, hazards ratio 0.73, 95% confidence interval 0.56 to 0.96, p = 0.026). The 3-year risk of target lesion revascularization was 7.5% in the SES group versus 12.6% in the pre-SES group (hazards ratio 0.57, 95% confidence interval 0.38 to 0.87, p = 0.01). In conclusion, the unrestricted use of SESs is safe and superior to the use of BMSs. The beneficial effects, reported after 1 and 2 years in reducing major adverse cardiac events, persisted with no evidence of a clinical late restenotic "catch-up" phenomenon.     

Clinical outcome following aleatory implantation of paclitaxel-eluting or sirolimus-eluting stents in complex coronary lesions

We compared the clinical efficacy of paclitaxel-eluting stents (PESs) and sirolimus-eluting stents (SESs) in a contemporary cohort of patients who had complex lesions. We collected data on 9-month outcomes in 529 patients (281 in the PES group and 248 in the SES group) whose de novo lesions were treated with drug-eluting stents. The end point was per-patient in-hospital and follow-up major adverse cardiac events, which were defined as a composite of death, myocardial infarction, and target vessel revascularization, including target lesion revascularization. There were no in-hospital deaths or repeat revascularizations; however, 5.7% of the PES group and 2% of the SES group developed a myocardial infarction (p = 0.04). At a median follow-up of 10.6 months, the rate of major adverse cardiac events was similar between groups (18.1% vs 21%, adjusted hazard ratio 0.85, 95% confidence interval 0.57 to 1.25), without any difference in the occurrence of death or myocardial infarction. Diabetes and total stent length were independent predictors of major adverse cardiac events. Propensity analysis confirmed the similarity between devices (hazard ratio 0.87, 95% confidence interval 0.62 to 1.25). Most restenoses were focal and only 2 patients required surgical revascularization. In conclusion, implantation of drug-eluting stents in complex lesions was associated with favorable results and most patients remained free from surgical revascularization at follow-up. Overall, the 2 available stent platforms had similar performance characteristics.     

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.     

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).     

Sirolimus-eluting stents at two years: a pooled analysis of SIRIUS, E-SIRIUS, and C-SIRIUS with emphasis on late revascularizations and stent thromboses

Prospective follow-up at 2 years was obtained for 98.7% of the pooled 1,510 patients enrolled in SIRIUS, E-SIRIUS and C-SIRIUS, 3 randomized controlled trials that compared sirolimus-eluting stents (SESs) with bare metal stents (BMSs) to treat long stenoses in small coronary arteries. By 720 days, clinically driven target lesion revascularizations were performed in 5.7% of patients with SESs versus 22.6% of patients with BMSs (risk ratio 0.25, 95% confidence interval 0.18 to 0.35, p <0.001). Of these, late target lesion revascularization (from 271 to 720 days) was performed in 12 patients who received SESs (1.6%) compared with 37 patients with BMSs (4.9%) (risk ratio 0.32, 0.17 to 0.61, p <0.001). Stent thromboses occurred in 7 of 758 patients with SESs (0.9%, 4 subacute, 3 late) and 5 of 752 patients with BMSs (0.7%, 1 subacute, 4 late) (risk ratio 1.39, 95% confidence interval 0.44 to 4.36, p = 0.774). The Kaplan-Meier estimate of freedom from major cardiac adverse events was 89.3% for patients with SESs versus 73.4% for patients with BMSs (p <0.001). This analysis demonstrates the sustained efficacy and safety of sirolimus-eluting stents at 2 years, characterized by a persistent significant benefit in freedom from repeat revascularization compared with BMSs and a low risk of late stent thrombosis, not different from BMSs.     

Outcome of sirolimus-eluting versus zotarolimus-eluting coronary stent implantation in patients with and without diabetes mellitus (a SORT OUT III Substudy)

Diabetes is associated with an increased risk of major adverse cardiac events after percutaneous coronary intervention. We compared clinical outcomes in patients with and without diabetes mellitus treated with the second-generation Endeavor zotarolimus-eluting stent (ZES) or the first-generation Cypher Select+ sirolimus-eluting stent (SES). We randomized 2,332 patients to treatment with ZESs (n = 1,162, n = 169 diabetics) or SESs (n = 1,170, n = 168 diabetics) and followed them for 18 months. Randomization was stratified by presence/absence of diabetes. The primary end point was major adverse cardiac events defined as a composite of cardiac death, myocardial infarction, or target vessel revascularization. Secondary end points included these individual end points plus all-cause mortality and target lesion revascularization. In diabetic patients, use of ZES compared to SES was associated with an increased risk of major adverse cardiac events (18.3% vs 4.8%, hazard ratio 4.05, 95% confidence interval 1.86 to 8.82), myocardial infarction (4.7% vs 0.6%, hazard ratio 8.09, 95% confidence interval 1.01 to 64.7), target vessel revascularization (14.2% vs 3.0%, hazard ratio 4.99, 95% confidence interval 1.90 to 13.1), and target lesion revascularization (12.4% vs 1.2%, hazard ratio 11.0, 95% confidence interval 2.59 to 47.1). In patients without diabetes differences in absolute risk decrease were smaller but similarly favored SES. In conclusion, implantation of ZESs compared to SESs is associated with a considerable increased risk of adverse events in patients with diabetes at 18-month follow-up.     

The efficacy of sirolimus-eluting stents versus bare metal stents for diabetic patients undergoing elective percutaneous coronary intervention

BACKGROUND: Diabetes mellitus is a well-known risk factor for future adverse cardiac events after coronary intervention with conventional metal stents. In this study, the impact of sirolimus-eluting stents (SES) were evaluated in a consecutive group of diabetic patients undergoing elective percutaneous coronary treatment and compared to a population treated with bare metal stents. METHODS AND RESULTS: From April 2002, a policy of routine SES implantation has been instituted in our hospital. During 1 year of enrollment, a total of 112 consecutive diabetic patients with de novo coronary lesions were electively treated with SES (SES group). A similar group for comparison comprised 118 consecutive patients treated with bare metal stents in the preceding period (the pre-SES group). After 1-year follow-up, the cumulative rate of major adverse cardiac events (death, myocardial infarction, and any repeat revascularization) was 17.3% in the SES group versus 30.2% in the pre-SES group (hazard ratio, 0.54 [95% confidence interval, 0.32-0.91]; p = 0.02), mainly due to a marked reduction in the need for repeat revascularization (10.2% versus 23.5%; hazard ratio, 0.40 [95% confidence interval, 0.21-0.78]; p = 0.007). CONCLUSIONS: Routine utilization of SES for diabetic patients significantly reduces the rate of adverse cardiac events at 1 year compared to bare metal stents.     

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.     

Comparison of frequency of major adverse events in patients with atrial fibrillation receiving bare-metal versus drug-eluting stents in their coronary arteries

In patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention with drug-eluting stent (DES) implantation, the available evidence from clinical trial data are inconclusive. We evaluated the safety and efficacy of the use of DESs versus bare-metal stents (BMSs) in a consecutive real-world cohort of patients with AF. Of 8,962 unselected patients with AF seen in our institution from 2000 through 2010, 833 (9%) had undergone percutaneous coronary intervention with stent implantation. BMSs were used for 678 patients (81%) and DESs for 155 (19%). During follow-up (median 688 days, interquartile range 1,114), all bleeding episodes, thromboembolism, and major adverse cardiac events (MACEs; i.e., death, acute myocardial infarction, target lesion revascularization) were recorded. Incidence of MACEs was similar in the 2 groups as was incidence of all-cause mortality. Results remained similar even after adjustment for age and other confounding factors. Factors independently associated with an increased risk of MACEs were older age (hazard ratio 1.024, 95% confidence interval 1.004 to 1.044, p = 0.02), implantation of stent during acute ST-segment elevation myocardial infarction (hazard ratio 1.81, 95% confidence interval 1.10 to 2.99, p = 0.02), and stent diameter (hazard ratio 1.09, 95% confidence interval 1.01 to 1.18, p = 0.03). Implantation of DESs was not significantly associated with a higher risk of major bleeding and we observed a similar ratio of serious events at follow-up after DES compared to BMS implantation. In conclusion, in our cohort, systematic use of DESs does not seem to be justified in most patients with AF because it was not associated with any clear advantage compared to BMSs.     

Impact of chronic renal insufficiency on clinical outcomes in patients undergoing percutaneous coronary intervention with sirolimus-eluting stents versus bare metal stents

Patients with chronic renal insufficiency (CRI) have higher rates of target vessel revascularization and mortality. The efficacy of sirolimus-eluting stents (SESs) to improve the clinical outcomes of these patients is unknown. We investigated the effect of SESs versus bare metal stents (BMSs) on outcomes of patients with CRI. Among the first 1,522 patients treated with SESs, 76 were identified with CRI and 1,446 without CRI. In-hospital and 1- and 6-month clinical outcomes were compared with 153 patients with CRI who were treated with BMSs. Patients with CRI were older, hypertensive, and diabetic and had more previous myocardial infarctions, revascularizations, and decreased left ventricular function (p <0.001). These patients had more saphenous vein graft lesions, were treated with more debulking devices (p <0.003), and had higher rates of in-hospital complications and mortality (p <0.001) compared with those without CRI. Among patients with CRI, treatment with SESs did not affect clinical outcomes at 1 month and was associated with lower incidences of target vessel revascularization (7.1% vs 22.1%, p = 0.02) at 6 months but did not affect other events, including mortality (16.7% vs 14.7% p = 0.89), compared with BMSs. However, treatment with SESs in patients without CRI was associated with significantly lower rates of major adverse cardiac events at 6 months (p <0.001). In conclusion, percutaneous coronary intervention with SESs in patients with CRI is associated with low rates of repeat revascularization compared with BMSs but has no effect on mortality at 6 months.     

Meta-analysis of long-term outcomes for drug-eluting stents versus bare-metal stents in primary percutaneous coronary interventions for ST-segment elevation myocardial infarction

The use of drug-eluting stents (DESs) in primary percutaneous coronary intervention (PPCI) has shown early benefit over bare-metal stents (BMSs) in decreasing adverse cardiac events. However, there are concerns regarding the increased risk of late and very late stent thrombosis (ST) after DES use. With the paucity of ST events individual trials may have been underpowered to detect significant differences. We sought to perform a meta-analysis to evaluate the available literature examining the outcomes of DESs and BMSs in PPCI after ≥3 years of follow-up. We analyzed 8 randomized clinical trials (RCTs) and 5 observational studies comparing DESs to BMSs in PPCI. Clinical end-point data were analyzed for RCTs and observational studies separately using random-effect models. RCTs included 5,797 patients in whom first-generation DESs (sirolimus- or paclitaxel-eluting stents) were compared to BMS control arms. Patients receiving DESs had a significantly lower risk of target lesion revascularization (odds ratio [OR] 0.48, confidence interval [CI] 0.37 to 0.61), target vessel revascularization (OR 0.53, CI 0.42 to 0.66), and accordingly major adverse cardiac events (OR 0.69; CI 0.56 to 0.84). Incidence of ST was not different between groups (OR 1.02, CI 0.76 to 1.37). There was no significant difference in mortality (OR 0.88, CI 0.68 to 1.12) or recurrent myocardial infarction (OR 0.97; CI 0.61 to 1.54). Among observational studies (n = 4,650) fewer studies reported on target lesion revascularization and target vessel revascularization, but the trend remained in favor of DESs. A small but statistically significant increase in ST was noted with DES use (OR 1.62, CI 1.18 to 2.21) at ≥3 years of follow up, without evidence of recurrent myocardial infarction. Those receiving DESs had a significantly lower mortality compared to those receiving BMSs (OR, 0.65, 95% CI 0.53 to 0.80, p <0.001). In conclusion, this meta-analysis of RCTs examining the long-term outcomes of first-generation DESs versus BMSs in PPCI, DES use resulted in decreased repeat revascularization with no increase in ST, mortality, or recurrent myocardial infarction.     

Long-term clinical outcomes and thrombosis rates of sirolimus-eluting versus paclitaxel-eluting stents in an unselected population with coronary artery disease (REWARDS registry)

Sirolimus-eluting stents (SESs) and paclitaxel-eluting stents (PESs) significantly decrease the need for repeat interventions compared with bare metal stents. Comparative outcome data from randomized, controlled, head-to-head trials using these systems in a selected group of patients and lesions are conflicting; therefore, we compared clinical outcomes of unselected patients who underwent contemporary percutaneous coronary intervention with SES or PES implantation. In the REWARDS registry, 1-year clinical outcomes of 1,925 patients who received SESs were compared with 844 patients who received PESs. Outcomes at 30 days and 6 months were similar between groups, with a trend toward higher rates of stent thrombosis in the SES group compared with the PES group. Stent thrombosis rate at 12 months was significantly higher in the SES than in the PES group, with cumulative stent thrombosis rates of 1.9% in the SES group and 0.8% in the PES group (p = 0.034). However, overall rates of major adverse cardiac events (MACEs) were similar in the 2 groups at 12 months. After adjusting for significant multivariate predictors of MACEs, the hazard ratio at 1 year was 1.06 (95% confidence interval 0.85 to 1.33, p = 0.607) and the major predictors for MACEs were a history of renal failure, diabetes, previous myocardial infarction, cardiogenic shock, class III or IV heart failure, type C lesions, and saphenous vein grafts. In conclusion, use of SESs and PESs in unrestricted, contemporary practice had comparable outcomes in terms of low rates of revascularization and clinical events. Stent thrombosis continues to be a major concern for SESs and PESs.     

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.     

Short- and long-term clinical benefit of sirolimus-eluting stents compared to conventional bare stents for patients with acute myocardial infarction

OBJECTIVES: This study investigated the clinical outcomes of patients with ST-segment elevation myocardial infarction (MI) treated with sirolimus-eluting stents (SESs) or with conventional bare stents. BACKGROUND: The clinical impact of SES implantation for patients with ST-segment elevation MI is currently unknown. METHODS: Primary angioplasty was performed with SESs in 186 consecutive patients with acute MI who were compared with 183 patients treated with bare stents. The incidence of death, reinfarction, and repeat revascularization was assessed at 30 and 300 days. RESULTS: Postprocedure vessel patency, enzymatic release, and the incidence of short-term adverse events were similar in both the sirolimus and the bare stents (30-day rate of death, reinfarction, or repeat revascularization: 7.5% vs. 10.4%, respectively; p = 0.4). Stent thrombosis was not diagnosed in any patient in the sirolimus group and occurred in 1.6% of patients treated with bare stents (p = 0.1). At 300 days, treatment with SESs significantly reduced the incidence of combined adverse events (9.4% vs. 17%; hazard ratio [HR] 0.52 [95% confidence interval (CI) 0.30 to 0.92]; p = 0.02), mainly due to a marked reduction in the risk of repeat intervention (1.1% vs. 8.2%; HR 0.21 [95% CI 0.06 to 0.74]; p = 0.01). CONCLUSIONS: Compared to conventional bare stents, the SESs were not associated with an increased risk of stent thrombosis and were effective in reducing the incidence of adverse events at 300 days in unselected patients with ST-segment elevation acute MI referred for primary angioplasty.     

Three-year clinical outcomes after coronary stenting of chronic total occlusion using sirolimus-eluting stents: insights from the rapamycin-eluting stent evaluated at Rotterdam cardiology hospital-(RESEARCH) registry.

BACKGROUND: We previously reported that the 1-year survival-free from target lesion revascularization was 97.4% in patients with chronic total occlusion (CTO) treated with sirolimus-eluting stents (SES). There are currently no long-term results of the efficacy of SES in this subset of lesions. We assessed the 3-year clinical outcomes of 147 patients with CTO treated with either SES or bare metal stents (BMS). METHODS AND RESULTS: A total of 147 (BMS = 71, SES = 76) patients were included. Four patients died in the BMS group while five patients died in the SES group, P = 0.8; two myocardial infarctions occurred in both groups, P = 0.9; and target vessel revascularization was performed in nine patients in the BMS and seven in the SES group, P = 0.5. The cumulative event-free survival of MACE was 81.7% in BMS group and 84.2% in SES group, P = 0.7. Two patients of the SES group had a coronary aneurism at 3-year angiographic follow-up. CONCLUSIONS: The use of SES was no longer associated with significantly lower rates of target vessel revascularization and major adverse cardiac events in patients with CTOs after 3 years of follow-up compared with BMSs.     

Promising efficacy of the sirolimus-eluting stent in patients with acute myocardial infarction

OBJECTIVES: This study investigated the safety and efficacy of sirolimus-eluting stents (SESs) on early and late outcomes in patients with acute myocardial infarction. METHODS: A series of 100 consecutive patients (September 2004 to November 2005)with acute myocardial infarction undergoing primary stenting using SES ptember 24 hr) was compared with 100 consecutive patients (September 2003 to August 2004) treated with bare metal stent (BMS). The frequency of major adverse cardiac events (MACE) and stent thrombosis, and status of ticlopidine administration were assessed at 270 days. RESULTS: The rates of premature discontinuation of ticlopidine (SES group <3 months: 11%, BMS group <1 month: 11%, p = NS) and stent thrombosis (SES group: 1%, BMS group: 0%, p = NS) were similar in the two groups. At follow-up, restenosis rate and target vessel revascularization rate were lower in the SES group(4% vs 19%, p < 0.001 and 4% vs 10%, p = 0.149, respectively). Furthermore, the occurrence of MACE at 270 days was significantly less frequent in the SES group compared with the BMS group (6% vs. 17%, p = 0.038). Multivariate analysis showed SES use tended to predict 270-day MACE (hazard ratio 0.37, 95% confidence interval 0.14-1.02, p = 0.055). Culprit lesion located in the left main trunk was identified as an independent predictor of 270-day MACE (hazard ratio 5.43, 95% confidence interval 1.07-27.59, p = 0.041). CONCLUSIONS: The use of a SES was not associated with increased risk of stent thrombosis compared with a BMS. With lower rates of restenosis and subsequent target vessel revascularization, SES placement could provide superior outcomes in patients with acute myocardial infarction.     

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.