Efficacy Of Sirolimus-eluting Stents Research Articles

Three-year follow-up outcomes of SES and PES in a randomized controlled study stratified by the presence of diabetes mellitus: J-DEsSERT trial

BackgroundThree-year clinical follow-up of patients with diabetes mellitus (DM) in the Japan-Drug Eluting Stents Evaluation; a Randomized Trial (J-DESsERT) using 2 different drug eluting stents (DES). A recent study demonstrated that efficacy of sirolimus eluting stents (SES) attenuated over time in diabetic patients. MethodsIn the largest trial of its kind, 1724 DM patients out of 3533 enrolled patients were randomized to either SES or paclitaxel eluting stents (PES). ResultsThere were no significant differences in baseline clinical characteristics aside from hypertension. Incidence of major adverse cardiac cerebrovascular events (MACCE) mainly due to higher target vessel failure (TVF) initially indicated a benefit in SES (MACCE rate at 1year: SES 9.4%, PES 12.2%, p=0.08); however this had attenuated by the time of the 3-year follow-up (MACCE rate from 1 to 3years: SES 8.4%, PES 6.1%, p=0.10). A similar pattern was observed in insulin-treated patients: MACCE rate from 1 to 3years was 10.5% in SES and 6.4% in PES (p=0.25). Angiographic follow-up also resulted in higher major adverse cardiac event (MACE) rates at 1year (presence 11.5%, absence 8.3%, p=0.04); however by 3years rates were similar regardless of the presence of angiographic follow-up (MACE rate at 3years: presence 16.0%, absence 14.5%, p=0.35). ConclusionsThe superiority of SES over PES in MACCE at 1year had attenuated by 3-year follow-up. Eventually, the 3-year safety and efficacy profiles were similar regardless of insulin treatment.

Abstract 11491: Differences in the Development of Restenosis Over Time for Various Drug-Eluting Stents

Objective: This study aims to compare the efficacy of sirolimus-eluting stents (SES), paclitaxel-eluting stents (PES), zotarolimus-eluting stents (ZES), and everolimus eluting stents (EES) via sequential angiographic follow-up and to reveal the development of restenosis over time. Methods: Patients were randomized to receive SES, PES, ZES, or EES, and follow-up angiography was performed at 6, 12 and 24months after percutaneous coronary intervention. Results: The baseline clinical characteristics of the patients and the coronary lesions are shown in (Table 1). In all groups, mean minimal lumen diameter decreased slightly during the 2-year period after the procedure (Figure 1). Compared with the SES group, the PES and the ZES groups showed greater late loss (LL) within 1 year. However, the SES group showed significantly greater LL compared with the other drug-eluting stents (DES) between 1 and 2 years (Figure 2). Conclusion: Serial angiographic analysis revealed differences in the rate of restenosis development over time for various DES. As DES are comprised of many components (metallic platform, alloy, drug and polymer), the progression of LL can be complex and affected by different factors.

Safety and Long-Term Efficacy of Sirolimus-Eluting Stents

Sirolimus was isolated in 1975 and was initially approved for the treatment of renal transplant rejection. The main mechanism of action is mTOR inhibition, which prevents cell cycle progression. The first-in-human study of the sirolimus-eluting stent (SES) was initiated in 1999 in Sao Paulo Brazil and Rotterdam. The study demonstrated a reduction in restenosis after SES implantation when compared with bare-metal stents. The first approved drug-eluting stent was the SES Cypher®. Several modifications in stent platform and polymer coating have been made, in an effort to improve deliverability and to reduce inflammatory response secondary to nonbiocompatible polymers. Bioabsorbable polymer and polymer-free technologies are the main characteristic of the second- and third-generation SES. Larger studies with longer follow-up are needed to prove the efficacy of those stents when compared with previous platforms.

Safety and Efficacy of Sirolimus-Eluting Stent in Diabetic Patients Compared with Non-Diabetic Patients Undergoing Percutaneous Coronary Intervention

Background : The research has been shown that the clinical outcomes of diabetic patients undergoing revascularization either coronary artery bypass grafting or percutaneous coronary intervention (PCI) are inferior to that of non-diabetic patients. Objectives : We have carried out the registry to assess the clinical outcomes of the patients with diabetes mellitus (DM) compared to the patients without DM after the PCI with sirolimus-eluting stent. Methods : Indolimus Diabetic registry is a single-centre; single-armed, retrospective registry that enrolled 530 patients who underwent PCI with Indolimus ® stent at the Sri Venkateswara Institute of Medical Sciences, Tirupati, India during the study period. The endpoint of the registry was a major adverse cardiac event (MACE) defined as a composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave not clearly attributable to a non-target vessel), target lesion revascularization (TLR) and target vessel revascularization (TVR) and that were observed at 30-days and at 6-monthsfollow-up. Results : Among 530 patients, 169 patients were having DM. It is noteworthy that the patients with DM were more often women (29.6% vs. 18.0%), hypertensive (54.4% vs. 34.1%) and higher incidence of revascularization (4.2% vs. 2.5%). Double vessel disease was more prevalent in diabetic population as compared to non-diabetics (37.9% vs. 24.9%). Total 617 lesions were encountered in 530 patients (202 in diabetic patients and 415 in non-diabetic patients). There was no significant difference observed in the lesion class. There was no statistical significant difference observed for cardiac death (1.8% vs. 1.7%, p =1.00) and MACE (1.8% vs. 1.9%, p =1.00) in diabetic and non-diabetic patients at 30-days follow-up. However, at 6-month follow-up, it has been observed that the occurrence of MACE was higher but not statistically significant in diabetic patients as compared to non-diabetic patients (4.1% vs. 2.5%, p =0.29). Conclusions : In this Indolimus Diabetic registry, MACE rate did not significantly differ between diabetic and non-diabetic population at 30-days and at 6-months follow-up. However, long term follow-up is needed to determine whether a similar safety profile is maintained.

Clinical Outcome of Unprotected Left Main Coronary Artery Disease in Patients With Acute Myocardial Infarction

The clinical outcome of patients with acute myocardial infarction (MI) with unprotected left main coronary artery (LMCA) stenosis is not fully understood. We sought to assess the outcomes of patients with acute MI who underwent percutaneous coronary intervention (PCI) for unprotected LMCA stenosis. A total of 587 patients enrolled in the Korea Acute Myocardial Infarction Registry with LMCA stenosis were analyzed. Patients with culprit LMCA had higher inhospital mortality than patients with non-culprit LMCA (16.0% versus 8.9%, P = 0.008), but had similar clinical outcomes during a 12-month follow-up. Compared to CABG, PCI using drug-eluting stents (DES) was more frequently performed with similar early and 12-month clinical outcomes. The efficacy of sirolimus-eluting stents, paclitaxel-eluting stents, and zotarolimus-eluting stents were comparable at 12-month clinical follow-up. Predictors of 12-month mortality included mechanical ventilation, cardiogenic shock, age > 65 years, and ejection fraction < 40%. Patients with acute MI and culprit LMCA have higher early mortality than patients with non-culprit LMCA. PCI with DES is frequently performed and the clinical outcome is similar between the 3 types of first-generation DES.

Sirolimus-eluting stents versus paclitaxel-eluting stents for coronary intervention in patients with renal failure on hemodialysis

Patients undergoing chronic hemodialysis (HD) are at high risk of restenosis and cardiac events after percutaneous coronary intervention (PCI). This study compared the clinical efficacy of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients undergoing HD. Between June 2004 and January 2010, the clinical outcomes of 41 consecutive patients on HD who underwent PCI with SES (62 lesions) were compared with those of 38 consecutive patients on HD who underwent PCI with PES (54 lesions). Patient and lesion characteristics were similar between both groups. The target lesion revascularization (TLR) (SES 36.6% vs. PES 15.8%; P=0.037) was significantly higher with SES (36.6%) than with PES (15.8%) (P=0.037), particularly in the context of severe calcified lesions that required rotational atherectomy (SES 72.7% vs. PES 16.7%; P=0.0067). However, 1year after PCI, there was no difference between the two groups in all-cause death, myocardial infarction or major adverse cardiac events. Patients undergoing HD are at a high risk of restenosis after PCI, even when using a drug-eluting stent. The TLR was higher with SES than with PES, particularly when used for severe calcified lesions that required rotational atherectomy.

Five-year clinical outcomes after implantation of sirolimus-eluting stents in patients with and without diabetes mellitus

Percutaneous coronary intervention in patients with diabetes mellitus (DM) is associated with worse clinical outcomes; however, the long-term efficacy of sirolimus-eluting stents (SES) in diabetic patients remains uncertain. We evaluated 5-year clinical outcomes after SES implantation in 197 consecutive patients (85 in the DM group and 112 in the non-DM group), and 246 lesions (106 and 140, respectively). The primary end point was major adverse cardiac events (MACE) defined as cardiac death, nonfatal myocardial infarction, target lesion revascularization (TLR), stent thrombosis or admission for congestive heart failure. Diabetic patient characteristics included 32 % who used insulin. The risk of congestive heart failure was significantly higher [20.0 vs. 5.4 %, odds ratio (OR) 4.417, 95 % confidence interval (CI) 1.659 to 11.759, p = 0.003] in the DM group compared with the non-DM group; however, MACE did not occur significantly more often (27.1 vs. 16.1 %, p = 0.060). Multivariate logistic regression analysis showed that diabetes was associated with congestive heart failure (OR 4.715, 95 % CI 1.743 to 12.759, p = 0.002) and multivessel disease was associated with major adverse cardiac events (OR 2.709, 95 % CI 1.053 to 6.965, p = 0.039). The cumulative rates (%) of TLR were as follows: after 1 year; 5.9 versus 5.4, 2 years; 7.1 versus 5.4, 3 years; 9.4 versus 7.1, 4 years; 9.4 versus 8.9, 5 years; 9.4 versus 8.9 (p = 0.652) in the DM group and the non-DM group, respectively. Diabetic patients had worse long-term prognosis in terms of congestive heart failure than non-diabetic patients undergoing PCI, even with SES. TLR was performed steadily for up to 5 years of follow-up following the late catch-up phenomenon both in diabetic and non-diabetic patients.

Long-term clinical outcomes following sirolimus-eluting stent implantation in patients with acute myocardial infarction. A meta-analysis of randomized trials

The aim of this study was to perform a meta-analysis of randomized trials, evaluating the long-term outcomes of sirolimus-eluting stents (SES) versus bare-metal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI). Despite short-term outcomes of patients with STEMI undergoing primary percutaneous coronary intervention indicate a benefit of SES in terms of reintervention, several concerns remain on the long-term safety and efficacy of SES. A systematic literature search of electronic resources, through October 2011, was performed using specific search terms. Included trials were randomized studies comparing SES to BMS in STEMI patients, with a follow-up ≥3 years. Seven trials were included, with a total of 2,364 patients. At a median follow-up of 3 years, SES significantly reduced the risk of target-vessel revascularization when compared with BMS [odds ratio (OR), 0.44; 95 % confidence interval (CI), 0.34-0.57; p < 0.0001], without increasing the risk of mortality (OR 0.78; 95 % CI, 0.57-1.08; p = 0.14), reinfarction (OR 0.91; 95 % CI, 0.61-1.35, p = 0.64) and early to late stent thrombosis (OR 0.77; 95 % CI, 0.49-1.20; p = 0.25). However after the first year, SES did not further reduce target-vessel revascularization (OR 1.06; 95 % CI, 0.64-1.74; p = 0.83) and increased the risk of very late stent thrombosis (OR 2.81; 95 % CI, 1.33-5.92; p = 0.007). At long-term follow-up, SES compared to BMS use in STEMI patients reduces the risk of target-vessel revascularization, without increasing the risk of death and reinfarction. However, the strong SES efficacy is counterbalanced by a significant risk of very late stent thrombosis.

AS-011: Safety and Efficacy of Late (12-48 hrs) Reperfusion Using Sirolimus-Eluting Stent Compared with Primary Stenting in 625 STEMI Patients

We retrospectively examined the safety and efficacy of sirolimus-eluting stent (Cypher Bx Velocity; SES) after late (presented from 12 to 48 hrs after the onset) reperfusion for ST-segment elevated myocardial infarction (STEMI) by comparing with those of primary stenting in consecutive 625 STEMIs during from 2004 August to 2010 February.

Five-year follow-up of the Sirolimus-Eluting Stents vs Vascular Brachytherapy for Bare Metal In-Stent Restenosis (SISR) trial

The aim of this study was to evaluate the 5-year clinical safety and efficacy outcomes of patients treated for in-stent restenosis of bare-metal stents (BMSs). The SISR trial is a prospective, randomized trial that compared the safety and efficacy of sirolimus-eluting stent (SES) vs vascular brachytherapy (VBT) for the treatment of BMS in-stent restenosis. A total of 384 patients with BMS in-stent restenosis were randomized to treatment with SES (n = 259) or VBT (n = 125) and were followed for 5 years. At 5 years, the rates of target lesion revascularization (TLR) had narrowed and were nonsignificant between the SES and VBT groups, with TLR rates of 24.7% and 31.2% (95% CI -16.3% to 2.8%, P = .179) respectively. Target vessel failure was 33.6% vs 36.8% (95% CI -13.5% to 6.7% P = .568) for SES compared with VBT. The rate of major adverse cardiac event at 5 years was 34.0% vs 36.8% (95% CI -13.1% to7.1%, P = .648) for the SES compared with VBT. There were no differences between SES and VBT in terms of survival free from TLR (72.9% vs 66.4%, log-rank P = .08) or from target vessel failure (64.4% vs 61.3%, log-rank P = .349). There were no significant differences in the rates of definite/probable stent thrombosis (5.9% vs 2.5%, 95% CI -7.9% to 1.3%, P = .182) between the 2 groups. At a 5-year follow-up, no differences in safety or efficacy outcomes were observed for treatment of BMS restenosis with SES vs VBT. There were no significant differences in survival free from TLR, target vessel revascularization, or major adverse cardiac events between the 2 groups at 5 years. Sirolimus-eluting stent is a viable treatment option compared with VBT for BMS restenosis.

The impact of preprocedural hemoglobin A1c on the efficacy of sirolimus-eluting and paclitaxel-eluting stents

Several reports have shown contrary results regarding the efficacy of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in diabetic patients. The association between hemoglobin A1c (A1c) before coronary intervention and the midterm clinical outcomes of patients treated with these stents is unclear. The enrolled population was 415 patients with diabetes or impaired glucose tolerance (IGT) who underwent follow-up angiography after being implanted with a SES (n = 282) or PES (n = 133). The enrolled population was classified into the optimal glycemic control group (n = 213) and suboptimal glycemic control group (n = 202), and the predictors of restenosis were examined in each group. In the optimal glycemic control group, the use of PES was an independent predictor of restenosis [odds ratio (OR) 9.98, 95% confidence interval (CI) 3.08-38.9, p < 0.0001]; on the other hand, the use of SES was a positive independent predictor of restenosis prevention (OR 0.10, 95% CI 0.03-0.32, p < 0.0001). In the suboptimal glycemic control group, neither stent was predictive of restenosis. In a subanalysis, preprocedural A1c (≥7.0%) was found to be an independent predictor of restenosis in the SES group (OR 3.61, 95% CI 1.14-12.8, p = 0.03), but not the PES group. Postprocedural A1c (≥7.0%) was not an independent predictor of restenosis in either stent group. This study showed that the superiority of SES compared to PES was attenuated in the suboptimal glycemic control group. Preprocedural A1c (≥7.0%) was found to be an independent predictor of restenosis in the SES group, but not in the PES group.

Impact of Hinge Motion on In-Stent Restenosis After Sirolimus-Eluting Stent Implantation

A tortuous lesion with hinge motion is reportedly a risk factor for in-stent restenosis (ISR) after bare metal stent implantation. Sirolimus-eluting stents (SESs) implantation has dramatically reduced ISR. However, SES is a closed-cell design stent, which has low conformability and flexibility. Several studies have reported a relationship between tortuous lesions and stent fracture, which is one of the causes of ISR. The efficacy of SES in a tortuous lesion with hinge motion has not been fully evaluated. The aim of this study was to investigate the relationship between tortuous lesions and ISR after SES implantation. Three year clinical follow-up data after SES implantation, including 6-9 month scheduled follow-up coronary angiography in 399 consecutive patients with 537 lesions, were obtained. Δangle was defined as the difference in the angle of the target lesion between the diastole and systole before the procedure. The incidence of ISR was 8.2%. The mean maximal angle and Δangle were larger in the ISR group (47 ± 22° vs. 37 ± 21°, P=0.004 and 20 ± 13° vs. 13 ± 10°, P < 0.0001, respectively). Independent predictors of ISR were Δangle, hemodialysis, aortic ostium stenting, and diabetes mellitus. Hinge motion-associated ISR (Δangle ≥ 16°) occurred in 28 lesions: stent fracture in 9, stent recoil in 6, edge injury in 10, and others in 3. The amount of hinge motion in tortuous lesions should be considered in the selection of drug eluting stent types.

Randomized study on provisional stenting with sirolimus-eluting stent vs. bare metal stent for the treatment of true coronary bifurcations: The PROSUMER (PROvisional with sirolimus-eluting vs. bare metal stents in truE bifuRcations) study

⁎ Corresponding author. Via Tommaso Inghirami 85, 00179 Rome, Italy. Tel.: +39 348 3392006; fax: +39 06 330 62516. E-mail address: f.pelliccia@mclink.it (F. Pelliccia). Percutaneous treatment of coronary bifurcations with stent implantation is still a matter of debate [1]. Despite the implementation of numerous techniques to stent both branches, none has shown clinical and angiographic superiority to the main branch (MB) stent technique with provisional T-stenting of the side branch (SB) in case of dissection or residual severe disease [2]. In addition, concerns have been raised about safety of drug-eluting stents (DES) because of the greater late and very late [3] stent thrombosis and mortality as compared to bare metal stents (BMS). Also, technical characteristics of stents (i.e. high radial force, favorable vessel wall covering percentage and larger patency of SBs) seem to be crucial factors in case of provisional T-stenting strategy [2,4]. To address these issues, we designed the PROSUMER (PROvisional with sirolimus-eluting vs. bare metal stents in truE bifuRcations) study in order to prospectively and randomly compare the safety and efficacy of sirolimus-eluting stent (SES) vs. a BMS in case of treatment of true coronary bifurcation lesions with provisional T-stenting. The studywasdesigned as a prospective, single-center pilot trial, and included consecutive angina patients with a de novo true coronary arterybifurcation lesion (Medina classifications1,1,1 or 1,0,1 or0,1,1)[5] who were allocated to SES (CypherTM, Johnson & Johnson, Miami Lakes, Fla) or a novel BMS (Horus S, International Biomedical Systems, Trieste, Italy). The BMS under investigation is made from 316 LVM stainless steel. The stent is a cylindrical helix with sinusoidal loops, consisting of medical-grade stainless-steel continuouswire, that has high radial force (1.5% diameter reduction at 200 mm Hg) with good scaffolding and favorable vesselwall coveragewith patency of SBs (covering percentage in the expanding state ranging between 19.1%—2.5 mm and 16.2%— 3.5 mm).All patientswere followedup to9 months. Theprimary clinical end point of the study was the occurrence of major adverse cardiac events (MACE), defined as the composite of cardiac or noncardiac death, Q-wave or non-Q-wave myocardial infarction, or target vessel revascularization. The primary angiographic end point of the study was the insegment per cent diameter stenosis of the SB at 9 month follow-up. Coronary angiograms were analyzed off-line with the use of an automated edge-detection system (Cardiovascular Medical System, MEDIS Imaging Systems, Leiden). Sixty consecutive patients (age: 62±12 years) were randomized to a SES (N=30) or a BMS (N=30) in the MB. The two study groups did not show any significant difference in baseline clinical and angiographic characteristics. Procedural success after stenting the MB was similar in the two groups (97%), with 2 cases of periprocedural non-Q-wave myocardial infarction (1 in the SES group and in 1 in the BMS group) caused by periprocedural occlusion of the nonstented SB because of dissection. The primary clinical endpoint of the study, cumulative MACE at 9month follow-up, occurred in 6 patients of the SES group and in 4 patients of the BMS group (20 vs. 17%; P=1.00) (Table 1). During follow-up, no patient died, but one patient of the SES group had stent thrombosis. No significant differences in the rate of target lesion revascularization and target vessel revascularization occurred between the two groups (Table 1). The primary study angiographic endpoint did not differ significantly between the SES and BMS groups (20% vs. 34%, P=0.38). When restenosis rates were analyzed by restenosis site, the two groups showed similar rates of binary restenosis occurring in both MB and SB, in MB only and in SB only (Table 1). Quantitative data at follow-up angiography (Table 2) revealed that, as compared with the BMS group, the SES group had significantly larger minimal lumen diameter and percent diameter restenosis as well as lower late loss at MB. Conversely, no significant difference was found between the two study groups in any angiographic variable at SB. The PROSUMER study shows that good long-term results when treating coronary bifurcations can be achieved with a strategy of provisional stenting with BMS as compared with SES, provided that a stent with favorable technical characteristics for bifurcations coupled with an optimal delivery technique are adopted. The results of PROSUMER show that binary restenosis rate at 9-month control angiography did not differ significantly between the SES and BMS

Comparison of Sirolimus-Eluting Stents With Paclitaxel-Eluting Stents in Saphenous Vein Graft Intervention (from a Multicenter Southern California Registry)

This study was designed to compare the safety and efficacy of sirolimus-eluting stents (SESs) to paclitaxel-eluting stents (PESs) in percutaneous intervention of saphenous vein graft (SVG) lesions. SVGs develop atherosclerosis at high rates and often require repeat revascularization. Percutaneous intervention with drug-eluting stents has become the preferred method of revascularization due to higher restenosis with bare metal stents and increased morbidity and mortality with repeat coronary artery bypass grafting. We sought to compare the rate of major adverse cardiac events and stent thrombosis between SESs and PESs in patients undergoing SVG intervention. A multicenter analysis of 172 patients with SVG lesions treated with SESs or PESs was performed. The 30-day and 1-year clinical outcomes of 102 patients receiving SESs were compared to those of 70 patients receiving PESs. There was no significant difference in baseline demographic, angiographic, and procedural characteristics between the SES and PES treatment groups. There was no statistical difference in major adverse cardiac events at 30 days and at 1 year (hazard ratio [HR] 1.58, 95% confidence interval [CI] 0.77 to 3.23, log-rank p = 0.21). There was also no difference in survival (HR 1.28, 95% CI 0.39 to 4.25, log-rank p = 0.69) or target vessel revascularization (HR 2.54, 95% CI 0.84 to 7.72, log-rank p = 0.09). In conclusion, this multicenter analysis of real-world patients demonstrated that SESs and PESs have similar clinical outcomes when used in SVG intervention.

FIVE-YEAR DURABILITY OF SIROLIMUS-ELUTING STENT IN PATIENTS WITH UNPROTECTED LEFT MAIN CORONARY ARTERIES COMPARED WITH BARE METAL STENTS: MULTICENTER REGISTRY IN ASIA

Aim: The aim of this study is to compare the safety and efficacy of Sirolimus-eluting stent (SES) and bare metal stent (BMS) on the outcome of patients with unprotected left main coronary arteries ...

5-Year Clinical Outcomes of the ARTS II (Arterial Revascularization Therapies Study II) of the Sirolimus-Eluting Stent in the Treatment of Patients With Multivessel De Novo Coronary Artery Lesions

The purpose of this study is to compare the 5-year clinical outcomes, safety, and efficacy of sirolimus-eluting stents (SES) in the ARTS II (Arterial Revascularization Therapies Study II) with the outcomes of coronary artery bypass graft (CABG) and bare-metal stenting (BMS) from the ARTS I. The long-term outcomes after SES implantation in patients with multivessel disease remains to be established. The ARTS I was a randomized trial of 1,205 patients with multivessel disease comparing CABG and BMS. The ARTS II study was a nonrandomized trial with the Cypher sirolimus-eluting stent (Cordis, a Johnson & Johnson Company, Warren, New Jersey), applying the same inclusion and exclusion criteria, end points, and protocol definitions. The ARTS II trial enrolled 607 patients, with an attempt to enroll at least one-third of patients with 3-vessel disease. At 5-year, the death/stroke/myocardial infarction event-free survival rate was 87.1% in ARTS II SES, versus 86.0% (p = 0.1) and 81.9% (p = 0.007) in ARTS I CABG and BMS cohorts, respectively. The 5-year major adverse cardiac and cerebrovascular event (MACCE) rate in ARTS II (27.5%) was significantly higher than ARTS I CABG (21.1%, p = 0.02), and lower than in ARTS I BMS (41.5%, p < 0.001). The cumulative incidence of definite stent thrombosis was 3.8%. Thirty-two percent (56 of 176) of major adverse cardiac events (MACE) at 5 years were related to possible, probable, or definite stent thrombosis. At 5 years, SES had a safety record comparable to CABG and superior to BMS, and a MACCE rate that was higher than in patients treated with CABG, and lower than in those treated with BMS. Approximately one-third of the events seen with SES could be prevented through the elimination of early, late, and very late stent thrombosis.

Paclitaxel-Eluting Versus Sirolimus-Eluting Stents in Diabetes Mellitus

Background— Diabetes is a powerful predictor of adverse events in patients undergoing percutaneous coronary intervention. Drug-eluting stents reduce restenosis rates compared with bare metal stents; however, controversy remains regarding which drug-eluting stents provides greater benefit in patients with diabetes. Accordingly, we compared the safety and efficacy of sirolimus-eluting stents (SES) with paclitaxel-eluting stents (PES) among diabetic patients in a contemporary registry. Methods and Results— Using the National Heart, Lung, and Blood Institute Dynamic Registry, we evaluated 2-year outcomes of diabetic patients undergoing percutaneous coronary interventions with SES ( n =677) and PES ( n =328). Clinical and demographic characteristics, including age, body mass index, insulin use, left ventricular function, and aspirin/clopidogrel use postprocedure, did not differ significantly between the groups except that PES-treated patients had a greater frequency of hypertension and hyperlipidemia. At the 2-year follow-up, no significant differences were observed between PES and SES with regard to safety or efficacy end points. PES- and SES-treated patients had similar rates of death (10.7% versus 8.2%, P =0.20), death and myocardial infarction (14.9% versus 13.6%, P =0.55), repeat revascularization (14.8% versus 17.8%, P =0.36), and stent thrombosis (1.3% versus 1.3%, P =0.95). After adjustment, no significant differences between the 2 stent types in any outcome were observed. Conclusions— PES and SES are equally efficacious and have similar safety profiles in diabetic patients undergoing percutaneous coronary interventions in clinical practice.

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

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. 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. 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). 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.

Abstract 2570: The Unrestricted Use Of Paclitaxel-eluting Stents: Five-year Results Of The Research Registry

Objectives: Although the safety of drug-eluting stents (DES) has been under scrutiny, limited follow-up data up to 5 years are available, particularly among real-world patients. Therefore, we evaluated the 5-year clinical event rates in patients from the The Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) registry to establish the safety and efficacy of sirolimus-eluting stent (SES) in an unselected all-comer population. Methods: On April 16, 2002, our institution commenced the use of SES (Cypher; Cordis Corporation, Miami Lakes, Florida) as the default strategy for all percutaneous coronary interventions at our institution. In the first 6 months of enrollment, 508 patients with de novo lesions were treated exclusively with SES (the SES group) and compared with a group of 450 consecutive patients treated with BMS for de novo lesions in the preceding 6 months (the pre-SES group), matched for stent diameter. Survival data was acquired from municipal civil registries. Health questionnaires have been sent to all living patients to obtain data on adverse clinical events were collected. Medical records will be reviewed and family doctors or referring cardiologists contacted as necessary. The primary end-point was composite major adverse events (MACE: all-cause death, myocardial infarction or target vessel revascularization [TVR]). Secondary endpoints included all-cause death, TVR and stent thrombosis. A propensity score-adjustment will be performed to compensate for differences in baseline characteristics between the groups. Findings: Survival data is currently available for 94% of the patients after 5 years. The 5-year all-cause mortality rates were 14.0% for SES and 13.4% for BMS (p=0.9). Data on the other 5-year endpoints is currently being collected and will be presented at the time of the meeting. Conclusions: There is no difference in the 5-year survival rates in the real-world unselected patients treated with SES, compared with BMS.

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.