Sirolimus-eluting Stent Implantation In Patients Research Articles

Optical Coherence Tomographic Evaluation of the Effect of Cigarette Smoking on Vascular Healing After Sirolimus-Eluting Stent Implantation

Cigarette smoking is known to be deleterious to patients with coronary artery disease; however, the effect of smoking on vascular responses after coronary drug-eluting stent implantation is unknown. We sought to examine vascular response after sirolimus-eluting stent implantation in patients with ongoing smoking using optical coherence tomography, compared with former smokers and nonsmokers. We identified 181 sirolimus-eluting stents in 140 subjects who underwent follow-up optical coherence tomography imaging. Subjects were divided into 3 groups: current smokers (n = 28), former smokers (n = 35), and nonsmokers (n = 77). Stent strut coverage, neointimal characteristics, and strut malapposition were evaluated. The incidence of uncovered stent struts was significantly higher in nonsmokers compared with current smokers (13.3 ± 13.3% vs 6.7 ± 8.3%; p = 0.001). On qualitative evaluation of neointimal morphology, the prevalence of heterogeneous neointima was higher in current smokers (71.9%) than in former smokers (36.0%) or nonsmokers (10.1%) (p = 0.004 and p <0.001, respectively). There was no difference in the incidence of malapposition among the 3 groups. Multivariate modeling showed that current smoking was negatively associated with the presence of uncovered struts (odds ratio 0.33; 95% confidence interval 0.14 to 0.79; p = 0.013) and positively associated with the presence of heterogeneous neointima (odds ratio 9.47; 95% confidence interval 3.79 to 23.72; p <0.001). In conclusion, the incidence of strut coverage was higher in current smokers compared with nonsmokers. However, the pattern of neointima was more heterogeneous in current smokers.

Long-term clinical outcomes after sirolimus-eluting stent implantation for unprotected left main coronary artery disease.

Previous studies reporting long-term (≥5year) clinical outcome in patients with unprotected left main coronary artery (LMCA) disease undergoing drug-eluting stent (DES) implantation are currently limited, although late adverse events beyond 1year are one of the major concerns of DES. We evaluated long-term clinical outcomes in 134 consecutive patients who underwent sirolimus-eluting stents (SES) for unprotected LMCA lesion in a single center from 2004 to 2009. The median follow-up duration was 3.8 (range: 0.5-7.9) years. Eight patients suffered from serious cardiovascular events potentially related to LMCA lesion (primary outcome measure) (sudden cardiac death: N=5, emergent coronary revascularization for the LMCA lesion: N=2, and acute congestive heart failure related to LMCA lesion: N=1) with the cumulative 5-year incidence of only 4.4%. The cumulative 5-year incidence of all-cause death, cardiac death, target vessel myocardial infarction, definite stent thrombosis, and target-lesion revascularization was 26.5, 8.1, 0, 0, and 12.9%, respectively. In a subgroup analysis, the cumulative incidence of the primary outcome measure was significantly higher in patients with 2-stenting (N=27) than in patients with 1-stenting (N=107) (14.0 and 2.2%, P<0.001). All 8 patients with serious adverse events had a true bifurcation lesion and 5 patients received 2-stenting for the LMCA lesion. SES implantation in patients with unprotected LMCA lesion was associated with a favorable long-term outcome with acceptably low rate of serious adverse event potentially related to LMCA lesion. However, complex LMCA lesions necessitating 2-stenting strategy might be associated with higher risk for serious adverse events.

Differential relative efficacy between drug-eluting stents in patients with bare metal and drug-eluting stent restenosis; evidence in support of drug resistance: insights from the ISAR-DESIRE and ISAR-DESIRE 2 trials

In drug-eluting stent (DES) restenosis, the contribution of drug hyporesponsiveness is poorly defined. We sought to evaluate if, in the setting of treatment for in-stent restenosis, the relative efficacy of sirolimus-eluting stents (SES) and of paclitaxel-eluting stents (PES) depends on the underlying substrate in which the stents are implanted, i.e., on whether the restenosis occurs within bare metal stents or within SES. We pooled data from the ISAR-DESIRE and ISAR-DESIRE 2 randomised trials and analysed outcomes in SES-treated and PES-treated patients. In all, 650 patients were included. Angiographic follow-up was available for 87% of patients. In SES-treated patients, both late loss (LL) and percentage diameter stenosis (%DS) were lower in patients treated for bare metal stent restenosis compared with SES restenosis (0.21±0.59 mm versus 0.41±0.66 mm, p=0.007; 27.6±19.4% versus 34.0±20.9%, p=0.015, respectively). In PES-treated patients, LL and %DS were similar in patients treated for bare metal stent restenosis compared with SES restenosis (0.48±0.59 mm versus 0.39±0.71, p=0.47; 33.5±22.2% versus 32.7±18.6%, p=0.75, respectively). Similarly, in terms of overall clinical efficacy, in SES-treated patients clinical outcomes were better in patients with bare metal stent restenosis compared with SES restenosis while in PES-treated patients outcomes were similar in both groups. At multivariate analyses the use of SES to treat restenosis within SES was predictive of both higher LL and %DS. The efficacy of sirolimus-eluting but not paclitaxel-eluting stents is significantly reduced when used for treatment of SES restenosis as compared to bare metal stent restenosis. The lower antirestenotic efficacy following SES implantation in patients with SES restenosis may support a role for drug resistance in restenosis within these stents.

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.

Comparison of efficacy between paclitaxel-eluting stents with different polymers in terms of major adverse cardiac events and stent thrombosis up to 12 months of clinical follow-up

Since the introduction of drug-eluting stents (DESs) in 2002, DESs have become widely accepted for the majority of coronary lesions in patients with stable angina; DESs have even been used in acute coronary syndromes [ 1 Morice M.C. Serruys P.W. Sousa J.E. et al. A randomized comparison of a sirolimus-eluting stent with standard stent for coronary revascularization. N Engl J Med. 2003; 346: 1773-1780 Crossref Scopus (3864) Google Scholar , 2 Lemos P.A. Serruys P.W. Sousa E. Drug eluting stents: costs versus clinical benefit. Circulation. 2003; 107: 3003-3007 Crossref PubMed Scopus (114) Google Scholar , 3 Kereiakes D.J. Hippocrates revisited: the evidence for drug eluting stents. Circulation. 2003; 107: 3012-3014 Crossref PubMed Scopus (32) Google Scholar , 4 Sousa J.E. Costa M.A. Abizaid A. et al. Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries. Circulation. 2001; 103: 192-195 Crossref PubMed Scopus (785) Google Scholar , 5 Lemos P.A. Lee C.H. Degertekin M. et al. Early outcome after sirolimus-eluting stent implantation in patients with acute coronary syndromes. J Am Coll Cardiol. 2003; 41: 2093-2099 Abstract Full Text Full Text PDF PubMed Scopus (166) Google Scholar ]. Previous randomized trials have shown the efficacy of slow-release polymeric sirolimus- (Cypher™; Cordis, Warren, NJ, USA), paclitaxel- (Taxus™; Boston Scientific, Natick, MA, USA), and zotarolimus-eluting stents (Endeavor™; Medtronic, Minneapolis, MN, USA) over bare metal stents in reducing neointimal hyperplasia, late luminal loss, and angiographic restenosis, leading to decreased target lesion revascularization [ 6 Dawkins K.D. Grube E. Guagliumi G. et al. Clinical efficacy of polymer-based paclitaxel-eluting stents in the treatment of complex, long coronary artery lesions from a multicenter, randomized trial: support for the use of drug-eluting stents in contemporary clinical practice. Circulation. 2005; 112: 3306-3313 Crossref PubMed Scopus (299) Google Scholar , 7 Moses J.W. Leon M.B. Popma J.J. et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003; 349: 1315-1323 Crossref PubMed Scopus (4066) Google Scholar , 8 Colombo A. Drzewiecki J. Banning A. et al. Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions. Circulation. 2003; 108: 788-794 Crossref PubMed Scopus (974) Google Scholar , 9 Grube E. Silber S. Hauptmann K.E. Mueller R. et al. TAXUS I: six- and twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions. Circulation. 2003; 107: 38-42 Crossref PubMed Scopus (846) Google Scholar , 10 Tanabe K. Serruys P.W. Grube E. et al. TAXUS III Trial: in-stent restenosis treated with stent-based delivery of paclitaxel incorporated in a slow-release polymer formulation. Circulation. 2003; 107: 559-564 Crossref PubMed Scopus (330) Google Scholar ]. Now, DESs are considered as first-line therapy for de novo lesions.

Safety and Efficacy of Sirolimus-Eluting Stent Implantation in Patients With Acute Coronary Syndrome in the Real World

The use of drug-eluting stents in patients with acute coronary syndrome (ACS), particularly those with acute myocardial infarction (AMI), is controversial owing to concerns about late adverse events. We evaluated the long-term safety of sirolimus-eluting stent implantation in patients with ACS. Of 10,778 patients treated exclusively with a sirolimus-eluting stent in the j-Cypher registry, the 3-year outcomes of 2,308 patients with ACS (953 patients with AMI) were compared to those of 8,470 patients without ACS. Compared to patients without ACS, the patients with ACS had a significantly greater adjusted risk of death or myocardial infarction (hazard ratio [HR] 1.24, 95% confidence interval [CI] 1.12 to 1.37, p <0.0001) and definite or probable stent thrombosis (HR 1.43, 95% CI 1.11 to 1.82, p = 0.006) within the first year after sirolimus-eluting stent implantation. However, after 1 year, patients with ACS no longer had a greater risk of death or myocardial infarction (HR 1.01, 95% CI 0.90 to 1.13, p = 0.87) and stent thrombosis (HR 1.32, 95% CI 0.92 to 1.86, p = 0.13). Of the patients with ACS, those with AMI had a greater risk of death or myocardial infarction (HR 1.33, 95% CI 1.12 to 1.6, p = 0.001) and stent thrombosis (HR 1.57, 95% CI 1.05 to 2.39, p = 0.03) than those with unstable angina pectoris within the first year. However, they had a similar risk of death or myocardial infarction (HR 1.00, 95% CI 0.78 to 1.22, p = 0.83) and stent thrombosis (HR 0.83, 95% CI 0.38 to 1.6, p = 0.59) after 1 year. The risk of late adverse events >1 year after sirolimus-eluting stent implantation was similar between those with and without ACS and between those with AMI and those with unstable angina pectoris.

Local persistent hypercoagulability after sirolimus-eluting stent implantation in patients with stable angina

Background Late stent thrombosis (LST) after sirolimus-eluting stent (SES) implantation has been demonstrated previously. Although incomplete neointimal coverage after SES implantation has been reported, local long-term hypercoagulability remains unknown. Methods We evaluated the local persistent coagulative response in eighty-three consecutive patients with stable angina, treated with either SES (n = 51) or BMS (n = 32) implantation for isolated de novo left anterior descending (LAD) stenosis. We measured prothrombin fragment F1 + 2 (frF1 + 2) and D-dimer levels sampled in the coronary sinus (CS) and sinus of Valsalva (V). The transcardiac gradient (Δ) was defined as the CS level minus V level. Results The ΔfrF1 + 2 and ΔD-dimer were significantly greater in the SES group than in the BMS group (0.50 ± 0.35 vs −0.14 ± 0.15 nmol/l, p = 0.009 and 0.24 ± 0.21 vs −0.05 ± 0.16 μg/ml, p = 0.041, respectively). We selected the hypocoagulative [ΔfrF1 + 2 < 0.15 (mean value − SD) nmol/l, n = 21] and hypercoagulative [ΔfrF1 + 2 > 0.85 (mean value + SD) nmol/l, n = 14] groups out of the SES patients. Multivariate analysis was performed to identify independent predictors of local hypercoagulability. Total SES length was the only independent predictor of local hypercoagulability. There was a significant positive correlation between the ΔfrF1 + 2 and total stent length in the SES group (r = 0.57, p < 0.05). Conclusions An increased local coagulative response was observed in the convalescent phase after SES implantation as compared to BMS. Careful long-term follow-up of patients after longer SES implantation is recommended in order to avoid LST.

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.

Prognostic Values of C-Reactive Protein Levels on Clinical Outcome After Implantation of Sirolimus-Eluting Stents in Patients on Hemodialysis

Percutaneous coronary intervention (PCI) using drug-eluting stents significantly reduces the risk of restenosis in the general population. However, in patients on hemodialysis, adverse cardiac events are frequently seen even if treated with drug-eluting stents. Recent studies suggest that C-reactive protein (CRP) reflects vascular wall inflammation and can predict adverse cardiac events. We evaluated possible prognostic values of CRP on outcomes in patients on hemodialysis undergoing PCI with drug-eluting stents. A total of 167 patients undergoing PCI with sirolimus-eluting stents for stable angina (322 lesions) were enrolled. They were divided into tertiles according to serum CRP levels. We analyzed the incidence of major adverse cardiovascular events including cardiovascular death, nonfatal myocardial infarction, and target lesion revascularization after PCI as well as quantitative coronary angiographic data. The mean follow-up was 31 months (SD, 14). Major adverse cardiac events occurred in 11 patients (19.6%) of the lowest tertile, in 22 patients (39.3%) of the middle tertile, and in 28 patients (50.9%) of the highest tertile during follow-up period (P=0.0009). There was a progressive increase in neointimal growth after sirolimus-eluting stent implantation during follow-up because preprocedural CRP levels were higher, despite similar angiographic data just after PCI. Angiographic restenosis at 6 to 8 months after PCI was seen in 10.6% in the lowest tertile, 17.9% in the middle tertile, and 32.0% in the highest tertile (P=0.0007). Increased preprocedural serum CRP levels would predict higher major adverse cardiac events and restenosis rates after sirolimus-eluting stents implantation in patients on hemodialysis.

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.

Comparison of Changes in Early Inflammatory Markers Between Sirolimus- and Paclitaxel-Eluting Stent Implantation

Systemic inflammation after coronary intervention identifies patients at increased risk of subsequent cardiac events. Cardiac events, especially in-stent restenosis, are less frequent after use of sirolimus-eluting stent (SES) compared with paclitaxel-eluting stent (PES). However, the underlying mechanism for this disparity is not well investigated. We hypothesize that an attenuated inflammatory response after SES implantation may be a contributor. In the present study, we sought to determine the early inflammatory response after SES implantation in patients with single-vessel disease compared with PES implantation, and evaluate the relationship between inflammatory response and late clinical outcomes in a randomized design. Thirty-two patients with stable angina were randomly enrolled into the two groups, SES or PSE group (n = 16 respectively). Peripheral blood samples were taken before PCI, 24 and 72 h after stenting. The plasma concentrations of C-reactive protein (CRP) and interleukin-6 (IL-6) were determined by enzyme-linked immunosorbent assay (ELISA). The clinical and angiographic follow-up was performed at 8 months after stenting. The data showed that there was no significant difference in clinical and angiographic baseline characteristics between the two groups. The plasma CRP and IL-6 levels at 24 h after stenting were significant higher in both groups compared with baseline (p < 0.01 respectively). Likewise, the CRP levels at 72 h after stenting were also significant higher compared with baseline in both groups (p < 0.01 respectively). However, the plasma levels of IL-6 at 24 h and CRP at 72 h after stenting were higher in PES group compared with SES group (p < 0.05). At 8 months follow-up, the rates of major adverse cardiac events, target lesion revascularization, in-stent and in-segment restenosis were similar in both groups. However, the late loss in both in-stent and in-segment was significantly higher in the PES group than in SES group (p < 0.001 respectively). Our findings suggest that a drug-eluting stent implantation could trigger a systemic inflammatory response as previously demonstrated. However, SES implantation results in a lower inflammatory response compared with PES implantation, which seems to be associated with greater late of in-stent and in-segment loss at 8-month follow-up with PES.

Long-Term Outcome in Patients Treated With Sirolimus-Eluting Stents in Complex Coronary Artery Lesions: 3-Year Results of the SCANDSTENT (Stenting Coronary Arteries in Non-Stress/Benestent Disease) Trial

Our purpose was to evaluate the long-term use of sirolimus-eluting stents (SES) and bare-metal stents (BMS) in patients with complex coronary artery lesions. Although the use of SES has proved to be effective in patients with simple coronary artery lesions, there are limited data of the long-term outcome of patients with complex coronary artery lesions. We randomly assigned 322 patients with total coronary occlusions or lesions located in bifurcations, ostial, or angulated segments of the coronary arteries to have SES or BMS implanted. At 3 years, major adverse cardiac events had occurred in 20 patients (12%) in the SES group and in 59 patients (38%) in the BMS group (p < 0.001). Four versus 2 patients suffered a cardiac death (p = NS), and 5 versus 1 died of a noncardiac disease (p = NS) in the SES versus the BMS group. Six patients in the SES group versus 15 patients in the BMS group suffered a myocardial infarction (p < 0.05) during the 3-year observation period, and target lesion revascularization was performed in 8 patients (4.9%) versus 53 patients (33.8%), respectively (p < 0.001); of these, 4 in the SES versus 7 in the BMS group were performed between 1 and 3 years after the index treatment (p = NS). According to revised definitions, stent thrombosis occurred in 5 patients (3.1%) in the SES group and in 7 patients (4.4%) in the BMS group (p = NS); very late stent thrombosis was observed in 4 versus 1 patient. A continued benefit was observed up to 3 years after implantation of SES in patients with complex coronary artery lesions. The rate of late adverse events was similar in the 2 groups, and stent thromboses occurred rarely after 1 year. (Sirolimus Eluting Stents in Complex Coronary Lesions [SCANDSTENT]; NCT00151658)

Assessment of potential relationship between wall shear stress and arterial wall response after bare metal stent and sirolimus-eluting stent implantation in patients with diabetes mellitus

Wall shear stress (WSS) has been associated with neointimal hyperplasia (NIH) following bare metal stent (BMS) implantation. Drug-eluting stents (DES) almost abolish NIH. Conversely, diabetes mellitus amplifies NIH response. The association between WSS and arterial wall response following DES and BMS implantation in diabetic patients remains to be evaluated. The study involved 20 diabetic patients randomized to BMS (n = 9) or sirolimus-eluting stent (SES; n = 11) implantation in native coronary arteries. A computational fluid dynamic model applied 3D intravascular ultrasound (IVUS) and two-plane angiographic to measure WSS (Pa). IVUS assessments were performed post-procedure and at 9-months follow-up. The target segment encompassed the stent plus 5 mm distal and proximal edges. A total of 93 subsegments were evaluated: in-stent segments divided in three subsegments (proximal, mid and distal; n = 60) and proximal and distal edges (n = 33). Stent length was similar between BMS (17.4 +/- 7.3 mm) and SES (19.8 +/- 6.8 mm) groups. NIH was observed in all BMS subsegments (n = 27) versus one subsegment in the SES group (n = 33). WSS ranged from 0.52 to 4.20 Pa in the BMS and from 0.42 to 3.06 Pa in the SES group. There was no correlation between WSS and NIH in either stent group. In addition, there were no correlation between the change of external elastic membrane (EEM) or plaque growth at the edges and WSS. WSS was not associated with NIH after implantation of SES or BMS in diabetic patients. Plaque growth or the change of EEM at the edges were not associated with WSS either.

Abstract 2151: Long-Term Outcome in Patients Treated with Sirolimus Eluting Stents in Complex Coronary Artery Lesions. Analysis of 3-year Results of the Randomized SCANDSTENT Trial

Background - The long-term outcome of patients with complex coronary artery lesions treated with drug-eluting stents is unknown. This study evaluated the 3-year clinical outcome of patients randomized in the SCANDSTENT study to have sirolimus-eluting stents (SES) or bare metal stents (BMS) implanted in their complex lesions. Methods and Results - We randomly assigned 322 patients with symptomatic coronary artery disease and either a total coronary occlusion, a lesion located in a bifurcation, in an ostial or in an angulated segment of the coronary artery to have SES or BMS implanted. At 3 years, major adverse cardiac events had occurred in 24 patients (15%) in the SES group and in 59 patients (37%) in the BMS group ( P &lt;0.001). Four versus 2 patients suffered a cardiac death (NS), and 5 versus 1 died of a non-cardiac disease (NS). Six patients in the SES group versus 15 patients in the BMS group suffered a myocardial infarction ( P &lt;0.05), and target lesion revascularization was performed in 8 patients (4.9%) versus 53 patients (33.8%), respectively ( P &lt;0.001); of these 4 in the SES versus 7 in the BMS group was performed between 1 and 3 years after the index treatment (NS). According to revised definitions, stent thrombosis occurred in 5 patients (3.1%) in the SES group and in 7 patients (4.4%) in the BMS group (NS); very late stent thromboses were observed in 4 versus 1 patient. Conclusions - A continued benefit was observed out to 3 years after implantation of SES in patients with complex coronary artery lesions. Late adverse events occurred less frequently in the SES group, and stent thromboses occurred rarely after 1 year.

Age-based clinical and angiographic outcomes after sirolimus-eluting stent implantation in patients with coronary artery disease

Advanced age independently predicts early and late mortality and major adverse cardiac events (MACE) after percutaneous coronary intervention (PCI). Randomized clinical trials indicate that sirolimus-eluting stent (SES) implantation reduces target lesion revascularization (TLR), but there are limited data on the impact of age on outcomes following SES implantation in patients with coronary artery disease (CAD) in real-world practice. A total of 333 CAD patients with 453 lesions were enrolled in this study. Subjects were divided into two groups according to age: a young group (< 65 years old, 244 patients with 369 lesions) and elderly group (= 65 years old, 89 patients with 113 lesions). Clinical follow-up and quantitative coronary angiography (QCA) were performed seven months after PCI. Baseline clinical, demographic, angiographic, and procedural chararcteristics were similar in both groups, except that there were more female patients in the elderly group (21.3% vs 9.8%, P = 0.006). Primary success rate was similar in both groups (96.5% in young group vs 95.7% in elderly group, P > 0.05). During angiographic follow-up at 7 months, binary in-stent restenosis and in-segment restenosis rates were not significantly different between the two groups (4.7% vs 1.8%; 9.7% vs 8.8%, P > 0.05 respectively). Both sub-acute and late thrombosis rates were similar in the two groups (0.3% vs 0.9% and 1.2% vs 0.9%, P > 0.05 respectively). TLR was not significantly different between the two groups (6.5% vs 3.5%; P = 0.246). The rates of bleeding, stroke, angina rehospitalization during the follow-up period were also similar in both groups (P > 0.05 respectively). Despite a high-risk clinical profile, coronary SES implantation can be safely and effectively performed in elderly patients with a similar procedural success rate, a low complication rate, and excellent 7-month outcomes.

Comparison of Long-Term Clinical Outcome After Sirolimus-Eluting Stent Implantation in Patients With and Without Hemodialysis

Poor clinical outcomes for hemodialysis (HD) patients compared to non-HD patients after coronary intervention have been reported. Although coronary intervention using sirolimus-eluting stents (SESs) might be expected to reduce restenosis in HD patients, little is known about the efficacy of the SESs. The purpose of the present study was to compare the clinical and angiographic outcomes of HD patients with non-HD patients after SES implantation. The study population consisted of 170 consecutive patients (234 lesions) who had undergone successful coronary SES implantation. The patients were classified into 2 groups, an HD group (18 patients, 27 lesions) and a non-HD group (152 patients, 207 lesions). The incidence of any clinical event was significantly higher in the HD group than in the non-HD group (50.0% versus 12.5%, P < 0.0001). Target lesion revascularization was necessary in 6 patients (33.3%) in the HD group and in 7 patients (4.6%) in the non-HD group (P < 0.0001). The Cox proportional-hazards regression model on cardiac events identified HD patients (P = 0.0301, hazard ratio = 2.704) as an explanatory factor. Moreover, the Cox proportional-hazards regression model on target lesion revascularization identified HD (P = 0.0004, hazard ratio = 6.921) and in-stent re-stenosis lesion (P = 0.0293, hazard ratio = 3.323) as explanatory factors. The present study suggests that compared with non-HD patients, HD patients with coronary artery disease treated by SESs have a poorer clinical outcome.

Angiographic and Clinical Outcome Following Sirolimus-Eluting Stent (Cypher) Implantation A Single Center Experience

To investigate the late outcomes of sirolimus-eluting stent implantation in patients with coronary artery disease. Drug-eluting stents reduce intimal hyperplasia, which is the main cause of in-stent restenosis. Sirolimus-eluting stents significantly reduce clinical and angiographic restenosis and improve event-free survival. The study population consisted of 207 patients (273 stents) who had undergone coronary Cypher stent implantation. Patients were eligible for enrollment if there was symptomatic coronary artery disease or positive exercise testing, and angiographic evidence of single or multivessel disease with a target lesion stenosis of > or = 70% in a > or = 2.25 mm vessel. Follow-up coronary angiography was performed 18 months after stent deployment. Patients were followed-up for a mean of 24.7 +/- 7.4 months. All patients survived after stent implantation, but 5 (2.4%) patients experienced acute ST elevation myocardial infarction and 4 (1.9%) patients developed non-Q wave myocardial infarction following angioplasty. Recurrent angina pectoris was observed in 16 (7.7%) patients (11 stable angina pectoris and 5 unstable angina pectoris). Angiographic evidence of restenosis was observed in these 20 (9.66%) patients. The 5 other patients had noncritical angiographic restenosis. Eleven (5.3%) patients underwent angioplasty because of restenosis, and coronary artery bypass grafting was conducted in the other 9 (4.3%) patients. The results of the present study indicate that Cypher stents could be implanted with a very high success rate and have encouraging long-term angiographic and clinical results.

Clinical Outcomes Following Sirolimus-Eluting Stent Implantation in Patients with End-Stage Renal Disease -Korean Multicenter Angioplasty Team (KOMATE) Registry-

Clinical Outcomes Following Sirolimus-Eluting Stent Implantation in Patients with End-Stage Renal Disease -Korean Multicenter Angioplasty Team (KOMATE) Registry-

Incidence and predictors of restenosis after sirolimus-eluting stent implantation in high-risk patients

Sirolimus-eluting stents (SESs) have not been evaluated systematically in clinical scenarios or with the vascular morphologies associated with the highest rates of restenosis. Between May 2002 and August 2003, 1379 percutaneous interventions were carried out at our center, 231 with SES implantation in patients with complex coronary lesions: (1) left main trunk, (2) bifurcations, (3) long lesions, (4) calcified lesions, (5) proximal segment of the left anterior descending coronary, (6) restenotic lesions, (7) total occlusions, (8) ostial lesions, and (9) vessels < 2.75 mm. Angiographic follow-up was carried out in the 6th month in 201 patients. Clinical, angiographic, and procedural variables were analyzed to assess predictors of restenosis. Of the patients, 42.6% were diabetic and 20.2% were insulin dependent. A total of 263 lesions was treated. Mean lesion length was 16.5 +/- 11 mm and mean vessel diameter was 2.54 +/- 0.7 mm. A total of 327 stents was implanted to fully cover the entire lesion, in most cases after predilatation (89.1%). The mean segment length covered by the stent was 26 +/- 12 mm and the stent length/lesion length ratio was 1.7 +/- 0.9. Binary restenosis was found in 8.7%, but there was no edge restenosis. The only predictors of restenosis were female sex (OR 3.44, 95% CI 1.31-8.99, P = .011) and lesion length > 30 mm (OR 3.39, 95% CI 1.07-10.77, P = .038). In scenarios that usually entail high restenotic risk in patients with conventional stent implantation, SESs had a low incidence of restenosis without edge complications.

Arterial Revascularisation Therapies Study Part II - Sirolimus-eluting stents for the treatment of patients with multivessel de novo coronary artery lesions.

To determine the safety and effectiveness of CYPHER(R) sirolimus-eluting stent implantation in patients with multivessel disease; and to compare outcomes against the historical results of the two arms of the Arterial Revascularisation Therapies Study (ARTS I). ARTS II is a 45 center, 607 patient single arm trial; the1-year outcomes were compared to the historical controls of the ARTS I trial, using conventional and Bayesian statistical methods. Patients were stratified by clinical site to ensure that at least one-third had 3-vessel disease to achieve the number of treatable lesions per patient comparable to ARTS I. Multivessel stenting was performed with sirolimus-eluting stents according to local institutional practice with the goal of achieving complete revascularisation. The majority of patients (53.5%) had 3-vessel disease and diabetes was present in 26.2%. Mean stented length was 72.5mm, with 3.7 stents implanted per patient. The 1-year survival rate was 99.0%, the composite of death / stroke and MI-free survival was 96.9%, freedom from revascularisation was 91.5% and the composite endpoint of MACCE-free survival was 89.5% (the primary endpoint). Diabetic patients treated with sirolimus-eluting stents were more likely to undergo repeat revascularisation (RR 1.97, 95% CI 1.16 - 3.34) and experience a MACCE (RR 1.85, 95% CI 1.16 - 2.97) than non-diabetics at 1-year. In the unadjusted comparison with the historical control arms of ARTS-I-CABG and ARTS-I-PCI, the respective relative risks (RR) and associated 95% confidence intervals (CI) for the endpoints were: (1) freedom from repeat revascularisation RR 2.03 (1.23-3.34) and RR 0.44 (0.31-0.61) respectively; and (2) MACCE free survival RR 0.89 (0.65-1.23) and RR 0.39 (0.30-0.51) respectively. The low incidence of MACCE and repeat revascularisation in ARTS II suggests that contemporary PCI with sirolimus-eluting stents is safe and efficacious for the treatment of multivessel coronary artery disease. Compared to the historical population of ARTS I, surgery still afforded a lower need for repeat revascularisation although overall MACCE rates in ARTS II approached the surgical results and were significantly better than bare stenting in ARTS I.