Randomized evaluation of two drug‐eluting stents with identical metallic platform and biodegradable polymer but different agents (paclitaxel or sirolimus) compared against bare stents: 1‐Year results of the PAINT trial

Objectives: We tested two novel drug‐eluting stents (DES), covered with a biodegradable‐polymer carrier and releasing paclitaxel or sirolimus, which were compared against a bare metal stent (primary objective). The DES differed by the drug, but were identical otherwise, allowing to compare the anti‐restenosis effects of sirolimus versus paclitaxel (secondary objective). Background: The efficacy of novel DES with biodegradable polymers should be tested in the context of randomized trials, even when using drugs known to be effective, such as sirolimus and paclitaxel. Methods: Overall, 274 patients with de novo coronary lesions in native vessels scheduled for stent implantation were randomly assigned (2:2:1 ratio) for the paclitaxel (n = 111), sirolimus (n = 106), or bare metal stent (n = 57) groups. Angiographic follow‐up was obtained at 9 months and major cardiac adverse events up to 12 months. Results: Both paclitaxel and sirolimus stents reduced the 9‐month in‐stent late loss (0.54–0.44 mm, 0.32–0.43 mm, vs. 0.90–0.45 mm respectively), and 1‐year risk of target vessel revascularization and combined major adverse cardiac events (P < 0.05 for both, in all comparisons), compared with controls. Sirolimus stents had lower late loss than paclitaxel stents (P < 0.01), but similar 1‐year clinical outcomes. There were no differences in the risk of death, infarction, or stent thrombosis among the study groups. Conclusion: Both novel DES were effective in reducing neointimal hyperplasia and 1‐year re‐intervention, compared to bare metal stents. Our findings also suggest that sirolimus is more effective than paclitaxel in reducing angiographic neointima, although this effect was not associated with better clinical outcomes.© 2009 Wiley‐Liss, Inc.     

The fine balance of quality and quantity: the time has come to define quality of PCI!

Drug‐eluting stents (DES) have revolutionized the treatment of coronary bifurcation lesions. Among different DES types, sirolimus‐eluting stents (SES) showed better outcomes than paclitaxel‐eluting stents. Because novel sirolimus analogues have been implemented in DES, a prospective observational comparison was undertaken to compare major mammalian target of rapamycin inhibitor‐eluting stents in the treatment of bifurcation lesions according to the provisional T‐stenting and small protrusion (TAP) technique. Overall, 187 patients (165 men, 65 ± 10 years) were enrolled in the study: 80 patients received a SES, whereas zotarolimus‐eluting stents (ZES) were implanted in 53 patients and everolimus‐eluting stents (EvES) in 62 patients. Primary end‐point of the study was the 12‐month incidence of target bifurcation failure (TBF) defined as occurrence of cardiovascular death, nonfatal myocardial infarction (MI), and target vessel revascularization (TVR) or angiographic documentation of >50% restenosis on the main vessel or TIMI flow <3 on the side branch. Groups were homogeneous according to main clinical and angiographic characteristics. Overall, 17 (9.1%) patients had TBF: 4 (2.1%) patients had nonfatal non‐ST‐segment elevation MI, 9 (4.8%) patients underwent TVR, and 6 (3.2%) patients had an angiographic restenosis. The rate of TBF was statistically different among the three groups (7.9% in SES group, 18% in ZES group, and 3.3% in EvES group, P = 0.024). Previous MI was associated with a worse outcome (P = 0.025), whereas final kissing balloon was associated with a better outcome (P = 0.045). In conclusion, in this prospective registry, significant differences between DES were found in the outcome of patients treated for coronary bifurcation lesions according to provisional TAP technique. Thus, prospective randomized trials in this field are needed. © 2010 Wiley‐Liss, Inc.     

Comparison of the efficacy and safety of paclitaxel-eluting coroflex please stents and paclitaxel-eluting stents in patients with coronary artery disease: A randomized PIPA trial

Objectives : To compare the safety and efficacy of the new Coroflex? Please stents with conventional Taxus? Liberte stents in patients with coronary artery lesions. Background : The Coroflex? Please stent is a new version of paclitaxel‐eluting stent, and observational cohort studies have reported similar angiographic and clinical outcomes as with the first‐generation stents. However, it has not been directly compared with the early generation paclitaxel‐eluting stents in a multicenter, prospective, and randomized study. Methods : We randomly assigned 319 patients to receive Coroflex? Please stents (159 patients; 198 lesions) or Taxus? Liberte stents (160 patients; 232 lesions). The primary end point was angiographic in‐segment late luminal loss at 9 months. Results : Most baseline clinical and angiographic characteristics were similar between these two groups. The Coroflex? Please and Taxus? Liberte stents showed similar in‐segment late loss (0.40 ± 0.53 mm vs. 0.39 ± 0.52 mm, P = 0.98) and rates of in‐segment binary restenosis (22.2% vs. 18.8%, P = 0.48) at 9 months. After clinical follow‐up for 12 months, the two groups had similar rates of death (1.3% vs. 1.3%, P > 0.99), myocardial infarction (3.8% vs. 7.5%, P = 0.22), stent thrombosis (2.5% vs. 1.9%, P = 0.72), and target‐lesion revascularization (7.5% vs. 7.5%, P = 0.99). Conclusions : The Coroflex? Please stent resulted in similar angiographic and clinical outcomes as the Taxus? Liberte stent in patients with coronary artery lesions. © 2012 Wiley Periodicals, Inc.     

Late target lesion revascularization after implantation of sirolimus‐eluting stent

Objectives : We evaluated the incidence, clinical presentation, and angiographic in‐stent restenosis (ISR) pattern of late target lesion revascularization (TLR) after sirolimus‐eluting stent (SES) implantation. Background : Late TLR is an unusual finding beyond 6–9 months after bare‐metal stent implantation. However, late TLR after SES implantation has not been sufficiently evaluated. Methods : The study population consisted of 804 patients with 1,020 native lesions that were patent at 6‐month follow‐up angiogram after SES implantation. Results : Late TLR was performed in 18 patients with 18 lesions (1.8%) at 24.1 ± 2.6 months (range; 18–30 months) after SES implantation. Clinical presentation of late TLR patients was silent ischemia in eight patients and recurrent angina in 10 patients, but none had an acute coronary syndrome. Angiographic ISR pattern of late TLR lesions were focal ISR in 12 lesions (67%) and diffuse ISR in six lesions (33%). Serial quantitative coronary angiographic analysis of these lesions showed a minimal lumen diameter of 2.6 ± 0.5 mm immediately after SES implantation, 2.4 ± 0.4 mm at 6‐month follow‐up and 0.7 ± 0.6 mm at 24‐month follow‐up (ANOVA P < 0.001). By stepwise multiple logistic regression analysis, the only independent predictor of late TLR was stent length (P < 0.001, OR = 1.040, 95% CI = 1.019–1.061). Conclusions : Late TLR was performed in 1.8% of 1,020 native lesions that were patent at 6‐month follow‐up angiogram. Clinical presentations of late TLR was either silent ischemia or recurrent angina, but not acute coronary syndrome. Two‐thirds of late TLR lesions had a focal angiographic ISR pattern. © 2007 Wiley‐Liss, Inc.     

Comparison of sirolimus‐eluting stent,paclitaxel‐eluting stent,and bare metal stent in the treatment of long coronary lesions

Objective: This study compared the efficacy of the sirolimus‐eluting stent (SES), the paclitaxel‐eluting stent (PES), and the bare metal stent (BMS) for long coronary lesions. Background: The outcome of drug‐eluting stent (DES) implantation in long coronary lesions remains unclear. Methods: The study involved 527 patients with de novo long coronary lesions (≥24 mm), which were treated with long (≥28 mm) SESs (223 lesions), PESs (194 lesions), or BMSs (201 lesions). Results: Lesions in the SES (36.0 ± 14.9 mm, P < 0.001) and PES (36.3 ± 14.5 mm, P < 0.001) groups were longer than those in the BMS group (32.0 ± 12.3 mm), meaning the two DES groups had longer stented segments than did the BMS group. Six‐month angiographic follow‐up showed the SES (9.3%, P < 0.001) and PES (21.3%, P < 0.001) groups had lower in‐segment restenosis rates than that of the BMS group (42.5%). The rate of major adverse cardiac events (MACE) including death, myocardial infarction, and target lesion revascularization at 9 months was higher in the BMS group (26.6%) than that in the SES (13.0%, P < 0.001) and PES (15.7%, P < 0.001) groups. Posthoc analysis of the two DES groups showed that the in‐segment restenosis rate was lower for the SES than that for the PES group (P = 0.002), while the MACE rate was similar. Conclusions: The use of DESs for long coronary lesions appears to be safe and more effective than the use of BMSs in terms of restenosis and adverse clinical events. SES use was associated with lower late luminal loss and a lower angiographic restenosis rate compared with PES use. © 2006 Wiley‐Liss, Inc.     

Decreased risk of stent fracture‐related restenosis between paclitaxel‐eluting stents and sirolimus eluting stents: Results of long‐term follow‐up

Objective: To compare the outcomes between paclitaxel‐eluting stents (PES) and sirolimus‐eluting stents (SES) for the treatment of drug‐eluting stent (DES) fracture. Background: DES fracture is considered as an important predictor of in‐stent restenosis (ISR). However, little data are available evaluating the optimal treatment for this complication of coronary stenting. Methods: From January 1, 2004 to December 31, 2008, patients with DES ISR treated with a second DES were identified and evaluated for stent fracture. Stent fracture was defined by the presence of strut separation in multiple angiographic projections, assessed by two independent reviewers. Target lesion revascularization (TLR) at 6 and 12 months were the primary end points. Results: Of 131 lesions with DES ISR treated with a second DES, we found 24 patients (24 lesions, 18.2%) with angiographically confirmed stent fracture. Of these, 20 patients (20 lesions) treated with either PES (n = 11/55%) or SES (n = 9/45%) were included in the study. TLR at 6 months occurred in 9% of patients treated with PES and 22% of those treated with SES (P = 0.41). After 12 months, TLR was 9% and 55.5%, respectively (P = 0.024). Conclusions: This study demonstrates a high incidence of stent fracture in patients presenting with DES ISR in need of further treatment with another DES. The suggested association between treatment of stent fracture‐associated DES ISR with PES as compared with SES, and better long‐term outcomes, is in need of confirmation by larger prospective registries and randomized trials. © 2011 Wiley Periodicals, Inc.     

Strategies for drug‐eluting stent treatment of bifurcation coronary artery disease in the United States: Insights from the e‐Cypher S.T.L.L.R.Trial

Objectives: Our goal is to report the first large multicenter data for percutaneous coronary intervention (PCI) of bifurcation disease with drug‐eluting stents (DES) in the United States. Background: Bifurcation PCI remains a challenge to this date. There are limited data on outcomes of patients treated with bifurcation DES implantation, particularly in the United States. Methods: There were 161 patients with bifurcation disease [side branch (SB) ≥2‐mm] treated with ≥1 sirolimus‐eluting stents at 41 centers participating in the Stent deployment Techniques on cLinicaL outcomes of patients treated with the cypheR?stent (STLLR) trial. There was no protocol mandated strategy for bifurcation PCI. One‐year outcome data were collected. Angiographic and clinical data were adjudicated independently. Results: There were 147 patients (91.3%) treated with single stent strategy. Only 14 (8.7%) patients received sirolimus‐eluting stents implantation in both branches. Among patients with single stent strategy, double wire strategy (DW) was selected in 27 (18.4%) patients whereas single wire strategy (SW) was selected in 120 (81.6%) patients. There were 48 (32.7%) Medina 1,1,1 bifurcations treated with SW (n = 34; 70.8%) and DW (n = 14; 29.2%). There were 26 procedures started with SW which had SB dilatation during the procedure, one as a bailout (TIMI‐1 grade flow in the SB). Overall 1‐year death, myocardial infarction, and target lesion revascularization occurred in 2.4, 4.0, and 5.6%, respectively. There was no significant difference in clinical outcomes between SW and DW. SB dilatation was associated with a high rate of stent thrombosis (8.6%). Conclusions: Main branch stenting without SB protection is the most common approach utilized in the STLLR study, which may reflect contemporary DES bifurcation strategies in the Unite States. This strategy was associated with an acceptable low incidence of adverse outcomes at 1‐year. © 2009 Wiley‐Liss, Inc.     

Efficacy of everolimus eluting stent implantation in patients with calcified coronary culprit lesions: Two‐year angiographic and three‐year clinical results from the SPIRIT II study

Background : Little is known about the impact of treatment with drug‐eluting stents (DES) on calcified coronary lesions. This analysis sought to assess the safety and efficacy of the XIENCE V everolimus‐eluting stent (EES) in patients with calcified or noncalcified culprit lesions. Methods : The study population consisted of 212 patients with 247 lesions, who were treated with EES alone. Target lesions were angiographically classified as none/mild, moderate, or severe grades of calcification. The population was divided into two groups: those with at least one target lesion moderately or severely calcified (the calcified group: 68 patients with 75 calcified lesions) and those with all target lesions having mild or no calcification (the noncalcified group: 144 patients). Six‐month and 2‐year angiographic follow‐up and clinical follow‐up up to 3 years were completed. Results : The baseline characteristics were not significantly different between both groups. When compared with the noncalcified group, the calcified group had significantly higher rates of 6‐month in‐stent angiographic binary restenosis (ABR, 4.3% vs. 0%, P = 0.03) and ischemia‐driven target lesion revascularization (ID‐TLR, 5.9% vs. 0%, P = 0.01), resulting in numerically higher major cardiac adverse events (MACE, 5.9% vs. 1.4%, P = 0.09). At 2 years, when compared with the noncalcified group, the calcified group presented higher in‐stent ABR (7.4% vs. 0%, P = 0.08) and ID‐TLR (7.8% vs. 1.5%, P = 0.03), resulting in numerically higher MACE (10.9% vs. 4.4%, P = 0.12). At 3 years, ID‐TLR tended to be higher in the calcified group than in the noncalcified group (8.6% vs. 2.4%, P = 0.11), resulting in numerically higher MACE (12.1% vs. 4.7%, P = 0.12). Conclusions: The MACE rates in patients treated with EES for calcified lesions were higher than in those for noncalcified lesions, but remained lower than the results of previously reported stent studies. EES implantation in patients with calcified culprit lesions was safe and associated with favorable reduction of restenosis and repeat revascularization. © 2010 Wiley‐Liss, Inc.     

Sirolimus versus paclitaxel coronary stents in clinical practice

Objectives: We aimed at comparing the long term clinical outcome of SES and PES in routine clinical practice. Background: Although sirolimus‐eluting stents (SES) more effectively reduce neointimal hyperplasia than paclitaxel‐eluting stents (PES), uncertainty prevails whether this difference translates into differences in clinical outcomes outside randomized controlled trials with selected patient populations and protocol‐mandated angiographic follow‐up. Methods: Nine hundred and four consecutive patients who underwent implantation of a drug‐eluting stent between May 2004 and February 2005: 467 patients with 646 lesions received SES, 437 patients with 600 lesions received PES. Clinical follow‐up was obtained at 2 years without intervening routine angiographic follow‐up. The primary endpoint was a composite of death, myocardial infarction (MI), or target vessel revascularization (TVR). Results: At 2 years, the primary endpoint was less frequent with SES (12.9%) than PES (17.6%, HR = 0.70, 95% CI 0.50–0.98, P = 0.04). The difference in favor of SES was largely driven by a lower rate of target lesion revascularisation (TLR; 4.1% vs. 6.9%, P = 0.05), whereas rates of death (6.4% vs. 7.6%, P = 0.49), MI (1.9% vs. 3.2%, P = 0.21), or definite stent thrombosis (0.6% vs. 1.4%, P = 0.27) were similar for both stent types. The benefit regarding reduced rates of TLR was significant in nondiabetic (3.6% vs. 7.1%, P = 0.04) but not in diabetic patients (5.6% vs. 6.1%, P = 0.80). Conclusions: SES more effectively reduced the need for repeat revascularization procedures than PES when used in routine clinical practice. The beneficial effect is maintained up to 2 years and may be less pronounced in diabetic patients. © 2010 Wiley‐Liss, Inc.     

Angiographic Markers of Restenosis after Drug‐Eluting Stent Implantation: Surrogates for Late Clinical Outcomes?

Introduction: Although angiographic measures of restenosis, including late lumen loss, binary angiographic restenosis, and follow‐up percent diameter stenosis have value in determining the efficacy of new drug‐eluting stents (DES) designs, their ability to predict clinical events, including death, myocardial infarction, and target lesion revascularization (TLR) has been questioned. Methods: We reviewed the available literature and recent DES clinical trials to determine the relationship between clinical and angiographic markers of restenosis and late clinical outcomes after stent use. Results: Angiographic markers are useful surrogates for predicting differences in TLR between bare metal and DES. Due to the curvilinear relationship between late lumen loss and TLR and the skewedness of the late lumen loss distribution, late lumen loss as a single index has been less effective at predicting clinical differences between different DES when the absolute values of late lumen loss are low. Beyond predicting clinical restenosis, follow‐up angiographic indices have been less predictive of other late clinical events, such as very late stent thrombosis or aneurysm formation. Conclusions: Angiographic markers of restenosis may be a useful surrogate for TLR in pilot studies of patients treated with DES, but their use as a surrogate marker for all clinical events after stent placement, including death, myocardial infarction, and stent thrombosis, may be confounded by the progression of atherosclerosis at remote sites and vagaries of the distribution of late lumen loss in patients treated with DES.     

Comparison of zotarolimus‐ versus everolimus‐eluting stents in the treatment of coronary bifurcation lesions

Objectives : To compare zotarolimus‐eluting stent (Endeavor Sprint®; ZES‐S) and the everolimus‐eluting stent (Xience V®; EES) in the treatment of coronary bifurcation lesions Background : Both these stents have demonstrated good outcomes in the treatment of coronary lesions. However, the outcomes with respect to treatment of bifurcation lesions have yet to be conclusively demonstrated. Methods : In this single centered, nonrandomized, open label study, we treated, between August 2006 and December 2008, 110 bifurcations with ZES‐S and, in a second stage of the study, 129 bifurcations with EES. The primary end point was to compare the rate of major adverse cardiac events (MACE) (death, myocardial infarction, and new target lesion revascularization) in‐hospital and at 12 months of follow‐up. Provisional T stenting was the strategy used in the majority of cases. Angiographic follow‐up was performed only in patients who presented signs or symptoms suggestive of angina or ischemia. Results : There were no significant differences in in‐hospital MACE between the groups (ZES‐S: 8.1%; EES: 6.2%; P = 0.5). At 12 months, the ZES‐S group had significantly more MACE than the EES group (23.1% vs. 4.5%; P < 0.001) and an elevated index of new revascularization of the bifurcation (17.5% vs. 3.2%; P < 0.001). There were no significant differences in mortality (four patients in ZES‐S vs. one in EES; P = 0.14). Conclusion : The treatment of coronary bifurcation lesions using everolimus‐eluting stents results in better outcomes at 12 months of follow‐up than zotarolimus‐eluting stents. © 2011 Wiley Periodicals, Inc.     

小直径肾动脉狭窄应用西罗莫司洗脱支架的安全性和有效性

目的评估小直径肾动脉粥样硬化性狭窄患者应用冠状动脉西罗莫司洗脱支架的安全性和有效性。方法两年内入选15例患者,平均年龄67·7岁。双侧肾动脉狭窄或闭塞和单侧肾动脉狭窄各6例,副肾动脉狭窄3例。应用2种国产西罗莫司洗脱(火鸟和同心)冠状动脉支架。研究主要终点包括术后1、3和6个月靶病变直径狭窄程度(再狭窄率)和肾功能状态。结果在15例患者19处病变共成功置入22个支架,其中西罗莫司洗脱支架19个,肾动脉金属裸支架3个。全部患者完成了1个月肾动脉Doppler超声随访和血清肌酐随访,其中5例和7例分别完成了3个月和6个月的前述随访,还有3例进行了6个月血管造影随访。随访结果均未显示靶血管再狭窄,并且肾功能较术前没有明显变化。结论冠状动脉西罗莫司洗脱支架可以安全和有效应用于治疗小直径肾动脉粥样硬化性狭窄患者。     

Long-term clinical and angiographic results of Sirolimus-Eluting Stent in Complex Coronary Chronic Total Occlusion Revascularization: the SECTOR registry

Background: Drug‐eluting stents showed a better angiographic and clinical outcome in comparison with bare metal stent in chronic total occlusions (CTOs) percutaneous revascularization, however, great concerns still remain regarding the rate of restenosis and reocclusion in comparison with nonocclusive lesions. Aim: To evaluate angiographic and clinical outcomes after sirolimus‐eluting stent (SES) implantation in the setting of a “real world” series of complex CTOs. Methods and Results: From January 2006 to December 2008, 172 consecutive patients with 179 CTO lesions were enrolled into registry. Among these, successful recanalization was obtained in 144 lesions (80.4%) with exclusive SES implantation in 104 lesions. The 9–12 months angiographic follow‐up was executed in 85.5% of lesions with evidence of angiographic binary restenosis in 16.8% of lesions. Total stent length and number of stent implanted were recognized as independent predictors of restenosis (odds ratio [OR] 4.7, 95% confidence interval [CI] 1.28–107.09, P = 0.02) and (OR 5.8, 95% CI 1.39–23.55, P = 0.01), respectively. The 2‐year clinical follow‐up showed rates of target lesion revascularization, non‐Q wave myocardial infarction, and total major adverse cardiovascular events (MACEs) of 11.1%, 2%, and 13.1%, respectively. Cox proportional‐hazard analysis showed diabetes as independent predictor of MACEs (hazard ratio [HR] 4.832; 95% CI, 0.730–0.861; P = 0.028). Conclusions: Data from this registry demonstrate the long‐term efficacy and safety of SES implantation after complex CTOs recanalization. (J Interven Cardiol 2011;24:426–436)     

Paclitaxel‐Eluting Stents: Are They All Equal?

In Germany, four different drug eluting stents (DES) systems are currently commercially available. Whereas sirolimus has been clinically tested in only a single type of stent with a single type of coating in only a single dose, paclitaxel has been tested on various stent designs, in various dose densities, and in various relase formulations with or without a polymer carrier. Therefore, the question arises: are all paclitaxel stents equally safe and effective? Six clinical randomized trials investigated the safety and efficacy of paclitaxel‐eluting stents in patients with de‐novo lesions: TAXUS‐I (61 pats), TAXUS‐II (536 pats), ASPECT (177 pats), ELUTES (190 pats), DELIVER‐I (1041 pats) and TAXUS‐IV (1314 pats). In the TAXUS‐series, paclitaxel released from the stent was controlled by the Translute? polymer. In the other studies, however, no polymer carrier was used. In TAXUS‐I, II & IV, the dose density of 1 μg/mm² significantly reduced angiographic parameters of restenosis and improved clinical outcomes. In ASPECT and ELUTES there was a dose‐dependent effect on angiographic parameters of restenosis with the best results for a paclitaxel dose density of apprimately 3.0 μg/mm². Clinical outcomes at 6 and 12 months, however, were not improved in these studies without coating. The studies unanimously show that the paclitaxel‐eluting stents are safe, if clopidogrel is added to ASA for 3 to 6 months. The safety of paclitaxel‐eluting stents is independent of the stent design, the dose density and the presence or absence of a polymer carrier system. For paclitaxel‐eluting stents using a polymer carrier, the dose density of 1 μg/mm² is highly effective, whereas for paclitaxel‐eluting stents without a polymer carrier, the minimal effective dose density is much higher (3 μg/mm²). Despite their improvement of angiographic parameters, paclitaxel‐eluting stents without a polymer carrier did not demonstrate a positive effect on clinical outcome. In contrast, polymer‐based paclitaxel elution produced significant clinical benefit. (J Interven Cardiol 2003;16:485–490)     

Sustained clinical safety and efficacy of a biodegradable‐polymer coated sirolimus‐eluting stent in “real‐world” practice: Three‐year outcomes of the CREATE (multi‐center registry of EXCEL biodegradable polymer drug eluting stents) study

Background: The CREATE is a post‐marketing surveillance multicenter registry that demonstrated satisfactory angiographic and clinical (at 18 months) outcomes of a biodegradable polymer based sirolimus‐eluting stent (EXCEL, JW Medical System, Weihai, China) for the treatment of patients in routine clinical practice. Objectives: To evaluate the three‐year clinical safety and efficacy outcomes in patients enrolled in the CREATE study. Methods: A total of 2077 all comers have been enrolled in the CREATE study at 59 centers from four countries. Recommended antiplatelet regimen was clopidogrel and aspirin for six months followed by chronic aspirin therapy. The prespecified primary outcome was the rate of major adverse cardiac events (MACE) at 12, 18, and 36 months. Results: Clinical follow‐up was completed in 2025 (97.5%) patients at three years. The average duration of clopidogrel treatment was 199.8 ± 52.7 days and 80.5% of discharged patients discontinued clopidogrel at six months. The cumulative rate of MACE was 4.5% and the rate of stent thrombosis was 1.53% at three years. At six months to three years, prolonged clopidogrel therapy (>6 months) was not beneficial in reducing cumulative hazards of MACE (3.4% vs. 3.1%, log rank P = 0.725) or stent thrombosis (1.5% vs. 0.6%, log rank P = 0.053). Conclusions: This study demonstrates sustained three‐year clinical safety and efficacy of biodegradable polymer‐based sirolimus‐eluting stents when used with six months of dual antiplatelet therapy in a “real‐world” setting. © 2011 Wiley Periodicals, Inc.     

Novel bioabsorbable salicylate‐based polymer as a drug‐eluting stent coating

Background: Permanent polymers used in current drug‐eluting stents (DES) can trigger chronic inflammation and hypersensitivity reactions, which may contribute to the increased risk of late thrombosis and rebound restenosis. Therefore, optimal polymer selection and the use of completely absorbable but biocompatible polymers are expected to minimize these risks. Objectives: We sought to evaluate a novel, potentially innately anti‐inflammatory, bioabsorbable salicylate‐based polymer as a DES coating, in a clinically relevant animal model. Methods: Four types of stents were implanted in pig coronary arteries using QCA to optimize stent apposition: bare metal stents (BMS); salicylic acid/adipic acid bioabsorbable polymer‐only coated metal stents (SA/AA); biostable polymeric sirolimus‐eluting stents (Cypher?); and metal stents coated with salicylic acid/adipic acid bioabsorbable polymer containing sirolimus (SA/AA + S). The dose density of sirolimus was 8.3 μg/mm of stent length (similar to Cypher?) with in vitro studies demonstrating elution over 30 days and complete polymer degradation in 37 days. Animals underwent angiographic restudy and were terminated at 1 month for complete histopathologic and histomorphometric analyses. Results: Both SA/AA + S and Cypher? stents had significantly lower angiographic % stenosis when compared with BMS and SA/AA polymer‐only groups (6 ± 4% and 5 ± 4% vs. 15 ± 7% and 16 ± 5%, respectively, P < 0.001). Intimal thickness was lower for SA/AA + S and Cypher? than for BMS (0.14 ± 0.06 and 0.13 ± 0.04 mm vs. 0.23 ± 0.05 mm, respectively, P < 0.001). Histologic % area stenosis was also lower for SA/AA + S and Cypher? when compared with BMS (22 ± 7% and 23 ± 6% vs. 33 ± 5%, respectively, P < 0.001). There was a strong trend toward reduced inflammatory response in the SA/AA and SA/AA + S when compared with BMS and Cypher? groups (P = 0.072). Conclusions: This study shows favorable vascular compatibility and efficacy for a novel bioabsorbable salicylate‐based polymer as a DES coating, and supports further research and development of this unique class of polymer materials for applications in cardiovascular devices. © 2008 Wiley‐Liss, Inc.     

Novel paclitaxel‐eluting,biodegradable polymer coated stent in the treatment of de novo coronary lesions: A prospective multicenter registry

Objectives: The purpose of the present study was to evaluate the efficacy and safety of a biodegradable polymer coated, paclitaxel eluting stent (Luc‐Chopin²) based on 9‐months angiographic and 12‐months clinical follow‐up results. Background: First‐generation drug‐eluting stents utilize nonbioabsorbable polymeric coatings, whose persistent presence in the arterial wall may negatively affect long‐term outcomes. Bioabsorbable coatings with a degradation period matched to that of the drug elution may be a better alternative, clinically and economically. Methods: We conducted a prospective, multicenter first‐in‐man registry of a novel, locally developed, bioabsorbable‐coated, paclitaxel‐eluting coronary stent in 116 patients with single‐lesion de novo coronary disease. Results: Major adverse cardiac events occurred in 7.8% patients within 12 months. There were no late thrombotic events, death, stroke, or surgical revascularization in that period. There were two myocardial infarctions, one related to recent subacute stent thrombosis and another associated with restenosis. By 12 months, target vessel revascularization was performed in 7.8%; 2.9% were ischemia‐driven and the rest were mandated at 9 months in accordance with a control angiography protocol. Core‐lab assessed binary in‐stent restenosis (≥50% DS) was noted in 11.9% patients and mean late loss was 0.46 ± 0.47 mm. Conclusions: This first‐in‐man experience obtained in a multicenter registry of real‐world de novo lesions (almost half of lesions were class B2 or C by AHA classification) showed a favorable safety profile and acceptable efficacy through 12 months. Randomized comparison with a benchmark nonbioabsorbable polymer coated paclitaxel eluting stent should be undertaken to validate this initial positive experience. © 2008 Wiley‐Liss, Inc.     

Unprotected left main coronary artery stenting with zotarolimus (Endeavor) drug‐eluting stents

Objectives: To report the safety and efficacy of zotarolimus eluting stents for treatment of unprotected left main coronary artery disease. Background: Percutaneous stent insertion is an increasingly popular alternative to bypass surgery for the management of left main (LM) coronary artery disease. While data support the use of sirolimus‐ and paclitaxel‐coated stents in the LM coronary artery, there are no published series reporting results with Endeavor (zotarolimus) stents, particularly in the context of unprotected left main (ULM) lesions. Methods: We retrospectively identified 40 consecutive patients who had ULM disease treated with Endeavor stents (ZES) and who had follow‐up angiography. The primary endpoint was the prevalence of major adverse cardiac events (MACE), including cardiac/unexplained death, nonfatal myocardial infarction (MI), and in‐stent restenosis (ISR)/target lesion revascularization (TLR). Results: Angiographic and procedural success was achieved in all cases. Follow‐up angiography occurred on average 5.6 ± 0.9 months after the index procedure. There were three incidences of ISR requiring TLR and another patient who had a NSTEMI in the follow‐up period. At late follow‐up (12.4 ± 1.8 months) three patients underwent CABG (one for RCA stenosis) and four patients died without knowledge of the status of the ULM stent (two cardiovascular and two deaths related to cancer progression). Conclusions: In conclusion, our experience with Endeavor stents for the treatment of ULM disease demonstrates excellent angiographic and clinical outcomes, with a 7.5% ISR/TLR rate and a 15% MACE rate, respectively, at an average clinical follow‐up of 12.4 months. © 2011 Wiley Periodicals, Inc.     

Sex‐specific outcomes following revascularization with zotarolimus‐eluting stents: Comparison of angiographic and late‐term clinical results

Objectives: We examined angiographic and late‐term clinical outcomes according to sex in recent percutaneous coronary intervention (PCI) trials involving zotarolimus‐eluting stents (ZES). Background. Differences in outcome between men and women undergoing PCI have been inconsistently described with bare metal and first‐generation drug‐eluting stents. Methods. Clinical and angiographic outcomes among ZES‐treated patients were evaluated by sex using propensity score modeling in a patient‐level systematic overview of six trials and were also compared to patients receiving bare metal stents (BMS). Results. Among 2,132 patients, 608 were female (28.5%). Compared to men, women were older and more frequently had diabetes, hypertension, and a smaller reference vessel diameter (P < 0.05 for all). For both sexes, the relative reductions in 8‐month angiographic binary restenosis and late lumen loss were statistically significant and of similar extent with ZES compared to BMS. By 2 years, treatment with ZES resulted in significantly lower target vessel revascularization (TVR) and target vessel failure (TVF; 10.0% vs. 21.5%, P = 0.0003) among women that paralleled risk reductions for men. However, among ZES‐treated patients, 2‐year rates of TVR (8.2% vs. 10.4%, P = 0.005) and TVF (9.9% vs. 12.8%, P = 0.004) were significantly lower among women, although rates of death and myocardial infarction were similar. Conclusions. Despite greater baseline clinical and angiographic risk than men, women undergoing PCI with ZES compared to BMS experienced significant reductions in angiographic restenosis and repeat revascularization yet similar safety. Among all patients treated with ZES, late‐term safety and efficacy outcomes are similar, if not lower, among women compared to men. © 2010 Wiley‐Liss, Inc.     

Five‐year clinical outcomes of sirolimus‐eluting versus paclitaxel‐eluting stents in high‐risk patients

Objectives and Background : First generation drug‐eluting stents have shown differential efficacy in high‐risk patient subsets at one year. It is unclear whether these differences endure over the medium‐ to long‐term. We compared the five‐year clinical efficacy and safety of sirolimus‐eluting stents (SES) and paclitaxel‐eluting stents (PES) in a population of high‐risk patients. Methods : The patient cohorts of the ISAR‐DESIRE, ISAR‐DIABETES, and ISAR‐SMART‐3 randomized trials were followed up for five years and data were pooled. The primary efficacy endpoint of the analysis was the need for target lesion revascularization (TLR) during a five‐year follow‐up period. The primary safety endpoint was the combination of death or myocardial infarction (MI) after five years. Results : A total of 810 patients (405 patients in the SES group and 405 patients in the PES group) was included. Over five years TLR was reduced by 39% with SES compared with PES stent (hazard ratio [HR] 0.61; 95% confidence interval [CI] 0.44–0.85; P = 0.004). No difference was observed according to death or MI rates between the two groups (HR 1.10; 95% CI 0.80–1.50; P = 0.57). Definite stent thrombosis occurred in 0.2% (n = 1) in the SES group and in 1.6% (n = 6) in the PES group (HR 0.16; 95% CI 0.02–1.34; P = 0.12). Conclusions : In high‐risk patient subsets the lower rate of 12‐month TLR observed with SES in comparison PES is maintained out to five years. In terms of safety, although there was no difference in the overall incidence of death or MI, there was a trend towards more frequent stent thromboses with PES. © 2011 Wiley‐Liss, Inc.