Randomized, double-blind, multicenter study of the polymer-based 17-beta estradiol-eluting stent for treatment of native coronary artery lesions: six-month results of the ETHOS I trial.

OBJECTIVES: The ETHOS I trial was the first in-human experience evaluating the safety and efficacy of two different release formulations of the 17-beta estradiol-eluting R-Stent versus uncoated control stents for the treatment of patients with single de novo native coronary lesions. BACKGROUND: Estrogens were reported to inhibit neointimal proliferation and to accelerate endothelial regeneration after coronary angioplasty and thus could be an ideal compound to deliver on a stent for the purpose of reducing in-stent restenosis. METHODS: Ninety-five patients were randomized to receive a slow-release (n = 32) or the moderate release (n = 31) formulations or the bare metal stent (n = 32). The primary end point was the 6-month percent in-stent volume obstruction by intravascular ultrasound (IVUS). RESULTS: Diabetes was present in 29.5% of patients; the mean reference vessel diameter was 2.90 mm; and the mean lesion length was 13.5 mm. Primary endpoint, 6-month percent in-stent volume obstruction by IVUS, did not differ significantly between the 3 groups (31% +/- 14%, 33% +/- 11%, and 31% +/- 14%, P = 0.83). Secondary endpoints also did not differ significantly between the groups including 6-month rates of in-lesion binary angiographic restenosis (13.3%, 14.3%, and 12.5%, P = 0.98), in-stent late loss (0.82 +/- 0.49 mm, 0.86 +/- 0.53 mm, and 0.84 +/- 0.46 mm, P = 0.97), target lesion revascularization (12.5%, 6.9%, and 6.5%, P = 0.64), and major adverse cardiac events (18.8%, 10.3%, and 6.5%, P = 0.31). CONCLUSIONS: In this first-in-man randomized trial, the 17-beta estradiol-eluting R-Stent, in either slow- or moderate-release formulations, was well-tolerated, but showed no benefit for treatment of coronary lesions when compared to controls.     

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

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

Reduced incidence of clinical restenosis with newer generation stents, stent oversizing, and high-pressure deployment: single-operator experience

BACKGROUND: Over the last 4 years, several newer generation stents have become available, promising to change the scenery of coronary angioplasty (PTCA) with its attendant restenosis rate. HYPOTHESIS: The aim of this study was to review prospectively the results of a single operator adopting a uniform approach with approximately 0.5 mm stent oversizing and high-pressure (> or = 12-16 bar) deployment and compare them with conventional PTCA in a series of 244 consecutive patients. METHODS: The study included 203 men and 41 women, aged 59 +/- 11 years, who presented with stable angina and/or positive exercise testing (n = 75), unstable angina (n = 161), or acute myocardial infarction (n = 8). Dilated vessels included the left anterior descending artery (n = 139), the right coronary artery (n = 86), the left circumflex artery (n = 47), the ramus branch (n = 4), or venous grafts (n = 2). Stents were implanted for dissection, suboptimal PTCA result, and electively. Two groups were compared: 83 patients who underwent balloon PTCA alone and 161 patients who also received stent(s). RESULTS: The two groups had similar demographics, age (58 +/- 10 vs. 59 +/- 11 years), initial vessel stenosis (92 +/- 7 vs. 93 +/- 6%), and left ventricular ejection fraction (51 +/- 9 vs. 51 +/- 8%). Procedural success was also similar (97.6 vs. 99.4%), but as expected the residual stenosis was much lower in the stent group (< or = 0 vs. 17%). The following stents were employed: J & J (n = 1), NIR (n = 117), ACS (n = 59), AVE (n = 9), Inflow GoldFlex (n = 9), Crossflex (n = 5), Wictor (n = 1), Jostent (n = 16), R stent (n = 9), Seaquence (n = 2) and Wallstent (n = 1). Single stents were used in 118 patients, two stents in 31 patients, three in 6 patients, and four in 6 patients. There was one in-hospital death at 3 days unrelated to the procedure. There were no events of subacute stent thrombosis; all patients in the stent group received combined therapy with aspirin and ticlopidine, the latter for 1 month. During 18 +/- 14 months, the clinical restenosis rate was significantly lower in the stent group (6.9%) than in the PTCA group (28.4%) (p = 0.001). CONCLUSION: In a series of 244 consecutive patients, newer generation stents and a consistent approach of stent oversizing and high-pressure stent deployment by a single operator resulted in high procedural success (99%), lack of stent thrombosis (0%), and a very low clinical restenosis rate (7%).     

置入国产雷帕霉素药物洗脱支架冠心病患者双联抗血小板治疗效果的研究

目的:对置入国产雷帕霉素支架(Firebird)的冠心病患者,12个月双联抗血小板(DAPT)后继续延长DAPT时间能否获益进行分析。方法:回顾性分析2007年1月至2009年12月,于北京安贞医院心内科置入Firebird支架的患者,按照DAPT的时间,分为12个月停用DAPT组和12个月DAPT组,通过门诊或电话随访,评价术后患者死亡、心肌梗死、脑卒中联合终点发生率,靶血管再次血运重建发生率。结果:共入选患者1 073例,随访平均(29.4±6.2)个月,按照排除标准筛选后共955例患者纳入分析,12个月停用DAPT患者410例,12个月DAPT组患者545例。12个月停用DAPT和12个月DAPT组死亡/心肌梗死/脑卒中发生率分别为5.2和1.6,P=0.016,多因素校正后,12个月停用DAPT组仍较12个月DAPT组显著增加死亡/心肌梗死/脑卒中风险(HR=3.56,95%CI:1.18~10.8,P=0.025)。结论:对于置入Firebird的患者,与12个月时停用DAPT仅使用阿司匹林比较,12个月后继续使用DAPT显著降低不良事件风险。     

Experimental efficacy of an everolimus eluting cobalt chromium stent.

INTRODUCTION: Rapamycin and its analogs are now being coated on different stent platforms, using different polymer matrices to prevent restenosis by impairing vascular smooth muscle cell proliferation and neointimal formation. METHODS: We evaluated the feasibility and compared the efficacy of biostable polymeric everolimus and sirolimus (CYPHER, Cordis) eluting stents in a porcine coronary model. Cobalt chromium balloon expandable stents (ML VISION, Guidant) were coated with a polymer containing everolimus (190 mug/cm(2)). Twelve pigs underwent placement of 36 oversized sirolimus (n = 12), everolimus (n = 12), and bare metal (cobalt chromium, n = 12) stents in the coronary arteries. RESULTS: At day 28, vessel injury scores were low (<0.25) and similar between each of the three test groups. The mean neointimal thickness was significantly lower in the everolimus- (0.13 +/- 0.07 mm, P = 0.02) and sirolimus-eluting stents (0.13 +/- 0.08 mm, P = 0.04) versus the bare metal stents (0.20 +/- 0.07 mm). The mean percent area stenosis was similar for the everolimus-eluting stents [(20.8 +/- 6.9)%] and the sirolimus-eluting stents [(20.8 +/- 7.6)%], and each was significantly less than that of bare metal stents [(26.1 +/- 7.8)%, P = 0.05]. CONCLUSION: Stent-based delivery of sirolimus and everolimus delivered via durable polymeric matrices are equally effective in the suppression of neointimal formation at day 28 in the porcine coronary model. Further study is necessary to document dose response and long-term comparative effects of these drug-eluting stents.     

Biodegradable-Polymer Biolimus-Eluting Stents versus Durable-Polymer Everolimus-Eluting Stents at One-Year Follow-Up: A Registry-Based Cohort Study

We compared outcomes of percutaneous coronary intervention patients who received biodegradable-polymer biolimus-eluting stents with those who received durable-polymer everolimus-eluting stents.At Tehran Heart Center, we performed a retrospective analysis of the data from January 2007 through December 2011 on 3,270 consecutive patients with coronary artery disease who underwent percutaneous coronary intervention with the biodegradable-polymer biolimus-eluting stent or the durable-polymer everolimus-eluting stent. We excluded patients with histories of coronary artery bypass grafting or percutaneous coronary intervention, acute ST-segment-elevation myocardial infarction, or the implantation of 2 different stent types. Patients were monitored for 12 months. The primary endpoint was a major adverse cardiac event, defined as a composite of death, nonfatal myocardial infarction, and target-vessel and target-lesion revascularization.Durable-polymer everolimus-eluting stents were implanted in 2,648 (81%) and biodegradable-polymer biolimus-eluting stents in 622 (19%) of the study population. There was no significant difference between the 2 groups (2.7% vs 2.7%; P=0.984) in the incidence of major adverse cardiac events. The cumulative adjusted probability of major adverse cardiac events in the biodegradable-polymer biolimus-eluting stent group did not differ from that of such events in the durable-polymer everolimus-eluting stent group (hazard ratio=0.768; 95% confidence interval, 0.421–1.44; P=0.388).We conclude that in our patients the biodegradable-polymer biolimus-eluting stent was as effective and safe, during the 12-month follow-up period, as was the durable-polymer everolimus-eluting stent.     

Biocompatibility of phosphorylcholine coated stents in normal porcine coronary arteries

OBJECTIVE: To improve the biocompatibility of stents using a phosphorylcholine coated stent as a form of biomimicry. INTERVENTIONS: Implantation of phosphorylcholine coated (n = 20) and non-coated (n = 21) stents was performed in the coronary arteries of 25 pigs. The animals were killed after five days (n = 6), four weeks (n = 7), and 12 weeks (n = 8), and the vessels harvested for histology, scanning electron microscopy, and morphometry. MAIN OUTCOME MEASURES: Stent performance was assessed by studying early endothelialization, neointima formation, and vessel wall reaction to the synthetic coating. RESULTS: Stent thrombosis did not occur in either group. Morphometry showed no significant differences between the two study groups at any time point. At five days both the coated and non-coated stents were equally well endothelialised (91% v 92%, respectively). At four and 12 weeks there was no difference in intimal thickness between the coated and non-coated stents. Up to 12 weeks postimplant the phosphorylcholine coating was still discernible in the stent strut voids, and did not appear to elicit an adverse inflammatory response. CONCLUSION: In this animal model the phosphorylcholine coating showed excellent blood and tissue compatibility, unlike a number of other polymers tested in a similar setting. Given that the coating was present up to 12 weeks postimplant with no adverse tissue reaction, it may be a potential candidate polymer for local drug delivery.     

Worse six-month outcome for patients with multiple stents in a single coronary artery

BACKGROUND: Before the "era" of optimal stent deployment, very few data concerning multiple stents in a single coronary artery showed restenosis rates up to 60%. OBJECTIVE: To evaluate the 6-month outcome of patients receiving multiple Palmaz-Schatz stents (> or =2 stents) in a single coronary artery compared to those receiving single stents. METHODS: Three hundred and forty-eight patients having multiple stents were compared to 174 patients receiving single stents during a 6-month follow-up. RESULTS: Repeat target lesion revascularization (RTLR), either repeat PTCA or CABG, was 10.4% in the single-stent group, 22.6% in the two-stent group, and 23.1% in the > or =2 stent group (p = 0.001, single versus 2 or > or =2 stents). There was not a significant difference between single stent and multiple stent groups in myocardial infarction and death during 6-month follow-up. Multivariate analysis showed multiple stents, diabetes mellitus, and type C lesion to be predictors of RTLR. CONCLUSIONS: Placement of two or more stents was associated with a significantly higher RTLR compared with single stent placement. The optimal approach to diffuse coronary artery disease remains to be defined.     

Sirolimus-eluting stents inhibit neointimal hyperplasia in diabetic patients. Insights from the RAVEL Trial.

Patients with diabetes mellitus have less favourable outcomes after percutaneous coronary intervention (PCI) than non-diabetics. We performed a subgroup analysis of the multicentre RAVEL trial to examine the impact of the sirolimus-eluting stent (SES) on outcomes in diabetic patients. The RAVEL study randomized 238 patients to treatment with either sirolimus-eluting or bare metal stents. Forty-four patients were diabetic; 19 received sirolimus-eluting stents and 25 were treated with bare metal stents. The differences in outcomes between diabetic and non-diabetic patients treated with SES (n=101) were also assessed. Follow-up angiography was performed at 6 months. Major adverse cardiac events (MACE) defined as death, myocardial infarction (MI), or target lesion revascularization (TLR) were analysed at 12-month follow-up. Six-month in-stent late lumen loss was significantly lower for the diabetic SES than the bare stent group (0.07+/-0.2 vs 0.82+/-0.5mm; P<0.001) and similar to that in non-diabetics treated with SES (-0.03+/-0.27mm). There was zero restenosis in the SES groups (diabetic and non-diabetic) compared to a 42% rate in the diabetic population assigned to bare metal stents (P=0.001). After 12 months, there was one non-Q-wave MI and one non-cardiac death in the diabetic SES group, while 12 patients in the bare metal stent group had MACE (one death, two MI, nine TLR) (P=0.01)-an event-free survival rate of 90% vs 52%, respectively (P<0.01). There were no TLRs in both SES groups compared to 36% rate in the diabetic bare metal stent group (P=0.007).Conclusion Diabetics treated with SES were associated with a virtual abolition of neointimal proliferation and low event rates at long-term follow-up.     

Stent-based delivery of ABT-578 via a phosphorylcholine surface coating reduces neointimal formation in the porcine coronary model.

Stent-based delivery of the antiproliferative and immunosuppressive macrocyclic lactone sirolimus reduces neointimal formation and restenosis by cytostatic inhibition of vascular smooth muscle cell proliferation. The objective of this study was to determine the feasibility and efficacy of stent-based delivery of ABT-578, a structurally unique macrocyclic lactone. Stainless steel balloon-expandable stents were coated with thin layer of phosphorylcholine (PC) or PC with ABT-578 (10 microg/mm). Fifteen juvenile domestic pigs underwent placement of oversized bare metal (n = 15), PC (n = 8), and PC with ABT-578 (n = 9) stents in the coronary arteries. At 28 days, histology demonstrated similar mean injury scores for the control, PC-, and ABT-578-coated stents. The mean neointimal area (mm2) was significantly reduced for ABT-578 (1.70 +/- 0.47) as compared with PC (2.82 +/- 1.24) and control (2.89 +/- 1.91) stents (P < or = 0.05). The 40% reduction in neointimal area resulted in significantly less mean percent diameter stenosis for ABT-578 (19.4% +/- 4.0%) as compared with PC (30.3 +/- 12.1 %) and control (29.4% +/- 15.5%) stents (P < or = 0.03). Twelve of the 45 bare metal stent cross-sections (26.7%) exhibited a giant cell reaction, while none of the sections from the ABT-578-eluting stents had a giant cell reaction (P = 0.004). Stent-based delivery of ABT-578 via a PC surface coating inhibits neointimal formation at 28 days in the porcine coronary model. Further study is necessary to determine the dose-response and long-term effects ABT-578-eluting stents in the porcine coronary model.     

Effect of local delivery of L-arginine on in-stent restenosis in humans

To determine whether intramural administration of L-arginine reduces intimal thickening after optimal Palmaz-Schatz stent deployment in humans, 50 patients with native coronary artery disease who received a single Palmaz-Schatz stent were enrolled in this pilot study. Patients were randomized into 2 treatment groups: an L-arginine group (n = 25) and a saline group (n = 25). After stent deployment, L-arginine (600 mg/6 ml) or saline (6 ml) was locally delivered via the Dispatch catheter (Scimed) over 15 minutes. Serial angiography and intravascular ultrasound examinations (motorized pull-back at 0.5 mm/s) were performed before and after the procedure, and at 6-month follow-up. Measurements of stent area, lumen area, and neointimal area were computed within the stents at 1-mm intervals, by technicians who were blinded to the treatment assignment. Using Simpson's rule, stent, plaque, and lumen volumes, neointimal volume within the stent, and percent neointimal volume were measured before and after the procedure, and at 6-month follow-up. The 6-month volume data in quantitative coronary ultrasound showed that neointimal volume in the L-arginine group was significantly less than in the saline group (25 vs 39 mm(3); p = 0.049). Similarly, percent neointimal volume was significantly less in the L-arginine group at 6-month follow-up (17 +/- 13% vs 27 +/- 21%; p = 0.048). Thus, these results showed that local delivery of L-arginine reduces in-stent neointimal hyperplasia in humans, indicating that this approach may be a novel strategy to prevent in-stent restenosis.     

Long-term clinical safety and efficacy of NIROYAL vs. NIR intracoronary stent.

Research in vitro and in animal models suggested that gold electroplating of stents can attenuate neointimal hyperplasia and reduce thrombogenicity. The objective of this study was to evaluate the safety and efficacy of the gold-coated NIROYAL stent in the treatment of stenosed coronary arteries and bypass grafts. We retrospectively studied 181 consecutive patients undergoing deployment of NIR (n = 87) or NIROYAL (n = 94) coronary stents in a single tertiary referral center from July 1997 to December 1998. Mean follow-up duration for the NIR and NIROYAL patient groups were 11.6 and 11.4 (range, 3-12) months, respectively. Stent thrombosis rates were 3/87 (3%) in the NIR and 0/94 (0%) in the NIROYAL group (P = 0.07). The need for target lesion revascularization (TLR) in the NIR patient group was 8/87 (9%) compared to 11/94 (12%) in the NIROYAL patient group (P = 0.6). The overall MACE rates for the NIR and NIROYAL patient groups were 24/87 (28%) and 22/94 (23%), respectively (P = 0.5). The present study, hence, implies equivalence between the stainless steel NIR and the gold-plated NIROYAL stent with no significant difference in immediate and long-term clinical performance profiles.     

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

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

Drug-eluting stent-supported percutaneous coronary intervention for chronic total coronary occlusion.

OBJECTIVES: This study sought to determine the clinical and angiographic outcomes after drug-eluting stent (DES)-supported percutaneous coronary intervention (PCI) for chronic total coronary occlusion (CTO). BACKGROUND: There are few data about the efficacy of DES-supported PCI for CTO. METHODS: All consecutive patients who had a sirolimus-eluting stent or a paclitaxel-eluting stent implanted for CTO from December 2003 to December 2004 were analyzed. Clinical and angiographic outcomes of patients treated with DES were compared with a case-matched control group of patients treated with bare metal stents (BMS) in the 12 months before the routine use of DES. RESULTS: Successful DES-supported PCI was performed in 92 patients and 104 CTO. The case-matched control group consisted of 26 patients and 27 CTO successfully treated with BMS. There were no differences between groups in baseline clinical and angiographic characteristics. Stent length in the DES group was higher as compared with that of BMS group (51+/-28 mm vs. 40+/-19 mm, P=0.073). The 6-month major adverse cardiac event (MACE) rate was lower in the DES group as compared with that of BMS group (9.8% vs. 23%, P=0.072). The angiographic follow-rate was 80% in the DES group and 81% in the BMS group. The 6-month restenosis rate was 19% in the DES group and 45% in the BMS group (P<0.001). By multivariate analysis, it was found that in the DES group, the only predictors of restenosis were stented segment length (OR 1.031, 95% CI 1.01-1.06, P=0.009) and a target vessel reference diameter<2.5 mm (OR 6.48, 95% CI 1.51-27.83, P=0.012), while the only predictor of MACE was stent length (OR 1.04, 95% CI 1.01-1.08, P=0.006). CONCLUSIONS: DES implantation for CTO decreases the risk of mid-term restenosis and MACE. Small vessels and diffuse disease requiring the implantation of multiple stents and very long stents for full coverage of the target lesion are still associated with a relatively high risk of restenosis.     

Stents in total occlusion for restenosis prevention. The multicentre randomized STOP study. The Israeli Working Group for Interventional Cardiology.

AIMS: This multicentre randomized study set out to evaluate whether coronary stenting improves the results of successful balloon angioplasty for chronic total occlusion. Balloon angioplasty for chronic total occlusion has a high restenosis rate. Several reports have suggested that coronary stenting may decrease the likelihood of restenosis and reocclusion. METHODS AND RESULTS: Patients with total coronary artery occlusions who had an optimal PTCA result were randomized either to no further treatment or additional stent implantation. The AVE microstent was used and all patients were scheduled for a 1-, 3-, and 6-month clinical follow-up. Repeat coronary angiography to assess the rate and pattern of restenosis was performed at 6 months or earlier if clinically indicated. Ninety-six patients were enrolled in this study. The mean age was 59. 3+/-10.3 years and 15 were females. Forty-eight patients were randomized to the stent arm, receiving 52 stents (lengths 18-39 mm). Stent implantation was successful in all and there were no major procedure-related complications. Sixty-nine patients (72%) were restudied after 6 months. The binary restenosis rates (50%), in the PTCA arm were 70.9% with a minimal lumen diameter of 1.01+/-0.79 mm compared to 42.1% in the stent arm with a minimal lumen diameter of 1.63+/-1.02 mm (P=0.034). Reocclusion occurred in 7.9% in the stent group compared to 16.1% in the PTCA group. Restenosis in the PTCA group was focal in 88% of patients and occurred at the point of total obstruction (within 5 mm), compared to diffuse instent restenosis, which occurred in 54% of the patients in the stent group. CONCLUSION: Coronary stenting can significantly decrease the rate of restenosis and reocclusion of total occlusions. As restenosis in the stent group was more diffuse, care should be taken to implant short stents at the site of occlusion.     

Long-term clinical outcomes after coronary angioplasty using long stents in small coronary vessels.

The role of coronary stenting in challenging situations, such as small vessels and long lesions, remains controversial. The aim of this study was to examine the procedural, in-hospital, and long-term clinical outcomes of patients undergoing angioplasty with long stents in small coronary vessels. We evaluated the procedural success rate and clinical outcomes in 252 consecutive subjects treated by means of the implantation of a single coronary stent in vessels with a mean reference diameter of < 2.5 mm; 128 patients received a short stent (< or = 16 mm) and 124 a long stent (> or = 18 mm). Lesion morphology was more complex in patients treated with long stents (P < 0.05). The mean stent length was 14 +/- 2 mm in the short-stent group and 25 +/- 3 mm in the long-stent group (P < 0.001). The overall procedural success rate (98.4% vs. 97.6%; P = NS) and the rate of major in-hospital adverse events (death, acute myocardial infarction, or target vessel revascularization; 1.6% vs. 2.4%; P = NS) was similar in the two groups. After 11.7 +/- 7 months of follow-up, there was no difference in the incidence of mortality and myocardial infarction (5% vs. 6.6%; P = NS), but revascularization tended to occur more frequently in the patients treated with long stents (21.7% vs. 13.9%; P = NS). In conclusion, the procedural success rate of single short or long stents in small coronary vessels was similar. Although the incidence of target vessel revascularization tended to be higher in the patients treated with longer stents, 2-year event-free survival was equivalent in the two groups (65% vs. 70%; P = NS).     

Coronary stent assessability by 64 slice multi-detector computed tomography.

BACKGROUND: We evaluated the assessability of contemporary stent platforms by 64-slice multi-detector computed tomography (MDCT). METHODS: Patients undergoing coronary stenting were included in a prospective protocol of MDCT imaging within 48 hr of stent implantation. MDCT data were acquired using a "Sensation 64" MDCT scanner (Siemens Medical Solutions, Forchheim, Germany). Stent assessability was assessed by two independent blinded observers and disagreement was resolved by a third observer. Assessability was defined at visualization of the in-stent lumen without influence of partial volume effects, beam hardening, motion, calcification, or contrast to noise limitations. RESULTS: Fifty four stents (Cypher n = 25, Vision/Minivision n = 19, Taxus Express n = 8, Liberte n = 1, Driver n = 1) in 44 patients were included in the study. The two independent observers classified 30 of 54 stents (56%) as assessable. Interobserver reproducibility was good with kappa = 0.66. Stent size was the most important determinant of assessability. Consistently assessable stents were 3.0 mm or larger (85%), whereas those under 3 mm were mostly nonassessable (26%). CONCLUSIONS: Contemporary stent designs evaluated on a 64-slice MDCT scanner showed artifact free assessability only in larger stents. Increase in spatial resolution of MDCT scanners or modifications in stent design will be necessary to noninvasive evaluate stents <3 mm in diameter, where in-stent restenosis is more frequent.     

Randomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels.

AIMS: Sirolimus- and paclitaxel-eluting stents effectively reduce restenosis in small coronary vessels. The relative efficacy of these drug-eluting stents in this high-risk subset is not known. METHODS AND RESULTS: A total of 360 patients undergoing percutaneous coronary intervention for de novo lesions in native coronary vessels with a diameter of <2.80 mm received randomly paclitaxel-eluting stents (n=180) or sirolimus-eluting stents (n=180). The primary endpoint was in-stent late luminal loss. Secondary endpoints were angiographic restenosis and need of target lesion revascularization. The study intended to show that the paclitaxel-eluting stent is not inferior to the sirolimus-eluting stent with respect to the primary endpoint. The non-inferiority margin was set at 0.16 mm. Follow-up angiography was performed in 87% of the patients. In-stent late luminal loss in the paclitaxel-eluting stent group was 0.32 mm (upper 95% boundary, 0.42 mm), which was greater than that in the sirolimus-eluting stent group, failing to show the non-inferiority of the paclitaxel-eluting stent to the sirolimus-eluting stent (P>0.99). Angiographic restenosis was found in 19.0% of the lesions in the paclitaxel-eluting stent group and 11.4% of the lesions in the sirolimus-eluting stent group (P=0.047). Target lesion revascularization was performed in 14.7% of the lesions treated with paclitaxel-eluting stents and 6.6% of the lesions treated with sirolimus-eluting stents (P=0.008). CONCLUSION: The paclitaxel-eluting stent is associated with a greater late luminal loss and is less effective in reducing restenosis in small coronary vessels than the sirolimus-eluting stent.     

Drug-eluting stents compared with thin-strut bare stents for the reduction of restenosis: a prospective, randomized trial.

AIM: Drug-eluting stents have considerably reduced restenosis. Their relative merits have been assessed on the basis of comparisons made with control bare stents with thick struts. However, increased strut thickness negatively affects restenosis. No direct comparisons between drug-eluting stents and bare stents with thin struts have been performed. The aim of this study was to evaluate the relative efficacy of sirolimus-eluting stents (Cypher) as compared with that of bare stents with thin struts (BeStent 2). METHODS AND RESULTS: A total of 500 patients with coronary artery disease were randomly assigned to receive a Cypher stent or BeStent. The primary endpoint was angiographic restenosis defined as a stenosis diameter > or = 50% at 6-month angiographic follow-up. The secondary endpoint was the need for target vessel revascularization (TVR) during the year following the procedure. Follow-up angiography was performed in 81.8% of the patients. Patients treated with Cypher stents had a lower angiographic restenosis rate [8.3 vs. 25.5%, relative risk, 0.33 (95% confidence interval, 0.19-0.56), P<0.001] and a lower incidence of TVR [7.2 vs. 18.8%, relative risk, 0.38 (0.22-0.66), P<0.001]. For smaller vessels (< 2.8 mm), the angiographic restenosis rates were 7.0% with the Cypher stent and 34.2% with the BeStent (P<0.001). For larger vessels (> or = 2.8 mm), angiographic restenosis rates were 10.0% with the Cypher stent and 13.1% with the BeStent (P=0.52). CONCLUSION: The drug-eluting stent, Cypher, is associated with a significantly lower risk of restenosis compared with the bare thin-strut BeStent. The advantage of the Cypher stent is vastly reduced in large vessels.     

Sirolimus- and paclitaxel-eluting stents in comparison with balloon angioplasty for treatment of in-stent restenosis.

This study evaluated the acute and follow-up effectiveness of sirolimus-eluting stents (SESs) and nonpolymer-based paclitaxel-eluting stents (PESs) in comparison will balloon angioplasty for treatment of complex in-stent restenosis (ISR) lesions. Drug-eluting stents have been demonstrated to be highly effective for treatment of de novo lesions. The use of drug-eluting stents for treatment of complex ISR is less well defined. Eighty one lesions with in-stent restenosis (lesion length < 30 mm in a native coronary artery) were treated with either PTCA alone (n = 26 lesions in 25 patients), PES (n = 27 lesions in 24 patients; Achieve, Cook; 3,1 mug paclitaxel/mm(2) nonpolymer-based coating), SES (n = 28 lesions in 28 patients; Cypher, Cordis; 140 mug sirolimus/cm(2) metal surface area). Nine-month MACE rates were 32%, 8%, and 14% (all due to repeated revascularization procedures, except one death in the SES group) in the PTCA, PES, and SES group, respectively. Postintervention minimal lumen diameter in stent was significantly greater in the SES and the PES group in comparison with the PTCA group (2.37 +/- 0.26, 2.54 +/- 0.42, 1.78 +/- 0.23 mm; P < 0.001). At 6-month angiographic follow-up, late loss in stent was 0.77 +/- 0.45, 0.43 +/- 0.53, and 0.29 +/- 0.52 mm for the PTCA, PES, and SES group, respectively (P = 0.005). In-lesion restenosis rate was 61% for the PTCA group, 20% for the PES group, and 13% for the SES group (P = 0.042). The implantation of SES as well as nonpolymer PES proved to be effective for treatment of ISR. The combination of improved acute gain and reduced late loss results in a significantly improved angiographic follow-up result in comparison with PTCA.