Outcomes after unrestricted use of everolimus-eluting stent compared to paclitaxel- and sirolimus-eluting stents

Compared to paclitaxel-eluting stents (PESs) and sirolimus-eluting stents (SESs), a paucity of data exists regarding the clinical outcome of everolimus-eluting stents (EESs) in unselected patients with the entire spectrum of obstructive coronary artery disease. The present study cohort included 6,615 consecutive patients at Washington Hospital Center who underwent coronary artery stent implantation with EESs (n = 519), PESs (n = 2,036), or SESs (n = 4,060). Patients who received bare metal stents, zotarolimus-eluting stents, or 2 different drug-eluting stent types were excluded. The analyzed clinical end points were death, death or Q-wave myocardial infarction, target lesion revascularization (TLR), target vessel revascularization, definite stent thrombosis, and major adverse cardiac events, defined as the composite of death, Q-wave myocardial infarction, or TLR at 1 year. The groups were well matched for the conventional risk factors for coronary artery disease, except for systemic hypertension, which differed among the groups. The unadjusted end points for EESs and PESs were death (4.5% vs 7.1%; p = 0.03), TLR (3.4% vs 4.6%; p = 0.24), target vessel revascularization (5.6% vs 7.1%; p = 0.46), death or Q-wave myocardial infarction (4.5% vs 7.4%; p = 0.02), and definite stent thrombosis (0.0% vs 0.7%; p = 0.09). The unadjusted end points for EES and SES were death (4.5% vs 5.2%; p = 0.45), TLR (3.4% vs 5.8%; p = 0.3), target vessel revascularization (5.6% vs 8.6%; p = 0.05), death or Q-wave myocardial infarction (4.5% vs 5.4%; p = 0.39), and definite stent thrombosis (0.0% vs 1.08%; p = 0.003). The rates of major adverse cardiac events were similar among the 3 groups. After multivariate analysis, the rate of death or Q-wave myocardial infarction between the EES and PES groups was no longer significant (hazard ratio 1.14, 95% confidence interval 0.59 to 2.20, p = 0.70). In conclusion, the results of the present study suggest the use of EES in routine clinical practice is both safe and effective but offers no clinically relevant advantage in terms of hard end points compared to PES or SES.     

Meta-analysis comparison (nine trials) of outcomes with drug-eluting stents versus bare metal stents in patients with diabetes mellitus

In patients with diabetes mellitus, outcome after drug-eluting stent (DES) versus bare metal stent (BMS) implantation remains under investigation; although lower reintervention rates were reported, incidence of death and myocardial infarction (MI) during follow-up is not completely characterized. Thus, we performed a meta-analysis of available randomized studies evaluating follow-up events of DESs versus BMSs in patients with diabetes mellitus. Randomized trials reporting outcome of DES versus BMS in diabetic patients with a follow-up > or =6 months were included. Outcomes analyzed were (1) death, (2) MI, (3) in-stent restenosis (ISR) and target lesion revascularization (TLR), and (4) stent thrombosis. Data were extracted by 2 independent reviewers. A total of 9 trials, including 1,141 patients, were found. ISR occurred in 8% of patients with DESs versus 41% of those with BMSs (odds ratio [OR] 0.13, 95 confidence interval [CI] 0.09 to 0.20, p <0.00001) and TLR in 8% versus 27% (OR 0.23, 95% CI 0.16 to 0.33, p <0.00001). There was no difference in the incidence of stent thrombosis (1.1% vs 1.2%, p = 0.98) or death (2.4% vs 2.3%, p = 0.91). MI occurred in 3.5% of patients with DESs versus 7.2% of those with BMSs (52% risk decrease, p = 0.02). Decrease of ISR with DESs was observed in noninsulin-treated (OR 0.17, 95% CI 0.11 to 0.26, p <0.00001) and insulin-treated (OR 0.22, 95% CI 0.13 to 0.37, p <0.00001) patients. In conclusion, diabetic patients receiving DESs have lower risk of ISR and TLR versus those treated with BMSs; use of DESs in patients with diabetes mellitus significantly decreases the incidence of MI during follow-up, without affecting mortality or stent thrombosis.     

Comparison of three-year clinical outcome of sirolimus- and paclitaxel-eluting stents versus bare metal stents in patients with ST-segment elevation myocardial infarction (from the RESEARCH and T-SEARCH Registries)

Sirolimus-eluting stents (SESs) recently proved to be superior to bare metal stents (BMSs) in decreasing the need for repeat revascularization in patients with ST-segment elevation myocardial infarction (STEMI) at 1 year. Whether this also holds for paclitaxel-eluting stents (PESs) is currently unclear and the long-term relatively efficacy of the 2 drug-eluting stents is currently unknown. We investigated the 3-year efficacy of SESs and PESs versus BMSs in patients with STEMI. Primary angioplasty was performed in a consecutive group of 505 patients (BMSs in 183, SESs in 186, PESs in 136). At 3 years, the cumulative mortality rate was comparable in the 3 groups: 13.3% in the BMS group, 11.5% in the SES group, and 12.4% in the PES group (nonsignificant for all). The rate of target vessel revascularization (TVR) was 12.0% in the BMS group compared with 8.0% and 7.7% in the SES and PES groups, respectively (p = 0.12 for BMS vs SES, 0.30 for BMS vs PES, 0.62 for SES vs PES). The cumulative incidence of death, MI, or TVR was 25.5% in the BMS group compared with 17.9% and 20.6% in the SES and PES groups, respectively (p = 0.06 for BMS vs SES, 0.32 for BMS vs PES, 0.45 for SES vs PES). Angiographic stent thrombosis occurred in 2.4% of all patients (BMS 1.6%, SES 2.7%, PES 2.9%). In conclusion, in this relatively small consecutive patient cohort, the use of SESs and PESs was no longer associated with significantly lower rates of TVR and major adverse cardiace events in patients with STEMI after 3 years of follow-up. A high frequency of stent thrombosis was observed in the 2 drug-eluting stent groups.     

Comparison of everolimus-eluting stent with paclitaxel-eluting stent in long chronic total occlusions

The aim of the present study was the comparison of the everolimus-eluting stent (EES) with the paclitaxel-eluting stent (PES) in patients treated for long chronic total occlusions (CTOs). Previous randomized trials have shown the superiority of EESs over PESs. No data exist about the efficacy and safety of EESs in patients treated for complex CTOs requiring multiple stent implantation. We identified 258 patients treated for CTOs who received multiple EESs (n = 112) or PESs (n = 146), with a total stent length of ≥40 mm. The primary end point was in-segment restenosis, defined as >50% luminal narrowing at the segment site, including the stent and 5 mm proximal and distal to the stent edges of the target vessel, on the follow-up angiogram. The secondary end point was the 9-month composite of major adverse cardiovascular events. The 2 patient groups were similar in all baseline characteristics. The median lesion length was 48 mm in the EES group and 46 mm in the PES group (p = 0.793). The incidence of the primary end point of the study was 11.8% in the EES group and 31.4% in the PES group (p = 0.001). The major adverse cardiovascular event rate was lower in the EES group than in the PES group (8.9% and 22.6%, respectively, p = 0.003). Definite or probable stent thrombosis occurred in 5 patients in the PES group (3.4%), with no stent thrombosis occurring in the EES group (p = 0.048). On multivariate analysis, EES was the only variable independently related to the risk of binary angiographic restenosis with an odds ratio of 0.29 (95% confidence interval 0.14 to 0.62; p = 0.002). In conclusion, in patients treated for long CTOs and requiring multiple stent implantation, EESs performed better than PESs, with a >50% reduction in the risk of restenosis and major adverse cardiovascular events.     

Comparison of one-year clinical outcomes with paclitaxel-eluting stents versus bare metal stents in everyday practice

BACKGROUND:

In randomized trials, paclitaxel-eluting stents (PES) have been shown to be superior to bare metal stents (BMS) in reducing restenosis. However, the effectiveness of PES in patients treated during routine practice has not been fully established.

METHODS:

A retrospective comparison of PES with BMS in consecutive patients undergoing percutaneous coronary intervention (PCI) from April 2003 to March 2004 was conducted. Outcomes included the composite of death, myocardial infarction and target lesion revascularization (TLR) at one year, as well as stent thrombosis.

RESULTS:

A total of 512 patients were treated with PES, and 722 patients were treated with BMS. Patients in the PES group were more likely to receive stents that were 20 mm in length or longer (52.2% versus 33.3%, P<0.0001), 2.5 mm in diameter or smaller (29.1% versus 12.5%, P<0.0001) and implanted in bifurcation positions (15.4% versus 11.6%, P=0.02). At one year, the composite outcome of death, myocardial infarction and TLR was 6.1% in the PES group compared with 10.8% in the BMS group (P=0.004). The one-year rate of stent thrombosis was 0.59% in the PES group compared with 0.28% in the BMS group (P=0.4).

CONCLUSIONS:

Despite being used in higher-risk lesions, there was a lower rate of major cardiac events at one year in patients treated with PES, primarily driven by the reduction in TLR. Thus, the experience with PES in contemporary practice applied to a broader population appears to be consistent with the results reported in randomized trials.     

Drug-Eluting Balloons Versus Everolimus-Eluting Stents for In-Stent Restenosis: A Meta-Analysis of Randomized Trials

ObjectivesIndividual randomized trials comparing drug-eluting balloons (DEB) versus everolimus-eluting stents (EES) for in-stent restenosis (ISR) were underpowered for clinical end-points. The objective of this study was to compare the clinical outcomes of DEB versus EES for any ISR.Materials & methodsElectronic databases were searched for randomized trials which compared DEB versus EES for any ISR (i.e., drug eluting or bare metal stents). Summary estimate risk ratios (RRs) were constructed using a DerSimonian and Laird random effects model.ResultsFive trials with 962 patients were included. In-segment minimum lumen diameter (MLD) was lower with DEB (standardized mean difference −0.24, 95% confidence interval [CI] −0.46 – −0.01) on angiographic follow-up at a mean of 8.6 months. There was no statistically significant difference in the risk of target vessel revascularization (TVR) at 1 year (RR 1.15, 95% CI 0.60–2.19), but TVR was increased with DEB at 3 years (RR 1.87, 95% CI 1.15–3.03). The risk of target lesion revascularization (TLR) was statistically increased with DEB (RR 2.17, 95% CI 1.13–4.19) at a mean of 24.4 months. There was no difference in the risk of MI, stent thrombosis, cardiac mortality and all-cause mortality between both groups.ConclusionIn patients with any type of ISR, DEB was associated a similar risk of TVR at 1-year, but increased risk of TVR and TLR at longer follow-up, as compared with EES. The quality of evidence was moderate, suggesting the need for further randomized trials with longer follow-up to confirm the role of DEB in the management of ISR.     

Performance of everolimus-eluting versus paclitaxel-eluting coronary stents in small vessels: results from the SPIRIT III and SPIRIT IV clinical trials

Background: Higher rates of adverse cardiac events have been observed in patients with small vessel disease. Therefore, we compared an everolimus‐eluting stent (EES) to a paclitaxel‐eluting stent (PES) for treatment of small (reference vessel diameter: RVD <2.5 mm) and larger vessels (≥2.5 mm) in a pooled analysis from the SPIRIT III (n = 1,002) and SPIRIT IV (n = 3,687) trials (randomized 2:1, EES vs. PES). Methods: Data of 4,689 total patients were pooled for a patient level analysis. Lesion length, RVD, and percent diabetics were matched between stent types. EES versus PES performance was evaluated at 1 year in patients with small (n = 1,019) and larger vessels (n = 2,586) who had a single lesion treated. Results: Mean RVD assessed by quantitative coronary angiography in patients with small vessels was 2.24 ± 0.19 and 2.25 ± 0.20 mm in the EES and PES groups, respectively. At 1 year, EES compared to PES in small vessel patients significantly reduced major adverse cardiac events (4.5% vs. 7.9%, P = 0.04), target lesion failure (4.4% vs. 7.9%, P = 0.03), target lesion revascularization (2.4% vs. 5.5%, P = 0.02), and stent thrombosis (0.2% vs. 1.2%, P = 0.04). Relative benefits of EES versus PES were comparable in small and larger vessels (P interaction > 0.05), although the absolute benefits were greater in patients with small vessel disease. Conclusion: In high‐risk patients requiring percutaneous coronary intervention in small coronary arteries, EES results in significantly improved 1‐year rates of event‐free survival compared to PES, with evidence present for both enhanced safety and efficacy. (J Interven Cardiol 2011;24:505–513)     

Two-year outcome of patients treated with sirolimus- versus paclitaxel-eluting stents in an unselected population with coronary artery disease (from the REWARDS Registry)

Multiple studies comparing sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with coronary artery disease have been performed. Despite these comparisons, it remains uncertain whether a differential in long-term efficacy and safety exists. Unselected patients treated exclusively with 1 drug-eluting stent type were enrolled in the Registry Experience at the Washington Hospital Center with Drug-Eluting Stents. There were 2,099 patients (3,766 lesions) treated with SES and 1,079 patients (1,850 lesions) treated with PES. Patients were followed at 30 days, 1 year, and 2 years for the clinical endpoints of death, myocardial infarction, target vessel revascularization, and definite and definite/probable stent thrombosis. Patients in the SES group had more dyslipidemia, history of congestive heart failure, and ostial lesions; patients treated with PES had more previous coronary artery bypass surgery, unstable angina, and type C lesions. At 2 years, unadjusted major adverse cardiac events (MACE) (22.6% vs 21.1%, p = 0.3) and target vessel revascularization (13.3% vs 11.2%, p = 0.1) were comparable. The incidence of definite stent thrombosis was higher in the SES group (1.8% vs 0.9%, p = 0.05) driven by early events. Similar results were seen after adjustment for baseline differences: MACE (hazard ratio 1.1, 95% confidence interval [CI] 0.9 to 1.3, p = 0.5), definite stent thrombosis (hazard ratio 2.3, 95% CI 1.0 to 5.2, p = 0.05), and target vessel revascularization (hazard ratio 1.1, 95% CI 0.9 to 1.4, p = 0.4). The incidence and rate of late stent thrombosis (>30 days) were similar (0.7% vs 0.5%, p = 0.4 and 0.24%/year, both groups, respectively). In conclusion, no major differential in long-term safety or efficacy was detected between SES and PES; both stent types were efficacious in reducing revascularization but were limited by a small continual increase in late stent thrombosis.     

Long-term (three-year) safety and efficacy of everolimus-eluting stents compared to paclitaxel-eluting stents (from the SPIRIT III Trial)

The safety and efficacy of the XIENCE V everolimus-eluting stent (EES) compared to the Taxus Express(2) paclitaxel-eluting stent (PES) has been demonstrated through 2 years in the SPIRIT II and III randomized clinical trials, but limited longer-term data have been reported. In the SPIRIT III trial, 1,002 patients with up to 2 lesions in 2 coronary arteries were randomized 2:1 to EESs versus PESs at 65 United States sites. At completion of 3-year follow-up, treatment with EES compared to PES resulted in a significant 30% decrease in the primary clinical end point of target vessel failure (cardiac death, myocardial infarction, or ischemic-driven target vessel revascularization, 13.5% vs 19.2%, hazard ratio 0.70, 95% confidence interval 0.50 to 0.96, p = 0.03) and a 43% decrease in major adverse cardiovascular events, cardiac death, myocardial infarction, or ischemic-driven target lesion revascularization (9.1% vs 15.7%, hazard ratio 0.57, 95% confidence interval 0.39 to 0.83, p = 0.003). In a landmark analysis, major adverse cardiovascular events were decreased to a similar extent with EES compared to PES 0 through 1 year and 1 year through 3 years (hazard ratio 0.56, 95% confidence interval 0.35 to 0.90; hazard ratio 0.59, 95% confidence interval 0.31 to 1.11, respectively). In conclusion, patients treated with EES rather than PES in the SPIRIT III trial had significantly improved event-free survival at 3 years. From 1 year to 3 years hazard curves continued to diverge in favor of EES, consistent with an improving long-term safety and efficacy profile of EES compared to PES, with no evidence of late catchup.     

Everolimus- and zotarolimus-eluting stents for bare metal stent in-stent restenosis treatment: a prospective study

Background: Treatment of in‐stent restenosis (ISR) is a challenging clinical problem. Recent studies have verified the safety and efficacy of first‐generation DES for the treatment of ISR. The safety and effectiveness of new‐generation drug‐eluting stents (nDES) for ISR has not been previously investigated. The aim of the present study was to prospectively evaluate the clinical outcomes after treatment with nDES implantation in patients with bare metal stent (BMS) ISR. Methods: Consecutive patients with ISR after BMS implantation were included. Primary end‐point was a major adverse cardiac event (MACE), defined as death, myocardial infarction (MI), or target vessel revascularization (TVR). The incidence of stent thrombosis was also evaluated. Results: A total of 46 consecutive patients were enrolled for the treatment of ISR, 23 patients from ZES and 23 from EES group. There were two (8.7%) cases of TVR in ZES cohort due to proliferative ISR at 6 and 7 months after DES implantation, and none in EES. One (4.3%) patient underwent percutaneous coronary intervention and the other (4.3%) was treated surgically. Neither acute nor subacute thrombosis was observed during the 13.3±6.3 months follow‐up period. In all other patients, stress test was negative for ischemia at 6 months. Conclusions: In this prospective study, we showed that direct nDES implantation is highly effective for ISR and seems to be a promising management for the treatment of ISR.     

The efficacy of everolimus-eluting stent implantation in patients with ST-segment elevation myocardial infarction: outcomes of 2-year clinical follow-up

First-generation drug-eluting stents (DES) demonstrated delay in vascular healing and increase in incidence of late and very late stent thrombosis compared with bare-metal stents (BMS). Second-generation DES, however, have shown a reduction of late and very late stent thrombosis compared with first-generation DES. Thus, we decided to evaluate whether the second-generation everolimus-eluting stent (EES) has an advantage over BMS in Japanese patients with ST-segment elevation myocardial infarction (STEMI). This study was conducted in two centers, retrospective, non-randomized and observational design in patients with STEMI. Three-hundred eighty patients were randomly selected to receive EES (198 patients) or cobalt-chromium BMS (182 patients). The primary endpoints were cardiac death, recurrent myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis (ST). At 2 years, the rates of TLR, TVR, and recurrent MI were significantly lower in the EES group than in the BMS group (TLR 1.5 vs. 8.3 %, p < 0.05; TVR 2.5 vs. 9.4 %, p < 0.05; recurrent MI 1.0 vs. 4.1 %, p < 0.05), and the rate of ST was also significantly lower in the EES group than in the BMS group (0.5 vs. 4.3 %, p < 0.05). Thus, major adverse cardiac events defined at the composite cardiac death, MI, TLR, TVR, or ST were significantly lower in EES group than in BMS group (3.0 vs. 9.9 %, p = 0.008). The rate of cardiac death, however, did not differ between both groups. In STEMI patients, EES may be associated with improved outcomes—specifically, a significant reduction in TVR, ST, and recurrent MI compared to BMS throughout 2 years.     

Drug Coated Balloon Is Less Effective for Treatment of DES In‐Stent Restenosis Both in Native Coronary Arteries and Saphenous Vein Grafts: Results From a Bicenter Registry

Background

The paclitaxel drug coated balloon (DCB) is an established treatment for bare metal stent (BMS) in‐stent restenosis (ISR) in native coronary arteries. The evidence of DCB‐application for drug eluting stent (DES) ISR both in native coronaries and saphenous vein grafts (SVG) is limited. Aim of our study was to compare the differential efficacy of DCB for treatment of BMS‐ and DES‐ISR in native coronary vessels and SVGs.

Methods and Results

N = 135 DCB‐treated patients with available follow up (FU) angiography were included in this retrospective study. Patients received treatment between April 2009 and March 2013 at 2 tertiary care hospitals in Germany. DCB was applied in BMS‐ISR (n = 65; 48%) and DES‐ISR (n = 70; 52%). DCB‐treated lesions were located in native coronary arteries (n = 110; 81%; BMS‐ISR: n = 58; 53%; DES‐ISR: n = 52; 47%) and SVGs (n = 25; 19%; BMS‐ISR: n = 7, 28%; DES‐ISR: n = 18, 72%). Median FU was 12 months. Endpoints were binary restenosis and target lesion revascularization (TLR). Binary restenosis (29% vs. 57%; P < 0.01) and TLR (18% vs. 46%; P < 0.01) were significantly more frequent in DES‐ISR versus BMS‐ISR. In SVGs, TLR was required in 72% (DES‐ISR) versus 14% (BMS‐ISR); P = 0.02. In the Kaplan–Meier‐analysis freedom from both endpoints was significantly decreased in the DES‐lesions both in the total population (binary restenosis P < 0.01; TLR P < 0.01) and native coronaries (binary restenosis P = 0.02; TLR P = 0.04).

Conclusions

DCB treatment is less effective in DES‐ISR than in BMS‐ISR. The diminished efficacy of DCB treatment is even more pronounced in DES‐ISR located within degenerated SVGs.

     

中国冠心病患者接受不同支架治疗预后的荟萃分析

目的比较中国冠心病患者置入药物洗脱支架(DES)和裸支架(BMS)或西罗莫司洗脱支架(SES)和紫杉醇洗脱支架(PES)之间,临床预后的差别。方法检索数据库,纳入随访时间≥6个月的、比较DES和BMS或SES和PES的临床研究。用STATA 10.0作荟萃分析,比较不同类型支架的临床预后,包括主要心血管不良事件(MACE)、靶病变血运重建(TLR)、靶血管血运重建(TVR)、支架内血栓形成和心肌梗死的发生情况。结果共纳入文献11篇(3780例),随访时间从6个月至3年。与BMS相比,DES可减少MACE(OR=0.471,95%CI0.336～0.662,P<0.001)、减少TVR(OR=0.250,95% CI0.148～0.422,P<0.001),但支架内血栓形成在两组间差异无统计学意义。而SES与PES相比,在MACE、TLR、TVR、支架内血栓、心肌梗死方面差异均无统计学意义。结论药物洗脱支架有效性、安全性高,药物支架中,西罗莫司支架和紫杉醇支架差异无统计学意义。     

Final 5-Year Follow-Up of a Randomized Controlled Trial of Everolimus- and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice: The COMPARE Trial (A Trial of Everolimus-Eluting Stents and Paclitaxel Stents for Coronary Revascularization in Daily Practice)

ObjectivesThis study sought to report the 5-year outcomes of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in an all-comers population undergoing percutaneous coronary intervention (PCI).BackgroundThe medium-term 1 and 2-year results of the prospective randomized COMPARE trial (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) showed superior clinical outcomes with EES compared with PES in an all-comers PCI population. Whether this benefit is sustained over longer-term follow-up is unknown. Furthermore, systematic long-term follow-up data on these metallic drug eluting stents with durable polymers are scarce.MethodsWe randomly assigned 1,800 patients undergoing PCI to EES or PES. The pre-specified composite primary endpoint was death, myocardial infarction (MI), or target vessel revascularization (TVR).ResultsFollow-up at 5 years was completed in 1,791 (99.5%) patients. Treatment with EES compared with PES led to a relative risk reduction of the primary endpoint by 27% (18.4% vs. 25.1%, p = 0.0005), driven by lower rates of MI (7.0% vs. 11.5%, p = 0.001) and TVR (7.4% vs. 11.4%, p = 0.003), but not with mortality (9.0% vs. 10.3%, relative risk 0.88, p = 0.36). Moreover, patients treated with EES compared with PES had lower rates of definite/probable stent thrombosis at 5 years (3.1% vs. 5.9%, p = 0.005). The hazard curves for TVR, MI, and stent thrombosis diverge over the first 3 years and, subsequently, progress in parallel.ConclusionsThe early- and medium-term superiority of EES over PES measured both by safety and efficacy endpoints is sustained at 5 years in this all-comer population. (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice [COMPARE]; NCT01016041)     

Long-term outcome of the unrestricted use of everolimus-eluting stents compared to sirolimus-eluting stents and paclitaxel-eluting stents in diabetic patients: The Bern–Rotterdam diabetes cohort study

Background

Newer generation everolimus-eluting stents (EES) improve clinical outcome compared to early generation sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES). We investigated whether the advantage in safety and efficacy also holds among the high-risk population of diabetic patients during long-term follow-up.

Methods

Between 2002 and 2009, a total of 1963 consecutive diabetic patients treated with the unrestricted use of EES (n = 804), SES (n = 612) and PES (n = 547) were followed throughout three years for the occurrence of cardiac events at two academic institutions. The primary end point was the occurrence of definite stent thrombosis.

Results

The primary outcome occurred in 1.0% of EES, 3.7% of SES and 3.8% of PES treated patients ([EES vs. SES] adjusted HR = 0.58, 95% CI 0.39–0.88; [EES vs. PES] adjusted HR = 0.29, 95% CI 0.13–0.67). Similarly, patients treated with EES had a lower risk of target-lesion revascularization (TLR) compared to patients treated with SES and PES ([EES vs. SES], 5.6% vs. 11.5%, adjusted HR = 0.68, 95% CI: 0.55–0.83; [EES vs. PES], 5.6% vs. 11.3%, adjusted HR = 0.51, 95% CI: 0.33–0.77). There were no differences in other safety end points, such as all-cause mortality, cardiac mortality, myocardial infarction (MI) and MACE.

Conclusion

In diabetic patients, the unrestricted use of EES appears to be associated with improved outcomes, specifically a significant decrease in the need for TLR and ST compared to early generation SES and PES throughout 3-year follow-up.     

Angiographic results of the first human experience with everolimus-eluting stents for the treatment of coronary lesions (the FUTURE I trial)

The purpose of this study was to report the angiographic findings of the first human evaluation of the everolimus-eluting stent (EES) for the treatment of noncomplex coronary lesions. Forty-two patients with de novo coronary lesions (2.75 to 4.00 mm vessels; lesion length, <18 mm) were prospectively randomized in a 2:1 ratio to receive either the EES (n = 27) or a metallic stent (n = 15). Baseline clinical and angiographic characteristics were similar among both groups. At 6-month follow-up, EES had a lower in-stent late lumen loss (0.10 +/- 0.22 vs 0.85 +/- 0.32 mm, p <0.0001) and in-segment diameter stenoses (20.7 +/- 12.3% vs 37.0 +/- 15.8%, p = 0.002). There was no in-stent restenosis with EES; however, 1 focal distal edge restenosis was present. There was 1 in-stent and 1 in-segment (proximal edge) restenosis in the metallic stent group. There was no stent thrombosis or aneurysm formation at follow-up in either group.     

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.     

Clinical and angiographic outcomes with an everolimus‐eluting stent in large coronary arteries: The SPIRIT III 4.0 mm registry

Objective : This study evaluates the safety and efficacy of the XIENCE V® 4.0 mm stent for the treatment of de novo native coronary artery lesions. Background : In the SPIRIT III trial, the XIENCE V® everolimus‐eluting stent (EES), compared with the TAXUS EXPRESS² paclitaxel‐eluting stent (PES) in 2.5–3.75 mm diameter coronary arteries, resulted in reduced angiographic late loss (LL), noninferior rates of target vessel failure (TVF), and fewer major adverse cardiac events (MACE). Methods : The SPIRIT III 4.0 mm registry was a concurrent arm of the SPIRIT III trial consisting of 69 nonrandomized patients with lesions ≤28 mm in length and reference vessel diameter 3.75–4.25 mm treated with a 4.0 mm EES. The primary endpoint was 8‐month in‐segment LL compared with the randomized PES arm. Results : In‐segment LL was 0.17 ± 0.38 mm in the 4.0 mm EES registry compared with 0.28 ± 0.48 mm in the PES arm (P < 0.0001 for noninferiority). The 1‐year rates of ischemia‐driven TVF (cardiac death, myocardial infarction [MI], or target vessel revascularization) and MACE (cardiac death, MI, or target lesion revascularization [TLR]) were numerically, but not statistically, lower in the 4.0 mm EES patients compared with the randomized PES patients (5.9 vs. 11.3%, P = 0.27 and 5.9 vs. 10.3%, P = 0.36, respectively). There was no difference in 8‐month LL or 1‐year TVF or MACE between the 4.0 mm EES and randomized EES patients. Conclusions : In large coronary arteries, the 4.0 mm EES results in low rates of LL at 8 months and adverse clinical events at 1 year. © 2009 Wiley‐Liss, Inc.     

Characterization of plaque prolapse after drug-eluting stent implantation in diabetic patients: a three-dimensional volumetric intravascular ultrasound outcome study.

OBJECTIVES: The aim of this research was to evaluate the plaque prolapse (PP) phenomenon after bare-metal (BMS) and drug-eluting stent (DES) implantation in patients with diabetes mellitus using 3-dimensional volumetric intravascular ultrasound (IVUS). BACKGROUND: Plaque prolapse has been observed in up to 22% of patients treated with BMS. Diabetic patients have a larger atherothrombotic burden and may be more prone to have PP. However, the incidence of PP and its clinical impact after DES implantation is unknown. METHODS: Three-dimensional IVUS was performed after intervention and at 9-month follow-up in 168 patients with diabetes (205 lesions) treated with bare BX Velocity stents ((BX Velocity/Sonic, Cordis, Johnson & Johnson) (BMS, n = 65), sirolimus-eluting stents (Cypher, Cordis) (SES, n = 69), and paclitaxel-eluting stents (Taxus, Boston Scientific, Natick, Massachusetts) (PES, n = 71). Intravascular ultrasound data at the sites of PP were compared with stented segments without PP in each lesion. Outcomes were evaluated at 9- and 12-month follow-up. RESULTS: There were 42 sites of PP (BMS = 11, SES = 11, PES = 20, p = NS) in 34 stented segments of 205 (16.6%) lesions. Plaque prolapse was more frequent in the right coronary artery and in chronic total occlusion lesions. Post-procedure PP volume was 1.95 mm3 in BMS, 2.96 mm3 in SES, and 4.53 mm3 in PES. At follow-up, tissue volume increased at PP sites in both BMS and PES, but not after SES. Neointimal proliferation was similar between PP and non-PP sites. Stent thrombosis and restenosis rates were similar between PP and non-PP lesions. CONCLUSIONS: The incidence of PP after implantation of new generation tubular stents in patients with diabetes remains high. Drug-eluting stent implantation was not associated with increased risk of PP. Plaque prolapse was not associated with stent thrombosis or increased neointimal proliferation.     

Comparison of Clinical Results Following the Use of Drug‐Eluting Balloons for a Bare‐Metal Stent and Drug‐Eluting Stent Instent Restenosis

Background

Drug‐eluting balloons (DEBs) have emerged as a potential alternative to current treatments of instent restenosis (ISR). The study aims to investigate the clinical outcomes of a DEB angioplasty to treat bare‐metal stent (BMS) ISR and drug‐eluting stent (DES) ISR at 1‐year clinical follow‐up period.

Methods

Between November 2011 and December 2014, 312 patients were diagnosed with coronary artery ISR at our hospital. A total of 426 coronary ISR lesions were treated with DEBs. The clinical outcomes, including target lesion revascularization (TLR), myocardial infarction, stroke, cardiovascular mortality, and all‐cause mortality were compared between the BMS‐ISR group and DES‐ISR group. Propensity score matched analysis was used to minimize bias.

Results

The average age of the patients was 64.99 ± 10.35 years, and 76.9% of the patients were male. After multivariate Cox regression analyses about 1‐year recurrent restenosis in DES‐ISR group, only end stage renal disease (ESRD) (P = 0.047) and previous DEB failure (P < 0.001) were identified with significant difference. After propensity score matched analysis, the bias of baseline characteristics showed no significant difference. The DES‐ISR group experienced more myocardial infarctions (2.8% vs 8.3%, P = 0.075), more TLR (8.1% vs 15.4%, P = 0.051), especially at nonostial lesion (5.7% vs 14.9%, P = 0.030) than the BMS‐ISR group. Higher incidence of major cardiac cerebral adverse events happened in the DES‐ISR group. (11.7% vs 22.1 %, P = 0.038)

Conclusion

During the 1‐year follow‐up period, DEBs angioplasty for BMS‐ISR had better clinical outcomes and less TLR than DES‐ISR. ESRD and previous DEB failure were associated to TLR in DES‐ISR group.