Long-term outcomes with drug-eluting stents versus bare metal stents in the treatment of saphenous vein graft disease (results from the REgistro Regionale AngiopLastiche Emilia-Romagna registry)

Percutaneous revascularization of saphenous vein grafts (SVGs) remains a challenging task. Drug-eluting stents (DESs) have been shown to decrease the incidence of restenosis in de novo native coronary artery lesions. However, their clinical value in SVGs remains to be established. We compared long-term clinical outcomes of percutaneous coronary intervention with DESs and bare metal stents (BMSs) for de novo lesions in SVGs. In a large prospective, multicenter registry, 360 patients underwent stenting of a de novo lesion in SVGs using BMSs (288 patients) or DESs (72 patients). Incidence of major adverse cardiac events (MACEs), including all-cause mortality, reinfarction, and target vessel revascularization, was recorded at a 12-month follow-up. Compared with the DES group, patients receiving BMSs were more likely to be men, to have chronic renal insufficiency or higher Charlson scores, but less likely to have undergone previous percutaneous coronary intervention. Incidence of MACEs at 12-month follow-up was similar in the 2 groups (17.8% in DES group vs 20.3% in BMS group, respectively, p = 0.460). Cox regression analysis identified age, chronic renal failure, cardiogenic shock at presentation, and ostial location of stenosis as independent predictors of long-term MACEs. In conclusion, our data suggest that rates of 12-month MACEs associated with the use of DESs and BMSs are similar in patients undergoing treatment of de novo lesions in SVGs.     

Comparison of outcomes between bare metal stents and drug-eluting stents for percutaneous revascularization of internal mammary grafts

Drug-eluting stents (DESs) decrease the need for repeat revascularization in native coronary arteries and vein grafts. This study examined the safety and efficacy of DESs for the treatment of lesions in the internal mammary artery (IMA) conduits and compared the outcomes with those from bare metal stents (BMSs). Records of 69 consecutive patients who underwent stenting of the IMA from 2001 to 2004 were reviewed and analyzed. Of these, 30 patients were treated with DESs (sirolimus- or paclitaxel-eluting stents) and 39 patients with BMSs. In-hospital and 6-month clinical outcomes were recorded and compared. Baseline characteristics were comparable between the 2 groups. Lesion location and characteristics were also similar, except for a trend toward longer stent lengths in the DES group (DES 20.2 +/- 7.7 mm vs BMS 14.8 +/- 3.5 mm, p = 0.255). There was no late thrombosis in either group. There were no significant differences in in-hospital and 1- and 6-month outcomes between the 2 groups, including target lesion revascularization with DESs (DESs 3.33% vs BMSs 10%, p = 0.38). In conclusion, DES implantation into IMAs appears safe and is associated with low rates of recurrences. These results may support expansion of use of DESs for the management of IMA stenotic lesions.     

Comparison of drug-eluting versus bare metal stents in cardiac allograft vasculopathy

Although not a definitive treatment, percutaneous coronary intervention offers a palliative benefit to patients with cardiac allograft vasculopathy. Given the superior outcomes with drug-eluting stents (DESs) over bare metal stents (BMSs) in native coronary artery disease, similar improvements might be expected in transplant patients; however, the results have been mixed. Consecutive cardiac transplantation recipients at a single center receiving a stent for de novo cardiac allograft vasculopathy from 1997 to 2009 were retrospectively analyzed according to receipt of a DES versus a BMS. The angiographic and clinical outcomes were subsequently evaluated at 1 year. The baseline clinical and procedural characteristics were similar among those receiving DESs (n = 18) and BMSs (n = 16). Quantitative coronary angiography revealed no difference in the reference diameter, lesion length, or pre-/postprocedural minimal luminal diameter. At the 12-month angiographic follow-up visit, the mean lumen loss was significantly lower in the DES group than in the BMS group (0.19 ± 0.73 mm vs 0.76 ± 0.97 mm, p = 0.02). The DES group also had a lower rate of in-stent restenosis (12.5% vs 33%, p = 0.18), as well as a significantly lower rate of target lesion revascularization (0% vs 19%, p = 0.03). At 1 year, DESs were associated with a lower composite rate of cardiac death and nonfatal myocardial infarction (12% vs 38%, p = 0.04). In conclusion, DESs are safe and effective in the suppression of neointimal hyperplasia after percutaneous coronary intervention for cardiac allograft vasculopathy, resulting in significantly lower rates of late lumen loss and target lesion revascularization, as well as a reduced combined rate of cardiac death and nonfatal myocardial infarction.     

Comparison of effects of drug-eluting stents versus bare metal stents on plasma C-reactive protein levels

After coronary stenting, inflammatory mechanisms play a crucial role in the pathogenesis of neointimal proliferation and in-stent restenosis. Drug-eluting stents (DESs) have been shown to decrease in-stent restenosis in different studies. We compared plasma C-reactive protein (CRP) levels after DES implantation with levels after bare metal stent (BMS) implantation. We performed percutaneous coronary intervention with a single stent in 67 patients (54 men; 59 +/- 9 years of age; n = 21 in the BMS group, n = 46 in the DES group) who had stable angina. Plasma CRP levels were determined before intervention and at 48 hours, 72 hours, and 2 weeks after coronary stenting. There was no difference in clinical and angiographic baseline characteristics except that the DES group had more patients with diabetes (34.8% vs 9.5%, p = 0.04), smaller reference vessels (2.95 +/- 0.53 vs 3.29 +/- 0.53 mm, p = 0.02), and smaller stent diameters (3.0 +/- 0.4 mm vs 3.4 +/- 0.5 mm, p <0.01). Plasma CRP levels at 48 hours (13.4 +/- 14.7 vs 5.9 +/- 4.9 mg/L, p <0.01) and 72 hours (16.7 +/- 19.8 vs 5.4 +/- 3.9 mg/L, p <0.01) after stent implantation were significantly higher in the BMS than in the DES group. In conclusion, DESs showed significantly lower plasma CRP levels after coronary stenting compared with BMSs. This may reflect the potent effects of DESs on acute inflammatory reactions induced by coronary intervention.     

Comparison of incidence and time course of neoatherosclerosis between bare metal stents and drug-eluting stents using optical coherence tomography

Recent studies have reported the development of neoatherosclerosis inside stents and subsequent acute coronary syndrome secondary to disruption of neointimal hyperplasia. The aim of the study was to compare the characteristics of neointimal hyperplasia and its time course between bare metal stents (BMSs) and drug-eluting stents (DESs) using optical coherence tomography. A total of 138 stents were divided into 3 groups according to the follow-up period: early phase, <9 months (25 BMSs and 27 DESs); intermediate phase, ≥9 and <48 months (18 BMSs and 43 DESs); and delayed phase, ≥48 months (13 BMSs and 12 DESs). Optical coherence tomographic analysis included the presence of lipid-laden intima, percentage of lipid-rich plaque, and signal attenuation. The optical coherence tomographic findings were compared between the BMSs and DESs in each period, and the difference between the periods was also determined. In the early phase, a greater incidence of lipid-laden plaque (37% vs 8%, p = 0.02) and a greater percentage of lipid-rich plaque (12.9 ± 25.1% vs 1.2 ± 4.3%, p = 0.01) were found in the DESs than in the BMSs. In the intermediate phase, the DES group continuously showed a significantly greater incidence of lipid-laden plaque (63% vs 28%, p = 0.03) and greater percentage of lipid-rich plaque (24.8 ± 28.1% vs 4.1 ± 7.3%, p <0.01). In addition, signal attenuation was greater in the DES group, suggesting early changes in neointimal hyperplasia properties. In the delayed phase, lipid-laden plaque was the predominant type in both groups. In conclusion, lipid-rich neoatherosclerosis develops inside stents earlier in DESs than in BMSs. After 48 months, most restenotic stents will have developed lipid-laden neointima in both groups.     

Comparison of drug-eluting versus bare metal stents on later frequency of acute myocardial infarction and death

In clinical trials of highly selected patients, drug-eluting stents (DESs) decreased restenosis but not the rate of acute myocardial infarction (AMI) or death. Whether DES use has an affect on the rate of AMI or death in unselected patients is uncertain. Bare metal stents (BMSs) were placed in 1,164 consecutive patients in the year before the introduction of DESs. DESs were subsequently placed in 1,285 consecutive comparable patients at Wake Forest Baptist Medical Center. Early and late clinical outcomes were compared. Propensity score analysis was used to adjust outcomes for baseline differences. Patient and procedural characteristics of the 2 groups were similar, with an overall incidence of 72% for acute coronary syndromes (p = NS). At 9 months, target vessel revascularization (2.8% vs 8.6%, p <0.001), AMI (3.7% vs 4.7%, p = 0.257), and death (4.9% vs 7.1%, p = 0.030) were lower in the DES group than in the BMS group. Propensity score-adjusted Cox proportional hazard ratios for DES versus BMS at 9 months were 0.71 (95% confidence interval 0.42 to 1.19) for AMI, 0.56 (95% confidence interval 0.36 to 0.87) for death, and 0.60 (95% confidence interval 0.42 to 0.86) for the combined end point of AMI or death. In conclusion, in this single-center observational study, use of DESs in consecutive unselected patients, most of whom would not have been eligible for inclusion in the randomized trials of DES versus BMS, was associated with lower AMI and death rates than in a comparable group of patients treated with BMSs in mid-term (9-month) follow-up.     

Effectiveness of sirolimus-eluting stent implantation for the treatment of ostial left anterior descending artery stenosis with intravascular ultrasound guidance

OBJECTIVES: This study was designed to evaluate the clinical and angiographic outcomes of sirolimus-eluting stent (SES) implantation for ostial left anterior descending (LAD) lesions compared with bare-metal stent (BMS) implantation. BACKGROUND: The effectiveness of SES implantation for ostial LAD lesions is currently unknown. METHODS: Sirolimus-eluting stents were implanted in 68 consecutive patients with ostial LAD stenoses. The control group was composed of 77 patients treated with BMS during the preceding two years. In the SES group, for complete lesion coverage, stent positioning was intentionally extended into the distal left main coronary artery (LMCA) in 23 patients (34%) with intermediate LMCA narrowing. RESULTS: Compared with the BMS group, the SES group had more multivessel involvement, received fewer debulking atherectomies, underwent more direct stenting, had a greater number of stents, and had more segments stented. The procedural success rate was 100% in both groups. The six-month angiographic restenosis rate was significantly lower in the SES group than in the BMS group (5.1% vs. 32.3%, p < 0.001). During the one-year follow-up period, neither death nor myocardial infarction occurred in either group, but target lesion revascularization was less frequent in the SES group than in the BMS group (0% vs. 17%, p < 0.001). In the SES group, there were no restenoses in cases with LMCA coverage, compared with three restenoses (7.9%) in cases with precise stent positioning (p = NS). CONCLUSIONS: Sirolimus-eluting stent implantation in ostial LAD lesions achieved excellent results regarding restenosis and clinical outcomes compared with BMS implantation. This finding may be associated with reduced neointimal hyperplasia and complete lesion coverage.     

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.     

Frequency of coronary arterial late angiographic stent thrombosis (LAST) in the first six months: outcomes with drug-eluting stents versus bare metal stents

Concerns have been raised about the long-term safety of drug-eluting stent (DES) implantation due to late angiographic stent thrombosis (LAST). We investigated the incidence and 6-month clinical and angiographic outcomes of LAST after DES versus bare metal stent (BMS) implantation. This study comprised 6,551 patients treated with BMSs (n = 4,104) or DESs (n = 2,447). LAST was defined as angiographically proved stent thrombotic occlusion with acute ischemic symptoms >30 days after stenting. Major adverse cardiac events were defined as death, Q-wave myocardial infarction, and target lesion revascularization. Patients treated with DESs had a significantly higher risk profile than did patients treated with BMSs. There were 8 cases (0.33%) of LAST in the DES group and 7 (0.17%) in the BMS group, showing similar event rates after risk adjustment (adjusted hazard ratio 1.2, 95% confidence interval 0.1 to 18.4, p = 0.9). Four patients with LAST treated with DESs (50%) and 1 treated with BMSs (14%) were associated with discontinuation of antiplatelet therapy. Two cases (25%) of LAST with DESs occurred in patients on aspirin monotherapy and another 2 cases (25%) occurred in patients on dual antiplatelet therapy. There was no case of in-hospital death associated with LAST events. At 6-month follow-up after LAST events, major adverse cardiac events occurred in only 3 patients (43%) in the BMS group. In conclusion, the incidence of LAST was similar after DES and BMS implantations. LAST treated with DESs was associated with antiplatelet therapy discontinuation in a significant number of patients, and LAST events also developed on dual antiplatelet therapy. Patients with LAST and DESs showed favorable outcomes during follow-up.     

Rates of stent thrombosis in bare-metal versus drug-eluting stents (from a large Australian multicenter registry)

Recent reports suggest that drug-eluting stents (DESs) may increase the risk of stent thrombosis (ST) relative to bare-metal stents (BMSs). Therefore, the aim of this study was to compare DES and BMS outcomes with a specific focus on ST. We analyzed 30-day and 1-year outcomes of 2,919 patients who underwent percutaneous coronary intervention with stent implantation from the Melbourne Interventional Group registry. Academic Research Consortium definitions of ST were used: (1) definite ST (confirmed using angiography in patients with an acute coronary syndrome), (2) probable ST (unexplained death <30 days or target-vessel myocardial infarction without angiographic confirmation), and (3) possible ST (unexplained death >30 days). Multivariate analysis was performed to identify predictors of ST. The incidence of ST (early or late) was similar between BMSs and DESs (1.6% vs 1.4%; p=0.66), and DES use was not predictive of ST. Independent predictors of ST included the absence of clopidogrel therapy at 30 days (odds ratio [OR] 2.58, 95% confidence interval [CI] 1.29 to 5.29, p<0.01), renal failure (OR 3.30, 95% CI 1.43 to 7.59, p<0.01), index procedure presentation with an acute coronary syndrome (OR 2.59, 95% CI 1.14 to 5.87, p=0.02), diabetes mellitus (OR 2.25, 95% CI 1.19 to 4.23, p=0.01), and total stent length >or=20 mm (OR 1.85, 95% CI 1.00 to 3.42, p=0.04). In conclusion, DESs were not associated with increased risk of ST compared with BMSs at 12 months in this large Australian registry that selectively used DESs for patients at high risk of restenosis.     

Gender-based outcomes in percutaneous coronary intervention with drug-eluting stents (from the National Heart, Lung, and Blood Institute Dynamic Registry)

Gender-based outcomes have not been evaluated in unselected patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DESs). We investigated whether gender influences the relative safety and efficacy of DESs compared with bare metal stents (BMSs) in routine clinical practice. Using the National Heart, Lung, and Blood Institute Dynamic Registry, in-hospital and 1-year outcomes were stratified by gender in patients who received > or =1 DES (486 women, 974 men) or BMS (631 women, 1,132 men). There were significant baseline differences by gender, including older age and a higher prevalence of co-morbidities in women and more previous coronary artery disease in men. There were no gender-related differences in in-hospital myocardial infarction, coronary artery bypass grafting, and death in those treated with BMSs or DESs. Antiplatelet use and stent thrombosis (1.3% of women vs 1.2% of men, p = 0.85) were similar at 1 year with DESs. At 1 year, patients with DESs had a lower rate of repeat PCI (14.1% in women vs 9.5%, p = 0.02; 12.0% in men vs 8.8%, p = 0.02). Adjusted 1-year outcomes in patients with BMSs and DESs, including death and myocardial infarction, were independent of gender. Use of DESs was the only factor, other than age, that conferred a lower risk for the need for repeat PCI in women (relative risk 0.61, 95% confidence interval 0.41 to 0.89, p = 0.01) and men (relative risk 0.68, 95% confidence interval 0.51 to 0.91, p = 0.001). In conclusion, the widespread use of DESs is safe and has decreased clinically driven revascularization compared with BMSs equally in women and men.     

药物洗脱支架与切割球囊预扩张后置入金属裸支架治疗前降支开口病变的近、远期临床疗效比较

目的 探讨药物洗脱支架(DES)治疗前降支开口病变的近、远期临床疗效,并与早期应用切割球囊预扩张后(CBA)置入金属裸支架(BMS)的近、远期临床疗效进行比较.方法 自2003年11月至2005年5月采用DES对51例连续前降支开口病变的患者进行介入治疗,选自2000年5月至2003年11月应用CBA+BMS治疗前降支开口病变的连续50例患者作为对照组,要求所有患者在介入治疗后6～8个月进行冠状动脉造影复查,DES组与CBA+BMS组患者分别完成了2年和4年的临床随访.结果 在DES组中1例于住院期间发生急性心肌梗死,住院期间主要不良心脏事件(MACE)发生率为1.96%(1/51),29例完成了6～8个月的冠状动脉造影复查,再狭窄发生率为10.3%(3/29).在2年临床随访中1例死亡,靶病变重建4例,MACE发生率为9.8%(5/51).在CBA+BMS组中住院期间无心脏事件,28例完成了6～8个月的冠状动脉造影复查,再狭窄发生率为17.9%(5/28).2年临床随访中1例死亡,行靶病变重建5例,MACE发生率为12%(6/50).结论 在2年的临床随访中,支架内再狭窄、MACE发生率两组比较差异均无统计学意义,研究结果 提示无论是采用DES还是CBA+BMS治疗前降支开口病变均有良好的近、远期疗效.     

Real-world bare metal stenting: identification of patients at low or very low risk of 9-month coronary revascularization.

The high cost of drug-eluting stents (DESs) has made identification of patients who are at low risk for subsequent revascularization after treatment with bare metal stents (BMSs) highly desirable. Previous reports from randomized trials suffer from biases induced by restricted entry criteria and protocol-mandated angiographic follow-up. Between 1994 and 2001, 5,239 consecutive BMS patients, excluding those with coil stents, technical failure, brachytherapy, staged procedure, or stent thrombosis within 30 days, were prospectively identified from a large single-center tertiary-referral-center prospective registry for long-term follow-up. We sought to identify characteristics of patients with very low (< or = 4%) or low (4-10%) likelihood of coronary revascularization 9 months after BMS. Nine-month clinical follow-up was obtained in 98.2% of patients. Coronary revascularization was required in 13.4% and did not differ significantly by stent type. On the basis of multivariate analysis identifying 11 independent correlates and previous reports, 20 potential low-risk patient and lesion groups (228 +/- 356 patients/groups) were identified (e.g, patients with all of the following: native vessel, de novo, reference diameter > or = 3.5 mm, lesion length < 5 mm, no diabetes, not ostial in location). Actual and model-based outcomes were analyzed. No group had both predicted and observed 9-month revascularization < or = 4% (very low risk). Conversely, 19 of 20 groups had a predicted and observed revascularization rate of 4-10% (low risk). In the real-world setting, the need for intermediate-term revascularization after BMS may be lower than expected, but it may be very difficult to identify patients at very low risk. Conversely, if the benefits of DESs are attenuated in routine practice, many groups of patients treated with BMSs may have nearly comparable results.     

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 effectiveness of bare metal stents versus drug-eluting stents in large (> or =3.5 mm) coronary arteries

Drug-eluting stents (DESs) are superior to bare metal stents (BMSs) in decreasing restenosis rates across a wide range of patient and lesion subsets. However, widespread utilization of DESs raises concerns with regard to risks of prolonged dual antiplatelet therapy, the potential for late adverse events such as late thrombosis, and cost. Vessel diameter and lesion length have been previously identified as predictors for restenosis for DESs and BMSs. This study compared the clinical outcomes of DESs versus BMSs in large coronary arteries (> or =3.5 mm). A cohort of 233 patients who underwent single-vessel angioplasty with DES implantation in large vessels was compared with 233 propensity-matched patients who received BMSs in vessels with similar reference vessel diameters. Clinical outcomes at 30 days, 6 months, and 1 year were compared between groups. Baseline clinical and procedural characteristics were similar. Target lesion revascularization and target vessel revascularization rates and the incidence of major adverse cardiac events were low and comparable between the 2 groups at all follow-up intervals. At 1 year, the primary outcome occurred in 8.5% of patients with DESs and 7.7% of patients with BMSs (p = 0.80). There were no episodes of subacute stent thrombosis or late thrombosis in either group. In conclusion, implantation of DESs in large coronary arteries confers no additional benefit compared with BMSs, and the 2 approaches are associated with equally favorable clinical outcomes at 1 year.     

Outcome of overlapping heterogenous drug-eluting stents and of overlapping drug-eluting and bare metal stents

Overlapping homogenous drug-eluting stents (DESs) may be used instead of overlapping bare metal stents (BMSs) to treat coronary lesions longer than available stents. Yet, no data are available on patients treated with overlapping heterogenous DESs or DESs and BMSs. We prospectively assessed 9-month clinical outcome and 6-month angiographic late loss (evaluated at 5 different lesion segments) in a consecutive series of 40 patients who received overlapping homogenous DESs (sirolimus-eluting stent [SES] or paclitaxel-eluting stent [PES]), heterogenous DESs (SES + PES), or overlapping DESs and BMSs. In 8 patients (7 with angiographic follow-up) with overlapping heterogenous DESs, no angiographic or clinical adverse event was observed. Moreover, in-segment late loss was similar to that of patients who received homogenous DESs. In 8 patients (7 with angiographic follow-up) with overlapping DESs and BMSs, there was a higher incidence of major adverse events (3 repeat percutaneous coronary interventions and 1 death, 50% adverse event rate) and worse in-segment binary restenosis rate compared with patients treated with homogenous or heterogenous DESs (p = 0.02 and 0.012, respectively). Late lumen loss at the site of stent overlap showed significant differences according to type of overlapped stent (1.00 +/- 0.76 mm in DES-BMS overlap, 0.32 +/- 0.55 mm in PES-PES overlap, 0.13 +/- 0.11 in SES-PES overlap, and 0.08 +/- 0.10 mm in SES-SES overlap, p = 0.005). In conclusion, the present study suggests that overlap of DESs and BMSs should be avoided because the antirestenotic effect of DESs is skewed by contiguous BMS implantation. Overlap between SESs and PESs in this very preliminary report was associated with no specific adverse event.     

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.     

Three-year clinical follow-up of the unrestricted use of sirolimus-eluting stents as part of the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) registry

Sirolimus-eluting stents (SESs) have been shown to decrease restenosis compared with bare metal stents (BMSs). Currently, there are limited data on the long-term efficacy of these devices in a real-world patient population. Furthermore, the potential of a late restenotic phenomenon has not yet been excluded. From April to October 2002, 508 consecutive patients with de novo lesions exclusively treated with SESs were enrolled and compared with 450 patients treated with BMSs in the preceding 6 months (control group). Patients in the SES group more frequently had multivessel disease and type C lesions, received more stents, and had more bifurcation stenting. After 3 years, the cumulative incidence of major adverse cardiac events (comprising death, myocardial infarction, and target vessel revascularization) was significantly lower in the SES group compared with the pre-SES group (18.9% vs 24.7%, hazards ratio 0.73, 95% confidence interval 0.56 to 0.96, p = 0.026). The 3-year risk of target lesion revascularization was 7.5% in the SES group versus 12.6% in the pre-SES group (hazards ratio 0.57, 95% confidence interval 0.38 to 0.87, p = 0.01). In conclusion, the unrestricted use of SESs is safe and superior to the use of BMSs. The beneficial effects, reported after 1 and 2 years in reducing major adverse cardiac events, persisted with no evidence of a clinical late restenotic "catch-up" phenomenon.     

Impact of diabetes mellitus on angiographic and clinical outcomes in the drug-eluting stents era

The effect of diabetes mellitus (DM) on angiographic restenosis and clinical outcomes after implantation of drug-eluting stents (DESs) has not been investigated in real-world practice. This study consisted of 226 patients who had DM and 560 patients who did not who underwent DES implantation between February 2003 and December 2003. We retrospectively compared the incidence of 6-month angiographic restenosis and 9-month major adverse cardiac events (MACEs), defined as cardiac death, myocardial infarction, and target lesion revascularization, between patients with and without DM. The 6-month angiographic restenotic rate (10.1% vs 8.2%, p = 0.41) and late loss (0.41 +/- 0.63 vs 0.36 +/- 0.65, p = 0.31) were similar between patients with and without DM. In addition, incidences of MACEs (4.9% vs 4.8%, p = 1.00) and target lesion revascularization (4.4% vs 4.1%, p = 0.84) were similar. Patients who had insulin-dependent DM manifested higher prevalences of restenosis (25.0% vs 8.5%, p = 0.04) and MACEs (17.2% vs 3.1%, p = 0.01) compared with patients who had non-insulin-dependent DM. In conclusion, in this study of real-world patients who underwent DES implantation, patients who had DM had restenotic rates and clinical outcomes that were similar to those in patients who did not have DM.     

Long‐Term Clinical Follow‐Up after Drug‐Eluting Stent Implantation for Bare Metal In‐Stent Restenosis

Objectives

We aimed to evaluate the long‐term safety and efficacy of drug‐eluting stent (DES) implantation in the treatment of diffuse bare metal stent (BMS) restenosis as compared to the treatment of de novo coronary lesions in high restenosis risk patient population.

Background

To date limited long‐term data are available about the treatment of BMS restenosis with DES.

Methods

Five hundred and fourteen consecutive patients who underwent DES implantation between January 2003 and October 2006 at our institute were studied: 201 patients received DES for treatment of BMS restenosis and 313 patients received DES for high restenosis risk de novo lesions. Outcomes were calculated using propensity score adjustment. Mean follow‐up length was 45.6 ± 21.5 months.

Results

The rates of acute coronary syndrome, three‐vessel disease, and diabetes were high in both restenosis and de novo groups: 44.8% versus 46.3%, 20.9% versus 28.7%, and 34.3% versus 38.9%, respectively. The incidence of ischemia‐driven target lesion revascularization (TLR) yielded similar results in the restenosis group and de novo group at 4 years (10.4% vs 12.4%, P = 0.490). All‐cause mortality was lower in the restenosis group at 4 years (7.4% vs 14.7%, P = 0.032); however, the incidence of definite and probable stent thrombosis did not differ (1.9% vs 1.6%, P = 0.708) between the 2 groups.

Conclusions

DESs are safe in the treatment of diffuse BMS restenosis and the rate of additional TLR is acceptable as compared to the use of DES in de novo lesions. (J Interven Cardiol 2013;26:271–277)