Early outcome of treatment of ostial de novo left anterior descending coronary artery lesions with drug-eluting stents

We investigated early and mid-term clinical and angiographic outcomes of patients who had de novo ostial left anterior descending coronary artery (LAD) lesions that were treated with drug-eluting stents (DESs) or bare metal stents (BMSs). We identified 43 consecutive patients who underwent percutaneous intervention for isolated de novo ostial LAD lesions with implantation of DESs and compared them with 43 patients who had similar lesions that were treated with BMSs. All stents were successfully implanted. There were no significant differences with respect to major in-hospital complications between the 2 groups. One patient in the BMS group died during hospitalization. Non-Q-wave myocardial infarction occurred in 2 patients (4.7%) in the DES and in 1 patient (2.3%) in the BMS group. At 9-month follow-up, 3 patients (7%) in the DES group and 11 (25.6%) in the BMS group underwent target lesion revascularization (p = 0.038); major adverse cardiac events were less frequent in the DES than in the BMS group (9.3% vs 32.6%, p = 0.015). Angiographic follow-up was available in 82% of patients in the DES group and 75% of those in the BMS group (p = 0.6) and showed lower binary restenotic rates (5.7% vs 31.3%, p = 0.01) and smaller late loss (0.30 +/- 0.81 vs 1.23 +/- 0.93 mm, p = 0.0001) in the DES group. In conclusion, DES implantation in de novo ostial LAD lesions appears safe and effective and is associated with a significant decrease in restenotic rates compared with historical experience with BMSs.     

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 effectiveness and safety of sirolimus-eluting stents versus bare-metal stents in patients with diabetes mellitus (from the Italian Multicenter Randomized DESSERT Study)

Few studies directly compared drug-eluting stents and bare-metal stents (BMSs) in diabetic patients. DESSERT was an Italian multicenter randomized trial to show the efficacy of sirolimus-eluting stents (SESs) compared with BMSs in de novo lesions of diabetic patients treated with insulin and/or oral antidiabetics for > or =3 months on top of glycoprotein IIb/IIIa inhibitors. The primary end point was in-stent late lumen loss, assessed using centralized quantitative coronary angiography at 8-month follow-up. Centrally adjudicated composite major adverse cardiac events (MACEs) and target-vessel failure (TVF; death, treated vessel-related acute myocardial infarction, and target-vessel revascularization) at 30 days and 9 and 12 months were secondary end points. Seventy-five patients were randomly assigned to an SES (109 lesions), and 75 (109 lesions), to a BMS. The 2 groups were well balanced for clinical, anatomic, and procedural characteristics. In-stent late lumen loss decreased from 0.96 +/- 0.61 mm for BMSs to 0.14 +/- 0.33 for SESs (p <0.001), and in-segment binary restenosis was 38.8% versus 3.6%, respectively (p <0.001). Twelve-month clinical events were significantly lower in the sirolimus group: MACEs 22.1% versus 40% (p = 0.023), target-lesion revascularization 5.9% versus 30% (p <0.001), and TVF 14.7% versus 34.3% (p = 0.008). At multivariate analysis, stent type was confirmed as an independent predictor of in-segment late loss (p <0.001), binary restenosis (p <0.001), 12-month TVF (p = 0.010), and 12-month MACEs (p = 0.037). In conclusion, the randomized DESSERT showed SESs to be safe and effective in decreasing both angiographic parameters of restenosis and incidence of MACEs compared with BMSs in diabetic patients with de novo 1- or 2-vessel coronary stenoses.     

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.     

Meta-analysis of long-term outcomes for drug-eluting stents versus bare-metal stents in primary percutaneous coronary interventions for ST-segment elevation myocardial infarction

The use of drug-eluting stents (DESs) in primary percutaneous coronary intervention (PPCI) has shown early benefit over bare-metal stents (BMSs) in decreasing adverse cardiac events. However, there are concerns regarding the increased risk of late and very late stent thrombosis (ST) after DES use. With the paucity of ST events individual trials may have been underpowered to detect significant differences. We sought to perform a meta-analysis to evaluate the available literature examining the outcomes of DESs and BMSs in PPCI after ≥3 years of follow-up. We analyzed 8 randomized clinical trials (RCTs) and 5 observational studies comparing DESs to BMSs in PPCI. Clinical end-point data were analyzed for RCTs and observational studies separately using random-effect models. RCTs included 5,797 patients in whom first-generation DESs (sirolimus- or paclitaxel-eluting stents) were compared to BMS control arms. Patients receiving DESs had a significantly lower risk of target lesion revascularization (odds ratio [OR] 0.48, confidence interval [CI] 0.37 to 0.61), target vessel revascularization (OR 0.53, CI 0.42 to 0.66), and accordingly major adverse cardiac events (OR 0.69; CI 0.56 to 0.84). Incidence of ST was not different between groups (OR 1.02, CI 0.76 to 1.37). There was no significant difference in mortality (OR 0.88, CI 0.68 to 1.12) or recurrent myocardial infarction (OR 0.97; CI 0.61 to 1.54). Among observational studies (n = 4,650) fewer studies reported on target lesion revascularization and target vessel revascularization, but the trend remained in favor of DESs. A small but statistically significant increase in ST was noted with DES use (OR 1.62, CI 1.18 to 2.21) at ≥3 years of follow up, without evidence of recurrent myocardial infarction. Those receiving DESs had a significantly lower mortality compared to those receiving BMSs (OR, 0.65, 95% CI 0.53 to 0.80, p <0.001). In conclusion, this meta-analysis of RCTs examining the long-term outcomes of first-generation DESs versus BMSs in PPCI, DES use resulted in decreased repeat revascularization with no increase in ST, mortality, or recurrent myocardial infarction.     

Comparison of frequency of major adverse events in patients with atrial fibrillation receiving bare-metal versus drug-eluting stents in their coronary arteries

In patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention with drug-eluting stent (DES) implantation, the available evidence from clinical trial data are inconclusive. We evaluated the safety and efficacy of the use of DESs versus bare-metal stents (BMSs) in a consecutive real-world cohort of patients with AF. Of 8,962 unselected patients with AF seen in our institution from 2000 through 2010, 833 (9%) had undergone percutaneous coronary intervention with stent implantation. BMSs were used for 678 patients (81%) and DESs for 155 (19%). During follow-up (median 688 days, interquartile range 1,114), all bleeding episodes, thromboembolism, and major adverse cardiac events (MACEs; i.e., death, acute myocardial infarction, target lesion revascularization) were recorded. Incidence of MACEs was similar in the 2 groups as was incidence of all-cause mortality. Results remained similar even after adjustment for age and other confounding factors. Factors independently associated with an increased risk of MACEs were older age (hazard ratio 1.024, 95% confidence interval 1.004 to 1.044, p = 0.02), implantation of stent during acute ST-segment elevation myocardial infarction (hazard ratio 1.81, 95% confidence interval 1.10 to 2.99, p = 0.02), and stent diameter (hazard ratio 1.09, 95% confidence interval 1.01 to 1.18, p = 0.03). Implantation of DESs was not significantly associated with a higher risk of major bleeding and we observed a similar ratio of serious events at follow-up after DES compared to BMS implantation. In conclusion, in our cohort, systematic use of DESs does not seem to be justified in most patients with AF because it was not associated with any clear advantage compared to BMSs.     

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.     

Meta-analysis of randomized trials of drug-eluting stents versus bare metal stents in patients with diabetes mellitus

Diabetes mellitus is a major risk factor for restenosis in patients undergoing percutaneous coronary intervention. Randomized controlled trials comparing drug-eluting stents (DESs) with bare metal stents (BMSs) showed a marked decrease in in-stent restenosis and target lesion revascularization with DESs in the total patient population enrolled in the studies, including patients with diabetes. However, it remains unclear whether the antirestenotic benefit of DESs is preserved in the high-risk diabetic subgroup. MEDLINE, EMBASE, ISI Web of Knowledge, Current Contents, International Pharmaceutical Abstracts, and recent Scientific Sessions databases were searched to identify relevant clinical trials comparing DESs with BMSs. A randomized controlled trial was included if it provided outcome data for patients with diabetes for > or =1 of the following: late lumen loss, in-stent restenosis, or target lesion revascularization. Data were combined using fixed-effects models, and standard tests for heterogeneity were performed. Eight studies with 1,520 patients with diabetes were identified that reported > or =1 outcome of interest. Mean late lumen losses (7 studies) were 0.93 mm (95% confidence interval [CI] 0.510 to 1.348) with BMSs and 0.18 mm (95% CI -0.088 to +0.446) with DESs. For patients receiving a DES, this translated into a marked decrease in in-stent restenosis (7 studies, RR 0.14, 95% CI 0.10 to 0.22, p <0.001) and target lesion revascularization (8 studies, RR 0.34, 95% CI 0.26 to 0.45, p <0.001). DES use is associated with a marked decrease in in-stent restenosis and target lesion revascularization in patients with diabetes. In conclusion, the analysis supports the current widespread use of DESs in these high-risk patients.     

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 bare-metal and drug-eluting stents in patients with chronic kidney disease (from the NHLBI Dynamic Registry)

Patients with chronic kidney disease (CKD) have a disproportionate burden of coronary artery disease and commonly undergo revascularization. The role and safety of percutaneous coronary intervention (PCI) using drug-eluting stents (DESs) verses bare-metal stents in patients with CKD not on renal replacement therapy has not been fully evaluated. This study investigated the efficacy and safety of DES in patients with CKD not on renal replacement therapy. Patients were drawn from the National Heart, Lung, and Blood Institute Dynamic Registry and were stratified by renal function based on estimated glomerular filtration rate (GFR). Of the 4,157 participants, 1,108 had CKD ("low GFR" <60 ml/min/1.73 m(2)), whereas 3,049 patients had normal renal function ("normal GFR" ≥60 ml/min/1.73 m(2)). For each stratum of renal function we compared risk of death, myocardial infarction, or repeat revascularization between subjects who received DESs and bare-metal stents at the index procedure. Patients with low GFR had higher 1-year rates of death and myocardial infarction and a decreased rate of repeat revascularization compared to patients with normal GFR. Use of DESs was associated with a decreased need for repeat revascularization in the normal-GFR group (adjusted hazard ratio 0.63, 95% confidence interval 0.50 to 0.79, p <0.001) but not in the low-GFR group (hazard ratio 0.69, 95% confidence interval 0.45 to 1.06, p = 0.09). Risks of death and myocardial infarction were not different between the 2 stents in either patient population. In conclusion, presence of CKD predicted poor outcomes after PCI with high rates of mortality regardless of stent type. The effect of DES in decreasing repeat revascularization appeared to be attenuated in these patients.     

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.     

Review of randomized clinical trials of drug-eluting stents for the prevention of in-stent restenosis

Drug-eluting stents (DESs) have shown significant promise at reducing rates of restenosis and subsequent revascularization compared with bare metal stents (BMSs). The purpose of this report is to provide a systematic review of the randomized clinical trials that have evaluated the efficacy and safety of DESs. A total of 28 randomized clinical trials were identified: 21 comparing a DES (sirolimus, paclitaxel, ABT-578, actinomycin, everolimus, or 7-hexanoyltaxol) with a BMS and 7 comparing a DES with another DES (sirolimus vs paclitaxel). Early sirolimus and polymeric paclitaxel studies in low-risk populations demonstrated marked reductions in restenosis according to angiographic and clinical parameters, compared with BMSs. These promising findings led to the more recent evaluations of DESs in higher risk patients in controlled and head-to-head comparisons. In these subsequent trials, sirolimus and paclitaxel DESs continued to exceed the therapeutic potential of BMSs, with a slight but consistent angiographic advantage being observed with the sirolimus DESs.     

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 long-term outcome of off-pump coronary artery bypass grafting versus drug-eluting stents in triple-vessel coronary artery disease

After the introduction of drug-eluting stents (DESs), percutaneous coronary intervention with DESs has challenged coronary artery bypass grafting as the gold standard for the treatment of 3-vessel coronary artery disease. The purpose of this study was to compare the long-term clinical results between percutaneous coronary intervention with DESs and off-pump coronary artery bypass grafting (OPCAB) in 3-vessel coronary artery disease. Two hundred ninety propensity-score matched patients with 3-vessel coronary artery disease treated by DESs or OPCAB were included. Mean follow-up duration was 58.8 ± 11.5 months (2 to 73) and follow-up rate was 97.9%. Five-year survival rates were 94.8 ± 2.1% in the DES group and 96.5 ± 1.5% in the OPCAB group (p = 0.658). Five-year rates of freedom from major adverse cardiac and cerebrovascular event were 71.6 ± 4.1% in the DES group and 89.6 ± 2.5% in the OPCAB group (p < 0.001). Freedom from nonfatal myocardial infarction and target vessel revascularization rates were the determining factors between the 2 groups (p = 0.018 and p < 0.001, respectively). The OPCAB group showed better clinical outcomes compared to the DES group in 3-vessel coronary artery disease after 5-year follow-up. Freedom from major adverse cardiac and cerebrovascular event rate was significantly higher in the OPCAB group mainly because of the lower incidence of target vessel revascularization and nonfatal myocardial infarction. Longer follow-up with randomization will clarify our present conclusions.     

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.     

Clinical outcomes after heterogeneous overlap stenting with drug-eluting stents and bare-metal stents for de novo coronary artery narrowings

When it is difficult to deliver multiple drug-eluting stents (DES) or when size constraints limit DES implantation, bare-metal stents (BMS) may be implanted contiguous to DES. However, the clinical outcomes after overlapping DES and BMS implantation are not known. From September 2004 to June 2006, 4,872 consecutive patients who underwent percutaneous coronary intervention consented to be enrolled in a prospective registry. Of these patients, 44 (0.9%) with de novo lesions were treated with DES and BMS overlap stenting. All patients were followed to 12 months for the assessment of clinical outcomes. The average implanted stent diameter was 2.68 +/- 0.30 mm for DES and 2.35 +/- 0.38 mm for BMS. Overlapping BMS were implanted distal to DES in all but 1 case. One patient (2.3%) experienced acute stent thrombosis and died 2 days after the procedure. No other patient died or had a myocardial infarction during 12 months. The target vessel revascularization rate at 12 months, however, was 31.8%, mainly driven by diffuse in-stent restenosis in the BMS segments. In conclusion, the incidence of DES and BMS overlap stenting is rare in daily practice, but this procedure is associated with a high rate of target vessel revascularization.     

Comparison of outcomes for patients receiving drug-eluting versus bare metal stents for non-ST-segment elevation myocardial infarction

The outcomes for patients undergoing percutaneous coronary interventions (PCI) with drug-eluting stents (DESs) and bare metal stents (BMSs) have been compared in many studies for patients with ST-segment elevation myocardial infarction. However, little is known about the relative outcomes for patients with non-ST-segment elevation myocardial infarction (NSTEMI). The aim of the present study was to compare the NSTEMI outcomes for PCI with DESs and BMSs. New York's PCI registry was used to propensity-match 4,776 pairs of patients with NSTEMI who had received DESs and BMSs from January 1, 2003 to December 31, 2007. These patients were followed up through December 31, 2008 to test for differences in mortality, target vessel revascularization, and total repeat revascularization. The outcomes were also compared for various patient subsets. At a median follow-up period of 3.68 years, the patients receiving DESs had significantly lower mortality (16.58% vs 14.52%, difference 2.06%, p<0.001), target vessel revascularization (13.08% vs 11.04%, p=0.009), and total repeat revascularization (22.16% vs 18.77%, p<0.001). The patients receiving paclitaxel-eluting and sirolimus-eluting stents both experienced superior outcomes compared to patients receiving BMSs. The patients receiving DESs had significantly lower mortality rates than their propensity-matched counterparts receiving BMSs when they were ≥65 years (difference 2.29%, p=0.01) and male (difference 2.77%, p=0.003). In conclusion, patients with NSTEMI undergoing PCI experienced lower 4-year mortality, target vessel revascularization, and repeat revascularization rates when they had received DESs than when they had received BMSs, and patients who were >65 years old, and men received notable benefits.     

The Cobalt chromium STent with Antiproliferative for Restenosis II (COSTAR II) trial study design: advancing the active-control evaluation of second-generation drug-eluting stents

BACKGROUND: Randomized clinical trials have demonstrated the superiority of drug-eluting stents (DESs) compared with bare-metal stents in reducing the need for revascularization and major adverse cardiac events (MACEs) in low-risk patients with single-vessel lesions. Rapid DES uptake has necessitated shifting the paradigm to active DES-controlled noninferiority study models with most studies using surrogate angiographic measurements to attain adequate statistical power. No previous prospective trial has specifically compared a new DES with an active-control DES in a high-risk patient population using primary clinical end points. OBJECTIVE: COSTAR II is designed to compare use of the investigational Costar stent (Conor MedSystems, Palo Alto, CA) with the Taxus (Boston Scientific, Maple Grove, MN) stent in single- and multivessel percutaneous coronary intervention. The primary end point is the clinical composite of MACE at 8 months supported by consistent results in the evaluation of 8-month MACE rates in the single- and multivessel cohorts and of in-segment late loss in a small angiographic substudy at 9 months. METHODS: A total of 1700 patients, 50% with single-vessel and 50% with multivessel disease, are randomized in a 3:2 ratio to receive either Costar or Taxus stent(s) in this prospective, multicenter, noninferiority study design. Because no prior data were available to determine control multivessel MACE rates, an imputed placebo statistical analysis plan incorporating a variable delta based on actually observed control DES MACE rates will be implemented. The results of COSTAR II will provide information about a novel coronary stent device as well as unique data regarding both control and test DES use in more complex "real-world" patients.