Objectives The aim of this study was to assess, after 2 years of follow-up, the safety, efficacy, and cost-effectiveness of a zotarolimus-eluting stent (ZES) compared with a paclitaxel-eluting stent ...(PES) in patients with native coronary lesions. Background Early drug-eluting stents were associated with a small but significant incidence of very late stent thrombosis (VLST), occurring >1 year after the index procedure. The ZES has shown encouraging results in clinical trials. Methods The ENDEAVOR IV trial (Randomized, Controlled Trial of the Medtronic Endeavor Drug ABT-578 Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions), a randomized (1:1), single-blind, controlled trial (n = 1,548) compared ZES versus PES in patients with single de novo coronary lesions. Two-year follow-up was obtained in 96.0% of ZES and 95.4% of PES patients. The primary end point was target vessel failure (TVF), and safety end points included Academic Research Consortium-defined stent thrombosis. Economic end points analyzed included quality-adjusted survival, medical costs, and relative cost-effectiveness of ZES and PES. Results The TVF at 2 years was similar in ZES and PES patients (11.1% vs. 13.1%, p = 0.232). There were fewer myocardial infarctions (MIs) in ZES patients (p = 0.022), due to fewer periprocedural non–Q-wave MIs and fewer late MIs between 1 and 2 years. Late MIs were associated with increased VLST (PES: 6 vs. ZES: 1; p = 0.069). Target lesion revascularization was similar comparing ZES with PES (5.9% vs. 4.6%; p = 0.295), especially in patients without planned angiographic follow-up (5.2% vs. 4.9%; p = 0.896). The cost-effectiveness of ZES and PES was similar. Conclusions After 2 years of follow-up, ZES demonstrated efficacy and cost-effectiveness comparable to PES, with fewer MIs and a trend toward less VLST. (The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions; NCT00217269 )
With use of endovascular targets of known length, IVUS lesion length measurements have been validated in vivo. Intravascular ultrasound imaging using motorized pullback of the transducer and imaging ...core through a stationary imaging sheath may prove to be a useful clinical and experimental adjunct to conventional cross-sectional image analysis.
Abstract Treatment for severe symptomatic aortic stenosis has changed significantly in recent years due to advances in transcatheter aortic valve replacement (TAVR). Recent studies with the CoreValve ...prosthesis have demonstrated superior results as compared to surgical aortic valve replacement in patients at increased risk for surgery, but there are limited data on gender-related differences in patient characteristics and outcomes with this device. We compared baseline characteristics and clinical outcomes in women and men undergoing TAVR with the CoreValve prosthesis. A total of 3687 patients (1708 women, 1979 men) were included. At baseline women tended to be slightly older and to have increased frailty, but they had fewer cardiac comorbidities, higher left ventricular systolic function, less coronary artery disease, and fewer prior strokes. All-cause mortality was 5.9% for women and 5.8% for men at 30 days (P=0.87) and 24.1% and 21.3%, respectively, at 1 year (P=0.08). The incidence of stroke was 5.7% among women and 4.0% among men at 30 days (P=0.02) and 9.3% and 7.7%, respectively, at 1 year (P=0.05). Women had a higher incidence of bleeding, including more life-threatening bleeds, as well as a greater incidence of major vascular complications than men at 30 days. Device success was achieved in 86.9% of women and 86.1% of men (P=0.50). In conclusion, although there were significant baseline differences and procedure-related complications between women and men undergoing TAVR with the CoreValve prosthesis, this analysis found no significant difference in 30-day or 1-year mortality.
The influence of vessel size on clinical and angiographic outcomes after new device angioplasty has not been well documented. We reviewed clinical and angiographic outcomes of 2,044 patients ...undergoing new device angioplasty of native vessels enrolled in the New Approaches to Coronary Interventions (NACI) Registry. Quantitative angiography was performed using standard methods. Patients were divided into 3 groups according to reference vessel diameter (RVD) (<2.75, 2.75 to 3.25, and >3.25 mm). Patients with the smallest vessels had a higher incidence of diabetes (26% vs 16%, p <0.01), multivessel disease (50% vs 45%, p <0.01), left anterior descending coronary artery disease (61% vs 39% p <0.01), and in general, more severe baseline lesion characteristics than patients with larger (>3.25 mm) vessels. Absolute baseline and final minimal lumen diameter (MLD) was also smaller in patients with RVD <2.75 mm despite similar final percent diameter stenosis. Although in-hospital events were similar, patients who underwent interventions in vessels <2.75 mm had an increased incidence of death (p <0.01), surgical revascularization (p <0.05), and target lesion revascularization (TLR) (p <0.01) at 1 year. Multivariate analysis by vessel size showed a stepwise increase in the risk of TLR by 1 year in patients with the smaller RVD (p = 0.0001) and the combined end point of 1 year death/Q wave-myocardial infarction/TLR (p = 0.02). Thus, despite similar early clinical events among patients undergoing new device angioplasty, patients who underwent treatment of smaller vessels had a significantly increased risk of major adverse clinical events and particularly TLR by 1 year after new device angioplasty of native coronary arteries.
To identify luminal dimension changes occurring within the stent alone and within the stent + margin segment, we reviewed the quantitative angiographic results obtained from the Scripps Coronary ...Radiation to Inhibit Proliferation Post Stenting (SCRIPPS) trial, a prospective randomized trial assessing the effect of iridium-192 (Ir-192) on the prevention of stent restenosis. Fifty-five patients were randomly assigned to receive Ir-192 or placebo sources after successful intervention. Procedural and 6-month follow-up cineangiograms were quantitatively reviewed in 52 patients to identify changes within the stent and the stent + margin segment. The percent diameter stenosis was lower within the stent than within the stent + margin segment after the procedure (6 ± 22% vs 21± 15%, p <0.0001) and at follow-up (28 ± 29% vs 42 ± 21%, p <0.0001). As a result, a lower restenosis rate was found within the stent than within the stent + margin (25% vs 37%, p <0.0001); isolated stent margin restenosis occurred in 11.5% of lesions. Treatment with Ir-192 reduced restenosis within the stent (8% vs 39%; p = 0.010) and within the stent + margin segment (17% vs 54%; p = 0.010); the reduction in restenosis at the margin only (8.3% vs 14.3%, p = 0.503) was not significant. The lowest relative risk for restenosis resulting from Ir-192 occurred within the stent (0.21; 95% confidecne interval CI 0.05 to 0.86) compared with the stent + margin segment (0.31; 95% CI 0.12 to 0.81) or the stent margin (0.58; 95% CI 0.12 to 2.91). In the SCRIPPS trial, 32% of restenosis occurred at the stent margins. Treatment with Ir-192 reduced restenosis primarily within the stent rather than the margin. Whether extending the treatment length to fully include the stent margins will further reduce restenosis requires further study.
To evaluate predictors of restenosis at margins of Palmaz-Schatz stents, intravascular ultrasound studies were performed after intervention and at follow-up (5.4 months) in 161 stented lesions. Of ...301 stent margins, 77 (26%) were restenotic at follow-up (>50% late lumen loss). Intimal hyperplasia was greater for restenotic than for nonrestenotic stents margins. The dominant periprocedural predictor of stent margin restenosis was the plaque burden of the continuous reference segment.
Preintervention intravascular ultrasound (IVUS) imaging was performed in 313 target lesions in 301 patients. Revascularization strategy intended before imaging was compared with the treatment ...actually performed; there was a change in therapy in 124 lesions (40%) in 121 patients (40%). This included: (1) assessment of lesion severity leading to revascularization when none had been planned (n = 20, 6%), (2) avoiding surgery or catheter-based revascularization that had originally been planned (n = 21, 7%), and (3) assessment of lesion composition leading to a change in revascularization strategy (n = 20, 6%) or for selecting the revascularization strategy (n = 63, 20%). Nine of these 121 patients were referred for coronary artery bypass graft surgery. IVUS minimal lumen diameter correlated well with angiography (r = 0.83); however, a disagreement was the reason for deciding to perform or not to perform revascularization in 41 lesions (13%). IVUS assessment of target lesion calcification, eccentricity and unusual morphology were the reasons for changing or selecting specific devices: (1) concentric and eccentric lesions with significant superficial calcium were treated with rotational atherectomy, excimer laser angioplasty or surgery; (2) eccentric lesions that did not contain significant superficial calcium were treated with directional atherectomy; (3) dissections and true aneurysms were treated with stent placement even if calcified; (4) thrombus-containing lesions in vein grafts were treated with thrombolytic therapy or extraction atherectomy, or both; and (5) fibrotic vein graft lesions were treated with balloon angioplasty or stent placement.
Objectives The aim of this study was to examine outcomes related to the use of the Endeavor zotarolimus-eluting stent (ZES) (Medtronic CardioVascular, Santa Rosa, California) compared with the TAXUS ...paclitaxel-eluting stent (PES) (Boston Scientific Corp., Natick, Massachusetts) in the 477 patients with diabetes mellitus (DM) enrolled in the randomized ENDEAVOR IV (Randomized Comparison of Zotarolimus- and Paclitaxel-Eluting Stents in Patients with Coronary Artery Disease) trial. Background Percutaneous coronary intervention (PCI) in diabetic patients is associated with increased rates of restenosis-related end points compared with PCI in nondiabetic patients. Although ZES has been associated with similar clinical efficacy compared with PES in the overall trial population of the ENDEAVOR IV trial, whether these results are maintained in the higher-risk restenosis subgroup of patients with DM has not been determined. Methods Clinical and angiographic outcomes were compared according to randomized treatment assignment to either ZES or PES. Results Baseline characteristics were similar among ZES (n = 241) and PES (n = 236) diabetic patients, with slightly longer lesion lengths in PES-treated patients (12.9 mm vs. 14.0 mm, p = 0.041). Among the 86 DM patients assigned to routine angiographic follow-up (18% of the overall DM cohort), in-stent percent diameter stenosis at 8 months was greater among ZES-treated patients (32.9 vs. 21.1, p = 0.023), with a trend toward higher in-stent late loss. One-year clinical outcomes were similar among DM patients treated with either ZES or PES (target vessel failure: 8.6% vs. 10.8%, p = 0.53; target lesion revascularization: 6.9% vs. 5.8%, p = 0.70; target vessel revascularization: 8.6% vs. 9.4%, p = 0.87). There were no significant interactions between DM status and stent type with respect to the outcomes measured, and the relative efficacy/safety of ZES and PES were similar among insulin- and noninsulin-requiring subgroups. Conclusions One-year clinical outcomes were similar among DM patients treated with ZES and PES in the ENDEAVOR IV trial. These findings parallel the overall trial results, which demonstrated similar efficacy and safety of ZES and PES for single de novo coronary lesions.
The mechanisms of excimer laser coronary angioplasty (ELCA) have never been studied in human coronary arteries in vivo.
ELCA was used to treat 202 lesions in 190 patients. Forty-nine lesions in 48 ...patients were studied by use of sequential (before and after ELCA and after adjunctive device therapy) intravascular ultrasound (IVUS). External elastic membrane (EEM), lumen, and plaque+media (P+M = EEM-lumen) cross-sectional areas (CSAs) and lesion arcs of calcium were measured before and after ELCA and after adjunct device use. Lumen improvement after ELCA (1.4 +/- 0.5 to 2.7 +/- 0.8 mm2) was the result of both tissue ablation (decrease in P+M CSA from 16.8 +/- 7.1 to 15.9 +/- 6.7 mm2, P < .0001) and vessel expansion (increase in EEM CSA from 18.2 +/- 7.1 to 18.6 +/- 6.8 mm2, P = .0245), with no change in calcium. The decrease in P+M CSA was 39% of the CSA of the laser catheter used. Dissections were present in 39% of lesions, 84% within superficial calcium; fibrocalcific deposits developed a "fragmented" appearance.
ELCA increased lumen CSA by both atheroablation and vessel expansion without calcium ablation. Superficial fibrocalcific deposits developed a characteristic fragmented appearance. These findings support both photoablation and forced vessel expansion as mechanisms of lumen enlargement and plaque dissection after ELCA.
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