Percutaneous recanalization of chronically occluded coronary arteries: procedural techniques, devices, and results.
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Angioplasty, Balloon, Coronary↗
Biomedical subjects
Martin B Leon
Publications and source records attributed to Martin B Leon.
Vascular response to sirolimus-eluting stents delivered with a nonaggressive implantation technique: comparison of intravascular ultrasound results from the multicenter, randomized E-SIRIUS, and SIRIUS trials.
BACKGROUND: The effectiveness of SES to reduce the risk of restenosis was initially demonstrated in short lesions using stent implantation with routine pre-dilatation and post-dilatation. This intravascular ultrasound (IVUS) substudy of the E-SIRIUS trial sought to evaluate local arterial responses to sirolimus-eluting stents (SES) delivered with a stent implantation technique allowing direct stenting and only selectively applying high-pressure post-dilatation. METHODS AND RESULTS: IVUS was performed immediately after intervention and at 8-month follow-up in 51 patients randomised to either bare-metal stents (BMS; Bx-Velocitytrade mark; N=20) or SES (Cyphertrade mark N=31). Direct stenting was allowed (24%) and post-dilation was performed only selectively (32%). Lumen dimensions, intimal hyperplasia and vessel remodeling were compared between SES and BMS. Subsequently, results of SES in the E-SIRIUS IVUS substudy (N=31) were compared to those of SES in the IVUS substudy of the SIRIUS trial (N=137). SES in SIRIUS IVUS substudy were delivered with 100% pre-dilatation and 77% post-dilatation. Baseline stent and reference segment measurements were similar between BMS and SES in E-SIRIUS IVUS patients. Using SES there was a 96% reduction in intimal hyperplasia volume within the stented segment (1.8+/-4.9 vs 50.6+/-39.7 mm3, P<0.001) and a significantly larger minimal lumen cross sectional area at 8-month follow-up (4.5+/-1.1 vs 2.3+/-0.9 mm2, P<0.001). No vessel remodeling was observed with the use of SES. The applied stent implantation technique resulted in a minimal stent/reference vessel area ratio of 0.75+/-0.17 in E-SIRIUS SES as compared to 0.84+/-0.23 in SIRIUS SES (P=0.046). Mean intimal hyperplasia cross-sectional area at follow-up was 0.1+/-0.2 mm2 in the SES group of E-SIRIUS and 0.5+/-0.8 mm2 in the SES group of SIRIUS (P=0.003). CONCLUSIONS: An implantation technique of SES which includes direct stenting and minimizes the use of high-pressure post-dilatation results in less optimal stent expansion. However, follow-up results compare very favourable to those of BMS and are characterised by even less intimal hyperplasia than after a more forceful implantation of SES.
Aged↗
Impact of moderate renal insufficiency on restenosis and adverse clinical events after paclitaxel-eluting and bare metal stent implantation: results from the TAXUS-IV Trial.
BACKGROUND: Mortality and restenosis may be increased in patients with mild to moderate renal insufficiency (RI) after coronary stent implantation. Whether drug-eluting stents safely reduce restenosis and enhance event-free survival in these patients is unknown. We sought to evaluate the impact of baseline RI on clinical and angiographic outcomes in patients undergoing elective percutaneous coronary intervention using either bare metal or paclitaxel-eluting stents. METHODS: In the TAXUS-IV trial, 1314 patients were randomized to either the polymer-based paclitaxel-eluting TAXUS stent or an identical-appearing bare metal stent. Outcomes were stratified on the basis of the presence of RI, defined as a baseline creatinine clearance < 60 cm3/min calculated by the Cockcroft-Gault formula. RESULTS: Baseline RI was present in 223 (17.2%) patients, in whom the mean creatinine clearance was 49.6 +/- 8.5 cm3/min. Compared with bare metal stents, treatment with the TAXUS stent resulted in lower rates of 9-month angiographic restenosis rates in both patients with (2.1% vs 20.5%, P = .009) and without (9.2% vs 27.8%, P < .0001) baseline RI. Similarly, 1-year target lesion revascularization rates were reduced with the TAXUS stent in patients with (3.3% vs 12.2%, P = .01) and without (4.7% vs 15.8%, P < .0001) baseline RI. The occurrence of death, myocardial infarction, and stent thrombosis at 1 year were similar in both randomization groups, independent of renal function. CONCLUSIONS: The polymer-based paclitaxel-eluting TAXUS stent safely reduces clinical and angiographic restenosis in patients with preserved as well as moderate impairment of baseline renal function.
Aged↗
Low hematocrit predicts contrast-induced nephropathy after percutaneous coronary interventions.
BACKGROUND: The relationship between low hematocrit and contrast-induced nephropathy has not been investigated. METHODS: Of 6,773 consecutive patients treated with percutaneous coronary intervention, contrast-induced nephropathy (an increase of >/=25% or >/=0.5 mg/dL in preprocedure serum creatinine, at 48 hours postprocedure) occurred in 942 (13.9%) patients. RESULTS: Rates of contrast-induced nephropathy steadily increased as baseline hematocrit quintile decreased (from 10.3% in the highest quintile to 23.3% in the lowest quintile) (chi(2) for trend, P < 0.0001). Stratification by baseline estimated glomerular filtration rate (eGFR) and baseline hematocrit showed that the rates of contrast-induced nephropathy were the highest (28.8%) in patients who had the lowest level for both baseline eGFR and hematocrit. Patients with the lowest eGFR but relatively high baseline hematocrit values had remarkably lower rates of contrast-induced nephropathy (15.8%, 12.3%, 17.1%, and 15.4% in 2nd, 3rd, 4th, and 5th quintiles of baseline hematocrit, respectively) (P < 0.0001). The rates of contrast-induced nephropathy increased with increment in change in hematocrit. Patients in the lowest quintile of baseline hematocrit with absolute hematocrit drop >5.9% had almost doubled rates of contrast-induced nephropathy compared with patients with hematocrit change <3.4% (38.1% vs. 18.8%, respectively) (P < 0.0001). By multivariate analysis, lower baseline hematocrit was an independent predictor of contrast-induced nephropathy; each 3% decrease in baseline hematocrit resulted in a significant increase in the odds of contrast-induced nephropathy in patients with and without chronic kidney disease (11% and 23%, respectively). When introduced into the multivariate model instead of baseline hematocrit, change in hematocrit also showed a significant association with contrast-induced nephropathy. CONCLUSION: Lower hematocrit is an important risk factor for contrast-induced nephropathy. Whether correcting the hematocrit prepercutaneous coronary intervention might decrease the rates of contrast-induced nephropathy should be addressed in a prospectively designed trial.
Adult↗
Local application of antisense for prevention of restenosis.
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Angioplasty↗
Evaluation of a novel endoluminal vascular occlusion device in a porcine model: early and late follow-up.
PURPOSE: To evaluate the efficacy of a new vascular occlusion device (VOD) in a preclinical controlled study versus embolization coils. METHODS: The Biomerix VOD was made from a biodurable porous polyurethane matrix in the shape of a cylinder measuring 1.5 cm long by 6.0 mm wide. Thirty-three swine were selected to undergo embolization of a 3 to 5-mm-diameter iliac artery using either a single VOD (27 animals) or sufficient Cook fibered stainless steel coils to achieve angiographic occlusion (6 controls). Test animals were assigned to undergo angiography at 1 week (n=11), 1 month (n=6), 3 months (n=6), or 6 months (n=4). Two control animals were assigned to angiographic follow-up at 1 week, 1 month, and 3 months. Test and control animals were euthanized at each time point to explant occluded vessels for histological analysis. Study endpoints were device utilization, time to occlusion, postdeployment migration, and persistent angiographic occlusion at 7, 30, 90, and 180 days. RESULTS: One VOD was deployed in each test animal, whereas a mean 3.3+/-0.8 coils were needed to achieve angiographic occlusion in the 6 controls (p<0.001). The time to occlusion was significantly shorter with the VOD (1.46+/-0.73 versus 5.83+/-1.60 minutes for the coils; p<0.001). There was no evidence of recanalization or filling defects at the site of VOD deployment, while filling defects were seen in 3 of 6 coil-treated controls. The VOD arm showed superior angiographic occlusion versus coils at the 1-week, 1-month, and 3-month angiographic follow-up time points. Histological evaluation showed that the VOD was equivalent to the embolization coils at the 1-week (n=6) and 1-month (n=6) endpoint (100% luminal occlusion). In the 3-month group (n=6), the VOD showed 95% to 100% luminal occlusion versus 90% to 95% in the control animals. In the 6-month group, VOD showed 85% to 95% occlusion. CONCLUSIONS: The Biomerix VOD appears highly effective and reliable, resulting in significantly faster and longer lasting occlusion compared with fibered stainless steel embolization coils.
Angiography↗
Update on drug-eluting coronary stents.
The introduction of drug-eluting stents (DES) to interventional cardiology practice has resulted in a significant improvement in the long-term efficacy of percutaneous coronary interventions. DES successfully combine mechanical benefits of bare-metal stents and stabilizing the lumen, with direct delivery and the controlled elution of a pharmacologic agent to the injured vessel wall to suppress further neointimal proliferation. The dramatic reduction in restenosis has resulted in the implementation of DES in clinical practice, and has rapidly expanded the whole spectrum of successfully treatable coronary conditions, particularly in high-risk patients and complex lesions. In this review the authors present current data on DES. Currently, two types of DES are available in the USA: sirolimus-eluting stents (SES) CYPHER (Cordis Corp., FL, USA) and paclitaxel-eluting stents (PES) TAXUS (Boston Scientific, MA, USA), and many more are on the way to approval. In addition to sirolimus and paclitaxel, several other drugs have been successfully used in DES. Everolimus and ABT-578 are both analogs of sirolimus that also have immunosuppressive and antiproliferative properties. Another approach in the development of DES is to use drugs that can accelerate re-endothelialization and restore normal endothelial function following vascular injury. Recent advances in vascular gene transfer have also demonstrated potential new treatment modalities for cardiovascular disease, particularly in the treatment of vascular restenosis.
Clinical Trials as Topic↗
Quantitative assessment of angiographic restenosis after sirolimus-eluting stent implantation in native coronary arteries.
BACKGROUND: Sirolimus-eluting stents (SESs) reduce angiographic restenosis in patients with focal, native coronary artery stenoses. This study evaluated the usefulness of SESs in complex native-vessel lesions at high risk for restenosis. METHODS AND RESULTS: Angiographic follow-up at 240 days was obtained in 701 patients with long (15- to 25-mm) lesions in small-diameter (2.5- to 3.5-mm) native vessels who were randomly assigned to treatment with SESs or bare-metal stents (BMSs) in the SIRIUS trial. Quantitative angiographic measurements of minimal lumen diameter and percent diameter stenosis were obtained within the treated segment, within the stent, and within its 5-mm proximal and distal edges. Patients treated with SESs had lower rates of binary (>50% diameter stenosis) angiographic restenosis within the segment (8.9% versus 36.3% with the BMS; P<0.001) and within the stent (3.2% versus 35.4% with the BMS; P<0.001). SESs were associated with significantly less late lumen loss within the treated segment, within the stent, and within its 5-mm proximal and distal edges (all P<0.001). The reduction of restenosis with the SES was consistent in patients at risk for restenosis, including those with small vessels, long lesions, and diabetes mellitus. The frequency of late aneurysms was similar in the 2 groups. CONCLUSIONS: Compared with BMSs, SESs reduced angiographic late lumen loss within the stent and its adjacent 5-mm margins in patients with complex native-vessel lesions.
Aged↗
Nonuniform strut distribution correlates with more neointimal hyperplasia after sirolimus-eluting stent implantation.
BACKGROUND: Little is known about causes of intimal hyperplasia (IH) after sirolimus-eluting stent (SES) implantation. METHODS AND RESULTS: Intravascular ultrasound was performed in 24 lesions with intra-SES restenosis and a comparison group of 25 nonrestenotic SESs. To assess stent strut distribution, the maximum interstrut angle was measured with a protractor centered on the stent, and the visible struts were counted and normalized for the number of stent cells. In SES restenosis patients, minimum lumen site was compared with image slices 2.5, 5.0, 7.5, and 10.0 mm proximal and distal to this site. The minimum lumen site had a smaller IVUS lumen area at follow-up (2.7+/-0.9 versus 6.2+/-1.9 mm2; P<0.01), larger maximum interstrut angle (135+/-39 degrees versus 72+/-23 degrees; P<0.01), larger IH area (3.4+/-1.5 versus 0.6+/-1.1 mm2; P<0.01) and thickness (0.7+/-0.3 versus 0.1+/-0.2 mm; P<0.01) at maximum interstrut angle, and fewer stent struts (4.9+/-1.0 versus 6.0+/-0.5; P<0.01) even when normalized for the number of stent cells (0.78+/-0.15 versus 0.97+/-0.07; P<0.01). Compared with nonrestenotic SES, the restenosis lesions also had a smaller minimal lumen area, larger IH area, thicker IH at maximum interstrut angle, fewer stent struts, and larger maximum interstrut angle. Multivariate analysis identified the number of visualized stent struts normalized for the number of stent cells and maximum interstrut angle as the only independent IVUS predictor of IH cross-sectional area (P<0.01 and P<0.01), minimum lumen area (P<0.01 and P<0.01), and IH thickness (P<0.01 and P<0.01). CONCLUSIONS: The number and distribution of stent struts affect the amount of neointima after SES implantation.
Aged↗
Impact of anemia on outcomes of patients undergoing percutaneous coronary interventions.
Of 6,929 consecutive patients who were treated with percutaneous coronary intervention, 1,708 (24.6%) had anemia according to criteria of the World Health Organization. Compared with patients who did not have anemia, those who did have anemia were older, more frequently women and African-American, had a smaller body mass index, and higher frequencies of cardiovascular risk factors and co-morbid conditions. Patients who had anemia compared with those who did not have anemia had significantly (p <0.0001) higher mortality rates during hospitalization (1.9% vs 0.4%) and at 1 year (12.8% vs 3.5%). After adjustment for potential confounders, baseline hematocrit remained a significant predictor of a 1-year mortality rate (hazard ratio 0.93 per 1% increase in hematocrit, 95% confidence interval 0.91 to 0.95).
Aged↗
Vascular remodeling and plaque composition between focal and diffuse coronary lesions assessed by intravascular ultrasound.
Coronary remodeling and plaque composition were compared between focal and diffuse coronary lesions. Negative remodeling and fibrous and calcified plaque compositions contribute to stenosis development in diffuse lesions more frequently than in focal lesions.
Coronary Artery Disease↗
A simple risk score for prediction of contrast-induced nephropathy after percutaneous coronary intervention: development and initial validation.
OBJECTIVES: We sought to develop a simple risk score of contrast-induced nephropathy (CIN) after percutaneous coronary intervention (PCI). BACKGROUND: Although several risk factors for CIN have been identified, the cumulative risk rendered by their combination is unknown. METHODS: A total of 8,357 patients were randomly assigned to a development and a validation dataset. The baseline clinical and procedural characteristics of the 5,571 patients in the development dataset were considered as candidate univariate predictors of CIN (increase >or=25% and/or >or=0.5 mg/dl in serum creatinine at 48 h after PCI vs. baseline). Multivariate logistic regression was then used to identify independent predictors of CIN with a p value <0.0001. Based on the odds ratio, eight identified variables (hypotension, intra-aortic balloon pump, congestive heart failure, chronic kidney disease, diabetes, age >75 years, anemia, and volume of contrast) were assigned a weighted integer; the sum of the integers was a total risk score for each patient. RESULTS: The overall occurrence of CIN in the development set was 13.1% (range 7.5% to 57.3% for a low [ or=16] risk score, respectively); the rate of CIN increased exponentially with increasing risk score (Cochran Armitage chi-square, p < 0.0001). In the 2,786 patients of the validation dataset, the model demonstrated good discriminative power (c statistic = 0.67); the increasing risk score was again strongly associated with CIN (range 8.4% to 55.9% for a low and high risk score, respectively). CONCLUSIONS: The risk of CIN after PCI can be simply assessed using readily available information. This risk score can be used for both clinical and investigational purposes.
Aged↗
Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: a meta-analysis.
OBJECTIVES: This study was designed to assess the safety of arteriotomy closure devices (ACDs) versus mechanical compression by meta-analysis in patients undergoing percutaneous transfemoral coronary procedures. BACKGROUND: Although ACDs are widely applied for hemostasis after percutaneous endovascular procedures, their safety is controversial. METHODS: Randomized, case-control, and cohort studies comparing access-related complications using ACDs versus mechanical compression were analyzed. The primary end point was the cumulative incidence of vascular complications, including pseudoaneurysm, arteriovenous fistula, retroperitoneal hematoma, femoral artery thrombosis, surgical vascular repair, access site infection, and blood transfusion. RESULTS: A total of 30 studies involving 37,066 patients were identified. No difference in complication incidence between Angio-Seal and mechanical compression was revealed in the diagnostic (Dx) setting (odds ratio [OR] 1.08, 95% confidence interval [CI] 0.11 to 10.0) or percutaneous coronary interventions (PCI) (OR 0.86, 95% CI 0.65 to 1.12). Meta-analysis of randomized trials only showed a trend toward less complications using Angio-Seal in a PCI setting (OR 0.46, 95% CI 0.20 to 1.04; p = 0.062). No differences were observed regarding Perclose in either Dx (OR 1.51, 95% CI 0.24 to 9.47) or PCI (OR 1.21, 95% CI 0.94 to 1.54) setting. An increased risk in complication rates using VasoSeal in the PCI setting (OR 2.25, 95% CI 1.07 to 4.71) was found. The overall analysis favored mechanical compression over ACD (OR 1.34, 95% CI 1.01 to 1.79). CONCLUSIONS: In the setting of Dx angiography, the risk of access-site-related complications was similar for ACD compared with mechanical compression. In the setting of PCI, the rate of complications appeared higher with VasoSeal.
Angioplasty, Balloon, Coronary↗
Role of the endothelium in modulating neointimal formation: vasculoprotective approaches to attenuate restenosis after percutaneous coronary interventions.
Restenosis at the site of an endoluminal procedure remains a significant problem in the practice of interventional cardiology. We present current data on intimal hyperplasia, which identify the major role of endothelial cells (ECs) in the development of restenosis. Considering endothelial denudation as one of the most important mechanisms contributing to restenosis, we focus more attention on methods of accelerating restoration of endothelial continuity. Prevention of restenosis may be achieved by promoting endothelial regeneration through the use of growth factors, EC seeding, vessel reconstruction with autologous EC/fibrin matrix, and the use of estrogen-loaded stents and stents designed to capture progenitor ECs.
Angioplasty, Balloon, Coronary↗
Impact of chronic kidney disease on prognosis of patients with diabetes mellitus treated with percutaneous coronary intervention.
Chronic kidney disease (CKD) is a frequent complication of diabetes mellitus. However, the role of CKD in outcomes of patients with diabetes who have undergone percutaneous coronary intervention (PCI) has not been studied specifically. Therefore, we investigated the impact of CKD on prognosis of patients with diabetes who underwent PCI. Of 1,575 diabetic patients who underwent PCI, 1,046 (66%) had preserved renal function, 492 (31%) had CKD (baseline serum creatinine >1.5 mg/dl or estimated glomerular filtration rate <60 ml/min/1.73 m(2)) without dialysis, and 37 (2.3%) were dependent on dialysis. Patients with CKD versus those without CKD had more in-hospital complications, including mortality (2.6% vs 0.5%, respectively; p <0.0001), neurologic events (3.1% vs 0.6%, p = 0.0001), and gastrointestinal bleeding (2.9% vs 0.9%, p = 0.01). Contrast-induced nephropathy after PCI (increase > or =25% and/or > or =0.5 mg/dl of serum creatinine before PCI vs 48 hours after PCI) was found in 15% of patients without CKD versus 27% of those with CKD, and de novo dialysis was instituted in 0.1% versus 3.1%, respectively. Contrast-induced nephropathy was independently predicted (all p <0.0001) by peri-PCI hypotension (odds ratio [OR] 2.62), insulin treatment (OR 1.84), and volume of contrast medium (OR 1.30). The 1-year mortality rate was strikingly higher (all p <0.0001) in patients with CKD who did not receive dialysis (16%) and those on dialysis (44%) compared with the group with preserved renal function (5%). Contrast-induced nephropathy was among the independent predictors of a 1-year mortality rate (OR 2.75, p <0.001).
Age Factors↗
Frequency, correlates, and clinical implications of myocardial perfusion after primary angioplasty and stenting, with and without glycoprotein IIb/IIIa inhibition, in acute myocardial infarction.
OBJECTIVES: We sought to determine the prognostic importance of myocardial reperfusion after various contemporary interventional strategies in patients with acute myocardial infarction (AMI). BACKGROUND: The frequency, correlates, and clinical implications of myocardial perfusion after primary angioplasty in AMI have not been examined in a large-scale prospective study. Similarly, whether glycoprotein (GP) IIb/IIIa inhibitors and/or stents improve myocardial perfusion beyond balloon angioplasty has not been investigated. METHODS: Tissue-level perfusion assessed by the myocardial blush grade was evaluated in 1,301 patients with AMI randomized to balloon angioplasty versus stenting, each with or without abciximab. RESULTS: Despite Thrombolysis In Myocardial Infarction flow grade 3 restoration in 96.1% of patients, myocardial perfusion was normal in only 17.4% of patients, reduced in 33.9%, and absent in 48.7%. Myocardial perfusion status post-coronary intervention stratified patients into three distinct risk categories, with 1-year mortality rates of 1.4% (normal blush), 4.1% (reduced blush), and 6.2% (absent blush) (p = 0.01). Among patients randomized to angioplasty, angioplasty + abciximab, stenting, and stenting + abciximab, normal myocardial perfusion was restored in 17.7%, 17.0%, 17.5%, and 17.6%, respectively (p = 0.95), which was associated with similar 1-year rates of mortality in patients randomized to stenting versus angioplasty (4.5% vs. 4.8%, p = 0.91) and abciximab versus no abciximab (4.3% vs. 5.0%, p = 0.63). CONCLUSIONS: Restoration of normal tissue-level perfusion is a powerful determinate of survival after primary PCI in AMI and is achieved in a minority of patients. Neither stents nor GP IIb/IIIa inhibitors significantly enhance myocardial perfusion compared to balloon angioplasty alone, underlying the similar long-term mortality with these different mechanical reperfusion strategies.
Abciximab↗
Cost-effectiveness of sirolimus-eluting stents for treatment of complex coronary stenoses: results from the Sirolimus-Eluting Balloon Expandable Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions (SIRIUS) trial.
BACKGROUND: Recently, sirolimus-eluting stents (SESs) have been shown to dramatically reduce the risk of angiographic and clinical restenosis compared with bare metal stent (BMS) implantation. However, the overall cost-effectiveness of this strategy is unknown. METHODS AND RESULTS: Between February and August 2001, 1058 patients with complex coronary stenoses were enrolled in the SIRIUS trial and randomized to percutaneous coronary revascularization with either a SES or BMS. Clinical outcomes, resource use, and costs were assessed prospectively for all patients over a 1-year follow-up period. Initial hospital costs were increased by 2881 dollars per patient with SESs. Over the 1-year follow-up period, use of SESs led to substantial reductions in the need for repeat revascularization, including repeat percutaneous coronary intervention and bypass surgery. Although follow-up costs were reduced by 2571 dollars per patient with SESs, aggregate 1-year costs remained 309 dollars per patient higher. The incremental cost-effectiveness ratio for SES was 1650 dollars per repeat revascularization event avoided or 27,540 dollars per quality-adjusted year of life gained, values that compare reasonably with other accepted medical interventions. Under updated treatment assumptions regarding available stent lengths and duration of antiplatelet therapy, use of SESs was projected to reduce total 1-year costs compared with BMSs. CONCLUSIONS: Although use of SESs was not cost-saving compared with BMS implantation, for patients undergoing percutaneous coronary intervention of complex coronary stenoses, their use appears to be reasonably cost-effective within the context of the US healthcare system.
Angioplasty, Balloon, Coronary↗
Treatment of left anterior descending coronary artery disease with sirolimus-eluting stents.
BACKGROUND: Revascularization strategies often hinge on the presence and degree of left anterior descending coronary artery (LAD) stenosis. A decision for bypass surgery is often based on the durability of surgical LAD revascularization compared with percutaneous approaches. By decreasing restenosis, drug-eluting stents may have reduced the "reintervention gap" between surgery and percutaneous intervention, making the percutaneous route preferable. METHODS AND RESULTS: Of the 1101 patients in the SIRIUS trial, 459 with an LAD stenosis were randomized to percutaneous intervention with either sirolimus-eluting or bare-metal stents. Baseline demographic, clinical, and angiographic data were obtained. Patients had 1-year clinical and 8-month angiographic follow-up. Baseline characteristics were similar in both groups. The majority of lesions were tubular type B lesions (69.7%) with a mean diameter of 2.73 mm and a mean length of 14.0 mm. The binary in-stent restenosis rate was 2% for the sirolimus stent group and 41.6% for the bare-metal arm (relative risk, 0.05; 95% CI, 0.02 to 0.1; P<0.001). One-year major adverse events (defined as cardiac death, Q-wave and non-Q-wave myocardial infarction, or target vessel revascularization) was decreased 59% in the sirolimus-stent group (9.8% versus 24.9%; relative risk, 0.39; 95% CI, 0.26 to 0.61; P<0.001). Subgroup analysis of 135 patients with proximal LAD lesions showed similar benefits. In-stent restenosis was 0 in the proximal LAD sirolimus-eluting group (n=67), compared with 38% in the bare-metal arm (n=68), and major adverse events demonstrated a similar trend, with a 50% decrease compared with control patients (10.4% versus 20.6%, P=NS). CONCLUSIONS: Sirolimus-eluting stents significantly decrease revascularization rates in LAD lesions. At 1 year, sirolimus-eluting stent revascularization rates are comparable to historic single vessel bypass surgery revascularization rates.
Aged↗