Clinical experience with a new biocompatible phosphorylcholine-coated coronary stent

AIMS: The BiodivYsio stent is a new stent coated with phosphorylcholine, a biocompatible molecule designed to reduce the formation of thrombus and potentially the risk of restenosis. The feasibility, safety, and efficacy of elective and urgent implantation of this coated coronary stent were prospectively studied. METHODS AND RESULTS: We studied 224 patients who underwent elective (67%) or bail-out implantation of 303 BiodivYsio stents in 286 lesions. Most lesions (62%) had unfavorable characteristics (type B2 or C) and half of them (50%) had thrombus and/or chronic total occlusion. Clinical follow-up was obtained in all patients at one month and in the first 132 patients at six months. Repeat angiography was undertaken in all patients with recurrent ischemia. Successful stent deployment was achieved in 284 lesions (99.3%). One emergency coronary artery bypass graft (CABG) was required. Angiographic success rate was 98.3% (281/286). There was 1 (0.4%) subacute stent thrombosis associated with Q-wave myocardial infarction and two (0.9%) in-hospital deaths. Reference vessel diameter was 2.82 +/- 0.32 mm. Minimum luminal diameter (MLD) increased from 0.38 +/- 0.25 mm to 2.97 +/- 0.35 mm and diameter stenosis decreased from 83.8 +/- 12.1% to 5.8 +/- 9.7%. Clinical restenosis rate was 6.1% (8/132 patients) at 6-month follow-up. Target vessel revascularization rate at 6-month follow-up was 5.4%. CONCLUSIONS: This initial clinical experience indicates that the implantation of stents coated with phosphorylcholine appears to be safe and efficacious in the treatment of complex coronary lesions and is associated with an extremely low target vessel revascularization rate.     

The SV stent study: a prospective, multicentre, angiographic evaluation of the BiodivYsio phosphorylcholine coated small vessel stent in small coronary vessels

OBJECTIVE: To evaluate the use of the phosphorylcholine (PC) coated BiodivYsio small vessel (SV) stent in native coronary vessels of small calibre. DESIGN AND SETTING: Prospective, multi-centre, multi-national registry with 6-month clinical and core-lab angiographic follow-up. Adverse events were adjudicated by a Clinical Events Committee (CEC) and included peri-procedural analysis of cardiac enzymes. PATIENTS: Patients with signs or symptoms of ischaemia with an identified target lesion in an epicardial vessel with reference diameter 2.0-2.75 mm were enrolled. Intervention in other epicardial territories in the same patient was permitted. RESULTS: Recruitment of 150 consecutive lesions (in 143 patients) was completed in 19 centres in Europe and Israel. The stent was deployed successfully in all but one lesion. At 6 months, 1 patient (1%) had experienced sudden cardiac death, 4 further patients (3%) had a non-Q wave MI, and a further 24 patients (17%) had repeat revascularisation of a study target vessel. The mean reference vessel diameter prior to stenting was 2.2 mm (S.D. 0.4). Mean minimal luminal diameters at pre-procedure, post procedure and follow-up were 0.6 mm (S.D. 0.3), 2.0 mm (S.D. 0.4) and 1.2 mm (S.D. 0.6), respectively. The late lumen loss index was 0.55 (S.D. 0.53) with a binary restenosis rate of 32%. CONCLUSIONS: In stenting of selected lesions in small vessels, the BiodivYsio SV stent demonstrated high rates of implant success. The rates of major adverse cardiac events (MACE), angiographic restenosis and repeat revascularisation are similar to those reported in other small vessel bare metal stent studies.     

Initial and follow-up results of the BiodivYsio phosphorylcholine coated stent for treatment of coronary artery disease.

BACKGROUND: The BiodivYsio stent is coated with a phosphorylcholine containing copolymer to confer biocompatibility. The present study was designed to assess the safety and efficacy of this coronary stent for the treatment of native coronary artery lesions in patients with coronary artery disease. METHODS AND RESULTS: From August 2001 to April 2003, 130 patients with lesions were treated with this stent. Elective stenting (ES) was performed in 90 patients and bailout stenting (BS) was performed in 40 patients with small vessels. Pre-interventional reference diameter, minimal lumen diameter (MLD), and lesion length were 2.68+/-0.51, 1.00+/-0.30, 12.78+/-4.32, respectively, and post-interventional MLD was 2.24+/-0.45 mm. The initial success rate was 100%. However, 2 non-Q-wave myocardial infarctions (non-QMI) occurred post-procedurally due to branch occlusion. A 6-month follow-up was performed. No subacute thrombosis occurred. In the ES group, 1 non-QMI occurred after the interventional procedure in another vessel. There was no death or coronary artery bypass grafting (CABG). The angiographic restenosis rate was 15.6%. In the BS group, there was no death, myocardial infarction or CABG. The angiographic restenosis rate was 17.5%. CONCLUSION: The BiodivYsio stent is safe and effective as a primary device for the treatment of native coronary artery lesions, especially in small vessels.     

Acute and mid-term results of phosphorylcholine-coated stents in primary coronary stenting for acute myocardial infarction.

The aim of this pilot study was to evaluate the safety and efficacy of the BiodivYsio phosphorylcholine-coated stent in the primary treatment of acute myocardial infarction. The BiodivYsio stent (Biocompatible) is a balloon-expandable stent, laser etched from a 316 L stainless steel tube. This device is coated with phosphorylcholine, a synthetic, hemocompatible phospholipid polymer that has been shown in experimental studies to reduce platelet and protein adhesion to the surface of the metal. One hundred consecutive patients within 24 hr of symptoms of onset of acute MI, treated with primary PTCA, were enrolled. After PTCA, stenting was attempted in all eligible lesions (reference diameter > or = 2.5 mm; no bend lesion > 45 degrees ). Poststenting regimens contained ticlopidine (500 mg/day) and aspirin (325 mg/day) and 6-12 hr of heparin infusion. Procedural success (TIMI > or = II and residual stenosis < 30%) was obtained in 70/74 cases (95%). TIMI grade III was restored in 90% of cases. In the patient group with procedural success (70 cases), 70 BiodivYsio stents were placed. After stenting, diameter stenosis decreased from 96% +/- 11% to 22% +/- 12% (P < 0.01) and minimal luminal diameter increased from 0.13 +/- 0.29 to 2.47 +/- 0.43 (P < 0.01). Nominal stent diameter was between 3.0 and 4.0 mm (mean, 3.5 +/- 0.4 mm). Stent length was between 11 and 28 mm (mean, 17 +/- 4.5 mm). Clinical follow-up was obtained in all patients; angiographic follow-up was performed in 65/70 (93%). No acute or subacute thrombosis was reported. Two in-hospital major adverse cardiac events (MACE) were reported due to a nontreated left main disease that required coronary artery bypass graft (CABG) surgery. At follow-up, MACE were found in 9 of 68 patients (13%), target lesion revascularization (TLR) in 6%, and CABG in the remaining 6%. Primary stenting with phosphorylcholine-coated stent leads to excellent short- and mid-term clinical outcomes and is associated with a restenosis rate of 12%.     

First human experience with angiopeptin-eluting stent: a quantitative coronary angiography and three-dimensional intravascular ultrasound study.

Angiopeptin has been shown to reduce in-stent restenosis in various animal models. Meanwhile, BiodivYsio DD phosphorylcholine (PC)-coated stent provides a platform for local delivery of antiproliferative agents to the coronary artery. We studied the feasibility, safety, and impact on tissue growth of angiopeptin-eluting BiodivYsio DD PC-coated stents in human native de novo coronary lesions. We enrolled 14 patients (16 lesions) who underwent intravascular ultrasound (IVUS)-guided angiopeptin-eluting stent implantation in native coronary arteries between 3.0 and 4.0 mm in diameter with lesion length相似文献   

Long-term clinical outcome after implantation of medium Palmaz (biliary) stents in very large native coronary arteries.

Intracoronary stenting has been shown to improve acute and long-term clinical results compared with coronary angioplasty. However, clinical outcome after medium Palmaz biliary (PB) stent implantation in very large native coronary arteries (> 4 mm in diameter) is unknown. This study evaluated restenosis and long-term clinical outcome after PB stenting in large native coronary arteries. Between June 1993 and December 1998, 55 patients with 56 lesions were treated with PB stents. Intracoronary stent deployment was successful in all 56 vessels attempted (100%). The mean stenosis was reduced from 65% +/- 10% to 4% +/- 14%. In 48 of the 56 vessels (86%), vessel size was greater than 4.0 mm in diameter and the mean reference vessel diameter was 4.73 +/- 0.7 mm after stenting. Angiographic success was achieved in 100%. Five patients had postprocedural cardiac enzyme elevation. There was no periprocedural death, emergency coronary artery bypass surgery, repeat target lesion revascularization, or acute stent thrombosis. Long-term clinical follow-up at mean of 28 +/- 15 months was obtained in 96% of the patients. Clinical restenosis rate occurred in 18% of ostial (6/34) and 0% of nonostial (0/22) lesions (P < 0.0001) with an overall clinical restenosis rate of 11%. Repeat angioplasty were performed in these six patients. There were three cardiac and three noncardiac deaths. The overall event-free survival at 1 and 3 years was 92% +/- 4% and 80% +/- 6%, respectively. PB stent implantation in very large native coronary arteries can be performed with a high degree of procedural success and low in-hospital complications. The long-term clinical outcome of patients undergoing PB stenting is associated with excellent event-free survival. However, stenting of ostial lesions remains as an important factor for restenosis even in very large coronary artery stenting.     

Prospective randomized study of the restenotic process in small coronary arteries using a Carbofilm coated stent in comparison with plain old balloon angioplasty: a multicenter study.

BACKGROUND: The optimal interventional approach to treat lesions in small coronary arteries is still undetermined and controversial. This randomized, multicenter trial was designed to compare the 6-months restenosis and clinical event rates in two treatment groups: balloon angioplasty as a primary strategy and provisional stenting versus primary implantation of a carbon coated stent (Carbosten). RESULTS: At 6 months the angiographic restenosis rate was significantly lower for the stented patients (11.6%) as compared to the balloon angioplasty patients (32.2%). However this advantage in restenosis rate did not translate into a clinical benefit in respect to target vessel revascularization rates. Conclusion: This trial demonstrated a remarkably low 6-months restenosis rate for lesions in small (<2.8 mm) coronary arteries treated with Carbosten implantation that is comparable to the rates found after drug eluting stent implantation and was significantly better in comparison to balloon angioplasty alone.     

Latin American randomized trial of balloon angioplasty vs coronary stenting for small vessels (LASMAL): immediate and long-term results

PURPOSE: To assess the potential role of coronary stent to improved acute success and reduce late restenosis in lesions with reference diameter <2.9 mm using a bare metal stent specifically designed for small coronary vessels. There is controversy on the results among previous studies comparing bare metal stent implantation with conventional balloon percutaneous transluminal coronary angioplasty (PTCA). Differences in baseline characteristics, inclusion and exclusion criteria, and stent design may account for these discrepancies. METHODS: The population of this multicenter, multinational randomized study (LASMAL) consisted of 246 patients undergoing percutaneous coronary intervention of small vessel reference diameter. They were randomized into 2 strategies of percutaneous revascularization: elective primary stent (n = 124) or conventional balloon PTCA with provisional stenting (n = 122) in the presence of acute, threatened closure or flow-limiting dissections. RESULTS: The clinical success rate was significantly better for the stent group (98.3% vs 91.8%; P = 0.038). At 30 days follow-up, requirements of target vessel revascularization (TVR) (6.6% vs 0.8%; P = 0.018) and incidence of major adverse cardiac and cerebrovascular events (MACCE) (9.8% vs 2.4%; P = 0.01) was significantly lower in the stent strategy. Postpercutaneous coronary intervention minimal luminal diameter (MLD) was significantly larger in the stent group (2.3 +/- 0.2 mm vs 2.2 +/- 0.2 mm; P = 0.003). At follow-up, MLD in the stent group was larger than with PTCA (1.7 +/- 0.7 mm vs 1.5 +/- 0.7 mm, respectively; P = 0.035). Net gain was also significantly better with stent strategy (1.1 +/- 0.7 mm vs 0.8 +/- 0.7 mm, respectively; P = 0.002). Stenting resulted in a significant lower angiographic binary restenosis (20% vs 31%; P = 0.02) than PTCA. Furthermore, patients treated with stent were more frequently free from MACCE at 9-month follow-up (death, acute myocardial infarction [AMI], stroke, repeat revascularization procedures) than those treated initially with PTCA (82.2% vs 72% of PTCA, P = 0.046). CONCLUSIONS: The use of a specifically designed bare metal coronary phosphoril choline-coated stent as primary device during percutaneous interventions in small coronary arteries was associated with high procedural success and low in-hospital and 30-day follow-up complications. At long-term follow-up, patients initially treated with stents had lower angiographic restenosis rate and were more frequently free from major adverse cardiac events.     

Percutaneous treatment of coronary bifurcations: lesion preparation before provisional bare metal stenting and subsequent immunosuppression with oral prednisone. The IMPRESS-Y study

Aim of the study was to assess the clinical and angiographic efficacy of oral treatment with prednisone at immunosuppressive dosage after percutaneous coronary interventions (PCI) in patients with bifurcation lesions treated with elective bare metal stent (BMS) implantation in the main-branch (MB) and provisional stenting in the side-branch (SB). Twenty-five patients were treated on 29 bifurcation lesions (58 vessel segments). Lesion preparation before stenting was performed with atherectomy in 7 cases, and balloon PCI over double wires in all other cases; none was treated directly with stents. The mean length of stents implanted in the MB was 19.6 +/- 4.9 mm (10-30 mm). Balloon PCI was successful in 23 of 29 SB and provisional stenting was needed in 6 SB (21%). All patients received oral prednisone according to the immunosuppressive protocol previously reported (1 mg/kg/day/10 days, 0.5 mg/kg/day/20 days, 0.25 mg/kg/day/15 days). At 12 months, one patient had recurrence of angina (4%) and two patients underwent repeated target lesion revascularization (8%). No patient died or had stent thrombosis. Quantitative coronary analysis was performed in all patients at 8 months. Global restenosis rate per vessel was 8.6% (5/58), and 17.2% (5/29) per lesion. The restenosis rate and late lumen loss were 3.4% and 0.36 +/- 0.6 mm, and 13.8% and 0.47 +/- 0.46 mm in the MB and the SB, respectively. Single stent implantation in the MB and provisional stenting of the SB is feasible in most cases after adequate lesion preparation. The systemic treatment with oral prednisone after BMS implantation offers good clinical and angiographic results even in the difficult setting of bifurcation lesions.     

Clinical outcomes after sirolimus-eluting stent implantation for de novo saphenous vein graft lesions.

The purpose of this study was to evaluate the clinical outcome of patients undergoing sirolimus-eluting stent implantation for de novo lesions within saphenous vein grafts (SVGs). Although the incidence of restenosis following sirolimus-eluting stenting (SES) of native coronary arteries is low, the efficacy of SES to treat de novo lesions within SVGs has not been well studied. A total of 35 patients underwent SES implantation of 39 lesions during 36 procedures. All patients had a minimum follow-up of 6 months following the index procedure. The mean bypass graft age was 10.1 +/- 6.5 years (range, 0-23 years). In-hospital major adverse cardiac events [death, myocardial infarction, thrombosis, or target vessel revascularization (TVR)] occurred in four patients (11%). Clinical follow-up was obtained in 100% of patients (mean follow-up, 7.5 +/- 2.2 months). There was one cardiac death, presumed due to stent thrombosis. TVR occurred in only two patients (6%). Myocardial infarction (MI) occurred in four patients (11%), all attributable to a nontarget vessel. The combined endpoint of death, MI, or TVR occurred in seven patients (20%). Freedom from death, nonfatal MI, thrombosis, or any revascularization was 65%. Early experience indicates sirolimus-eluting stents for de novo saphenous vein graft lesions have a low (6%) rate of clinically driven target vessel revascularization. By 7-month follow-up, event-free survival is limited primarily by disease in nontarget vessels.     

Direct coronary stent implantation: safety, feasibility, and predictors of success of the strategy of direct coronary stent implantation.

This prospective study was designed to evaluate the feasibility, safety, predictive factors of success, and 6-month follow-up of stent implantation without balloon predilatation (direct stenting) in 250 patients undergoing elective stent implantation. Balloon dilatation prior to stent implantation was a prerequisite to facilitate passage and deployment of the stent. Stent technology has changed tremendously, resulting in stents with improved properties, which may allow stent placement without prior balloon dilatation. Patients with coronary lesions suitable for elective stent implantation were included in this trial. Coronary interventions were undertaken predominantly via the transradial route using 6 Fr guiding catheters. Direct stent implantation was attempted using AVE GFX II coronary stent delivery systems. Upon failure, predilatation was undertaken before reattempting stent implantation. Patient data and ECGs were obtained from case records and from personal or telephone interviews 6 months after the procedure. Values were presented as mean +/- standard deviation. Student's t-test, two-tailed at 5% level of significance, was used to compare the difference of two means. Multivariate logistic regression analysis was performed to establish predictive factors for failure of direct stenting. Two hundred and sixty-six direct stent implantations were attempted in 250 patients. Direct stenting was successful in 226 (85%) cases. Out of 40(15%) cases where direct stenting failed, balloon predilatation facilitated stent implantation in 39. In one lesion, stent implantation was not possible despite adequate predilatation. Predictive factors for failure of direct stenting on multivariate analysis were LCx lesions (P < 0.01), complex lesions (P < 0.01), and longer stents (P < 0.001). Minimal luminal diameter and percentage diameter stenosis of lesions in the successful and the failure group were not significantly different (0.94 +/- 0.39 mm vs. 0.84 +/- 0.41 mm, P = NS, and 70.2 +/- 11.2 vs. 73.2 +/- 11.2, P = NS). Stent loss occurred in five (2.0%) cases, with successful retrieval in four. One stent was lost permanently in a small branch of the radial artery. Post-percutaneous coronary intervention (post-PCI) myocardial infarction occurred in four (1.6%) patients. There were no other in-hospital events. Six-month-follow up information was obtained in 99% of patients. Subacute stent thrombosis was noted in four (1.6%) cases. Target vessel-related myocardial infarction rate was 3.2%, of which half was caused by subacute stent thrombosis. The overall reintervention rate (coronary artery bypass grafting or PCI) was 9.7%. Target lesion revascularization by PCI occurred in only 4.0%. At 6 months, overall mortality was 2.0%, of which 1.2% was due to coronary events. Direct stent implantation is safe and feasible in the majority of cases with low rate of complications. Unfavorable factors include circumflex lesion, more complex lesion morphology, and increasing length of stent. Severity of stenosis does not appear to be of predictive value. Long-term outcome is favorable with a low target lesion revascularization rate.     

Randomized comparison of coronary stent implantation and balloon angioplasty in the treatment of de novo coronary artery lesions (START): a four-year follow-up.

OBJECTIVE: The purpose of this study was to test the hypothesis that stent implantation in de novo coronary artery lesions would result in lower restenosis rates and better long-term clinical outcomes than balloon angioplasty. BACKGROUND: Placement of an intracoronary stent, as compared with balloon angioplasty, has proven to reduce the rate of restenosis. However, the long-term clinical benefit of stenting over angioplasty has not been assessed in large randomized trials. METHODS: We randomly assigned 452 patients with either stable (129 patients) or unstable (323 patients) angina pectoris to elective stent implantation (229 patients) or standard balloon angioplasty (223 patients). Coronary angiography was performed at baseline, immediately after the procedure and six months later. End points were the rate of restenosis at six months and a composite of death, myocardial infarction (MI) and target vessel revascularization over four years of follow-up. RESULTS: Procedural success rate was achieved in 84% and 95% (balloon angioplasty vs. stent, respectively). The increase in the minimal luminal diameter was greater in the stent group both after the intervention (2.02 +/- 0.6 mm vs. 1.43 +/- 0.6 mm in the angioplasty group; p < 0.0001), and at six-month follow-up (1.98 +/- 0.7 mm vs. 1.63 +/- 0.7 mm; p < 0.001). The corresponding restenosis rates were 22% and 37%, respectively (p < 0.002). After four years, no differences in mortality (2.7% vs. 2.4%) and nonfatal MI (2.2% vs. 2.8%) were found between the stent and the angioplasty groups, respectively. However, the requirement for further revascularization procedures of the target lesions was significantly reduced in the stent group (12% vs. 25% in the angioplasty group; relative risk 0.49, 95% confidence interval 0.32 to 0.75, p = 0.0006); most of the repeat procedures (84%) were carried out within six months of entry into the study. CONCLUSIONS: Patients who received an intracoronary stent showed a lower rate of restenosis than those treated with conventional balloon angioplasty. The benefit of stenting was maintained four years after implantation, as manifested by a significant reduction in the need for repeat revascularization.     

Acute and long-term outcomes of stenting in coronary vessel > 3.0 mm, 3.0-2.5 mm, and < 2.5 mm.

We compared the acute and long-term outcomes of stentings in coronary vessels > 3.0 mm, 3.0-2.5 mm, and < 2.5 mm. A total of 1,152 patients underwent coronary stenting was divided into three groups based on the reference vessel size. Group A consisted of 598 patients (667 lesions) with a reference vessel diameter > 3.0 mm, group B 485 patients (544 lesions) with a reference vessel diameter of 3.0-2.5 mm, and group C 114 patients (119 lesions) with a reference vessel diameter < 2.5 mm. The procedural success, stent thrombosis, and in-hospital cardiac event rate were similar in the three groups. At 6-month angiographic follow-up, the lesion restenotic rate was significantly higher in the small-vessel group (14%, 22%, and 26% in groups A, B, and C, respectively; P = 0.011). These differences appeared to result from a lesser acute gain and a lesser net gain in small-vessel group; the late luminal loss was similar in the three groups. During a follow-up duration of 28 +/- 3 months, group C patients had a significantly lower rate of event-free survival than the group A and B patients (71% vs. 85% and 82%; P = 0.002). Stepwise regression analysis demonstrated that complex lesion (P = 0.032) and long lesion (P = 0.046) are independent predictors of restenosis in very-small-vessel (< 2.5 mm) stenting. In conclusion, the acute results of stenting in small coronary arteries appear safe and feasible with a high procedural success rate and a low incidence of stent thrombosis. Stenting in patients with a small coronary artery appears to have a similar in-hospital cardiac event rate, but a higher angiographic restenosis rate and a lower event-free survival rate, compared to stenting in patients with a larger coronary artery. The predictors of restenosis in very-small-vessel stenting are complex lesions and long lesions. Cathet Cardiovasc Intervent 2001;53:314-322. Copyright Wiley-Liss, Inc.     

Six-month angiographic and 12-month clinical follow-up of MultiLink long (25 to 35 mm) stents for long coronary narrowings in patients with angina pectoris

There are limited prospective angiographic data on stent deployment for long coronary lesions. This multicenter prospective study enrolled 120 patients with a single de novo stenosis >20 mm in length, in a native vessel > or =3 mm diameter, suitable for a MultiLink stent 25 to 35 mm in length with additional stent deployment if required. Quantitative angiography before and immediately after stenting and at 6-month follow-up assessed restenosis for the complete lesion and for 5-mm segments of the stented and adjacent nonstented vessel. By 1 year, myocardial infarction had occurred in 3% and target vessel repeat revascularization in 12% of patients. The mean stented length (35.8 +/- 14.6 mm) closely matched mean lesion length (30.1 +/- 13.5 mm). Restenosis to > or =50% diameter loss occurred in 32% of patients, but to > or =70% in only 8%. Of the 147 segments (5 mm in length) with baseline stenosis <25%, only 3 patients (2%) developed restenosis of > or =50%, and only in 1 of these was it > or =70%. Stenting of long narrowings is associated with good clinical outcome and a low rate of severe restenosis. Mildly diseased segments of long lesions covered by a stent rarely became severely narrowed and had negligible influence on the overall restenosis rate. These data support a strategy of full lesion coverage by stent deployment.     

Clinical and angiographic outcomes following elective implantation of the Carbostent in patients at high risk of restenosis and target vessel failure.

The Carbostent is a new balloon-expandable, stainless steel, tubular stent with innovative multicellular design and unique turbostratic carbon coating. The aim of this study was to assess clinical and angiographic outcomes after Carbostent implantation in 112 patients poorly suitable for an effective treatment with stenting because of the high risk of thrombosis, late restenosis, and clinical target vessel failure. The inclusion criteria were age > 75 years, diabetes mellitus, a lesion length > 10 mm, a reference vessel diameter < 3.0 mm, an ostial location of the target lesion, and chronic total occlusion. Overall, a total of 175 stents ranging from 9 to 25 mm in length were placed in 147 lesions. There were no stenting attempt failures. The acute gain after stent implantation was 2.46 +/- 0.51 mm, and the residual stenosis 0 +/- 4%. No stent thrombosis occurred, nor myocardial infarction. The 6-month event-free survival rate was 74% +/- 5%. The 6-month angiographic follow-up showed a late loss of 0.81 +/- 0.88 mm and a binary (> or = 50%) restenosis rate of 25%. The results of this study suggest that the Carbostent may be highly effective in patients at high risk of restenosis and target vessel failure.     

Clinical and angiographic outcome after coronary arterial stenting with the carbostent

The Carbostent is a new balloon-expandable, stainless steel, tubular stent with innovative multicellular design and unique turbastratic carbon coating (Carbofilm). This open nonrandomized 2-center study assesses the immediate and long-term clinical and angiographic outcomes after Carbostent implantation in patients with native coronary artery disease. The Carbostent was implanted in 112 patients with 132 de novo lesions. Most patients (55%) had unstable angina, and 38% of lesions were type B2-C. The mean lesion length was 12.5 +/- 7.0 mm, and 29% of lesions were > 15 mm in length. No stent deployment failure occurred, as well as acute or sub-acute stent thrombosis. The 6-month event-free survival was 84 +/- 4%. One patient with a stented right coronary artery and no restenosis at the angiographic follow-up died after 6 months of fatal infarction due to abrupt closure of a nontarget vessel. In-hospital non-Q-wave myocardial infarction occurred in 1 patient, and 11 patients had repeat target lesion revascularization (target lesion revascularization rate 10%). The 6-month angiographic follow-up was obtained in 108 patients (96%) (127 lesions). Angiographic restenosis rate was 11%. The loss index was 0.29 +/- 0.28. The results of this study indicate a potential benefit of Carbostent for the prevention of stent thrombosis and restenosis in these relatively high-risk patients. A larger trial is being planned to confirm these promising results.     

Comparison of zotarolimus-eluting and sirolimus-eluting stents in patients with native coronary artery disease: a randomized controlled trial.

OBJECTIVES: This trial examined the relative clinical efficacy, angiographic outcomes, and safety of zotarolimus-eluting coronary stents (ZES) with a phosphorylcholine polymer versus sirolimus-eluting stents (SES). BACKGROUND: Whether a cobalt-based alloy stent coated with the novel antiproliferative agent, zotarolimus, and a phosphorylcholine polymer may provide similar angiographic and clinical benefit compared with SES is undetermined. METHODS: A prospective, multicenter, 3:1 randomized trial was conducted to evaluate the safety and efficacy of ZES (n = 323) relative to SES (n = 113) in 436 patients undergoing elective percutaneous revascularization of de novo native coronary lesions with reference vessel diameters between 2.5 mm and 3.5 mm and lesion length > or =14 mm and < or =27 mm. The primary end point was 8-month angiographic in-segment late lumen loss. RESULTS: Angiographic in-segment late lumen loss was significantly higher among patients treated with ZES compared with SES (0.34 +/- 0.44 mm vs. 0.13 +/- 0.32 mm, respectively; p < 0.001). In-hospital major adverse cardiac events were significantly lower among patients treated with ZES (0.6% vs. 3.5%, p = 0.04). In-segment binary angiographic restenosis was also higher in the ZES cohort (11.7% vs. 4.3%, p = 0.04). Total (clinically and non-clinically driven) target lesion revascularization rates at 9 months were 9.8% and 3.5% for the ZES and SES groups, respectively (p = 0.04). However, neither clinically driven target lesion revascularization (6.3% zotarolimus vs. 3.5% sirolimus, p = 0.34) nor target vessel failure (12.0% zotarolimus vs. 11.5% sirolimus, p = 1.0) differed significantly. CONCLUSIONS: Compared with SES, treatment with a phosphorylcholine polymer-based ZES is associated with significantly higher late lumen loss and binary restenosis at 8-month angiographic follow-up. (The Endeavor III CR; http://clinicaltrials.gov/ct/show/NCT00265668?order=1?).     

Effects of stent length and lesion length on coronary restenosis

The choice of drug-eluting versus bare metal stents is based on costs and expectations of restenosis and thrombosis risk. Approaches to stent placement vary from covering just the zone of maximal obstruction to stenting well beyond the lesion boundaries (normal-to-normal vessel). The independent effects of stented lesion length, nonstented lesion length, and excess stent length, on coronary restenosis have not been evaluated for bare metal or drug-eluting stents. We analyzed the angiographic follow-up cohort (1,181 patients) from 6 recent bare metal stent trials of de novo lesions in native coronary arteries. Stent length exceeded lesion length in 87% of lesions (mean lesion length 12.4 +/- 6.3 mm, mean stent length 20.0 +/- 7.9 mm, mean difference 7.6 +/- 7.9 mm). At 6- to 9-month follow-up, the mean percent diameter stenosis was 39.1 +/- 20.1%. In an adjusted multivariable model of percent diameter stenosis, each 10 mm of stented lesion length was associated with an absolute increase in percent diameter stenosis of 7.7% (p <0.0001), whereas each 10 mm of excess stent length independently increased percent diameter stenosis by 4.0% (p <0.0001) and increased target lesion revascularization at 9 months (odds ratio 1.12, 95% confidence interval 1.02 to 1.24). Significant nonstented lesion length was uncommon (12.5% of cases). In summary, stent length exceeded lesion length in most stented lesions, and the amount of excess stent length increased the risk of restenosis independent of the stented lesion length. This analysis supports a conservative approach of matching stent length to lesion length to reduce the risk of restenosis with bare metal stents.     

Coronary intervention in the diabetic patient: improved outcome following stent implantation compared with balloon angioplasty

BACKGROUND: Diabetic patients undergoing coronary interventional procedures are at increased risk of restenosis and adverse clinical events. The relative impact of stents compared with balloon angioplasty on the outcome of percutaneous intervention in diabetics remains controversial. HYPOTHESIS: The goal of this study was to determine whether stent placement was superior to balloon angioplasty in reducing restenosis of diabetic patients undergoing coronary intervention. METHODS: The STRESS Trial was a prospective randomized comparison of stent placement and balloon angioplasty in the treatment of new native coronary lesions. Of 594 randomized patients. 92 (16%) were diabetic. In this substudy analysis of the STRESS Trial, the outcomes after stenting and balloon angioplasty in diabetic patients were compared. The primary endpoint was restenosis as determined by angiography at 6 months. Clinical outcomes at 1 year were assessed. RESULTS: Procedural success was achieved in 82% of diabetic patients assigned to angioplasty and in 100% assigned to stenting (p < 0.01). Compared with angioplasty, stenting resulted in a larger postprocedural lumen diameter (2.34 +/- 0.44 vs. 1.87 +/- 0.52 mm, p < 0.001) and greater acute luminal gain (1.61 +/- 0.47 vs. 1.06 +/- 0.46 mm, p < 0.001). At 6 months, stenting conferred a larger lumen (1.69 +/- 0.57 vs. 1.38 +/- 0.60 mm, p = 0.03) and greater net luminal gain (0.97 +/- 0.55 vs. 0.52 +/- 0.52 mm, p < 0.001). Restenosis occurred in 60% of the angioplasty group and in 24% of the stent group (p < 0.01). This was accompanied by a lower need for repeat target vessel revascularization after stenting (31 vs. 13%, p < 0.03). CONCLUSIONS: Compared with balloon angioplasty, stent placement in diabetic patients with focal de novo lesions resulted in superior procedural results, reduced restenosis, and improved clinical outcome with fewer repeat revascularization procedures.     

Effect of statin therapy on restenosis after coronary stent implantation

The effect of statins on the development of restenosis and clinical outcome after coronary stent implantation was assessed in a retrospective analysis of 525 consecutive patients. Baseline clinical, angiographic, and procedural characteristics did not differ between 258 patients with and 267 patients without statin therapy. Statin therapy was associated with a significantly (p<0.04) improved survival free of myocardial infarction and a significant reduction in repeat target vessel revascularization procedures (27.9% vs. 36.7%, p<0.05) during 6-month follow-up. Minimal lumen diameter was significantly larger (1.98+/-0.88 vs. 1.78+/-0.88 mm, p = 0.01), late lumen loss was significantly less (0.64+/-0.8 vs. 0.8+/-0.8 mm, p = 0.032), and net gain significantly increased (1.2+/-0.88 vs. 0.98+/- 0.92 mm, p = 0. 009) in patients receiving statin therapy. Dichotomous angiographic restenosis (> or =50%) rates were significantly lower, with 25.4% in the statin group compared with 38% in the no-statin group (p<0.005). Multivariate analysis identified statin therapy (p = 0.005), minimal lumen diameter immediately after stenting (p = 0.02), and stent length (p = 0.02) as independent predictors for subsequent restenosis development. Thus, statin therapy is associated with reduced recurrence rates and improved clinical outcome after coronary stent implantation.