Comparison of initial efficacy and long-term follow-up of heparin-coated Jostent with conventional NIR stent

The implantation of heparin-coated stents was reported to be well tolerated, but there are conflicting results about acute in-hospital complications. (sub)acute thrombosis rates, and long-term follow-up compared to uncoated stents. We compared the angiographic and clinical results after coronary placement of two stent models: the heparin-coated premounted Jostent and the uncoated premounted NIR stent. Of 710 patients revascularized, a total of 426 patients received Jostent (n = 230) or NIR stent (n = 196) implantation. The primary end points were acute or subacute thrombosis, urgent CABG, AMI or death, while the secondary end points were the comparison of the restenosis rates of the stents at the 6th month and of the functional angina classification of the stent groups at the 1st, 6th and 12th months. There were no significant differences between the Jostent and NIR stent groups regarding angiographic and procedural success. Acute thrombosis rates in the Jostent and NIR stent groups were similar while no subacute thrombosis was observed in either group. The major adverse cardiac event rates of the groups also did not differ. Angiographic restenosis occurred in 17% of the Jostent group and 16% of the NIR stent group (NS). The combined clinical and angiographic restenosis rate was also similar between the Jo and NIR groups (19% and 18%, respectively). Comparison of functional angina classes at the 1st, 6th and 12th months revealed no significant difference between the study groups. In conclusion, when compared with implantation of an uncoated premounted NIR stent, implantation of a heparin-coated premounted Jostent does not provide any more benefit with respect to initial efficacy, sub(acute) thrombosis and 6-month restenosis rates and 12-month clinical outcomes.     

Early and late outcome of stenting in a consecutive series of patients with coronary lesions in vessels less than 2.8 mm in diameter

In an attempt to determine the early and late outcomes of small vessel stenting, we retrospectively evaluated our database on 51 consecutive patients (41 males, mean age, 57.1 +/- 10.1 years) who underwent stenting of at least one significant lesion in a coronary artery with a reference vessel diameter (RVD) <2.8 mm between March 1999 and March 2001. Sixty balloon expandable tubular stents were implanted in 57 lesions (29 Type B2/C, mean RVD: 2.54 +/- 0.16 mm) without intravascular ultrasound guidance under a heparin-aspirin-ticlopidine regimen. The mean diameter stenosis (DS) decreased from 75.8 +/- 13.6% to 4.2 +/- 1.9% (P<0.0001) with stenting at a mean deployment pressure of 13.6 +/- 1.7 atm and a final balloon to RVD ratio (FB/RVD) of 1.08 +/- 0.03. All stents were deployed successfully. Acute stent thrombosis occurred in 3 patients (6%), one died, and 2 developed non-Q-wave myocardial infarction (procedural success 94%). Clinical follow-up, available in 48 patients, revealed a 29% target lesion revascularization rate, a 2% myocardial infarction rate, and a 71% event-free survival at a mean of 11.6 months. Angiographic follow-up, available in 40 patients, showed a DS of 48.8 +/- 31.3% and a binary restenosis rate of 50% at a mean of 7.7 months. The FB/RVD ratio was significantly lower in the group with restenosis than in the group without (1.06 +/- 0.02 vs 1.1 +/- 0.05, P = 0.04). Subgroup analysis yielded a significantly greater rate of restenosis in diabetics with complex (Type B2/C) lesion morphology compared to nondiabetics with simple (Type A/B1) lesions (75% vs 21%, P < 0.05). In conclusion, stenting in vessels <2.8 mm was found to be associated with a high rate of acute stent thrombosis and in-stent restenosis. Further analysis detected a subgroup of patients without diabetes or complex lesions who could be stented with an acceptable in-stent restenosis rate.     

Results of the Jostent coronary stent graft implantation in various clinical settings: procedural and follow-up results.

The Jostent coronary stent graft (CSG) is composed of a PTFE layer sandwiched between two stainless steel stents, initially introduced for the treatment of coronary perforations and aneurysms with excellent results. By providing a mechanical barrier, this stent design also may be beneficial in the treatment of complex ulcerated lesions and in-stent restenosis by preventing debris protrusion and neointimal proliferation through the stent struts. To evaluate the safety and efficacy of this stent graft, we implanted 78 CSGs in 70 patients for a broad range of indications, including coronary perforations, aneurysms, degenerated saphenous vein grafts, complex lesions, and in-stent restenosis. The primary angiographic success rate (95.9%) was high, and using intravascular ultrasound (IVUS) guidance during stent implantation and high inflation pressures (19.3 +/- 3.2 atm), stent expansion with optimal symmetry was achieved in 94.7%. One limitation of the Jostent CSG was the side-branch occlusion rate (18.6%) and the resulting non-Q-wave infarction rate in seven cases (mean CK elevation, 238 U/l), acute Q-wave MI in two cases, and transient ventricular fibrillation in one patient after occlusion of the proximal RCA side branch without further complications. Subacute stent thrombosis occurred in four cases (5.7%) 7 to 70 days after stent implantation, despite using combined antiplatelet therapy with aspirin (ASA), ticlopidine, and/or clopidogrel for 30 days. Angiographic follow-up was available in 56 patients (80.0%) after a mean of 159 +/- 49 days, and follow-up IVUS was available in 38 cases. The overall restenosis rate (> 50% diameter stenosis) was 31.6% manifest primarily as edge restenosis (29.8% stent edge vs. 8.8% stent center; P < 0.001). IVUS examinations showed a minimal late lumen loss of 0.4 +/- 2.2 mm(2) within the center of the stent graft vs. 3.2 +/- 2.3 mm(2) at the stent edges (P < 0.001). The restenosis rate in the prespecified subgroups was 33.3% for saphenous vein grafts (2/6 lesions), 30.0% in complex lesions (6/20 lesions), and 38.5% (10/26 lesions) for the treatment of in-stent restenosis. Implantation of the Jostent CSG is feasible and safe, even in complex lesion subsets, and is associated with high primary success rates provided major side branches are avoided. The use of this stent may require an extended time course of antiplatelet therapy. Frequent focal stent edge renarrowing influences the overall restenosis rate. However, in treatment of complex in-stent restenosis and vein graft lesions, stent grafts may offer benefit over conventional therapies. Covered stents such as the JoMed coronary stent graft may become essential for bailout treatment of coronary perforations.     

Clinical and angiographic follow-up after single long GFX coronary stent implantation.

In order to identify predictors of late restenosis after GFX stent implantation, procedural and 6-month clinical and angiographic follow-up data of prospectively entered 141 consecutive lesions treated with a single long (24 or 30 mm) GFX stent were compared to 66 consecutive lesions requiring a single short (12 or 18 mm) stent. The initial clinical success rate of 97% and thrombosis rate of 1.4% with long stents were similar to 97% and 0% with short stents (P = NS). Their respective binary restenosis rates were 34.7% and 23.3% for long and short stents as a whole (P = NS), but being 10.0% for 12 mm, 26.0% for 18 mm, 31.3% for 24 mm, and 39.2% for 30 mm. When proximal and distal reference diameters at baseline were compared between the lesions with and without restenosis, proximal reference diameters were not statistically different (3.02+/-0.42 mm vs. 3.18+/-0.62 mm) and the restenosis group had significantly smaller distal reference diameters (2.15+/-0.48 mm vs. 2.55+/-0.53 mm, P<0.0001). The treatment of long lesions with single long-stent implantation can be accomplished with high success and low complication rates. Single long-stent implantation may be effective, if the distal reference size of the long narrowing is big enough to accept the stent.     

Heparin-coated Wiktor stents in human coronary arteries (MENTOR trial). MENTOR Trial Investigators

The purpose of this study was to determine the feasibility, safety, and efficacy of elective stenting with heparin-coated Wiktor stents in patients with coronary artery disease. In experimental studies, heparin coating has been shown to prevent subacute thrombosis and restenosis. Recently, a new method of heparin coating was developed, resulting in a more stable and predictable heparin layer on stent devices. This trial constitutes the first in-human use of this coating procedure, applied on the well-known Wiktor stent device. Heparin-coated Wiktor stent implantation was performed in 132 consecutive patients (132 lesions) in a multicenter international trial from September 1996 to February 1997. Forty-three percent of patients had unstable angina, 33% had previous myocardial infarction, and 10% had diabetes mellitus. Patients were followed for 12 months for occurrence of major adverse cardiovascular events, and 96% of the eligible patients underwent quantitative angiographic control at 6 months. Stent deployment was successful in 95.5% of lesions. Minimal lumen diameter increased by 1.67 +/- 0.48 mm (from 1.02 +/- 0.38 mm before to 2.69 +/- 0.37 mm after the stent implantation). Mean percent diameter stenosis decreased from 67.4 +/- 11.3% before to 18.9 +/- 7.7% after the intervention. A successful intervention (<50% diameter stenosis and no major adverse cardiac events within 30 days) occurred in 97% of the patients. The subacute thrombosis rate was 0.8%, which compares favorably with historical controls of this stent, and a low incidence of postprocedural increase in creatine kinase-MB was noted. At 6 months, event-free survival was 85% and angiographic restenosis rate was 22% with late loss of 0.78 +/- 0.69 mm and a loss index of 0.48 +/- 0.44. Heparin-coated Wiktor stents appeared to be an efficacious device to treat Benestent-like lesions, yielding angiographic and clinical results comparable to a heparin-coated Palmaz-Schatz stent. Despite its use in more complex lesions, the incidence of subacute thrombosis appeared to be lower than historical controls with a similar noncoated stent.     

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.     

Long-Term Restenosis After Multiple Stent Implantation: A Quantitative Angiographic Study

Elective high pressure stent implantation in focal coronary lesions has a high procedural success and low incidence of restenosis in comparison with balloon angioplasty. For the treatment of diffusely diseased coronary arteries, however, a high incidence of subacute thrombosis and late restenosis has been reported. The aim of this study was the prospective evaluation of procedural and long-term outcome after implantation of multiple stents. In a consecutive series of 48 patients, 48 lesions were treated with the implantation of 120 stents (2.5 ± 1.0 stents/lesion). Stent implantation was performed electively in 15%, for dissection in 56%, and for suboptimal balloon angioplasty result in 29% of patients. The lesion length before stenting, including balloon angioplasty induced dissections, was 28.5 ± 9.8 mm (range 20–62), the mean length of the stented segment was 40 ± 16 mm. The procedure was successful in 45 patients (95%). Procedural related complications included two urgent bypass operations (4%) and one transmural myocardial infarction (2%). Two subacute stent thrombosis events (4%) occurred, both in-hospital, 1 and 3 days after implantation. Follow-up was obtained in 43 eligible patients at 6.4 ± 1.3 months, revealing an overall restenosis rate of 30% (13 patients). Quantitative angiography (CAAS II, edge detection algorithm) showed a minimal lumen diameter of 0.93 ± 0.28 mm (diameter stenosis 62%± 13%) before treatment, 2.81 ± 0.26 mm (diameter stenosis –4 ± 13%) after stenting, and 1.79 ± 0.58 mm (diameter stenosis 30%± 20%) at follow-up. Predictors of restenosis were not identified. Thus, multiple stent implantation has high procedural success and the late restenosis of long lesions after multiple stents compares favorably with balloon angioplasty.     

西罗莫司和紫杉醇洗脱支架治疗支架内再狭窄的临床近期及10个月疗效

目的比较西罗莫司洗脱支架（Cypher或Cypher select）和紫杉醇洗脱支架（TAXUS）治疗支架内再狭窄的临床近期及10个月疗效。方法自2002年12月至2005年3月,对253例支架内再狭窄的患者采用了药物洗脱支架（DES）治疗并完成了10个月的临床随访和冠状动脉造影复查。253例中男性218例,女性35例,年龄30～80岁,平均年龄57．2岁。结果253例（262处病变）中152例使用Cypher支架176个,101例使用TAXUS支架132个。使用的Cypher和TAXUS支架的平均直径分别为（2．96±0．27）mm和（3．05±0,35）mm,P=0．04,平均长度分别为（23.31±6．68）mm和（23．56±6．54）mm,P=0．745。支架内再狭窄表现为100％闭塞29处,≥90％狭窄143处,〈90％狭窄90处。病变类型为A、B1、B2和C型各为9处、45处、73处和135处。PCI的成功率两组均为100％,住院期间无死亡,Cypher组主要心脏不良事件（MACE）发生率为2．63％,TAXUS组为2．97％,P=0．872。10个月临床造影显示在Cypher支架和TAXUS支架组中造影再狭窄率分别为14．0％和29．4％,P=0．075,MACE发生率分别为6．7％和16．0％,P=0．031。结论应用Cypher和TAXUS支架治疗支架内再狭窄有良好的近期临床疗效,10个月疗效Cypher支架优于TAXUS支架。     

Expansion of the Multilink-Tristar stent after direct implantation and predilatation: comparison of clinical,angiography and intravascular ultrasound parameters

Coronary stenting has become the primary therapeutic option for many coronary lesions. As opposed to conventional stenting the advantages of direct stenting are a reduction of procedural time, radiation exposure and costs. However, data about the incidence of in-stent restenosis are so far not available. It was the aim of this prospective study to compare the expansion of the Multilink stent after direct stenting and predilatation by quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS). Between January 2000 and June 2001, 82 patients were assigned to direct stenting (46 lesions) or predilatation (40 lesions) in lesions of coronary arteries > 3 mm. The procedural success rate was 92% in patients undergoing direct stenting. The baseline clinical characteristics were similar in both groups. The comparison of the angiographic data shows that direct stenting was performed in lesions with a lower degree of stenosis (71 +/- 12% vs 79 +/- 11%, p = 0.01) and that significantly shorter stents were used (14.4 +/- 3.0 vs 17.8 +/- 4.1 mm, p = 0.0007). The mean stenosis length was not significantly different in either group (10.5 +/- 3.4 vs 11.7 +/- 4.3 mm, n.s.). The QCA data after stent implantation show no differences of either implantation technique. Stent expansion was assessed by IVUS estimation of the proximal, distal and minimal in stent area. The minimal in-stent area (9.53 +/- 3.23, mm2 vs 8.65 +/- 1.96 mm2, n.s.) and the stent symmetry index (0.88 vs 0.88 n.s.) were not different in either patient group. These results indicate that in this subset of selected coronary lesions > 3 mm, elective stent implantation with and without predilatation effectively can achieve comparable stent expansion as assessed by QCA and IVUS. In comparison to conventional stent implantation stents, which were implanted without predilatation, were significantly shorter to cover the same lesion length.     

Immediate and mid-term results after multilink stent implantation in native coronary arteries

Different stent designs have widely disparate characteristics that may exert a positive or negative impact on their early and mid-term outcomes. The MultiLink stent (Guidant/Advanced Cardiovascular Systems, Santa Clara, CA) is a new coronary stent with only very limited data. In this report, we examined the results of 50 consecutive patients treated with 57 premounted sheathless MultiLink stents in 53 native coronary arteries with reference diameter ≥2.7 mm. Successful stenting was achieved in 98% of patients, resulting in an improvement in diameter stenosis from 91% ± 11% to 1% ± 3% (P = 0.0001). At 1 month, there was no death, myocardial infarction, or stent thrombosis. Angiographic restudy at a mean of 5.0 ± 1.8 months in 94% of patients revealed an in-stent restenosis rate of 20.7%. The restenosis rates for diabetic patients (vs. nondiabetic patients), type C lesions (vs. type A/B1 lesions), and the use of 35-mm-long stents (vs. 15-mm-long stents) were 45.4% (14.3%), 56% (≤11%), and 80% (8.8%), respectively (P < 0.05). In conclusion, the present study demonstrates that the MultiLink stent has an excellent performance profile, is associated with a low risk of stent thrombosis in native coronary vessels, and yields a favorable restenosis rate, particularly after the use of short (15 mm) stents to treat simple lesions. Cathet. Cardiovasc. Intervent. 47:23–27, 1999. © 1999 Wiley-Liss, Inc.     

Stenting very small coronary narrowings (< 2 mm) using the biocompatible phosphorylcholine-coated coronary stent.

Published data regarding stenting very small arteries are still limited. 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 implantation of the 2.0 mm coated coronary stent were prospectively studied. We studied 97 patients from three centers who underwent elective, urgent, or bailout implantation of 106 BiodivYsio mini-stents (2.0 mm) in 101 lesions. Forty percent of lesions had unfavorable characteristics (type B2 or C) and 16% had thrombus and/or chronic total occlusion. Successful stent deployment was achieved in 100/101 lesions (99%). MLD increased from 0.49 +/- 0.31 mm to 1.89 +/- 0.41 mm and diameter stenosis decreased from 89% +/- 7% to 5.6% +/- 6%. Small vessel stenting was the only procedure in 71% patients. There was one acute stent thrombosis case. During 6-month follow-up, none died, one had MI, and one was referred to CABG due to nontarget lesion progression. Angiographic restenosis that required target lesion revascularization was performed in 8/18 that had catheterization due to chest pain or significant ischemia. Most patients improved in their clinical symptoms. The rate of major adverse cardiac events was 4.1% at 30-day and 10.3% at 6-month follow-up. This initial clinical experience indicates that the implantation of 2.0 mm stents coated with phosphorylcholine appears to be safe and efficacious in the treatment of complex coronary lesions and is associated with low target vessel revascularization rate in spite of the very small vessel diameter.     

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.     

A randomized comparison of the value of additional stenting after optimal balloon angioplasty for long coronary lesions: final results of the additional value of NIR stents for treatment of long coronary lesions (ADVANCE) study

OBJECTIVES: We sought to investigate the clinical benefit of additional stent implantation after achieving an optimal result of balloon angioplasty (BA) in long coronary lesions (>20 mm). BACKGROUND: Long coronary lesions are associated with increased early complications and late restenosis after BA. Stenting improves the early outcome, but stent restenosis is also related to both lesion length and stent length. METHODS: A total of 437 patients with a single native lesion 20 to 50 mm in length were included and underwent BA, using long balloons matched to lesion length and vessel diameter (balloon/artery ratio 1.1) to achieve a diameter stenosis (DS) <30% by on-line quantitative coronary angiography (QCA). "Bail-out stenting" was performed for flow-limiting dissections or >50% DS. Patients in whom an optimal BA result was achieved were randomized to additional stenting (using NIR stents) or no stenting. The primary end point was freedom from major adverse cardiac events (MACE) at nine months, and core laboratory QCA was performed on serial angiograms. RESULTS: Bailout stenting was necessary in 149 patients (34%) and was associated with a significantly increased risk of peri-procedural infarction (p < 0.02). Among the 288 randomized patients, the mean lesion length was 27+/-9 mm, and the vessel diameter was 2.78+/-0.52 mm. The procedural success rate was 90% for the 143 patients assigned to BA alone (control group), as compared with 93% in the 145 patients assigned to additional stenting (stent group), which resulted in a superior early minimal lumen diameter (0.54 mm, p < 0.001) and led to reduced angiographic restenosis (27% vs. 42%, p = 0.022). Freedom from MACE at nine months was 77% in both groups. CONCLUSIONS: A strategy of provisional stenting for long coronary lesions led to bailout stenting in one-third of patients, with a threefold increase in peri-procedural infarction. Additional stenting yielded a lower angiographic restenosis rate, but no reduction in MACE at nine months.     

Outcome of percutaneous hybrid coronary revascularization: bare metal stents jeopardize the benefit of sirolimus-eluting stents in the real world

BACKGROUND: In an effort to contain procedural costs while limiting the risk of in-stent restenosis, hybrid percutaneous revascularization (ie, stenting with at least one sirolimus-eluting stent [SES] and at least one bare metal stent [BMS] in the same patient) is felt to be a cost-effective alternative to exclusive SES use. OBJECTIVE: To describe the outcome of hybrid percutaneous revascularization for the treatment of patients with multiple coronary artery lesions. METHODS AND RESULTS: Fifty-six patients (42 men; mean age [+/- SEM] 64+/-2) underwent hybrid stenting (average of 1.2 SES/patient and 1.3 BMS/patient). SES were used to treat lesions at higher restenotic potential, including longer lesions, smaller target vessels and bifurcation lesions (mean stent length [+/- SEM] was 21.1+/-1.2 mm for SES and 16.0+/-0.6 mm for BMS; stent diameter mean [+/- SEM] was 2.9+/-0.0 mm for SES and 3.1+/-0.1 mm for BMS; bifurcation lesions were 43% for SES and 7% for BMS; all P<0.01). At nine months of clinical follow-up, no death or myocardial infarction was reported. Twenty-one patients underwent clinically driven repeat coronary angiography at a mean (+/- SEM) of 8+/-1 of months (range two to 12 months) follow-up. Target lesion revascularization procedures were recorded in six patients (11%) for nine lesions (6%). Of these lesions, seven were categorized after blinded analysis as due to in-BMS restenosis and two to in-SES restenosis (P=0.01); three patients (5.4%) underwent reangioplasty for de novo lesions. There was one case of acute in-SES thrombosis. SES showed significantly less neointimal hyperplasia (late lumen loss was 0.4+/-0.1 mm for SES and 1.3+/-0.1 mm for BMS; loss index was 0.15+/-0.05 for SES and 0.48+/-0.05 for BMS; all P<0.001). CONCLUSIONS: The use of SES resulted in less neointimal hyperplasia even when used to treat lesions at higher risk for restenosis based on angiographic characteristics. BMS implantation significantly limits this beneficial effect, compromising the outcome of hybrid percutaneous coronary revascularization.     

Acute angiographic and clinical results of the NIR w/SOX stent.

Acute angiographic and clinical results of the NIR w/SOX stent (Boston Scientific/Scimed, Inc., Maple Grove, Minnesota) were evaluated. Between March 2000 and May 2000, a total of 102 lesions in 88 patients underwent stenting with the NIR w/SOX stent. The reference vessel diameter and lesion length were 2.97 +/- 0.50 mm and 16.2 +/- 6.5 mm, respectively. The minimal lumen diameter increased from 0.68 +/- 0.45 to 3.07 +/- 0.50 mm. Stent delivery failure was observed in 4 lesions (3.9%). On the other hand, the NIR w/SOX stent was successfully delivered in 7 of 9 lesions that had unsuccessful delivery of other kinds of stents. Angiographic success was observed in all except 1 lesion where the NIR w/SOX stents could not be delivered. There were no procedural myocardial infarctions or deaths. In one case, procedural coronary bypass surgery was performed. There was no acute closure or subacute stent thrombosis. Despite unfavorable lesion characteristics, the NIR w/SOX stent achieves high procedural success and acceptable stent delivery. Furthermore, it may have a high probability to be delivered in lesions where other kinds of stent result in unsuccessful delivery.     

Direct coronary stenting versus stenting with balloon pre-dilation: immediate and follow-up results of a multicentre, prospective, randomized study. The DISCO trial. DIrect Stenting of COronary Arteries.

AIMS: To assess the safety of direct coronary stenting, its influence on costs, duration of the procedure, radiation exposure, clinical outcome and angiographic restenosis. METHODS AND RESULTS: We randomized 416 patients (446 lesions) to direct stent implant or stent implant following balloon pre-dilation. Patients >75 years old, heavily calcified lesions, bifurcations, total occlusions, left main lesions and very tortuous vessels were excluded. Direct stenting was successful in 217/224 lesions (96.8%). No single loss or embolization of the stent occurred. All stents in the group with pre-dilation were effectively deployed. The immediate post-procedure angiographic results were similar with both techniques. Fluoroscopy and procedural time were significantly lower in direct stenting (6.4+/-0.3 and 21+/-0.9 min) than in pre-dilated stenting (9.1+/-0.4 and 27.5+/-1.1 min) (P>0.001). Major adverse cardiac events during hospitalization were one in direct and four in pre-dilated stenting (P=0.05) but there were no significant differences at follow-ups at 1, 6 and 12 months between the two groups. Angiographic reevaluation at 6 months was performed in 94% of the cases. Restenosis rate was 16.5% in direct stenting and 14.3% in pre-dilated stenting (P=ns). CONCLUSIONS: Direct stenting is as safe as pre-dilated stenting in selected coronary lesions. Acute angiographic results are similar but procedural costs, duration of the procedure and radiation exposure are lower in direct stenting. Overall success rate, mid-term clinical outcome and restenosis are similar with both techniques.     

Long-term outcomes of bifurcation lesions after implantation of drug-eluting stents with the "mini-crush technique".

OBJECTIVES: To evaluate clinical and angiographic long-term outcome of "the mini-crush" technique for treating bifurcation lesions. BACKGROUND: Despite proven efficacy of drug-eluting stent (DES) within most lesions subsets, bifurcation lesions continue to exhibit high restenosis rate using current DES stenting technique. METHODS: We report a new stenting technique which was employed in 45 consecutive patients (52 lesions) between April 2004 and July 2005 to treat true bifurcation lesions using DES in both branches. RESULTS: Using this technique procedural success was obtained in 100% of cases, without complications and with excellent angiographic result in 96.1% and 98.1% of main vessel and side branch. Preprocedure reference vessel diameter and minimal lumen diameter (MLD) were 2.68 +/- 0.48 and 0.90 +/- 0.55 mm for the main branch, respectively and 2.28 +/- 0.34 and 1.14 +/- 0.47 mm for the side branch, respectively. Postprocedure MLD was 2.56 +/- 0.39 mm for the main branch and 2.16 +/- 0.29 mm for the side branch. There were no in-hospital major adverse cardiac events (MACE). At 72 days after procedure there was one case of side branch stent thrombosis (2.2%), which resulted in non Q-wave MI. Angiographic follow up was obtained in 100% of patients at 7.5 +/- 1.3 months. Target lesion revascularization (TLR) was 12.2%; no death and Q-wave MI were observed; reference vessel diameter and MLD for the main branch were 2.79 +/- 0.51 and 1.99 +/- 0.65 mm respectively and for the side branch 2.28 +/- 0.40 and 1.63 +/- 0.48 mm respectively. Restenosis rate in the main branch was 12.2% while in the side branch was 2.0%. CONCLUSIONS: In-hospital outcome indicates that the mini-crush technique for bifurcation lesions with DES can be easily performed. It provides very low total MACE rate and restenosis at 8-month follow-up. These results confirmed the advantage of this specific technique to give complete coverage of the ostium of the side branch using two stents technique.     

Short stent implantation for routine use is feasible in a high proportion of coronary interventions and yields a low restenosis rate

Stent length predicts restenosis. The feasibility of using a short stent (<10 mm) routinely was investigated in 331 consecutive patients treated for 424 coronary artery lesions. A single short stent provided suitable coverage and achieved a residual stenosis <30%, with or without predilatation, in 252/424 lesions (59.4%). Longer stents were implanted in 58/424 lesions (13.7%), while only percutaneous transluminal coronary angioplasty was performed in 114/242 lesions (26.9%). Angiographic success and procedural success were achieved in 250/252 lesions (99.2%). Restenosis occurred in 36/231 lesions (15.6%) after short stenting, in 10/53 lesions (18.9%) after long stents, in 21/88 lesions (23.9%) after percutaneous transluminal coronary angioplasty, and in 67/372 lesions (18.0%) controlled angiographically. Only small vessel diameter predicted restenosis after short stenting. Thus, a single short stent implanted directly or after predilatation is sufficient to achieve an acceptable angiographic result in more than in nearly 60% of all treated lesions. Short stenting results in a low restenosis rate.     

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.     

Thrombotic and hemorrhagic complications of stenting coronary arteries: Incidence,management and prevention

Stents are intravascular prostheses which provide endoluminal scaffolding, effectively reducing elastic recoil and sealing local dissections. Stents have become the treatment of choice for acute vessel closure following percutaneous coronary intervention. In addition, by providing a large, smooth lumen, stenting increases procedural success and decreases late restenosis compared with conventional balloon angioplasty. All stents evaluated clinically are constructed of non-corrosive metallic alloys which are inherently thrombogenic.The incidence of stent thrombosis ranges from 0.4-18%. While acute thrombosis is uncommon, subacute thrombosis may occur from 5 to 21 days (mean 7 days) after placement. Predictors of stent thrombosis include stenting for bailout indication, angiographically visible thrombus after implantation, stenting of smaller vessels, presence of residual dissection after stenting, poor distal runoff, incomplete stent expansion and stenting in the setting of acute myocardial infarction. Stent thrombosis is associated with high incidence of Q-wave myocardial infarction (70–90%) and mortality (7–20%), and is best treated with emergency catheterization and balloon angioplasty.To prevent stent thrombosis, aggressive procedural and postprocedural pharmacological regimens employing antiplatelet agents (aspirin, dipyridamole and dextran) and anticoagulation (heparin followed by warfarin) have been used. While these regimens have reduced the incidence of stent thrombosis to <5%, they are associated with a high incidence of vascular and hemorrhagic complications, increased length of hospitalization and total cost. To decrease the incidence of stent thrombosis and obviate the need for anticoagulation, strategies such as intravascular ultrasound guided optimal stenting and addition of the antiplatelet agent ticlopidine, are being evaluated. In the future coating of stents with agents such as heparin, may further reduce the risk of thrombosis and the requirement for long-term anticoagulation.