Safety and utility of intravascular ultrasound-guided carotid artery stenting.

Intravascular ultrasound (IVUS) is useful in evaluating coronary stent deployment. The aim of this study was to assess the safety and utility of IVUS in carotid artery stenting (CAS). Ninety-eight consecutive high-risk patients (107 arteries) underwent CAS. IVUS was performed prior to predilatation in 87 of the 107 vessels and in all 107 following stent deployment when an optimal angiographic appearance was obtained. Quantitative carotid angiography (QCA) and IVUS analysis were performed offline. Procedural success was 97%. Combined stroke or death at 30 days was 5.6%. IVUS measurements of the minimum lumen diameter (MLD) of the distal internal carotid artery (ICA) reference segment were similar to QCA (4.60 +/- 0.74 vs. 4.74 +/- 0.71 mm; P = 0.21). The ICA stent MLD was significantly smaller by IVUS compared to QCA (3.65 +/- 0.68 vs. 4.31 +/- 0.76 mm; P < 0.001). IVUS detected stent malapposition in 11%. IVUS findings, after an optimal angiographic result, necessitated additional treatment in 9% of procedures. Calcium was detected in more arteries with IVUS than angiography (61% vs. 46%; P < 0.05). Arteries with superficial lesion calcification subtending three or four quadrants by IVUS had a 31% incidence of stroke compared with a 1% incidence in arteries without severe superficial calcium (P < 0.001). We found IVUS imaging in CAS to be safe even prior to plaque dilatation. IVUS provides a more accurate assessment of stent dimensions, expansion, and apposition than angiography. Severe calcification by IVUS was associated with a higher risk of stroke.     

Quantitative Coronary Angiographic Analysis of Spasm and Elastic Recoil After High Speed Rotational Atherectomy

This study evaluates the short-term changes in coronary artery segments treated with high speed rotational atherectomy (HSRA). Quantitative coronary angiographic (QCA) analysis indices, such as degree of expected ablation, elastic recoil, and segmental spasm, were examined in 133 patients and restudied 24 hours after HSRA. The study was also designed to compare the early results of three different HSRA strategies: stand-alone (SA) HSRA; HSRA with adjunctive high (≥ 4 atm) pressure (HP BA) and low (≥ 2 atm) pressure balloon angioplasty (LP BA). Previous studies have suggested negligible elastic recoil after HSRA as well as demonstrated the possibility of further continuous improvement in vessel patency up to 24 hours postprocedure. From a total of 656 patients treated with HSRA, a cohort of 133 patients with successful HSRA of 167 lesions were restudied angiographically at 24 hours. Serial QCA evaluation of the treatment site was performed. Analysis of the relative gain in minimal luminal diameter (MLD) assessed at 24 hours postprocedure showed that the highest gain group (> 40%) had narrower initial lesions compared to moderate gain (1%–40%), or MLD loss groups (MLD 0.5 ± 0.4 mm vs 1.0 ± 0.3 and 1.5 ± 0.4, respectively, P < 0.01). The initial percent diameter stenosis was also higher in the high gain group (77.1 ± 16.0 vs 61.9 ± 11.8 and 53.0 ± 11.9, P < 0.01). Immediately postprocedure there was a significant increase in MLD and a decrease in percent diameter stenosis. There was no difference in residual lesion characteristics postprocedure. While progressive MLD decrease was observed in the loss group (MLD postprocedure 1.6 ± 0.5 and 1.2 ± 0.6 at 24 hours, P < 0.01), a continuous increase in MLD was noted in the high gain group (MLD postprocedure 1.7 ± 0.5 mm vs at 24 hours 2.0 ± 0.5 mm, P < 0.01). The high gain group was characterized by the most lesion debulking, the most pronounced segmental spasm, and the least elastic recoil. Adjunctive HP BA was associated with the largest size vessels (D ref. in SA HSRA group was 2.6 ± 0.8 mm vs 2.9 ± 0.6 mm in LP BA and 3.0 ± 0.7 mm in HP BA groups, P < 0.01), the lowest elastic recoil (SA HSRA 23.8%± 20.9% vs LP BA 15%± 16.8% and HP BA 5.7%± 14.4%, P < 0.05), and the highest incidence of vessel dissection (SA HSRA 8.1% vs LP BA 14.7% and HP BA 34.0%, P < 0.05). However, these larger vessels underwent the least amount of lesion debulking (SA HSRA 46.4%± 27.2% vs LP BA 38.6%± 24.0% and HP BA 30.5%± 19.5%, P _{SA HSRA vs. HP BA} < 0.001). There are measurable degrees of elastic recoil and local spasm observed after HSRA. HSRA of the most severe lesions yields the highest procedural gain, the lowest elastic recoil and the highest index of lesion ablation. In addition, some late increase in the MLD due to the resolution of spasm is observed at 24 hours postprocedure. SA HSRA is associated with higher degrees of expected lesion ablation. This is comparable to the degree of improvement in MLD, where adjunctive percutaneous transluminal coronary angioplasty is utilized as assessed at 24 hours postprocedure. HSRA with adjunctive HP BA yields immediate results showing the least elastic recoil and spasm at the expense of the highest incidence of dissection and side branch loss.     

Quantitative measurements of in-stent restenosis: A comparison between quantitative coronary ultrasound and quantitative coronary angiography.

While quantitative coronary angiography (QCA) remains the standard used to assess new interventional therapies, intracoronary ultrasound (ICUS) is gaining interest. The aim of the study was to determine the relationship between QCA and quantitative coronary ultrasound (QCU) measurements after stenting. Sixty-two consecutive patients with both QCA and QCU analysis after stent implantation were included in the study. The mean luminal diameter (QCU vs. QCA) were 2.74 +/- 0.46 mm and 2.41 +/- 0.49 mm (P < 0.0001), the minimal luminal diameter (MLD) 2.08 +/- 0.44 mm and 1.62 +/- 0.42 mm (P < 0. 0001), and the projected QCU MLD 1.90 +/- 0.42 mm (P < 0.0001 with respect to QCA). Percentage obstruction diameter (QCU vs. QCA) were 41.53% +/- 10.78% and 43.15% +/- 12.72% (P = NS). The stent diameter (QCU vs. QCA) were 3.54 +/- 0.65 mm and 3.80 +/- 0.37 mm (P = 0. 0004). Stent length measured by QCU were longer at 31.11 +/- 13.54 mm against 28.63 +/- 12.75 mm, P < 0.0001 with respect to QCA. In conclusion, while QCA and QCU appear to be comparable tools for measuring corrected stent diameters and stent lengths, smaller luminal diameters were found using QCA. This is of particular relevance to quantitative studies addressing absolute changes in vascular or luminal diameters. Cathet. Cardiovasc. Intervent. 48:133-142, 1999.     

Efficacy of directional coronary atherectomy before stent implantation for coronary ostial lesions

We evaluated stent implantation following directional coronary atherectomy (DCA) for coronary ostial lesions. The subjects were 27 patients (27 lesions) who underwent stent deployment after DCA, and 47 patients (47 lesions) who underwent stent deployment alone as the control group. There were no differences in numbers of lesions with multi-vessel disease, left anterior descending artery lesions, de novo lesions or reference vessel diameters in the two groups. The percent diameter stenosis after stent implantation was lower in the DCA-stent group than in the stent-alone group (9 +/- 10% versus 17 +/- 14%, respectively; p < 0.01). The initial procedural success rate was 92.6% in the DCA-stent group and 91.4% in the stent-alone group. The initial clinical success rate was 100% in the DCA-stent group and 95.7% in the stent-alone group. The restenosis rate was lower in the DCA-stent group (20% versus 43% in the stent-alone group). This study showed that debulking by DCA before stenting is more effective compared to stenting alone.     

Angiographic, intravascular ultrasound, and fractional flow reserve evaluation of direct stenting vs. conventional stenting using BeStent2 in a multicentre randomized trial.

AIMS: Direct stenting (DS) may not be as safe and effective as conventional stenting. The objective was to demonstrate equivalence of post-procedural mean luminal diameter (MLD) by angiography after BeStent2 placement between DS and pre-dilatation (PD) strategy. METHODS AND RESULTS: Two hundred and two patients with a single de novo lesion (diameter >/=3.0 mm and length 相似文献   

Does stent design affect probability of restenosis? A randomized trial comparing Multilink stents with GFX stents

BACKGROUND: Experimental studies have revealed that stent configuration influences intimal hyperplasia. The purpose of this study was to evaluate clinical outcomes for 2 stent designs in a randomized trial with quantitative coronary angiography (QCA) and intravascular ultrasonography (IVUS). METHODS: We randomly assigned 100 patients with 107 lesions and symptomatic coronary artery disease to deployment of a Multilink stent (Advanced Cardiovascular Systems, Guidant, Santa Clara, Calif) or a GFX stent (Applied Vascular Engineering, Santa Rosa, Calif) with IVUS guidance. QCA and IVUS studies were performed before and after intervention and at follow-up (4.2 +/- 1.0 months). RESULTS: There were no significant differences in baseline characteristics and QCA and IVUS parameters before and after intervention between the 2 groups. However, minimal lumen diameter at follow-up was significantly larger in the Multilink group (2.46 +/- 0.59 vs 2.08 +/- 0.79 mm, P <.05). Maximal in-stent intimal hyperplasia was significantly larger in the GFX group (2.9 +/- 1.7 vs 1.8 +/- 1.2 mm(2), P <.01). The restenosis rate differed between the 2 groups (Multilink 4% vs GFX 26%, P =.003). In multiple stepwise logistic regression analysis, the only predictor that significantly correlated with restenosis was stent type (P <.01). The odds ratio for the GFX stent-treated vessels was 18.65 (95% confidence interval 2.10-165.45). CONCLUSIONS: With deployment of the GFX stent, a thicker neointima develops within the stent. Stent configuration may affect clinical outcomes.     

Stent design-related coronary artery remodeling and patterns of neointima formation following self-expanding and balloon-expandable stent implantation.

The self-expanding Wallstent (WS) and balloon-expandable Palmaz-Schatz stents (PS) display different mechanical and dynamical stent properties. We analyzed the impact of the respective stent design on coronary wall geometry using quantitative coronary angiography (QCA) and intracoronary ultrasound (ICUS) measurements. Serial measurements were performed within the stent and within reference segments of 50 patients (25 WS, 25 PS). Relative changes for each parameter in both stent designs were calculated (Mann-Whitney U-test; 95% CI). The luminal net gain in WS was not significantly higher in WS compared with PS (1.63 +/- 1.11 vs. 1.44 +/- 0.63 mm; P = 0.2554). The respective loss indexes were also similar (0.38 +/- 0.42 vs. 0.36 +/- 0.23; P = 0.8578). The WS segments showed significant postinterventional stent expansion with positive vessel remodeling. The neointima formation was significantly higher in WS segments (4.23 +/- 2.07 vs. 2.22 +/- 2.22 mm(2)). The coronary wall morphology and stent geometry after 6.5 +/- 1.2 months are related to the stent design. In WS segments, the neointima formation was balanced by postinterventional stent expansion, resulting in a comparable relative lumen loss in both stent types. The respective stent design had no impact on the vessel reference segments.     

Short- and long-term outcomes of Wiktor stent implantation at low versus high pressures. Austrian Wiktor Stent Study Group.

A prospective, randomized, multicenter trial was conducted to evaluate whether high-pressure postdilation of the Wiktor stent provides short- and long-term benefits compared with the conventional low-pressure implantation technique. From June 1995 through May 1996, 181 patients were randomly assigned to either low-pressure (6 to 12 atm, group A, n = 94) Wiktor stent placement or to high-pressure postdilation (> or = 13 atm, group B, n = 87) after stent deployment. All patients were followed up clinically for 7 +/- 3 months, with an angiographic follow-up in 154 patients (85%). After stent implantation, neither minimal lumen diameter (MLD) nor percent diameter stenosis (%DS) differed significantly between the 2 groups (MLD, 2.8 +/- 0.5 vs 2.9 +/- 0.5 mm; %DS, 17 +/- 8% vs 16 +/- 9% for groups A and B, respectively). However, a trend toward a larger mean lumen diameter within the stent was observed in group B (3.3 +/- 0.6 vs 3.5 +/- 0.5 mm for groups A and B, respectively; difference between means 0.14 mm, 95% confidence interval -0.01 to 0.29, p = 0.08). Angiographic follow-up revealed similar MLD and %DS in both treatment groups (MLD, 2.1 +/- 0.7 vs 2.2 +/- 0.8 mm; %DS, 31 +/- 17% vs 30 +/- 24% for groups A and B, respectively, p = NS). Acute stent thrombosis occurred in 2 patients (1%) (1 patient in each group), and subacute thrombosis in 1 patient (0.6%) in group A. There was 1 death in group A, and target lesion restenosis (> or = 50% DS) was observed in 15% of patients with no differences between the groups. In conclusion, this study demonstrated favorable short- and long-term results of Wiktor stent implantation. Despite a trend toward additional initial lumen gain by high-pressure postdilation, this did not translate into a measurable improvement in long-term outcome.     

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.     

Revisiting late loss and neointimal volumetric measurements in a drug-eluting stent trial: analysis from the SPIRIT FIRST trial.

This study was conducted to reevaluate the significance of angiographic late loss and to assess the agreement between new proposed neointimal volumetric measurements derived from quantitative coronary angiography (QCA) and standard intravascular ultrasound (IVUS)-based parameters. Neointimal volumetric measurements may better estimate the magnitude of neointimal growth after stenting than late loss. In 56 in-stent segments (27, everolimus; 29, bare metal) in the SPIRIT FIRST study, we compared QCA measures with the corresponding IVUS parameters. Two IVUS-late loss models were derived from minimal luminal diameter (MLD) using either a circular model or a so-called projected MLD. QCA-neointimal volume was calculated as follows: stent volume (mean area of the stented segment x stent length) at post procedure - lumen volume (mean area of the stented segment x stent length) at follow-up (the stent length either from nominal stent length or the length measured by QCA). Videodensitometric neointimal volume was also evaluated. Each of the three neointimal volume and percentage volume obstruction by QCA showed significant correlation with the corresponding IVUS parameters (r = 0.557-0.594, P < 0.0001), albeit with a broad range of limits of agreement. Late loss and volumetric measurements by QCA had a broader range of standard deviation than those by IVUS. QCA-volumetric measurements successfully confirmed the efficacy of everolimus-eluting stents over bare metal stents (P < 0.05). Our proposed QCA volumetric measurements may be a practical surrogate for IVUS measurements and a discriminant methodological approach for assessment of treatment effects of drug-eluting stents.     

Preventive effects of the heparin-coated stent on restenosis in the porcine model.

The coronary stent reduces acute coronary arterial occlusion and late restenosis during and after coronary intervention. However, stent thrombosis and restenosis are still major limitations in the widespread use of the coronary stent. Local drug delivery using the heparin-coated stent may be a new approach, which reduces the incidence of stent thrombosis and restenosis. In order to evaluate the effects of the heparin-coated stent on stent restenosis, heparin-coated stents were compared with control stents in a porcine coronary stent restenosis model. Stent overdilation injury (stent:artery = 1.3:1.0) was performed with bare Wiktor stents (group I, n = 10) and heparin-coated Wiktor stents (group II, n = 20; HEPAMED, Medtronics) in porcine coronary arteries. Follow-up quantitative coronary angiography (QCA) was performed at 4 weeks after stenting, and histo-pathologic assessments of stented porcine coronary arteries were compared in both groups. On QCA, percent diameter stenosis was significantly higher in group I than in group II (16.3% +/- 6.62% vs. 9.6% +/- 5.06%, P < 0.05). The injury score of stented porcine coronary arteries was the same in both groups (1. 26 +/- 0.23 vs. 1.20 +/- 0.22). The area of pathologic stenosis of the stented arteries was higher in group I than in group II (41.6% +/- 12.5% vs. 27.1% +/- 9.9%, P < 0.005). The neointimal area was higher in group I than in group II (4.58 +/- 1.41 mm(2) vs. 2.57 +/- 1.07 mm(2), P < 0.05). By immunohistochemistry, the proliferating cell nuclear antigen (PCNA) index was higher in group I compared with group II (11.2% +/- 6.75% vs. 6.3% +/- 4.14%, P < 0.05). The heparin-coated stent is effective in the prevention of late coronary stent restenosis in a porcine coronary stent restenosis model. This may be related to the inhibition of neointimal cell proliferation.     

Randomized comparison of the coil-design Crossflex and the tubular NIR stent.

The purpose of this study was to compare the angiographic outcome of implantation of the coil-design Crossflex stent with the tubular NIR stent for treatment of coronary artery stenoses. Two hundred twenty-three patients with one genuine coronary artery lesion were randomized to implantation with a 15 mm Crossflex stent (n = 112) or a 16 mm NIR stent (n = 111). The patients had angiographic follow-up after 6 months. Primary endpoint was minimal luminal diameter (MLD) after 6 months. There was a similar clinical outcome in the two groups. At 6-month follow-up, the MLD was significantly lower in the Crossflex group (1.94 +/- 0.79 mm) than in the NIR group (2.37 +/- 0.84 mm; P < 0.001). Early gain was the same in the two groups. Late loss and percent diameter stenoses were significantly higher in the Crossflex group. The binary restenoses rate was 26% and 17% in the Crossflex and the NIR groups, respectively (P = NS). The coil-design Crossflex stent was found to be inferior to the tubular NIR stent concerning late loss and MLD at 6-month follow-up.     

A new intracoronary measurement catheter, MetriCath, compared to intravascular ultrasound and quantitative coronary angiography in a stented porcine coronary model.

The purpose of this study was to compare measurements by MetriCath to intravascular ultrasound (IVUS) and quantitative coronary angiography (QCA). The MetriCath system consists of a low-pressure (200 mm Hg) balloon catheter connected to a pressure transducer and infusion pump linked to a computer that records pressure-volume curves. Cross-sectional area of blood vessels is obtained directly from the unrestrained and in-stent pressure-volume measurements. We compared stent cross-sectional area measurements by MetriCath, IVUS, and QCA in a porcine stented coronary artery model. Comparison of area measurements in 14 stents showed no significant differences between the three methods (P = 0.66). On average, values differed 0.37 +/- 0.60 mm(2) between MetriCath and QCA, 0.13 +/- 0.55 mm(2) between MetriCath and IVUS, and 0.22 +/- 0.80 mm(2) between IVUS and QCA. This corresponds to 6.2% +/- 10%, 3.0% +/- 9.0%, and 3.1% +/- 12.9% relative difference from the average of two corresponding measurements. Linear regression analysis showed excellent correlation between measurements (r = 0.99 for all comparisons). The differences in in-stent area measurements between MetriCath and both QCA and IVUS were small. Considering the ease and rapidity of obtaining MetriCath results, this technique may form an alternative to the others in evaluating stent expansion. Based on these findings, clinical evaluation seems warranted.     

A porcine coronary stent model of increased neointima formation in the left anterior descending coronary artery

BACKGROUND: Clinical trials suggest an increased frequency of restenosis after coronary intervention in left anterior descending (LAD) compared to the left circumflex or right coronary arteries. Experimental studies correlate stent-induced arterial injury and the extent of neointima formation. This study investigates whether the coronary artery affects the relationship between arterial injury and neointima hyperplasia in the porcine stent model. METHODS: Non-lipemic farm pigs underwent stent placement in the LAD (n = 26) and the right coronary artery (RCA; n = 30). Quantitative coronary angiography (QCA) was performed before and after stent placement, and at follow-up; quantitative histomorphometry and injury score were analyzed at 30-day follow-up. RESULTS: Initial procedure balloon/artery ratios (LAD 1.17 +/- 0.11 vs RCA 1.17 +/- 0.09, P = NS), and minimal stent lumen diameters (MLD; LAD 2.91 +/- 0.31 vs RCA: 2.93 +/- 0.28 mm, P = NS) were similar suggesting no difference in deployment technique. At follow-up there was more restenosis in the LAD (diameter stenosis: 55.0 +/- 26.4% vs 37.3 +/- 18.1%, and MLD: 1.24 +/- 0.78 mm vs. 1.71 +/- 0.57 mm, P < 0.05 for both comparisons). No differences were seen for injury score (1.09 +/- 0.51 vs 1.01 +/- 0.57; LAD vs RCA) or stent area (6.13 +/- 0.99 vs 6.55 +/- 1.42 mm2). Histomorphometry demonstrated smaller lumen area (2.15 +/- 0.94 vs 2.96 +/- 1.29 mm2) and thicker neointima (0.63 +/- 0.25 vs 0.51 +/- 0.17 mm; all P < 0.05) in the LAD. Multiple linear regression analysis identified the LAD as an independent predictive factor for increased neointima formation. CONCLUSIONS: These observations establish an animal model that is consistent with clinical experience showing that restenosis after stenting is more common in the LAD. The findings may be useful for understanding and developing systemic and local antirestenotic strategies.     

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.     

Does Carbofilm Coating Affect In‐Stent Intimal Proliferation? A Randomized Trial Comparing Rx Multi‐Link Penta and Tecnic Carbostent™ Stents: SIROCCO Trial

OBJECTIVES:To compare the volume of in-stent neointimal proliferation, assessed by intravascular ultrasound (IVUS), at 6-month follow-up after implantation of a coronary Carbofilm-coated stent (Tecnic Carbostent, Sorin Biomedica Cardio, Saluggia, Italy) versus a conventional 316 L stent (Rx Multi-Link Penta, Abbott Laboratories, Abbott Park, IL). BACKGROUND:Many trials suggest that stent characteristics and coating could be important determinants of restenosis. METHODS:From October 2004 to May 2005, 63 patients were randomized to Tecnic (T, n = 30) or Penta (P, n = 33). The primary end-point was in-stent volume of neointimal hyperplasia (NIH) measured by IVUS at 6 months. The secondary end-points included binary restenosis, minimal luminal diameter (MLD), target lesion revascularization, and major adverse cardiac events. RESULTS:There were no significant differences between T and P as to mean age, male gender, clinical status, complexity of the lesion, lesion length, reference vessel diameter before percutaneous coronary intervention (PCI), MLD pre-PCI, and stent-to-artery ratio. However, MLD poststenting was greater in P group than T group (2.81 +/- 0.45 mm vs. 2.49 +/- 0.33 mm, P < 0.002). At 6 months, angiographic late lumen loss (0.61 +/- 0.51 mm vs. 0.92 +/- 0.61 mm, P < 0.043), in-stent obstruction (25.86 +/- 16.48% vs. 38.33 +/- 19.56%, P = 0.021), and in-stent late loss volume (31.62 +/- 29.75 mm(3) vs. 57.28 +/- 37.16 mm(3), P = 0.016) were significantly lower in T group than in P group. CONCLUSION:Penta stent appears to offer a better deployment and a larger MLD post-PCI than Carbofilm-coated stent. However, a thicker NIH was observed on Penta stent at 6-month follow-up, when compared to Tecnic.     

Initial experience with the novel 6 Fr-compatible system for debulking de novo coronary arterial lesions.

The purpose of this study was to determine the efficacy of a novel system for debulking of de novo native coronary arterial lesions. The Helixciser De Novo system is a novel 6 Fr-compatible catheter with a cutter encased in a slotted-orifice housing to excise atheromatous plaque. The cutter rotates at 15,000 rpm, debulking the plaque as it tracks through the lesion over a straight wire or a self-expanding nitinol helical-shaped wire. The tissue is aspirated via an Archimedes screw pump to vacuum collection chamber. The device was evaluated in a porcine toxic coronary stent model of chronic occlusion and in five patients with focal de novo native coronary arterial lesions. Procedural variables along with outcomes were reviewed. Quantitative angiography (QCA) and volumetric intravascular ultrasound (IVUS) analysis were performed. In a porcine model of chronic occlusion, QCA demonstrated pretreatment minimal lumen diameter (MLD) increased from 0.77 +/- 0.59 to 1.88 +/- 0.25 mm postdebulking. IVUS analysis demonstrated pretreatment lumen volume (LV) increased from 15.8 +/- 22.2 to 46.4 +/- 28.9 mm(3) postdebulking. In human clinical feasibility cases, QCA demonstrated pretreatment MLD increased from 0.96 +/- 0.40 to 2.04 +/- 0.19 mm postdebulking. IVUS analysis demonstrated pretreatment LV increased from 38.40 +/- 12.78 to 52.05 +/- 15.68 mm(3) postdebulking. Preliminary results document the feasibility of Helixcision De Novo for treatment of focal de novo native coronary arterial lesions. Quantitative angiographic and IVUS analysis indicate that this system can effectively debulk plaque from selected noncalcified atherosclerotic lesions and thus may represent an alternative treatment strategy for coronary artery disease.     

雷帕霉素与紫杉醇洗脱支架术治疗多支病变冠心病患者疗效的比较

目的比较雷帕霉素洗脱支架(CYPHER)与紫杉醇洗脱支架(TAXUS)治疗多支冠状动脉病变患者的疗效及安全性。方法2003年6月至2004年12月在我院置入药物洗脱支架的416例多支病变冠心病患者,剔除合并左主干病变、急性心肌梗死、再次血管重建及合用普通支架者。随机分为两组:CYPHER支架组210例,TAXUS支架组206例。比较两组支架术后近期及远期疗效。结果支架置入术前两组患者冠心病危险因素、心功能状况及冠状动脉病变特征无统计学差异。两组PCI手术成功率、平均支架置入数(3.24±1.25)比(3.19±1.38)枚/例及并发症发生率均无统计学差异。术后平均随访(19.5±8.9)个月,总随访率、心绞痛复发率、造影复查再狭窄率、主要不良心脏事件发生率、心功能改善率及无事件存活率均无统计学差异。与CYPHER支架组比较TAXUS支架组术后亚急性血栓发生率有增高趋势,但无统计学差异(1.0%比0.5%,P>0.05)。用QCA测量术后6～9个月冠状动脉造影结果,支架内最小管腔直径(MLD)、节段内MLD、支架内晚期管腔丢失及节段内晚期管腔丢失两组间比较均无统计学差异。结论多支冠状动脉病变患者置入CYPHER和TAXUS两种药物洗脱支架均能达到成功率高,再狭窄率低,远期临床疗效好的结果,两者疗效及安全性无统计学差异。     

血管内超声与定量冠脉造影应用于冠脉临界病变诊治的比较

目的 研究血管内超声（intravascular ultrasound,IVUS）在优化民航飞行员冠脉临界病变诊断和治疗中的应用。 方法 通过定量冠脉造影（quantitative coronary angiography,QCA）和IVUS对120例飞行员患者165处冠脉临界病的最小管腔直径（minimal lumen diameter,MLD）、直径狭窄率（diamter stenosis,DS）与最小管腔面积（minimal lumen area,MLA）、面积狭窄率（area stenosis,AS）等参数进行对比分析;对IVUS提示管腔MLA<4 mm2飞行员患者的冠脉临界病变行支架植入术。 结果 ①同一临界病变处QCA显示的MLD,DS及MLA,AS值均小于IVUS相应的测量值,且差异有统计学意义（P<0.01）,表明IVUS对冠脉病变狭窄定量测量方面准确性更高;②IVUS提高血栓病变（15.0% vs. 2.5%,P<0.05）和心肌桥（42.5% vs. 2.5%,P<0.01）的诊断率;③与QCA相比,IVUS直接显示介入治疗中支架的贴壁情况,指导支架扩张完全。 结论 IVUS较QCA能更准确地检测冠脉临界病变范围,更灵敏地诊断血栓和心肌桥,利于全面优化临界病变的诊疗。     

定量多层螺旋CT冠状动脉成像与定量冠状动脉造影的对比研究

目的通过与同期定量冠状动脉造影(QCA)作对照,评价定量冠状动脉多层螺旋CT(QCT)成像对冠状动脉疾病的诊断价值。方法选择冠心病患者78例,利用QCA和QCT测量同一病变的最小管腔直径、最小管腔面积、参考直径、参考面积、靶病变长度、直径狭窄率、面积狭窄率等指标,比较2种方法结果的相关性及一致性。结果 78例患者中,存在明显冠状动脉病变62例(79.49%),QCT和QCA一致认为重度狭窄(>75%)的节段共为47段,其中右冠状动脉1 5段,前降支27段,回旋支5段。QCT和QCA测量的最小管腔面积、面积狭窄率比较,差异有统计学意义(P<0.05),2种测量最小管腔直径、参考直径、参考面积、靶病变长度和直径狭窄率的比较,差并均无统计学意义(P>0.05)。QCT和QCA测量最小管腔直径,靶病变长度,参考直径,参考面积,直径狭窄率一致性较好(0.5≤r_c≤0.85),最小管腔面积、面积狭窄率则一致性不佳(r_c<0.5)。结论 QCT检查能良好评价冠状动脉病变.可用于术前即可指导对经皮冠状动脉介入治疗中球囊和支架的选择。