Intravascular ultrasonography in the evaluation of results of coronary angioplasty and stenting

The main advantage of intravascular ultrasonography (IVUS) over angiography in assessing the effect of coronary interventions is the ability of IVUS to directly visualize the vessel wall. IVUS often reveals a high residual plaque burden after angiographically successful angioplasty, and this can motivate the operator to use additional, more aggressive measures in an attempt to increase lumen dimensions. Studies using IVUS imaging before and after balloon angioplasty have shown that luminal gain after percutaneous transluminal coronary angioplasty (PTCA) results from a combination of plaque reduction and vessel wall stretch. Minimal luminal area and residual area stenosis after PTCA and stent deployment, as measured by IVUS, have been shown to be predictors of restenosis. IVUS studies have pointed to vessel shrinkage, not intimal hyperplasia, as the main mechanism of restenosis after PTCA. IVUS guidance of stent deployment has often revealed inadequate stent expansion despite optimal results on angiography, leading to high-pressure stent deployment with significant additional luminal gain. Restenosis rates may be lower with IVUS-guided stent deployment.     

Preventive mechanisms and effects of pemirolast potassium on restenosis after percutaneous transluminal coronary angioplasty: serial coronary angiography and intravascular ultrasound studies

Pemirolast potassium, an antiallergic agent, has preventive effects against restenosis after percutaneous transluminal coronary angioplasty (PTCA). This study investigated the mechanism of the preventive effects of pemirolast on restenosis using serial intravascular ultrasound (IVUS). Initial elective PTCA was performed in consecutive 106 patients from March 1996 through August 1997. Patients with type C lesions or graft stenosis were excluded from the study. A total of 97 patients with 110 lesions, 48 patients (56 lesions) in the pemirolast treated group and 49 patients (54 lesions) in the control group were analyzed. Restenosis was defined as a diameter stenosis of > or = 50% at follow-up study. Patients in the pemirolast group received 20 mg/day from the morning after angioplasty until the time of follow-up (mean 6 months). The lumen cross-sectional area, vessel area, plaque area, and % plaque area were measured by quantitative coronary ultrasound and compared after PTCA and at follow-up between the patients without restenosis in the pemirolast (28 lesions) and control (27 lesions) groups. There was no significant change in baseline characteristics between the 2 groups. Restenosis rate per lesion was significantly lower in the pemirolast group than in the control group (23.2% vs 44.4%, p < 0.05, respectively). After angioplasty and at follow-up study, there was no difference in lumen and vessel cross-sectional areas between the 2 groups. However, plaque and % plaque area in the pemirolast group were smaller than in the control group at follow-up study (8.9 +/- 2.3 vs 11.8 +/- 3.5 mm2, p < 0.005, 56.0 +/- 9.0% vs 64.0 +/- 10.4%, p < 0.005, respectively). These results suggest that suppression of neointimal hyperplasia is the preventive mechanism of pemirolast against restenosis after angioplasty. Pemirolast may be more effective against restenosis after coronary stenting.     

Effects of adjunctive balloon angioplasty after intravascular ultrasound-guided optimal directional coronary atherectomy: the result of Adjunctive Balloon Angioplasty After Coronary Atherectomy Study (ABACAS).

OBJECTIVES: This study was conducted to evaluate: 1) the effect of adjunctive percutaneous transluminal coronary angioplasty (PTCA) after directional coronary atherectomy (DCA) compared with stand-alone DCA, and 2) the outcome of intravascular ultrasound (IVUS)-guided aggressive DCA. BACKGROUND: It has been shown that optimal angiographic results after coronary interventions are associated with a lower incidence ofrestenosis. Adjunctive PTCA after DCA improves the acute angiographic outcome; however, long-term benefits of adjunctive PTCA have not been established. METHODS: Out of 225 patients who underwent IVUS-guided DCA, angiographically optimal debulking was achieved in 214 patients, then theywere randomized to either no further treatment or to added PTCA. RESULTS: Postprocedural quantitative angiographic analysis demonstrated an improved minimum luminal diameter (2.88 +/- 0.48 vs. 2.6 +/- 0.51 mm; p = 0.006) and a less residual stenosis (10.8% vs.15%; p = 0.009) in the adjunctive PTCA group. Quantitative ultrasound analysis showed a larger minimum luminal diameter (3.26 +/- 0.48 vs. 3.04 +/- 0.5 mm; p < 0.001) and lower residual plaque mass in the adjunctive PTCA group (42.6% vs. 45.6%; p < 0.001). Despite the improved acute findings in the adjunctive PTCA group, six-month angiographic and clinical results were not different. The restenosis rate (adjunctive PTCA 23.6%, DCA alone 19.6%; p = ns) and target lesion revascularization rate (20.6% vs. 15.2%; p = ns) did not differ between the groups. CONCLUSIONS: With IVUS guidance, aggressive DCA can safely achieve optimal angiographic results with low residual plaque mass, and this was associated with a low restenosis rate. Although adjunctive PTCA after optimal DCA improved the acute quantitative coronary angiography and quantitative coronary ultrasonography outcomes, its benefit was not maintained at six months.     

血管内超声指导下对小血管病变的介入治疗

目的评价血管内超声(IVUS)对小血管病变介入治疗的临床意义。方法回顾性分析2010年10月²013年2月于我院接受介入治疗的单支小血管(≤2.5mm)病变患者共237例,其中,IVUS指导下介入治疗的患者105例(Ⅰ组),冠状动脉造影(CAG)指导下介入治疗的患者132例(Ⅱ组)。分析2组患者基线资料、病变特点、介入治疗及随访期间心脏不良事件和再狭窄情况。结果 2组患者介入治疗均成功,Ⅰ组和Ⅱ组置入支架直径[(2.50±0.40)mmvs(2.34±0.37)mm]、支架长度[(28.75±7.77)mmvs(35.78±10.45)mm]、支架高压后扩张(91.4%vs55.3%)和支架内再狭窄(1.9%vs 7.6%)比较,差异有统计学意义(P=0.002,P=0.000,P=0.000,P=0.042);2组串联支架、CAG随访比较差异无统计学意义(P>0.05)。2组患者住院及随访1、3和6个月期间,均无主要不良心脏事件发生。结论对于小血管病变的介入治疗,IVUS具有较好的指导作用。     

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.     

小冠状动脉狭窄性病变的介入治疗

目的 :探讨小冠状动脉 （直径 <3 mm）狭窄性病变实施普通球囊、切割球囊或小支架介入治疗的疗效和并发症。方法 :小冠脉狭窄性病变介入治疗 （PCI）患者 13 6（男 87,女 49）例 ,年龄 3 2～ 85（54± 17）岁。根据手术方法分为普通球囊组、切割球囊组和小支架组。残余狭窄率 <3 0 %且无动脉夹层、撕裂等并发症者为手术成功 ,术后 6个月复查冠脉造影。结果 :普通球囊组 3 2例 ,手术成功 2 6例 （81% ） ,出现动脉夹层或扩张不满意改支架术 6例 （2 4% ）。切割球囊组 48例 ,手术成功 43例 （90 % ） ,出现动脉夹层或扩张不满意改支架术 3例 ,出现造影剂血管外漏 2例。支架组 56例 ,手术成功 53例 （95% ） ,出现造影剂血管外漏 2例 ,出现心包填塞抢救成功 1例。3组均未出现血管急性闭塞。术后 6个月 ,切割球囊组、小支架组、普通球囊组冠脉造影狭窄率分别为 2 3 % （11例 ）、16% （9例 ）、3 8% （12例 ）。结论 :小冠脉狭窄性病变实施介入治疗能取得显著效果 ,小支架术优于普通球囊扩张术 ,切割球囊扩张与普通球囊扩张具有近似疗效     

Treatment Strategies for Long and Calcified Lesions

This study discusses the treatment strategies used to approach long lesions, lesions in small vessels, and calcified lesions. Traditional treatment strategies for these lesion subtypes have yielded high acute complication rates and poor long-term outcome. A prospective analysis of 160 lesions was performed using intravascular ultrasound (IVUS) guided PTCA for the treatment of long lesions and lesions in small vessels, while a retrospective analysis of 106 calcified lesions was performed that were treated with the combination of rotablation and stenting. Acute and short-term results of TVUS guided PTCA with spot stenting show a 30-day major adverse cardiac event rate (MACE) of 5% with a high procedural success rate (96%), while the long-term outcome resulted in an agiographic restenosis rate of 17.4% and a target lesion revascularization rate of 13%. The combination of rotablation and stenting also rendered results in calcified lesions of a 93% angiographic success rate and a long-term outcome of restenosis of 22.5%. Optimal coronary stenting after rotational atherectomy in calcified lesions can be performed with a high success rate, an acceptable rate of procedural complications, and a low rate of stent thrombosis. This approach was associated with a low incidence of angiographic restenosis compared with results obtained with other interventional approaches. IVUS guided PTCA with spot stenting allows safe treatment of long lesions and lesions in small vessels. Short-term and long-term outcomes including 6-month MACE and angiographic restenosis appear to be better than results achieved in historical controls that utilize balloon angioplasty alone or stents in a manner where the lesion is covered from the proximal normal segment to the distal normal segment.     

Intravascular ultrasonic predictors of angiographic restenosis after long coronary stenting

The intravascular ultrasound (IVUS) criteria for stent optimization have not been determined in stenting long lesions. We evaluated the predictors of angiographic restenosis and compared it with stent lumen cross-sectional area (CSA) and stent length between short (stent length <20 mm) and long (> or =20 mm) coronary stenting. IVUS-guided coronary stenting was successfully performed in 285 consecutive patients with 304 native coronary lesions. Six-month follow-up angiogram was performed in 236 patients (82.8%) with 246 lesions (80.9%). Results were evaluated using conventional (clinical, angiographic, and IVUS) methods. The overall angiographic restenosis rate was 22.8% (56 of 246 lesions) (short stent 17.6% vs. long stent 32.2%, p = 0.009). Using multivariate logistic regression analysis, the independent predictors of angiographic restenosis were the IVUS stent lumen CSA (odds ratio 1.51, 95% confidence intervals 1.18 to 1.92, p = 0.001) and stent length (odds ratio 0.95, 95% confidence intervals 0.91 to 1.00, p = 0.039). The angiographic restenosis rate was 54.8% for stent lumen CSA of <5.0 mm2 (short stent 37.5% vs. long stent 73.3%, p = 0.049), 27.4% for CSA between 5.0 and 7.0 mm2 (short stent 24.1% vs. long stent 31.7%, p = 0.409), 10.5% for CSA between 7.0 and 9.0 mm2 (short stent 10.0% vs. long stent 12.5%, p = 0.772), and 11.4% for stent lumen CSA of > or =9.0 mm2 (short stent 10.4% vs. long stent 13.3%, p = 0.767) (p = 0.001). Compared with short coronary stenting, long coronary stenting is effective treatment modality to cover long lesions with comparable long-term clinical outcomes in cases of stent lumen CSA of > or =7.0 mm2. Regardless of the stent length, the most important factor determining angiographic restenosis was the IVUS stent lumen CSA in relatively large coronary artery lesions.     

Six-month outcome after excimer laser coronary angioplasty for diffuse in-stent restenosis in native coronary arteries

This study evaluated the intermediate-term follow-up after excimer laser coronary angioplasty (ELCA) and adjunctive percutaneous transluminal coronary angioplasty (PTCA) in patients with diffuse in-stent restenosis (lesion length >10 mm). Clinical and angiographic follow-up were performed at 6 months. Quantitative coronary angiography performed at 3 stages-during stent implantation, before and after ELCA + PTCA, and at follow-up-included measurements of the minimum lumen diameter (MLD) and percent diameter stenosis (DS). Sixteen consecutive patients were included. The (median + range) stent length was 36 mm (range 15 to 105), with a restenotic lesion length of 32 mm (range 10 to 90). After ELCA + PTCA, the MLD increased from 0.60 +/- 0.41 to 2.28 +/- 0.50 mm, whereas the DS decreased from 76 +/- 16% to 22 +/- 8%. Despite adjunctive high-pressure PTCA, the MLD after ELCA + PTCA remained smaller than the MLD after initial stent implantation, (2.28 +/- 0. 50 mm vs 2.67 +/- 0.32 mm, p = 0.014). Adverse events included ELCA-related acute coronary occlusion in 4 patients and a per-procedural intracerebral hematoma in 1. At 6 months, there was recurrence of angina in all patients. Angiographic follow-up was completed in 13 patients (87%), showing a reocclusion in 6 (46%), a >50% DS in 6 (MLD 1.03 +/- 0.87 mm, DS 68 +/- 24%), and a distal de novo lesion in 1. Despite satisfactory acute angiographic results, the recurrence of significant restenosis in all patients suggests that ELCA + PTCA is not a suitable stand-alone therapy for diffuse in-stent restenosis of long stented segments.     

Use of stents for small coronary arteries. Results of the Multi-Link 2.5 Portuguese Registry.

INTRODUCTION: Stents are being used with increasing frequency in percutaneous transluminal coronary angioplasty (PTCA) but their use in small vessels is still controversial, due to the possibility of excessively high rates of adverse events and restenosis. OBJECTIVE: To assess the safety and clinical efficacy of ACS RX Multi-Link (ML) 2.5 mm stents, in "de novo" coronary stenosis. DESIGN: Prospective Registry, with 6 months clinical follow-up, involving all Portuguese centers of Interventional Cardiology. POPULATION: Between April 7 and November 20 1998, 102 patients were enrolled, 82 male and with ages ranging from 30 to 86 years (average 58 +/- 11). Clinical presentation for PTCA was stable angina in 53%, unstable angina in 36% and silent ischemia in 11%. There was a history of previous myocardial infarction in 29% of patients. The main risk factors were hypertension (58%), hyperlipidemia (57%), smoking (25%) and diabetes (20%). Multivessel coronary artery disease was present in 46% of patients and left ventricular function was normal in 89%. Of the 217 existing lesions, 188 (87%) were treated: 35 with balloon angioplasty and 153 with stent implantation, 114 of which were ML 2.5 mm: 79 of 15 mm in length and 35 of 25 mm. METHODS: Angiographic success with ML stent implantation and major adverse cardiac events (MACE)--myocardial infarction (MI), coronary artery bypass graft (CABG), new target vessel revascularizations and death--were evaluated during hospital stay, and at 1 and 6 months clinical follow-up. RESULTS: Angiographic success was 97.4%. In one patient it was not possible to cross the lesion, in another there was stent migration and in a third distal coronary flow after stenting was TIMI grade 1. Clinical success was 96.1% and there were no cases of death, Q-wave MI or urgent CABG. Two patients had non-Q wave MI and two required urgent repeat angioplasty. Subacute stent thrombosis occurred in 1 patient. There were no additional MACE at 1 month follow-up. At 6-month follow-up (in 97% of patients) MACE had occurred in 14.1%: 2 deaths (one non-cardiac), 3 MI (one non-Q) and 14 new PTCA (one in a non-ML stent). There was no need for CABG in any patient. Six-month survival rate was 97.9%, 94.9% were free of infarction and 84.8% were free of infarction and new revascularization. CONCLUSIONS: Multi-Link 2.5 mm stent implantation appears to be safe and efficient with a low incidence of immediate and 6-month adverse events in the range of centers and operators of the Registry.     

Six-month angiographic follow-up after intravascular ultrasound-guided stenting of infarct-related artery: comparison with non-infarct-related artery

BACKGROUND: Compared with balloon angioplasty, stenting has been established as an effective treatment modality to reduce restenosis in patients with acute myocardial infarction. However, the immediate results that predict favorable long-term outcomes in the acute infarct stenting are unknown. Therefore, we evaluated long-term outcomes of stenting for infarct-related artery (IRA) lesions by using intravascular ultrasound (IVUS) compared with that of stenting for non-IRA lesions. METHODS: IVUS-guided coronary stenting was successfully performed in 510 native coronary lesions (105 IRA vs 405 non-IRA). A 6-month follow-up angiogram was performed in 419 (82.2%) lesions: 87 (82.9%) IRA lesions and 332 (82.0%) non-IRA lesions. Coronary stenting on the IRA lesions was successfully performed within 7 to 10 days after onset of infarction in 42 patients and within 12 hours in 45 patients. Results were evaluated by clinical, angiographic, and IVUS methods. RESULTS: There were no significant differences in clinical and angiographic variables between the two groups. IVUS variables including reference vessel area and minimal stent area were also similar between the two groups. There was no significant difference in angiographic restenosis rate between the two groups in cases of minimal stent area > or = 7 mm(2): 12.8% (6 of 47) in IRA versus 19.1% (33 of 173) in non-IRA lesions (P = .315). However, the angiographic restenosis rate in cases of minimal stent area <7 mm(2) was 50% (20 of 40) in IRA lesions versus 31.5% (50 of 159) in non-IRA lesions (P = .028). CONCLUSIONS: Angiographic restenosis is significantly higher in stenting for IRA lesions compared with that for non-IRA lesions in cases of minimal stent area < 7 mm(2).     

Optimal coronary balloon angioplasty with provisional stenting versus primary stent (OCBAS): Immediate and long-term follow-up results

Objective. This study sought to compare two strategies of revascularization in patients obtaining a good immediate angiographic result after percutaneous transluminal coronary angioplasty (PTCA): elective stenting versus optimal PTCA. A good immediate angiographic result with provisional stenting was considered to occur only if early loss in minimal luminal diameter (MLD) was documented at 30 min post-PTCA angiography.Background. Coronary stenting reduces restenosis in lesions exhibiting early deterioration (>0.3 mm) in MLD within the first 24 hours (early loss) after successful PTCA. Lesions with no early loss after PTCA have a low restenosis rate.Methods. To compare angiographic restenosis and target vessel revascularization (TVR) of lesions treated with coronary stenting versus those treated with optimal PTCA, 116 patients were randomized to stent (n = 57) or to optimal PTCA (n = 59). After randomization in the PTCA group, 13.5% of the patients crossed over to stent due to early loss (provisional stenting).Results. Baseline demographic and angiographic characteristics were similar in both groups of patients. At 7.6 months, 96.6% of the entire population had a follow-up angiographic study: 98.2% in the stent and 94.9% in the PTCA group. Immediate and follow-up angiographic data showed that acute gain was significantly higher in the stent than in the PTCA group (1.95 vs. 1.5 mm; p < 0.03). However, late loss was significantly higher in the stent than the PTCA group (0.63 ± 0.59 vs. 0.26 ± 0.44, respectively; p = 0.01). Hence, net gain with both techniques was similar (1.32 ± 0.3 vs. 1.24 ± 0.29 mm for the stent and the PTCA groups, respectively; p = NS). Angiographic restenosis rate at follow-up (19.2% in stent vs. 16.4% in PTCA; p = NS) and TVR (17.5% in stent vs. 13.5% in PTCA; p = NS) were similar. Furthermore, event-free survival was 80.8% in the stent versus 83.1% in the PTCA group (p = NS). Overall costs (hospital and follow-up) were US $591,740 in the stent versus US $398,480 in the PTCA group (p < 0.02).Conclusions. The strategy of PTCA with delay angiogram and provisional stent if early loss occurs had similar restenosis rate and TVR, but lower cost than primary stenting after PTCA.     

冠状动脉血管的口径对PTCA术后再狭窄的影响

经皮冠状动脉腔内成形术（PTCA）术后再狭窄仍然是目前的重要难题之一。本研究对303例PTCA成功者，测定正常冠状动脉管径和PTCA术后再狭窄管径，结合临床冠心病危险因子及与再狭窄相关连的病变形态因子的定量分析进行对比研究，采用Automatededgedetecting法测出术前正常冠状动脉管径（NCD）按NCD的大小分为三组，A组NCD＜25mm；B组2．5～3．0mm；C组≥3．0mm；同时分别测出A、B、C三组术前、术后PTCA部位的最小血管径（MVD．mm）以及PTCA术后3个月追踪造影时PTCA部位的MVD，采用Caliper法分别计算出PTCA前、后狭窄率、3个月后追踪时再狭窄率。结果显示，冠心病的危险因子、PTCA前偏心性病变、钙化病变及扩张后冠状动脉夹层在三组间未见显著差异，PTCA前NCD（mm）、MVD（mm）及PTCA术后MVD（mm）C组显著高于A组（P＜0．01），再狭窄率A组显著高于C组（P＜0．01）。我们认为正常冠状动脉径较细者，PTCA术后容易发生再狭窄，冠状动脉本身的粗细可以作为PTCA术后再狭窄的独立预测因子之一。     

A controlled trial of corticosteroids to prevent restenosis after coronary angioplasty. M-HEART Group

A multicenter, double-blind, placebo-controlled trial was conducted to determine if corticosteroids influence the development of restenosis after successful percutaneous transluminal coronary angioplasty (PTCA). Either placebo or 1.0 g methylprednisolone (steroid) was infused intravenously 2-24 hours before planned PTCA in 915 patients. The PTCA patient success rate was 87% (mean) in the eight centers. There were no differences in clinical or angiographic baseline variables between the two groups. End-point analysis (angiographic restenosis, death, recurrent ischemia necessitating early restudy, and coronary artery bypass graft surgery) showed that there was no significant difference comparing placebo- with steroid-treated patients. Angiographic restudy showed the lesion restenosis rate to be 39% (120 of 307 lesions) after placebo and 40% (117 of 291) after steroid treatment (p = NS). We conclude that pulse steroid pretreatment does not influence the overall restenosis rate after successful PTCA.     

Percutaneous transluminal coronary angioplasty for chronic dialysis patients

Accelerated forms of atherosclerosis continue to be responsible for considerable morbidity and mortality among patients on chronic hemodialysis, and coronary artery disease is responsible for approximately 20-30% of the deaths of such patients. The suitability of such patients for percutaneous transluminal coronary angioplasty (PTCA), however, remains unknown. Accordingly, the purpose of this study was to evaluate the feasibility of PTCA in a group of chronic dialysis patients. PTCA was performed on a total of 15 dialysis patients with medically refractory angina pectoris. Angiographic success was obtained in 16 of 21 (76%) stenoses attempted after the first PTCA. Restenosis was observed in 6 of 16 (38%) lesions, which was significantly related to longer dialysis history (p less than 0.01), and low maximal inflation pressure (p < 0.05). Five of the 6 patients with restenosis underwent a second PTCA, however, all 4 patients with successful second PTCA developed recurrence of angina. Three of 4 patients with a second episode of restenosis underwent a third PTCA, and angina recurred in 2. Thus, PTCA is a reasonable initial strategy for patients with chronic hemodialysis, especially when dialysis history is short. For restenotic lesions and when there is a long dialysis history, restenosis rates are high and coronary bypass surgery should be considered.     

First human experience with local delivery of novel antisense AVI-4126 with Infiltrator catheter in de novo native and restenotic coronary arteries: 6-month clinical and angiographic follow-up from AVAIL study

BACKGROUND: A novel antisense phosphorodiamidate morpholino oligomer, AVI-4126, was shown to be effective in reducing neointimal formation in different animal models following delivery by pluronic gels, porous balloon catheters, and coated stents. The purpose of the AVAIL study was to investigate both the safety and the efficacy of AVI-4126 delivered locally via Infiltrator catheter after percutaneous coronary intervention in humans. METHODS: The AVAIL trial is a prospective, evaluator-blinded, randomized study including clinical follow-up at 30 days and 6 months after intervention and 6-month angiographic and intravascular ultrasound (IVUS) follow-up. An Infiltrator catheter was advanced to target lesion and either drug was delivered (Groups A and B) or catheter was advanced (Group C) after stent implantation in de novo lesions or percutaneous transluminal coronary angioplasty in restenotic lesions. Primary end points include major adverse cardiovascular events (MACE), target vessel revascularization (TVR), angiographic restenosis, and IVUS at 6 months. RESULTS: Forty-four patients with either de novo lesions or restenosis were randomized into three groups: (A) low dose, 3 mg (19 patients); (B) high dose, 10 mg (15 patients), and (C) control (10 patients). Baseline angiographic characteristics did not differ between the groups (reference vessel diameter, 2.5-4 mm; lesion length, <16 mm). Procedural success was 81. 82% (unable to advance Infiltrator catheter to target lesion in 8 patients, 5 from Group B and 3 from Group C). There was no in-hospital or 30-day MACE recorded in any group. Clinical follow-up was available in 25 patients. At 6 months, four patients (50%) from the control group (Group C, n=8) and 7 (100%) patients from the low-dose group (Group A, n=7) required TVR. In contrast, in the high-dose group (Group B, n=10) only 1 patient (10%) needed TVR. Angiographic follow-up in 25 patients (Group A, 8 patients; Group B, 7 patients; and Group C, 10 patients) demonstrated late loss of 1.4+ to 0.54, 0.8+ to 0.55, and 1.5+ to 0.65, respectively (P=.025). Binary restenosis was 38% in Group C (control), 29% in Group A (low dose), and 0% in Group B (high dose). CONCLUSION: Local delivery of antisense is feasible. These preliminary findings from the small cohort of patients require confirmation in a larger trial utilizing more sophisticated drug-eluting technologies.     

Initial management and long-term clinical outcome of restenosis after initially successful percutaneous transluminal coronary angioplasty.

Restenosis remains a critical limitation after percutaneous transluminal coronary angioplasty (PTCA). The clinical experience with restenosis was reviewed in 1,490 patients who had restenosis of at least 1 site within 1 year of their PTCA. The source of data was the clinical database at Emory University. Patients who had previous coronary bypass surgery or PTCA and patients who underwent PTCA in the setting of acute myocardial infarction were excluded. When restenosis was angiographically documented, 363 were treated medically, 1,051 with repeat PTCA, and 76 with coronary bypass surgery. In the repeat PTCA group there were 778 patients who originally had 1-vessel disease and 273 with multiple vessel disease. Re-dilatation of restenotic sites was performed in 95%. Angiographic success of all lesions dilated was achieved in 99%. Coronary bypass surgery was required in 2.5% of patients with restenosis first treated with repeat PTCA. One patient with multiple vessel disease died. Coronary bypass surgery was performed in fewer patients aged greater than or equal to 65 years, but more patients with multiple vessel disease. Two (2.6%) of the coronary bypass surgery patients had Q-wave myocardial infarction and there were no deaths. In the PTCA group, 5-year actuarial survival was 95%, and cardiac survival 96%. Freedom from cardiac events or further revascularization procedures was 51% at 5 years. Patients treated with PTCA and medically treated patients had similar cardiac survival rates. The most important correlates of cardiac survival were age and the presence of diabetes mellitus. At 5 years, cardiac survival without diabetes was 97 and 83% with diabetes (p less than 0.0001).(ABSTRACT TRUNCATED AT 250 WORDS)     

Comparison of stenting with balloon angioplasty for lesions of small coronary vessels in patients with diabetes mellitus.

PURPOSE: We sought to assess whether stenting is a better treatment strategy than percutaneous transluminal coronary angioplasty (PTCA) for lesions in small coronary vessels of diabetic patients. METHODS: We studied the 100 diabetic patients who were enrolled in the Intracoronary Stenting or Angioplasty for Restenosis Reduction in Small Arteries trial; 51 patients were randomly assigned to receive a stent and 49 to PTCA alone. Small vessels were considered those with a reference diameter of 2.0 to 2.8 mm. The primary endpoint of the study was the incidence of restenosis, defined as 50% or greater diameter stenosis at follow-up angiography (performed in 83 of the 100 patients). The secondary endpoint was clinical restenosis, defined as the need for target vessel revascularization within 1 year. RESULTS: Angiographic restenosis occurred in 18 (44%) of the patients who received a stent and in 19 (45%) of the PTCA patients (P = 0.90). Target vessel revascularization was needed in 13 (25%) of the stent patients and 10 (20%) of the PTCA patients (P = 0.55). During the 1-year follow-up, 5 (10%) of the stent patients died or incurred myocardial infarction, compared with 3 (6%) of the PTCA patients (P = 0.50). CONCLUSIONS: Patients with diabetes who undergo percutaneous coronary interventions for lesions in small vessels have an especially high risk of restenosis that does not appear to be attenuated by stenting.     

Current role of laser angioplasty of restenotic coronary stents

Treatment of in-stent restenosis (ISR) with conventional percutaneous transluminal coronary angioplasty (PTCA) causes significant recurrent neointimal tissue growth in 30-85%. Therefore, laser ablation of intrastent neointimal hyperplasia before balloon dilation can be an attractive alternative. However, the long-term outcomes of such treatment have not been studied thoroughly enough. This prospective case-control study evaluated angiographic and clinical outcomes of PTCA alone and a combination of excimer laser coronary angioplasty (ELCA) and adjunct PTCA in 125 patients with ISR. ELCA was performed before balloon dilation in 67 patients, PTCA alone was performed in 58 patients. Basic demographic and clinical data were comparable in both groups. Lesions included in ELCA group were longer (17.1+/-9.9 vs 13.6+/-9.1 mm; p = 0.034), more complex (36.5% type C stenoses vs 14.3%; p = 0.006), and more frequently had reduced distal blood flow (TIMI <3: 18.9% vs 4.8%; p = 0.025) compared to lesions in the PTCA group. Immediate angiographic results of PTCA and ELCA + PTCA appeared to be comparable. PTCA alone was successful in 57 patients (98.3%), ELCA + PTCA, in 66 patients (98.5%). The rates of hospital complications were comparable (3.0% in ELCA group vs 8.6% in PTCA group). The 1-year follow-up showed that the rates of major adverse cardiac events (MACE) were comparable in the 2 groups (37.3% in ELCA group vs 46.6% in PTCA group). The rates of target vessel revascularization (TVR) within 1 year after the intervention were also similar in the 2 groups (32.8% vs 34.5%). The data mean that ELCA in patients with complex ISR is efficient and safe. Despite a higher complexity of lesions in the ELCA group, no increase in the rate of complications was registered.     

Reduction of restenosis by vessel size adapted percutaneous transluminal coronary angioplasty using intravascular ultrasound

Restenosis following percutaneous transluminal coronary angioplasty (PTCA) remains a serious problem in interventional cardiology. Recent trials using stent implantation have proposed a reduction in restenosis, presumably due to a higher initial luminal gain. This study was conducted to evaluate if the short- and long-term results following conventional PTCA may be favorable, if balloon dilation was performed according to measurements gained by intravascular ultrasound (IVUS) (vessel size adapted PTCA). The use of intracoronary stents might be omitted if comparable long-term results could be achieved by this modified technique of balloon angioplasty. This unicenter and nonrandomized pilot trial was initiated in January 1995 with 252 patients who had 271 lesions. IVUS was performed before and after intervention to determine the external elastic membrane (EEM) diameter at the lesion site. The balloon catheter was sized according to the EEM diameter measured by IVUS (EEM 10%). The mean balloon diameter was 4.1 +/- 0.5 mm, the dilation time 130 +/- 60 seconds with a balloon pressure of 7.0 +/- 2.0 atm. Clinical acute and 1-year long-term follow-up were obtained for all patients and follow-up angiography in 71% of patients. Acute events occurred postinterventionally in 5 patients (2%). The cumulative event rate during long-term follow-up was 14%. The angiographic restenosis rate (diameter stenosis >50%) after 1 year was 19%. Vessel size adapted PTCA using IVUS led to favorable acute and long-term results with a low restenosis rate and a low 1-year clinical event rate. Despite dissections that occur frequently using large balloon sizes, an increased rate of major complications did not occur, indicating a safe procedure and substantiating the philosophy of "therapeutic dissections." The results need to be verified in a randomized trial.