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.     

Excimer Laser Angioplasty with Adjunctive Balloon Dilatation Versus Balloon Dilatation Alone for the Treatment of In-Stent Restenosis: Results of a Randomized Single-Center Study

Background: Laser ablation of neointimal tissue prior to balloon dilatation has been shown to be a potential treatment modality for restenosis within previously implanted stents. It remains controversial whether this treatment provides superior acute and long-term results compared to conventional balloon dilatation. Methods and Results: Between November 1995 and November 1996, 96 patients with significant (≥ 50%) in-stent restenosis were randomized to receive excimer laser angioplasty with adjunctive balloon dilatation (ELCA + PTC A, n = 47) or PTCA alone (n = 49). Both groups did not differ with regard to gender, clinical history, location of the lesion, reference diameter, or lesion length. Angiographic success was achieved in 46 patients with ELCA + PTCA (98%) and in 48 patients with PTCA alone (98%). In-hospital complications included acute closure in one patient of each group, one CABG, one repeat PTCA, and one non-Q wave MI with ELCA + PTCA, versus two bleeding and one death with PTCA. Clinical follow-up was obtained in all patients, while angiographic follow-up was available in 35 of 47 (ELCA+PTCA) versus 35 of 49 (PTCA) patients with a mean follow-up time of 163 ± 81 days. With ELCA+PTCA, MLD increased from 0.82 ± 0.38 to 1.99 ± 0.33 mm versus 0.81 ± 0.39 mm to 2.07 ± 0.60 mm with PTCA (P = NS). At follow-up, MLD was 1.32 ± 0.60 mm with ELCA + PTCA versus 1.45 ± 0.75 mm with PTCA (P = NS). Late adverse events included nine repeat PTCA with ELCA +PTCA (19%) versus 12 with PTCA (24%), three CABG with ELCA +PTCA (6%) versus two with PTCA (4%), and one death (2%) with PTCA (P = NS). Angiographic restenosis rate was 52% with ELCA + PTCA versus 47% with PTCA alone (P = NS). Conclusion: Our data suggest that excimer laser angioplasty with adjunctive balloon dilatation for the treatment of in-stent restenosis provides similar acute results as plain balloon dilatation and may offer no advantage over PTCA alone with regard to intermediate-term outcomes.     

Six-month clinical and angiographic outcome after successful excimer laser angioplasty for in-stent restenosis

OBJECTIVES: This study evaluated the clinical and angiographic six-month follow-up after excimer laser coronary angioplasty (ELCA) for restenosed coronary stents. BACKGROUND: Excimer laser coronary angioplasty has recently been shown to be safe and efficient for the treatment of in-stent restenosis. METHODS: Ninety-six consecutive patients successfully treated with ELCA within 141 stents were included in a six-month clinical and angiographic follow-up. RESULTS: During follow-up there was one sudden death and one patient with documented myocardial infarction. Angina pectoris classified as > or = Canadian Cardiovascular Society II reoccurred in 49 patients. Follow-up angiography was obtained in 89 patients (93%) with 133 stents. Quantitative coronary angiography revealed a mean diameter stenosis of 77 +/- 10% before intervention, 41 +/- 12% after laser treatment and 11% +/- 12% after adjunctive percutaneous transluminal coronary angioplasty (p < 0.001). Six months after ELCA the mean diameter stenosis had increased to 60 +/- 26% (p < 0.001). A > or =50% diameter stenosis was present in 48 patients (54%); in 24 of these patients diameter stenosis was > or =70%. Total occlusions occurred in an additional 10 patients (11%). There was a trend toward an increased recurrent restenosis rate in patients with diabetes mellitus and long lesions or total occlusions (p = 0.059). Forty-eight patients (50%) received medical treatment after six months. Reinterventions were necessary in 30 patients (31%), and coronary artery bypass surgery was performed in 17 patients (18%). Event-free survival was 50%. CONCLUSIONS: Excimer laser angioplasty for in-stent restenosis was associated with a high incidence of recurrent restenosis in this group of patients, suggesting that this technique is unlikely to reduce recurrent in-stent restenosis and that other approaches are necessary.     

Direct Stenting Application in Acute Coronary Syndromes

Although published reports about direct stenting in treating stable coronary artery disease have been increasing, the number of studies regarding direct stenting for acute coronary syndrome is limited. In this study, we report immediate and mid-term results of patients who underwent direct stenting for treating acute coronary syndrome. The average lesion length was 12.1 ± 3.3 mm. The preprocedure average minimum luminal diameter (MLD) was 0.67 ± 0.33 mm. Post-procedure average MLD was 3.19 ± 0.42 mm. In 35 of the 36 cases (97%), the stent delivery system crossed the lesion and was implanted successfully. In one case, an acute occlusion, which was treated by percutaneous transluminal coronary angioplasty (PTCA), occurred. The rate of procedure success was 94%. The amount of contrast media used was 88 ± 16 ml and duration of radiation exposure was 9 ± 2 min. Control angiography was performed in 28 out of 35 cases (80%). Seven patients who did not consent to coronary angiography were asymptomatic and had negative exercise tests. MLD was 2.66 ± 0.53 mm after a six month follow-up. The clinical and angiographic restenosis rates were 14% (5/35) and 18% (5/28), respectively. Three of the five cases of restenosis were treated by excimer laser coronary angioplasty (ELCA) and PTCA and the other two were treated with PTCA only. Target lesion revascularization rate was 14% (5/35). The rate of major adverse cardiac events (MACE) was 17% (6/35) after the six month follow-up period. Based on these results, we conclude that direct stenting for acute coronary syndrome is safe if the lesion is determined to be suitable.     

Contribution of early lumen loss after balloon angioplasty for in-stent restenosis to lumen loss at follow-up.

The treatment of in-stent restenosis using balloon angioplasty alone often produces excellent early results, but is associated with high rate of recurrence. Previous studies have demonstrated significant tissue reintrusion shortly after the treatment of in-stent restenosis with balloon angioplasty. The study was designed to elucidate the contribution of early lumen loss 6 hr after balloon angioplasty to lumen loss at follow-up. We prospectively performed quantitative coronary angiography and intravascular ultrasound in 12 patients with in-stent restenosis before intervention, after the final procedure, 6 hr later (5.6 +/- 1.4 hr), and at follow-up (7.7 +/- 2.3 months). Compared with immediately after balloon angioplasty, by 6 hr postintervention, the minimum lumen diameter (MLD) and lumen cross-sectional area had decreased significantly (2.48 +/- 0.44 to 2.01 +/- 0.57 mm, P = 0.01, and 7.0 +/- 1.2 to 5.5 +/- 1.4 mm2, P = 0.004, respectively). Furthermore, the MLD decreased further between 6 hr postintervention and long-term follow-up (2.01 +/- 0.57 to 1.55 +/- 0.64 mm; P = 0.001). Patients who showed recurrence of restenosis at follow-up had greater early lumen loss than patients without recurrence of restenosis (0.71 +/- 0.31 vs. 0.23 +/- 0.13 mm; P = 0.006). Diffuse lesions had greater early lumen loss compared to focal lesions (0.75 +/- 0.35 vs. 0.28 +/- 0.13 mm; P = 0.008). Early lumen loss is common after the treatment of in-stent restenosis by balloon angioplasty. Within the first 6 hr postintervention, 32% +/- 29% of acute lumen gain is lost, and early lumen loss contributed to 42% +/- 18% of total lumen loss at follow-up.     

Effectiveness of excimer laser coronary angioplasty in treatment of patients with in-stent restenosis

In-stent restenosis (ISR), when treated with balloon angioplasty (PTCA) alone, has an angiographic recurrence rate of 30-85%. Ablating the hypertrophic neointimal tissue prior to PTCA is an attractive alternative, however late outcomes of such treatment have not been fully determined. This multicenter case control study assessed angiographic and clinical outcomes of 137 consecutive procedures in 125 patients treated for ISR with either PTCA alone (n = 58) or excimer laser assisted coronary angioplasty (ELCA, n = 67). Demographics were similar. Lesions selected for ELCA compared with those selected for \PTCA were longer (17.1+/-9.9 mm vs. 13.6+/-9.1 mm; p=0,034), more complex (ACC/AHA type C: 36,5% vs. 14,3%; p=0,006), and with reduced antegrade flow (TIMI flow < 3: 18,9% vs. 4,8%; p = 0,025). ELCA- and PTCA treated patients had similar rates of procedural success (98,5 and 98,3%, respectively, p=1,0), major clinical complications (3,0% and 8,6%; respectively, NS), major cardiac events at 1 year (37,3 and 46,6%. respectively, NS), and target lesion revascularization (32,8 and. 34,5%; respectively, NS). These data suggest that ELCA in patients with complex in-stent restenosis is as safe and effective as PTCA. Despite higher lesion complexity in ELCA-treated patients, no increase in event rates was observed.     

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.     

Clinical and angiographic outcome in the laser angioplasty for restenotic stents (LARS) multicenter registry.

In-stent restenosis (ISR), when treated with balloon angioplasty (PTCA) alone, has an angiographic recurrence rate of 30%-85%. Ablating the hypertrophic neointimal tissue prior to PTCA is an attractive alternative, yet the late outcomes of such treatment have not been fully determined. This multicenter case control study assessed the angiographic and clinical outcomes of 157 consecutive procedures in 146 patients with ISR at nine institutions treated with either PTCA alone (n = 64) or excimer laser assisted coronary angioplasty (ELCA, n = 93)) for ISR. Demographics were similar except more unstable angina at presentation in ELCA-treated patients (74.5% vs. 63.5%; P = 0.141). Lesions selected for ELCA were longer (16.8 +/- 11.2 mm vs. 11.2 +/- 8.6 mm; P < 0.001), more complex (ACC/AHA type C: 35.1% vs. 13.6%; P < 0.001), and with compromised antegrade flow (TIMI flow < 3: 18.9% vs. 4.5%; P = 0.008) compared to PTCA-treated patients. ELCA-treated patients had similar rate of procedural success [93 (98.9% vs. 62 (98.4%); P = 1.0] and major clinical complications [1 (1.1%) vs. 1 (1.6%); P = 1.0]. At 30 days, repeat target site coronary intervention was lower in ELCA-treated patients (1.1% vs. 6.4% in PTCA-treated patients; P = 0.158), but not significantly so. At 1 year, ELCA-treated patients had similar rate of major cardiac events (39.1% vs. 45.2%; P = 0.456) and target lesion revascularization (30.0% vs. 32.3%; P = 0.646). These data suggest that ELCA in patients with complex in-stent restenosis is as safe and effective as balloon angioplasty alone. Despite higher lesion complexity in ELCA-treated patients, no increase in event rates was observed. Future studies should evaluate the relative benefit of ELCA over PTCA alone for the prevention of symptom recurrence specifically in patients with complex in-stent restenosis.     

普通球囊与切割球囊成形术对冠状动脉支架内再狭窄的近远期疗效

目的　对切割球囊成形术 (CBA)与普通球囊成形术 (POBA)支架内再狭窄病变的近远期血管造影结果比较 ,评价 CBA对支架内再狭窄病变的有效性。方法　 37例 ,共 39处病变 ,2 3处进入 CBA组 ,16处进入 POBA组。分别比较术后即刻及远期定量冠状动脉造影最小血管径 (ML D)、狭窄度 (DS)、再狭窄率、即刻管腔获得 (AL G)、即刻血管弹性回缩 (AR)及弹性回缩率 (ARR)。结果　术后即刻 ML D、DS、AL G两组差异无显著性。 CBA组最大扩张压、AR及 ARR均较 POBA组低 (P<0 .0 5或 P<0 .0 0 1)。随访造影结果 ,CBA组 ML D明显大于 POBA组 (P<0 .0 5 ) ;DS及再狭窄率均小于 POBA组 (P<0 .0 1)。结论　 CBA组的低压扩张治疗支架内再狭窄病变是有效的 ,对血管损伤小于 POBA,且获得较 POBA低的再狭窄率 ,值得进一步探讨     

Percutaneous transluminal coronary angioplasty after previous coronary artery bypass surgery

To improve symptomatic status and avoid repeat coronary artery bypass graft surgery (CABG), 115 lesions were approached for transluminal coronary angioplasty (PTCA) in 94 patients (82 men, 12 women) with angina pectoris and prior CABG at a mean of 60 months (range 4 to 192) after CABG. Fifteen patients were in Canadian Cardiovascular Society functional class I, 32 were in class II, 31 were in class III, and 16 were in class IV. Patients were 37 to 76 years old (mean 57). PTCA was successful (at least a 40% reduction in stenosis diameter and improvement in symptomatic status) in 83 patients (88%) and 103 (90%) lesions. Mean stenosis was reduced from 80 +/- 14% to 20 +/- 16% (mean +/- standard deviation) and mean pressure gradient from 41 +/- 7 mm Hg to 14 +/- 6 mm Hg. Seven patients had lesions that could not be crossed for technical reasons and these patients underwent non-emergency CABG. Four patients required emergency CABG after PTCA; 1 patient subsequently died and 2 survived acute myocardial infarction. One patient had a femoral artery laceration, which required surgical repair. At a mean follow-up of 8 +/- 4 months, 63 patients (76%) with initially successful results were free of angina or in improved condition. Of the remaining 20 patients, 18 consented to repeat coronary angiography. Four patients did not have restenosis. Of the 14 patients with documented restenosis, 5 underwent successful repeat PTCA, 5 had repeat CABG, and 4 were treated medically. Thus, when coronary anatomy is suitable, PTCA is an effective alternative to reoperation in symptomatic patients with prior CABG.     

Coronary stenting or balloon angioplasty for chronic total coronary occlusions: the Taiwan experience (a single-center report)

The authors conducted this study to compare the restenosis and reocclusion rates of primary balloon angioplasty alone versus angioplasty followed by stenting in Taiwanese patients with chronic total occlusions. They also evaluated whether stenting reduced the incidence of restenosis and improved left ventricular function in these patients. From October 1998 to April 2000, a total of 294 patients with chronic total occlusion (Thrombolysis in Myocardial Infarction grade 0 flow) underwent recanalization using balloon angioplasty alone or followed by stent implantation. Of these, only 129 patients were included after procedural failure and patients lost to follow-up; 62 patients were placed in the stent group, while 67 patients were assigned to the percutaneous transluminal coronary angioplasty (PTCA) group. Coronary angiography was performed at baseline and at 6 months follow-up or earlier if angina or objective evidence of ischemia involving the target vessel or other vessels was present. Procedural success was 60%. Minimal lumen diameter increased significantly after stenting: 2.97 +/-0.41 vs 2.24 +/-0.41 (p < 0.001); 60% of patients in the stent group were free of restenosis, whereas only 33% in the PTCA group were free of restenosis at follow-up. Only 1 patient in the stent group had reocclusion, as opposed to 17 (25%) patients in the PTCA group (p < 0.001). The follow-up minimal lumen diameter (MLD) at 6 months was significantly larger in the stent group: 1.80 +/-0.85 mm vs 1.08 +/-0.82 mm (p < 0.001). Left ventricular function improved in the stent group, but not in the PTCA group (58.44 +/-16.58% to 63.60 +/-14.59% [p < 0.001] vs 54.13 +/-15.66% to 54.31 +/-15.60% [p = 0.885]). More patients had angina in the PTCA group than in the stented group 43 vs 29 (p = 0.053). The postprocedural MLD and reference vessel diameter (RVD) were the strong predictors of restenosis and follow-up MLD (p < 0.001). Stenting of chronically occluded arteries significantly reduced the incidence of reocclusion and restenosis, at the same time improving left ventricular function in these patients. This should be the procedure of choice after successful angioplasty of chronically occluded vessels.     

The Falconª Eccentric Coronary Balloon Angioplasty Catheter: A Randomized Safety and Efficacy Study

Percutaneous coronary angioplasty (PTCA) is usually performed using concentric shaped balloon catheters with the guidewire passing through the center of the shaft. The Falcona balloon catheter features a guide wire lumen on the outside of the balloon so that an eccentric balloon catheter profile is obtained concentrating the dilating force on the wire supported side, allowing lower inflation pressures and potentially causing less vessel injury. The aim of this study was to evaluate the safety and efficacy of this new balloon catheter in patients with stable and unstable angina. In 95 prospectively randomized patients, 57 lesions were dilated with a concentric balloon and 51 with the eccentric balloon. Technical success in the two groups was similar (73.3% vs. 74.5% control vs. Falcon respectively). Procedural success was 96.5% vs. 96.1% in the control and Falcon groups respectively. The mean increase in minimum luminal diameter (MLD) was 1.01 +/- 0.41 mm in the control vs 0.85 +/- 0.45 mm in Falcon (p = 0.053). There was an increase in type A dissections in the Falcon group 18 (36.75%) vs. 10 (19.23%) in the control group (p = 0.07) with no difference in stent implantation, myocardial infarction, CABG or death between the two groups. All patients with a technically successful PTCA were followed up. Seventeen (43.6%) in the control and 11 (32.4%) in the Falcon had repeat coronary angiography (p = 0.38), 12 (30.8%) vs. 7 (20.6%) had repeat PTCA (p = 0.37) and time to PTCA was 116 +/- 70 days vs. 154 +/- 103 days respectively (p = 0.36). The Falcon performed technically as well as the concentric balloons. Despite a smaller MLD and increase in Type A dissections there was no associated increase in complications or reintervention for restenosis. Further investigation is required to evaluate the role of this mechanism of dilatation in restenosis.     

High-energy eccentric excimer laser angioplasty for debulking diffuse iIn-stent restenosis leads to better acute- and 6-month follow-up results

BACKGROUND: Restenosis of diffuse in-stent stenosis (> 10 mm) treated with percutaneous transluminal coronary angioplasty (PTCA) is as high as 80%. The excessive tissue-hyperplasia led to debulking before PTCA. Because debulking is limited by the intensity and applicability of its use, the large debulking trials were criticized and showed no major benefit. Considering that a significantly greater diameter than its own diameter can be ablated by the Eccentric Excimer Laser (eccELCA), we evaluated its effectiveness and safety in a prospective study. METHODS: Thirty-nine patients with diffuse in-stent restenosis (3.4 +/- 0.6 mm diameter; 14 +/- 9 mm in length) were treated by EccELCA followed by PTCA. In addition to clinical/angiographic target lesion revascularization (TLR) and major adverse cardiac events (MACE), the study endpoints were diameter stenosis (DS) and minimal lumen diameter (MLD), which were calculated before EccELCA, after EccELCA, after adjunctive PTCA and at 6-month follow-up. RESULTS: Procedural success was 99.8%. Delivered laser energy was 2,134 +/- 856 Joules. DS decreased from 84 +/- 14% to 23 +/- 11% after eccELCA (p = 0.0018) to 9 +/- 5% after PTCA (p = 0.001) and was 31 +/- 12% at follow-up (p = 0.0041). MLD increased from 0.7 +/- 0.2 mm to 2.2 +/- 0.4 mm after EccELCA (p = 0.0017), to 2.7 +/- 0.4 mm after PTCA (p = 0.001) to 1.7 +/- 0.3 mm at follow-up (p = 0.0049). Maximal balloon inflation pressure was 9.4 +/- 4.0 atmospheres. At follow-up angiography, TLR = 23.1%, clinical TLR = 12.8%, and MACE = 0%. CONCLUSION: Due to a greater debulking effect, additional lumen gain can be achieved immediately and at follow-up through the high-energy use of EccELCA for debulking and through the use of lower balloon inflation pressures for adjunctive PTCA. Clinical and angiographic TLR is significantly lower than other debulking techniques or PTCA alone and comparable with local irradiation therapy.     

The French Randomized Optimal Stenting Trial: a prospective evaluation of provisional stenting guided by coronary velocity reserve and quantitative coronary angiography. F.R.O.S.T. Study Group

OBJECTIVES: We sought to make a prospective comparison of systematic stenting with provisional stenting guided by Doppler measurements of coronary velocity reserve and quantitative coronary angiography. BACKGROUND: Despite the increasing use of stents during percutaneous transluminal coronary angioplasty, it is unclear whether systematic stenting is superior to a strategy of provisional stenting in which stents are placed only in patients with unsatisfactory results or as a bail-out procedure. METHODS: Two hundred fifty-one patients undergoing elective coronary angioplasty were randomly assigned either to provisional stenting (group 1, in which stenting was performed if postangioplasty coronary velocity reserve was <2.2 and/or residual stenosis > or =35% or as bail-out) or to systematic stenting (group 2). The primary end point was the six-month angiographic minimal lumen diameter (MLD). Major adverse cardiac events were secondary end points (death, acute myocardial infarction and target lesion revascularization). RESULTS: Stenting was performed in 48.4% of patients in group 1 and 100% of patients in group 2 (p<0.01). Six months after angioplasty, the MLD did not differ between groups (1.90+/-0.79 mm vs. 1.99+/-0.70 mm, p = 0.39), as was the rate of binary restenosis (27.1% vs. 21.4%, p = 0.37). Among patients with restenosis, 13/32 (40.6%) in group 1 but 100% (25/25) in group 2 had in-stent restenosis (p<0.01). Target lesion revascularization (15.1% vs. 14.4% in groups 1 and 2 respectively, p = 0.89) and major adverse cardiac events (15.1% vs. 16.0%, p = 0.85) were not significantly different. CONCLUSIONS: Systematic stenting does not provide superior angiographic results at six months as compared with provisional stenting.     

Acute closure during coronary excimer laser angioplasty and conventional balloon dilatation: a comparison of management outcome and prediction

Of 523 consecutive patients undergoing elective percutaneoustransluminal coronary angioplasty (PTCA) and 83 patients treatedwith coronary excimer laser angioplasty (ELCA), 17 (3.3%) hadin-laboratory occlusion following PTCA and 25 (30%)followingELCA; they were enrolled into a prospective study. Successfulmanagement (reopened vessel, patency at repeat angiography within24 h, no death, no myocardial infarction (MI), no emergencybypass surgery) including repeat lasing, subsequent PTCA, useof intracoronary nitroglycerin or streptokinase was achievedin 24 (96%) of the 25 patients with acute occlusion during ELCA.An anterior MI occurred in one patient of the laser group. Repeatballoon dilatation was successfully performed in seven of the17 patients (41%) with acute closure during PTCA. Among the10 patients with persistent occlusion after PTCA, five developeda limited myocardial infarction (35%). One patient requiredemergency CABG, and died peri-operatively. Severe spasm priorto occlusion defined by a new coronary flow depression withoutevidence of dissection or thrombus showed a significant positiveassociation with acute occlusion during ELCA (P =0.0008). Thus, in contrast to occlusion during PTCA, subsequent balloondilatation was successfully performed in the majority of patientswith acute occlusion during ELCA, implying that different underlyingmechanisms are responsible for this complication. In this limitedpatient group, occlusion after excimer laser angioplasty wasmuch more frequent than closure during PTCA, but was infrequentlyassociated with major events such as myocardial infarction ordeath.     

Cutting balloon versus conventional balloon angioplasty for the treatment of in-stent restenosis: results of the restenosis cutting balloon evaluation trial (RESCUT)

OBJECTIVES: The aim of this trial was to compare cutting balloon angioplasty (CBA) with conventional balloon angioplasty (i.e., percutaneous transluminal coronary angioplasty [PTCA]) for the treatment of patients with coronary in-stent restenosis (ISR). BACKGROUND: Retrospective studies suggest CBA might be superior to conventional PTCA in the treatment of ISR. METHODS: The Restenosis Cutting Balloon Evaluation Trial (RESCUT) is a multicenter, randomized, prospective European trial including 428 patients with all types of ISR (e.g., focal, multifocal, diffuse, proliferative). RESULTS: In both groups, the majority of ISR lesions were shorter than 20 mm. The length of restenotic stents was similar (CBA: 18.6 +/- 9.7 mm; PTCA: 18.3 +/- 8.7 mm). The number of balloons used to treat ISR was lower in the CBA group: only one balloon was used in 82.3% of CBA cases, compared with 75% of PTCA procedures (p = 0.03). Balloon slippage was less frequent in the CBA group (CBA 6.5%, PTCA 25%; p < 0.01). There was a trend toward a lower need for additional stenting in the CBA group (CBA 3.9%, PTCA 8.0%; p = 0.07). At seven-month angiographic follow-up, the binary restenosis rate was not different between the groups (CBA 29.8%, PTCA 31.4%; p = 0.82), with a similar pattern of recurrent restenosis. Clinical events at seven months were also similar. CONCLUSIONS: Cutting balloon angioplasty did not reduce recurrent ISR and major adverse cardiac events, as compared with conventional PTCA. However, CBA was associated with some procedural advantages, such as use of fewer balloons, less requirement for additional stenting, and a lower incidence of balloon slippage.     

Treatment of focal in-stent restenosis with balloon angioplasty alone versus stenting: Short- and long-term results

BACKGROUND: Although both percutaneous transluminal coronary angioplasty (PTCA) and additional stenting can be used for the treatment for focal in-stent restenosis (ISR), no large-scale comparative data on the clinical outcomes after these interventional procedures have been reported. METHODS: In the current study we compared the in-hospital and long-term clinical results of PTCA alone (n = 266 patients, n = 364 lesions) versus stenting (n = 135 patients, n = 161 lesions) for the treatment of focal ISR, defined as a lesion length less than or equal to 10 mm. RESULTS: There were significantly more diabetic patients in the PTCA group than in the stent group (36% vs 26%, P =.04), but other baseline characteristics were similar. Lesion length and preprocedure minimal lumen diameter (MLD) were also similar in the two groups, but the stent group had a larger reference vessel diameter (3.40 +/- 0.73 mm vs 2.99 +/- 0.68 mm, P <.001). Stenting achieved a larger postprocedure MLD than PTCA did (2.95 +/- 0.95 mm vs 2.23 +/- 0.60 mm, P <.001) and a smaller residual diameter stenosis (11% +/- 15% vs 23% +/- 16%, P =.04). Angiographic success was achieved in all cases. The rate of death/Q-wave infarction of urgent revascularization was higher with PTCA than with stent (5.6% vs 0.7%, P =.02). Postprocedure creatine kinase myocardial band enzyme elevation >5 times normal was more frequent with stent (18.5% vs 9.7%, P =.05). At 1 year the two interventional strategies had similar cumulative mortality (4.6% PTCA vs 5.1% stent, P not significant) and target lesion revascularization rate (24.6% PTCA vs 26.5% stent, P not significant). By multivariate analysis, the sole predictor of target lesion revascularization was diabetes (odds ratio 2.4, 95% confidence intervals 1.2-4.7, P =.01). CONCLUSION: Repeat stenting for the treatment of focal ISR had a higher postprocedure creatine kinase myocardial band elevation rate and similar long-term clinical results compared with PTCA alone.     

Intracoronary β-irradiation prevents excessive in-stent neointimal proliferation in de novo lesions of patients with high plasma ACE levels. The BetAce randomized trial

BACKGROUND: This study evaluated vascular brachytherapy (VBT) as a potent antiproliferative treatment to prevent in-stent restenosis (ISR) after coronary angioplasty of de novo lesions in patients carrying the D allele of the I/D polymorphism of the ACE gene and high ACE plasma levels (>34 U/l). METHODS AND MATERIALS: A prospective randomized trial was designed to detect a 30% improvement in the minimal lumen diameter (MLD) of the stenotic artery, as measured by quantitative coronary analysis (QCA), 6 months following VBT at the time of stented angioplasty. All patients were carriers of the D allele of the ACE gene, with plasma ACE levels >34 U/l. RESULTS: Thirty-one patients (33 stenoses) were allocated to stent implantation (control group) and 30 patients (31 stenoses) to VBT and stented angioplasty. After angioplasty, in-stent MLD was similar in the two groups. At 6 months in the control group, in-stent MLD had decreased to 1.74+/-0.8 versus 2.25+/-1.05 mm in the VBT group (P=.04). The mean in-stent diameter was 2.3+/-0.8 mm in the control group versus 2.9+/-1.05 mm after VBT (P=.02), and the restenosis rate was 37.5% versus 17.9%, respectively (P=.08). At 6 months, a higher need for target vessel revascularization (TVR) was observed in the control group: 35.5% versus 13.3% (P=.04). CONCLUSIONS: This randomized study confirms that patients with high plasma ACE concentrations are exposed to an increased risk for ISR after coronary stenting. The preventive use of VBT in these patients reduced neointimal formation by 65% such that the MLD at follow-up was increased by 29% compared with the control group.     

Prediction of restenosis after percutaneous transluminal coronary angioplasty using coronary flow reserve. Kansai Doppler Guide Wire Study Group

This multi-center prospective study attempted to predict restenosis after percutaneous transluminal coronary angioplasty(PTCA) using coronary flow reserve. Intracoronary blood flow velocity was measured in 47 patients(37 males, 10 females, mean age 66 +/- 9 years) with a Doppler guide wire, following successful PTCA. Twenty-four patients had prior myocardial infarction. After successful PTCA, a Doppler guide wire was placed at the distal portion of the target lesion, and coronary blood flow velocity was measured before and during intravenous administration of adenosine triphosphate. Follow-up coronary angiography was performed 154 +/- 69 days after PTCA, and the diameter stenosis of the target lesion was measured using quantitative coronary angiography. Follow-up angiography showed restenosis in 13 patients(28%). Sensitivity and specificity for predicting restenosis were low(50%, 45%, respectively) with a post-PTCA% diameter stenosis cut-off point of 27%. Sensitivity and specificity were 67% and 61% with a minimal lumen diameter cut-off of 1.8 mm. The reference coronary artery diameter(cut-off point 2.5 mm) was better for predicting restenosis(sensitivity 78% and specificity 76%). Sensitivity and specificity were 62% and 67%, respectively, using coronary flow reserve(cut-off point 2.0). The restenosis rate of patients with a reference diameter of more than 2.5 mm was 10%, but 54% for those with less than 2.5 mm(p < 0.05). In patients with a reference diameter of less than 2.5 mm, coronary flow reserve was useful for predicting restenosis(cut-off point 1.9, sensitivity 71% and specificity 83%). Coronary flow reserve is useful for predicting restenosis after PTCA, when combined with reference coronary artery diameter.     

High speed rotational atherectomy for diffuse in-stent restenosis: short- and mid-term follow-up results.

Between January 1997 to May 1998, 37 consecutive patients underwent high speed rotational atherectomy with adjunctive balloon angioplasty for the management of first-time diffuse variety of in-stent restenosis in the native coronary arteries. Their age ranged from 38 to 71 years (mean 54.3 +/- 9.7 years). All the patients underwent initial stent implantation at moderate to high pressure. Patients were either symptomatic or demonstrated significant ischaemia by non-invasive testing. The median time from the index procedure to in-stent restenosis was 20 weeks (range 9-40 weeks). Majority (78.1%) of lesions were in the territory of left anterior descending coronary artery. The mean lesion length was 24.3 +/- 8.3 mm (range 12-42 mm). Five lesions each (12.2%) were total occlusion and ostial in location. High speed rotational atherectomy was performed using stepped burr technique in majority (90.2%) with the largest burr corresponding to approximately 70 percent of the reference vessel diameter. The initial burr size ranged from 1.5-2.0 mm, final burr was 1.75-2.25 mm and the average number of burrs used per target vessel was 2.2 +/- 0.3 (range 1-3). Adjunctive balloon angioplasty was performed in all (100%) cases using a semi-compliant oversized balloon (balloon-to-artery ratio 1.1:1) inflated at a pressure of 6.5 +/- 2.1 atmospheres (range 4-10). The procedure was successful in all cases without any major complications (death, Q-MI, CABG or repeat PTCA). Over a median follow-up of 10 months, 27 (73%) patients were asymptomatic. Recurrence of clinical events occurred in 10 (27%) patients at median interval of 16 weeks after rotational atherectomy. Angina was controlled on drug therapy in six (16.2%) and target vessel revascularisation was required in three (8.1%) cases. By the Kaplan-Meier estimate, an event-free survival (absence of death, Q-MI, recurrence of angina, target vessel revascularisation) was 97.3, 94.6, 75.7 and 72.6 percent at 1, 3, 6 and 12 months, respectively. Thus, rotational atherectomy using a stepped burr approach for adequate debulking, followed by adjunctive balloon angioplasty is safe with excellent in-hospital results for the treatment of diffuse in-stent restenosis. Although recurrence of symptoms develops in approximately one-fourth of patients on follow-up, it is much less than reported with balloon angioplasty in this subgroup of patients.