Laser balloon angioplasty: clinical, angiographic and histologic results

Laser balloon angioplasty combines conventional coronary angioplasty with laser energy to transiently heat vascular tissue. Laser balloon angioplasty, was performed in 21 patients (aged 56 +/- 13 years), including 10 patients treated urgently after acute failure of conventional angioplasty and 11 patients treated with elective laser balloon angioplasty. Immediately after conventional angioplasty, laser doses (1 to 10 doses of 205 to 380 J each) were delivered during inflation of the laser balloon to a pressure of 4 atm. Seven (70%) of 10 patients with acute failure of conventional angioplasty were successfully treated with laser balloon angioplasty, but 3 (30%) were unsuccessfully treated with the laser procedure and required emergency coronary artery bypass surgery. In all three failures, the 3 mm laser balloon angioplasty catheter was not the optimal size for the vessel. In the 11 patients treated with elective laser balloon angioplasty (reference diameter 2.94 +/- 0.22 mm), the minimal luminal diameter increased from 0.45 +/- 0.25 to 1.85 +/- 0.46 mm after conventional angioplasty and to 2.44 +/- 0.29 mm after laser balloon angioplasty (p less than 0.001). This corresponded to a decrease in diameter stenosis from 84 +/- 9% before to 35 +/- 16% after conventional angioplasty and to 15 +/- 10% after laser balloon angioplasty (p less than 0.001). There were no instances of myocardial infarction, emergency coronary artery bypass surgery or death and no acute complications related to delivery of laser energy in this group. Follow-up coronary angiography was performed 5.5 +/- 1.1 months after laser balloon angioplasty in 18 patients discharged from the hospital after a successful procedure. Ten patients (56%) had angiographic restenosis, defined as recurrent diameter stenosis greater than 50%. Six patients were subsequently treated by directional coronary atherectomy, which revealed intimal proliferation indistinguishable from that in patients with restenosis after conventional angioplasty. In conclusion, laser balloon angioplasty may be effective in sealing severe coronary dissections and reversing abrupt closure associated with failed conventional angioplasty. After uncomplicated conventional angioplasty, laser balloon angioplasty improves immediate luminal dimensions, but restenosis appears to be mediated by intimal hyperplasia, similar to that seen after conventional angioplasty.     

Immediate and Remote Results of Endovascular Recanalization of Chronic Coronary Artery Occlusions

We compared early and long-term follow-up results of balloon angioplasty and stenting of chronic coronary occlusions. The initial success rate was 75% (82 of 109 patients). Proportion of patients free of angina was 57 and 69% after successful balloon angioplasty and stenting, respectively. Stenting of coronary occlusions yielded better immediate angiographic results than did balloon angioplasty: residual stenosis and minimal diameter of artery after stenting were 13.5-12.4% and 2.7-0.2 mm, respectively; those after balloon angioplasty were 23.2-15.6% and 2.3-0.2 mm, p<0,05, respectively. Four-year clinical outcome was better in stenting than in angioplasty group: free of angina were 52 and 22% of patients in stenting and angioplasty group, respectively (p<0,05). There was no difference at follow-up between two groups in the rate of myocardial infarction, death, repeat revascularization. Repeat coronary angiography was performed after 38-24 months in 44% of patients. The rate of 'late' restenosis was 32% in stenting and 73% in balloon angioplasty group (p<0,05); mean stenosis and minimal diameter of artery after stenting were 43.5-12.4% and 1.7-0.6 mm, respectively; those after balloon angioplasty were 67.5-15.6% and 0.72+0.5 mm, respectively (p<0,05).     

Results of intracoronary stents for management of coronary dissection after balloon angioplasty

Dissections after coronary balloon angioplasty are risk factors for acute or subacute vessel closures. Intracoronary stenting was developed to avoid these complications by pressing the intimal and medial flaps against the vessel wall, thus reducing the risk of acute thrombosis. A total of 22 stents were implanted into the coronary arteries of 15 patients with dissections after balloon angioplasty causing angina pectoris or ischemic electrocardiographic changes. Stent delivery was successful in all cases. In 1 patient acute stent thrombosis was documented and treated successfully by thrombolytic therapy. Another patient underwent coronary artery bypass surgery 24 hours later because of persisting angina. Angiograms after 24 hours documented vessel patency in the remaining 14 patients. Late control angiograms after 4 to 6 months were obtained in 12 of 14 patients. Vessel patency without significant restenosis was observed in 8 patients, restenosis in 3 and reocclusion in 1 patient. All 3 patients with multiple stent implantation had restenosis (n = 2) or reocclusion (n = 1), compared with 1 patient with single stent implantation. Thus, intracoronary stenting appears to be a secure and effective method of handling bailout situations caused by dissection after balloon angioplasty, with good long-term results when only a single stent is implanted.     

Quantitative angiographic comparison of the immediate success of coronary angioplasty, coronary atherectomy and endoluminal stenting

Coronary atherectomy and coronary stenting effectively reduce the severity of coronary artery stenoses, but direct comparisons of these interventions with conventional balloon angioplasty have not been performed. To compare the immediate efficacy of these 3 interventions, the angiographic morphology and the severity of the residual coronary stenosis were quantitatively evaluated in 18 patients undergoing coronary atherectomy and in 21 patients treated by endoluminal coronary stenting. Each of these groups of patients was compared with a matched group of coronary angioplasty patients selected from a large, computerized data-base. The variables matched included patient age and sex, lesions site and severity, and lesion complexity. Both coronary atherectomy and coronary stenting more effectively reduced the severity of the coronary stenosis when compared with balloon angioplasty. The luminal diameter stenosis was reduced from 69 +/- 10 to 22 +/- 20% in the atherectomy group compared with a reduction from 74 +/- 11 to 44 +/- 14% in the matched coronary angioplasty population (p = 0.008). Similarly, the luminal diameter stenosis was reduced from 77 +/- 11 to 26 +/- 12% in the stented group compared with a reduction from 81 +/- 10 to 42 +/- 14% in the matched coronary angioplasty group (p = 0.014). In addition, moderate or severe coronary dissections were noted more frequently in the coronary angioplasty groups than in their respective atherectomy and stent groups (0 vs 33%, p = 0.008, and 5 vs 19%, p = 0.15, respectively).(ABSTRACT TRUNCATED AT 250 WORDS)     

Effectiveness of rotational atherectomy of right coronary artery ostial stenosis

Balloon angioplasty and stenting of right coronary ostial stenosis may frequently be impeded by lesion calcification, whereas rotational atherectomy, which ablates calcified plaque, should treat these lesions effectively. Accordingly, we evaluated procedural success and longterm clinical outcome of rotational atherectomy of right coronary ostial stenosis. Procedural data were obtained from a comprehensive interventional registry and follow-up information was obtained by chart review and patient enquiry. All patients who developed recurrent angina underwent angiographic restudy. During a 5-year interval, 119 patients underwent rotational atherectomy of right coronary ostial stenosis. Multilesion interventions were performed in 55% of patients. Ostial lesions were 3.73+/-3.69 mm in length (mean +/- SD), and 57.1% were significantly calcified. Reference vessel diameter was 3.42+/-0.56 mm. Maximum burr:artery ratio was 0.64+/-0.1 with adjunct balloon angioplasty in 89.1% and adjunct stenting in 9.2%. Procedural success (<50% residual stenosis without major complication) was 97.5%, with 1.7% uncomplicated failure and 0.8% Q-wave infarction. Maximum residual stenosis was 15+/-17%. During 6-month follow-up, available in 94% of patients, 82.7% remained angina-free, 10.9% developed recurrent angina due to right coronary ostial restenosis, and 6.4% developed recurrent angina due to another lesion. Two years after intervention, target lesion revascularization rate was 16%. Predictors of symptomatic angiographic restenosis were dissection >10 mm, final minimal luminal diameter <2.5 mm, lesion length >10 mm, restenotic lesion, and diabetes. We conclude that rotational atherectomy of right coronary ostial stenosis results in excellent acute procedural success and in low incidence of clinical recurrence, with a high proportion of patients remaining angina-free 2 years after intervention.     

Emergency Coronary Stenting with Wiktor Stent Ñ Immediate and Late Results

In case of failed angioplasty, coronary stenting has gradually emerged as a non-surgical method to restore vessel patency and optimize coronary blood flow. There is still little clinical and angiographic information on the use of radiopaque single loose interdigitating wire stents in angioplasty complicated by threatened or acute closure. Seventy-one patients received Wiktor stents after threatened vessel closure in 53 cases and acute closure in 18 cases. Stent delivery was successful in 98%. In-hospital death occurred in 1 case (1.4%). Stents occlusion were faced in 10 cases (14%), of which 6 presented early and 4 late after the procedure. Urgent bypass surgery was needed in 9 cases (12%) and 7 patients (10%) developed acute myocardial infarction. Serious bleeding complications occurred in 7 cases (10%) and vascular repair was performed in 4 patients (5%). During a follow-up of 20 +/- 10 months, 2 patients died, no myocardial infarction was observed and recurrence of angina was noted in 17 patients (24%). Angiographic analysis showed an acute gain in minimal lumen diameter of 1.71 +/- 0.22 mm and a late loss of 0.63 +/- 0.17 mm. Angiographic restenosis (diameter stenosis > 50%) presented in 20% of patients. Therefore, Wiktor stenting yields similar results than currently used stents in acute closure and strictly defined threatened vessel closure following angioplasty.     

Pressure wire guide provisional coronary stent implantation

OBJECTIVES: Whether coronary artery lesion successfully dilated by balloon angioplasty should be stented or not is unclear. The purpose of this study is to evaluate the provisional stent implantation method assessing residual ischemia by pressure wire. METHODS: Thirty-one patients with de-novo lesions suitable for stenting were enrolled in a pressure wire guided provisional stent study. The pressure wire was used to assess the fractional flow reserve(FFR) before and after balloon angioplasty. When the FFR after angioplasty was less than 0.75, stent implantation was planned. Patients with lesions consisting of an intermediate stenosis proximal to the target lesion, chronic total occlusion, bypass graft and left main lesion were excluded from the study. Stent implantation was permitted even if the FFR was more than 0.75 when the operator thought stenting was necessary. Medical treatment was given with aspirin 162 mg/day, cilostazol 200 mg/day for 6 months and additional ticlopidine 200 mg/day for a month after stenting the lesion. RESULTS: Target vessel was the left anterior descending coronary artery in 19 lesions, the right coronary artery in 3, and the circumflex coronary artery in 9. Stent implantation was performed in seven (23%) of 31 lesions and the other 24(77%) lesions were treated with only balloon angioplasty. The FFR before intervention was 0.58 +/- 0.16, and improved to 0.87 +/- 0.07 (p < 0.0001). Percentage diameter stenosis before intervention was 70.7 +/- 12.6% and improved to 20.1 +/- 13.3% (p < 0.0001) after intervention. There was no major cardiac event (death, coronary artery bypass grafting, myocardial infarction, stent thrombosis). Six months follow-up angiography was performed in 27 patients (87%). Angiographic restenosis (percentage diameter stenosis > or = 50%) was found in four patients (15%). A new lesion was found in two patients. Target vessel revascularization was performed in six patients (21%). CONCLUSIONS: Lesions successfully dilated by balloon angioplasty with FFR > or = 0.75 do not require stenting.     

Effect of intracoronary stenting on intimal dissection after balloon angioplasty: results of quantitative and qualitative coronary analysis

The effect of the Palmaz-Schatz stent on the angiographic appearance and residual luminal stenosis in patients with intimal dissection after balloon angioplasty was evaluated in 84 consecutive patients (90 lesions). Coronary angiography was performed before angioplasty, after conventional angioplasty and after stent implantation. The degree of intimal disruption was assessed as follows: grade 0, no dissection; grade 1, simple dissection (intraluminal linear defect or extraluminal cap extravasation); or grade 2, complex dissection (nonlinear spiral defect or luminal defect with multiple irregular borders). Quantitative coronary analysis of digitized cineangiograms was performed with use of a computerized automatic edge detection algorithm. After balloon angioplasty, 31 (34%) of 90 lesions demonstrated intimal dissection (18 simple, 13 complex). After stent implantation, intimal dissection improved by greater than or equal to 1 grade in 29 (94%) of the 31 lesions with 27 (87%) reduced to grade 0 (that is, no dissection). Dissection grade improved after stenting in 16 (89%) of 18 simple dissections and in all 13 complex dissections. Mean diameter stenosis was 77 +/- 17% before angioplasty, 47 +/- 17% after angioplasty and 14 +/- 10% after stenting (before angioplasty vs. after angioplasty and after angioplasty vs. after stenting, p less than 0.0001). In conclusion, intracoronary stenting is effective in reducing the residual luminal stenosis and in improving the angiographic appearance of intimal dissections after conventional balloon angioplasty.     

Percutaneous transluminal coronary angioplasty in patients with prior myocardial infarction: angioplasty at a distance from the prior infarct zone

Patients undergoing coronary angioplasty who have had a prior transmural myocardial infarction in the distribution of a contralateral coronary artery are considered a high-risk group because of potentially severe left ventricular dysfunction if an ischemic complication occurs. The purpose of this study was to evaluate the safety and efficacy of coronary angioplasty in 28 patients with prior myocardial infarction remote from the artery undergoing dilatation. Prior myocardial infarction was defined by the presence of pathologic Q waves on ECG or segmental akinesis on ventriculography. Angioplasty was successful in 30 of 33 lesions (91%) and in 25 of 28 patients (89%). Mean stenosis diameter was reduced from 91% +/- 7% to 28% +/- 16%; mean translesional gradient after angioplasty was 6 +/- 5 mm Hg. No patient developed severe hemodynamic deterioration from transient coronary occlusion during balloon inflation or from an acute ischemic complication. Three patients underwent coronary artery bypass surgery after unsuccessful angioplasty. There were no new Q wave infarctions or deaths. The results of coronary angioplasty in patients with prior infarction were compared with those of 203 patients without prior remote infarction. Primary success and occurrence of major complications were comparable in both groups. At a mean follow-up of 12 +/- 6 months, 18 of the 25 patients (72%) who underwent initially successful dilatation have remained symptom free with angioplasty alone. Therefore, coronary angioplasty is a suitable therapeutic procedure in carefully selected patients with angina pectoris and prior myocardial infarction at a distance from the site of angioplasty.     

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

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

Clinical and angiographic outcome after cutting balloon angioplasty

The cutting balloon is a new device for coronary angioplasty, that, by the combination of incision and dilatation of the plaque, is believed to be promising for treatment of in-stent restenosis. The purpose of the study was to evaluate the safety and efficacy of CBA. We reviewed the immediate and 6-month follow-up angiographic and clinical outcome of 147 patients (109 men and 38 women) with a mean age of 67.3 +/- 10 undergoing this procedure at eight interventional centers in Austria. The target lesions treated with CBA were in-stent restenosis in 61% of patients, stenosis after balloon angioplasty in 8% of patients, and native lesions in 33% of patients. Sixty-five percent of the patients included had multivessel disease. Lesion type was A in 18% of patients, B1 in 31% of patients, B2 in 39% of patients, and C in 12% of patients. The degree of stenosis was 87% +/- 9%, the length of the target lesion treated with CBA was 8.8 +/- 5.1 mm. Target vessel was left circumflex artery in 22 cases, right coronary artery in 36 cases, and left anterior descending artery in 89 cases. The overall procedural success rate was 90.5%. "Stand-alone" CBA was performed in 63% of patients, the procedure was combined with coronary stenting in 16% of patients, and with balloon angioplasty in 21% of patients. Coronary complications occurred in eight cases (5.4%) with coronary dissection in seven (total dissection rate of 4.7%) and urgent bypass surgery in one case (0.7%). No further complications such as death, occlusion, or perforation of coronary arteries, embolization, or thrombosis were observed. Six-month clinical follow-up revealed q-wave myocardial infarction in 2.7% of patients, aortocoronary bypass surgery in 8.5% of patients, and repeated percutaneous coronary intervention in 17% of patients (11.5% with stenting). Six-month angiographic follow-up of patients with recurrent angina showed target lesion restenosis (> 50% diameter stenosis) in 14% of patients, late lumen loss with < or = 50% diameter stenosis in 6% of patients and progression of "other than target" lesions with > 50% diameter stenosis in 14% of patients. This series demonstrates the safety and feasibility of cutting balloon angioplasty in patients with complex coronary artery disease and in-stent restenosis.     

The treatment of coronary atherosclerosis: effect of the use of stents on immediate and long term results of coronary angioplasty

Immediate and long term results of 2 methods of coronary angioplasty (balloon dilatation and stenting) were analyzed retrospectively. During 10 years proportion of stent implantations increased 30-fold reaching 95-97% of coronary interventions. This was associated with improvement of immediate results of angioplasty: lowered rates of myocardial infarctions, urgent coronary artery bypass graftings and acute coronary artery occlusions (from 2.7% after balloon angioplasty to 0.6% after stenting). Improved long-term prognosis after stenting manifested in lower frequency of cardiovascular events. Five year survival was 98,8 and 92.7% after stenting and balloon angioplasty, respectively (p=0.004). However effect of stenting on rates of angiographic restenosis and repeat revascularizations was less pronounced (27.1 and 30.4%, respectively, after stenting vs. 30.1 and 34.5%, respectively, after balloon angioplasty).     

Effect of cilostazol on restenosis after coronary angioplasty and stenting in comparison to conventional coronary artery stenting with ticlopidine

BACKGROUND: The role of antiplatelet therapy with ticlopidine plus aspirin in the prevention of subacute thrombosis after coronary artery stenting has been established. However, restenosis remains a major limitation in coronary artery stenting. METHODS: To compare the effect of cilostazol on restenosis after coronary angioplasty and stenting with that of ticlopidine after coronary artery stenting, 213 patients with 230 lesions who underwent successful coronary interventions were evaluated. Optimal results (residual stenosis less than 30%) were obtained by balloon angioplasty in 112 lesions, 64 lesions were treated with aspirin 81 mg/day (balloon-aspirin group) and 48 lesions with cilostazol 200 mg/day and aspirin 81 mg/day (balloon-cilostazol group). Stent implantation was performed in the remaining 118 lesions; 55 lesions were treated with ticlopidine 200 mg/day and aspirin 243 mg/day (stent-ticlopidine group) and 63 lesions with cilostazol 200 mg/day and aspirin 81 mg/day (stent-cilostazol group). Concomitant medications were continued for 4 to 6 months of follow-up. RESULTS: No adverse events including acute occlusion and subacute thrombosis occurred in any groups. Although immediate gain and minimal lumen diameter immediately after angioplasty were significantly larger in stent groups than those in balloon groups, net gain at follow-up was significantly larger in cilostazol groups (1.54+/-0.83 mm in balloon-cilostazol group and 1.65+/-0.78 mm in stent-cilostazol group) than other groups (1.02+/-0.81 mm in balloon-aspirin group and 1.21+/-0.70 in stent-ticlopidine group) as a result of significantly lower late loss and loss index in cilostazol groups. The restenosis rate was significantly lower in cilostazol groups (12.5% in balloon-cilostazol group and 14.3% in stent-cilostazol group) than other groups (43.8% in balloon-aspirin group and 32.7% in stent-ticlopidine group). The rate of recurrent angina was significantly lower in cilostazol groups (4.3% in balloon-cilostazol group and 1.9% in stent-cilostazol group) than in other groups (17.5% in balloon-aspirin group and 14.0% in stent-ticlopidine groups). CONCLUSIONS: Both optimal balloon angioplasty with cilostazol and coronary artery stenting with cilostazol have a potential to reduce restenosis compared with optimal balloon angioplasty with aspirin or conventional coronary artery stenting with ticlopidine plus aspirin.     

The clinical and angiographic evolution of dilated lesions in the proximal segment of the anterior descending coronary artery: stent versus balloon

INTRODUCTION AND OBJECTIVES: The restenosis rate after coronary balloon angioplasty of lesions located in the proximal segment of the left anterior descending coronary artery is high, having been recommended elective stent implantation in order to improve the outcomes. The aim of this study was to analyze clinical, anatomic and angiographic factors related to the short-term outcome after angioplasty of severe lesions in the proximal segment of the left anterior descending artery, with and without stent implantation. MATERIAL AND METHODS: We study 87 patients with severe stenosis (> or = 70%) of the proximal segment of left anterior descending artery treated successfully with angioplasty. In 54 patients (62%) a conventional balloon was used (group A) and in 33 (38%) a stent was implanted (group B). RESULTS: Mean age of patients was 61.9 +/- 12 years old, 74% were male and angioplasty was performed because of unstable angina in 72%. At the end of the follow-up (mean 6.3 +/- 1.5 months), 21% of patients in group B had angina vs 54% in group A (p = 0.03). Group B patients experienced a lower restenosis rate (30% vs. 50%; p = 0.07) and less repeat angioplasty procedures (33% vs 21%; p = NS) than group A. These results were maintained independently of the vessel diameter (< 3 mm or > or = 3 mm) or when an optimal result (< 25%) after balloon angioplasty was obtained. CONCLUSIONS: In our experience, stenting of lesions located in the proximal segment of the left anterior descending artery appears imply a better short-term clinical, angiographic outcome and a lower restenosis rate than lesions treated with conventional balloon angioplasty, even despite an optimal result after balloon angioplasty or independently of the vessel diameter. Future studies will be necessary to confirm these results.     

Outcome after prolonged balloon inflations of greater than 20 minutes for initially unsuccessful percutaneous transluminal coronary angioplasty.

Prolonged balloon inflation with or without autoperfusion techniques is a common initial approach to major dissection or abrupt occlusion after percutaneous transluminal coronary angioplasty (PTCA). To assess such a strategy in the setting of unsuccessful angioplasty, 40 patients who underwent prolonged balloon inflations of greater than 20 minutes between January and July of 1991 after initially unsuccessful angioplasty were studied. These patients (median age 59 years) underwent PTCA for progressive or unstable angina (16[40%]), symptomatic or asymptomatic residual stenosis after myocardial infarction (10[25%]), acute myocardial infarction (3[8%]), stable angina (3[8%]), reinfarction (2[5%]), and other indications (6[15%]). The significant stenoses were primarily in the proximal and midportions of the right coronary (53%), left anterior descending (30%) and left circumflex (17%) coronary arteries. Before prolonged balloon inflation, the longest single inflation was 11 +/- 6 minutes and the total time of all inflations was 17 +/- 8 minutes (mean +/- standard deviation). Stenosis was reduced from 91 +/- 9 to 68 +/- 16% before prolonged inflation. After prolonged balloon inflation of 30 +/- 9 minutes, the residual stenosis was 47 +/- 21% (p = 0.0001 vs value before prolonged inflation). Furthermore, improvements in the appearance of filling defects or dissections, or both, occurred in 19 patients (48%). Procedural success was obtained in 32 of 40 patients (80%). Coronary bypass grafting was performed in 8 patients (20%): 4 after unsuccessful PTCA (3 emergently) and 4 electively after initially successful PTCA. Although 5 patients had creatine kinase-MB elevations greater than 20 IU/liter after the procedure, only 1 sustained a Q-wave myocardial infarction. There were no deaths in the hospital.(ABSTRACT TRUNCATED AT 250 WORDS)     

Elective Coronary Stenting as an Adjunct to Balloon Angioplasty in Stable Coronary Artery Disease: No Association with Incidence of Acute Complications. Results of the PTCA Registry of the German Community Hospitals

Background: Elective coronary stenting has hem shown to reduce the rate of recurrent stenoses after angioplasty but no firm data are available on its possible association with in-hospital ischemic complications . Methods: We analyzed the data of the registry of the German community hospitals covering approximately one quarter of all interventions in Germany. We included all angioplasty procedures performed in patients with stable coronary artery disease in 1996. Interventions with elective coronary stenting were compared to those with conventional balloon angioplasty. Interventions with bailout stenting were excluded . Results: Of 19,170 angioplasty procedures, 32.2% included elective coronary stenting. The immediate angiographic success rate (residual stenosis < 50%) was 90.6% of the procedures with stents versus 86.3% of those without stents (P < 0.001). The overall incidence of complications (death, myocardial infarction, bypass surgery, vessel closure, reintervention) was 3.9% and 3.8% (NS). Major events (death, myocardial infarction, bypass surgery) were more common in the stent-treated group (1.8% vs 1.4%, P = 0.027). In multivariate analysis, the following factors were significantly associated with complications: residual stenosis ≥ 50%, female gender, angioplasty of proximal left anterior descending coronary artery, morphological fype of lesion B2 or C, and multivessel disease. Angioplasty of restenoses after previous angioplasty was associated with significantly less risk than of de novo lesions. Stents were neutral with respect to the overall incidence of complications . Conclusions: Complications after elective coronary angioplasty remain largely unpredictable in individual patients despite the identification of several clinical and procedural risk factors. Elective coronary stenting is not associated with the immediate therapeutic risk of angioplasty in stable coronary artery disease .     

Comparison of Angiographic and Clinical Outcome After Cutting Balloon and Conventional Balloon Angioplasty in Vessels Smaller than 3 mm in Diameter: A Randomized Trial

OBJECTIVES: The purpose of the study was to evaluate and compare the immediate and six month follow-up angiographic and clinical outcome of cutting balloon angioplasty and conventional balloon angioplasty in small vessels (less than 3 mm in diameter). METHODS AND RESULTS: Between August 1995 and August 1996 a total of 71 eligible symptomatic patients with angiographically proven significant lesions in their coronary arteries smaller than 3 mm and requiring revascularization, were randomized to receive treatment by either cutting balloon angioplasty (CB) or conventional balloon angioplasty (BA). òStand-aloneó CB was performed on 51 lesions in 36 patients and BA on 47 lesions in 35 patients. Basic angiographic and clinical characteristics were similar in both groups. The overall procedural success rates for CB and BA groups were 92% and 97%, respectively. The immediate post-procedural minimal luminal diameter, residual stenosis and acute gain were similar in the CB and BA cohorts (1.93 +/- 0.36 mm, 24 +/- 12%, 1.18 +/- 0.45 mm vs. 2.01 +/- 0.34 mm, 22 +/- 9%, 1.26 +/- 0.35 mm, respectively). Total dissection rate and C-F dissections were fewer in the CB group (37%, 6% vs. 51%, 19%, respectively, p < 0.05). Six month follow-up angiographic restenosis rate was lower in the CB group (27% vs. 47%, p < 0.05). We also detected a significant difference of total number of all events at nine month clinical follow up (28% vs. 51%, p < 0.05). CONCLUSION: CB angioplasty can be performed with a comparable success rate to conventional BA in small vessels. Fewer bail-out procedures are needed as CB causes fewer and less severe dissections. There is also a significant reduction in six month restenosis rate. We suggest that CB might be a better option for revascularizing vessels smaller than 3 mm in diameter which are inherently more prone to immediate complications and late restenosis with BA.     

Coronary stenting without predilatation in a broad spectrum of clinical and angiographic situations

BACKGROUND: Direct coronary stenting without balloon predilatation has the potential benefits of a reduced risk of extended dissections, reduced fluoroscopy exposure, reduced procedural time, and potential cost savings. With the availability of superior stents and delivery systems, we review our experience with direct stent deployments in a large selected patient cohort. METHODS: We prospectively studied 158 consecutive cases of attempted coronary stenting without balloon predilatation over a 1-year period. RESULTS: Indications for the procedure included unstable angina (71%), stable angina (24%) and acute myocardial infarction (5%). Target vessels were the anterior descending artery (56%), right coronary artery (30%), circumflex artery (8%), and vein grafts (6%). Pre-procedural TIMI flows were grade 3 (91.7%), grade 2 (5.8%), grade 1 (1.3%) and 0 (1.3%). Lesion types were graded A (27%), B (61%), and C (12%). Stent types included NIR Primo (80.4%), ACS Multi-Link RX Duet (10.1%), NIR (5.1%), and others (4.4%). Stents ranged from 3.0Eth 4.0 mm in diameter (median = 3 mm) and 8Eth 32 mm in length (median = 16 mm). Stents were successfully deployed in 155 cases (98.1%); 2 (1.3%) required predilatation and 1 (0.6%) deployed stent could not be expanded and was opened by rotablation. All except the rotablator case achieved final TIMI grade 3 flow, and 66% did not require further balloon dilatation. There were no deaths or cases of urgent bypass surgery. Case duration and radiation exposure in direct stenting (32.8 +/- 18.9 minutes and 6.7 +/- 6.2 minutes, respectively) compared favorably to those in a matched group of patients in conventional stenting (47 +/- 18 minutes and 11 +/- 7 minutes) and coronary angioplasty (40 +/- 12 minutes and 10 +/- 6 minutes) for single-lesion cases (p < 0.005). Creatine kinase elevation related to the procedure was observed in 5 patients. Subacute stent thrombosis occurred in 2 (1.3%) cases. CONCLUSION: Direct coronary stenting was successfully and safely accomplished in a variety of clinical situations in selected patients.     

Major dissection during coronary angioplasty: outcome using prolonged balloon inflation versus coronary stenting

BACKGROUND: Abrupt or threatened closure is the major acute complication following conventional coronary angioplasty with a persistent incidence of 2% to 10%. OBJECTIVES: In order to evaluate the safety and efficacy of endoluminal stenting and autoperfusion balloon angioplasty in the setting of abrupt or threatened closure following coronary angioplasty, the short- and long-term clinical and angiographic follow-up of respectively 45 and 51 patients treated by either method were compared. METHODS: From August 1986 through August 1992, consecutive patients treated by either endoluminal stenting or autoperfusion balloon angioplasty for abrupt closure following coronary angioplasty, were entered into an observational trial that requested clinical follow-up and repeat angiography at 6 months. RESULTS: Except for vessel localization, baseline clinical, angiographic and procedural characteristics were comparable. The in-hospital clinical and angiographic outcome was similar (p = 0.85) with 69% event-free patients in both treatment groups. The postprocedural minimal luminal diameter was larger following stenting: 2.67 +/- 0.76mm versus 2.07 +/- 0.70mm (autoperfusion balloon) (p = 0.0002). At follow-up, there were less events in the stent group: 11% versus 34% for the autoperfusion balloon angioplasty group, (p = 0.03). Restenosis rates were 5% (2/37 patients, stent) versus 27% (11/41 patients, autoperfusion balloon) (p = 0.02). CONCLUSIONS: Autoperfusion balloon angioplasty and endoluminal stenting are effective and safe therapeutic options for abrupt or threatened closure following coronary angioplasty with a comparable short-term clinical and angiographic outcome. However, during follow-up, more complications occur following autoperfusion balloon angioplasty. This is explained by a higher restenosis rate in this treatment group.     

Stent or angioplasty after recanalization of chronic coronary occlusions? (The SARECCO Trial).

This study tests whether stent implantation without anticoagulation after catheter recanalization of coronary occlusions can improve outcome compared with balloon angioplasty alone. One hundred ten patients were randomly assigned to angioplasty alone (no stent group) or stent implantation (stent group) after successful recanalization and balloon angioplasty. The type of stent and angioplasty technique utilized were decided by the operator. The acute procedural success in both groups was 100%. The acute minimal lumen diameter (MLD) was 1.85 +/- 0.44 mm in the no stent group versus 2.54 +/- 0.53 mm in the stent group (p <0.01). The diameter stenosis was 21 +/- 13% versus 3 +/- 14% (p <0.01). This was achieved not only by the stent implantation itself but primarily by a larger maximum balloon diameter in the stent group after stent implantation (3.32 +/- 0.55 mm vs 2.86 +/- 0.4 mm, p <0.05). After 4 months, the MLD was 1.15 +/- 0.73 mm in the no stent group versus 1.81 +/- 0.9 mm in the stent group (p <0.01). The diameter stenosis was 56 +/- 29% versus 34 +/- 28% (p <0.01). After 2 years, event-free survival was 26% in the no stent group and 52% in the stent group (p <0.05). Thus, acute and long-term procedural and angiographic success of stent implantation without anticoagulation after recanalization of total coronary occlusions is superior to that of balloon angioplasty alone. This beneficial effect is mainly the result of the larger balloon diameters, which may be used after stent implantation.