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At least 19 recordsLinked to original sources

PubMed1997

Prospective, randomized, multicenter comparison of laser-facilitated balloon angioplasty versus stand-alone balloon angioplasty in patients with obstructive coronary artery disease. The Laser Angioplasty Versus Angioplasty (LAVA) Trial Investigators.

OBJECTIVES: The goal of this study was to examine the relative safety and efficacy of laser-facilitated percutaneous transluminal coronary angioplasty (PTCA) versus "stand-alone" PTCA. BACKGROUND: Plaque debulking with lasing before PTCA may result in improved lumen dimensions and decreased rates of periprocedural ischemic complications, thus improving short- and long-term outcomes after percutaneous intervention. The mid-infrared holmium:yttrium-aluminum-garnet (YAG) laser has been shown to be effective in a variety of plaque subtypes and may be particularly useful in high risk acute ischemic syndromes. METHODS: A total of 215 patients (mean [+/-SD] age 61 +/- 12 years) with 244 lesions were prospectively randomized at 14 clinical centers to laser versus stand-alone PTCA. After laser treatment, all patients underwent PTCA; 148 patients (69%) had unstable angina. RESULTS: The procedural success rate without major catheterization laboratory complications was similar in patients assigned to laser treatment or PTCA alone (96.6% vs. 96.9%, p = 0.88), as was the in-hospital clinical success rate (89.7% vs. 93.9%, p = 0.27). There was no difference in postprocedural diameter stenosis after laser treatment compared with PTCA (18.3% +/- 13.6% vs. 19.5% +/- 15.1%, p = 0.50). However, use of the laser, versus PTCA alone, did result in significantly more major and minor procedural complications (18.0% vs. 3.1%, p = 0.0004), myocardial infarctions (4.3% vs. 0%, p = 0.04) and total in-hospital major adverse events (103% vs. 4.1%, p = 0.08). At a mean follow-up time of 11.2 +/- 7.7 months, there were no differences in late or event-free survival in patients assigned to laser treatment versus PTCA alone. CONCLUSIONS: Compared with stand-alone PTCA, laser-facilitated PTCA results in a more complicated hospital course, without immediate or long-term benefits.

Angioplasty, Balloon, Coronary↗

PubMed1999

A randomized trial comparing primary angioplasty with a strategy of short-acting thrombolysis and immediate planned rescue angioplasty in acute myocardial infarction: the PACT trial. PACT investigators. Plasminogen-activator Angioplasty Compatibility Trial.

OBJECTIVES: The study evaluated the efficacy and safety of a short-acting reduced-dose fibrinolytic regimen to promote early infarct-related artery (IRA) patency during the inherent delay experienced by infarct patients referred for angioplasty as the principal recanalization modality. BACKGROUND: Previous approaches using long-acting, full-dose thrombolytic infusions rarely showed benefit, but they did increase adverse event rates. METHODS: Following aspirin and heparin, 606 patients were randomized to a 50-mg bolus of recombinant tissue-type plasminogen activator (rt-PA) (alpha half-life 4.5 min) or to placebo followed by immediate angiography with angioplasty if needed. The end points included patency rates on catheterization laboratory (cath lab) arrival, technical results when PTCA (percutaneous transluminal coronary angioplasty) was performed, complication rates, and left ventricular (LV) function by treatment assignment and time to restored patency following angioplasty. RESULTS: Patency on cath lab arrival was 61% with rt-PA (28% Thrombolysis in Myocardial Infarction trial [TIMI]-2, 33% TIMI-3), and 34% with placebo (19% TIMI-2, 15% TIMI-3) (p = 0.001). Rescue and primary PTCA restored TIMI-3 in closed arteries equally (77%, 79%). No differences were observed in stroke or major bleeding. Left ventricular function was similar in both treatment groups, but convalescent ejection fraction (EF) was highest with a patent IRA (TIMI-3) on cath lab arrival (62.4%) or when produced by angioplasty within an hour of bolus (62.5%). However, in 88% of angioplasties, the delay exceeded 1 h: convalescent EF 57.3%. CONCLUSIONS: Tailored thrombolytic regimens compatible with subsequent interventions lead to more frequent early recanalization (before cath arrival), which facilitates greater LV function preservation with no augmentation of adverse events.

Aged↗

PubMed1993

Utilization of coronary angioplasty and cost of angioplasty disposables in 14 western European countries. European Angioplasty Survey Group.

An inventory has been made of the practice of angioplasty in 14 European countries from 1985 onwards. The numbers of procedures performed varied in 1985 from 3 to 186 per million inhabitants, in 1991 from 52 to 716. All countries showed a steady increase, but the highest performer. Belgium, achieved only 55% of the number of angioplasties performed in 1991 in the U.S.A. No relation was found between the number of angioplasties and death rate for ischaemic heart disease, national income, number of cardiologists or spending on health care. The number of catheterization laboratories was related to the number of procedures. Prices of angioplasty disposables varied widely between countries. In 1989 Italy and Spain had very high costs, averaging almost 2500 ECU and 2000 ECU for ACS and Schneider balloon catheters respectively, while Switzerland and the U.K. were cheap with costs between 700 ECU and 500 ECU for the same products. In 1991 average prices for balloon catheters fell by 25% in Spain, while in Switzerland average prices increased by 10%, bringing the almost four-fold price difference in 1989, down to a difference of 2.5 in 1991. If the U.S.A. is taken as a standard and set against the death rate from ischaemic heart disease in Western Europe in 1991 the number of 'missing' angioplasties was 215,500, the U.K. accounting for 42% of this deficit.

Angioplasty, Balloon, Coronary↗

PubMed2004

Promising efficacy of primary gradual and prolonged balloon angioplasty in small coronary arteries: a randomized comparison with cutting balloon angioplasty and conventional balloon angioplasty.

BACKGROUND: Small vessel size represents a critical risk factor for an adverse outcome after both conventional balloon angioplasty (POBA) and stenting. Gradual and prolonged balloon angioplasty (GPBA) has been shown to cause less arterial trauma, which results in higher procedural success rates and fewer in-hospital complications than POBA. The aim of this study was to assess the clinical and angiographic benefits of primary GPBA with a perfusion balloon in small coronary arteries, as compared with cutting balloon angioplasty (CBA) and POBA. METHODS: A total of 263 patients with symptoms and reference diameters <3.0 mm were randomly assigned to undergo GPBA (n = 85), CBA (n = 88), or POBA (n = 90). The cumulative inflation time must be >10 minutes in GPBA. Crossover to stent was allowed for inadequate results. Follow-up angiography was performed after 6 months. The primary end point was angiographic restenosis at follow-up. RESULTS: Compared with POBA, GPBA resulted in a lower final residual diameter stenosis (27.3% vs 34.2%, P =.01) and decreased the need for stent placement (8.0% vs 22.2%, P =.031). At follow-up, the restenosis rates were lower with GPBA (31.3%, P =.034) and CBA (32.9%, P =.059) than POBA (50.6%). Target lesion revascularization was less frequently needed with GPBA (20.5%, P =.043) and CBA (20.0%, P =.033) than POBA (37.6%). Additionally, the event-free survival rate was higher with GPBA (77.1%, P =.033) and CBA (76.4%, P =.047) than POBA (58.8%). CONCLUSIONS: In small coronary arteries, both GPBA and CBA resulted in favorable angiographic and clinical outcomes. With a lower restenosis rate and target lesion revascularization rate, GPBA may be a superior strategy for small vessels compared with POBA.

Aged↗

PubMed2004

Benefits of direct angioplasty for women and men with acute myocardial infarction: results of the Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndromes Angioplasty (GUSTO II-B) Angioplasty Substudy.

BACKGROUND: Direct angioplasty (PTCA) and thrombolytic therapy are the chief therapies for treating an ST-segment elevation myocardial infarction (MI). OBJECTIVE: This study was designed to evaluate sex differences in the relative benefit of direct PTCA versus thrombolytic therapy among patients enrolled in the Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndromes Angioplasty (GUSTO II-B PTCA) Substudy. METHODS: Women and men presenting with an acute ST-segment elevation MI were randomized to receive either direct PTCA or accelerated tissue plasminogen activator (t-PA). Patients were then randomized to treatment with either heparin or bivalirudin. A gender analysis of outcome was performed. RESULTS: Women were older than men (68.6 +/- 11.5 vs 59.5 +/- 12.0 years, P <.001) and were more likely to have diabetes (22.5% vs 13.5%, P <.0001) and hypertension (53.3% vs 34.8%, P =.001). After adjusting for differences in baseline variables, the odds ratio (OR) for reaching a 30-day clinical end point (death, nonfatal infarction, or nonfatal disabling stroke) was similar for women and men (1.35, 95% CI 0.88-2.08). The OR for reaching a clinical end point at 30 days for the PTCA-treated women compared with the t-PA-treated women was 0.685 (95% CI 0.36-1.32) and similar to the OR in men, 0.565 (95% CI 0.35-0.91), P for interaction =.535. Because women had a higher event rate than men, the absolute number of major events prevented when treating women with direct PTCA was higher than men (56 events/1000 women treated with PTCA vs 42 events per 1000 men treated with PTCA). CONCLUSIONS: Although the relative benefit of direct PTCA to t-PA for the treatment of an acute MI appears to be similar in women and men, women may derive a larger absolute benefit from direct PTCA.

Aged↗

PubMed1995

Progression of coronary artery disease in patients receiving percutaneous transluminal coronary angioplasty: angiographic comparison of angioplasty and non-angioplasty sites.

Long-term follow-up of coronary artery stenosis was carried out in 81 patients undergoing successful percutaneous transluminal coronary angioplasty (PTCA). Progression of coronary stenosis was observed in 38 patients with 52 sites, and regression was seen in 23 patients with 23 sites during 2 years or more of follow-up. Progressive change occurred in three sites of 97 PTCA lesions and 49 of 1,090 non-PTCA lesions (no significant difference). On the other hand, regressive change was observed in 19 sites of PTCA lesions and four of non-PTCA lesions (p < 0.05). The percentage of narrowing in PTCA lesions was 28.0 +/- 14.4% at 3-6 months after PTCA, and this improved to 22.8 +/- 15.8% at late study angiography. Coronary score changes were -0.16 +/- 0.54 in PTCA lesions, and 0.08 +/- 0.46 in non-PTCA lesions (p < 0.01). We concluded that the progression of obstructive coronary artery disease in sites with previous PTCA is less than in those with non-PTCA.

Aged↗

PubMed1991

Experience with laser-assisted balloon angioplasty and a rotary angioplasty instrument: lessons learned.

Favorable early results with mechanical angioplasty devices and laser-assisted balloon angioplasty have resulted in aggressive marketing and a rapid increase in the use of these devices for the treatment of femoropopliteal occlusive disease. Recent reports, however, have questioned the durability of these less invasive procedures. Since 1986 we have been involved in the clinical investigation of the Kensey dynamic angioplasty instrument and laser-assisted balloon angioplasty. One hundred two balloon angioplasty procedures assisted by the Nd:YAG laser (n = 56) and the Kensey dynamic angioplasty instrument (n = 46) were performed for the treatment of femoropopliteal occlusive lesions. Both Kensey dynamic angioplasty instrument and laser-assisted balloon angioplasty groups were similar with regard to age, operative indication, preoperative ankle-brachial index, lesion length, and distal runoff. Mean follow-up was 19 months in the Kensey dynamic angioplasty instrument group and 15 months in the laser-assisted balloon angioplasty group. Technically successful recanalization was achieved in 67% of Kensey dynamic angioplasty instrument-assisted balloon angioplasty procedures and 82% of laser-assisted balloon angioplasty procedures. Early hemodynamic and clinical improvement was obtained in 59% of Kensey dynamic angioplasty instrument-assisted balloon angioplasty procedures and 57% of laser-assisted balloon angioplasty procedures. Two-year clinical success by life-table analysis was 37% in the Kensey dynamic angioplasty instrument group and 19% in the laser-assisted balloon angioplasty group. The level of subsequent surgical revascularization was not altered in any patient by Kensey dynamic angioplasty instrument-assisted balloon angioplasty or laser-assisted balloon angioplasty.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed1996

Do excimer laser angioplasty and rotational atherectomy facilitate balloon angioplasty? Implications for lesion-specific coronary intervention.

OBJECTIVES: This study sought to determine whether adjunctive balloon angioplasty after rotational atherectomy and excimer laser angioplasty provides better lumen enlargement ("facilitated angioplasty") than angioplasty alone. BACKGROUND: Adjunctive angioplasty is often used immediately after atherectomy and laser angioplasty to further enlarge lumen dimensions, but it is not known whether this practice is superior to angioplasty alone. METHODS: Balloon angioplasty was performed in 1,266 native coronary lesions alone (n = 541) or after extraction atherectomy (n = 277), rotational atherectomy (Rotablator) (n = 211) or excimer laser angioplasty (n = 237). Quantitative angiographic analysis included final lumen diameter, final diameter stenosis and efficiency of balloon-mediated lumen enlargement. RESULTS: Compared with angioplasty alone (33 +/- 12% [mean +/- SD]), final diameter stenosis was higher for adjunctive angioplasty after extraction atherectomy (37 +/- 16%, p < 0.001) and excimer laser angioplasty (37 +/- 16%, p < 0.001) and lower after rotational atherectomy (27 +/- 15%, p < 0.001). However, there was significant undersizing of balloons after all three devices. To correct for differences in balloon size, the efficiency index (final lumen diameter/balloon diameter ratio) was calculated and was higher for adjunctive angioplasty after the Rotablator (0.78 +/- 0.14, p < 0.001) than after angioplasty alone (0.69 +/- 0.12). The efficiency indexes suggested facilitated angioplasty after rotational atherectomy for ostial, eccentric, ulcerated and calcified lesions and lesions > 20 mm long. Facilitated angioplasty was also observed after extraction atherectomy and excimer laser angioplasty for ostial lesions, but not for any other lesion subsets. CONCLUSIONS: Rotational atherectomy, extraction atherectomy and excimer laser angioplasty can facilitate the results of balloon angioplasty. However, the extent of facilitated angioplasty is dependent on the device and baseline lesion morphology, consistent with the need for lesion-specific coronary intervention.

Aged↗

PubMed1996

Randomised trial of excimer laser angioplasty versus balloon angioplasty for treatment of obstructive coronary artery disease.

BACKGROUND: Excimer laser coronary angioplasty is reported to give excellent procedural results for treatment of complex coronary lesions, but this method has not been compared with balloon angioplasty in a randomised trial. METHODS: Patients (n = 308) with stable angina and coronary lesions longer than 10 mm on visual assessment were included. 151 patients (158 lesions) were assigned randomly to laser angioplasty and 157 (167 lesions) to balloon angioplasty. The primary clinical endpoints were death, myocardial infarction, coronary bypass surgery, or repeat coronary angioplasty of the randomised segment during 6 months of follow-up. The primary angiographic endpoint was the minimal lumen diameter at follow-up in relation to the baseline value (net gain), as determined by quantitative coronary angiography. FINDINGS: Laser angioplasty was followed by balloon angioplasty in 98% of procedures. The angiographic success rate was 80% in patients treated with laser angioplasty compared with 79% in patients treated with balloon angioplasty. There were no deaths. Myocardial infarction, coronary bypass surgery, and repeat angioplasty occurred in 4.6%, 10.6%, and 21.2%, respectively, of the patients in the laser angioplasty group compared with 5.7%, 10.8%, and 18.5% of the balloon angioplasty group. Net mean (SD) gain in minimal lumen diameter was 0.40 (0.69) mm in patients treated with laser angioplasty and 0.48 (0.66) mm in those treated with balloon angioplasty (p = 0.34). The restenosis rate (> 50% diameter stenosis) was 51.6% in the laser angioplasty group versus 41.3% in the balloon angioplasty group (p = 0.13). INTERPRETATION: Excimer laser angioplasty followed by balloon angioplasty provides no benefit additional to balloon angioplasty alone with respect to the initial and long-term clinical and angiographic outcome in the treatment of obstructive coronary artery disease.

Adult↗

PubMed1993

Are residual stenoses after excimer laser angioplasty and coronary atherectomy due to inefficient or small devices? Comparison with balloon angioplasty.

OBJECTIVES: The purpose of this study was to determine whether residual stenoses after excimer laser angioplasty and atherectomy were due to inefficient tissue ablation/removal or to undersized devices. BACKGROUND: Significant residual stenoses are commonly observed after use of laser and atherectomy devices. It is not known whether these residual stenoses are due to inefficient or undersized devices. METHODS: To determine the relative contribution of these factors, the minimal lumen diameter, percent diameter stenosis and normal reference diameter were measured immediately before and after coronary interventions in 696 lesions, including transluminal extraction atherectomy, high speed mechanical rotational atherectomy, excimer laser angioplasty and conventional balloon angioplasty. The ratio of the diameter of the device to the normal reference diameter (D/A, a measure of device sizing) and the ratio of the residual lumen diameter after use of the device to the device diameter (RLD/D, a measure of the efficiency of lumen enlargement) were calculated. RESULTS: Baseline diameter stenoses were similar for all interventions. The percent diameter stenoses were greater immediately after extraction atherectomy (60 +/- 21%), rotational atherectomy (54 +/- 23%) and excimer laser angioplasty (61 +/- 18%) compared with balloon angioplasty (26 +/- 12%, p < 0.001). The D/A ratio was smaller after extraction atherectomy (0.63 +/- 0.14), rotational atherectomy (0.59 +/- 0.17) and excimer laser angioplasty (0.51 +/- 0.11) compared with balloon angioplasty (1.05 +/- 0.13, p < 0.001). The RLD/D ratio was similar after extraction atherectomy (0.73 +/- 0.24) and balloon angioplasty (0.71 +/- 0.11) but was greater after rotational atherectomy (0.92 +/- 0.16, p < 0.001) and excimer laser angioplasty (0.85 +/- 0.30, p < 0.01) compared with balloon angioplasty. CONCLUSIONS: Residual stenoses after extraction atherectomy, rotational atherectomy and excimer laser angioplasty were more severe than after balloon angioplasty but were due to undersized devices (low D/A ratio), not to inefficient devices (low RLD/D ratio). Rotational atherectomy and excimer laser angioplasty were more efficient (higher RLD/D) than balloon angioplasty, whereas extraction atherectomy and balloon angioplasty were similar.

Aged↗

PubMed1996

Excimer laser angioplasty versus balloon angioplasty in functional and total coronary occlusions.

Registries of excimer laser coronary angioplasty have reported good results in the treatment of complex coronary artery disease, including total or subtotal coronary occlusions. One hundred three patients (103 lesions) with a functional or total coronary occlusion were included in a randomized trial (Amsterdam-Rotterdam [AMRO] trial, total of 308 patients), 49 patients were allocated to laser angioplasty and 54 patients to balloon angioplasty. The primary clinical end points were death, myocardial infarction, coronary bypass surgery, or repeated coronary angioplasty of the randomized segment during a 6-month follow-up period. The primary angiographic end point was the minimal lumen diameter at follow-up in relation to the baseline value (net gain), as determined by an automated contour-detection algorithm. Laser angioplasty was followed by balloon angioplasty in all procedures. The angiographic success rate was 65% in patients treated with excimer laser-assisted balloon angioplasty compared with 61% in patients treated with balloon angioplasty alone. No deaths occurred. There were no significant differences between the laser angioplasty group and the balloon angioplasty group in the incidence of myocardial infarctions (1 patient vs 3, respectively, p = 0.36), coronary bypass surgery (4 patients vs 2, respectively, p = 0.34), repeat angioplasty (10 patients vs 8, respectively, p = 0.46) or primary clinical end point (15 patients vs 12, respectively, p = 0.34). The net gain in minimal lumen diameter and restenosis rate (>50% diameter stenosis at follow-up) were 0.81 +/- 0.74 mm and 66.7%, respectively, in patients treated with laser angioplasty compared with 1.04 +/- 0.68 mm and 48.5%, respectively, in patients treated with balloon angioplasty (p = 0.59 and p = 0.15, respectively). Excimer laser-assisted balloon angioplasty demonstrated no benefit over balloon angioplasty with respect to initial and long-term clinical and angiographic outcome in the treatment of patients with functional or total coronary occlusions of >10 mm in length.

Adult↗

PubMed1999

Is a strategy of intended incomplete percutaneous transluminal coronary angioplasty revascularization acceptable in nondiabetic patients who are candidates for coronary artery bypass graft surgery? The Bypass Angioplasty Revascularization Investigation (BARI).

OBJECTIVES: Our objective was to determine whether a strategy of intended incomplete percutaneous transluminal coronary angioplasty revascularization (IR) compromises long-term patient outcome. BACKGROUND: Complete angioplasty revascularization (CR) is often not planned nor attempted in patients with multivessel coronary disease, and the extent to which this influences outcome is unclear. METHODS: Before randomization, in the Bypass Angioplasty Revascularization Investigation, all angiograms were assessed for intended CR or IR via angioplasty. Outcomes were compared among patients with IR intended if assigned to angioplasty, randomized to coronary artery bypass graft surgery (CABG) versus angioplasty; and within angioplasty patients only, among patients with IR versus CR intended. RESULTS: At 5 years, there was a trend for higher overall (88.6% vs. 84.0%) and cardiac survival (94.5% vs. 92.1%) in CABG versus angioplasty patients with IR intended. The excess mortality in angioplasty patients occurred solely in diabetic subjects; overall and cardiac survival were similar among nondiabetic CABG and angioplasty patients. Freedom from myocardial infarction (MI) at 5 years was higher in nondiabetic CABG versus angioplasty patients (92.4% vs. 85.2%, p = 0.02), vet was similar to the rate observed (85%) in nondiabetic CABG and angioplasty patients with CR intended. Five-year rates of death, cardiac death, repeat revascularization and angina were similar in all angioplasty patients with IR versus CR intended. However, a trend for greater freedom from subsequent CABG was seen in CR patients (70.3% vs. 64.0%, p = 0.08). CONCLUSIONS: Intended incomplete angioplasty revascularization in nondiabetic patients with multivessel disease who are candidates for both angioplasty and CABG does not compromise long-term survival; however, subsequent need for CABG may be increased with this strategy. Whether the risk of long-term MI is also increased remains uncertain.

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PubMed2006

Safety of single versus multi-vessel angioplasty for patients with acute myocardial infarction and multi-vessel coronary artery disease: report from the New York State Angioplasty Registry.

BACKGROUND: The conventional strategy for primary angioplasty during acute myocardial infarction is angioplasty of the infarct-related vessel, even in patients with multi-vessel disease. Patients, however, often have significant lesions in multiple coronary arteries and a strategy for multi-vessel angioplasty during acute myocardial infarction has not been explored. The purpose of this study was to examine whether multi-vessel angioplasty is as safe as infarct-related vessel angioplasty in patients with multi-vessel coronary artery disease during acute myocardial infarction. METHODS: Using the 2000-2001 New York State Angioplasty Registry database, we compared the in-hospital clinical outcomes of patients with multi-vessel disease (>70% stenosis in at least two major coronary arteries), who underwent either multi-vessel angioplasty (n=632) or infarct-related vessel angioplasty (n=1350) within 24 h of acute myocardial infarction. Patients with previous myocardial infarction, angioplasty, bypass surgery, or cardiogenic shock were excluded. RESULTS: Patients in the multi-vessel angioplasty group were less likely to be female, to have peripheral vascular disease or diabetes. They had more complex lesions and were more likely to receive stents. In-hospital mortality was three-fold lower (0.8 versus 2.3%, P=0.018) in the multi-vessel angioplasty group. No differences were observed in other ischemic complications, renal failure, or length of stay. After multivariate analysis, multi-vessel angioplasty remained a significant predictor of lower in-hospital death (odds ratio=0.27, 95% confidence interval=0.08-0.90, P=0.03). CONCLUSIONS: Despite the added complexity of multi-vessel angioplasty, patients in this group had significantly lower in-hospital mortality. Therefore, a strategy of multi-vessel angioplasty during acute myocardial infarction may be safe compared with infarct-related angioplasty in selected patients.

Angioplasty, Balloon, Coronary↗

PubMed2000

Primary angioplasty versus intravenous thrombolysis for acute myocardial infarction.

BACKGROUND: Intravenous thrombolytic therapy is the standard care for patients with acute myocardial infarction, based upon its widespread availability and ability to reduce patient mortality well demonstrated in randomised trials. Despite its proven efficacy, thrombolytic therapy has limitations. Many patients are ineligible for treatment with thrombolytics. Of those given thrombolytic therapy, 10 to 15 percent have persistent occlusion or reocclusion of the infarct-related artery. Consequently, primary angioplasty (primary PTCA) has been advocated as a better treatment of myocardial infarction. OBJECTIVES: To determine whether primary coronary angioplasty is superior to thrombolytic therapy for the treatment of patients with acute myocardial infarction. SEARCH STRATEGY: Electronic search of The Cochrane Library (1998; Issue 2). MEDLINE (to January 1998); references from reviews, trials and previously published meta-analyses; and experts. Date of most recent searches January 1998. SELECTION CRITERIA: All unconfounded, randomised controlled trials comparing primary angioplasty against intravenous thrombolysis in patients with acute myocardial infarction DATA COLLECTION AND ANALYSIS: At least two independent reviewers abstracted data on morbidity and mortality and trial characteristics. The following outcomes were assessed: total mortality at the end of the study, reinfarction, stroke of any type, composite endpoint of death and reinfarction, recurrent ischemia, severe bleeding and coronary artery bypass grafting. MAIN RESULTS: Ten trials including 2573 subjects were identified. Compared to thrombolytic therapy, primary angioplasty was associated with a significant reduction in short-term mortality at the end of the studies (relative reduction in risk RRR = 32% 95%CI = 5%;50%). Similar reductions were observed for the rate of reinfarction (RRR = 52%, 95%CI = 30%;67%), recurrent ischemia (RRR = 54%; 95%CI = 39%, 66%) and for the combined criteria death or reinfarction (RRR = 46%; 95%CI=30%;58%). The frequency of strokes of any cause was significantly decreased by 66% (95%CI=28%;84%). No significant difference was observed for the incidence of major bleeding (relative risk RR =1.18, 95%CI = 0.73;1.90) but the confidence interval was large. The superiority of the primary angioplasty over thrombolysis in terms of the composite endpoint (mortality and reinfarction) was less with accelerated t-PA (RR=0.70, 95%CI=0.51;0. 97) than with streptokinase (RR=0.30, 95%CI=0.17;0.53). The biggest and most recent trial, Gusto 2B ( approximately approximately GUSTO-2B 97 approximately approximately ), which involved general as well as higly specialised centres, obtained less favorable results. REVIEWER'S CONCLUSIONS: This meta-analysis suggests that angioplasty provides a short-term clinical advantage over thrombolysis which may not be sustained. Primary angioplasty when available promptly at experienced centres, may be considered the preferred strategy for myocardial reperfusion. In most situations, however, optimal thrombolytic therapy should still be regarded as an excellent reperfusion strategy.

Angioplasty, Balloon, Coronary↗

PubMed1995

Peripheral transluminal angioplasty under ultrasound guidance: initial clinical experience and prevalence of lower limb lesions amenable to ultrasound-guided angioplasty.

PURPOSE: Currently, endovascular techniques require monitoring by radiographic imaging for accurate catheter placement. The aim of this study was first to determine the feasibility of angioplasty under ultrasound guidance using a special catheter system. Based on this outcome, the second goal was to investigate the prevalence of lesions amenable to ultrasound-guided angioplasty. METHODS: A balloon catheter system (Echomark) has been developed, which allows accurate catheter guidance by ultrasound imaging. An ultrasound-sensitive piezoelectric sensor positioned in the middle of the balloon portion of the angioplasty catheter is interfaced to an external duplex scanner via the catheter system. The exact position of the balloon relative to the transducer is calculated and reproduced on the screen of the duplex scanner to guide balloon positioning. In the feasibility assessment of the procedure, 16 patients with disabling claudication and rest pain were selected for balloon angioplasty under ultrasound guidance based on arteriographic and hemodynamic lesion criteria of > 50% stenosis with a peak systolic velocity ration > 2.5 in a lesion < 4 cm long that could be imaged by duplex ultrasonography. A fall in the peak systolic velocity ratio below 2.0 was selected for a procedural endpoint corresponding to < 30% residual stenosis on the completion angiogram. In the second part of the study, the prevalence of stenoses amenable to ultrasound-guided angioplasty was studied in 80 patients presenting with symptoms of peripheral arterial disease. RESULTS: In the feasibility study, 20 stenoses (5 common iliac, 6 external iliac, and 8 superficial femoral arteries and 1 graft) meeting the inclusion criteria were subjected to ultrasound-guided angioplasty with confirmation by completion angiography. The procedure was possible in 18 (90%) of the 20 stenoses. The two failures occurred in iliac arteries that could not be imaged by duplex scanning due to obesity, bowel gas, and/or vessel wall calcification. In one case, the peak systolic velocity ratio exceeded 2.5 despite a satisfactory control arteriogram; redilation was performed, and the ratio fell below 2.0. In the second part of the study, 21 (26.2%) of the 80 patients had 29 stenoses that were amenable to angioplasty according to angiographic criteria (> 50% stenosis and < 4 cm length). All these stenoses were evaluated with duplex scanning to determine their suitability for angioplasty under ultrasound guidance. Twenty-three (79%) of the 29 lesions selected for angioplasty were well visualized by duplex, and angioplasty would have been possible based on our initial clinical experience. CONCLUSIONS: Angioplasty under ultrasound control is a feasible technique for peripheral lesions. Ultrasound allows monitoring of both anatomical and hemodynamic parameters during angioplasty and thus provides a procedural endpoint that correlates to the control angiogram. A large proportion (79%) of stenoses deemed suitable for angioplasty can be well visualized by ultrasound, but obesity, vessel wall calcification, and bowel gas may limit the ability to obtain a satisfactory ultrasound image. Ultrasound-guided angioplasty is a potentially useful procedure that warrants further investigation.

Angioplasty, Balloon↗

PubMed1999

Laser angioplasty of restenosed coronary stents: results of a multicenter surveillance trial. The Laser Angioplasty of Restenosed Stents (LARS) Investigators.

OBJECTIVES: This study evaluated safety and efficacy of excimer laser angioplasty for treatment of restenosed or occluded coronary stents. BACKGROUND: Balloon angioplasty of in-stent restenosis is limited by a high recurrence rate. Debulking by laser angioplasty is a novel concept to treat in-stent restenosis. METHODS: A total of 440 patients with restenoses or occlusions in 527 stents were enrolled for treatment with concentric or eccentric laser catheters and adjunctive balloon angioplasty. RESULTS: Laser angioplasty success (< or =50% diameter stenosis after laser treatment or successful passage with a 2.0-mm or 1.7-mm eccentric laser catheter) was achieved in 92% of patients. Adjunctive balloon angioplasty was performed in 99%. Procedural success (laser angioplasty success followed by < or =30% stenosis with or without balloon angioplasty) was 91%. There was neither a significant difference in success with respect to lesion length, nor were there differences between small and large vessels or native vessels and vein grafts. Success was higher and residual stenosis lower using large or eccentric catheters. Serious adverse events included death (1.6%, not directly laser catheter related), Q-wave myocardial infarction (0.5%), non-Q-wave infarction (2.7%), cardiac tamponade (0.5%) and stent damage (0.5%). Perforations after laser treatment occurred in 0.9% of patients and after balloon angioplasty in 0.2%. Dissections were visible in 4.8% of patients after laser treatment and in 9.3% after balloon angioplasty. Reinterventions during hospitalization were necessary in 0.9% of patients; bypass surgery was performed in 0.2%. CONCLUSIONS: Excimer laser angioplasty with adjunctive balloon angioplasty is a safe and efficient technology to treat in-stent restenoses. These data justify a randomized comparison with balloon angioplasty.

Adult↗

PubMed2000

Relation between hospital primary angioplasty volume and mortality for patients with acute MI treated with primary angioplasty vs thrombolytic therapy.

CONTEXT: Institutional experience with primary angioplasty has been suggested as a factor in selecting a reperfusion strategy for patients with acute myocardial infarction (AMI). However, no large studies have directly compared outcomes of primary angioplasty vs thrombolytic therapy as a function of institutional experience. OBJECTIVE: To compare outcomes among patients with AMI who were treated with primary angioplasty vs thrombolytic therapy at hospitals with different volumes of primary angioplasty. DESIGN: Retrospective cohort. SETTING: A total of 446 acute care hospitals with 112 classified as low volume (</=16 procedures), 223 as intermediate volume (17-48 procedures), and 111 as high volume (>/=49 procedures) based on their annual primary angioplasty volume. PATIENTS: A total of 62 299 patients with AMI treated with primary angioplasty or thrombolytic therapy from June 1, 1994, through July 31, 1999. MAIN OUTCOME MEASURE: In-hospital mortality. RESULTS: Mortality was lower among patients who received primary angioplasty compared with those who received thrombolysis at hospitals with intermediate volumes (4.5% vs 5.9%; P<.001) and high volumes (3.4% vs 5.4%; P<.001) of primary angioplasty. At low-volume hospitals, there was no significant difference in mortality between patients treated with primary angioplasty vs those treated with thrombolysis (6.2% vs 5.9%; P =.58). Adjusting for differences in demographic, medical history, clinical presentation, treatment, and hospital characteristics did not significantly alter these findings. CONCLUSIONS: In this study, patients with AMI treated at hospitals with high or intermediate volumes of primary angioplasty had lower mortality with primary angioplasty than with thrombolysis, whereas patients with AMI treated at hospitals with low angioplasty volumes had similar mortality outcomes with primary angioplasty or thrombolysis.

Aged↗

PubMed1995

Angioplasty of complex lesions in ischemic rest angina: results of the Thrombolysis and Angioplasty in Unstable Angina (TAUSA) trial.

OBJECTIVES: This study sought to analyze the role of complex lesion morphology on the acute results of angioplasty. BACKGROUND: Acute complications of angioplasty are higher in unstable than in stable angina. The unstable culprit lesion is usually complex, indicative of plaque disruption and thrombus formation. Previous nonrandomized studies have shown that the presence of intracoronary thombus increases morbidity after coronary angioplasty. The role of complex morphology in coronary angioplasty outcome was studied in a prespecified subgroup analysis of a large multicenter coronary angioplasty trial. METHODS: The results of coronary angioplasty from the Thrombolysis and Angioplasty in Unstable Angina (TAUSA) trial were analyzed. This large trial randomized 469 patients in double-blinded manner to receive either intracoronary urokinase or placebo during coronary angioplasty of the culprit lesion in ischemic rest angina with or without recent infarction. The study presented here analyzes in detail the results of coronary angioplasty in complex versus simple lesions in the urokinase and placebo groups. Complex lesions were defined before angioplasty by a core laboratory as having one or more of the following: irregular borders, overhanging edges, ulcerations or intraluminal filling defects proximal or distal to the lesion. RESULTS: Of the 469 patients, 458 had identifiable culprit lesions, of which 245 were complex and 213 were simple. Complex lesions were associated with a higher abrupt closure rate than simple lesions (10.6% vs. 3.3%, respectively, p < 0.003). Patients with complex lesions also had higher recurrent in-hospital angina (p < 0.02) and emergent bypass surgery (p < 0.02). Further analysis of complex lesions revealed that abrupt closure was particularly high in the urokinase group (15.0% vs 5.9% for the placebo group, p < 0.03), and most abrupt closures were thrombotic. Composite clinical end points were also significantly higher with complex lesions and urokinase. In the placebo group, complex lesions had a higher abrupt closure rate as well as postcoronary angioplasty filling defects, but clinical end points were not significantly different. CONCLUSIONS: Complex lesions before coronary angioplasty increase acute complication rates after coronary angioplasty. Urokinase as administered in the TAUSA trial had significant adverse effects, especially in complex lesions. However, even in the placebo arm, complex lesions were associated with higher complication rates than simple lesions. Newer antithrombotic measures that particularly target the platelet may eventually decrease complication rates in these lesions.

Angina, Unstable↗