Short- and long-term results of abciximab versus aspirin in conjunction with thrombolysis for patients with peripheral occlusive arterial disease and arterial thrombosis

Acute peripheral occlusive arterial disease is an important cause of morbidity and mortality, particularly among older persons. Catheter-directed thrombolytic therapy is the treatment of choice but has limitations: long lytic times, occlusions refractory to thrombolysis, and a high rate of restenosis. We conducted a pilot study to evaluate the use of the platelet GP IIb/IIIa receptor antagonist abciximab versus aspirin in conjunction with thrombolysis in patients with acute peripheral occlusive arterial disease associated with arterial thrombosis. A total of 84 patients were randomized into two equal groups to receive 5 mg recombinant tissue plasminogen activator intravenously and 500 IU heparin/hour along with either 500 mg acetylsalicylic acid or a bolus of 0.25 mg/kg abciximab followed by 10 microg/min abciximab over 12 hours (heparin reduced to 250 IU/hour). Primary efficacy criteria included the number of rehospitalizations, reinterventions, and amputations during the following 6 months. Secondary endpoints were the changes in the Fontaine stage, Bollinger index (vessel occlusion), ankle-to-brachial ratios, distance to claudication after 6 months, and the duration of the initial local lysis treatment. Adjunctive use of abciximab reduced the rates of rehospitalization, reinterventions, and amputations versus results with the use of aspirin (10 vs 14 occurrences, respectively; 9 vs 11; 3 vs 5; when summed, intergroup difference p < 0.05). Secondary peripheral occlusive arterial disease variables became highly significant versus aspirin (p < 0.001 or greater) at 3 and 6 months after treatment. The duration of lysis was markedly shorter upon addition of abciximab versus aspirin (75 vs 110 min; p < 0.001). No major bleeding complications or embolisms occurred. These preliminary results indicate that abciximab may have a useful role when used adjunctively with a thrombolytic agent in older persons with acute peripheral occlusive arterial disease and arterial thrombosis.     

Haemodilution in patients with peripheral arterial occlusive disease.

Haemodilution is an efficient conservative therapy of peripheral arterial occlusive disease. Already a single isovolaemic haemodilution (replacement of 500 ml blood for Haes* 0.5, 10%) increases the pain-free walking distance by 85%. These effects can be maintained by a constant therapy over six weeks and following haemodilution once or twice per month. The haematocrit values should be between 38 and 42%. The haemodilution should be done hyper- or isovolaemically. Not more than 250 ml blood and 500 ml Haes should be infused during one session in order to avoid hypovolaemia. This means an infusion of 250 ml Haes, venesection of 250 ml blood via the same access and then infusion of the remaining 250 ml. The whole procedure should not last more than one hour. Blood pressure, heart rate, lung auscultation and percussion as well as creatinine values has to be controlled during an intensive therapy. If the hydroxyethyl starch concentration exceeds 150 g per week pruritus may occur in singular cases, if the concentration exceeds 700 g per week it is observed in 50% of the cases. Provided the preventive measures are observed haemodilution is an efficient and good therapy which also increases the compliance to practice vascular exercise.     

Early results after percutaneous transluminal coronary angioplasty in 400 patients

In a consecutive series of 400 patients treated by percutaneous transluminal coronary angioplasty 212 had single vessel disease, 142 had multivessel disease with only one vessel dilated, and 46 had multivessel dilatation. In addition sequential stenoses were dilated in the same vessel in all groups. There was no mortality among patients with single vessel disease. Success rates varied from 83% to 90% according to the artery in which angioplasty was attempted. Urgent surgery was required by 3.8%. Primary success was lower (74%) in the presence of multivessel disease and complications were more frequent, with four deaths (2.8%). In 46 patients with multivessel disease in whom all important lesions were dilated during the same procedure the overall primary success rate was 76% and within the last year of the study it was 91%. One (2%) patient died and three (7%) required urgent surgery. Twelve (86%) out of 14 stenosed vein grafts were successfully dilated and eight (53%) chronically occluded vessels were re-opened; in both groups there were no deaths, no infarctions, and no need for urgent surgery. In all groups symptoms improved greatly and predischarge exercise tests showed that there was no reversible ischaemia in 94% of patients with single vessel disease or in 65% of patients with incomplete revascularisation. Six months after the procedure 95% of the patients had improved symptomatically and 80% had normal exercise tests after one year. Percutaneous transluminal coronary angioplasty is the method of choice in single vessel disease and its use also results in a high proportion of other patients becoming symptom free. Complication rates are low and for selected patients results that are equivalent to those of cardiac surgery are obtained.     

Follow-up clinical results in patients undergoing percutaneous transluminal coronary angioplasty

Complete follow-up data were obtained from 229 consecutive patients who underwent percutaneous transluminal coronary angioplasty (PTCA) between 1979 and 1982 (mean follow-up 14 months, range 6 to 37). Single-vessel disease was present in 143 and multivessel disease in 86. PTCA was successful in 153 patients (67%). Failure was followed initially by bypass surgery in 59 and by continued medical therapy in 17. After successful PTCA, 90% of patients were improved subjectively and 74% were asymptomatic at follow-up. After unsuccessful PTCA but prompt bypass, 90% were improved subjectively and 85% were asymptomatic. Among the 229 patients, 39 (17%) required an additional intervention because of angina during follow-up; 15 of these had repeat PTCA and 18 had bypass surgery. Among patients with successful PTCA, revascularization was complete in 77% and partial in 23%. The completeness of revascularization with PTCA had a significant impact on follow-up. The follow-up data of patients with successful single-vessel PTCA and of those with multivessel disease with complete revascularization were similar. When the patients with complete revascularization were compared with those with multivessel disease but incomplete revascularization, the follow-up data were characterized by a higher incidence of angina or need for bypass surgery in the latter group (63%) than in the former group (29%); those with incomplete revascularization also had a significantly reduced event-free survival.     

Renal arterial pathology after percutaneous transluminal angioplasty

Percutaneous transluminal angioplasty (PTA) has been shown to cause cracking of the intimo and atherosclerotic plaque in the renal arteries of two cases, who died from incidental causes about a week after the procedure. In addition, movement or redistribution of atheromatous gruel was seen into the cracks and dissections at the intima-medial junction and media. Thus, enlargement of the lumen by redistribution of the lipid mass by 'warm flow' may be an important beneficial result of angioplasty. One case also showed severe fragmentation of medial elastic fibres at the orifice, with rupture of the internal elastic membrane.     

Subintimal angioplasty. Technique, results and role in the treatment of peripheral arterial occlusive disease

Subintimal angioplasty consists in entering the subintimal space proximal to the occlusion, traversing the occlusion creating by angioplasty a subintimal channel exiting downstream in the natural lumen. Major complications rarely occur but compromising important collaterals or run-off vessels may be very deleterious. Subintimal angioplasty is indicated in patients with critical limb ischemia, unfit for anesthesia or in the absence of a suitable venous conduit. This technique is mainly effective in long and tibioperoneal occlusions, a location in which transluminal angioplasty usually fails. Further studies are required to determine the modalities of associated anti-thrombotic treatment and if subintimal angioplasty can be used as primary treatment in critical leg ischemia.     

Assessment of immediate and long-term functional results of percutaneous transluminal coronary angioplasty

Assessment of the functional significance of coronary artery lesions during cardiac catheterization has recently become possible by calculating coronary flow reserve from both myocardial contrast appearance time and density in the resting and hyperemic states determined from digitized coronary cineangiograms. However, the interobserver and intraobserver variabilities, as well as the short-, medium-, and long-term variabilities of the coronary flow reserve measurements, have to be established before this technique becomes an acceptable means of assessing the immediate and long-term functional results of revascularization procedures such as percutaneous transluminal coronary angioplasty (PTCA). Variability was defined as the mean difference and standard deviation of the difference between duplicate determinations of coronary flow reserve. The intraobserver variability (mean difference +/- SD) in the measurement of coronary flow reserve was -0.01 +/- 0.07. Interobserver variability by two observers was +0.08 +/- 0.52. Short-term variability based on the analysis of two coronary cineangiograms taken 5 minutes apart was -0.02 +/- 0.26. Medium-term variability (coronary cineangiographies repeated 1-3 hours apart) was found to be -0.06 +/- 0.52. Long-term variability (coronary cineangiographies repeated 3-5 months apart) was 0.11 +/- 0.63. Having established the reproducibility of this radiographic method, we studied the prospective changes in coronary flow reserve in 25 patients undergoing PTCA for single vessel coronary artery disease. Coronary flow reserve measurements and quantitative coronary cineangiography were performed before, immediately after, and 3-5 months after PTCA. PTCA resulted in an immediate increase in coronary flow reserve from 1 +/- 0.3 to 2.3 +/- 0.6 with a concomitant increase in obstruction area from 0.9 +/- 0.3 to 3.3 +/- 0.7 mm2. Nine of the 25 patients developed restenosis defined as a diameter stenosis greater than 50% at follow-up. The other 16 patients had a coronary flow reserve of 3.3 +/- 0.6, which was measured 3-5 months after PTCA. Coronary flow reserve measurement from digitized coronary cineangiograms is a reproducible method for the assessment of the physiological importance of coronary artery obstructions. Short-, medium-, and long-term investigations of the functional results of interventions such as pharmacological therapy or revascularization can be performed reliably with this technique.     

Percutaneous transluminal laser angioplasty in peripheral arterial occlusive disease--development of a new laser catheter system

Percutaneous laser angioplasty in arterial occlusive disease has lately been performed clinically for the first time. Perforation of the arterial wall and formation of aneurysms are serious risks. Two novel laser catheters for laser angioplasty with minimized perforation risk are presented. Catheter I (5F) and II (6.3F) are designed in the same manner. The distal tip of these catheters is ovally formed and marked by a small X-ray dense metal ring. The silica fiber has a core diameter of 400 micron (I) respectively 600 micron (II). Its tip is also marked X-ray densely and therefore the position of the fiber tip can be controlled exactly during laser angioplasty. Using a guide wire and applicating short laser pulses the perforation risk can be minimized. In a total of 132 atherosclerotic stenosed or obstructed human arteries laser angioplasty was performed in vitro using a Nd:YAG laser. There were two perforations (1.5%). The degree of stenosis was reduced from 87 (90)% to 54 (52)%. Using the 600-micron-fiber (catheter II) the velocity of laser angioplasty was increased 2.5 times compared to laser angioplasty using the 400-micron-fiber.     

Variability of non-response to aspirin in patients with peripheral arterial occlusive disease during long-term follow-up

Non-responsiveness to aspirin as detected by laboratory tests may identify patients at high risk for future vascular events. The aim of this prospective study was to evaluate whether non-responsiveness to aspirin is stable over time. Ninety-eight patients with stable peripheral arterial occlusive disease (PAOD) treated with 100 mg/d aspirin were followed over a median timeframe of 17 months. Platelet function tests were performed initially and at follow-up using arachidonic acid-induced light transmittance aggregometry (LTA) in native platelet-rich plasma with the Behring Coagulation Timer® and by measuring the collagen?epinephrine closure time (CT) on a Platelet Function Analyzer (PFA-100®). When determining platelet function using LTA, four patients (4.1%) had residual platelet function (i.e., MaxAggr ≥78%) despite aspirin treatment, whereas, according to the PFA-100® results, 12 patients (12.2%) were identified as non-responders (i.e., CT <192 s). Fifty-seven patients who were still under treatment with 100 mg/d aspirin at the time of follow-up provided a second blood sample. Further platelet function tests with the PFA-100® system identified a persistent non-responsiveness to aspirin over time in three patients (5.3%) whereas four (7.0%) and 15 (26.3%) patients had changes in response status when platelet function was assessed by LTA and on the PFA-100®, respectively. We conclude that true non-responsiveness to aspirin is a rare phenomenon in stable PAOD patients. Furthermore, we conclude that in a number of patients, aspirin non-responsiveness is not stable over time.     

Predictors of long-term cardiac survival in patients with multivessel coronary artery disease undergoing percutaneous transluminal coronary angioplasty

The predictors of 5-year cardiac survival in patients with multivessel coronary artery disease (CAD) undergoing percutaneous transluminal coronary angioplasty (PTCA) were analyzed in a series of 637 consecutive patients. The average age was 59 +/- 11 years in 472 men and 165 women. Diabetes mellitus, previous myocardial infarction and unstable angina were present in 119 (19%), 261 (41%) and 305 (47%) patients, respectively. Angiographically, 460 patients had 2-vessel and 177 patients had 3-vessel CAD. The left ventricular contraction score was greater than or equal to 12 in 55 patients. Angiographic success (less than 50% residual stenosis) was achieved in 85% of the 1,343 narrowings and clinical success was obtained in 526 (83%) of the 637 patients. Complete revascularization was obtained in 177 (34%) of 526 successful patients. Procedure-related complications resulted in death in 9 patients (1.4%), in Q-wave myocardial infarction only in 6 patients (0.9%) and in emergency bypass surgery in 44 patients (6.9%) (of whom 10 had Q-wave myocardial infarction). Follow-up for greater than or equal to 1 year and up to 6 years after PTCA was obtained in 608 (95%) of the 637 patients. To determine the predictors of 5-year cardiac survival, 28 clinical, angiographic and procedural variables were analyzed by Cox proportional-hazards regression. The estimated 5-year survival after PTCA was 88 +/- 2% in successful patients and 77 +/- 5% in patients in whom PTCA was unsuccessful (p less than 0.001). When clinical success was forced into the Cox regression, the left ventricular contraction score of greater than or equal to 12, diabetes mellitus and age greater than or equal to 65 years showed additional adverse effects on survival.(ABSTRACT TRUNCATED AT 250 WORDS)     

肾动脉粥样硬化性狭窄介入治疗的长期效果

目的观察动脉粥样硬化性肾动脉狭窄（ARAS）行肾动脉介入治疗的安全性、近期及远期效果。方法冠状动脉造影发现动脉粥样硬化的患者同时行肾动脉造影,肾动脉狭窄〉70％的150例患者行肾动脉介入治疗。长期随诊观察血压及肾功能变化。结果150例患者中96％合并冠心病,54％为3支病变患者,共植入170枚支架,成功率99．3％。住院期间死亡3例,随访期间死亡2例。临床随访7个月至5年,随访率为98．6％（145例）。166支血管再狭窄10支,占6．0％。肾动脉造影复查30例,肾血管再狭窄5例,其中3例行再次介入治疗。结论冠心病合并肾动脉狭窄行介入治疗是安全有效的,术后大部分患者血压可以得到改善,肾功能基本保持稳定。     

老年冠心病患者经皮冠状动脉腔内成形术结果评价

目的评价一组老年冠心病患者行经皮冠状动脉腔内成形术（ＰＴＣＡ）的疗效。方法将６５例老年（８９支血管）和１１７例老年前期（１４９支血管）冠心病患者的ＰＴＣＡ结果作对比研究。结果老年组血管扩张成功率９４．４％，临床成功率９２．３％，主要并发症发生率为６．１％，再狭窄发生率为３２．５％。以上结果与老年前期组比较差异均无显著性。术后症状改善率两组相同，都在９０．０％以上。仅老年组再次ＰＴＣＡ频率明显高于老年前期组（ｘ２检验，Ｐ值＜０．０５）。结论对于老年冠心病患者，ＰＴＣＡ是一种有效及安全的冠脉血管重建措施。     

Early results after percutaneous transluminal coronary angioplasty in 400 patients.

In a consecutive series of 400 patients treated by percutaneous transluminal coronary angioplasty 212 had single vessel disease, 142 had multivessel disease with only one vessel dilated, and 46 had multivessel dilatation. In addition sequential stenoses were dilated in the same vessel in all groups. There was no mortality among patients with single vessel disease. Success rates varied from 83% to 90% according to the artery in which angioplasty was attempted. Urgent surgery was required by 3.8%. Primary success was lower (74%) in the presence of multivessel disease and complications were more frequent, with four deaths (2.8%). In 46 patients with multivessel disease in whom all important lesions were dilated during the same procedure the overall primary success rate was 76% and within the last year of the study it was 91%. One (2%) patient died and three (7%) required urgent surgery. Twelve (86%) out of 14 stenosed vein grafts were successfully dilated and eight (53%) chronically occluded vessels were re-opened; in both groups there were no deaths, no infarctions, and no need for urgent surgery. In all groups symptoms improved greatly and predischarge exercise tests showed that there was no reversible ischaemia in 94% of patients with single vessel disease or in 65% of patients with incomplete revascularisation. Six months after the procedure 95% of the patients had improved symptomatically and 80% had normal exercise tests after one year. Percutaneous transluminal coronary angioplasty is the method of choice in single vessel disease and its use also results in a high proportion of other patients becoming symptom free. Complication rates are low and for selected patients results that are equivalent to those of cardiac surgery are obtained.