Effect of nadroparin, a low-molecular-weight heparin, on clinical and angiographic restenosis after coronary balloon angioplasty: the FACT study. Fraxiparine Angioplastie Coronaire Transluminale

BACKGROUND: Experimental studies suggest that the antiproliferative effect of heparin after arterial injury is maximized by pretreatment. No previous studies of restenosis have used a pretreatment strategy. We designed this study to determine whether treatment with nadroparin, a low-molecular-weight heparin, started 3 days before the procedure and continued for 3 months, affected angiographic restenosis or clinical outcome after coronary angioplasty. METHODS AND RESULTS: In a prospective multicenter, double-blind, randomized trial, elective coronary angioplasty was performed on 354 patients who were treated with daily subcutaneous nadroparin (0.6 mL of 10,250 anti-Xa IU/mL) or placebo injections started 3 days before angioplasty and continued for 3 months. Angiography was performed just before and immediately after angioplasty and at follow-up. The primary study end point was angiographic restenosis, assessed by quantitative coronary angiography 3 months after balloon angioplasty. Clinical follow-up was continued up to 6 months. Clinical and procedural variables and the occurrence of periprocedural complications did not differ between groups. At angiographic follow-up, the mean minimal lumen diameter and the mean residual stenosis in the nadroparin group (1.37+/-0.66 mm, 51.9+/-21.0%) did not differ from the corresponding values in the control group (1.48+/-0.59 mm, 48.8+/-18.9%). Combined major cardiac-related clinical events (death, myocardial infarction, target lesion revascularization) did not differ between groups (30.3% versus 29.6%). CONCLUSIONS: Pretreatment with the low-molecular-weight heparin nadroparin continued for 3 months after balloon angioplasty had no beneficial effect on angiographic restenosis or on adverse clinical outcomes.     

Mechanisms of luminal enlargement and quantification of vessel wall trauma following balloon coronary angioplasty and directional atherectomy

OBJECTIVES: The purpose of this study was to assess the dual action of lumen enlargement and vessel wall damage following either balloon angioplasty or directional atherectomy, using intracoronary ultrasound, and angioscopy. BACKGROUND: Differences in the mechanisms of action of balloon angioplasty and directional atherectomy may have a significant bearing on the immediate outcome and the restenosis rate at 6 months. METHODS: A total of 36 patients were studied before and after either balloon angioplasty (n = 18) or directional atherectomy (n = 18). Ultrasound measurements included changes in lumen area, external elastic membrane area and plaque burden. In addition, the presence and extent of dissections were assessed to derive a damage score. Angioscopic assessment of the dilated or atherectomized stenotic lesions was translated into semi-quantitative dissection, thrombus and haemorrhage scores. RESULTS: Atherectomy patients had a larger angiographic vessel size compared with the angioplasty group (3.55 +/- 0.46 mm vs 3.00 +/- 0.64 mm, P < 0.05); however, minimal lumen diameter (1.18 +/- 0.96 mm vs 0.85 +/- 0.49 mm) and plaque burden (17.04 +/- 3.69 vs 15.23 +/- 4.92 mm2) measurements did not differ significantly. As a result of plaque reduction, atherectomy produced a larger increase in luminal area than the angioplasty group (5.80 +/- 1.78 mm2 vs 2.44 +/- 1.36 mm2, P < 0.0001). Lumen increase after angioplasty was the result of 'plaque compression' (50%) and wall stretching (50%). Additionally, in both groups there was indirect angioscopic evidence of thrombus 'microembolization' as an adjunctive mechanism of lumen enlargement. Angioscopy identified big flaps in six and small intimal flaps in 11 of the atherectomized patients as compared with five and 12 patients in the angioplasty group. Changes in thrombus score following both coronary interventions were identical (0.72 +/- 3.42 points atherectomy vs -0.38 +/- 3.27 points balloon angioplasty, ns). CONCLUSIONS: Lumen enlargement after directional atherectomy is mainly achieved by plaque removal (87%), whereas balloon dilation is the result of vessel wall stretching (50%) and plaque reduction (50%). Despite the fact that the luminal gain achieved by directional atherectomy is twice that achieved with balloon angioplasty, the extent of trauma induced by both techniques seems to be similar.     

Procedural outcome and follow-up results of balloon angioplasty versus new device interventions for treatment of true bifurcation stenoses

Strategies for dilatation of bifurcation stenoses have continued to evolve over the past several years. However, there is limited experience on the efficacy of various nonballoon interventional devices and their results in comparison with balloon angioplasty. We, therefore, analysed our data in 72 patients of coronary artery disease with true bifurcation stenoses with balloon angioplasty or new device interventions (NDI). All patients underwent dilatation of both the primary vessel and side branch ostial stenosis. Balloon angioplasty using double guidewire with sequential or simultaneous (kissing balloon) balloon inflation in the two vessels was performed in 42 patients. Thirty patients underwent NDI, using directional coronary atherectomy (DCA) in 12, rotablation in 6 and elective coronary stents in 12 patients. There were no significant differences in the baseline clinical and angiographic variables between patients in the two groups. While the preprocedural luminal diameter stenosis was similar, the residual stenosis was significantly less, both in the primary vessel and side branch, after NDI compared to balloon angioplasty. The procedure was successful in 96.6 percent patients treated with NDI and 83.3 percent with balloon angioplasty (p < 0.01) with relief of obstruction in both branches without any major complications. Freedom from subsequent coronary events in the form of angina, myocardial infarction, PTCA, bypass graft surgery of death was significantly more, both at 6 months (92% versus 65.6%, p < 0.001) and 12 months (81.8% versus 53.1%, p < 0.001) in the group of patients treated with NDI compared to balloon angioplasty. It is, therefore, concluded that NDI including DCA, rotablation and elective stenting are associated with higher rate of success, lesser complications and better event-free survival in comparison to balloon angioplasty for treatment of true bifurcation stenoses.     

Ultrastructure and distribution of axon terminals from the reticular thalamic nucleus to the anteroventral thalamic nucleus of the rat

The Bard Atherectomy Catheter is a new rotational atherectomy device that consists of a flexible, hollow, thin-walled cutting catheter that, while rotated at 1,500 revolutions per minute, is advanced across the lesion over a special spiral guidewire system. We report the initial clinical experience with this device in 20 peripheral lesions in ten patients. The majority of patients were treated for limb salvage. All lesions were successfully intervened on by atherectomy followed by adjunctive balloon angioplasty. A reduction to less than 50% stenosis was achieved in 13 of the 20 lesions (65%) after atherectomy but in all 20 lesions (100%) after adjunctive angioplasty for all lesions and stenting for dissections in two. Baseline minimal lesion lumen diameter was 0.8 +/- 0.7 mm with a reference vessel diameter of 4.2 +/- 1.7 mm (75 +/- 21% stenosis). The lumen improved to 2.0 +/- 0.8 mm (45 +/- 19% stenosis) (P < 0.001) following atherectomy and to 3.9 +/- 1.9 mm (13 +/- 16% stenosis) (P < 0.001) after adjunctive angioplasty. The average weight of removed atheroma was 45 +/- 58 mg. All ten patients had initial improvement in symptoms. At 6 months follow-up there was persistent improvement in eight patients and two subjects had undergone amputations. Our early clinical experience with this low profile, flexible atherectomy device, that enables extraction of a large amount of atheroma, suggests that it will become a valuable addition to current atherectomy technologies in small- and medium-sized vessels. The value of this device in coronary vessels is under investigation.     

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.     

Are directional coronary atherectomy and Palmaz-Schatz stent more efficacious than conventional balloon angioplasty for treating de novo coronary artery lesions?

It is unclear whether new devices such as directional coronary atherectomy (DCA) or Palmaz-Schatz stent implantation improve long-term outcomes compared with conventional balloon angioplasty in patients with stable angina and de novo coronary artery lesions of type A or type B except for complete occlusive lesions investigated by the American College of Cardiology/American Heart Association task force on percutaneous transluminal coronary angioplasty. A total of 146 patients with stable angina and simple lesions were assigned to either conventional balloon angioplasty (62 patients), DCA (50 patients), or Palmaz-Schatz implantation (34 patients). The acute results and late outcomes were assessed by coronary angiography. The results of the three procedures were similar with respect to procedural success and complications. Patients who underwent stenting or DCA had a larger immediate increase in the diameter of the lumen and a larger luminal diameter immediately after the procedure than those who underwent balloon angioplasty. At six months follow-up, the patients treated by stenting continued to have a larger luminal diameter and a lower rate of restenosis than those treated with balloon angioplasty (2.30 +/- 0.66 vs 1.85 +/- 0.83 mm, p < 0.005; 5.9% vs 29%, p < 0.05) and DCA (2.30 +/- 0.66 vs 1.90 +/- 0.96 mm, p < 0.05; 5.9% vs 24%, NS). The patients treated with balloon angioplasty had a smaller late loss than those treated with DCA or Palmaz-Schatz stent. The patients treated with DCA had a larger loss index than those treated with balloon angioplasty or Palmaz-Schatz stent. Stenting was a significant factor in decreasing the rate of restenosis by logistic regression analysis, compared with balloon angioplasty. The angiographic outcomes were better in patients who received a stent than in those who received other treatments. This study suggests that even lesions stable for treatment by balloon angioplasty and DCA can also be treated with Palmaz-Schatz stents.     

Randomised comparison of implantation of heparin-coated stents with balloon angioplasty in selected patients with coronary artery disease (Benestent II)

BACKGROUND: The multicentre, randomised Benestent-II study investigated a strategy of implantation of a heparin-coated Palmar-Schatz stent plus antiplatelet drugs compared with the use of balloon angioplasty in selected patients with stable or stabilised unstable angina, with one or more de-novo lesions, less than 18 mm long, in vessels of diameter 3 mm or more. METHODS: 827 patients were randomly assigned stent implantation (414 patients) or standard balloon angioplasty (413 patients). The primary clinical endpoint was event-free survival at 6 months, including death, myocardial infarction, and the need for revascularisation. The secondary endpoints were the restenosis rate at 6 months and the cost-effectiveness at 12 months. There was also one-to-one subrandomisation to either clinical and angiographic follow-up or clinical follow-up alone. Analyses were by intention to treat. FINDINGS: Four patients (one stent group, three angioplasty group) were excluded from analysis since no lesion was found. At 6 months, a primary clinical endpoint had occurred in 53 (12.8%) of 413 patients in the stent group and 79 (19.3%) of 410 in the angioplasty group (p=0.013). This significant difference in clinical outcome was maintained at 12 months. In the subgroup assigned angiographic follow-up, the mean minimum lumen diameter was greater in the stent group than in the balloon-angioplasty group, (1.89 [SD 0.65] vs 1.66 [0.57] mm, p=0.0002), which corresponds to restenosis rates (diameter stenosis > or =50%) of 16% and 31% (p=0.0008). In the group assigned clinical follow-up alone, event-free survival rate at 12 months was higher in the stent group than the balloon-angioplasty group (0.89 vs 0.79, p=0.004) at a cost of an additional 2085 Dutch guilders (US$1020) per patient. INTERPRETATION: Over 12-month follow-up, a strategy of elective stenting with heparin-coated stents is more effective but also more costly than balloon angioplasty.     

Differences in restenosis propensity of devices for transluminal coronary intervention. A quantitative angiographic comparison of balloon angioplasty, directional atherectomy, stent implantation and excimer laser angioplasty. CARPORT, MERCATOR, MARCATOR, PARK, and BENESTENT Trial Groups

With the increasing clinical application of new devices for percutaneous coronary revascularization, maximization of the acute angiographic result has become widely recognized as a key factor in maintained clinical and angiographic success. What is unclear, however, is whether the specific mode of action of different devices might exert an additional independent effect on late luminal renarrowing. The purpose of this study was to investigate such a difference in the degree of provocation of luminal renarrowing (or 'restenosis propensity') by different devices, among 3660 patients, who had 4342 lesions successfully treated by balloon angioplasty (n = 3797), directional coronary atherectomy (n = 200), Palmaz-Schatz stent implantation (n = 229) or excimer laser coronary angioplasty (n = 116) and who also underwent quantitative angiographic analysis pre- and post-intervention and at 6-month follow-up. To allow valid comparisons between the groups, because of significant differences in coronary vessel size (balloon angioplasty = 2.62 +/- 0.55 mm, directional coronary atherectomy = 3.28 +/- 0.62 mm, excimer laser coronary angioplasty = 2.51 +/- 0.47 mm, Palmaz-Schatz = 3.01 +/- 0.44 mm; P < 0.0001), the comparative measurements of interest selected were the 'relative loss' in luminal diameter (RLoss = loss/vessel size) to denote the restenosis process, and the 'relative lumen at follow-up' (RLfup = minimal luminal diameter at follow up/vessel size) to represent the angiographic outcome. For consistency, lesion severity pre-intervention was represented by the 'relative lumen pre' (RLpre = minimal luminal diameter pre/vessel size) and the luminal increase at intervention was measured as 'relative gain' (relative gain = gain/ vessel size). Differences in restenosis propensity between devices was evaluated by univariate and multivariate analysis. Multivariate models were constructed to determine relative loss and relative lumen at follow-up, taking account of relative lumen pre-intervention, lesion location, relative gain, vessel size and the device used. In addition, model-estimated relative loss and relative lumen at follow-up at given relative lumen pre-intervention relative gain and vessel size, were compared among the four groups. Significant differences were detected among the groups both with respect to these estimates, as well as in the degree of influence of progressively increasing relative gain, on the extent of renarrowing (relative loss) and angiographic outcome (relative lumen at follow-up), particularly at higher levels of luminal increase (relative gain). Specifically, lesions treated by balloon angioplasty or Palmaz-Schatz stent implantation (the predominantly 'dilating' interventions) were associated with more favourable angiographic profiles than directional atherectomy or excimer laser (the mainly 'debulking' interventions). Significant effects of lesion severity and location, as well as the well known influence of luminal increase on both luminal renarrowing and late angiographic outcome were also noted. These findings indicate that propensity to restenosis after apparently successful intervention is influenced not only by the degree of luminal enlargement achieved at intervention, but by the device used to achieve it. In view of the clinical implications of such findings, further evaluation in larger randomized patient populations is warranted.     

Myocardial infarction as a complication of new interventional devices

Percutaneous transluminal coronary balloon angioplasty has been associated with acute myocardial infarction (MI) as a complication of the procedure. Abrupt closure, distal coronary embolization, intimal dissection, coronary spasm, and acute thrombosis are the principal etiologies. New interventional devices (stent, laser, and atherectomy catheters) have been introduced as alternatives or adjuncts to balloon angioplasty. With use of the New Approaches to Coronary Intervention Registry, the incidence, predictors, and outcome of MI as a complication of using these devices as the primary mode of intervention were studied. There were 3,265 patients from 39 participating centers in the cohort treated with new devices. MI was reported as an in-hospital complication of using new devices in 154 patients (4.7%), including Q-wave MI in 36 patients (1.1%), and non-Q-wave MI in 119 patients (3.6%). MI rates were not significantly different among all patients with devices in the cohort treated with atherectomy (directional, extractional, rotational), laser (AIS, Spectranetics) or the Palmaz-Schatz stent. Multivariate logistic regression showed that post-procedure MI was associated with multivessel disease, high surgical risk, postinfarction angina, and presence of a thrombus prior to the procedure. Prior percutaneous transluminal coronary angioplasty was inversely related to the incidence of MI. When a specific cause of MI could be detected, the main etiologies were: coronary embolus 16.9%, and abrupt closure 27.3%. Other major in-hospital complications were higher in the MI group than the non-MI group: death 7.8% versus 0.8% (p <0.001), and bypass surgery 13.6% versus 1.7% (p <0.001). At 1 year, mortality rates remain higher at 12.9% in the MI group versus 4.9% in the non-MI group (p <0.01). Despite different indications for the use of new devices, they were not predictors for MI with the exception of the rotablator. The incidence of MI (1.1% Q-wave, 3.6% non-Q-wave) was comparable to previously reported rates for balloon angioplasty. The occurrence of MI is associated with an increase in other in-hospital complications and a doubling of 1-year mortality.     

Preliminary experience with adjunct directional coronary atherectomy after high-speed rotational atherectomy in the treatment of calcific coronary artery disease

A high-speed rotational atherectomy was performed followed by adjunct directional atherectomy in 10 patients with symptomatic coronary artery disease and calcified target lesions and the results were evaluated using quantitative coronary arteriography and intravascular ultrasound. Target lesion calcium is common in obstructive coronary artery disease. High-speed rotational coronary atherectomy preferentially abrades noncompliant atherosclerotic plaque material, especially calcium, but often requires adjunct balloon angioplasty to achieve optimal lumen dimensions. Directional coronary atherectomy has limited efficacy in heavily calcified plaque; usually, it is a definitive primary procedure in large arteries with noncalcified target lesions. Neither of these devices alone is effective in treating calcified target lesions in large coronary arteries. Before intervention, after rotational and adjunct directional atherectomy, these measurements were obtained: quantitative coronary arteriographic measurements of minimal lumen diameter and percent diameter stenosis and intravascular ultrasound measurements of external elastic membrane, lumen, and plaque+media cross-sectional areas; percent cross-sectional narrowing; minimal lumen diameter; and target-lesion arc of calcium. With use of quantitative coronary arteriography, the preintervention minimal lumen diameter measured 0.7 +/- 0.4 mm, increased to 1.5 +/- 0.5 mm after rotational atherectomy (p = 0.0013) and to 2.5 +/- 0.3 mm after adjunct directional atherectomy (p < 0.001). The preintervention percent diameter stenosis measured 78 +/- 15%, decreased to 50 +/- 17% after rotational atherectomy (p = 0.0011), and to 17 +/- 11% (p < 0.001) after adjunct directional coronary atherectomy.(ABSTRACT TRUNCATED AT 250 WORDS)     

Randomized comparison of coronary stenting with balloon angioplasty in selected patients with acute myocardial infarction

BACKGROUND: Although the benefits of primary angioplasty in acute myocardial infarction have been demonstrated, several areas for improvement remain. Therefore, a prospective randomized trial comparing primary stenting with balloon angioplasty in patients with acute myocardial infarction was conducted. METHODS AND RESULTS: Patients with acute myocardial infarction were randomly assigned to undergo either primary stenting (n=112) or balloon angioplasty (n=115). The clinical end points were death, recurrent infarction, subsequent bypass surgery, or repeat angioplasty of the infarct-related vessel. The overall mortality rate at 6 months was 2%. Recurrent infarction occurred in 8 patients (7%) after balloon angioplasty and in 1 (1%) after stenting (P=0.036). Subsequent target-vessel revascularization was necessary in 19 (17%) and 4 (4%) patients, respectively (P=0.0016). The cardiac event-free survival rate in the stent group was significantly higher than in the balloon angioplasty group (95% versus 80%; P=0.012). CONCLUSIONS: In selected patients with acute myocardial infarction, primary stenting can be applied safely and effectively, resulting in a lower incidence of recurrent infarction and a significant reduction in the need for subsequent target-vessel revascularization compared with balloon angioplasty.     

The atherosclerotic Yucatan animal model to study the arterial response after balloon angioplasty: the natural history of remodeling

OBJECTIVE: Remodeling in de novo atherosclerosis and in restenosis after balloon angioplasty constitutes a change in total arterial circumference which, together with plaque growth or neointimal formation, determines the lumen of the artery. To better understand the fundamental biology of neointimal formation, remodeling and their interaction, animal studies are needed. In this study, we described in detail the methodology used and the natural history of neointimal formation and remodeling after balloon angioplasty in atherosclerotic Yucatan micropigs. METHODS AND RESULTS: Atherosclerosis was induced in 60 peripheral arteries of sixteen Yucatan micropigs by a combination of denudation and atherogenic diet. Balloon angioplasty was performed in 38 arteries, with serial intravascular ultrasound (IVUS) and quantitative angiography before and after intervention and at 2, 4, 7, 14 or 42 days follow-up. Remodeling, expressed as late media-bounded area (MBA) loss, increased progressively over time. At 42 days, late MBA loss after balloon angioplasty was significantly different compared to late MBA loss in control arteries, 2.2 +/- 1.0 versus -0.3 +/- 1.1 mm2 and p = 0.02. Late lumen loss increased over time and was highest at 42 days after balloon angioplasty (2.8 +/- 0.7 mm2). The contribution of neointimal formation to late lumen loss decreased over time and the contribution of late MBA loss to late lumen increased over time and was highest at 42 days (78%). Medial necrosis was 48% at two days after balloon angioplasty and the repopulation of the media was almost completed at seven days. CONCLUSION: Remodeling following balloon angioplasty has an early onset and progresses with neointimal formation to cause restenosis over the standard 42-day time course for Yucatan micropigs. This correlates to six months renarrowing in humans. In this model, atherosclerosis and the natural history of restenosis, both with respect to neointimal formation and remodeling, resemble the human disease quite closely.     

Impact of diabetes mellitus on percutaneous revascularization (CAVEAT-I). CAVEAT-I Investigators. Coronary Angioplasty Versus Excisional Atherectomy Trial

We examined the relation between diabetes mellitus and outcomes in patients undergoing percutaneous coronary revascularization in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I), a randomized trial comparing treatment with either percutaneous transluminal coronary angioplasty or directional atherectomy for de novo lesions in native coronary arteries. Acute success and complication rates, 6-month angiographic restenosis rates, and 1-year clinical outcomes were compared between diabetic and nondiabetic patients undergoing each procedure. Acute success rates between diabetic (n = 191) and nondiabetic (n = 821) patients were similar for both revascularization techniques. Except for the need for dialysis, complication rates were also similar. Six months after atherectomy, diabetic patients had significantly more angiographic restenosis than nondiabetics (59.7% vs 47.4%) and significantly smaller minimum luminal diameters (1.20 vs 1.40 mm). Diabetics undergoing atherectomy required more frequent bypass surgery (12.8% vs 8.5%) and more repeat percutaneous revascularizations (36.5% vs 28.1%) than nondiabetics undergoing atherectomy. Restenosis rates, minimum luminal diameters and repeat revascularizations between diabetics and nondiabetics undergoing angioplasty were similar. The higher restenosis and repeat revascularization rates and the smaller minimum luminal diameter at follow-up in diabetic patients suggest that atherectomy may provide only modest benefit for these patients. The increased restenosis rate in diabetics undergoing atherectomy (but not angioplasty) requires further evaluation.     

Comparison of primary coronary stenting to primary balloon angioplasty with stent bailout for the treatment of patients with acute myocardial infarction

This study compares the immediate and long-term outcomes of a primary coronary stenting strategy with primary balloon angioplasty with stent bailout in the treatment of patients with acute myocardial infarction (AMI). One hundred forty-seven consecutive patients who underwent primary balloon angioplasty with stent bailout (n = 94) or primary stenting (n = 53) for AMI were clinically followed for 8.1 +/- 5.7 and 8.5 +/- 4.5 months, respectively. Immediate results, as well as in-hospital and long-term ischemic events (death, reinfarction, and repeat revascularization) were compared between both groups. Angiographic success was 91.5% in the balloon angioplasty group and 94% in the stent group. In-hospital and late follow-up combined ischemic events were 22 of 94 (23%) versus 0 of 53 (0%); p < 0.001 and 33 of 78 (42%) versus 13 of 53 (25%), p = 0.04 for the balloon angioplasty and stent groups, respectively. At 6 months, the cumulative probability of repeat target lesion revascularization was higher in the balloon angioplasty group (47% vs 18%, p = 0.0006) as was the probability of late target revascularization (36% vs 18%, p = 0.046); the cumulative event-free survival after 6 months was significantly lower in the balloon angioplasty group (44% vs 80%, p = 0.0001). This study demonstrates that a primary stent placement strategy in patients with AMI is safe, feasible, and superior to primary balloon angioplasty with stent bailout. Primary stenting results in a larger postprocedural minimal luminal diameter, a lower early and late recurrent ischemic event rate, and a lower incidence of target lesion revascularization at follow-up.     

Characterisation of a pea hsp70 gene which is both developmentally and stress-regulated

OBJECTIVES: We sought to evaluate the immediate angiographic results and intermediate-term follow-up after percutaneous treatment of left main coronary stenoses in the new device era. BACKGROUND: Historically, balloon angioplasty of left main coronary stenoses has been associated with high procedural morbidity and poor long-term results. It is not clear whether new devices are more effective in this anatomic setting. METHODS: Between July 1993 and July 1995, we performed initial left main coronary interventions on 46 patients (mean age 67 +/- 12 years, 26% women). Quantitative angiography was available for 42 of 46 interventions, and clinical follow-up was obtained for all patients at 1 month, 6 months and 1 year after initial revascularization. RESULTS: Most interventions (42 of 46) were performed in patients with "protected" coronary stenoses to the left coronary system owing to the presence of one or more patent left main coronary grafts. Seventy-seven percent of screened patients were deemed unsuitable for repeat coronary artery bypass surgery. Procedures performed included stenting in 73% of patients (alone in 30% and after rotational atherectomy in 43%), rotational atherectomy in 58% (alone in 15% and before stenting in 43%), directional atherectomy in 4% and angioplasty alone in 7%. Initial procedural success was achieved in all interventions, with no deaths, myocardial infarctions (creatine kinase, MB fraction > 50 IU/liter) or emergent bypass surgery. Follow-up data to date (median duration 9 months, range 6 to 19) demonstrate a 98% overall survival rate and a 6-month event-free survival rate of 78% (six target vessel revascularizations [TVRs], four non-TVRs). CONCLUSIONS: Treatment of protected left main coronary artery stenoses can be accomplished safely and effectively with new device technology. Intermediate-term follow-up demonstrates an acceptably low rate of death, myocardial infarction or repeat revascularization at 6 months and 1 year.     

Treatment of ostial lesions of the left anterior descending coronary artery with Palmaz-Schatz coronary stent

We evaluated acute and long-term clinical and angiographic results of elective Palmaz-Schatz coronary stent implantation for left anterior descending coronary artery (LAD) ostial stenosis in 23 consecutive patients. Eight patients had stable angina, 14 had unstable angina, and 1 had recent myocardial infarction. Sixteen patients had single-vessel, 5 had double-vessel, and 2 had triple-vessel disease. Clinical success without major complications (death, acute myocardial infarction, emergency coronary artery bypass grafting) was obtained in all cases and technical success in 20 cases (86.9%). After stenting, minimal lumen diameter increased from 1.05 +/- 0.45 mm to 2.89 +/- 0.52 mm (p < 0.001), and percent diameter stenosis decreased from 65.49% +/- 13.36% to 2.94% +/- 19.93% (p < 0.001). One case of subacute thrombosis and no major bleeding occurred. Twenty patients were followed-up for 6 months, during which no acute cardiac event (death, acute myocardial infarction) was observed. Eighteen patients were eligible for follow-up coronary angiography; restenosis (> or = 50% diameter stenosis) was observed in 4 (22.2%). Minimal lumen diameter was 1.77 +/- 0.55 mm, percent diameter stenosis was 39.66% +/- 17.62%, late loss was 1.01 +/- 0.69 mm, net gain was 0.79 +/- 0.55 mm, and loss index (late loss/acute gain) was 0.53 +/- 0.37. This study suggests that elective Palmaz-Schatz stent implantation may be a safe and successful treatment of LAD ostial lesions and provides a large increase in lumen diameter.     

Short- and long-term clinical and quantitative angiographic results with the new, less shortening Wallstent for vessel reconstruction in chronic total occlusion: a quantitative angiographic study

OBJECTIVES: This study was designed to examine whether oversized implantation of the new, less shortening Wallstent provides a more favorable long-term clinical and angiographic outcome in chronic total occlusions than does conventional coronary balloon angioplasty. BACKGROUND: Restenosis and reocclusion remain major limitations of balloon angioplasty for chronic total occlusions. Enforced mechanical remodeling by implantation of the oversized Wallstent may prevent elastic recoil and improve accommodation of intimal hyperplasia. METHODS: Lumen dimension was measured by a computer-based quantitative coronary angiography system (CAAS II). These measurements (before and after intervention and at 6-month follow-up) were compared between the groups with Wallstent implantation (20 lesions, 20 patients) and conventional balloon angioplasty (266 lesions, 249 patients) for treatment of chronic total occlusion. Acute gain (minimal lumen diameter after intervention minus that before intervention), late loss (minimal lumen diameter after intervention minus that at follow-up) and net gain (acute gain minus late loss) were examined. RESULTS: Wallstent deployment was successful in all patients. High pressure intra-Wallstent balloon inflation (mean +/- SD 14 +/- 3 atm) was performed in all lesions. Although vessel size did not differ between the Wallstent and balloon angioplasty groups, acute gain was significantly greater in the Wallstent group (2.96 +/- 0.55 vs. 1.61 +/- 0.34 mm, p < 0.0001). Although late loss was also significantly larger in the Wallstent group (0.81 +/- 0.95 vs. 0.43 +/- 0.68 mm, p < 0.05), net gain was still significantly greater in this group (2.27 +/- 1.00 vs. 1.18 +/- 0.69 mm, p < 0.0001). Angiographic restenosis (> or = 50% diameter stenosis) occurred at 6 months in 29% of lesions in the Wallstent group and in 45% of those in the balloon angioplasty group (p = 0.5150). CONCLUSIONS: Implantation of the oversized Wallstent, with full coverage of the lesion length, ensures resetting of the vessel size to its original caliber before disease and allows greater accommodation of intimal hyperplasia and chronic vessel recoil. Wallstent implantation provides a more favorable short- and long-term clinical and angiographic outcome than does conventional balloon angioplasty for chronic total occlusions.     

Optimal burr and adjunctive balloon sizing reduces the need for target artery revascularization after coronary mechanical rotational atherectomy

We analyzed the effect of differing burr and balloon sizes during mechanical rotational atherectomy on the need for target vessel revascularization at 6 months. The ideal burr/artery ratio and adjunctive balloon/artery ratio for optimizing acute luminal results and minimizing restenosis is unknown. Six-month clinical follow-up was obtained in 311 patients (339 lesions) treated with rotational atherectomy from August 1993 to September 1994, to determine whether procedural results or technique were related to the need for target vessel revascularization. Target vessel revascularization, defined as repeat percutaneous intervention or bypass surgery within 6 months after rotational atherectomy, occurred in 19% of patients. Larger burr/artery ratios, defined as the final burr size divided by the reference artery size, were correlated with decreased postatherectomy diameter stenosis (p <0.009) and decreased final diameter stenosis (p <0.03). However, there was no statistical association between postatherectomy or final diameter stenosis with need for revascularization (p = not significant [NS]). The need for revascularization was lowest for burr/artery ratio between 0.6 to 0.85 (15%) versus burr/artery <0.6 or >0.85 (25%) (p <0.04). Postatherectomy, smaller balloon/artery ratios, defined as the final balloon size divided by the reference artery size, were correlated with lower repeat revascularization rates. Balloon/artery ratios <0.95 (target vessel revascularization = 11% vs 25% in balloon/artery >0.95) were associated with the best luminal results and the least risk for clinical restenosis (p <0.006). For rotational atherectomy, despite improvement in acute luminal results with increased burr/artery ratio, the use of a moderate burr/artery ratio correlated with the lowest revascularization rates. There was no correlation between postatherectomy or final diameter stenosis and need for repeat interventions. However, the use of large balloon/artery ratios after rotablator was associated with higher target vessel revascularization rates.     

Evaluation of the systematic use of wide lumen 6 French guiding catheters in conventional coronary angioplasty

The aim of this study was to evaluate the results of systematic use of 6 French guiding catheters in conventional balloon coronary angioplasty without any restriction of indications apart from coronary lesions necessitating other techniques such as atherectomy. Therefore, after a learning period, 200 consecutive procedures performed between November 1993 and June 1994 for the treatment of 234 lesions were analysed prospectively. Fifty-one patients had stable and 70 unstable angina. In 79 cases, the angioplasty was performed on the culprit lesion of a myocardial infarction. An angiographic success was obtained for 206 lesions or 88% of cases which increased to 95% after exclusion of attempted recanalisation. There were 3 cases of damage to the ostium and 7 patients underwent implantation of a stent with the same catheter for occlusive or threatening dissection. There were 10 ischaemic complications (5%) (7 non-Q wave infarctions, 2 Q wave infarctions, 1 aorto-coronary bypass, no deaths) and 8 local complications at the site of arterial catheterisation during the hospital period. These results demonstrate the feasibility of coronary angioplasty with wide lumen 6 French guiding catheters and show that they amy be used in first intention for all conventional balloon angioplasty procedures.     

Contemporary percutaneous treatment of unprotected left main coronary stenoses: initial results from a multicenter registry analysis 1994-1996

BACKGROUND: Coronary artery bypass surgery (CABG) has been considered the therapy of choice for patients with unprotected left main (ULMT) coronary stenoses. Selected single-center reports suggest that the results of percutaneous intervention may now approach those of CABG. METHODS AND RESULTS: To assess the results of percutaneous ULMT treatment from a wide variety of experienced interventional centers, we requested data on consecutive patients treated after January 1, 1994, from 25 centers. One hundred seven patients were identified who were treated either electively (n=91) or for acute myocardial infarction (n=16). Of patients treated electively, 25% were considered inoperable, and 27% were considered high risk for bypass surgery. Primary treatment included stents (50%), directional atherectomy (24%), and balloon angioplasty (20%). Follow-up was 98.8% complete at 15+/-8 months. Results varied considerably, depending on presentation and treatment. For patients with acute myocardial infarction, technical success was achieved in 75%, and survival to hospital discharge was 31%. For elective patients, technical success was achieved in 98.9%, and in-hospital survival was strongly correlated with left ventricular ejection fraction (P=.003). Longer-term event (death, infarction, or bypass surgery) -free survival was correlated with ejection fraction (P<.001) and was inversely related to presentation with progressive or rest angina (P<.001). Surgical candidates with ejection fractions > or = 40% had an in-hospital survival of 98% and a 9-month event-free survival of 86+/-5%, whereas patients with ejection fractions < 40% had 67% and 22+/-12% in-hospital and 9-month event-free survivals, respectively. Nine hospital survivors (10.6%) experienced cardiac death within 6 months of hospital discharge. CONCLUSIONS: While results for selected patients appear promising, until early post-hospital discharge cardiac death can be better understood and minimized, percutaneous revascularization of ULMT stenosis should not be considered an alternative to bypass surgery for most patients. When percutaneous revascularization of ULMT is required, directional atherectomy and stenting appear to be the preferred techniques, and follow-up angiography 6 to 8 weeks after treatment is probably advisable.