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PubMed1999

Percutaneous revascularization modalities in heart transplant recipients.

Accelerated allograft vasculopathy significantly limits the survival of heart transplant recipients. The prevalence of allograft coronary artery disease is as high as 18% by 1 year and 50% by 5 years following heart transplant. Heart failure and sudden cardiac death are the two most common clinical presentations. In heart transplant recipients with severe, discrete focal allograft vascular disease, percutaneous balloon angioplasty is a viable palliative option. However, its application is limited by a significant restenosis rate and progression of allograft disease in nontreated segments. Diffuse disease with tapering of vessels may be approached by debulking devices. Emerging revascularization modalities for focal stenoses and some of the diffuse tapering vessels include coronary stents, rotational atherectomy, various wavelength lasers, and, to a lesser extent, directional atherectomy. Conceivably, stents will reduce restenosis rates related to focal, discrete plaques; yet it is unknown whether they will be efficacious in short- and long-term treatment of diffusely diseased segments affected by allograft disease. Accurate assessment of clinical outcomes and long-term evaluation is imperative prior to acceptance of these devices as fundamental interventional tools for treatment of allograft coronary artery disease.

Adult↗

PubMed1999

Clinical, angiographic, and procedural correlates of abrupt vascular closure during coronary intervention: a 10-year experience at Mayo Clinic.

A large matched-cohort study was carried out to determine correlates of in-hospital abrupt vascular closure (AC). Univariate analysis identified current cigarette smoking (P = 0.021), myocardial infarction within 24 hr prior to procedure (P = 0.0035), emergency procedure (P = 0.02), lesion thrombus (P = 0.0001), and lesion angulation (P = 0.021) as significant clinical and angiographic variables. Relative to balloon angioplasty (PTCA), use of atherectomy (P = 0.015) and laser devices (P = 0.018) but not elective stent placement (P = 0.97) were associated with increased risk of AC. In the multivariate model, current cigarette smoking (P = 0.0474), lesion thrombus (P = 0.0001), lesion angulation (P = 0.0124), use of atherectomy devices (P = 0.001), and laser devices (P = 0.0037) remained as significant correlates of increased AC events. In conclusion, the risk of AC appears associated primarily with lesion characteristics and use of nonballoon devices other than stents. Elective stent placement did not appear to reduce AC risk over conventional PTCA; the small number of patients studied may have prevented any benefit from being observed.

Angioplasty, Balloon, Coronary↗

PubMed2000

Angiographic patterns of in-stent restenosis and implications on subsequent revascularization.

Stent implantation has become the mainstay of percutaneous revascularization for most coronary lesions; in-stent restenosis (ISR) can occur in 6%-40% of stent procedures and the subsequent response to repeat intervention can possibly be predicted by the angiographic patterns of ISR. This study evaluated the incidence and predictors of angiographic patterns of ISR and its impact on subsequent target lesion revascularization (TLR) in 100 consecutive patients having Palmaz-Schatz ISR undergoing intervention. Diffuse ISR (>/=10 mm) was observed in 78% and focal ISR (>10 mm) in 22%. Diffuse vs. focal ISR occurred earlier after stent implantation and was more common in diabetics. Angiographic predictors of diffuse ISR were stent implantation for a restenotic lesion, long lesions, smaller vessel, stenting without debulking, and high-pressure balloon inflation (>16 atm). TLR after repeat intervention was 46% for diffuse and 14% for focal ISR (P < 0.02). Rotational atherectomy resulted in lower TLR (31%) vs. PTCA or restent (64%) in diffuse ISR (P < 0.004). Therefore, diffuse ISR is more common than focal ISR, usually occurs in the setting of aggressive intimal hyperplasia, and can be predicted by clinical and angiographic variables. Also, diffuse intimal hyperplasia within a stent responds poorly to PTCA and may benefit from a more aggressive debulking strategy such as rotational atherectomy. Cathet. Cardiovasc. Intervent. 49:23-29, 2000.

Aged↗

PubMed2001

Angiographic analysis of immediate and long-term results of PTCR vs. PTCA in complex lesions (COBRA study).

We conducted a prospective, randomized trial to compare immediate and long-term effects of percutaneous transluminal coronary angioplasty (PTCA) and high-frequency rotational atherectomy (PTCR) in patients with angiographically predefined complex coronary artery lesions (AHA type B2 and C). The relation of lesion characteristics to procedural results is reported in this angiographic analysis. Patients were randomly assigned to balloon angioplasty (n = 250 patients) or rotational atherectomy (n = 252 patients). Quantitative coronary angiography could be performed in 447 patients to evaluate immediate results and in 293 patients with a 6-month angiographic follow-up. Procedural success was comparable in the PTCR and in the PTCA group (80% vs. 76%, P = 0.260). The need for stent implantation due to a residual stenosis >50% or a bail-out situation was significantly higher in the PTCA group (9.7% vs. 2.0%, P = 0.001). In both treatment groups, diameter stenosis was effectively reduced and MLD increased. The acute gain did not differ between the two groups. At 6-month control, the restenosis rate was comparable in the PTCR and in the PTCA group (37% vs. 35%, P = 0.658), whereas diameter stenosis was significantly more severe in the PTCR group than in the PTCA group (52% vs. 46%, P = 0.039) and, correspondingly, the MLD was significantly smaller in the PTCR group (1.29 mm vs. 1.44 mm, P = 0.031). Late loss was about the same in both groups, however, net gain and net gain index were significantly higher in the PTCA group (0.82 mm vs. 0.64 mm, P = 0.008; and 31% vs. 24%, P = 0.009). Analysis of procedural results for various lesion characteristics revealed no significant difference between treatment groups. In this randomized trial, complex coronary artery lesions were treated with comparable results for angiographic and procedural success and the restenosis rate by both, PTCA and PTCR. Late loss, however, was significantly higher and net gain significantly smaller after PTCR. Stents, although infrequently used, had a relevant impact on immediate PTCA results but not on late results. Cathet Cardiovasc Intervent 2001;53:359-367.

Aged↗

PubMed1997

Coronary artery and saphenous vein graft remodeling: a review of histologic findings after various interventional procedures--Part VI.

Catheter balloon angioplasty is a well accepted form of nonsurgical treatment of acutely and chronically obstructed coronary artery vessels. It is also the centerpiece for various new intervention techniques. Their morphologic effects on the site of obstruction has been termed "remodeling." Part VI of this six-part series focuses on atherectomy and restenosis tissue obtained by atherectomy procedures.

Angioplasty, Balloon↗

PubMed1999

Periprocedural creatine kinase-MB elevations: long-term impact and clinical implications.

Since the introduction of percutaneous transluminal coronary angioplasty (PTCA), percutaneous intervention with balloon catheters, stents, and atherectomy devices has become a widely accepted practice. The persistent complication of non-Q-wave myocardial infarction (MI), as evidenced by increased cardiac enzyme levels after intervention, has aroused only moderate concern because its incidence was perceived to be small and not clinically relevant. With more systematic assessments of cardiac enzymes--specifically, creatine kinase (CK) and its MB isoform--evidence has begun to clarify both the incidence and the prognosis of periprocedural non-Q-wave MI: It appears to occur nearly three times more often than is clinically evident across all device types (8 to 9% of all interventions) and is directly and continuously associated with adverse outcomes, including late death. Although directional and rotational atherectomy improve angiographic outcome compared with PTCA, periprocedural infarction occurs at least twice as often with these newer technologies; the incidence associated with stent placement is comparable to and possibly higher than that of PTCA. Factors that may cause elevated CK-MB levels include distal embolization, side branch occlusion, thrombus, and coronary spasm. Analyses of the major trials of platelet glycoprotein (GP) IIb/IIIa receptor inhibitors, a class of potent antiplatelet agents, show striking effectiveness of these drugs in reducing the incidence of "enzyme-only" or "silent" MI and in improving long-term clinical outcomes. The findings implicate platelet mediation in the occurrence of periprocedural infarction and suggest an important role for antiplatelet therapy, particularly GP IIb/IIIa receptor inhibition, in protecting patients undergoing percutaneous intervention.

Angioplasty, Balloon, Coronary↗

PubMed1997

[Increased apoptosis and necrosis of coronary plaques in unstable angina].

In acute coronary syndromes, arteriosclerotic plaques are characterized by inflammation and decreased smooth muscle cell density. The underlying pathogenic processes remain unclear. Among others, increased programmed cell death (apoptosis) is postulated. Coronary atherectomy specimens from 26 patients with unstable angina (group 1) and from 24 patients with stable angina (group 2) were examined, using immunohistochemistry (TUNEL test to detect fragmented DNA) and transmission electron microscopy. The objectives of the present study were to evaluate plaque group differences in the cellular composition, to detect and quantify cell death, and to differentiate between apoptosis and necrosis. Group 1 lesions contained more macrophages and lymphocytes as well as significantly (p = 0.01) less smooth muscle cells compared with group 2 lesions, whereas both revealed a comparable cell density. All plaques showed signals for fragmented DNA. TUNEL-positive cells were seen more frequently in lesions with unstable angina (p = 0.04). Ultrastructural analysis revealed signs of programmed cell death, such as nuclear alterations, cellular condensation due to lost adhesion, and apoptotic bodies. Importantly, group I lesions comprised significantly more apoptotic SMCs and apoptotic macrophages compared with group 2 lesions (28% vs. 16%; p = 0.02). Also, cellular necroses were found to be increased in lesions with unstable angina (18% vs. 8%; p = 0.02). The density of macrophages showed a positive correlation to the incidence of cellular necroses in group 1 lesions (r = 0.44; p = 0.02), but not in group 2 lesions. In both plaque groups, this determinant was independent from cellular apoptosis, also at high levels as found with unstable angina. The present study on coronary atherectomy specimens with unstable angina reveals intimal macrophage infiltration and the density of apoptotic as well as necrotic intimal cells to be increased, whereas the content of intact SMCs was reduced. Increased, macrophage-independent apoptosis strongly points to the presence of one or several pro-apoptotic intimal factor(s) predisposing to plaque rupture. Implications of our findings may be directed to identify this (these) factor(s) and to modulate endogenous apoptotic activity with the ultimate goal to raise regional smooth muscle cell density.

Angina, Unstable↗

PubMed1993

Molecular biology: insight into the causes and prevention of restenosis after arterial intervention.

Very little is known about the development of postatherectomy or postangioplasty restenosis. Morphologically, restenosis lesions are primarily composed of smooth muscle cells with associated matrix proteins and develop within 3-6 months. Although some degree of smooth muscle cell proliferation is a necessary part of the healing process after injury, it is unclear why only some individuals develop clinically significant lesions. Platelet deposition and release of growth factors have been postulated to be important in initiating the cellular growth response after vascular injury. Current data suggest that growth factors synthesized locally in the vessel wall may be very important in controlling smooth muscle proliferation. In addition, atherosclerotic plaques contain many procoagulant proteins that are exposed by angioplasty or atherectomy. These proteins stimulate a coagulation response and the activation of thrombin, resulting in platelet aggregation and thrombus formation. Thrombin mediates several biologic responses that may facilitate vascular lesion formation and can act directly as a smooth muscle mitogen. Vascular lesion formation as a result of percutaneous transluminal coronary angioplasty or atherectomy may be stimulated by a combination of factors, including platelet deposition and thrombin action, ultimately generating an autocrine growth response in the vessel wall.

Angioplasty, Balloon, Coronary↗

PubMed2005

C-Type natriuretic peptide and natriuretic peptide receptors are expressed by smooth muscle cells in the neointima after percutaneous coronary intervention.

Understanding restenosis after percutaneous coronary intervention (PCI) remains a challenge. Neointimal proliferation is the main cause of restenosis. C-Type natriuretic peptide (CNP) plays a role in relaxation and growth inhibition of vascular smooth muscle cells (SMCs); the effects depend on the presence of specific natriuretic peptide receptors (NPRs) consisting of NPR-A, NPR-B, and NPR-C. To test the hypothesis that CNP and NPRs may be involved in restenosis, we immunohistochemically studied the expression of CNP and NPRs during the post-PCI healing process; 10 sites after PCI obtained at autopsy and 14 atherectomy specimens obtained from restenotic sites were investigated. Frozen sections were stained with antibodies against CNP, NPRs, SMCs, macrophages, and endothelial cells. Within 2 months after PCI, most neointimal SMCs expressed CNP and NPR-A. The expression of CNP and NPR-A in these neointimal SMCs decreased from 6 months onward. In contrast, NPR-C was strongly expressed in neointimal SMCs from 1 to 9 months after PCI. In atherectomy specimens, most neointimal SMCs showed weak positivity for CNP and NPR-A, but NPR-C was strongly expressed in the neointimal SMCs. These findings strongly suggest that a paracrine and autocrine system of CNP and NPRs may be important in controlling neointimal growth after PCI in humans.

Aged↗

PubMed2005

Eosinophilic infiltration in restenotic tissue following coronary stent implantation.

OBJECTIVES: The aim of our study was to compare the histopathological features of restenotic tissue after balloon angioplasty and after stent placement. We emphasized on specific types of inflammatory cells to evaluate the type of tissue immune response in both situations. METHODS: A total of 32 patients underwent elective directional coronary atherectomy; 16 patients had restenosis after balloon angioplasty, 16 patients had in-stent restenosis (ISR). Atherectomy specimens were stained with antibodies against T cells, eosinophils, smooth muscle cell actin, macrophages and with antibodies against T cell activation markers. Quantitative morphometric analysis was performed using image analysis software. RESULTS: In-stent restenotic tissue contained more smooth muscle cells (P < 0.001), anti-CD3 positive T cells (P < 0.001) and eosinophils (P = 0.012). Anti-CD40L positive activated T cells were more numerous in ISR lesions (P = 0.003) and were frequently clustered around stent imprints in the tissue. Five ISR specimens contained grossly visible stent fragments amidst the restenotic tissue. In all cases of balloon restenosis, T cells and eosinophils (if present) were concentrated around lipid rich tissue. CONCLUSIONS: Our study indicates involvement of inflammatory responses in both types of restenosis, with significantly more eosinophils encountered in case of in-stent restenosis. In contrast with clustering of inflammatory cells around stent struts after stent placement, the inflammatory cells in balloon restenosis were located in association with lipid rich tissue, suggesting different inflammatory triggers in balloon restenosis and in-stent restenosis.

Aged↗

PubMed2006

In vivo coronary plaque histology in patients with stable and acute coronary syndromes: relationships with hyperlipidemic status and statin treatment.

OBJECTIVES: Aim of the study was to investigate whether maintained moderate statin treatment influence atheroma, macrophage content, neoangiogenesis and/or haemorrhage in coronary plaques from patients with non-fatal coronary syndromes. METHODS: A total of 48 patients underwent elective directional coronary atherectomy on "de novo" culprit lesions; 16 patients had non-treated hypercholesterolemia, 16 patients received maintained moderate statin treatment for hypercholesterolemia and 16 had no lipoprotein abnormalities. These three patients groups were matched for age and clinical diagnosis of stable angina (SA) or unstable angina/non-ST-elevation myocardial infarction (UA/NSTEMI). Atherectomy specimens were stained with antibodies against macrophages, endothelial cells and glycophorin A. Results of histology and immunohistochemistry were morphometrically analyzed by using computer-assisted image analysis. RESULTS: Atheroma and fibrous tissue, neoangiogenesis, macrophage and haemorrhage (i.e., glycophorin A) differed between the three groups (P<0.05). Statin-treated group showed significantly decreased atheroma (P=0.016), fibrous tissue (P=0.42), macrophage content (P=0.012), neoangiogenesis (P=0.00048) and haemorrhage (P=0.0092) as compared with the non-treated hyperlipidemic group. CONCLUSIONS: The present findings show that maintained moderate statin treatment may contribute to plaque stabilization in non-fatal coronary syndromes by decreasing intraplaque neoangiogenesis and haemorrhage, lipid burden and macrophage content, and, on the other hand, by increasing plaque collagenization.

Acute Disease↗

PubMed2003

Beta-blockers reduce the incidence of clinical restenosis: prospective study of 4840 patients undergoing percutaneous coronary revascularization.

BACKGROUND: Restenosis after percutaneous transluminal coronary intervention (PCI) remains a serious complication in the treatment of coronary artery disease. Although beta-adrenergic receptor blockers (BBs) effectively reduce many cardiac events, no large prospective studies have examined the association of BBs with restenosis. METHODS: We prospectively evaluated the association of BBs (prescribed at hospital discharge) with clinical restenosis in 4840 patients who underwent stent placement (60%), balloon angioplasty (32%), or rotational atherectomy (8%). Clinical restenosis was defined as repeat target lesion revascularization or coronary artery bypass grafting within 6 months of PCI. Other end points included 9-month clinical restenosis, repeat target lesion PCI (only), long-term (5-year) target lesion repeat-PCI, and major adverse cardiac events (MACE). Multivariable regression adjusted the effect of BBs on clinical restenosis for 15 covariables. RESULTS: The average patient age was 63 years, 75% were men, and 37% received a BB prescription. The incidence of clinical restenosis was 12% overall and was lower among those prescribed a BB (10.0% for BB, 13.5% for none, adjusted odds ratio [OR] 0.76, P =.004). Other predictors of decreased restenosis included stent use, age, and smoking; predictors of increased restenosis included diabetes, atherectomy, and number of treated vessels. BBs also reduced 9-month clinical restenosis (10.3% vs 13.5%, OR 0.75, P =.004), MACE (16.5% vs 20.9%, OR 0.75, P <.001), 6-month target lesion restenosis (7.8% vs 10.2%, OR 0.75, P =.006), and 5-year target lesion restenosis (12.0% vs 14.0%, OR 0.83, P =.046). CONCLUSIONS: beta-Adrenergic receptor blockers prescribed after PCI reduced the risk of clinical restenosis, target lesion restenosis, and MACE in this cohort of 4840 patients. The mechanism by which beta-blockers conferred a protective effect against restenosis remains to be determined.

Adrenergic beta-Antagonists↗

PubMed2001

Immediate and one-year outcome in patients with coronary bifurcation lesions in the modern era (NHLBI dynamic registry).

Balloon angioplasty of bifurcation lesions has been associated with lower success and higher complication rates than most other lesion types. The development of alternative strategies such as debulking and stenting, either alone or in combination, are currently used relatively often. The relative role of these newer approaches in improving acute or long-term outcome, however, remains uncertain. Of the total of 2,436 patients treated between July 1997 to February 1998 in the National Heart, Lung, and Blood Institute Dynamic Registry, there were 321 patients (group 1) with bifurcation lesions and 2,115 patients without any bifurcation lesions attempted (group 2). Treatment strategies in terms of major devices used were significantly different between the 2 groups (group 1 vs 2): balloon angioplasty alone (23.1% vs 26.5%), balloon angioplasty and rotational atherectomy (6.9% vs 4.4%), balloon angioplasty and stent (55.8% vs 59.9%), and balloon angioplasty, rotational atherectomy, and stent (10.3% vs 7%) with p <0.01. There were no significant differences between the groups in terms of age, gender, and frequency of prior myocardial infarction (MI) or coronary artery bypass graft surgery (CABG). Complete angiographic success was achieved in only 86% of bifurcation lesions versus 93.5% of nonbifurcation lesions (p <0.001). In-hospital complication rates were increased in patients with bifurcation lesions compared with the nonbifurcation group: MI, 3.7% versus 2.6%; CABG, 2.2% versus 1.1%; side branch occlusion, 7.3% versus 2.3% (p <0.001); and the composite of death, MI, and any CABG, 7.2% versus 5.0%. At 1-year follow-up, major adverse cardiac events were 25% higher in group 1 than in group 2 (32.1% vs 25.7%, p <0.05). We conclude that despite the widespread use of newer percutaneous devices, treatment of bifurcation lesions remains difficult and is associated with decreased success and increased complication rates compared with nonbifurcation lesions.

Aged↗

PubMed2003

Efficacy and safety of minimal dose (< or =1,000 units) unfractionated heparin with abciximab in percutaneous coronary intervention.

Abciximab decreases adverse cardiac ischemic events, and in some subgroups, decreases the need for revascularization after percutaneous coronary intervention (PCI). However, abciximab may cause bleeding complications and thrombocytopenia after PCI. We hypothesized that the efficacy and safety of PCI would be maintained, if not improved, when performed using abciximab accompanied by only minimal doses (< or =1,000 U) of unfractionated heparin. In this prospectively designed observational study, we assessed 500 consecutive patients who underwent PCI, consisting of either stent deployment or high-speed rotational atherectomy, and who received abciximab accompanied by only a minimal dose of unfractionated heparin, as directed by a novel dosing strategy: (1) if the patient was previously receiving an infusion of heparin, then it was terminated upon arrival to the cardiac catheterization laboratory, and no further heparin was administered; or (2) if the patient was not receiving an infusion of heparin, then a single bolus infusion of 1,000 U was administered after establishment of vascular access. The median activated clotting time for the patients during PCI was 168 seconds (25% quartiles, 153 to 185). The technical success rate was 99.8%. There were no major adverse clinical events during the 24 hours after PCI. The incidence of non-Q-wave myocardial infarction was 1.6%. The incidences of major and minor bleeding complications were 0.2% and 3.6%, respectively, and the incidence of thrombocytopenia was 2.2%. During the 30 days after PCI, there was 1 major adverse clinical event (0.2%). During the 1 year after PCI, among the remaining patients, there were 92 adverse events (18.4%). We conclude that, in the context of historical data, the efficacy and safety of PCI using either stent deployment or high-speed rotational atherectomy is maintained, if not improved, when performed using abciximab accompanied by only minimal doses of unfractionated heparin.

Abciximab↗

PubMed1996

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.

Aged↗

PubMed1997

Differential expression of 92-kDa gelatinase in primary atherosclerotic versus restenotic coronary lesions.

Rupture of atherosclerotic plaque resulting in intravascular thrombosis and myocardial infarction (MI), while a common sequelae of de novo atherosclerotic lesions, is an uncommon consequence of restenosis. We hypothesize that the rarity of MI associated with restenotic lesions is a result of cellular and biochemical modifications induced by the local response to mechanical injury rendering the site resistant to rupture. Clinical and angiographic features of patients presenting with symptomatic primary (n = 24) or restenotic coronary lesions (n = 12) who underwent directional atherectomy were compared. Histologic analysis and immunostaining for 92-kDa gelatinase were performed on each atherectomy specimen. There was no significant difference between the 2 groups regarding age, gender, incidence of diabetes, smoking, hypertension, hypercholesterolemia, or previous MI. Lesion length, extent, and distribution of disease and percent stenosis were not significantly different between groups. However, 8% of primary lesions were hypercellular compared with 75% of restenotic specimens (p = 0.0001). Hypercellularity in restenotic specimens was shown by adjacent section staining to be composed of smooth muscle cells. Ninety-two kDa gelatinase was expressed in 79% of primary lesions versus 0% of restenotic specimens (p = 0.0001). Thrombus was identified in 54% of primary lesions versus 22% of restenotic lesions (p <0.05). These findings suggest that, independent of clinical or angiographic influences, balloon injury induces increased lesion cellularity and reduced expression of 92-kDa gelatinase, possibly resulting in a reduced propensity for plaque rupture and thrombosis.

Aged↗

PubMed1997

New Approaches to Coronary Intervention (NACI) registry: history and methods.

The New Approaches to Coronary Intervention (NACI) registry was funded in 1990 by the National Heart, Lung, and Blood Institute to evaluate the safety and efficacy of new coronary interventional devices. The registry collected data from 39 clinical centers on 8 new devices: 3 atherectomy devices, 2 stents, 2 laser devices and the laser balloon. The original funding called for a total of 500 patients to be recruited for each device. One device (the laser balloon) was removed from use early in the recruitment period. Subsequent funding was obtained for an additional 500 patients treated with directional atherectomy, and 500 additional female patients who were recruited when the main recruitment had finished. When all recruitment was finished in March 1994, a total of 4,429 patients had been recruited. Consecutive patients treated with a new device at each clinical site were recruited regardless of underlying clinical condition or result. Patients were followed for 1 year by telephone contact at 6 weeks, 6 months and 1 year. Overall 1-year follow-up compliance was excellent at 96% of patients. The NACI database was designed to allow analysis of the complex relationships between patient, lesion and device. In particular, the mode of use of each device, the treatment order, and the outcome after each device attempt were recorded. All in-hospital clinical events were recorded as well as an assessment of the success of the procedure by the operator. The results of each telephone follow-up included any interim cardiac events, anginal status, and results of any subsequent angiograms or exercise test. Any repeat percutaneous procedures or bypass surgery on an NACI patient were recorded in the same detail as the original procedure. All data collected were subjected to extensive editing at the coordinating center to ensure both internal and external consistency. An angiographic core laboratory was also funded for NACI in 1992 to provide uniform analyses of procedural angiograms. Measurements were made at each step of the procedure, that is preprocedure, after each device use, and postprocedure. Both quantitative and qualitative measurements were made at each step using standardized definitions, enabling a complete description of the procedure to be analyzed. Angiograms were made available to the core laboratory for 89% of all initial procedures.

Aged↗

PubMed1999

Coronary artery stent restenosis responds favorably to repeat interventions.

One hundred sixty patients who underwent a percutaneous intervention for treatment of in-stent restenosis were evaluated on clinical follow-up to determine the predictors of reintervention, and also to compare rotational atherectomy with repeat percutaneous transluminal coronary angioplasty (PTCA) for this condition. Current smoking and saphenous vein graft location were the independent predictors of target vessel revascularization (TVR), and there was no difference in the rate of TVR between rotational atherectomy and re-PTCA.

Angioplasty, Balloon, Coronary↗