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J J Popma

Publications and source records attributed to J J Popma.

At least 55 records · Page 3Linked to original sources
PubMed2000

Three-year clinical and angiographic follow-up after intracoronary radiation : results of a randomized clinical trial.

BACKGROUND: Although several early trials indicate treatment of restenosis with radiation therapy is safe and effective, the long-term impact of this new technology has been questioned. The objective of this report is to document angiographic and clinical outcome 3 years after treatment of restenotic stented coronary arteries with catheter-based (192)Ir. METHODS AND RESULTS: A double-blind, randomized trial compared (192)Ir with placebo sources in patients with previous restenosis after coronary angioplasty. Over a 9-month period, 55 patients were enrolled; 26 were randomized to (192)Ir and 29 to placebo. At 3-year follow-up, target-lesion revascularization was significantly lower in the (192)Ir group (15. 4% versus 48.3%; P<0.01). The dichotomous restenosis rate at 3-year follow-up was also significantly lower in (192)Ir patients (33% versus 64%; P<0.05). In a subgroup of patients with 3-year angiographic follow-up not subjected to target-lesion revascularization by the 6-month angiogram, the mean minimal luminal diameter between 6 months and 3 years decreased from 2.49+/-0.81 to 2.12+/-0.73 mm in (192)Ir patients but was unchanged in placebo patients. CONCLUSIONS: The early clinical benefits observed after treatment of coronary restenosis with (192)Ir appear durable at late follow-up. Angiographic restenosis continues to be significantly reduced in (192)Ir-treated patients, but a small amount of late loss was observed between the 6-month and 3-year follow-up time points. No events occurred in the (192)Ir group to suggest major untoward effects of vascular radiotherapy. At 3-year follow-up, vascular radiotherapy continues to be a promising new treatment for restenosis.

Aged↗
PubMed2000

Relation of coronary artery size to one-year clinical events after new device angioplasty of native coronary arteries (a New Approach to Coronary Intervention [NACI] Registry Report).

The influence of vessel size on clinical and angiographic outcomes after new device angioplasty has not been well documented. We reviewed clinical and angiographic outcomes of 2,044 patients undergoing new device angioplasty of native vessels enrolled in the New Approaches to Coronary Interventions (NACI) Registry. Quantitative angiography was performed using standard methods. Patients were divided into 3 groups according to reference vessel diameter (RVD) (<2.75, 2.75 to 3.25, and >3.25 mm). Patients with the smallest vessels had a higher incidence of diabetes (26% vs. 16%, p<0.01), multivessel disease (50% vs. 45%, p<0.01), left anterior descending coronary artery disease (61% vs. 39% p<0.01), and in general, more severe baseline lesion characteristics than patients with larger (>3.25 mm) vessels. Absolute baseline and final minimal lumen diameter (MLD) was also smaller in patients with RVD <2.75 mm despite similar final percent diameter stenosis. Although in-hospital events were similar, patients who underwent interventions in vessels <2.75 mm had an increased incidence of death (p<0.01), surgical revascularization (p<0.05), and target lesion revascularization (TLR) (p<0.01) at 1 year. Multivariate analysis by vessel size showed a stepwise increase in the risk of TLR by 1 year in patients with the smaller RVD (p = 0.0001) and the combined end point of 1 year death/Q wave-myocardial infarction/TLR (p = 0.02). Thus, despite similar early clinical events among patients undergoing new device angioplasty, patients who underwent treatment of smaller vessels had a significantly increased risk of major adverse clinical events and particularly TLR by 1 year after new device angioplasty of native coronary arteries.

Angioplasty↗
PubMed2000

Ad hoc coronary intervention.

Ad hoc coronary intervention is a percutaneous revascularization procedure performed at the same sitting as diagnostic cardiac catheterization. While this appears to be an efficient strategy, the safety and cost of ad hoc coronary intervention compared with delayed coronary intervention have not been clearly documented. Special preparation and precautions are necessary for patients in whom ad hoc coronary intervention is anticipated. Ad hoc coronary intervention is not appropriate if informed consent has not been previously obtained or if it would pose greater risks than delayed intervention. While ad hoc coronary intervention is often efficient and effective, its use should be individualized. Cathet. Cardiovasc. Intervent. 49:130-134, 2000.

Cardiac Catheterization↗
PubMed2000

Importance of lesion length on new device angioplasty of native coronary arteries. NACI Investigators. New Approaches to Coronary Interventions.

The influence of lesion length on early and late outcomes after new device angioplasty has not been well documented. We reviewed the clinical and angiographic outcomes of 2,980 patients (3,902 lesions) undergoing new device angioplasty of native vessels enrolled in the New Approaches to Coronary Interventions (NACI) Registry. Patients were divided into three groups according to the longest lesion length (< 10, 10-20, and > 20 mm) treated. Patients with the longest lesions had more multivessel disease (56.9% vs. 49.0%, P<0.05), right coronary artery disease (52.7% vs. 32.0%, P<0.001), and total occlusions (19.1% vs. 2.5%, P<0.001) than patients with shorter lesions. Longest lesions had the smallest minimal lumen diameter (P<0.001) at baseline and at the end of the procedure. Although in-hospital events were similar, there were differences in clinical outcomes at 1 year due mainly to more target lesion revascularization in the longest lesion group (P<0.01). Multivariate analysis showed that each 1-mm increase in lesion length was associated with an increase relative risk of 1.014 (95% CI, 1.004-1.025) for target lesion revascularization at 1 year. We conclude that despite similar early clinical events, patients undergoing new device angioplasty of longer lesions have more target lesion revascularization at 1 year.

Aged↗
PubMed2000

Angiographic and clinical outcomes after rescue coronary stenting.

The role of coronary stenting in improving outcomes after failed thrombolysis has not been well described. This study represents a registry of rescue coronary interventions performed during a 3 year period in which interventional treatment was changing for this high risk population. We analyzed acute angiographic results and clinical outcomes in 108 consecutive patients treated for thrombolytic failure with either balloon angioplasty (n = 63) or coronary stenting (n = 45). The overall in-hospital mortality rate was 5.5%, and there was no increase in complications in the stent group. Coronary stenting was associated with improved angiographic results including lower residual stenosis in the culprit artery (15 +/- 10% vs. 31 +/- 22%, P < 0.001) without increasing bleeding complications. The rate of in-hospital and long term target vessel revascularization in the stent group was significantly lower than in the unmatched PTCA group. Rescue coronary stenting is safe, improves acute angiographic results compared to PTCA alone and leads to excellent in-hospital and long term outcomes.

Angioplasty, Balloon, Coronary↗
PubMed2000

Provisional stenting strategies: systematic overview and implications for clinical decision-making.

Coronary stents reduce the rates of abrupt closure, emergency coronary artery bypass graft surgery and restenosis, but do not prevent myocardial infarction or death at six months. The financial burden of increased stent use and the difficulty in managing in-stent restenosis have provided the impetus to develop provisional stenting strategies. Patients at low risk for restenosis after balloon angioplasty may not derive additional benefit from stent implantation and may be successfully managed with percutaneous transluminal coronary angioplasty (PTCA) alone. Numerous patient, lesion and procedural predictors of restenosis have been identified. Postprocedural assessment using quantitative coronary angiography, intravascular ultrasound (IVUS), coronary flow velocity reserve (CVR) or fractional flow reserve (FFR) may further enhance the ability to predict adverse outcomes after PTCA. Several studies have been performed to investigate the feasibility of provisional stenting strategies using various modalities to identify low risk patients who could be managed with PTCA alone. An optimal or "stent-like" angiographic result after PTCA is associated with favorable clinical outcomes. Preliminary results of studies using IVUS or CVR to guide provisional stenting appear promising. Angiography alone may be inadequate to identify truly low risk patients and may need to be combined with clinical factors, assessment of recoil, IVUS or physiologic indexes. Strategies that avoid unnecessary stenting in even a small proportion of patients may have large impacts on health care costs. Provisional stenting may potentially reduce costs and rates of in-stent restenosis without compromising the quality of health care delivery.

Blood Vessel Prosthesis Implantation↗
PubMed2000

Evolving trends in interventional device use and outcomes: results from the National Cardiovascular Network Database.

BACKGROUND: Although multiple new coronary interventional devices have been approved for marketing in the United States, use of these technologies in general clinical practice and their associated outcomes have not been reported. METHODS AND RESULTS: Using the National Cardiovascular Network's Coronary Interventional Database, we examined temporal trends in the use and outcomes of coronary stents, lasers, directional atherectomy, and rotational atherectomy devices at 12 US hospitals between January 1994 and December 1997 (n = 76,904). Over this period, the percentage of cases involving coronary stents rose more than 12-fold (from 5.4% in 1994 to 69.0% in 1997). In contrast, use of atherectomy-type devices declined significantly. Device selection was strongly influenced by the patient's coronary anatomy and procedural indication, but less by age, sex, or race. Device use also varied significantly among individual centers (4-fold variation among sites in stent use and 6-fold variation in atherectomy use) even after adjusting for patient characteristics. Although overall mortality rates were unchanged during this 4-year period, procedural success rates have improved and complication rates have declined significantly. Lengths of postprocedure hospital stay also fell significantly for all patients undergoing coronary intervention in this time period. CONCLUSIONS: Percutaneous interventional strategies are rapidly changing with the explosive growth of coronary stent use and the decline in use of atherectomy devices. Patient outcomes, including complication rates and postprocedure lengths of stay, have also improved as the new interventional strategies have been refined in clinical practice.

Angioplasty, Balloon, Coronary↗
PubMed2000

Heparin infusion prior to stenting (HIPS) trial: final results of a prospective, randomized, controlled trial evaluating the effects of local vascular delivery on intimal hyperplasia.

BACKGROUND: Local delivery of pharmacologic agents or genes at the site of angioplasty is a promising approach to reduce restenosis. However, there are unresolved questions concerning the safety and feasibility of local vascular delivery in clinical practice as well as the efficacy of delivered drug. To this end, the safety, feasibility, and efficacy of local delivery of heparin were evaluated in the Heparin Infusion Prior to Stenting (HIPS) trial. METHODS AND RESULTS: A total of 179 patients were enrolled in this multicenter, randomized, prospective, core laboratory-evaluated trial. Patients were randomly assigned to 5000 U heparin either administered to the coronary artery lumen or infused into the arterial wall immediately after angioplasty and before stent placement. End points included procedural events and clinical, angiographic, and intravascular ultrasound events at 6 months. Patient groups were evenly matched. There was no difference in the incidence of arterial injury, defined as an increase in arterial dissection, acute closure, or decrease in Thrombolysis In Myocardial Infarction grade blood flow in the group receiving local delivery. At follow-up there was no difference in the major adverse event rate between intraluminal (22.7%) and local groups (24.7%). There was no difference between intraluminal and local therapy in the angiographic in-stent restenosis rate (12.5%, 12.7%) or the in-stent volumetric analysis by intravascular ultrasound (IVUS) (37.19 +/- 20. 86 mm(3) vs 43.79 +/- 25.52 mm(3)). CONCLUSIONS: Local delivery of 5000 U heparin into the arterial wall before stent implantation is safe and feasible. There was not a favorable effect of locally delivered heparin on clinical, angiographic, or IVUS end points of restenosis. The use of IVUS to measure volume of intimal hyperplasia in a multicenter, core laboratory-controlled trial is feasible.

Blood Flow Velocity↗
PubMed2000

Preintervention lesion remodelling affects operative mechanisms of balloon optimised directional coronary atherectomy procedures: a volumetric study with three dimensional intravascular ultrasound.

AIMS: To classify atherosclerotic coronary lesions on the basis of adequate or inadequate compensatory vascular enlargement, and to examine changes in lumen, plaque, and vessel volumes during balloon optimised directional coronary atherectomy procedures in relation to the state of adaptive remodelling before the intervention. DESIGN: 29 lesion segments in 29 patients were examined with intravascular ultrasound before and after successful balloon optimised directional coronary atherectomy procedures, and a validated volumetric intravascular ultrasound analysis was performed off-line to assess the atherosclerotic lesion remodelling and changes in plaque and vessel volumes that occurred during the intervention. Based on the intravascular ultrasound data, lesions were classified according to whether there was inadequate (group I) or adequate (group II) compensatory enlargement. RESULTS: There was no significant difference in patient and lesion characteristics between groups I and II (n = 10 and 19), including lesion length and details of the intervention. Quantitative coronary angiographic data were similar for both groups. However, plaque and vessel volumes were significantly smaller in group I than in II. In group I, 9 (4)% (mean (SD)) of the plaque volume was ablated, while in group II 16 (11)% was ablated (p = 0.01). This difference was reflected in a lower lumen volume gain in group I than in group II (46 (18) mm(3) v 80 (49) mm(3) (p < 0.02)). CONCLUSIONS: Preintervention lesion remodelling has an impact on the operative mechanisms of balloon optimised directional coronary atherectomy procedures. Plaque ablation was found to be particularly low in lesions with inadequate compensatory vascular enlargement.

Adult↗
PubMed2000

Development and evaluation of models to predict death and myocardial infarction following coronary angioplasty and stenting.

Prior estimates of the risk death and myocardial infarction following percutaneous coronary intervention (PCI) may not be uniformly applicable due to recent significant changes in clinical practice. Accordingly, we studied 2,804 cases from January 1997 through February 1999, in order to develop risk models to predict death, and post-procedural myocardial infarction following PCI. Risk models were constructed using multivariate logistic regression, artificial neural networks and prognostic risk scoring systems. Composite logistic regression models and artificial neural networks performed similarly in predicting the risk of major acute complications (c-index for predicting death of 0.812 and 0.807, respectively). Risk scoring models, based on the composite logistic regression beta coefficients, performed only slightly worse (c-index death = 0.794). Risk score models appear to provide reasonable discrimination while offering the potential for simple clinical implementation in the estimation of the risk of death and myocardial infarction in interventional cardiology.

Angioplasty, Balloon, Coronary↗
PubMed1999

Quantitative angiographic analysis of stent restenosis in the Scripps Coronary Radiation to Inhibit Intimal Proliferation Post Stenting (SCRIPPS) Trial.

To identify luminal dimension changes occurring within the stent alone and within the stent + margin segment, we reviewed the quantitative angiographic results obtained from the Scripps Coronary Radiation to Inhibit Proliferation Post Stenting (SCRIPPS) trial, a prospective randomized trial assessing the effect of iridium-192 (Ir-192) on the prevention of stent restenosis. Fifty-five patients were randomly assigned to receive Ir-192 or placebo sources after successful intervention. Procedural and 6-month follow-up cineangiograms were quantitatively reviewed in 52 patients to identify changes within the stent and the stent + margin segment. The percent diameter stenosis was lower within the stent than within the stent + margin segment after the procedure (6 +/- 22% vs 21+/- 15%, p <0.0001) and at follow-up (28 +/- 29% vs 42 +/- 21%, p <0.0001). As a result, a lower restenosis rate was found within the stent than within the stent + margin (25% vs 37%, p <0.0001); isolated stent margin restenosis occurred in 11.5% of lesions. Treatment with Ir-192 reduced restenosis within the stent (8% vs 39%; p = 0.010) and within the stent + margin segment (17% vs 54%; p = 0.010); the reduction in restenosis at the margin only (8.3% vs 14.3%, p = 0.503) was not significant. The lowest relative risk for restenosis resulting from Ir-192 occurred within the stent (0.21; 95% confidence interval [CI] 0.05 to 0.86) compared with the stent + margin segment (0.31; 95% CI 0.12 to 0.81) or the stent margin (0.58; 95% CI 0.12 to 2.91). In the SCRIPPS trial, 32% of restenosis occurred at the stent margins. Treatment with Ir-192 reduced restenosis primarily within the stent rather than the margin. Whether extending the treatment length to fully include the stent margins will further reduce restenosis requires further study.

Brachytherapy↗
PubMed1999

Comparative analysis of early and late angiographic outcomes using two quantitative algorithms in the Balloon versus Optimal Atherectomy Trial (BOAT).

Although substantial intersystem variability has been shown among several commercially available quantitative angiographic (QA) analysis algorithms, no previous study has compared the angiographic findings using 2 different QA systems performed at the same central angiographic laboratory. The purpose of this study was to compare the early and late QA results obtained with the CMS (MEDIS) and ARTREK (ImageComm) QA systems in the Balloon versus Optimal Atherectomy Trial. Directional atherectomy (n = 496) or balloon angioplasty (n = 490) was performed in 986 patients; late QA follow-up was available in 767 patients (77.7%). QA analysis was performed by 2 independent observers using the CMS and ARTREK systems. Correlation between the 2 QA systems for baseline measurements was good (Pearson's R = 0.78), although the CMS system resulted in larger baseline reference diameter (RD) (3.22 +/- 0.45 vs 3.07 +/- 0.40 mm; p <0.0001) and baseline minimal lumen diameters (MLD) (1.05 +/- 0.35 vs 0.92 +/- 0.32; mm p <0.0001) than the ARTREK system. The final and follow-up RD (+0.17 and +0.11 mm, respectively) were also larger using the CMS system. In contrast, the final and follow-up measurements of MLD and percent diameter stenosis were not significantly different using the 2 QA systems. The QA system did not affect the ability to detect a difference in restenosis rates (>50% follow-up diameter stenosis) between the 2 treatment groups (CMS, directional atherectomy [31.8%]; balloon angioplasty [40.5%]; p = 0.013 and ARTREK, directional atherectomy [33.9%], balloon angioplasty [41.3%]; p = 0.036). Only lesion irregularity contributed to the difference in baseline measurements of MLD and percent diameter stenosis. We conclude that important differences in measurements of RD, baseline MLD, and percent diameter stenosis were noted using the CMS and ARTREK systems. Both systems, however, were able to detect a treatment benefit associated with directional atherectomy in BOAT. The comparability of other angiographic systems will require similar evaluation in other studies.

Algorithms↗
PubMed1999

Clinical and angiographic follow-Up after primary stenting in acute myocardial infarction: the Primary Angioplasty in Myocardial Infarction (PAMI) stent pilot trial.

BACKGROUND: Restenosis has been reported in as many as 50% of patients within 6 months after PTCA in acute myocardial infarction (AMI), which necessitates repeat target-vessel revascularization (TVR) in approximately 20% of patients during this time period. Routine (primary) stent implantation after PTCA has the potential to further improve late outcomes. METHODS AND RESULTS: Primary stenting was performed as part of a prospective study in 236 consecutive patients without contraindications who presented with AMI of <12 hours' duration at 9 international centers. A mean of 1.4+/-0.7 stents were implanted per patient (97% Palmaz-Schatz) at 17.3+/-2.4 atm. During a clinical follow-up period of 7.4+/-2.6 months, death occurred in 4 patients (1.7%), reinfarction occurred in 5 patients (2.1%), and TVR was required in 26 patients (11.1%). By Cox regression analysis, small reference-vessel diameter and the number of stents implanted were the strongest determinants of TVR. Angiographic restenosis occurred in 27.5% of lesions. By multiple logistic regression analysis, the number of stents implanted and the absence of thrombus on the baseline angiogram were independent determinants of binary restenosis. CONCLUSIONS: A strategy of routine stent implantation during mechanical reperfusion of AMI is safe and is associated with favorable event-free survival and low rates of restenosis compared with primary PTCA alone.

Angioplasty, Balloon, Coronary↗
PubMed1999

Intravascular ultrasound predictors of target lesion revascularization after stenting of protected left main coronary artery stenoses.

We evaluated the predictors of late clinical outcomes after stenting of protected left main coronary artery (LMCA) stenoses. Intravascular ultrasound (IVUS) guided stenting of protected LMCA stenoses was performed in 87 consecutive patients between January 1994 and December 1996. Results were evaluated using conventional (clinical, angiographic, and IVUS) methodology. Late (12 month) clinical follow-up information was obtained in all patients. Initial procedural success was achieved in 86 patients (99%). There was 1 in-hospital death (in the 1 patient with a procedural failure). There were no other in-hospital complications, including Q-wave myocardial infarction, emergency bypass surgery, or repeat coronary angioplasty. The overall target lesion revascularization (TLR) rate was 13%. Using multivariate logistic regression analysis, the only independent predictor of TLR was the postintervention lumen area by IVUS. A final lumen area > or =7.0 mm2 was obtained in 74 patients (86%); the TLR rate for these patients was 7%. This was compared with patients with a final lumen area <7.0 mm2 in whom the TLR rate was 50% (p = 0.0011). Stenting of protected LMCA stenoses is safe and effective with acceptable long-term clinical outcomes. The most important factor determining long-term success was the postintervention lumen area by IVUS.

Aged↗
PubMed1999

Effects of dopamine and aminophylline on contrast-induced acute renal failure after coronary angioplasty in patients with preexisting renal insufficiency.

In phase 1 of this study, 60 patients undergoing coronary angioplasty were randomized to receive saline, dopamine, or aminophylline; the overall incidence of contrast-induced renal failure was 38%, without difference among the 3 groups. In phase 2 of this study, 72 patients with established contrast-induced renal failure were randomized to receive saline or dopamine; dopamine had a deleterious effect on the severity of renal failure, prolonging the course.

Acute Kidney Injury↗
PubMed1999

Risk of distal embolization and infarction with transluminal extraction atherectomy in saphenous vein grafts and native coronary arteries. NACI Investigators. New Approaches to Coronary Interventions.

Lower success rates have been reported when treating high-risk lesions in saphenous vein grafts (SVGs) and native coronary arteries with balloon angioplasty. The transluminal extraction atherectomy catheter (TEC) has been proposed to reduce the incidence of distal embolization (DE) in subsets of high-risk lesions. To define the utility of TEC in reducing the incidence of DE, all patients who were enrolled in the New Approaches to Coronary Interventions (NACI) Registry and had TEC planned as the sole treatment were studied (329 patients with 381 lesions). Of the lesions treated, 75.9% were in SVGs; 37.5% were thrombotic; and 15% were total occlusions. Adjunctive percutaneous transluminal coronary angioplasty (PTCA) was performed in 87.4% of lesions. Multivariate predictors of DE were: noncardiac disease, stand alone TEC, thrombus, and larger vessel size. DE was associated with an 18.5% in-hospital mortality vs. 3.0% without DE (P < 0.01) and a 25.9% MI rate vs. 5.0% without DE (P < 0.01). In conclusion, in this high-risk subset of patients, TEC is associated with an 8.3% incidence of DE with thrombotic and SVGs lesions. DE associated with TEC appears to carry high morbidity and mortality. Additional techniques to control DE are needed to reduce the frequency of complications in these patients.

Aged↗
PubMed1999

Acute and nine-month clinical outcomes after "suboptimal" coronary stenting: results from the STent Anti-thrombotic Regimen Study (STARS) registry.

OBJECTIVES: This registry collected the 30-day and 9-month clinical outcomes of patients whose coronary stent implantation was suboptimal, and compared them with the cohort of patients with "optimal" stenting in the randomized portion of the STent Anti-thrombotic Regimen Study (STARS) trial. BACKGROUND: Although "optimal" stenting combined with an aspirin and ticlopidine regimen carries a low (0.5%) incidence of subacute stent thrombosis, only limited data are available for patients in whom stents are deployed suboptimally. METHODS: In the STARS, 312 (15.9%) of 1,965 patients enrolled were excluded from participation in the randomized trial based on a perceived "suboptimal" result of coronary stenting. Of these, 265 patients met prespecified criteria for suboptimal stenting, and were followed in a parallel registry, which was compared with the randomized STARS optimal stenting cohort. The primary end point was a 30-day composite of death, emergent target lesion revascularization, angiographic thrombosis of the target vessel without revascularization and nonfatal myocardial infarction (MI) unrelated to direct procedural complications. RESULTS: Registry patients had a similar frequency of the primary end point compared with the overall randomized cohort (3.0% vs. 2.2%), with this end point correlating to use of multiple stents, smaller final lumen diameter and absence of ticlopidine from the poststent regimen. Overall 30-day mortality (1.1% vs. 0.06%, p = 0.009) and periprocedural non-Q wave MI (8.7% vs. 4.2%, p = 0.003) were more frequent in registry patients, and appeared to be related to acute procedural complications. Clinical restenosis was significantly higher for registry patients (26.8% vs. 16.0%, p = 0.001), relating to greater prevalence of independent predictors such as smaller final lumen diameter and multiple stent use. CONCLUSIONS: In the STARS registry, the inability to perform optimal stenting correlated with smaller final lumen diameter and longer stent length. With ticlopidine-containing regimens, the acute clinical results of "suboptimal" stent deployment are clinically acceptable, although they are not quite as good as those of optimal stenting using similar drug therapy.

Acute Disease↗