Effects of coronary stents on cardiovascular outcomes in broad-based clinical practice.

BACKGROUND: Although stents have been shown to reduce the need for repeated percutaneous coronary intervention (PCI) in randomized trials, the effects of stents in broad-based, diverse clinical practice have not been well studied, nor has their effect on subsequent myocardial infarction or cardiac death. METHODS: A retrospective cohort study was performed that included all 43 hospitals performing PCI in Pennsylvania in the last quarter of 1995, with the use of the Pennsylvania Health Care Cost Containment Council database. All 5258 patients who underwent PCI, excluding those with previous PCI within the preceding 6 months, were included. The primary outcomes were in-hospital events (death or coronary bypass), 6-month revascularization rates, and 6-month rates of cardiac death or myocardial infarction. RESULTS: A total of 1240 patients (24%) had a stent procedure. Compared with nonstent procedures, stents reduced the risk of in-hospital events (multivariable odds ratio adjusted for patient and hospital level differences, 0.63; 95% confidence interval, 0.41-0.97), primarily because of a 52% reduction in the need for coronary bypass. Stents also reduced the need for follow-up revascularization procedures (multivariable hazard ratio, 0.72; 95% confidence interval, 0.59-0. 87), primarily because of a 31% reduction in repeated PCI. However, stents had no effect on 6-month rate of myocardial infarction or cardiac death (multivariable hazard ratio, 0.97; 95% confidence interval, 0.71-1.33). CONCLUSIONS: Using stents decreases the need for repeated PCI in broad-based clinical practice, confirming results from randomized trials. However, this study did not detect any effect on subsequent myocardial infarction or cardiac death.

Combination therapy with clopidogrel and aspirin after coronary stenting.

Combination antiplatelet therapy using aspirin and ticlopidine has been the standard of care for prevention of subacute thrombosis following coronary stent implantation. However, the use of ticlopidine is associated with a significant risk of adverse hematologic side effects. Clopidogrel is an inhibitor of ADP-induced platelet aggregation that has a better safety profile than ticlopidine. We examined the 30-day clinical outcome following coronary stent implantation in 253 consecutive patients treated with clopidogrel and aspirin. Follow-up was achieved in 99% of patients and four adverse events were documented. Two patients had angiographically confirmed subacute stent thrombosis (0.8%), and both of these patients underwent successful repeat angioplasty at the stent site. There were two patient deaths during follow-up (0. 8%). One was sudden within 1 week of stent placement and the other occurred in a patient with multisystem organ failure after an extensive myocardial infarction that antedated the stent procedure, with no clinical evidence for stent thrombosis. The combined frequency of subacute stent thrombosis and death was 1.6%. This is comparable to prior studies using the combination of ticlopidine and aspirin following stenting. Therefore, clopidogrel in combination with aspirin appears to be a safe and effective therapy in the prevention of subacute thrombosis following coronary stent implantation.

Predictors of clinical outcome following percutaneous intervention for in-stent restenosis.

Percutaneous intervention for the first episode of in-stent restenosis was performed in 177 patients 5.4 +/- 0.3 months after native coronary stent implantation. Medical records were reviewed and patients contacted 13.3 +/- 1.2 months after in-stent intervention to ascertain the subsequent clinical course. The effects of demographic, procedural, and angiographic variables on clinical outcomes were determined. At 2 years, Kaplan-Meier estimated survival was 93 +/- 3% and freedom from death, myocardial infarction, and a third target artery revascularization (TAR) was 67 +/- 4%. The actuarial frequency of a third TAR was 26 +/- 4% at 1 year. Stratification of outcomes according to timing of in-stent intervention revealed an approximate twofold higher frequency of adverse events among patients with early (

Randomized trial of contrast media utilization in high-risk PTCA: the COURT trial.

BACKGROUND: Previous in vitro and in vivo studies have suggested an association between thrombus-related events and type of contrast media. Low osmolar contrast agents appear to improve the safety of diagnostic and coronary artery interventional procedures. However, no data are available on PTCA outcomes with an isosmolar contrast agent. METHODS AND RESULTS: A multicenter prospective randomized double-blind trial was performed in 856 high-risk patients undergoing coronary artery intervention. The objective was to compare the isosmolar nonionic dimer iodixanol (n=405) with the low osmolar ionic agent ioxaglate (n=410). A composite variable of in-hospital major adverse clinical events (MACE) was the primary end point. A secondary objective was to evaluate major angiographic and procedural events during and after PTCA. The composite in-hospital primary end point was less frequent in those receiving iodixanol compared with those receiving ioxaglate (5.4% versus 9.5%, respectively; P=0.027). Core laboratory defined angiographic success was more frequent in patients receiving iodixanol (92.2% versus 85. 9% for ioxaglate, P=0.004). There was a trend toward lower total clinical events at 30 days in patients randomized to iodixanol (9.1% versus 13.2% for ioxaglate, P=0.07). Multivariate predictors of in-hospital MACE were use of ioxaglate (P=0.01) and treatment of a de novo lesion (P=0.03). CONCLUSIONS: In this contemporary prospective multicenter trial of PTCA in the setting of acute coronary syndromes, there was a low incidence of in-hospital clinical events for both treatment groups. The cohort receiving the nonionic dimer iodixanol experienced a 45% reduction in in-hospital MACE when compared with the cohort receiving ioxaglate.

American College of Cardiology/European Society of Cardiology International Study of Angiographic Data Compression Phase I: The effect of lossy data compression on recognition of diagnostic features in digital coronary angiography.

OBJECTIVES: This study intended to determine the effect of varying degrees of lossy Joint Photographic Experts Group (JPEG) compression on detection of coronary angiographic features. BACKGROUND: Compression of digital coronary angiograms facilitates playback of images and decreases cost. There are little data on the effect of compression on the accuracy of coronary angiography. METHODS: At six centers, 71 angiographers each reviewed a set of 100 angiographic sequences. The 100 sequences were divided into four, 25-sequence subsets. Each subset of 25 was displayed either as original images or at one of three compression ratios (CRs) (6:1, 10:1 or 16:1). The effect of lossy compression on the sensitivity and specificity for detection of diagnostic features was determined. The effect of compression on subjective measures of image quality graded by the angiographers was also examined. RESULTS: Lossy compression at a ratio of 16:1 decreased the sensitivity for the detection of diagnostic features (76% vs. 80% p = 0.004). The largest effect was in the detection of calcification (52% vs. 63% at 16:1 compression vs. original images, p < 0.001). Subjective indicators of image quality indicated a reduction in confidence in interpretation at CRs of 10:1 and 16:1. CONCLUSIONS: With increased ratios of lossy compression, a degradation of digital coronary angiograms occurs that results in decreased diagnostic accuracy. The sensitivity for detection of common diagnostic features was decreased, and subjective assessment of image quality was impaired. Caution is warranted in the interpretation of coronary angiograms that have been subjected to lossy JPEG compression beyond a ratio of 6:1.

American College of Cardiology/ European Society of Cardiology international study of angiographic data compression phase I. The effects of lossy data compression on recognition of diagnostic features in digital coronary angiography.

OBJECTIVES: This study intended to determine the effect of varying degrees of lossy Joint Photographic Experts Group (JPEG) compression on detection of coronary angiographic features. Background Compression of digital coronary angiograms facilitates playback of images and decreases cost. There are little data on the effect of compression on the accuracy of coronary angiography. METHODS: At six centers, 71 angiographers each reviewed a set of 100 angiographic sequences. The 100 sequences were divided into four, 25-sequence subsets. Each subset of 25 was displayed either as original images or at one of three compression ratios (CRs) (6:1, 10:1 or 16:1). The effect of lossy compression on the sensitivity and specificity for detection of diagnostic features was determined. The effect of compression on subjective measures of image quality graded by the angiographers was also examined. RESULTS: Lossy compression at a ratio of 16:1 decreased the sensitivity for the detection of diagnostic features (76% vs. 80%P=0.004). The largest effect was in the detection of calcification (52% vs. 63% at 16:1 compression vs. original images, P<0.001). Subjective indicators of image quality indicated a reduction in confidence in interpretation at CRs of 10:1 and 16:1. CONCLUSIONS: With increased ratios of lossy compression, a degradation of digital coronary angiograms occurs that results in decreased diagnostic accuracy. The sensitivity for detection of common diagnostic features was decreased, and subjective assessment of image quality was impaired. Caution is warranted in the interpretation of coronary angiograms that have been subjected to lossy JPEG compression beyond a ratio of 6:1.

Efficacy of coronary stenting versus balloon angioplasty in small coronary arteries. Stent Restenosis Study (STRESS) Investigators.

OBJECTIVES: The goal of this study was to compare the efficacy of elective stent implantation and balloon angioplasty for new lesions in small coronary arteries. BACKGROUND: Palmaz-Schatz stents have been designed and approved by the Food and Drug Administration for use in coronary arteries with diameters > or = 3.0 mm. The efficacy of elective stent placement in smaller vessels has not been determined. METHODS: By quantitative coronary angiography, 331 patients in the Stent Restenosis Study (STRESS) I-II were determined to have a reference vessel < 3.0 mm in diameter. Of these, 163 patients were randomly assigned to stenting (mean diameter 2.69 +/- 0.21 mm), and 168 patients were assigned to angioplasty (mean diameter 2.64 +/- 0.24 mm). The primary end point was restenosis, defined as > or = 50% diameter stenosis at 6-month follow-up angiography. Clinical event rates at 1 year were assessed. RESULTS: Baseline clinical and angiographic characteristics were similar in the two groups. Procedural success was achieved in 100% of patients assigned to stenting and in 92% of patients assigned to angioplasty (p < 0.001). Abrupt closure within 30 days occurred in 3.6% of patients in both groups. Compared with angioplasty, stenting conferred a significantly larger postprocedural lumen diameter (2.26 vs. 1.80 mm, p < 0.001) and a larger lumen at 6 months (1.54 vs. 1.27 mm, p < 0.001). Restenosis (> or = 50% diameter stenosis at follow-up) occurred in 34% of patients assigned to stenting and in 55% of patients assigned to angioplasty (p < 0.001). At 1 year, event-free survival was achieved in 78% of the stent group and in 67% of the angioplasty group (p = 0.019). CONCLUSIONS: These findings suggest that elective stent placement provides superior angiographic and clinical outcomes than balloon angioplasty in vessels slightly smaller than 3 mm.

Complications of cardiac angiography using low- or high-osmolality contrast agents in patients with left main coronary stenosis.

Recently published guidelines suggest that, in view of cost concerns, low-osmolal contrast should be selectively used in patients at increased risk of experiencing a contrast-related complication during cardiac angiography. The suggested criteria include the presence of left main coronary disease. However, the presence of left main disease is not usually known prior to angiography. Contrast-related complications of cardiac angiography were therefore analyzed in a group of 111 clinically stable patients found to have left main coronary stenosis, to determine if use of low-osmolality contrast had any beneficial effect when compared to standard contrast. Data were gathered prospectively as part of a randomized controlled trial, and the subgroup of patients with left main disease was analyzed retrospectively. Complications were divided into minor, intermediate, and major categories. In the 58 patients who received high-osmolar contrast, there were 4 contrast-related minor reactions, 8 intermediate events requiring treatment, and 1 major adverse event. Among the 53 patients who received low-osmolar contrast, there were no minor reactions, 7 intermediate events requiring treatment, and no major adverse events. The only difference of borderline significance was in the incidence of minor reactions requiring no treatment (P = 0.05). Although small and therefore not definitive, this study suggests that 1) universal use of low-osmolar contrast agents would not be expected to eliminate the risk of contrast-related reactions to cardiac angiography; 2) the well-documented clinical differences between high- and low-osmolar contrast primarily involve mild reactions; and 3) standard high-osmolar contrast is reasonably safe in clinically stable patients with left main coronary stenosis. The results therefore are consistent with the notion that selective use of low-osmolar contrast only in unstable patients is safe and appropriate.

Acute and long-term outcome after Palmaz-Schatz stenting: analysis from the New Approaches to Coronary Intervention (NACI) registry.

The randomized Stent Restenosis Study (STRESS) and Belgium Netherlands Stent (Benestent) trials established that elective use of Palmaz-Schatz stents (PSSs) in native coronary arteries with de novo lesions is associated with increased procedural success and reduced restenosis. However there are other clinical indications for which stents are commonly used (unplanned use, vein grafts, restenosis lesions) that are not addressed in these studies. From 1990-1992, 688 lesions in 628 patients were treated with PSSs in the New Approaches to Coronary Intervention (NACI) registry. Angiographic core laboratory readings were available for 543 patients (595 lesions, of which 106 were stented for unplanned indications, 239 were in saphenous vein bypass grafts, and 296 were previously treated). The cohort of patients in whom stents were placed for unplanned indications had more women, current smokers, and had a higher incidence of recent myocardial infarction (MI). Patients who underwent stenting of saphenous vein grafts were older, had a higher incidence of diabetes mellitus, unstable angina, prior MI, and congestive heart failure. Lesion success was similar in all cohorts (98%), but procedural success was significantly higher for planned stenting (96% vs 87%; p < 0.01). Predictors of adverse events in-hospital were presence of a significant left main stenosis and stenting for unplanned indication. The incidence of target lesion revascularization by 30 days was significantly higher for patients undergoing unplanned stenting due to a higher risk for stent thrombosis. Recent MI, stenting in native lesion, and small postprocedural minimum lumen diameter independently predicted target lesion revascularization at 30 days. Independent predictors of death, Q-wave myocardial infarction, or target lesion revascularization at 1 year included severe concomitant disease, high risk for surgery, left main disease, stenting in the left main coronary artery, and low postprocedure minimum lumen diameter.