Jeffery W. Moses

Catheter-based reperfusion of unprotected left main stenosis during an acute myocardial infarction (the ULTIMA experience)

The ULTIMA registry was a prospective, multicenter, international registry of 277 patients who underwent percutaneous coronary interventions of unprotected left main trunk stenosis. The 40 patients who underwent an emergency percutaneous left main intervention for acute myocardial infarction are the focus of this study. We compared the results of primary angioplasty with primary stenting, characterizing both the short-term (in-hospital) and long-term (12-month) outcomes. Of the 40 patients, 23 underwent primary angioplasty, whereas 17 underwent primary stenting. The angiographic success rate was an 88% for the cohort. The in-hospital death or coronary artery bypass grafting rate was 65% for the entire group, 74% for the percutaneous transluminal coronary angioplasty group (PTCA), and 53% for the stent group (p = 0.2). The in-hospital death rate was 55% for the entire cohort, 70% for the PTCA group, and 35% for the stent group (p = 0.1). The 12-month rate of death or bypass surgery was 83% and 58% for the PTCA and stent groups, respectively (p = 0.047). The 12-month survival rate was 35% and 53% for the PTCA and stent groups, respectively (p = 0.18). Bypass surgery was required in 6 patients in the PTCA group and 2 patients in the stent group (p = 0.07). Patients undergoing percutaneous interventions for unprotected left main myocardial stenosis during an acute myocardial infarction are critically ill; an initial percutaneous revascularization approach appears feasible and may be the preferred revascularization strategy. Primary stenting was associated with improved clinical outcomes.

Extent and distribution of in-stent intimal hyperplasia and edge effect in a non-radiation stent population.

Intimal hyperplasia within the body of the stent is the primary mechanism for in-stent restenosis; however, stent edge restenosis has been described after brachytherapy. Our current understanding about the magnitude of in vivo intimal hyperplasia and edge restenosis is limited to data obtained primarily from select, symptomatic patients requiring repeat angiography. The purpose of this study was to determine the extent and distribution of intimal hyperplasia both within the stent and along the stent edge in relatively nonselect, asymptomatic patients scheduled for 6-month intravascular ultrasound (IVUS) as part of a multicenter trial: Heparin Infusion Prior to Stenting. Planar IVUS measurements 1 mm apart were obtained throughout the stent and over a length of 10 mm proximal and distal to the stent at index and follow-up. Of the 179 patients enrolled, 140 returned for repeat angiography and IVUS at 6.4 +/- 1.9 months and had IVUS images adequate for analysis. Patients had 1.2 +/- 0.6 Palmaz-Schatz stents per vessel. There was a wide individual variation of intimal hyperplasia distribution within the stent and no mean predilection for any location. At 6 months, intimal hyperplasia occupied 29.3 +/- 16.2% of the stent volume on average. Lumen loss within 2 mm of the stent edge was due primarily to intimal proliferation. Beyond 2 mm, negative remodeling contributed more to lumen loss. Gender, age, vessel location, index plaque burden, hypercholesterolemia, diabetes, and tobacco did not predict luminal narrowing at the stent edges, but diabetes, unstable angina at presentation, and lesion length were predictive of in-stent intimal hyperplasia. In a non-radiation stent population, 29% of the stent volume is filled with intimal hyperplasia at 6 months. Lumen loss at the stent edge is due primarily to intimal proliferation.

Evidence based management of patients undergoing PCI. Conclusion.

A panel of leaders in the field of interventional cardiology convened to discuss the evidence‐based management of patients undergoing percutaneous coronary intervention (PCI). The articles in this supplement are based on individual presentations given during the panel meeting. Following are key points of the panels discussion and areas that the panel has indicated warrant further study.

Bailout and Corrective Use of Gianturco-Roubin Flex Stents After Percutaneous Transluminal Coronary Angioplasty: Operator Reports and Angiographic Core Laboratory Verification From the National Heart, Lung, and Blood Institute/New Approaches to Coronary Intervention Registry☆

OBJECTIVES We sought to determine the in-hospital clinical outcome and angiographic results of patients prospectively entered into the National Heart, Lung, and Blood Institute/New Approaches to Coronary Intervention (NHLBI/NACI) Registry who received Gianturco-Roubin stents as an unplanned new device. BACKGROUND Between August 1990 and March 1994, nine centers implanted Gianturco-Roubin flex stents as an unplanned new device in the initial treatment of 350 patients (389 lesions) who were prospectively enrolled in the NHLBI/NACI Registry. METHODS Patients undergoing implantation of the Gianturco-Roubin flex stent were prospectively entered into the Gianturco-Roubin stent portion of the NHLBI/NACI Registry. Only subjects receiving the Gianturco-Roubin stent as a new device in an unplanned fashion are included. RESULTS The mean age of the patient group was 61.8 years, and the majority of the patients were men. A history of percutaneous transluminal coronary angioplasty (PTCA) was present in 35.4% of the group, and 16.9% had previous coronary artery bypass graft surgery. Unstable angina was present in 67.7%. Double- or triple-vessel coronary artery disease was present in 55.4%, and the average ejection fraction was 58%. The presence of thrombus was noted in 7.3%, and 7.2% had moderate to severe tortuosity of the lesion. The angiographic success rate was 92%. Individual clinical sites reported that 66.3% of the stents were placed after suboptimal PTCA, 20.3% for abrupt closure and 13.4% for some other technical PTCA failure. Major in-hospital events occurred in 9.7% of patients, including death in 1.7%, Q wave myocardial infarction in 3.1% and emergency bypass surgery in 6%. Abrupt closure of a stented segment occurred in 3.1% of patients at a mean of 3.9 days. Cerebrovascular accident occurred in 0.3%, and transfusion was required in 10.6%. Vascular events with surgical repair occurred in 8.6% of patients. CONCLUSIONS Despite these complications, the use of this device for the treatment of a failed or suboptimal PTCA result remains promising given the adverse outcome of abrupt closure with conventional (nonstent) treatment.

Effect of percutaneous coronary interventions for in-stent restenosis in degenerated saphenous vein grafts without distal embolic protection

OBJECTIVES This study was designed to investigate the impact of percutaneous coronary interventions (PCIs) in degenerated saphenous vein grafts (SVGs) without distal embolic protection. BACKGROUND Distal embolic protection devices have been shown to reduce the incidence of no reflow/slow flow during PCI of de novo lesions in degenerated SVGs. It is unclear whether PCI of in-stent restenosis (ISR) lesions in degenerated SVGs is associated with no reflow/slow flow and whether distal embolic protection is beneficial in these cases as well. METHODS We studied 54 consecutive patients with treated ISR lesions in degenerated SVGs who underwent PCI without distal embolic protection in a single center. Procedural and in-hospital outcomes were examined. The average age was 71 +/- 8 years; 32% of the patients had diabetes. The mean lesion length was 13 +/- 6 mm and the procedural success rate was 98% (53/54). Cutting balloon angioplasty was used in 46% (25/54) of cases, and a new stent was inserted in 46% (25/54) of patients. Gamma brachytherapy was performed in 19% (10/54) of patients. During the procedure there were no episodes of no reflow/slow flow, and there were no patients with in-hospital Q-wave or non-Q-wave myocardial infarction. There was one in-hospital noncardiac death. CONCLUSIONS In this consecutive series of patients with ISR of degenerated SVGs undergoing PCI without distal protection, there were no episodes of slow flow/no reflow and no procedure-related myocardial infarctions. It appears that distal embolic protection may not be necessary during PCI of ISR lesions in degenerated SVGs.

Comparison of Outcomes in Men Versus Women Having Percutaneous Coronary Interventions in Small Coronary Arteries

Previous studies investigating the effect of gender on outcomes after percutaneous coronary intervention (PCI) have reported that women have higher in-hospital adverse event rates and a higher mortality rate than men. 1,2 This has been attributed to both the smaller size of women 3,4 and to the older age of women at the time of PCI. Older populations who undergo PCI are associated with increased rates of comorbid disease and an increased cardiac risk factor profi le. 5 Because women tend to have smaller coronary arteries than men, we hypothesized that the adverse outcomes may be partly due to the smaller coronary artery diameters. To test this hypothesis we compared men and women with small coronary arteries to evaluate whether gender remained a determinant

Relation between the degree of procedural anticoagulation and complications after coronary stent implantation

The impact of the degree of anticoagulation in patients who underwent stent implantation without glycoprotein IIb/IIIa inhibitors was examined in 1,020 patients. High levels of procedural anticoagulation with heparin were found to increase hemorrhagic complications without improving clinical or angiographic outcomes.

Updating the chest pain algorithm: incorporating new evidence.

In 2003, we published our chest pain protocol for the management of acute coronary syndromes (ACSs) and acute myocardial infarction. Our algorithm was specifically designed for our institution, which was primary percutaneous coronary intervention (PCI) for all ST-elevation myocardial infarctions (STEMIs) and a preferred invasive approach for non-STEMIs. Since 2003, there have been numerous changes in the adjunctive pharmacotherapeutic armamentarium for PCI in both the STEMI and non-STEMI ACS context. We present our updated chest pain algorithm with a brief review of the rapidly evolving changes in adjunctive pharmacotherapy for PCI and provide a rationale for the changes that we have made to our institutional protocol. Clinical pathways need to be consistently updated and revises by incorporating new evidence from clinical trials in order to maintain clinical relevance.

The use of the Gianturco-Roubin intracoronary stent: the New Approaches to Coronary Intervention (NACI) registry experience.

The objective of this study is to compare the in-hospital and follow-up outcome in patients receiving the Gianturco-Roubin stent (GRS) who were enrolled in the New Approaches to Coronary Intervention (NACI) registry. The GRS was approved by the US Food and Drug Administration (FDA) in August 1992 for the treatment of acute or threatened closure after a percutaneous intervention. The application of intracoronary stenting has broadened substantially in the last few years, but less is known about the use of this device for other indications. Since the NACI registry includes patients stented for other indications, a comparison of these groups with patients being stented for acute or threatened closure was undertaken. A GRS was deployed in 497 NACI registry patients. Of these, 466 patients received a GRS in 1 of 3 of the following ways: (1) 351 unplanned stenting after conventional angioplasty of the same lesion; (2) 54 after failed/suboptimal use of a new device in the same lesion; and (3) 61 in planned stenting procedures. This analysis focuses on these 3 patient subgroups and compares their in-hospital outcome and subsequent follow-up to 1 year. There were 520 stented segments in the 466 patients. The group with stenting after failed/suboptimal new-device use had a higher incidence of myocardial infarction (MI) and cardiogenic shock than either the patients with unplanned stenting after percutaneous transluminal coronary angioplasty (PTCA) or planned stenting (MI 22.2% vs 12.0% vs 0%, respectively, and cardiogenic shock 5.6% vs 0.9% vs 0%, respectively; p < 0.05). This group also had significantly lower procedural success (58.7% vs 75.3% vs 81.5%, respectively; p < 0.05). Although not statistically significant, the requirement for transfusion was higher in the unplanned and new-device stented groups than in the planned group (10.5% vs 16.7% vs 1.6%, respectively). Likewise, the incidence of Q-wave MI was higher in the new-device group (22.2% vs 12% vs 0%, respectively; p < 0.05). Despite a higher, in-hospital complication rate in the unplanned groups, follow-up from discharge to 1 year showed similar outcome. In particular, percutaneous reintervention of the stented segment occurred in: 13.0% in the unplanned after new device; 17.4% in the unplanned after PTCA; and 26.2% in the planned group. Although not statistically significant, the higher incidence of percutaneous target lesion revascularization in the planned group probably represents the greater incidence of restenotic lesions in this cohort. In this very heterogeneous group of patients, including those with failure of another new device, the use of the GRS is associated with acceptable in-hospital and follow-up complication rates, although complications were clearly greater when unplanned use of the stent was needed, particularly after failure of another new device. Although the experience is small, patients having the GRS placed in an elective fashion, i.e., the planned group, appear to experience lower in-hospital complication rates, although they have a higher rate of subsequent target lesion revascularization, in this group of predominantly restenotic lesions.

Updating the chest pain algorithm: incorporating new evidence on emerging antiplatelet agents.

In 2008, we published our chest pain protocol for the management of acute coronary syndromes (ACS) and acute myocardial infarction. Our algorithm was specifically designed for our institution, which includes primary percutaneous intervention (PCI) for all ST-elevation myocardial infarctions (STEMIs) and a preferred invasive approach for non-STEMIs. Since 2008, there have been changes in the adjunctive pharmacotherapeutic armamentarium for PCI in both the STEMI and non-STEMI ACS context. In particular, recent data on the novel antiplatelet agent prasugrel, dosing of clopidogrel after PCI, and interactions with clopidogrel and other medicines and substrates, which can lead to decreased platelet response to clopidogrel, have led us to update our ACS clinical pathway. We present our updated chest pain algorithm with a brief review of the rapidly evolving changes in adjunctive pharmacotherapy for PCI, and provide rationale for the changes that we have made to our institutional protocol. Clinical pathways need to be regularly updated and revised by incorporating new evidence from clinical trials to ensure optimal clinical care.