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(Circulation. 1997;96:367-371.)
© 1997 American Heart Association, Inc.

Articles

Meeting Highlights

46th Annual Scientific Sessions of the American College of Cardiology

James J. Ferguson, MD

From St Luke's Episcopal Hospital/Texas Heart Institute, Baylor College of Medicine, and the University of Texas Health Science Center at Houston.

Correspondence to James J. Ferguson, MD, Cardiology Research, 1-191, Texas Heart Institute, PO Box 20345, Houston, TX 77225.

	Introduction

Top Introduction GUSTO III Antiplatelet Therapy in Acute... Invasive Versus Conservative... Argatroban in Acute MI InTIME Trial Transmyocardial Laser... Ibutilide for Atrial... Losartan in the Elderly Fluvastatin and Restenosis Cutting Balloon Angioplasty Aggressive Rotablator Therapy

 
The following studies were presented at the 46th Annual Scientific Sessions of the American College of Cardiology, March 16-19, 1997, Anaheim, Calif.

	GUSTO III

Top Introduction GUSTO III Antiplatelet Therapy in Acute... Invasive Versus Conservative... Argatroban in Acute MI InTIME Trial Transmyocardial Laser... Ibutilide for Atrial... Losartan in the Elderly Fluvastatin and Restenosis Cutting Balloon Angioplasty Aggressive Rotablator Therapy

 
Dr Eric Topol, Cleveland Clinic, Cleveland, Ohio, presented the third Global Use of STrategies to Open occluded coronary arteries (GUSTO III) study. This was a randomized trial that compared recombinant plasminogen activator (RPA) with accelerated tissue plaminogen activator (TPA) in patients within 6 hours of an acute myocardial infarction (MI). Between November 1996 and January 1997, a total of 15 060 patients were enrolled at 880 hospitals in 20 countries. Qualifying patients were randomized in a 2:1 fashion to RPA (two 10-µm boluses 30 minutes apart) or TPA (90-minute accelerated regimen). Patients were treated with adjunctive aspirin (150 to 325 mg/d) and intravenous heparin. The primary end point of the study was all-cause mortality at 30 days. Of the total population enrolled, 13.5% were >75 years of age and 27.5% were women.

With regard to the primary end point of the trial, 30-day mortality in the RPA group was 7.43%, versus 7.2% in the TPA group (P=.63). There also were no significant differences between the RPA and TPA groups in 24-hour (2.99% versus 2.67%) or in-hospital mortality rates (6.96% versus 6.25%). The incidence of severe bleeding complications was similar between groups (0.72% with RPA versus 0.82% with TPA). In the RPA group, the incidence of hemorrhagic stroke was 0.91% (versus 0.88% with TPA), the incidence of nonhemorrhagic stroke was 0.61% (versus 0.73% with TPA), and the incidence of any stroke was 1.67% (versus 1.83% with TPA). When patients were stratified by age, there were still no significant differences in mortality between the RPA and TPA groups in patients <75 years of age (5.2% in both) or patients >75 years of age (21.5% versus 20.2%).

Dr Topol concluded that RPA did not reduce 30-day mortality compared with TPA. There was no significant difference between the two drugs in the incidence of stroke. It remains uncertain whether RPA and TPA can be regarded as "equivalent." Further analysis of the preliminary data and more extended follow-up will be helpful in this regard.

	Antiplatelet Therapy in Acute Coronary Syndromes

Top Introduction GUSTO III Antiplatelet Therapy in Acute... Invasive Versus Conservative... Argatroban in Acute MI InTIME Trial Transmyocardial Laser... Ibutilide for Atrial... Losartan in the Elderly Fluvastatin and Restenosis Cutting Balloon Angioplasty Aggressive Rotablator Therapy

 
Dr Harvey White, Auckland, New Zealand, presented the results of the Platelet Receptor Inhibition for ischemic Syndrome Management) (PRISM) study. A total of 3231 patients with unstable angina or non–Q-wave MI already on aspirin therapy, were randomized to receive heparin (5000-U bolus; 1000 U/h infusion titrated to activated partial thromboplastin times (aPTTs) of 1.5 to 2 times control) or the platelet glycoprotein IIb/IIIa receptor antagonist tirofiban (0.6 µg/kg per minute for 30 minutes followed by 0.15 µg/kg per minute) for 48 hours. One quarter of the patients enrolled had a final diagnosis of non–Q-wave MI. To qualify for the study, patients had to have an episode of chest pain within 24 hours of enrollment. The primary end point of the trial was the combined incidence of death, MI, and refractory ischemia at 48 hours. At 48 hours, the composite end point was significantly reduced with tirofiban (3.8% versus 5.9%). The individual end point components also tended to be reduced with tirofiban: refractory ischemia (3.6% versus 5.3%), MI (0.9% versus 1.3%) and death (0.4% versus 0.8%). At 30 days, the initial benefit of tirofiban had eroded somewhat and was no longer significant with respect to refractory ischemia (10.8% versus 10.8%), MI (4.0% versus 4.2%), or the composite end point (12.8% versus 13.9%). However, mortality at 30 days was significantly lower (2.3% versus 3.6%; P=.02) in the tirofiban group. There was no significant increase in major bleeding events with tirofiban.

Dr White concluded that clinical events were reduced with tirofiban during drug administration. There was a consistent effect on component end points. At 30 days, mortality was significantly reduced in patients treated with aspirin plus tirofiban compared with those treated with aspirin plus heparin.

Dr Pierre Theroux, Montreal Heart Institute, Montreal, Ontario, Canada, presented the results of the Platelet Receptor Inhibition for Ischemic Syndrome Management in Patients Limited by very Unstable Signs and symptoms (PRISM-PLUS) study, which further investigated tirofiban in the context of overall patient management, including cardiac catheterization and revascularization if clinically indicated. This study included 1815 patients with unstable angina and non–Q-wave MI. A total of 45% of the patients in PRISM-PLUS were diagnosed as having a non–Q-wave MI.

The study was originally designed to have three arms: tirofiban alone, heparin alone, and heparin plus tirofiban. One arm (tirofiban alone) was dropped by the DSMB because of excess events, which were not consistent across all the components of the composite end point or across time. Patients received a 48-hour infusion of study drug and could then undergo angiography. If no angiography was performed, the study drug was stopped. If a coronary intervention was performed, the study drug information was continued for at least 12 hours after the procedure. A total of 90% of study participants underwent angiography; 35.8% were subsequently managed medically, 30.5% underwent PTCA, and 23.4% underwent CABG.

At 7 days, events were reduced in the heparin plus tirofiban arm versus the heparin alone arm: 9.3% versus 12.7% for refractory ischemia, 3.9% versus 7.0% for MI, 1.9% versus 1.9% for death, and 12.9% versus 17.9% for composite events. At 30 days there was evidence of sustained but somewhat less prominent benefits: 10.6% versus 13.4% for refractory ischemia, 6.6% versus 9.2% for MI, 3.6% versus 4.5% for death, and 18.5% versus 22.3% for composite events. Tirofiban therapy was not associated with a significant increase in major bleeding events (1.8% versus 1.2%), intracranial hemorrhage (0% overall), decrease in hemoglobin >4 g (4.0% versus 3.0%), or transfusion (3.5% versus 2.3%). Dr Theroux concluded that in patients with unstable angina and non–Q-wave MI, compared with heparin alone, tirofiban plus heparin therapy was associated with a significant reduction in ischemic events at 7 days. At 30 days, the early benefits were largely maintained, although some of the initial early benefits were lost. These benefits were achieved without an increased risk of major bleeding.

	Invasive Versus Conservative Management of Acute Coronary Syndromes

Top Introduction GUSTO III Antiplatelet Therapy in Acute... Invasive Versus Conservative... Argatroban in Acute MI InTIME Trial Transmyocardial Laser... Ibutilide for Atrial... Losartan in the Elderly Fluvastatin and Restenosis Cutting Balloon Angioplasty Aggressive Rotablator Therapy

 
Dr William Boden, Veterans Affairs Upstate Health Care System, Syracuse, NY, presented results from the Veterans Affairs Non–Q Wave Infarction Strategies in-Hospital (VANQWISH) trial. This trial, conducted at 15 Veterans Administration centers across the country, was designed to compare early and late clinical outcomes in patients with unstable angina randomized to "invasive" and "conservative" care. All patients admitted to the participating institutions between April 1993 and December 1995 with suspected MI were screened for possible randomization. To qualify for the study, patients had to have a clinical presentation consistent with acute MI, elevated total creatine kinase (CK) and CK-MB isoenzymes, and no new Q waves on the ECG. High-risk patients (those with congestive heart failure, recurrent ischemia, or ventricular arrhythmias), and patients with recent revascularization were excluded from the study. Patients were then randomized to an invasive strategy or a conservative strategy. In the invasive arm, cardiac catheterization was performed within 3 to 7 days, and subsequent management was performed according to TIMI-IIIB guidelines (PTCA for single-vessel disease, CABG for multivessel disease). In the conservative arm, a radionuclide ventriculogram was performed as the initial noninvasive test within 3 to 5 days to assess left ventricular ejection fraction, a symptom-limited exercise test within 5 to 7 days, and invasive therapy undertaken only if prespecified criteria were met. This was designed as an equivalence study and assumed a 20% event rate in each trial arm during follow-up, an 85% power, and a 5% two-sided significance level. The primary end point of the trial was a composite of all-cause mortality and nonfatal MI at a minimum of 12 months' follow-up. A total of 2738 patients were screened; 1450 were deemed to have a protocol eligible non–Q-wave MI, and 920 patients were randomized. The incidence of death at hospital discharge (mean, 8.8 days) was 4.5% in the invasive arm and 1.3% in the conservative arm (P=.0067). The incidence of death before 1 month was 4.8% in the invasive arm and 2.0% in the conservative arm (P=.031); after 1 month the incidence of death was 12.3% in the invasive arm and 10.9% in the conservative arm (P=NS). The incidence of primary end point events (death and nonfatal MI) at hospital discharge was 7.8% in the invasive arm and 3.3% in the conservative arm (P=.0044). At 1 month, it was 10.4% in the invasive arm and 5.7% in the conservative arm (P=.012), and at 1 year it was 24% in the invasive arm and 18.6% in the conservative arm (P=.052). Hospital lengths of stay were significantly longer in the invasive than the conservative arm (9.5 versus 8.2 days, P<.0001).

Dr Boden concluded that the incidence of death and nonfatal MI complicating non–Q-wave MI is significant, on the order of 32% at long-term follow-up in this trial. Non–Q-wave MI patients managed conservatively fared significantly better in terms of death or recurrent nonfatal MI and had significantly shorter hospital stays than those treated with an invasive strategy. All-cause mortality in patients randomized to the invasive arm was significantly higher at discharge, at 1 month, and during cumulative long-term follow-up. Patients in the VANQWISH trial did not benefit from early aggressive management; on the contrary, aggressively managed patients appeared to do worse. Dr Boden strongly recommended an initial conservative management strategy to stabilize patients followed by selectively utilized coronary angiography and myocardial revascularization.

Dr Salim Yusuf, McMaster University in Hamilton, Canada, presented the results of the Organization for the Assessment of Strategies for Ischemic Syndromes (OASIS) registry, which includes 6-month data from nearly 8000 patients with unstable angina in the United States, Canada, Brazil, Poland, Hungary, and Australia. The registry noted significant differences in practice patterns between countries. In the United States and Brazil, the use of cardiac catheterization (68% versus 36%) and revascularization (PTCA, 23% versus 12%; CABG, 24% versus 13%) was much more frequent than in Australia, Poland, and Hungary; rates in Canada were intermediate between the two groups. Despite these differences in treatment strategies, there were no differences observed in the subsequent incidence of death or MI. When participating centers were stratified by the presence or absence of cardiac catheterization facilities, 7-day, 30-day, and 6-month outcomes were fairly similar. In patients admitted to centers with catheterization laboratory facilities, the incidence of cardiovascular death was 4.5%, of refractory/unstable angina was 4.9%, and of either adverse outcome was 8.7% by 7 days. Comparable figures for patients in institutions without catheterization laboratory facilities were 5.4%, 3.7%, and 8.3%, respectively. Similar findings were evident by 30 days (the rate of death was 6.3% versus 8.3%, of refractory/unstable angina was 8.5% versus 6.7%; and of a combination was 13.5% versus 13.5% in institutions with catheterization laboratories versus those without, respectively) and 6 months (the rate of death was 9.7% versus 11.9%, of refractory/unstable angina was 17.4% versus 14%, and of a combined end point was 24.5% versus 22.9% in institutions with catheterization laboratories versus those without, respectively).

Dr Yusuf concluded that the availability of catheterization laboratory facilities was a major determinant of the subsequent use of angiography and revascularization. Patients in centers with catheterization laboratory facilities still have a relatively high rate of cardiovascular death and MI as well as a two times higher rate of stroke or major bleeding than patients at institutions without catheterization laboratories; however, their need for subsequent hospitalization due to angina is somewhat lower. According to Dr Yusuf, overall, a routine early aggressive strategy may not be preferable.

	Argatroban in Acute MI

Top Introduction GUSTO III Antiplatelet Therapy in Acute... Invasive Versus Conservative... Argatroban in Acute MI InTIME Trial Transmyocardial Laser... Ibutilide for Atrial... Losartan in the Elderly Fluvastatin and Restenosis Cutting Balloon Angioplasty Aggressive Rotablator Therapy

 
Dr Pierre Theroux also presented the results of the Argatroban in Myocardial Infarction (AMI) trial. AMI was a placebo-controlled phase II dosing study of the direct thrombin inhibitor Argatroban as an adjunct to thrombolytic therapy in the treatment of acute MI. A total of 1080 patients with acute MI at 57 clinical sites were treated with streptokinase (1.5 million U) and randomized to receive either 1.0 or 3.0 µg/kg per minute of Argatroban or placebo. To qualify for the study, patients had to have documented ST-segment elevation and be randomized within 6 hours of the onset of pain. The primary end point of the angiographic reperfusion arm of the study (n=180) was the degree of flow at 90-minute angiography (frequency of TIMI grade 3 flow, TIMI frame count). The primary goal of the clinical outcome arm of the study (n=910) was to assess the effect of therapy on clinical outcome (death, new MI, congestive heart failure or shock, and urgent intervention) at 30 days.

At 90 minutes, the incidence of TIMI grade 3 flow was 45.5% in the placebo group, 56.4% in the 1.0-µg Argatroban group, and 44% in the 3.0-µg Argatroban group. Among patients treated within 3 hours of the onset of pain, the respective TIMI III flow rates were 55.0%, 33.9%, and 26.3% (P=.03). In the overall study population, TIMI frame counts were slightly but not significantly lower in the 3.0-mg Argatroban group. There was a nonsignificant trend toward fewer adverse clinical events in the Argatroban groups (16.2% with placebo, 19.9 in the 1.0-µg Argatroban group, and 18.8 in the 3.0-µg Argatroban group). Among patients treated within 3 hours of the onset of pain, the respective rates of adverse clinical events were 16.1%, 20.7%, and 13.6% (P=.26). The incidence of stroke or major bleeding events was not significantly increased with Argatroban.

Dr Theroux concluded that in patients treated with streptokinase for acute MI there was no significant benefit of Argatroban therapy on 90-minute TIMI flow rates, although there were improvements in flow as judged by TIMI frame counts if therapy was initiated within 3 hours of symptoms. The study was not powered to detect differences in individual clinical events and showed no difference in the overall population in clinical outcomes with Argatroban. There was again a nonsignificant trend toward better composite outcomes in the high-dose Argatroban group if therapy was initiated early. Argatroban did exhibit a very favorable safety profile; further studies of Argatroban in the setting of acute MI are ongoing.

	InTIME Trial

Top Introduction GUSTO III Antiplatelet Therapy in Acute... Invasive Versus Conservative... Argatroban in Acute MI InTIME Trial Transmyocardial Laser... Ibutilide for Atrial... Losartan in the Elderly Fluvastatin and Restenosis Cutting Balloon Angioplasty Aggressive Rotablator Therapy

 
Dr Peter den Heijer, University Hospital of Groningen, Netherlands, presented the results of the Intravenous nPA for Treatment of Infarcting Myocardium Early (InTIME) trial, a phase II controlled angiographic dose-ranging trial of novel plasminogen activator (NPA) or lanoteplase, a variant of TPA with a half-life that is 10 times greater than that of TPA) conducted at 77 sites in 13 countries. A total of 602 patients were randomized to either front-loaded TPA (100 mg) or to one of four doses of NPA (administered as a weight-adjusted bolus of 15, 30, 60, or 120 kU/kg). The primary end point of the trial was 90-minute TIMI flow grade. The highest dose group of NPA achieved patency (TIMI flow grade 2 or 3) in 83% of patients, compared with 71.4% in the TPA group (P<.05). Complete reperfusion (TIMI flow grade 3) was achieved in 57.1% of the NPA group and 46.4% of the RPA group (P=.11). After 30 days, there was a trend toward fewer adverse outcomes (death, second nonfatal MI, major bleeding, and heart failure) in the NPA group (11% versus 24% in the TPA group).

Dr den Heijer concluded that NPA is capable of achieving rapid and effective clot lysis with a simple single bolus administration. The InTIME II trial will be a much larger worldwide trial that will be powered to compare NPA and the best available current standard thrombolytic therapy, with mortality as a primary end point.

	Transmyocardial Laser Revascularization

Top Introduction GUSTO III Antiplatelet Therapy in Acute... Invasive Versus Conservative... Argatroban in Acute MI InTIME Trial Transmyocardial Laser... Ibutilide for Atrial... Losartan in the Elderly Fluvastatin and Restenosis Cutting Balloon Angioplasty Aggressive Rotablator Therapy

 
Dr James Lowe, Duke University, Durham, NC, presented the results of the Transmyocardial Laser Revascularization versus Medical Management in Patients Unamenable to Conventional Revascularization trial conducted at 12 clinical centers in the United States. In the trial, 198 patients with class 3 or 4 angina ineligible for conventional coronary artery bypass surgery were randomized to either medical therapy (n=101) or transmyocardial laser revascularization (TMR) (n=97). In this technique, using a small thoracotomy, 25 to 30 small holes are drilled with a CO₂ laser directly into the wall of the heart in areas of hibernating myocardium. Through these holes blood from inside the heart is supposed to directly nourish otherwise underperfused heart muscle. After 6 months, patients in the medical group who developed unstable angina were eligible to cross over to TMR. The primary end points of the trial were change in anginal status and change in myocardial perfusion as assessed by thallium scintigraphy. Secondary end points included change in myocardial function, change in quality of life, and morbidity and mortality. The mean age of patients in the study was 61 years (range, 30 to 83); the mean ejection fraction was 50% (range, 21% to 73%).

In 71% of the TMR group, there was a significant decrease in anginal symptoms; no such improvement was noted in the medical group. There was no significant difference between groups with single photon emission computed tomography–thallium perfusion, but there was a trend favoring the TMR group. TMR patients reported better quality of life (largely due to improvement of symptoms). Although there was no significant difference in mortality between groups, subsequent hospitalization for unstable angina was much more frequent in the medically treated group. A total of 37 patients in the medically treated group crossed over to TMR after developing recurrent unstable angina. Operative mortality in these unstable patients was dramatically higher (20%) than the mortality in patients originally randomized to TMR (3%).

Dr Lowe concluded that in patients with angina ineligible for bypass surgery, TMR is associated with improvement in angina status, improvement in quality of life, and better event-free survival compared with medical therapy. TMR does not appear to be a favorable therapeutic option in patients with refractory unstable angina.

	Ibutilide for Atrial Fibrillation

Top Introduction GUSTO III Antiplatelet Therapy in Acute... Invasive Versus Conservative... Argatroban in Acute MI InTIME Trial Transmyocardial Laser... Ibutilide for Atrial... Losartan in the Elderly Fluvastatin and Restenosis Cutting Balloon Angioplasty Aggressive Rotablator Therapy

 
Dr Peter Kowey, Lankenau Hospital and Medical Research Center, Wynnewood, Pa, presented the results of the Ibutilide for Post-CABG Atrial Fibrillation/Flutter Termination trial. In this study, 302 patients who developed atrial fibrillation (n=201) or flutter (n=101) after CABG or valve surgery were randomized to receive placebo or one of three doses of the class III anti-arrhythmic drug ibutilide (0.25, 0.5, or 1.0 mg). Study drug was administered as a 10-minute intravenous infusion that could be repeated as necessary after 10 minutes. The primary end point of the study was the restoration of sinus rhythm for any period of time during the initial 1.5 hours after drug infusion. This was achieved in 15% of the placebo group, 40% of the 0.25-mg group, 47% of the 0.5-mg group, and 57% of the 1.0-mg group. Drug therapy appeared more successful in terminating atrial flutter; up to 80% of patients in the 1.0-mg group with atrial flutter were successfully converted. The average time to termination was 32 minutes (range, 3 to 90); 64% of patients were still in sinus rhythm 24 hours after treatment. Ventricular arrhythmias were more frequent (9.6%) in the ibutilide-treated patients than in those treated with placebo (1.2%); in most cases this involved extrasystoles or nonsustained monomorphic ventricular tachycardia. The incidence of torsades de pointes was <2%.

Dr Kowey concluded that ibutilide is an effective form of therapy for terminating postoperative atrial fibrillation or flutter. It appears to have an acceptable safety profile and to be more effective at higher doses.

	Losartan in the Elderly

Top Introduction GUSTO III Antiplatelet Therapy in Acute... Invasive Versus Conservative... Argatroban in Acute MI InTIME Trial Transmyocardial Laser... Ibutilide for Atrial... Losartan in the Elderly Fluvastatin and Restenosis Cutting Balloon Angioplasty Aggressive Rotablator Therapy

 
Dr Bertram Pitt, University of Michigan, Ann Arbor, Mich, presented the results of the Evaluation of Losartan in the Elderly (ELITE) trial. This study, conducted by 125 investigators in 24 countries, randomized 722 elderly (>65 years) patients with heart failure (NYHA class 2 to 4, ejection fraction <40%) to receive either the ACE inhibitor captopril (n=370) or the angiotensin receptor blocker losartan (n=352) for 48 weeks. The primary end point of the study was the incidence of persistent renal dysfunction (as measured by increased serum creatinine); a secondary end point of the trial was the incidence of hospitalization for heart failure and all-cause mortality. The overall incidence of renal dysfunction was the same (10.5%) in both groups; there were no differences in the incidence of hypotension, no differences in functional class, and no differences in the frequency of subsequent heart failure hospitalizations. Significantly more captopril patients discontinued the study drug because of side effects. There was a significant difference in mortality at long-term follow-up (400 days) between groups. All cause mortality was 4.8% in the losartan group compared with 8.7% in the captopril group (RR=.54). This difference arose largely from a decrease of sudden death in the losartan group (1.4% versus 3.8%). There did not appear to be any differences in other types of mortality.

Dr Pitt concluded that while there does not appear to be any difference between losartan and captopril in the incidence of renal dysfunction, losartan is better tolerated than captopril. There is no difference between the two drugs in the incidence of heart failure admissions, but losartan is associated with a significantly lower total mortality. A larger-scale mortality trial is ongoing.

	Fluvastatin and Restenosis

Top Introduction GUSTO III Antiplatelet Therapy in Acute... Invasive Versus Conservative... Argatroban in Acute MI InTIME Trial Transmyocardial Laser... Ibutilide for Atrial... Losartan in the Elderly Fluvastatin and Restenosis Cutting Balloon Angioplasty Aggressive Rotablator Therapy

 
Dr Patrick Serruys, Thoraxcenter, Rotterdam, Netherlands, presented the results of the FLuvastatin Angioplasty REstenosis (FLARE) trial, a placebo-controlled, randomized, multicenter trial of the HMG-CoA reductase inhibitor fluvastatin in the prevention of restenosis after PTCA. Patients scheduled for elective PTCA were randomized before the procedure to undergo at least 2 weeks of pretreatment with placebo (n=528) or fluvastatin (n=526). Patients then underwent PTCA, and after completion of a successful procedure (percent diameter stenosis <50% with PTCA alone), continued on either placebo (n=422) or fluvastatin (n=409) for 6 months after the procedure. The primary end point of the study was the QCA-measured minimal lumen diameter (MLD) at 6-month angiography. Patients treated with fluvastatin had significant decreases in their total cholesterol, LDL, and triglyceride levels. At 6-month follow-up angiography, the MLD in the fluvastatin group was 1.54 mm, compared with 1.52 mm in the placebo group. There were no significant differences in initial gain (0.81 mm with fluvastatin versus 0.80 mm with placebo), late loss (0.23 mm in both groups), or net gain (0.57 mm in both groups). The categorical incidence of restenosis (>50% diameter stenosis at follow-up) was 28.3% in the fluvastatin group and 30.1% in the placebo group. There was, however, significantly fewer subsequent clinical events (death or nonfatal MI) in the fluvastatin group (death, 0.7% versus 1.6%; MI, 0.7% versus 2.4%; combined, 1.5% versus 4.0%) when clinical follow-up to 300 days was tabulated. Interestingly, the combined incidence of death, MI, and revascularization was not different between groups (22.5% in the fluvastatin group, 23.3% in the placebo group).

Dr Serruys concluded that fluvastatin does not significantly affect angiographic restenosis after PTCA, although there appears to be a beneficial effect of fluvastatin therapy on the incidence of death and nonfatal MI. A larger trial powered to clinical outcome end points is currently underway.

	Cutting Balloon Angioplasty

Top Introduction GUSTO III Antiplatelet Therapy in Acute... Invasive Versus Conservative... Argatroban in Acute MI InTIME Trial Transmyocardial Laser... Ibutilide for Atrial... Losartan in the Elderly Fluvastatin and Restenosis Cutting Balloon Angioplasty Aggressive Rotablator Therapy

 
Dr Raoul Bonan, Montreal Heart Institute, Montreal, Ontario, Canada, presented the results of a multicenter, 1245-patient, randomized trial of cutting balloon angioplasty versus conventional PTCA. This report included 1028 patients (1074 total of lesions) randomized to either cutting balloon angioplasty with the Barath cutting balloon or standard PTCA. The cutting balloon is a unique device that has microtomes attached to a balloon: on balloon inflation the lesion is scored and then dilated with theoretically a much more controlled injury to the vessel wall than with conventional angioplasty. To be included in the study, the patient had to have short (<20 mm), de novo, type A or B lesions in native vessels. Patients with total occlusions, recent MI, or calcified lesions were excluded from the study. Adjunctive stenting was permitted but strongly discouraged. The procedural results, in terms of angiographic success and per lesion success, were virtually identical between the two groups. Procedural complications of death (0.6% with cutting balloon versus 0% with PTCA), CABG (1.2% versus 1.2%), Q-wave MI (0.8% versus 0.6%), and abrupt closure (2.2% versus 1.7%) were very similar between groups. There was a higher incidence of coronary perforation in the cutting balloon group (1.3% versus 0%). Analyses of restenosis on 6-month follow-up angiography are pending. Dr Bonan concluded that the acute clinical results of cutting balloon angioplasty are comparable to those of conventional PTCA. There is a higher incidence of perforation with cutting balloon angioplasty but no other differences in procedural complications. Long-term angiographic follow-up will be available soon.

	Aggressive Rotablator Therapy

Top Introduction GUSTO III Antiplatelet Therapy in Acute... Invasive Versus Conservative... Argatroban in Acute MI InTIME Trial Transmyocardial Laser... Ibutilide for Atrial... Losartan in the Elderly Fluvastatin and Restenosis Cutting Balloon Angioplasty Aggressive Rotablator Therapy

 
Dr Patrick Whitlow, Cleveland Clinic, Cleveland, Ohio, presented the results of the Study To determine Rotablator And Transluminal Angioplasty Strategy (STRATAS), a 17-center clinical trial of an aggressive versus a conservative debulking strategy in patients undergoing rotational atherectomy. A total of 500 patients scheduled for elective Rotablator procedures were randomized to be treated with an aggressive strategy (70% to 90% burr:artery ratio; adjunctive balloon inflations, if necessary, of no greater than 1 atm) or according to "standard" current rotational atherectomy practice (50% to 70% burr:artery ratio, adjunctive balloon inflations of at least 4 atm). The primary end point of the study was angiographic: minimal lumen diameter of the treatment site at 6-month follow-up angiography. Secondary end points included categorical restenosis rates, need for target vessel revascularization, and clinical outcome. Patients were enrolled between March 1995 and September 1996.

Of the treated lesions, two thirds were in the left anterior descending coronary artery, one third were moderately to heavily calcified, 81% were de novo, and 12% were >20 mm. The average lesion length was 12.4 mm. Angiographic success was high in both groups: 97% as assessed visually and 93% as assessed by the angiographic core laboratory. At least 90% of the patients in each of the groups were able to achieve <50% residual stenoses without major clinical complications. Procedurally, the reference vessel size was 2.37 mm in the conventional group and 2.41 mm in the aggressive group; the preintervention MLDs were 0.78 and 0.75 mm; the postintervention MLDs were 1.80 and 1.78 mm; and the immediate postprocedural residual percent diameter stenoses were 26.5% and 27.8%, respectively. The incidence of procedure-induced transient slow flow was more than twice as high in the aggressive group, 15.3% versus 7.3%. There was a trend toward somewhat more frequent major complications (death, Q-wave MI, emergency surgery) in the conventional group (3.6% versus 2.0%) and more frequent perforations in the conventional group (1.2% versus 0.4%). The incidence of CK-MB elevation was comparable between groups. Interestingly, the single factor most strongly associated with adverse outcomes of dissection, CK-MB elevation, or death–Q-wave MI–CABG was prolonged decelerations of the atherectomy device, such as a decrease of >5000 rpm for >10 seconds or a decrease of >7000 rpm for >5 seconds.

At 6 months, there was no significant difference between the two groups in the primary end point of the study, target-lesion MLD. Clinical events of death (4.0% in the conventional group versus 1.6% in the aggressive group), Q-wave MI (0.8% versus 2.0%), CABG (3.6% versus 1.6%), and percutaneous revascularization (20.2% versus 24.9%) were not significantly different between groups. There were no significant differences in target lesion revascularization or categorical restenosis.

Dr Whitlow concluded that overall Rotablator therapy is associated with high (>90%) procedural success. Significant decelerations are strongly associated with CK-MB elevations and adverse clinical outcomes. However, conventional and aggressive Rotablator strategies yield equivalent clinical outcomes.

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				P. W. Armstrong, Y. Fu, W.-C. Chang, E. J. Topol, C. B. Granger, A. Betriu, F. Van de Werf, K. L. Lee, R. M. Califf, and f. t. G.-I. Investigators Acute Coronary Syndromes in the GUSTO-IIb Trial : Prognostic Insights and Impact of Recurrent Ischemia Circulation, November 3, 1998; 98(18): 1860 - 1868. [Abstract] [Full Text] [PDF]

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				J. Green, T. P. Wharton, and J. V. Tu Use of Cardiac Procedures in the United States and Canada N. Engl. J. Med., October 2, 1997; 337(14): 1008 - 1009. [Full Text]

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