beta-blockers before percutaneous coronary intervention do not attenuate postprocedural creatine kinase isoenzyme rise.

BACKGROUND: beta-blocker (BB) use reduces infarct size in spontaneously occurring nonreperfused infarcts but probably does not change infarct size in patients treated with reperfusion therapy. A recent observational study suggested that BB use concurrent with percutaneous coronary intervention (PCI) decreased the risk of creatine kinase (CK)-MB elevation. The cogency of such a conclusion is dependent on the ability to risk-adjust for the multiple differences in patients treated with and without BBs. METHODS AND RESULTS: Using propensity score and multivariate regression analyses, 6200 consecutive patients were analyzed to assess the relationship between BB use before PCI and per protocol-measured CK and CK-MB rise. There were several highly significant (P<0.001) differences between patients with and without BB treatment (eg, age, prior infarction, unstable angina). Maximum CK and CK-MB levels were higher in patients taking BBs (CK median, 95 U [interquartile range: 61, 175]; CK-MB, 3 U [2, 5]) than in patients not taking BBs (CK, 91 U [60, 157]; CK-MB, 3 U [2, 4]) (P=0.011 and P=0.021 for CK and CK-MB, respectively). After adjustment for significant differences in baseline characteristics there was no difference in either maximum CK rise (P=0.21) or maximum CK-MB rise (P=0.99). CONCLUSIONS: The results of this large observation study do not support the contention that BB use before PCI decreases myocardial injury.

Long-term clinical outcomes after unprotected left main trunk percutaneous revascularization in 279 patients.

BACKGROUND: Percutaneous coronary revascularization (PCI) has been increasingly applied to unprotected left main trunk (LMT) lesions, with varied long-term success. This study attempts to define the predictors of outcome in this population. METHODS AND RESULTS: Two hundred seventy-nine consecutive patients who had LMT PCI at 1 of 25 sites between 1993 and 1998 were studied. Forty-six percent of these patients were deemed inoperable or at high surgical risk. Thirty-eight patients (13.7%) died in hospital, and the rest were followed up for a mean of 19 months. The 1-year incidence was 24.2% for all-cause mortality, 20.2% for cardiac mortality, 9.8% for myocardial infarction, and 9.4% for CABG. Independent correlates of all-cause mortality were left ventricular ejection fraction /=2.0 mg/dL, and severe lesion calcification. For the 32% of patients <65 years old with left ventricular ejection fraction >30% and without shock, the prevalence of these adverse risk factors was low. No periprocedural deaths were observed in this low-risk subset, and the 1-year mortality was only 3.4%. CONCLUSIONS: Patients undergoing unprotected LMT PCI have frequent serious comorbidities and consequently have high event rates. PCI may be an alternative to CABG for a select proportion of elective patients and may also be appropriate for highly symptomatic inoperable patients. Meticulous follow-up of hospital survivors is required because of the rather high mortality during the first few months after treatment.

Prognostic value of absolute versus relative measures of the procedural result after successful coronary stenting: importance of vessel size in predicting long-term freedom from target vessel revascularization.

BACKGROUND: The procedural result is a major determinant of the incidence of 6-month target vessel revascularization (TVR) after successful coronary stenting. However, the prognostic implications of the different measures of the procedural result or procedural end points have not been directly compared. In this study, we sought to assess and compare the impact of achieving different procedural end points on the long-term (2-year) incidence of TVR. METHODS AND RESULTS: We studied 234 patients in whom 1 or 2 stents were successfully deployed and ultrasound imaging performed after angiographic optimization. End points included a visually estimated angiographic residual stenosis <10% and ultrasound stent-to-mean reference lumen area > or = 80%. After 2 years, TVR was required in 48 (20.5%) patients. Qualitative predictors of TVR were vein graft lesions, 3-vessel disease, and baseline TIMI flow grade < 3. Quantitatively, reference diameter by quantitative coronary angiography (QCA), final minimum lumen diameter (MLD) by QCA, and in-stent minimum lumen area (MLA) by ultrasound were predictive of TVR. Stent-to-reference ratios were not significantly predictive of TVR. By multivariable analysis, vein graft location and MLA by ultrasound were the only significant predictors of TVR (relative risk, 2.9 [1.5, 5.4] and 0.72 [0.6, 0.9], respectively). Receiver operator curves for MLD by QCA and MLA by ultrasound were similar in predicting TVR. Neither was significantly superior to reference vessel diameter. CONCLUSIONS: Commonly used angiographic and ultrasound stent-to-reference ratios do not predict the incidence of TVR. Absolute measures of the lumen size (MLA by ultrasound and MLD by QCA) were the most important quantitative predictors of TVR within 2 years. This emphasizes the role of the vessel size as the limiting factor in determining the long-term outcome of coronary stenting.

Results of the study to determine rotablator and transluminal angioplasty strategy (STRATAS).

Rotational atherectomy is used to debulk calcified or complex coronary stenoses. Whether aggressive burr sizing with minimal balloon dilation (<1 atm) to limit deep wall arterial injury improves results is unknown. Patients being considered for elective rotational atherectomy were randomized to either an "aggressive" strategy (n = 249) (maximum burr/artery >0.70 alone, or with adjunctive balloon inflation < or = 1 atm), or a "routine" strategy (n = 248) (maximum burr/artery < or =0.70 and routine balloon inflation > or =4 atm). Patient age was 62 +/- 11 years. Fifty-nine percent routine and 60% aggressive strategy patients had class III to IV angina. Fifteen percent routine and 16% aggressive strategy patients had a restenotic lesion treated; lesion length was 13.6 versus 13.7 mm. Reference vessel diameter was 2.64 mm. Maximum burr size (1.8 vs 2.1 mm), burr/artery ratio (0.71 vs 0.82), and number of burrs used (1.9 vs 2.7) were greater for the aggressive strategy, p <0.0001. Final minimum lumen diameter and residual stenosis were 1.97 mm and 26% for the routine strategy versus 1.95 mm and 27% for the aggressive strategy. Clinical success was 93.5% for the routine strategy and 93.9% for the aggressive strategy. Creatine kinase-myocardial band (CK-MB) was >5 times normal in 7% of the routine versus 11% of the aggressive group. CK-MB elevation was associated with a decrease in rpm of >5,000 from baseline for a cumulative time >5 seconds, p = 0.002. At 6 months, 22% of the routine patients versus 31% of the aggressive strategy patients had target lesion revascularization. Angiographic follow-up (77%) showed minimum lumen diameter to be 1.26 mm in the routine group versus 1.16 mm in the aggressive group, and the loss index 0.54 versus 0.62. Dichotomous restenosis was 52% for the routine strategy versus 58% for the aggressive strategy. Multivariable analysis indicated that left anterior descending location (odds ratio 1.67, p = 0.02) and operator-reported excessive speed decrease >5,000 rpm (odds ratio 1.74, p = 0.01) were significantly associated with restenosis. Thus, the aggressive rotational atherectomy strategy offers no advantage over more routine burr sizing plus routine angioplasty. Operator technique reflected by an rpm decrease of >5,000 from baseline is associated with CK-MB elevation and restenosis.

Unexpected mortality reduction with abciximab for in-stent restenosis.

Treatment of in-stent restenosis is generally considered low risk, and it is not clear if adjunctive use of abciximab is beneficial in this low-risk population. We determined the effect of adjunctive abciximab during percutaneous coronary intervention (PCI) for treatment of in-stent restenosis. Two hundred and ninety-three patients with in-stent restenosis underwent PCI at the Cleveland Clinic between January 1996 and December 1998. Patients undergoing directional atherectomy, laser treatment and brachytherapy were excluded (9 patients). Of the remaining 284, seventy-nine patients received abciximab during PCI and 205 were treated without abciximab. The groups were similar with respect to age, gender, left ventricular function, number of vessels involved, history of prior coronary artery bypass grafting and unstable symptoms at presentation. There were more diabetics, hypertensives, and patients with elevated cholesterol in the abciximab-treated group. At 1-year follow-up, there was a significantly lower incidence of myocardial infarction (2.5% versus 5.3%; p < 0.05) and lower mortality (1.2% versus 5.8%; p < 0.01) in the abciximab-treated group. There was no difference in the incidence of revascularization. The findings of a lowered mortality and myocardial infarction rate with abciximab warrants further prospective study in patients with in-stent restenosis.

Quality of life after coronary revascularization in the United States and Canada.

Cardiac procedures are performed less frequently in Canada than in the United States (US), yet rates of cardiac death and myocardial infarction are similar. We therefore sought to compare long-term symptoms and quality of life in Canadian and American patients undergoing initial coronary revascularization. The 161 patients enrolled in the Bypass Angioplasty Revascularization Investigation at the Montreal Heart Institute were compared with 934 patients enrolled at 7 US sites. Patients' outcomes were documented for 5 years after random assignment to percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery. Functional status was assessed using the Duke Activity Status Index. Canadian patients were significantly younger and had more angina at study entry. Death and nonfatal myocardial infarction were not significantly different between Canadian and US patients after adjustment for baseline risk. Canadian patients had significantly greater improvements in functional status at 1-year follow-up (Duke Activity Status Index score + 13.5 vs. + 6.0, p = 0.002), but this difference progressively narrowed over 5 years. Angina was equally prevalent in Canadian and US patients at 1 year (16% vs. 19%), but significantly more prevalent in Canadian patients at 5 years (36% vs. 16%, p = 0.001). Repeat revascularization procedures were performed less often over 5 years among Canadian patients (26% vs. 34%, p = 0.08), especially coronary artery bypass graft surgery after initial percutaneous transluminal coronary angioplasty (18% vs. 32%, p = 0.03). These results suggest more anginal symptoms are required in Canada before coronary revascularization, but as a result Canadians receive greater improvements in quality of life after the procedure.

Effectiveness of rotational atherectomy of right coronary artery ostial stenosis.

Balloon angioplasty and stenting of right coronary ostial stenosis may frequently be impeded by lesion calcification, whereas rotational atherectomy, which ablates calcified plaque, should treat these lesions effectively. Accordingly, we evaluated procedural success and longterm clinical outcome of rotational atherectomy of right coronary ostial stenosis. Procedural data were obtained from a comprehensive interventional registry and follow-up information was obtained by chart review and patient enquiry. All patients who developed recurrent angina underwent angiographic restudy. During a 5-year interval, 119 patients underwent rotational atherectomy of right coronary ostial stenosis. Multilesion interventions were performed in 55% of patients. Ostial lesions were 3.73+/-3.69 mm in length (mean +/- SD), and 57.1% were significantly calcified. Reference vessel diameter was 3.42+/-0.56 mm. Maximum burr:artery ratio was 0.64+/-0.1 with adjunct balloon angioplasty in 89.1% and adjunct stenting in 9.2%. Procedural success (<50% residual stenosis without major complication) was 97.5%, with 1.7% uncomplicated failure and 0.8% Q-wave infarction. Maximum residual stenosis was 15+/-17%. During 6-month follow-up, available in 94% of patients, 82.7% remained angina-free, 10.9% developed recurrent angina due to right coronary ostial restenosis, and 6.4% developed recurrent angina due to another lesion. Two years after intervention, target lesion revascularization rate was 16%. Predictors of symptomatic angiographic restenosis were dissection >10 mm, final minimal luminal diameter <2.5 mm, lesion length >10 mm, restenotic lesion, and diabetes. We conclude that rotational atherectomy of right coronary ostial stenosis results in excellent acute procedural success and in low incidence of clinical recurrence, with a high proportion of patients remaining angina-free 2 years after intervention.

Safety of femoral closure devices after percutaneous coronary interventions in the era of glycoprotein IIb/IIIa platelet blockade.

We compared in-hospital femoral complications of Angio-Seal, Perclose, and manual compression in consecutive patients who underwent percutaneous coronary interventions in the era of glycoprotein IIb/IIIa platelet inhibition. Femoral closure devices have a similar overall risk profile as manual compression, even in patients treated with glycoprotein IIb/IIIa platelet inhibition, although certain rare complications such as retroperitoneal hemorrhage and severe access-site infection may be more common with the use of these devices.

Relation between lesion characteristics and risk with percutaneous intervention in the stent and glycoprotein IIb/IIIa era: An analysis of results from 10,907 lesions and proposal for new classification scheme.

BACKGROUND: The currently used American College of Cardiology/American Heart Association lesion classification scheme dates from an era when balloon angioplasty was the only percutaneous treatment available and major complications occurred in approximately 7% of patients. Major advances in treatment options would suggest that this scheme may be outmoded, but the schemes that have been suggested to update lesion classification have not been widely accepted. METHODS AND RESULTS: Four thousand one hundred eighty-one consecutive patients (6,676 lesions) formed a training set and 2,146 patients (4,231 lesions) formed a validation set treated from 1995 to 1997 at a single center used by 3 hospital groups. Twenty-seven pretreatment candidate variables were analyzed with the use of stepwise proportional logistic regression, and 9 (nonchronic total occlusion with TIMI flow 0, degenerated vein graft, vein graft age >10 years, lesion length >/= 10 mm, severe calcium, lesion irregularity, large filling defect, angulated >/= 45 degrees plus calcium, and eccentricity) were independently correlated (P<0.05) with ranked adverse outcome (death, Q-wave or creatine kinase >/= 3x normal myocardial infarction, or emergency coronary artery bypass grafting>>creatine kinase 2 to 3x myocardial infarction>>possibly related to non-Q-wave myocardial infarction>>no complication). A scheme based on these findings and the old American College of Cardiology/American Heart Association scheme were found to have c-statistics in the validation set of 0.672 and 0.620 (P = 0.010 vs old scheme), respectively. CONCLUSIONS: Appreciation of these contemporary risk factors for complications of coronary intervention may assist in patient selection and in risk adjustment for comparison of outcomes between providers.

Relationship of extent of revascularization with angina at one year in the Bypass Angioplasty Revascularization Investigation (BARI).

OBJECTIVES: To determine the relative degree of revascularization obtained with bypass surgery versus angioplasty in a randomized trial of patients with multivessel disease requiring revascularization (Bypass Angioplasty Revascularization Investigation [BARI]), one-year catheterization was performed in 15% of patients. BACKGROUND: Complete revascularization has been correlated with improved outcome after coronary artery bypass grafting (CABG) but not with percutaneous transluminal coronary angioplasty (PTCA). Relative degrees of revascularization after PTCA and surgery have not been previously compared and correlated with symptoms. METHODS: Consecutive patients at four BARI centers consented to recatheterization one year after revascularization. Myocardial jeopardy index (MJI), the percentage of myocardium jeopardized by > or =50% stenoses, was compared and correlated with angina status. RESULTS: Angiography was completed in 270 of 362 consecutive patients (75%) after initial CABG (n = 135) or PTCA (n = 135). Coronary artery bypass grafting patients had 3+/-0.9 distal anastomoses and PTCA patients had 2.4+/-1.1 lesions attempted at initial revascularization. At one year, 20.5% of CABG patients had > or =1 totally occluded graft and 86.9% of vein graft, and 91.6% of internal mammary artery distal anastomotic sites had <50% stenosis. One year jeopardy index in surgery patients was 14.1+/-11%, 46.6+/-20.3% improved from baseline. Initial PTCA was successful in 86.9% of lesions and repeat revascularization was performed in 48.4% of PTCA patients by one year. Myocardial jeopardy index one year after PTCA was 25.5+/-22.8%, an improvement of 33.8+/-26.1% (p<0.01 for greater improvement with CABG than PTCA). At one year, 29.6% of PTCA patients had angina versus 11.9% of surgery patients, p = 0.004. One-year myocardial jeopardy was predictive of angina (odds ratio 1.28 for the presence of angina per every 10% increment in myocardial jeopardy, p = 0.002). Randomization to PTCA rather than CABG also predicted angina (odds ratio 2.19, p = 0.03). CONCLUSIONS: In this one-year angiographic substudy of BARI, CABG provided more complete revascularization than PTCA, and CABG likewise improved angina to a greater extent than PTCA.

Clinical correlates of the initial and long-term cost of coronary bypass surgery and coronary angioplasty.

BACKGROUND: Medical costs vary substantially among patients. Understanding the baseline factors that predict subsequent cost may allow better selection of therapy for individual patients. Understanding the postprocedure events that increase cost should help to improve efficiency and effectiveness of coronary revascularization. METHODS: Data on 4-year costs were collected from patients randomly assigned to coronary angioplasty or bypass surgery as part of the BARI (Bypass Angioplasty Revascularization Investigation) trial. Regression models first examined factors known at the time of randomization that prospectively predicted initial procedure cost and long-term cost. Subsequent models tested the value of postrandomization events as explanatory variables for cost. RESULTS: The independent baseline predictors of higher initial percutaneous transluminal coronary angioplasty cost included 3-vessel disease (+12%) and acute presentations (+22%), whereas the independent predictors of higher initial coronary artery bypass grafting cost included the number of comorbid conditions (+5% per condition) and female sex (+7%). The independent baseline predictors of 4-year cost included heart failure (+26%), diabetes (+22%), comorbidity (+10%), and angioplasty assignment in patients with 2-vessel disease (-15%). Postrandomization models showed higher initial and long-term costs were strongly correlated with the number of repeat revascularization procedures (+30% to +128%) and the occurrence of clinical complications (+8% to +131%). CONCLUSIONS: Two-vessel disease identifies patients likely to have lower costs after angioplasty, whereas heart failure, comorbid conditions, and diabetes identify patients likely to accrue higher costs after either angioplasty or bypass surgery. Long-term costs can be potentially reduced by interventions that decrease procedural complications or reduce the need for repeat revascularization.

An embolization containment device.

A coaxial catheter system for containment of distal embolization is described. Utilizing a novel 0.014" hypotube with a distal elastomeric occlusion balloon, the PercuSurge GuardWire functions as a guidewire while trapping distal embolization resulting from more proximal intervention. The particulate debris is evacuated with a single operator exchange aspiration catheter (Export catheter) prior to deflation of the distal occlusion balloon. This animal study confirmed the feasibility of concept. The system was easily delivered through tortuous coronary anatomy. The GuardWire served as an adequate rail for delivery of dilatation balloons and a multitude of stents. There was no evidence of deep wall damage from low-pressure inflation and apposition of the distal occlusion balloon.

Coronary artery stent restenosis responds favorably to repeat interventions.

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

The importance of proteinuria as a determinant of mortality following percutaneous coronary revascularization in diabetics.

OBJECTIVES: The aims of this study were to compare mortality and clinical events following percutaneous coronary intervention (PCI) between nondiabetics and diabetics with and without proteinuria. BACKGROUND: Diabetics have increased rates of late myocardial infarction, repeat revascularization and mortality when compared with nondiabetics following PCI. Proteinuria is a marker for diabetic nephropathy and potentially a surrogate marker for advanced atherosclerosis. It is unknown if proteinuria is a predictor of outcome in diabetics following PCI. METHODS: We performed an observational study of 2,784 patients who underwent PCI at the Cleveland Clinic between January 1993 and December 1995. There were 2,247 nondiabetics and 537 diabetics with urinalysis and follow-up data available (proteinuria n = 217, nonproteinuria n = 320). The diabetic proteinuria group was further prospectively stratified into low concentration (n = 182) and high concentration (n = 35). The end points were all-cause mortality and the composite end point of death, nonfatal myocardial infarction (MI) and need for revascularization. RESULTS: The mean follow-up time was 20.2 months. The two-year mortality rate was 7.3% and 13.5% for nondiabetics and diabetics, respectively (p < 0.001). The two-year mortality rate was 9.1% and 20.3% for the nonproteinuria and proteinuria groups, respectively (p < 0.001). There was a graded increase in mortality comparing the diabetic group. The two-year mortality rate was 9.1%, 16.2% and 43.1% for the nonproteinuria, low concentration and high concentration groups, respectively (p < 0.001). The difference in survival between the nondiabetic and nonproteinuric diabetics was not significant (p = 0.8). CONCLUSIONS: The presence of proteinuria is the key determinant of risk following PCI for diabetics. Diabetics without evidence of proteinuria have similar survival compared with nondiabetics.

Contemporary percutaneous treatment of unprotected left main coronary stenoses: initial results from a multicenter registry analysis 1994-1996.

BACKGROUND: Coronary artery bypass surgery (CABG) has been considered the therapy of choice for patients with unprotected left main (ULMT) coronary stenoses. Selected single-center reports suggest that the results of percutaneous intervention may now approach those of CABG. METHODS AND RESULTS: To assess the results of percutaneous ULMT treatment from a wide variety of experienced interventional centers, we requested data on consecutive patients treated after January 1, 1994, from 25 centers. One hundred seven patients were identified who were treated either electively (n=91) or for acute myocardial infarction (n=16). Of patients treated electively, 25% were considered inoperable, and 27% were considered high risk for bypass surgery. Primary treatment included stents (50%), directional atherectomy (24%), and balloon angioplasty (20%). Follow-up was 98.8% complete at 15+/-8 months. Results varied considerably, depending on presentation and treatment. For patients with acute myocardial infarction, technical success was achieved in 75%, and survival to hospital discharge was 31%. For elective patients, technical success was achieved in 98.9%, and in-hospital survival was strongly correlated with left ventricular ejection fraction (P=.003). Longer-term event (death, infarction, or bypass surgery) -free survival was correlated with ejection fraction (P<.001) and was inversely related to presentation with progressive or rest angina (P<.001). Surgical candidates with ejection fractions > or = 40% had an in-hospital survival of 98% and a 9-month event-free survival of 86+/-5%, whereas patients with ejection fractions < 40% had 67% and 22+/-12% in-hospital and 9-month event-free survivals, respectively. Nine hospital survivors (10.6%) experienced cardiac death within 6 months of hospital discharge. CONCLUSIONS: While results for selected patients appear promising, until early post-hospital discharge cardiac death can be better understood and minimized, percutaneous revascularization of ULMT stenosis should not be considered an alternative to bypass surgery for most patients. When percutaneous revascularization of ULMT is required, directional atherectomy and stenting appear to be the preferred techniques, and follow-up angiography 6 to 8 weeks after treatment is probably advisable.

Intravascular ultrasound assessment of the prevalence and causes of angiographic "haziness" following high-pressure coronary stenting.

Haziness at sites of balloon angioplasty is believed to represent plaque fractures or platelet deposition. The etiology of haziness adjacent to coronary stents remains uncertain. This study examines the prevalence and etiology of "peri-stent" haziness following high-pressure deployment. Consecutive patients undergoing coronary stenting and intravascular ultrasound imaging were included. Haziness was defined as nonhomogeneous contrast density and/or indistinct vessel borders by consensus of 2 observers. Patients were excluded if angiography revealed an obvious cause of haziness (thrombus, dissection). Matched control segments without haziness were selected for comparison. The most diseased site within the reference segment was identified by ultrasound. Lumen and plaque areas, percent plaque area, and plaque echo density were assessed. Haziness was identified within 31 segments in 30 patients (15% of 201 angiograms examined). At hazy sites, ultrasound revealed a large percent plaque area in 15, dissections in 14, and near-normal findings in 2 segments. In the absence of dissection, percent plaque area and lumen area step-down from the stent to the diseased reference were greater than controls (percent plaque area 64 +/- 12% vs 56 +/- 10%, p = 0.04 and lumen step-down 35 +/- 20% vs 13 +/- 25%, p = 0.006). With dissections, percent plaque area and lumen step-down were not different from controls (p = 0.13 and 0.30, respectively), but underlying plaques were more frequently echolucent (64% vs 23%, p = 0.02). Thus, in this study, peri-stent haziness was evident in 15% of patients after high-pressure coronary stent deployment. Etiologies identified by intravascular ultrasound included unrecognized reference plaque and angiographically occult dissections.

Late myocardial ischemic events after saphenous vein graft intervention--importance of initially "nonsignificant" vein graft lesions.

Patients undergoing percutaneous coronary revascularization (PCR) for narrowed saphenous vein grafts (SVGs) have a high incidence of subsequent cardiac events, but the relative contribution of treated and untreated SVGs, and of native coronary narrowings to late events is uncertain. This study evaluated the role of progression of SVG disease at untreated sites to cardiac events in these patients. All patients with successful PCR of SVG lesions who were enrolled in clinical trials with mandated repeat angiography from 1990 to 1994 were studied. One hundred three patients (age 63 +/- 8 years, 82% men, ejection fraction 54 +/- 12%, graft age 8 +/- 4 years), contributing 1,095 analyzable 15- to 25-mm SVG segments were followed 29 +/- 13 months (4 patients were lost to follow-up). Actuarial event-free (death, myocardial infarction, bypass surgery, or PCR) and overall survival at 12 months were 47 +/- 5% and 94 +/- 2%, respectively. Fifty-six percent of all early (< or = 12 months) events resulted from ischemia from recurrence at initially treated SVG sites, 26% at nontreated SVG sites, and 14% at nontreated native coronary sites. By 36 months, event-free and overall survival were 25 +/- 6% and 86 +/- 4%, respectively. Events occurring > 12 months after initial treatment resulted most frequently from ischemia from progression of narrowing at untreated SVG sites (46%). Ischemic events from initially untreated SVG sites were correlated with initial percent stenosis (initial, 41% to 50%; 45% events, 31% to 40%; 18% events, < or = 30%; 2% events, p <0.001) and reference SVG diameter (p = 0.003). Recurrent ischemic events from initially treated SVG sites were independently correlated with initial percent stenosis (initial > 75%; 43% events, 50% to 75%; 27% events, < 50%; 18% events, p = 0.01), but not with final percent stenosis. The frequent occurrence of events from nontreated 41% to 50% stenoses suggests a need for increased surveillance in patients with these lesions. The low incidence of events from initially treated lesions < 50% suggests that the hypothesis that "nonsignificant" 41% to 50% lesions might best be treated at the time other more severe narrowings are treated should be examined.

Impact of diabetes mellitus on percutaneous revascularization (CAVEAT-I). CAVEAT-I Investigators. Coronary Angioplasty Versus Excisional Atherectomy Trial.

We examined the relation between diabetes mellitus and outcomes in patients undergoing percutaneous coronary revascularization in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I), a randomized trial comparing treatment with either percutaneous transluminal coronary angioplasty or directional atherectomy for de novo lesions in native coronary arteries. Acute success and complication rates, 6-month angiographic restenosis rates, and 1-year clinical outcomes were compared between diabetic and nondiabetic patients undergoing each procedure. Acute success rates between diabetic (n = 191) and nondiabetic (n = 821) patients were similar for both revascularization techniques. Except for the need for dialysis, complication rates were also similar. Six months after atherectomy, diabetic patients had significantly more angiographic restenosis than nondiabetics (59.7% vs 47.4%) and significantly smaller minimum luminal diameters (1.20 vs 1.40 mm). Diabetics undergoing atherectomy required more frequent bypass surgery (12.8% vs 8.5%) and more repeat percutaneous revascularizations (36.5% vs 28.1%) than nondiabetics undergoing atherectomy. Restenosis rates, minimum luminal diameters and repeat revascularizations between diabetics and nondiabetics undergoing angioplasty were similar. The higher restenosis and repeat revascularization rates and the smaller minimum luminal diameter at follow-up in diabetic patients suggest that atherectomy may provide only modest benefit for these patients. The increased restenosis rate in diabetics undergoing atherectomy (but not angioplasty) requires further evaluation.

Comparison of patients with either < 70% diameter narrowing or > or = 70% narrowing of the right coronary artery when performing rotational atherectomy on > or = 1 narrowing in the left coronary arteries.

This study compares the complication rates of patients undergoing rotational atherectomy of the left coronary system who had either minimal or significant narrowing of the right coronary artery (RCA). A series of 1,872 patients from a multicenter registry who were treated for left coronary artery disease were divided into <70% diameter stenosis (mild) and > or = 70% stenosis (severe) of the RCA. The patient demographics, lesion characteristics, and frequency of procedural complications for each group were compared. Of the 1,872 patients undergoing rotational atherectomy of the left coronary system, 86.3% (n = 1,616) had mild RCA disease and 13.7% (n = 256) had severe RCA disease. Comparing the mild and severe groups, death (0.8% vs 3.1%, p <0.005), non-Q-wave myocardial infarction (5.1% vs 8.6%, p <0.04), and bypass surgery (2.7% vs 5.8%, p <0.02) were increased in the severe group. Within the severe group, 7 of 8 deaths were in the 128 patients with total occlusion of the RCA. Multivariate analysis demonstrated that RCA stenosis increases the risk of death by 4.9, bypass surgery by 2.6, and non-Q-wave myocardial infarction by 1.8. Patients treated for left coronary disease who have > or = 70% stenosis of the RCA have increased complications during rotational atherectomy.