Background-Revascularization strategies often hinge on the presence and degree of left anterior d... more Background-Revascularization strategies often hinge on the presence and degree of left anterior descending coronary artery (LAD) stenosis. A decision for bypass surgery is often based on the durability of surgical LAD revascularization compared with percutaneous approaches. By decreasing restenosis, drug-eluting stents may have reduced the "reintervention gap" between surgery and percutaneous intervention, making the percutaneous route preferable. Methods and Results-Of the 1101 patients in the SIRIUS trial, 459 with an LAD stenosis were randomized to percutaneous intervention with either sirolimus-eluting or bare-metal stents. Baseline demographic, clinical, and angiographic data were obtained. Patients had 1-year clinical and 8-month angiographic follow-up. Baseline characteristics were similar in both groups. The majority of lesions were tubular type B lesions (69.7%) with a mean diameter of 2.73 mm and a mean length of 14.0 mm. The binary in-stent restenosis rate was 2% for the sirolimus stent group and 41.6% for the bare-metal arm (relative risk, 0.05; 95% CI, 0.02 to 0.1; PϽ0.001). One-year major adverse events (defined as cardiac death, Q-wave and non-Q-wave myocardial infarction, or target vessel revascularization) was decreased 59% in the sirolimus-stent group (9.8% versus 24.9%; relative risk, 0.39; 95% CI, 0.26 to 0.61; PϽ0.001). Subgroup analysis of 135 patients with proximal LAD lesions showed similar benefits. In-stent restenosis was 0 in the proximal LAD sirolimus-eluting group (nÏ67), compared with 38% in the bare-metal arm (nÏ68), and major adverse events demonstrated a similar trend, with a 50% decrease compared with control patients (10.4% versus 20.6%, PÏNS). Conclusions-Sirolimus-eluting stents significantly decrease revascularization rates in LAD lesions. At 1 year, sirolimuseluting stent revascularization rates are comparable to historic single vessel bypass surgery revascularization rates. (Circulation. 2004;110:374-379.) Key Words: angioplasty â…¢ stents â…¢ cardiovascular disease D espite advances in technology and numerous clinical trials, the choice of which revascularization strategy is best for patients with left anterior descending coronary artery (LAD) disease remains controversial. Bypass surgery provides the most benefit in patients with proximal LAD stenoses who receive arterial revascularization with a mammary artery conduit. Percutaneous intervention has failed to match the outcomes obtained with bypass surgery, primarily because of significant requirements for repeat revascularization procedures because of restenosis. 6 -8 Recently, sirolimus-eluting stents have been shown to dramatically reduce restenosis. This reduction in restenosis may have narrowed the "reintervention gap" enough to eliminate the major advantage of bypass surgery for the treatment of LAD disease. The objective of this study was to determine the clinical outcome after percutaneous intervention of the LAD with sirolimus-eluting stents. This analysis was composed of patients from a study of Sirolimus-Eluting Balloon-Expandable Stents in the Treatment of Patients with de novo Native Coronary Artery Lesions (the SIRIUS study). 10 Briefly, SIRIUS was a randomized, double-blind trial performed at 53 investigational sites and complied with the Declaration of Helsinki regarding investigation in humans. It was approved by the US Food and Drug Administration and the Institutional Review Board at each participating center. All patients gave written informed consent. Patients were eligible if they had a history of stable or unstable angina and signs of myocardial ischemia. In addition, patients were required to have a single de novo target lesion in a native coronary artery of 51% to 99% diameter stenosis and of 15 to 30 mm in length (visual angiographic estimates). Patients were excluded for recent myocardial infarction (within 48 hours), left ventricular ejection fraction Ͻ25%, or target lesions in a left main, ostial, or bifurcation location. Thrombotic and severely calcified lesions were also ex-
Smaller reference vessel diameter is a recognized determinant of in-stent restenosis. The SIRIUS ... more Smaller reference vessel diameter is a recognized determinant of in-stent restenosis. The SIRIUS 2.25 trial was a prospective, nonrandomized study including 100 patients (mean age 63.4 years; 64% men, 40% with diabetes mellitus) assessing the safety and efficacy of the 2.25-mm sirolimus-eluting Bx Velocity stent in patients with de novo native coronary lesions. Using propensity score matching for gender, diabetes mellitus, left anterior descending artery target vessel, lesion length, and reference vessel diameter, the outcomes were compared with historical control groups (angioplasty and Palmaz-Schatz stent arms from the STRESS/BENESTENT I/II trials and the Bx Velocity bare metal stent arm from the RAVEL and SIRIUS trials having a reference vessel diameter <3 mm). Use of the 2.25-mm sirolimus-eluting Bx Velocity stent was associated with a high rate of procedural success (97%) and a low rate of in-hospital major adverse cardiac events (2%). The primary end point, 6-month in-lesion binary angiographic restenosis, occurred less frequently in patients treated with the 2.25-mm sirolimus-eluting Bx Velocity stent than in each of 3 historical controls (16.9% vs 30.6%, p = 0.12; 36.5%, p <0.001; 45.9%, p <0.001, respectively). This translated into lower rates of 6-month target lesion revascularization in the 2.25-mm sirolimus-eluting Bx Velocity stent group (4.0% vs 15.0% in each of 3 control groups, p = 0.01 to <0.001). By multivariate analysis, in-lesion binary restenosis was predicted by multiple implanted stents (odds ratio 10.4, p = 0.002). Four of 13 patients who developed restenosis (30.8%) had a diffuse pattern of restenosis. In the long lesion tertile (mean lesion length 19.5 mm), the in-lesion binary restenosis rate was 27.6%. In conclusion, use of the 2.25-mm sirolimus-eluting Bx Velocity stent was safe and provided favorable 6-month clinical outcomes. Use of multiple stents (in longer lesions) was an independent predictor of in-lesion restenosis.
Journal of the American College of Cardiology, Jul 31, 1991
Laser balloon angioplasty combines conventional coronary angioplasty with laser energy to transie... more Laser balloon angioplasty combines conventional coronary angioplasty with laser energy to transiently heat vascular tissue. Laser balloon angioplasty was performed in 21 patients (aged 56 ± 13 years), including 10 patients treated urgently after acute failure of conventional angioplasty and 11 patients treated with elective laser balloon angioplasty. Immediately after conventional angioplasty, laser doses (1 to 10 doses of 205 to 380 J each) were delivered during inflation of the laser balloon to a pressure of 4 atm.
Background-Sirolimus-eluting stents (SESs) reduce angiographic restenosis in patients with focal,... more Background-Sirolimus-eluting stents (SESs) reduce angiographic restenosis in patients with focal, native coronary artery stenoses. This study evaluated the usefulness of SESs in complex native-vessel lesions at high risk for restenosis. Methods and Results-Angiographic follow-up at 240 days was obtained in 701 patients with long (15-to 25-mm) lesions in small-diameter (2.5-to 3.5-mm) native vessels who were randomly assigned to treatment with SESs or bare-metal stents (BMSs) in the SIRIUS trial. Quantitative angiographic measurements of minimal lumen diameter and percent diameter stenosis were obtained within the treated segment, within the stent, and within its 5-mm proximal and distal edges. Patients treated with SESs had lower rates of binary (Ͼ50% diameter stenosis) angiographic restenosis within the segment (8.9% versus 36.3% with the BMS; PϽ0.001) and within the stent (3.2% versus 35.4% with the BMS; PϽ0.001). SESs were associated with significantly less late lumen loss within the treated segment, within the stent, and within its 5-mm proximal and distal edges (all PϽ0.001). The reduction of restenosis with the SES was consistent in patients at risk for restenosis, including those with small vessels, long lesions, and diabetes mellitus. The frequency of late aneurysms was similar in the 2 groups. Conclusions-Compared with BMSs, SESs reduced angiographic late lumen loss within the stent and its adjacent 5-mm margins in patients with complex native-vessel lesions. (Circulation. 2004;110:3773-3780.)
Background-PTCA is performed primarily to improve health-related quality of life (HRQOL) in patie... more Background-PTCA is performed primarily to improve health-related quality of life (HRQOL) in patients with symptomatic coronary artery disease. In patients undergoing PTCA, smoking has been shown to increase risks of late myocardial infarction and death. Whether smoking also affects HRQOL after PTCA is currently unknown. Methods and Results-We examined the relation between smoking status and HRQOL among 1432 patients who underwent PTCA as part of 2 multicenter clinical trials. HRQOL was assessed with the use of the Medical Outcomes Study SF-36 questionnaire. Patients were classified as smokers (nÏ301), quitters (nÏ141), or nonsmokers (nÏ990) on the basis of their smoking status at the time of their index procedure and during the first year of follow-up. For the overall population, HRQOL improved significantly after PTCA for all scales except general health perception, with improvements ranging from 5.5 points for mental health to 23.2 points for role-physical functioning. After adjustment for baseline characteristics and initial HRQOL, nonsmokers had gains at 6 months that were larger than those of smokers for all health domains: physical function 15.4 versus 10.4 points), role-physical (24.5 versus 13.9), pain (18.4 versus 13.3), general health perception (1.7 versus Ϫ4.5), vitality (11.0 versus 4.7), social function (12.8 versus 3.5), role-emotional (13.5 versus 6.7), and mental health (6.8 versus 0.8; PϽ0.02 for all comparisons). Quitters had 6-month HRQOL improvements that were greater than those in smokers for all domains as well. Findings were similar at 1 year. Conclusions-Quality-of-life benefits of PTCA are diminished by continued smoking. Efforts to promote smoking cessation at the time of PTCA may substantially improve the health outcomes of these procedures. (Circulation. 2000;102:1369-1374.)
Background-Percutaneous coronary interventions (PCIs) in saphenous vein grafts (SVGs) with thromb... more Background-Percutaneous coronary interventions (PCIs) in saphenous vein grafts (SVGs) with thrombus have a high frequency of distal embolization. Acolysis (therapeutic ultrasound) can break up thrombus in vitro in animal models and humans. Whether this is beneficial during percutaneous SVG interventions is unknown. Methods and Results-We performed a trial of coronary ultrasound thrombolysis in which patients with an acute coronary syndrome undergoing PCI in SVGs were randomly assigned to receive acolysis or abciximab. The primary end point was a successful procedure, defined as final luminal diameter stenosis 30% or less with Thrombolysis In Myocardial Infarction grade 3 flow and freedom from major adverse cardiac events (composite of death, Q-wave, and non-Q-wave myocardial infarction [MI], emergency bypass procedure, disabling stroke, and target lesion revascularization). Of 181 enrolled, 92 received acolysis and 89 abciximab. Angiographic procedural success was achieved in 63% of acolysis patients and 82% of abciximab patients (PÏ0.008). Incidence of major adverse cardiac events at 30 days was 25% with acolysis and 12% with abciximab (PÏ0.036), attributable mainly to a greater frequency of non-Q-wave MI with acolysis (19.6% versus 7.9%, PÏ0.03). The incidence of Q-wave MI was also higher with acolysis (5.4% versus 2.2%, PÏnonsignificant). The primary end point was achieved in 53.8% of acolysis patients and 73.1% of abciximab patients (PÏ0.014).
Catheterization and cardiovascular diagnosis, 1996
Overnight chronic urokinase infusion was used to successfully treat thrombotic occlusion of a sap... more Overnight chronic urokinase infusion was used to successfully treat thrombotic occlusion of a saphenous vein graft. Following removal of the infusion catheter, a 3-cm linear thrombus was observed extending from the graft into the ascending aorta. This mobile thrombus was successfully treated with coumadinization for 9 wk. Potential preventive measures for this complication of indwelling catheters are discussed.
based on data derived from 9 multicenter trials, have recently reported in the Circulation that t... more based on data derived from 9 multicenter trials, have recently reported in the Circulation that the rate of target lesion revascularization (TLR) in patients undergoing contemporary percutaneous coronary intervention (PCI) was significantly lower in smokers despite the lack of differences regarding angiographic restenosis. 1 The subtitle of the article questions the possible existence of "another smoker's paradox."
Catheterization and cardiovascular diagnosis, 1992
Abrupt closure of the dilated segment occurs in approximately 4 to 7% of cases following conventi... more Abrupt closure of the dilated segment occurs in approximately 4 to 7% of cases following conventional percutaneous coronary angioplasty. Additional balloon angioplasty reverses roughly 40% of these closures, to yield an overall 1.6 to 3.4% rate of emergent surgery. The impact of new devices on the incidence and reversal rate of abrupt closure has not been examined. Abrupt closure occurred in 80 (4.2%) of 1,919 consecutive coronary angioplasties performed in our single center, 389 (20%) of which were performed using newer interventions (208 Palmaz-Schatz stents, 170 directional coronary atherectomies, and 11 elective laser balloon angioplasties). Abrupt closure was less frequent following newer coronary interventions (1.8%) compared to standard balloon angioplasty (4.9%, P < 0.01), possibly reflecting case selection. When abrupt closure did occur, percutaneous rescue was successful in 53 (66%) patients, including 42 (53%) who were rescued using standard or perfusion balloon angiop...
The aim was to test the hypothesis that acute intravenous cocaine administration can cause corona... more The aim was to test the hypothesis that acute intravenous cocaine administration can cause coronary microvascular constriction culminating in myocardial ischaemia and cardiogenic shock. Systemic haemodynamic variables and coronary blood flow were measured in 14 Yorkshire swine at baseline and following intravenous administration of 1, 3, and 10 mg.kg-1 of cocaine. Epicardial coronary artery diameter was measured from coronary arteriograms and coronary flow velocity was recorded with a Doppler flow wire. Cocaine produced a decrease in mean arterial pressure (65%), cardiac output (80%), and stroke volume (80%), and an increase in pulmonary artery diastolic pressure (60%). Although coronary blood flow decreased by 70%, epicardial coronary cross sectional area decreased by only 37-45%. Pretreatment with prazosin did not abolish the decrease in coronary blood flow. After administration of 10 mg.kg-1 of cocaine, five of 14 animals developed myocardial ischaemia and cardiogenic shock, culminating in ventricular fibrillation and death. In anaesthetised Yorkshire swine, cumulative intravenous doses of cocaine caused a significant reduction in coronary blood flow resulting in myocardial ischaemia, which cannot be attributed to epicardial vasoconstriction alone. This suggest that cocaine-induced coronary ischaemia may result from microvascular constriction, which is only partially prevented by alpha 1 blockade. In addition, direct toxic effects of cocaine on the myocardium may also contribute to the development of cardiogenic shock.
Less than a year after their release, drug-eluting stents are being used in more than 70% of pati... more Less than a year after their release, drug-eluting stents are being used in more than 70% of patients who undergo percutaneous intervention for obstructive coronary disease in the United States. This unprecedented quick adoption was fueled by results of several randomized trials that demonstrated a profound reduction in restenosis rates compared with bare-metal stents. Subset analysis of the drug-eluting stent trials shows a strong restenosis reduction rate across a wide range of patient characteristics; however, these broad beneficial effects are based on randomized subjects who may not represent the actual population currently being treated with coronary stents. This review presents an analysis of the available data on the approved drug-eluting stents, including patient subsets that may or may not benefit; potential stent-specific complications; and a discussion of costs, risks, and cost-effectiveness.
Background. For minimally invasive cardiac operations to be widely applicable, the risks must be ... more Background. For minimally invasive cardiac operations to be widely applicable, the risks must be equivalent to those of standard open-chest operations. This study analyzed the outcomes of patients recorded in the multicenter Port Access (PA) International Registry to establish operative risks.
Patients with chronic kidney disease have high rates of myocardial infarction and death following... more Patients with chronic kidney disease have high rates of myocardial infarction and death following an initial attack. Proximal location of coronary atherosclerotic lesions has been linked to the risk of acute myocardial infarction and to infarction-associated mortality. To examine if the spatial distribution of lesions differs in patients with and without chronic kidney disease, we used quantitative coronary angiography to
The purpose of this research was to determine the relative safety and efficacy of multiple (≥2) o... more The purpose of this research was to determine the relative safety and efficacy of multiple (≥2) overlapping Cypher sirolimus-eluting stents (SES) (Johnson & Johnson, New Brunswick, New Jersey).Overlapping coronary stents are common. The periprocedural and late clinical and angiographic consequences of overlapped coronary stents are not clearly defined, particularly for drug-eluting stents.All patients enrolled into five clinical trials of the SES were analyzed. Three of these trials were prospective randomized comparisons of the SES to the bare-metal stent (BMS), and two were prospective non-randomized trials of SES-treated patients with historical controls. All clinical and angiographic outcomes in overlap-stent–treated patients were compared by stent type and with single-stent–treated patients for the same stent device.In all, 575 patients with stent overlap (337 SES, 238 BMS) and 1,162 patients with single stents (697 SES, 465 BMS) were analyzed. Stent overlap was associated with a greater late lumen loss in stent and more frequent angiographic restenosis regardless of stent type. Among overlap-stent–treated patients, the SES provided similar magnitude of restenosis benefit as observed for single-stent–treated patients. Overlapped SES was not associated with an increase in myocardial infarction.The strategy of SES overlap, when required, is both safe and efficacious in reducing restenosis with no increase in the incidence of myocardial infarction or major adverse cardiovascular events, when compared with a bare metal coronary stent prosthesis.
Catheterization and Cardiovascular Diagnosis, 1991
Distal microvascular spasm Is a somewhat uncommon occurrence following PTCA and often does not re... more Distal microvascular spasm Is a somewhat uncommon occurrence following PTCA and often does not respond well to nitroglycerin. We report several patients who developed distal microvascular spasm that was refractory to intracoronary nitroglycerin but responded promptly to intracoronary verapamll.
Catheterization and Cardiovascular Diagnosis, 1994
Restenosis rates following Palmaz-Schatz stenting vary between 13 and 36%. To determine whether t... more Restenosis rates following Palmaz-Schatz stenting vary between 13 and 36%. To determine whether the nearly three-fold interseries difference in restenosis rates reflects systematic factors (demographic and procedural variables such as post-treatment lumen diameter) rather than random variation, we pooled 486 lesions treated with the Palmaz-Schatz coronary stent in the US. Multicenter Registry (n = 259) with the singlecenter Beth Israel Hospital experience (n = 227) and analyzed the combined series using a continuous geometric model of restenosis.
Catheterization and cardiovascular diagnosis, 1991
During the initial perioperative period (1 mo to 1 yr) after saphenous vein coronary grafting, ea... more During the initial perioperative period (1 mo to 1 yr) after saphenous vein coronary grafting, early stenosis and occlusion occurs in 5-8% of grafts due to intimal hyperplasia. We report a patient who developed ostial stenosis within 4 mo of bypass surgery at the aortotomy site of two vein grafts. Balloon angioplasty of the elastic stenoses did not provide significant luminal enlargement, but successful treatment of the lesions was obtained using directional atherectomy. Histological examination demonstrated intimal hyperplasia. Directional atherectomy may be an excellent technique for treatment of elastic ostial vein graft stenoses in lieu of conventional balloon dilatation.
Catheterization and Cardiovascular Diagnosis, 1992
Balloon aortic valvuloplasty (BAV) was performed in 219 elderly patients with aortic stenosis bet... more Balloon aortic valvuloplasty (BAV) was performed in 219 elderly patients with aortic stenosis between December 1985 and April 1990. Forty-three patients underwent repeat BAV for symptomatic restenosis of the aortic valve 13?8 mo following initial BAV. To evaluate the outcome following initial and repeat BAV, hemodynamic results were analyzed according to the following subgroups: BAV l-initial BAV for all patients (n =219); BAV 1 1-initial BAV in those who had only one BAV (n = 176); BAV 1 2-the initial BAV in those who had repeat BAV (n = 43); and BAV 2-repeat BAV (n = 43).
Background-Revascularization strategies often hinge on the presence and degree of left anterior d... more Background-Revascularization strategies often hinge on the presence and degree of left anterior descending coronary artery (LAD) stenosis. A decision for bypass surgery is often based on the durability of surgical LAD revascularization compared with percutaneous approaches. By decreasing restenosis, drug-eluting stents may have reduced the "reintervention gap" between surgery and percutaneous intervention, making the percutaneous route preferable. Methods and Results-Of the 1101 patients in the SIRIUS trial, 459 with an LAD stenosis were randomized to percutaneous intervention with either sirolimus-eluting or bare-metal stents. Baseline demographic, clinical, and angiographic data were obtained. Patients had 1-year clinical and 8-month angiographic follow-up. Baseline characteristics were similar in both groups. The majority of lesions were tubular type B lesions (69.7%) with a mean diameter of 2.73 mm and a mean length of 14.0 mm. The binary in-stent restenosis rate was 2% for the sirolimus stent group and 41.6% for the bare-metal arm (relative risk, 0.05; 95% CI, 0.02 to 0.1; PϽ0.001). One-year major adverse events (defined as cardiac death, Q-wave and non-Q-wave myocardial infarction, or target vessel revascularization) was decreased 59% in the sirolimus-stent group (9.8% versus 24.9%; relative risk, 0.39; 95% CI, 0.26 to 0.61; PϽ0.001). Subgroup analysis of 135 patients with proximal LAD lesions showed similar benefits. In-stent restenosis was 0 in the proximal LAD sirolimus-eluting group (nÏ67), compared with 38% in the bare-metal arm (nÏ68), and major adverse events demonstrated a similar trend, with a 50% decrease compared with control patients (10.4% versus 20.6%, PÏNS). Conclusions-Sirolimus-eluting stents significantly decrease revascularization rates in LAD lesions. At 1 year, sirolimuseluting stent revascularization rates are comparable to historic single vessel bypass surgery revascularization rates. (Circulation. 2004;110:374-379.) Key Words: angioplasty â…¢ stents â…¢ cardiovascular disease D espite advances in technology and numerous clinical trials, the choice of which revascularization strategy is best for patients with left anterior descending coronary artery (LAD) disease remains controversial. Bypass surgery provides the most benefit in patients with proximal LAD stenoses who receive arterial revascularization with a mammary artery conduit. Percutaneous intervention has failed to match the outcomes obtained with bypass surgery, primarily because of significant requirements for repeat revascularization procedures because of restenosis. 6 -8 Recently, sirolimus-eluting stents have been shown to dramatically reduce restenosis. This reduction in restenosis may have narrowed the "reintervention gap" enough to eliminate the major advantage of bypass surgery for the treatment of LAD disease. The objective of this study was to determine the clinical outcome after percutaneous intervention of the LAD with sirolimus-eluting stents. This analysis was composed of patients from a study of Sirolimus-Eluting Balloon-Expandable Stents in the Treatment of Patients with de novo Native Coronary Artery Lesions (the SIRIUS study). 10 Briefly, SIRIUS was a randomized, double-blind trial performed at 53 investigational sites and complied with the Declaration of Helsinki regarding investigation in humans. It was approved by the US Food and Drug Administration and the Institutional Review Board at each participating center. All patients gave written informed consent. Patients were eligible if they had a history of stable or unstable angina and signs of myocardial ischemia. In addition, patients were required to have a single de novo target lesion in a native coronary artery of 51% to 99% diameter stenosis and of 15 to 30 mm in length (visual angiographic estimates). Patients were excluded for recent myocardial infarction (within 48 hours), left ventricular ejection fraction Ͻ25%, or target lesions in a left main, ostial, or bifurcation location. Thrombotic and severely calcified lesions were also ex-
Smaller reference vessel diameter is a recognized determinant of in-stent restenosis. The SIRIUS ... more Smaller reference vessel diameter is a recognized determinant of in-stent restenosis. The SIRIUS 2.25 trial was a prospective, nonrandomized study including 100 patients (mean age 63.4 years; 64% men, 40% with diabetes mellitus) assessing the safety and efficacy of the 2.25-mm sirolimus-eluting Bx Velocity stent in patients with de novo native coronary lesions. Using propensity score matching for gender, diabetes mellitus, left anterior descending artery target vessel, lesion length, and reference vessel diameter, the outcomes were compared with historical control groups (angioplasty and Palmaz-Schatz stent arms from the STRESS/BENESTENT I/II trials and the Bx Velocity bare metal stent arm from the RAVEL and SIRIUS trials having a reference vessel diameter &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;3 mm). Use of the 2.25-mm sirolimus-eluting Bx Velocity stent was associated with a high rate of procedural success (97%) and a low rate of in-hospital major adverse cardiac events (2%). The primary end point, 6-month in-lesion binary angiographic restenosis, occurred less frequently in patients treated with the 2.25-mm sirolimus-eluting Bx Velocity stent than in each of 3 historical controls (16.9% vs 30.6%, p = 0.12; 36.5%, p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;0.001; 45.9%, p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;0.001, respectively). This translated into lower rates of 6-month target lesion revascularization in the 2.25-mm sirolimus-eluting Bx Velocity stent group (4.0% vs 15.0% in each of 3 control groups, p = 0.01 to &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;0.001). By multivariate analysis, in-lesion binary restenosis was predicted by multiple implanted stents (odds ratio 10.4, p = 0.002). Four of 13 patients who developed restenosis (30.8%) had a diffuse pattern of restenosis. In the long lesion tertile (mean lesion length 19.5 mm), the in-lesion binary restenosis rate was 27.6%. In conclusion, use of the 2.25-mm sirolimus-eluting Bx Velocity stent was safe and provided favorable 6-month clinical outcomes. Use of multiple stents (in longer lesions) was an independent predictor of in-lesion restenosis.
Journal of the American College of Cardiology, Jul 31, 1991
Laser balloon angioplasty combines conventional coronary angioplasty with laser energy to transie... more Laser balloon angioplasty combines conventional coronary angioplasty with laser energy to transiently heat vascular tissue. Laser balloon angioplasty was performed in 21 patients (aged 56 ± 13 years), including 10 patients treated urgently after acute failure of conventional angioplasty and 11 patients treated with elective laser balloon angioplasty. Immediately after conventional angioplasty, laser doses (1 to 10 doses of 205 to 380 J each) were delivered during inflation of the laser balloon to a pressure of 4 atm.
Background-Sirolimus-eluting stents (SESs) reduce angiographic restenosis in patients with focal,... more Background-Sirolimus-eluting stents (SESs) reduce angiographic restenosis in patients with focal, native coronary artery stenoses. This study evaluated the usefulness of SESs in complex native-vessel lesions at high risk for restenosis. Methods and Results-Angiographic follow-up at 240 days was obtained in 701 patients with long (15-to 25-mm) lesions in small-diameter (2.5-to 3.5-mm) native vessels who were randomly assigned to treatment with SESs or bare-metal stents (BMSs) in the SIRIUS trial. Quantitative angiographic measurements of minimal lumen diameter and percent diameter stenosis were obtained within the treated segment, within the stent, and within its 5-mm proximal and distal edges. Patients treated with SESs had lower rates of binary (Ͼ50% diameter stenosis) angiographic restenosis within the segment (8.9% versus 36.3% with the BMS; PϽ0.001) and within the stent (3.2% versus 35.4% with the BMS; PϽ0.001). SESs were associated with significantly less late lumen loss within the treated segment, within the stent, and within its 5-mm proximal and distal edges (all PϽ0.001). The reduction of restenosis with the SES was consistent in patients at risk for restenosis, including those with small vessels, long lesions, and diabetes mellitus. The frequency of late aneurysms was similar in the 2 groups. Conclusions-Compared with BMSs, SESs reduced angiographic late lumen loss within the stent and its adjacent 5-mm margins in patients with complex native-vessel lesions. (Circulation. 2004;110:3773-3780.)
Background-PTCA is performed primarily to improve health-related quality of life (HRQOL) in patie... more Background-PTCA is performed primarily to improve health-related quality of life (HRQOL) in patients with symptomatic coronary artery disease. In patients undergoing PTCA, smoking has been shown to increase risks of late myocardial infarction and death. Whether smoking also affects HRQOL after PTCA is currently unknown. Methods and Results-We examined the relation between smoking status and HRQOL among 1432 patients who underwent PTCA as part of 2 multicenter clinical trials. HRQOL was assessed with the use of the Medical Outcomes Study SF-36 questionnaire. Patients were classified as smokers (nÏ301), quitters (nÏ141), or nonsmokers (nÏ990) on the basis of their smoking status at the time of their index procedure and during the first year of follow-up. For the overall population, HRQOL improved significantly after PTCA for all scales except general health perception, with improvements ranging from 5.5 points for mental health to 23.2 points for role-physical functioning. After adjustment for baseline characteristics and initial HRQOL, nonsmokers had gains at 6 months that were larger than those of smokers for all health domains: physical function 15.4 versus 10.4 points), role-physical (24.5 versus 13.9), pain (18.4 versus 13.3), general health perception (1.7 versus Ϫ4.5), vitality (11.0 versus 4.7), social function (12.8 versus 3.5), role-emotional (13.5 versus 6.7), and mental health (6.8 versus 0.8; PϽ0.02 for all comparisons). Quitters had 6-month HRQOL improvements that were greater than those in smokers for all domains as well. Findings were similar at 1 year. Conclusions-Quality-of-life benefits of PTCA are diminished by continued smoking. Efforts to promote smoking cessation at the time of PTCA may substantially improve the health outcomes of these procedures. (Circulation. 2000;102:1369-1374.)
Background-Percutaneous coronary interventions (PCIs) in saphenous vein grafts (SVGs) with thromb... more Background-Percutaneous coronary interventions (PCIs) in saphenous vein grafts (SVGs) with thrombus have a high frequency of distal embolization. Acolysis (therapeutic ultrasound) can break up thrombus in vitro in animal models and humans. Whether this is beneficial during percutaneous SVG interventions is unknown. Methods and Results-We performed a trial of coronary ultrasound thrombolysis in which patients with an acute coronary syndrome undergoing PCI in SVGs were randomly assigned to receive acolysis or abciximab. The primary end point was a successful procedure, defined as final luminal diameter stenosis 30% or less with Thrombolysis In Myocardial Infarction grade 3 flow and freedom from major adverse cardiac events (composite of death, Q-wave, and non-Q-wave myocardial infarction [MI], emergency bypass procedure, disabling stroke, and target lesion revascularization). Of 181 enrolled, 92 received acolysis and 89 abciximab. Angiographic procedural success was achieved in 63% of acolysis patients and 82% of abciximab patients (PÏ0.008). Incidence of major adverse cardiac events at 30 days was 25% with acolysis and 12% with abciximab (PÏ0.036), attributable mainly to a greater frequency of non-Q-wave MI with acolysis (19.6% versus 7.9%, PÏ0.03). The incidence of Q-wave MI was also higher with acolysis (5.4% versus 2.2%, PÏnonsignificant). The primary end point was achieved in 53.8% of acolysis patients and 73.1% of abciximab patients (PÏ0.014).
Catheterization and cardiovascular diagnosis, 1996
Overnight chronic urokinase infusion was used to successfully treat thrombotic occlusion of a sap... more Overnight chronic urokinase infusion was used to successfully treat thrombotic occlusion of a saphenous vein graft. Following removal of the infusion catheter, a 3-cm linear thrombus was observed extending from the graft into the ascending aorta. This mobile thrombus was successfully treated with coumadinization for 9 wk. Potential preventive measures for this complication of indwelling catheters are discussed.
based on data derived from 9 multicenter trials, have recently reported in the Circulation that t... more based on data derived from 9 multicenter trials, have recently reported in the Circulation that the rate of target lesion revascularization (TLR) in patients undergoing contemporary percutaneous coronary intervention (PCI) was significantly lower in smokers despite the lack of differences regarding angiographic restenosis. 1 The subtitle of the article questions the possible existence of "another smoker's paradox."
Catheterization and cardiovascular diagnosis, 1992
Abrupt closure of the dilated segment occurs in approximately 4 to 7% of cases following conventi... more Abrupt closure of the dilated segment occurs in approximately 4 to 7% of cases following conventional percutaneous coronary angioplasty. Additional balloon angioplasty reverses roughly 40% of these closures, to yield an overall 1.6 to 3.4% rate of emergent surgery. The impact of new devices on the incidence and reversal rate of abrupt closure has not been examined. Abrupt closure occurred in 80 (4.2%) of 1,919 consecutive coronary angioplasties performed in our single center, 389 (20%) of which were performed using newer interventions (208 Palmaz-Schatz stents, 170 directional coronary atherectomies, and 11 elective laser balloon angioplasties). Abrupt closure was less frequent following newer coronary interventions (1.8%) compared to standard balloon angioplasty (4.9%, P < 0.01), possibly reflecting case selection. When abrupt closure did occur, percutaneous rescue was successful in 53 (66%) patients, including 42 (53%) who were rescued using standard or perfusion balloon angiop...
The aim was to test the hypothesis that acute intravenous cocaine administration can cause corona... more The aim was to test the hypothesis that acute intravenous cocaine administration can cause coronary microvascular constriction culminating in myocardial ischaemia and cardiogenic shock. Systemic haemodynamic variables and coronary blood flow were measured in 14 Yorkshire swine at baseline and following intravenous administration of 1, 3, and 10 mg.kg-1 of cocaine. Epicardial coronary artery diameter was measured from coronary arteriograms and coronary flow velocity was recorded with a Doppler flow wire. Cocaine produced a decrease in mean arterial pressure (65%), cardiac output (80%), and stroke volume (80%), and an increase in pulmonary artery diastolic pressure (60%). Although coronary blood flow decreased by 70%, epicardial coronary cross sectional area decreased by only 37-45%. Pretreatment with prazosin did not abolish the decrease in coronary blood flow. After administration of 10 mg.kg-1 of cocaine, five of 14 animals developed myocardial ischaemia and cardiogenic shock, culminating in ventricular fibrillation and death. In anaesthetised Yorkshire swine, cumulative intravenous doses of cocaine caused a significant reduction in coronary blood flow resulting in myocardial ischaemia, which cannot be attributed to epicardial vasoconstriction alone. This suggest that cocaine-induced coronary ischaemia may result from microvascular constriction, which is only partially prevented by alpha 1 blockade. In addition, direct toxic effects of cocaine on the myocardium may also contribute to the development of cardiogenic shock.
Less than a year after their release, drug-eluting stents are being used in more than 70% of pati... more Less than a year after their release, drug-eluting stents are being used in more than 70% of patients who undergo percutaneous intervention for obstructive coronary disease in the United States. This unprecedented quick adoption was fueled by results of several randomized trials that demonstrated a profound reduction in restenosis rates compared with bare-metal stents. Subset analysis of the drug-eluting stent trials shows a strong restenosis reduction rate across a wide range of patient characteristics; however, these broad beneficial effects are based on randomized subjects who may not represent the actual population currently being treated with coronary stents. This review presents an analysis of the available data on the approved drug-eluting stents, including patient subsets that may or may not benefit; potential stent-specific complications; and a discussion of costs, risks, and cost-effectiveness.
Background. For minimally invasive cardiac operations to be widely applicable, the risks must be ... more Background. For minimally invasive cardiac operations to be widely applicable, the risks must be equivalent to those of standard open-chest operations. This study analyzed the outcomes of patients recorded in the multicenter Port Access (PA) International Registry to establish operative risks.
Patients with chronic kidney disease have high rates of myocardial infarction and death following... more Patients with chronic kidney disease have high rates of myocardial infarction and death following an initial attack. Proximal location of coronary atherosclerotic lesions has been linked to the risk of acute myocardial infarction and to infarction-associated mortality. To examine if the spatial distribution of lesions differs in patients with and without chronic kidney disease, we used quantitative coronary angiography to
The purpose of this research was to determine the relative safety and efficacy of multiple (≥2) o... more The purpose of this research was to determine the relative safety and efficacy of multiple (≥2) overlapping Cypher sirolimus-eluting stents (SES) (Johnson & Johnson, New Brunswick, New Jersey).Overlapping coronary stents are common. The periprocedural and late clinical and angiographic consequences of overlapped coronary stents are not clearly defined, particularly for drug-eluting stents.All patients enrolled into five clinical trials of the SES were analyzed. Three of these trials were prospective randomized comparisons of the SES to the bare-metal stent (BMS), and two were prospective non-randomized trials of SES-treated patients with historical controls. All clinical and angiographic outcomes in overlap-stent–treated patients were compared by stent type and with single-stent–treated patients for the same stent device.In all, 575 patients with stent overlap (337 SES, 238 BMS) and 1,162 patients with single stents (697 SES, 465 BMS) were analyzed. Stent overlap was associated with a greater late lumen loss in stent and more frequent angiographic restenosis regardless of stent type. Among overlap-stent–treated patients, the SES provided similar magnitude of restenosis benefit as observed for single-stent–treated patients. Overlapped SES was not associated with an increase in myocardial infarction.The strategy of SES overlap, when required, is both safe and efficacious in reducing restenosis with no increase in the incidence of myocardial infarction or major adverse cardiovascular events, when compared with a bare metal coronary stent prosthesis.
Catheterization and Cardiovascular Diagnosis, 1991
Distal microvascular spasm Is a somewhat uncommon occurrence following PTCA and often does not re... more Distal microvascular spasm Is a somewhat uncommon occurrence following PTCA and often does not respond well to nitroglycerin. We report several patients who developed distal microvascular spasm that was refractory to intracoronary nitroglycerin but responded promptly to intracoronary verapamll.
Catheterization and Cardiovascular Diagnosis, 1994
Restenosis rates following Palmaz-Schatz stenting vary between 13 and 36%. To determine whether t... more Restenosis rates following Palmaz-Schatz stenting vary between 13 and 36%. To determine whether the nearly three-fold interseries difference in restenosis rates reflects systematic factors (demographic and procedural variables such as post-treatment lumen diameter) rather than random variation, we pooled 486 lesions treated with the Palmaz-Schatz coronary stent in the US. Multicenter Registry (n = 259) with the singlecenter Beth Israel Hospital experience (n = 227) and analyzed the combined series using a continuous geometric model of restenosis.
Catheterization and cardiovascular diagnosis, 1991
During the initial perioperative period (1 mo to 1 yr) after saphenous vein coronary grafting, ea... more During the initial perioperative period (1 mo to 1 yr) after saphenous vein coronary grafting, early stenosis and occlusion occurs in 5-8% of grafts due to intimal hyperplasia. We report a patient who developed ostial stenosis within 4 mo of bypass surgery at the aortotomy site of two vein grafts. Balloon angioplasty of the elastic stenoses did not provide significant luminal enlargement, but successful treatment of the lesions was obtained using directional atherectomy. Histological examination demonstrated intimal hyperplasia. Directional atherectomy may be an excellent technique for treatment of elastic ostial vein graft stenoses in lieu of conventional balloon dilatation.
Catheterization and Cardiovascular Diagnosis, 1992
Balloon aortic valvuloplasty (BAV) was performed in 219 elderly patients with aortic stenosis bet... more Balloon aortic valvuloplasty (BAV) was performed in 219 elderly patients with aortic stenosis between December 1985 and April 1990. Forty-three patients underwent repeat BAV for symptomatic restenosis of the aortic valve 13?8 mo following initial BAV. To evaluate the outcome following initial and repeat BAV, hemodynamic results were analyzed according to the following subgroups: BAV l-initial BAV for all patients (n =219); BAV 1 1-initial BAV in those who had only one BAV (n = 176); BAV 1 2-the initial BAV in those who had repeat BAV (n = 43); and BAV 2-repeat BAV (n = 43).
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Papers by Richard Kuntz