Michael W. Cleman
Yale University
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Featured researches published by Michael W. Cleman.
The New England Journal of Medicine | 1994
David L. Fischman; Martin B. Leon; Donald S. Baim; Richard A. Schatz; M. Savage; Ian M. Penn; Katherine M. Detre; Lisa Veltri; Donald R. Ricci; Masakiyo Nobuyoshi; Michael W. Cleman; Richard R. Heuser; David Almond; Paul S. Teirstein; R. David Fish; Antonio Colombo; Jeffrey A. Brinker; Jeffrey W. Moses; Alex Shaknovich; John W. Hirshfeld; Stephen Bailey; Stephen G. Ellis; Randal Rake; Sheldon Goldberg
BACKGROUND Coronary-stent placement is a new technique in which a balloon-expandable, stainless-steel, slotted tube is implanted at the site of a coronary stenosis. The purpose of this study was to compare the effects of stent placement and standard balloon angioplasty on angiographically detected restenosis and clinical outcomes. METHODS We randomly assigned 410 patients with symptomatic coronary disease to elective placement of a Palmaz-Schatz stent or to standard balloon angioplasty. Coronary angiography was performed at base line, immediately after the procedure, and six months later. RESULTS The patients who underwent stenting had a higher rate of procedural success than those who underwent standard balloon angioplasty (96.1 percent vs. 89.6 percent, P = 0.011), a larger immediate increase in the diameter of the lumen (1.72 +/- 0.46 vs. 1.23 +/- 0.48 mm, P < 0.001), and a larger luminal diameter immediately after the procedure (2.49 +/- 0.43 vs. 1.99 +/- 0.47 mm, P < 0.001). At six months, the patients with stented lesions continued to have a larger luminal diameter (1.74 +/- 0.60 vs. 1.56 +/- 0.65 mm, P = 0.007) and a lower rate of restenosis (31.6 percent vs. 42.1 percent, P = 0.046) than those treated with balloon angioplasty. There were no coronary events (death; myocardial infarction; coronary-artery bypass surgery; vessel closure, including stent thrombosis; or repeated angioplasty) in 80.5 percent of the patients in the stent group and 76.2 percent of those in the angioplasty group (P = 0.16). Revascularization of the original target lesion because of recurrent myocardial ischemia was performed less frequently in the stent group than in the angioplasty group (10.2 percent vs. 15.4 percent, P = 0.06). CONCLUSIONS In selected patients, placement of an intracoronary stent, as compared with balloon angioplasty, results in an improved rate of procedural success, a lower rate of angiographically detected restenosis, a similar rate of clinical events after six months, and a less frequent need for revascularization of the original coronary lesion.
The New England Journal of Medicine | 1997
M. Savage; John S. Douglas; David L. Fischman; Carl J. Pepine; Spencer B. King; Jeffrey A. Werner; Steven R. Bailey; Paul Overlie; Sarah H. Fenton; Jeffrey A. Brinker; Martin B. Leon; Sheldon Goldberg; Richard R. Heuser; Richard W. Smalling; Robert D. Safian; Michael W. Cleman; Maurice Buchbinder; David Snead; Randal Rake; Sharon Gebhardt
BACKGROUND Treatment of stenosis in saphenous-vein grafts after coronary-artery bypass surgery is a difficult challenge. The purpose of this study was to compare the effects of stent placement with those of balloon angioplasty on clinical and angiographic outcomes in patients with obstructive disease of saphenous-vein grafts. METHODS A total of 220 patients with new lesions in aortocoronary-venous bypass grafts were randomly assigned to placement of Palmaz-Schatz stents or standard balloon angioplasty. Coronary angiography was performed during the index procedure and six months later. RESULTS As compared with the patients assigned to angioplasty, those assigned to stenting had a higher rate of procedural efficacy, defined as a reduction in stenosis to less than 50 percent of the vessel diameter without a major cardiac complication (92 percent vs. 69 percent, P<0.001), but they had more frequent hemorrhagic complications (17 percent vs. 5 percent, P<0.01). Patients in the stent group had a larger mean (+/-SD) increase in luminal diameter immediately after the procedure (1.92+/-0.30 mm, as compared with 1.21+/-0.37 mm in the angioplasty group; P<0.001) and a greater mean net gain in luminal diameter at six months (0.85+/-0.96 vs. 0.54+/-0.91 mm, P=0.002). Restenosis occurred in 37 percent of the patients in the stent group and in 46 percent of the patients in the angioplasty group (P=0.24). The outcome in terms of freedom from death, myocardial infarction, repeated bypass surgery, or revascularization of the target lesion was significantly better in the stent group (73 percent vs. 58 percent, P = 0.03). CONCLUSIONS As compared with balloon angioplasty, stenting of selected venous bypass-graft lesions resulted in superior procedural outcomes, a larger gain in luminal diameter, and a reduction in major cardiac events. However, there was no significant benefit in the rate of angiographic restenosis, which was the primary end point of the study.
Journal of the American College of Cardiology | 1994
Michael P. Savage; David L. Fischman; Richard A. Schatz; Paul S. Teirstein; Martin B. Leon; Donald S. Baim; Stephen G. Ellis; Eric J. Topol; John W. Hirshfeld; Michael W. Cleman; Maurice Buchbinder; Steven R. Bailey; Richard R. Heuser; Craig M. Walker; R. Charles Curry; Sharon Gebhardt; Randal Rake; Sheldon Goldberg
Objectives. The purpose of this study was to examine the long-term clinical and angiographic outcome after coronary implantation. Background. Previous reports haw shown a discordance between the excellent initial angiographic results and subsequent adverse clinical events after coronary artery stenting. Methods. Single Palmaz-Schatz stents were electively implanted in the native coronary arteries of 300 consecutive patients. Angiograms were obtained at baseline, after balloon angioplasty, after stent implantation and at 6 months after implantation. Films were analyzed by a panel of engiographers utilizing en automated edge detection program, Clinical events, including death, myocardial infarction, coronary bypass surgery and repeat angioplasty, were recorded for 1 year. Results. Although there were no acute in-laboratory vessel closures, stent thrombosis occurred in 14 patients (4.7%) at a mean ±SD of 5 ± 3 days after implantation. Two hundred fifty-eight (90%) of 286 eligible patients had follow-up angiography at 6.1 ± 2.2 months after stent implantation. Minimal lumen diameter increased from 0.80 ± 039 mm at baseline to 1.65 +- 0.51 mm after angioplasty and further increased to 2.55 ± 0.49 mm after stent placement (p = 0.0001). At follow-up there was a 0.85-mm late loss in lumen diameter, with a final minimal lumen diameter at 6 months of 1.70 ± 0.71 mm. Restenosis, defined as ≥ 50% diameter stenosis at follow-up, occurred in 14% of patients with previously untreated lesions and in 39% of patients with previous angioplasty (p < 0.001). Clinical events after 1 year for the entire group of 300 patients included death in 0.7%, myocardial infarction in 3.7%, bypass grafting in 8% and repeat angioplasty in 13%. Freedom from any adverse clinical event was 80% for all treated patients and 87% for those with previously untreated lesions. Conclusions. Elective use of this balloon-expandable stent in the native coronary circulation is associated with a low restenosis rate by quantitative angiography in previously untreated lesions and a favorable clinical outcome with an excellent event-free survival rate at 1 year.
Circulation | 1995
David J. Cohen; Harlan M. Krumholz; Craig A Sukin; Kalon K.L. Ho; Richard B. Siegrist; Michael W. Cleman; Richard R. Heuser; Jeffrey A. Brinker; Jeffrey W. Moses; M. Savage; Katherine M. Detre; Martin B. Leon; Donald S. Baim
BACKGROUND Coronary stenting has been shown to improve initial success, reduce angiographic restenosis, and reduce the need for repeat revascularization compared with conventional balloon angioplasty (PTCA). Although previous studies have demonstrated that initial hospital costs for stenting are considerably higher than those for conventional PTCA, the impact of coronary stenting on long-term medical care costs remains unknown. METHODS AND RESULTS Between January 1991 and June 1993, 207 consecutive patients with symptomatic coronary disease requiring revascularization of a single coronary lesion were randomized to receive initial treatment by either PTCA (n = 105) or Palmaz-Schatz coronary stent implantation (n = 102) in the multicenter STRESS trial. Detailed resource utilization and cost data were collected for each patients initial hospitalization and for any subsequent hospital visits for 1 year after randomization. Compared with conventional angioplasty, coronary stenting resulted in additional catheterization laboratory costs, increased vascular complications, and longer length of stay. Initial hospital costs were thus approximately
Journal of the American College of Cardiology | 1995
S. Chiu Wong; Donald S. Baim; Richard A. Schatz; Paul S. Teirstein; Spencer B. King; R.Charles Curry; Richard R. Heuser; Stephen G. Ellis; Michael W. Cleman; Paul Overlie; John W. Hirshfeld; Craig M. Walker; Frank Litvack; Jeffrey A. Brinker; Maurice Buchbinder; Sheldon Goldberg; Ya Chien Chuang; Martin B. Leon
2200 higher for stenting than for PTCA (
Journal of the American College of Cardiology | 1998
M. Savage; David L. Fischman; Randal Rake; Martin B. Leon; Richard A. Schatz; Ian M. Penn; Masakiyo Nobuyoshi; Jeffrey W. Moses; John W. Hirshfeld; Richard R. Heuser; Donald S. Baim; Michael W. Cleman; Jeffrey A. Brinker; Sharon Gebhardt; Sheldon Goldberg
9738 +/- 3248 versus
Circulation | 1997
Louis I. Heller; Christopher U. Cates; Jeffrey J. Popma; Lawrence I. Deckelbaum; James Joye; Seth T. Dahlberg; Bernard J. Villegas; Anita Arnold; Robert Kipperman; W. Carter Grinstead; Sharon J. Balcom; Yunsheng Ma; Michael W. Cleman; Richard M. Steingart; Jeffrey A. Leppo
7505 +/- 5015; P < .001). Over the first year of follow-up, however, patients assigned to initial stenting were less likely to require rehospitalization for a cardiac condition and underwent fewer subsequent revascularization procedures. Follow-up medical care costs thus tended to be lower for stenting than for conventional angioplasty (
Journal of the American College of Cardiology | 1993
David L. Fischman; M. Savage; Martin B. Leon; Richard A. Schatz; Stephen G. Ellis; Michael W. Cleman; John W. Hirshfeld; Paul S. Teirstein; Steven R. Bailey; Craig M. Walker; Sheldon Goldberg
1918 +/- 4841 versus
Circulation | 1996
Daniel B. Mark; J. David Talley; Eric J. Topol; Lee Bowman; Lai Choi Lam; Keaven M. Anderson; James G. Jollis; Michael W. Cleman; Kerry L. Lee; Thomas Aversano; William J. Untereker; Linda Davidson-Ray; Robert M. Califf
3359 +/- 7100, P = .21). Nonetheless, cumulative 1-year medical care costs remained higher for patients undergoing initial stenting (
Journal of the American College of Cardiology | 1986
Daniel Wohlgelernter; Michael W. Cleman; H. Ainsley Highman; Robert C. Fetterman; James S. Duncan; Barry L. Zaret; C. Carl Jaffe
11,656 +/- 5674 versus