Author + information
- Received January 13, 1994
- Revision received April 11, 1994
- Accepted June 2, 1994
- Published online November 1, 1994.
- Michael P. Savage, MD, FACCa,
- David L. Fischman, MD, FACCa,
- Richard A. Schatz, MD, FACCa,2,
- Paul S. Teirstein, MD, FACCa,
- Martin B. Leon, MD, FACCb,2,
- Donald Baim, MD, FACCc,
- Stephen G. Ellis, MD, FACCd,
- Eric J. Topol, MD, FACCd,
- John W. Hirshfeld, MD, FACCe,
- Michael W. Cleman, MD, FACCf,
- Maurice Buchbinder, MD, FACCg,
- Steven Bailey, MD, FACCh,
- Richard Heuser, MD, FACCi,
- Craig M. Walker, MD, FACCj,
- R.Charles Curry Jr., MD, FACCk,
- Sharon Gebhardt, RNa,
- Randal Rake, BSa,
- Sheldon Goldberg, MD, FACCa,∗,
- For the palmaz-schatz stent study groupa,1
- ↵∗Address for correspondence: Dr. Sheldon Goldberg, Jefferson Medical College, 1025 Walnut Street, Suite 403, Philadelphia, Pennsylvania 19107.
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.
↵2 Drs. Schatz and Leon are paid consultants of Johnson & Johnson Interventional Systems; Dr. Schatz has a royalty agreement with Johnson & Johnson.
↵1 A complete list of participating institutions and coinvestigators appears in Reference 6.
☆ This study was supported in part by a grant from Johnson & Johnson Interventional Systems, Warren, New Jersey.
- Received January 13, 1994.
- Revision received April 11, 1994.
- Accepted June 2, 1994.