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One-year follow-up of the Stent Restenosis (STRESS I) Study
C J George1, D S Baim, J A Brinker
1University of Pittsburg, Pennsylvania 15261, USA.
Insights
The Stent Restenosis Study (STRESS I) found no significant difference in clinical events between coronary stents and angioplasty after one year. This suggests elective stenting is as safe as angioplasty for treating coronary artery disease.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Device Research
Background:
- Coronary artery disease (CAD) remains a leading cause of mortality worldwide.
- Percutaneous coronary intervention (PCI) is a common treatment for CAD, with stenting and balloon angioplasty being primary methods.
- Early studies are crucial for understanding the long-term safety and efficacy of novel cardiovascular devices like coronary stents.
Purpose of the Study:
- To compare the 1-year safety and clinical outcomes of Palmaz-Schatz coronary stent implantation versus conventional balloon angioplasty (PTCA).
- To evaluate freedom from major adverse cardiac events (MACE) and need for revascularization in patients with symptomatic ischemic heart disease.
- To assess the incidence of restenosis and angina in the early experience with coronary stenting.
Main Methods:
- A randomized controlled trial (STRESS I) involving 407 patients with symptomatic ischemic heart disease and new native coronary lesions.
- Patients were assigned to either Palmaz-Schatz coronary stent implantation or conventional PTCA.
- Follow-up data, including clinical events and anginal status, were collected for up to 1 year post-procedure.
Main Results:
- At 1 year, freedom from all clinical events (death, myocardial infarction, revascularization) was 75% for stents and 70% for PTCA (not statistically significant).
- Freedom from death, myocardial infarction, or target lesion revascularization was 79% for stents versus 74% for PTCA (not statistically significant).
- Freedom from angina at 1 year was similar in both groups (84%), with no significant late adverse effects identified for stent implantation.
Conclusions:
- Elective coronary stenting demonstrated comparable safety to conventional balloon angioplasty at the 1-year follow-up in the STRESS I trial.
- While no significant differences were observed, the study's limitations include low statistical power and specific patient selection criteria.
- Further research with larger cohorts and diverse patient populations is warranted to confirm these findings and optimize anticoagulation strategies for stent procedures.
Abstract:
We present the completed 1-year follow-up results of the original Stent Restenosis Study (STRESS I), in which 407 patients with symptomatic ischemic heart disease and new lesions of the native coronary circulation were randomly assigned to treatment with either the Palmaz-Schatz coronary stent or conventional percutaneous transluminal coronary angioplasty (PTCA). The present study compares the safety of elective stenting to balloon angioplasty (PTCA) in terms of freedom from clinical events up to 1 year after treatment. Patients were enrolled and treated from January 1991 through February 1993, and follow-up data were collected and verified until July 1995. Ninety-seven percent of all patients had complete follow-up (deceased or alive with known clinical status) beyond 8 months, and 94% beyond 11 months. Anginal status between 9 to 15 months postprocedure was available for 78% of patients. At 1 year, 154 patients (75%) assigned to stent implantation and 141 (70%) to PTCA were free of all clinical events (death, myocardial infarction, or any revascularization procedure), and 162 stent patients (79%) and 149 PTCA patients (74%) were free from death, myocardial infarction, or target lesion revascularization. Symptom-driven target lesion revascularization occurred in 12% of the stent group versus 17% of the PTCA group. None of these differences in clinical events was statistically significant. Only 2 patients in the stent group and 7 in the PTCA group had a first event after 239 days, and freedom from angina at 1 year was reported in equal frequency in both groups (84%). There appear to be no late adverse effects of stent implantation. However, these results are limited by low statistical power, narrow patient selection, and the anticoagulation regimen used in the early experience with this device.