Continued benefit of coronary stenting versus balloon angioplasty: Five-year clinical follow-up of Benestent-I trial

Objectives This study sought to establish whether the early favorable resul ts in the Benestent-I randomized trial comparing elective Palmaz-Schatz ste nt implantation with balloon angioplasty in 516 patients with stable angina pectoris are maintained at 5 years. Background The size of the required sample was based on a 40% reduction in clinical events in the stent group. Seven months and one-year follow-up in this trial showed a decreased incidence of restenosis and clinical events i n patients randomized to stent implantation, Methods Data at five years were collected by outpatient visit, via telephon e and via the referring cardiologist. Three patients in the stent group and one in the percutaneous transluminal coronary angioplasty (PTCA) group wer e lost to follow-up at five years. Major clinical events, anginal status an d use of cardiac medication were recorded according to the intention to tre at principle. Results No significant differences were found in anginal status and use of cardiac medication between the two groups. In the PTCA group, 27.3% of pati ents underwent target lesion revascularization (TLR) versus 17.2% of patien ts in the stent group (p = 0.008). No significant differences in mortality (5.9% vs. 3.1%), cerebrovascular accident (0.8% vs. 1.2%), myocardial infar ction (9.4% vs. 6.3%) or coronary bypass surgery (11.7% vs. 9.8%) were foun d between the stent and PTCA groups, respectively. At five years, the event -free survival rate (59.8% vs. 65.6%; p = 0.20) between the stent and PTCA groups no longer achieved statistical significance. Conclusions The original 10% absolute difference in TLR in favor of the ste nt group has remained unchanged at five years, emphasizing the long-term st ability of the stented target site. (J Am Coll Cardiol 2001;37:1598-603) (C ) 2001 by the American College of Cardiology.