Very long-term (15 to 23 years) outcomes of successful balloon angioplasty compared with bare metal coronary stenting

Abstract

Background: Target lesion revascularization (TLR) continues to occur beyond 4 years after bare metal stent (BMS) implantation. However, long-term outcomes after balloon angioplasty (BA) compared with BMS are currently unknown.

Methods and results: From 1989 to 1990, 659 patients (748 lesions) underwent successful BA with final balloon ≥3.0 mm excluding patients with acute myocardial infarction and were compared with 405 patients (424 lesions) with BMS implantation from June 1990 to 1993. Cumulative incidences of death and target lesion thrombosis (>1 year) were similar between the BA group and the BMS group (44.4% versus 45.4%, P=0.60; and 1.5% versus 0.7%, P=0.99; respectively). Cumulative incidence of TLR during overall follow-up was significantly higher after BA than after BMS implantation (44.6% versus 36.0%, P<0.001), whereas cumulative incidence of late TLR (>4 years) tended to be lower in the BA group than in the BMS group (16.3% versus 21.4%, P=0.16). Cumulative incidence of late TLR after BA was significantly lower in patients with small percent diameter stenosis (%DS) at early follow-up angiography compared with large %DS (14.5% versus 28.0%, P=0.02). In lesions with serial angiography, late lumen loss from early (6 to 14 months) to long-term (4 to 10 years) follow-up angiography was significantly smaller in the BA group (n=42) than in the BMS group (n=55) (-0.08±0.45 mm versus 0.11±0.46 mm, P=0.047).

Conclusions: Compared with BMS implantation, BA was associated with a trend for less late TLR beyond 4 years and with significantly smaller late lumen loss from early to long-term follow-up angiography.

Keywords: bare metal stent; coronary artery disease; late restenosis; percutaneous transluminal coronary angioplasty; prognosis.

Figure 1.

Study flow chart of patients in the BA group and the BMS group. AMI indicates acute myocardial infarction; BMS, bare-metal stents; BA, balloon angioplasty.

Figure 2.

Representative cases of balloon angioplasty. A, Angiograms of a patient with non-TLR and TLR; B, angiograms of a patient with thrombosis at the target lesion; C, angiograms of a patient with a myocardial infarction related to adjacent nontarget lesion; D, angiograms of a patient with late aneurysm formation that was not evident at 1 year. TLR indicates target lesion revascularization.

Figure 3.

A, Kaplan–Meier curves for all-cause death, cardiac death, and sudden death; B, Kaplan–Meier curves for the composite of death, myocardial infarction, coronary artery bypass grafting, and TLR and for the composite of death and myocardial infarction; C, Kaplan–Meier curves for TLR during overall follow-up; D, Kaplan–Meier curves for target lesion thrombosis beyond 1 year. BA indicates balloon angioplasty; BMS, bare metal stent; MI, myocardial infarction; TLR, target lesion revascularization; PCI, percutaneous coronary intervention; and CABG, coronary artery bypass grafting.

Figure 4.

A, Landmark analysis for late TLR comparing the BA group with the BMS group; B, landmark analysis for late TLR in dichotomized BA patients according to %DS at early follow-up angiography. BA indicates balloon angioplasty; BMS, bare metal stent; MI, myocardial infarction; TLR, target lesion revascularization; PCI, percutaneous coronary intervention; CABG, coronary artery bypass grafting; and %DS, percent diameter stenosis.

Figure 5.

Serial quantitative coronary angiographic analysis in the BA and in BMS groups. A, Patients with complete serial analysis; B, patients with paired angiograms at early and long-term follow-up; C, patients with paired angiograms at early and very long-term follow-up. BA indicates balloon angioplasty; BMS, bare metal stent; RD, reference diameter; and MLD, minimal luminal diameter.