CLINICAL STUDIES
Optimal coronary balloon angioplasty with provisional stenting versus primary stent (OCBAS)
Immediate and long-term follow-up results
Alfredo Rodríguez, MD, PhD, FACC*,
Francisco Ayala, MD*,
Victor Bernardi, MD*,
Omar Santaera, MD*,
Eugenio Marchand, MD*,
Cesar Pardiñas, MD*,
Carlos Mauvecin, MD*,
Daniel Vogel, MD*,
Lari C. Harrell, BS ,
Igor F. Palacios, MD, FACC on behalf of the OCBAS investigators
* Cardiac Unit Otamendi/Anchorena Hospital, Buenos Aires, Argentina
Cardiac Unit, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA
Manuscript received December 10, 1997;
revised manuscript received July 1, 1998,
accepted July 17, 1998.
Address for correspondence: Dr. Alfredo Rodríguez, Ayacucho 1547 10 "B," 1112 Buenos Aires, Argentina
selfcare{at}pinos.com
Objective. This study sought to compare two strategies of revascularization in patients obtaining a good immediate angiographic result after percutaneous transluminal coronary angioplasty (PTCA): elective stenting versus optimal PTCA. A good immediate angiographic result with provisional stenting was considered to occur only if early loss in minimal luminal diameter (MLD) was documented at 30 min post-PTCA angiography.
Background. Coronary stenting reduces restenosis in lesions exhibiting early deterioration (>0.3 mm) in MLD within the first 24 hours (early loss) after successful PTCA. Lesions with no early loss after PTCA have a low restenosis rate.
Methods. To compare angiographic restenosis and target vessel revascularization (TVR) of lesions treated with coronary stenting versus those treated with optimal PTCA, 116 patients were randomized to stent (n = 57) or to optimal PTCA (n = 59). After randomization in the PTCA group, 13.5% of the patients crossed over to stent due to early loss (provisional stenting).
Results. Baseline demographic and angiographic characteristics were similar in both groups of patients. At 7.6 months, 96.6% of the entire population had a follow-up angiographic study: 98.2% in the stent and 94.9% in the PTCA group. Immediate and follow-up angiographic data showed that acute gain was significantly higher in the stent than in the PTCA group (1.95 vs. 1.5 mm; p < 0.03). However, late loss was significantly higher in the stent than the PTCA group (0.63 ± 0.59 vs. 0.26 ± 0.44, respectively; p = 0.01). Hence, net gain with both techniques was similar (1.32 ± 0.3 vs. 1.24 ± 0.29 mm for the stent and the PTCA groups, respectively; p = NS). Angiographic restenosis rate at follow-up (19.2% in stent vs. 16.4% in PTCA; p = NS) and TVR (17.5% in stent vs. 13.5% in PTCA; p = NS) were similar. Furthermore, event-free survival was 80.8% in the stent versus 83.1% in the PTCA group (p = NS). Overall costs (hospital and follow-up) were US $591,740 in the stent versus US $398,480 in the PTCA group (p < 0.02).
Conclusions. The strategy of PTCA with delay angiogram and provisional stent if early loss occurs had similar restenosis rate and TVR, but lower cost than primary stenting after PTCA.
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Abbreviations and Acronyms
| | CABG | = coronary artery bypass graft | | MLD | = minimal luminal diameter | | OCBAS | = Optimal Coronary Balloon Angioplasty with Provisonal Stenting vs. Stent Trial | | PTCA | = percutaneous transluminal coronary angioplasty | | QCA | = quantitative coronary angiography | | TVR | = target vessel revascularization |
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