Balloon optimization versus stent study (BOSS): provisional stenting and early recoil after balloon angioplasty.

"Optimal" percutaneous transluminal coronary angioplasty (PTCA) may have a late restenosis rate similar to stenting. We sought to assess short- and long-term results of a provisional stenting/optimal PTCA approach compared with elective stenting in a prospective, randomized study. A total of 97 patients with discrete, de novo lesions in native coronary arteries > or =3 mm in diameter were randomized 2:1 in PTCA with prolonged perfusion balloon inflation (n = 66) versus elective stenting (n = 31). Recoil after PTCA was assessed by routine delayed angiograms (5 and 20 minutes). Cross over to stent was allowed for an inadequate result; there was no on-line quantitative angiography. An independent core angiographic laboratory assessed all results and evaluated the adequacy of the subjective interpretation. Within the PTCA arm, there were 24 (36%) crossovers to stenting (5 of 24 [21%] due to recoil), whereas 2 stents could not be delivered to the lesion and crossed over to PTCA. As assessed by quantitative angiography, baseline reference vessel diameters were similar between the PTCA and stent groups. The immediate lumen diameter achieved with PTCA was smaller than that achieved with stenting (2.18+/-0.49 vs. 2.44+/-0.38 mm, respectively, p = 0.01). There were no differences in angiographic results between elective and crossover stenting and there were no in-hospital complications in any patient. Target lesion revascularization at 8 months was 19% (n = 6) in the elective stent arm versus 21% (n = 14) in the PTCA arm, p = NS; respective rates in PTCA alone and crossed over-to-stent subsets were 23% (n = 10) versus 17% (n = 4), p = NS. Angiographic restenosis was 47% after elective stenting versus 38% after PTCA (intention to treat), p = NS. By received treatment, it was 41% (11 of 27) in the group treated with the PTCA versus 33% (5 of 15) in the crossover-to-stent arm (p = NS). Thus, provisional stenting can be safely performed in the treatment of discrete, native de novo lesions. Early recoil after PTCA cannot be reliably assessed without quantitative angiography.

Retrospective comparative study of primary intracoronary stenting versus balloon angioplasty for acute myocardial infarction.

Balloon angioplasty has been shown to be an effective therapy for the treatment of acute myocardial infarction but is associated with a high restenosis rate, substantial early recoil, persistent thrombus and need for intracoronary thrombolysis, and a high rate of reclosure. Because many of the limitations of balloon angioplasty in the noninfarction setting are addressed by intracoronary stenting, we examined the results of primary stenting of 18 consecutive patients treated for acute myocardial infarction, and compared the results to those achieved with primary balloon angioplasty in 18 prior cases. Despite the presence of thrombus prior to angioplasty in 13 of the stented patients, no intracoronary thrombolytic therapy was required. Mean percent stenosis using quantitative coronary angiography was 17.7 +/- 10.2% after primary stenting compared with 43.7 +/- 20.3% after primary balloon angioplasty (P < .001). One stent patient who had all anticoagulant and antiplatelet therapy withdrawn early suffered subacute thrombosis. Patients were followed up to 3 yr. Complications were similar in two groups. We conclude that primary stenting for acute myocardial infarction results in superior angiographic appearance as well as resolution of thrombus without the need for routine thrombolysis, and is associated with a low complication rate and excellent short-term clinical patency.