Why the study?
Is a handmade balloon expandable coil stent safe and effective for patients requiring coronary stenting?
Is a handmade balloon expandable coil stent safe and effective for patients requiring coronary stenting?
A handmade balloon expandable coil stent can be successfully and safely implanted at low cost, with no acute stent thrombosis observed in initial clinical experience.
May support bailout use of low-cost handmade stents; leaves open need for randomized trials to confirm safety and durability.
To defray the escalating cost of coronary stenting, we handmade a balloon expandable coil stent with stainless steel wire. Preliminary comparison with the Palmaz-Schatz stent showed that, when implanted in porcine iliac arteries, there was no difference in immediate angiographic results or in the degree of foreign body reaction at 6 wk. Subsequently, a total of 73 stents were implanted in 52 patients, either as a bailout device (54%) or for suboptimal angiographic results (46%). All but two implantations were successful. The postprocedural regimen consisted of heparin 1,000 IU/hr, aspirin 250 mg daily, and ticlopidine 500 mg daily. In-hospital complications were limited to two groin hematomas, one necessitating blood transfusion. Importantly, stent thrombosis was not observed. While 6-mo follow-up is pending, we already conclude that a balloon expandable coil stent can be handmade easily at low cost and implanted safely in patients.
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Scheerder et al. (1996) studied this question.
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