To visualize intracoronary lesions in patients with different clinical expressions of coronary disease, we performed coronary angioscopy during coronary-artery bypass surgery in 10 patients with unstable angina and 10 patients with stable coronary disease. We examined a total of 32 vessels, using flexible fiberoptic angioscopes. Twenty-two vessels had no acute intimal lesion; three had complex plaques, six had thrombi, and one had both. Coronary angiography correctly identified the absence of complex plaque and thrombus in 22 vessels, but it detected only one of four complex plaques and one of seven thrombi. On angioscopy, none of the 17 arteries in the patients with stable coronary disease had either a complex plaque or thrombus. In the "offending" arteries of the patients with unstable angina, all three patients with accelerated angina had complex plaques and all seven with angina at rest had thrombi. We conclude that angioscopy frequently reveals complex plaques or thrombi not detected by coronary angiography. Our observations suggest that anginal syndromes that are refractory to medical treatment can be caused by unstable pathologic processes in the intima. Ulceration of plaques may increase the frequency and severity of effort angina, and the subsequent development of partially occlusive thrombi may cause unstable rest angina.
Background-Fixed drug release kinetics and vessel wall partitioning may limit the effectiveness of drug-eluting stents.We report preliminary experience using a new coronary stent with programmable pharmacokinetics. Methods and Results-A newly designed metallic stent contains honeycombed strut elements with inlaid stacked layers of drug and polymer. In vitro studies evaluated recipes for loading paclitaxel to establish the parameters for controlling drug release. Manipulation of the layers of biodegradable polymer and drug allowed varying of the initial 24-hour burst release of paclitaxel from 69% to 8.6% (PϽ0.0001). Late release of drug could be adjusted dependently or independently of early burst release. A biphasic release profile was created by the addition of blank layers of polymer within the stack. In the 30-day porcine coronary model (nϭ17 pigs), there was a 70% reduction in late loss (0.3Ϯ0.5 versus 1.0Ϯ0.5 mm, Pϭ0.04), a 28% increase in luminal volume (132Ϯ12 versus 103Ϯ21 mm 3 , Pϭ0.02), and a 50% decrease in histological neointimal area (2.0Ϯ0.5 versus 4.0Ϯ1.6 mm 2 ; PϽ0.001) compared with bare metal controls. Temporal and regional variations in vascular healing were seen histologically. Conclusions-Layered polymer/drug inlay stent technology permits flexible and controllable pharmacokinetic profiles.Programmable, complex chemotherapy using this approach may be feasible for the treatment of cardiovascular disease.
This novel eluting stent platform, using an erodable polymer with complete elution of low doses of paclitaxel, is safe. The inhibition of the in-stent neointimal hyperplasia was best in the long release groups.
Seventy samples of human cadaver atherosclerotic aorta were irradiated in vitro using a 308 nm xenon chloride excimer laser. Energy per pulse, pulse duration and frequency were varied. For comparison, 60 segments were also irradiated with an argon ion and an Nd:YAG (neodymium:yttrium aluminum garnet) laser operated in the continuous mode. Tissue was fixed in formalin, sectioned and examined microscopically. The Nd:YAG and argon ion-irradiated tissue exhibited a central crater with irregular edges and concentric zones of thermal and blast injury. In contrast, the excimer laser-irradiated tissue had narrow deep incisions with minimal or no thermal injury. These preliminary experiments indicate that the excimer laser vaporizes tissue in a manner different from that of the continuous wave Nd:YAG or argon ion laser. The sharp incision margins and minimal damage to adjacent normal tissue suggest that the excimer laser is more desirable for general surgical and intravascular uses than are the conventionally used medical lasers.
Excimer laser angioplasty can be safely and effectively applied, even in a variety of complex lesions not well suited for percutaneous transluminal coronary angioplasty. These types may include aorto-ostial, long lesions, total occlusions crossable with a wire, diffuse disease and vein grafts. Most recent data show a trend for the selection of predominantly complex lesions and a reduction in the incidence of perforation. This procedure may broaden the therapeutic window for the interventional treatment of selected complex coronary artery disease.
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