Limitations of embolic protection in saphenous vein graft intervention: insights from 202 consecutive patients.

Between January 2003 and September 2006, a total of 2,541 patients had percutaneous coronary intervention (PCI). Of these, 202 (226 grafts) had at least one saphenous vein graft (SVG) intervention. Adjunctive distal embolic protection (DEP) devices were attempted in 123 SVGs (54.4%). The 30-day major adverse cardiac event (occurrence of death, myocardial infarction, or target vessel revascularization) rate in the overall group was 11.9%. The presence of angiographic thrombus independently predicted DEP use while the presence of in-stent restenosis predicted no DEP use. Although the presence of all angiographic technical feasibility criteria independently predicted DEP use, only 72 (32.4%) and 33 (14.6%) of the SVGs would have been eligible for the occlusive balloon- and filter-based distal embolic criteria, respectively. The most common technical reason for ineligibility was a graft size smaller than 3.0 mm, followed by the lack of a long enough landing zone. In a subset of 21 (9.3%) completely occluded lesions which would have excluded DEP use, angiographic success was 66.7%, and that was predicated on successful debulking with rheolytic thrombectomy in 13 (61.9%) with subsequent DEP in 5 (23.8%). In conclusion, not all grafts can be protected, and even in those that can, such protection may be incomplete. Newer embolic protection devices, such as the Proxis((R)), were recently introduced to expand the applicability to a wider population of vein grafts. However, further design improvements such as device miniaturizations applicable to sub-3.0-mm vessels and better particle removing/filtering mechanisms are needed in order to expand the use of embolic protection to reduce the persistently high complication rates associated with this difficult- to-treat subset of patients.

Angiographic and clinical outcomes of bivalirudin versus heparin in patients with acute coronary syndrome undergoing percutaneous coronary intervention.

BACKGROUND: Heparin with adjunctive glycoprotein IIb/IIIa platelet receptor (GP IIb/IIIa) inhibitors has demonstrated its effectiveness in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). Bivalirudin, a direct thrombin inhibitor, has recently been shown to be an effective alternative for patients undergoing elective PCI. OBJECTIVES: To assess the angiographic and clinical outcomes of adjunctive pharmacological strategies in a high-risk population presenting with ACS. METHODS: Of 891 consecutive PCI patients with ACS, 304 received bivalirudin (60.5% male, 68+/-11 years) and were compared with 283 who received heparin (58.7% male, 66+/-12 years). A 30-day major adverse cardiac event was defined as the occurrence of cardiac death, nonfatal myocardial infarction, urgent revascularization or major hemorrhage. RESULTS: Adjunctive GP IIb/IIIa inhibitors were used in 14.1% of the bivalirudin group and in 72.4% of the heparin group (P<0.010). The occurrence of Thrombolysis In Myocardial Infarction (TIMI) flow less than grade 3 was lower and the achievement of angiographic success was higher in the bivalirudin group than in the heparin group (5.2% versus 8.2%, 94.7% versus 89.7%, P=0.039 and P<0.010, respectively). There was no difference between groups in the incidence of bleeding events (bivalirudin 2.0% versus heparin 3.5%, P not significant) and in 30-day major adverse cardiac events (bivalirudin 8.3% versus heparin 5.7%, P=0.223). CONCLUSIONS: In the high-risk cohort undergoing PCI, bivalirudin with provisional GP IIb/IIIa inhibitors achieved better angiographic results. Although not powered to show a difference, and while acknowledging that a selection bias could have affected the data, the present study showed that bivalirudin may be as clinically effective and safe as heparin with adjunctive GP IIb/IIIa inhibitors.

Study of antirestenosis with the BiodivYsio dexamethasone-eluting stent (STRIDE): a first-in-human multicenter pilot trial.

The aim of this multicenter pilot study was to evaluate the acute safety and efficacy of the dexamethasone-eluting stent (0.5 microg/mm(2) of stent) implanted in patients with de novo single-vessel disease. This study included 71 patients, 42% of whom had unstable angina pectoris. An appropriately sized BiodivYsio Matrix Lo stent loaded with a total dexamethasone dose of 0.5 microg/mm(2) of stent was used. Technical device success rate was 95%. Six-month MACE occurred in two patients (3.3%). Binary restenosis rate was 13.3%. Late loss was 0.45. Late loss and percent diameter stenosis were lower in the unstable angina pectoris patients compared to the stable patients (0.32 +/- 0.39 vs. 0.60 +/- 0.55 mm, P < 0.07, and 26.86 +/- 14 vs. 38.40 +/- 16%, P < 0.02). This study demonstrated the feasibility and safety of the implantation of a dexamethasone-eluting stent and its effect on in-stent neointimal hyperplasia.