Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: A meta-analysis

stent thrombosis and associated MACE argue that the goal for paclitaxel delivery is transient and low-level paclitaxel release as opposed to the QuaDDS design with protracted and high-dose release of 7-hexanoyltaxol. DM

sion in patients undergoing percutaneous transfemoral coronary procedures? Methods: The study design was a meta-analysis of randomized, case-control, and cohort studies comparing ACDs versus mechanical compression in patients undergoing diagnostic cardiac catheterization or percutaneous coronary intervention (PCI). The primary end point was the cumulative incidence of vascular complications, including pseudoaneurysm, arteriovenous fistula, retroperitoneal hematoma, femoral artery thrombosis, surgical vascular repair, access site infection, and blood transfusion. Multiple analyses were performed by pooling observational studies or randomized clinical trials in PCI patients, in patients undergoing diagnostic cardiac catheterization (Dx), and in all patients (diagnostic and PCI). The ACDs evaluated included Perclose, Angio-Seal and VasoSeal. Results: A total of 30 studies involving 37,066 patients were identified. When compared with mechanical compression, there was no difference in the risk of vascular complications in patients treated with Angio-Seal in the Dx setting (odds ratio [OR], 1.08; 95% confidence interval [CI], 0.11–10.0) or PCI setting (OR, 0.86; 95% CI, 0.65–1.12). Meta-analysis limited to randomized trials only showed a nonsignificant trend toward a lower risk of complications using Angio-Seal in the PCI setting (OR, 0.46; 95% CI, 0.20 –1.04; p⫽0.062). No significant differences were observed with Perclose in either Dx (OR, 1.51; 95% CI, 0.24 –9.47) or PCI (OR, 1.21; 95% CI, 0.94 –1.54) setting. An increased risk of complications was found with VasoSeal in the PCI setting (OR, 2.25; 95% CI, 1.07– 4.71). The overall analysis favored mechanical compression over ACD (OR, 1.34; 95% CI, 1.01–1.79 for ACDs vs. mechanical compression). Conclusions: In the setting of Dx angiography, the risk of access-site-related complications was similar for ACDs compared with mechanical compression. In the setting of PCI, the rate of complications appeared higher with VasoSeal when compared with mechanical compression. Pooled data from observational studies and randomized clinical trials favor mechanical compression over ACDs. Perspective: The use of vascular closure devices continues to be controversial. To date, no study has been able to show a clear-cut reduction in vascular complications with ACDs, and, if anything, a few studies have shown that incidences of rare and potentially serious vascular complications such as arterial thrombosis, embolization and infection at the arteriotomy site are higher with the use of ACDs. The researches should be praised for performing such a thorough and comprehensive systematic review of published clinical trials and registries. Their analysis confirms the lack of benefit following employment of ACDs. MM

Oral Rapamycin to Inhibit Restenosis After Stenting of De Novo Coronary Lesions: The Oral Rapamune to Inhibit Restenosis (ORBIT) Study Waksman R, Ajani AE, Pichard AD, et al. J Am Coll Cardiol 2004;44:1386 –92. Study Question: The aim of this study was to establish safety and feasibility of oral rapamycin at two doses—2 mg and 5 mg—in achieving low rates of repeat target-lesion revascularization (TLR) in de novo native coronary artery lesions. Methods: Oral Rapamune to Inhibit Restenosis (ORBIT) was an open-label study of 60 patients with de novo lesions treated with bare metal stents in up to two vessels. After a loading dose of 5 mg, patients received either a daily dose of 2 mg (n⫽30) or 5 mg (n⫽30) for 30 days. Six-month angiographic, intravascular ultrasound (IVUS), and clinical follow-up were conducted. Results: Baseline clinical and procedural characteristics were similar: 10% of patients in the 2-mg group and 30% in the 5-mg group did not complete the course; 43% in the 2-mg group and 66% in the 5-mg group had side effects. At 6-month follow-up, late loss (0.6⫾0.5 mm vs. 0.7⫾0.5 mm; p⫽NS), in-stent binary restenosis (7.1% vs. 6.9%; p⫽NS), in-stent percent volume obstruction by IVUS (29% vs. 24%; p⫽NS), and clinically driven TLR (14.3% vs. 6.9%; p⫽NS) were similar in the 2-mg and 5-mg groups. Conclusions: Investigators conclude that oral rapamycin for the prevention of restenosis is safe, feasible, and associated with low rates of repeat revascularization. Perspective: In this preliminary analysis, oral rapamycin administration for the prevention of restenosis was safe and feasible. Lower rates of restenosis and later loss than anticipated were observed in both dosing strategies (without dose-response). The ORBIT II study, an international, multicenter, randomized trial, has been initiated and will determine whether systemic oral administration of rapamycin will be a therapeutic option for patients undergoing PCI. DM

Vascular Complications Associated With Arteriotomy Closure Devices in Patients Undergoing Percutaneous Coronary Procedures: A Meta-Analysis Nikolsky E, Mehran R, Halkin A, et al. J Am Coll Cardiol 2004;44:1200 –9. Study Question: What is the safety of arteriotomy closure devices (ACDs) when compared with mechanical compres-

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