Robert J Applegate

Journal - The Journal of invasive cardiology (United States )

Journal - The Journal of invasive cardiology (United States )

Abstract :

OBJECTIVES: The objective of the study was to assess the efficacy and safety of a novel vascular closure device, the Angio-Seal Evolution (EVCD), in patients undergoing routine cardiac catheterization (CATH) and intervention (PCI) via a retrograde femoral artery access. BACKGROUND: Successful use of current-generation vascular closure devices is highly dependent on operator methodology. To reduce dependence on operator technique, the EVCD was modified to automate the closure process, specifically the compaction of the extravascular collagen sponge that creates a sandwich under pressure against the intra-arterial anchor. METHODS: This was a prospective ten-site registry including 1,004 patients undergoing 1,010 procedures with in-laboratory closure using the EVCD after CATH and PCI. The primary outcome measure was the rate of major vascular complications, and secondary outcomes were deployment success, time to hemostasis and in-hospital rates of minor vascular complications through 30 days. Clinical trial identifier NCT 00817349. RESULTS: There were 575 CATH (56.9%) and 435 PCI (43.1%) closures. Overall deployment success was 99.7%; 99.8% for CATH and 99.5% for PCI. Major vascular complications occurred in 0.4% including 0.2% in CATH and 0.7% in PCI. Minor vascular complications occurred in 2.4%, with 0.5% for CATH and 4.9% for PCI. CONCLUSIONS: Automation of the anchor-collagen closure of femoral artery access sites with the Angio-Seal ECVD resulted in excellent efficacy and safety after routine cardiac catheterization and intervention.

Journal - The Journal of invasive cardiology (United States )

Journal - Journal of the American College of Cardiology

Abstract :

Objective: The aim was to compare 2-year outcomes with the routine useof drug-eluting stents (DES) (>75% "off-label") with a comparablegroup treated with bare-metal stents (BMS). Background: Safety concerns >1 year from implantation have been raisedabout DES used "off-label." There are limited data comparingDES and BMS in "off-label" patients. Methods: Clinical outcomes (nonfatal myocardial infarction [MI], all-causemortality) were assessed in 1,164 consecutive patients who receivedBMS in the year before introduction of DES at Wake Forest UniversityBaptist Medical Center and 1,285 consecutive patients who receivedDES after it became our routine choice. "On-label" stent usewas defined as treatment for a single de novo lesion <30mm, without recent MI or other major illnesses. Results: At 2 years, the hazard ratio for DES compared with BMS for nonfatalMI or death was 0.77 (95% confidence interval [CI] 0.62 to 0.95),for all-cause mortality 0.71 (0.54 to 0.92), and stent thrombosis(ST) 0.97 (0.49 to 1.91). "On-label" stent procedures were associatedwith lower risk of MI, death, and ST than "off-label" stentprocedures. For "off-label" stent procedures, the hazard ratiofor DES compared with BMS for nonfatal MI or death was 0.78(95% CI 0.62 to 0.98), all-cause mortality 0.72 (0.54 to 0.94),and ST 0.91 (0.46 to 1.80). The hazard of nonfatal MI or deathwas similar or lower for DES than BMS in high-risk subgroups,including renal failure and recent MI. Conclusions: The routine clinical use of drug-eluting stents for "off-label"indications was associated with lower nonfatal MI and deathat 2 years than in a comparable group of patients treated withBMS.Abbreviations: ARC = Academic Research Consortium • BMS = bare-metal stent(s) • DES = drug-eluting stent(s) • HR = hazard ratio • MI = myocardial infarction • ST = stent thrombosis

Journal - Journal of the American College of Cardiology

Abstract :

OBJECTIVES: The study assessed clinical outcomes of closure device use followingpercutaneous coronary revascularization using current standardsof anticoagulation and antiplatelet therapy. BACKGROUND: Evaluation of the outcomes of patients by use of vascular closuredevices during coronary interventions employing current standardsof anticoagulation and glycoprotein (GP) IIb/IIIa inhibitortherapy is limited. METHODS: We evaluated outcomes of 4,525 consecutive patients who underwentpercutaneous coronary intervention between July 1997 and April2000. All patients received anticoagulation with heparin andGP IIb/IIIa inhibitor therapy with abciximab. The closure methodwas manual in 1,824 patients, Angioseal in 524 patients andPerclose in 2,177 patients. Procedural and hospital vascularoutcomes were evaluated. RESULTS: Closure device success was 97.1% Angioseal and 94.1% Perclose(p < 0.05). Minor vascular complications occurred in 1.8%of manual patients, 1.1% of Angioseal patients and 1.2% of Perclosepatients (p = NS); major complications occurred in 1.3% of manualpatients, 1.1% of Angioseal patients and 1.0% of Perclose patients(p = NS). Multivariate logistic regression identified only closuredevice failure as an independent predictor of a vascular complication.In patients with successful closure with a device, minor complications(0.8% vs. 1.8%, p < 0.05) and any complication (1.5% vs.2.5%, p < 0.05) were reduced compared to manual compression. CONCLUSIONS: Arterial closure following coronary interventions using anticoagulationand GP IIb/IIIa inhibitor therapy can be safely and effectivelyperformed, with vascular complication rates similar to or lowerthan with manual pressure. Additionally, vascular complicationrates using GP IIb/IIIa inhibitor therapy regardless of themethod of arterial closure are equivalent to or lower than previouslypublished rates of vascular complications.Abbreviations: ACT • activated clotting time • GEE • generalized estimating equation • GP • glycoprotein • IV • intravenous • OR • odds ratio • PCI • percutaneous coronary intervention