Randomized trial of simple versus complex drug-eluting stenting for bifurcation lesions: the British Bifurcation Coronary Study: old, new, and evolving strategies.

BACKGROUND: The optimal strategy for treating coronary bifurcation lesions remains a subject of debate. With bare-metal stents, single-stent approaches appear to be superior to systematic 2-stent strategies. Drug-eluting stents, however, have low rates of restenosis and might offer improved outcomes with complex stenting techniques. METHODS AND RESULTS: Patients with significant coronary bifurcation lesions were randomized to either a simple or complex stenting strategy with drug-eluting stents. In the simple strategy, the main vessel was stented, followed by optional kissing balloon dilatation/T-stent. In the complex strategy, both vessels were systematically stented (culotte or crush techniques) with mandatory kissing balloon dilatation. Five hundred patients 64+/-10 years old were randomized; 77% were male. Eighty-two percent of lesions were true bifurcations (>50% narrowing in both vessels). In the simple group (n=250), 66 patients (26%) had kissing balloons in addition to main-vessel stenting, and 7 (3%) had T stenting. In the complex group (n=250), 89% of culotte (n=75) and 72% of crush (n=169) cases were completed successfully with final kissing balloon inflations. The primary end point (a composite at 9 months of death, myocardial infarction, and target-vessel failure) occurred in 8.0% of the simple group versus 15.2% of the complex group (hazard ratio 2.02, 95% confidence interval 1.17 to 3.47, P=0.009). Myocardial infarction occurred in 3.6% versus 11.2%, respectively (P=0.001), and in-hospital major adverse cardiovascular events occurred in 2.0% versus 8.0% (P=0.002), respectively. Procedure duration and x-ray dose favored the simple approach. CONCLUSIONS: When coronary bifurcation lesions are treated, a systematic 2-stent technique results in higher rates of in-hospital and 9-month major adverse cardiovascular events. This difference is largely driven by periprocedural myocardial infarction. Procedure duration is longer, and x-ray dose is higher. The provisional technique should remain the preferred strategy in the majority of cases. Clinical Trial Registration Information- URL: http://www.clinicaltrials.gov. Unique identifier: NCT 00351260.

Hospital and operator variations in drug-eluting stent use: a multi-level analysis of 5967 consecutive patients in Scotland.

OBJECTIVE: To determine whether drug-eluting stent (DES) use varies among Scottish hospitals, and the extent to which any variations are explained by differences between operators, patients and lesions. METHODS: Multi-level analysis of consecutive patients treated with percutaneous coronary intervention (PCI) between April 2005 and March 2006 in Scotland, using the Scottish Coronary Revascularization Registry. RESULTS: A total of 38 operators performed 5967 PCI procedures on 8489 lesions. Crude level of DES use was 47.6%, and the results varied among hospitals (range 30.6-61.8%, chi(2) = 341.6, P < 0.0001). There was significant between-operator variation in the null model. This was attenuated by the addition of hospital as a fixed effect. Nonetheless, the final model demonstrated significant between-operator variability [sigma(2) = 0.486 (0.249-0.971)] and between-hospital variation, after case-mix adjustment. CONCLUSIONS: Within Scotland, marked variation existed among hospitals in the use of DES. Operator was the most important factor at patient level, and hospital of treatment, rather than case-mix, was the most important modifier of between-operator variation. Patient selection for DES is complex and may contribute to much of the variations demonstrated. Consensus criteria would provide more detail than is included in current guidance, may aid decision-making for individual patients, reduce opportunity costs and ensure equity of access.

Drug-eluting stents versus bare-metal stents for off-label indications: a propensity score-matched outcome study.

BACKGROUND: The US Food and Drug Administration recently concluded that data on off-label drug-eluting stent (DES) safety are limited. However, in actual clinical practice, DES are often used for off-label indications, and observational studies demonstrate that complications are higher when compared with on-label use. We aimed to determine whether clinical outcomes differ after DES and bare-metal stent implantation in a patient cohort defined by DES off-label indications. METHODS AND RESULTS: We used the national revascularization registry in Scotland to identify patients who underwent coronary stenting for an off-label indication between January 2003 and September 2005. Individual-level linkage to comprehensive national admission and death databases was used to ascertain the end points of death, myocardial infarction, and target-vessel revascularization. We calculated propensity scores on the basis of clinical, demographic, and angiographic variables and matched DES to bare-metal stents on a 1:1 basis. The final study population consisted of 1642 patients, well matched for important covariables at baseline. Event-free survival was calculated over 24 months with the Kaplan-Meier method. All-cause death was more common after bare-metal stent implantation during follow-up (7.7% versus 6.6%; hazard ratio 0.63; 95% confidence interval, 0.40 to 0.99; P=0.04). No difference in the rates of myocardial infarction were noted (7.3% versus 7.5%; hazard ratio 1.02; 95% confidence interval, 0.69 to 1.54; P=0.92). Target-vessel revascularization was reduced in patients treated with DES (13.9% versus 10.7%; hazard ratio 0.67; 95% confidence interval, 0.49 to 0.93; P=0.02). CONCLUSIONS: At 24 months, patients treated with DES for off-label indications had lower rates of death and target-vessel revascularization and similar rates of myocardial infarction, as compared with patients treated with bare-metal stents.

Reduced vascular complications and length of stay with transradial rescue angioplasty for acute myocardial infarction.

OBJECTIVES: The aim of this study was to compare clinical outcomes for transradial and transfemoral percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction undergoing rescue angioplasty. BACKGROUND: Transfemoral percutaneous coronary intervention in patients with acute myocardial infarction treated with systemic thrombolysis is associated with a significant risk of vascular complications. A transradial approach may reduce vascular complications, improve mobilization and facilitate earlier discharge. METHODS: In a retrospective analysis, clinical outcomes for 287 consecutive patients undergoing rescue angioplasty for acute myocardial infarction were determined. Data were recorded using a standardized proforma and analyzed using SPSS. RESULTS: Procedural success was similar for the transradial and transfemoral routes (98% vs. 93%; P = 0.3). There was a reduction in vascular complications (0 (0%) vs. 32 (13%); P < 0.01) and post-procedural length of stay (7.0 +/- 7.9 vs. 7.9 +/- 5.6 days; P < 0.005) in the radial group when compared with the femoral group. There were no differences in procedural or in-hospital mortality, procedure duration, or radiation dose between the two groups. CONCLUSION: Rescue angioplasty performed via the radial artery is safe, effective, and associated with a reduction in vascular complications and length of hospital stay when compared with the femoral approach. These findings suggest that where facilities and experience allow rescue angioplasty in patients with acute myocardial infarction should be performed via the radial artery.

Randomized, controlled study of long-acting local anesthetic (levobupivacaine) in femoral artery sheath management during and after percutaneous coronary intervention.

OBJECTIVE: To assess the effect of long-acting local anesthetic (levobupivacaine) in addition to lidocaine for the management of femoral artery sheaths during and after percutaneous coronary intervention (PCI). BACKGROUND: Femoral artery sheaths are commonly used during PCI. Sheath removal is often delayed after the procedure by which time short-acting local anesthetic agents may no longer be effective. METHODS: Sixty patients were randomized to either usual care or the administration of local levobupivacaine after PCI. Patients were asked to report their pain experienced on a visual analogue score. RESULTS: Thirty patients received additional levobupivacaine (0.5%) and 30 received standard care. There were no procedural differences between the groups, except that more patients in the control group received intravenous (IV) morphine at the time of sheath removal. There was no difference between the control group and levobupivacaine group in pain scores at the time of sheath insertion. (2.0 +/- 0.4 versus 1.8 +/- 0.3; p = 0.80). Both groups recorded low pain scores while waiting for sheath removal, and the score was slightly (but not significantly) lower in the levobupivacaine group (1.3 +/- 0.2 versus 0.8 +/- 0.2; p = 0.09). Pain scores were lower in the levobupivacaine group during sheath removal 2.2 +/- 0.4 versus 1.1 +/- 0.2; p = 0.02). There were no differences in terms of blood pressure between the groups at any time point. CONCLUSIONS: Levobupivacaine reduced the need for IV opiate and provided better analgesia than lidocaine alone in patients undergoing PCI.