Clinical Outcomes and OCT Analysis After Culotte Stenting With 2nd- and 3rd-Generation Everolimus-Eluting Stents: Two-Year Follow-Up of the CELTIC Bifurcation Study.

PURPOSE: The aim of this study was to provide 2-year clinical outcomes for patients with Medina 1,1,1 bifurcation lesions treated with a culotte technique, comparing Synergy and Xience drug eluting stent (DES) platforms. A sub-group analysis of 9-month Optical Coherence Tomography (OCT) was performed to assess stent healing. METHODS: A total of 170 patients with non-left main stem Medina 1,1,1 lesions, were randomized to treatment with Synergy or Xience DES. The primary outcome was a composite of death, myocardial infarction, stroke, target vessel failure, stent thrombosis and angiographic restenosis. Qualitative and quantitative analyses of 30 bifurcations were carried out on OCT images taken at 9-month follow-up. RESULTS: After 2 years, the primary outcome had occurred in 17.7% of patients in the Synergy group and 18.8% of patients in the Xience group. The non-inferiority test was met (p = 0.0055). MACCE occurred in 7.3% of all patients by 2 years. OCT analysis found smaller stent and lumen areas in patients treated with Synergy stents. There was a higher proportion of malapposed struts in patients treated with Xience stents. CONCLUSIONS: The first report of the CELTIC bifurcation study demonstrated a low MACCE rate after 9 months. There was little accrual of events after this timepoint. There was no difference in clinical outcomes between the platforms tested. OCT analysis demonstrated excellent healing of both platforms.

Culotte stenting for coronary bifurcation lesions with 2nd and 3rd generation everolimus-eluting stents: the CELTIC Bifurcation Study.

AIMS: The aim of this study was to provide contemporary outcome data for patients with de novo coronary disease and Medina 1,1,1 lesions who were treated with a culotte two-stent technique, and to compare the performance of two modern-generation drug-eluting stent (DES) platforms, the 3-connector XIENCE and the 2-connector SYNERGY. METHODS AND RESULTS: Patients with Medina 1,1,1 bifurcation lesions who had disease that was amenable to culotte stenting were randomised 1:1 to treatment with XIENCE or SYNERGY DES. A total of 170 patients were included. Technical success and final kissing balloon inflation occurred in >96% of cases. Major adverse cardiovascular or cerebrovascular events (MACCE: a composite of death, myocardial infarction [MI], cerebrovascular accident [CVA] and target vessel revascularisation [TVR]) occurred in 5.9% of patients by nine months. The primary endpoint was a composite of death, MI, CVA, target vessel failure (TVF), stent thrombosis and binary angiographic restenosis. At nine months, the primary endpoint occurred in 19% of XIENCE patients and 16% of SYNERGY patients (p=0.003 for non-inferiority for platform performance). CONCLUSIONS: MACCE rates for culotte stenting using contemporary everolimus-eluting DES are low at nine months. The XIENCE and SYNERGY stents demonstrated comparable performance for the primary endpoint.

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.

Vitamin E modulation of C-reactive protein in smokers with acute coronary syndromes.

Acute coronary syndromes are characterized by the expression of proinflammatory cytokines such as C-reactive protein (CRP). Sustained upregulation of inflammatory markers is associated with an adverse prognosis. Vitamin E is known to have significant anti-inflammatory properties and has been associated with a reduction in cardiovascular events in some studies of high-risk patients. The mechanism of benefit remains controversial. We conducted a randomized, double-blind placebo controlled trial of vitamin E 400 IU daily for 6 months in 110 patients with acute coronary syndromes. Serum samples were collected at enrollment and at 2, 4, and 6 months. CRP, interleukin-6 and the soluble cell adhesion molecules were measured. Vitamin E levels increased significantly in the treatment group (from 31 micromol/l at baseline to 51 micromol/l, p <.0001) and were unchanged in the placebo group (32 micromol/l at baseline to 34 micromol/l, p = NS). CRP levels fell in both the vitamin E group and the placebo group over the treatment period (from 17.2 +/- 2.9 to 6.1 +/- 0.8 mg/l and from 21.5 +/- 4.9 to 5.9 +/- 0.9 mg/l, p = NS for the difference between active and placebo groups). However, vitamin E treatment was associated with significantly lower 6 month CRP levels in smokers versus smokers on placebo (4.7 +/- 0.71 mg/l vs. 8.26 +/- 1.5 mg/l, p =.02). Vitamin E reduces CRP levels in smokers with acute coronary syndromes for up to 6 months after hospitalization.

Percutaneous treatment of coronary subclavian steal syndrome.

Coronary subclavian steal syndrome arises when a stenosis of the subclavian artery results in reduced antegrade or retrograde flow in an internal mammary artery with resultant coronary ischemia. This occurs in patients who have previously undergone surgical coronary revascularization utilizing an internal mammary artery graft. This syndrome can be successfully treated percutaneously with excellent immediate and long-term results.

Catheter-induced left main dissection: a treatment dilemma.

Diagnostic angiography is a routine diagnostic procedure in modern day cardiological practice. However, there are potential life threatening complications which can occasionally occur. We describe one such complication and detail the management and clinical outcome.

Impact of restenosis and disease progression on clinical outcome after multivessel stenting in diabetic patients.

Clinical outcome after percutaneous coronary intervention (PCI) is significantly worse in diabetic patients in comparison to nondiabetic patients. The subset of diabetic patients in the ARTS trial treated with multivessel stenting had the lowest 1-year event-free survival. We examined our experience of multivessel PCI in diabetics to assess clinical outcome outside clinical trials and to determine if repeat revascularizations are the result of restenosis or the progression of nontreated disease. Between January 2000 and December 2001, we performed multivessel PCI in 99 diabetic patients. Our group was well matched with those in the ARTS trial, with mean age of 69 +/- 8 years, male sex 70%, hypertension 68%, hypercholesterolemia 51%, and mean LV ejection fraction 60%. The mean number of diseased segments treated was 2.8 +/- 0.9 and 56% of the patients had three-vessel disease. There were 2.3 +/- 0.6 stents implanted per patient. Target vessels included the LAD in 90%, LCx in 77%, and the RCA in 87% of cases. The in-hospital MACE rate was 8%, which included eight nonfatal MI but no deaths or repeat revascularizations. After a mean follow-up of 14 +/- 8 months, there were 4 deaths (4%), no further MIs, and 21 (21%) repeat revascularizations (2 CABG; 19 PCI), giving a 1-year event-free survival of 67%. There were 18 repeat revascularizations (2 CABG; 16 PCI) for restenosis, but in 9 of the 18 (50%) patients treatment was also required for progression of disease. Three further patients had PCI for symptomatic disease progression without restenosis. Thus, disease progression contributed to 57% of repeat revascularization procedures. The medium- and longer-term success of multivessel PCI in diabetic patients is limited principally by the need for repeat revascularization. However, it is important to realize that these revascularizations are performed not only for restenosis but also for disease progression in more than 50% of patients. Consequently, even if drug-eluting stent technology can eliminate restenosis, disease progression will continue to impact the clinical outcome of diabetic patients after PCI.

Acute profound thrombocytopenia after use of eptifibatide for coronary stenting.

This is a case report of a patient who developed profound thrombocytopenia during treatment with eptifibatide after PCI of the mid right coronary artery.

Percutaneous intervention for atherosclerotic disease in saphenous vein grafts.

The long term benefit of coronary artery bypass surgery (CABG) is limited by development of atherosclerotic disease in the bypass conduits. Percutaneous revascularisation is frequently the preferred method of treated symptomatic saphenous vein graft (SVG) atherosclerotic disease. The immediate and long term results of percutaneous intervention for SVGs is reviewed. Therapeutic considerations as well as novel technical advances are overviewed