TCT-440 Two-year Clinical Outcomes Of Primary Stenting Of Totally Occluded Native Coronary Arteries III (PRISON III): A Randomized Comparison Of Sirolimus-Eluting Stent Implantation With Zotarolimus-Eluting Stent Implantation For The Treatment Of Total Coronary Occlusions

TCT-440 Two-year Clinical Outcomes Of Primary Stenting Of Totally Occluded Native Coronary Arteries III (PRISON III): A Randomized Comparison Of Sirolimus-Eluting Stent Implantation With Zotarolimus-Eluting Stent Implantation For The Treatment Of Total Coronary Occlusions

www.jacc.tctabstracts2012.com TUESDAY, OCTOBER 23, 8:00 AM–10:00 AM Chronic Total Occlusions Outcome Event rate 95% CI Studies Patients Lesions...

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TUESDAY, OCTOBER 23, 8:00 AM–10:00 AM

Chronic Total Occlusions

Outcome

Event rate 95% CI

Studies

Patients

Lesions

Death

65

19191

20050

64 (0.33%)

0.25 – 0.43%

Emergent coronary artery bypass graft surgery

65

19191

20050

23 (0.12%)

0.08 – 0.18%

Stroke

65

19191

20050

12 (0.06%)

0.03 – 0.11%

TCT-439

Myocardial infarction

54

15057

15519

413 (2.7%)

2.5 – 3.0%

Incidence of Procedural Complications in Patients Undergoing Percutaneous Coronary Chronic Total Occlusion Interventions: A Systematic Review and Meta-Analysis

Q Wave myocardial infarction

45

12692

13034

29 (0.2%)

0.2 – 0.3%

Vishal Patel1, Kimberly Brayton1, Owen Mogabgab1, Tesfaldet Michael2, Nathan Lo3, Mohammed Alomar4, Deborah Shorrock3, Shuaib Abdullah3, Subhash Banerjee5, Emmanouil Brilakis6 1 University of Texas at Southwestern, Dallas, TX, 2University of Texas Southwestern Medical Center & Dallas VA Medical Center, Dallas, TX, 3UTSW Medical Center/Dallas VAMC, Dallas, TX, 4Dallas VA Medical Center, Dallas, TX, 5UT Southwestern Medical Center and VA North Texas Health Care System, Dallas, TX, Dallas, TX, 6VA North Texas Healthcare System and UT Southwestern Medical Center, Dallas, USA

Coronary perforation (per lesion)

50

13365

14106

481 (3.4%)

3.1 – 3.7%

Tamponade

53

11841

12545

65 (0.5%)

0.4 – 0.7%

Acute Stent thrombosis

24

7331

7907

21 (0.3%)

0.2 – 0.4%

Vascular complication

15

7909

8054

44 (0.6%)

0.4 – 0.7%

Background: Successful percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) is associated with improvement in angina, left ventricular function, and increased survival. However, the safety profile of CTO PCI has been poorly studied. Methods: We conducted a systematic review and meta-analysis of 65 studies published between 2000 and 2011 reporting procedural complications of CTO PCI. Data on the frequency of death, emergent coronary artery bypass graft surgery (CABG), stroke, myocardial infarction (MI), perforation, tamponade, stent thrombosis, major vascular or bleeding events, contrast nephropathy, and radiation skin injury were collected. Results: We aggregated data from 19,191 patients who underwent CTO PCI of 20,050 target vessels. Mean age was 62.4 years, 82% were men, and 15% had prior CABG. The CTO artery was the right coronary (42%), left anterior descending (34%), circumflex (21%) or a bypass graft (0.6%). Angiographic success was achieved in 76.5% of patients. The incidence of procedural complications is shown in the Table. Compared to angiographically successful procedures, unsuccessful procedures had higher rates of death (0.42% vs 1.54%, p⬍0.0001), perforations (3.65% vs 10.70%, p⬍0.0001), and tamponade (0% vs 1.65%, p⬍0.0001). In patients with successful procedures there was a trend towards lower rates of emergent CABG (0.04% vs 0.17%, p⫽0.77), stroke (0.14% vs 0.54%, p⫽0.15), and Q wave MI (0.26% vs 0.54%, p⫽0.26). In 886 lesions treated with a retrograde approach, the success rate was 79.8% with no deaths and low rates of emergent CABG (0.17%) and tamponade (1.2%). Conclusions: This systematic review and meta-analysis of CTO PCI complications demonstrates low risk for major procedural complications suggesting that CTO PCI may be associated with a favorable risk/benefit profile.

Major bleed

14

7716

7886

58 (0.8%)

0.6 – 1%

Contrast nephropathy

13

4796

4995

165 (3.4%)

2.9 – 4.0%

Radiation injury

7

2857

2979

3 (0.1%)

0.02 – 0.3%

Hall D Tuesday, October 23, 2012, 8:00 AM–10:00 AM Abstract nos: 439-456

PO STERS

Event rate, n (%)

TCT-440 Two-year Clinical Outcomes Of Primary Stenting Of Totally Occluded Native Coronary Arteries III (PRISON III): A Randomized Comparison Of Sirolimus-Eluting Stent Implantation With Zotarolimus-Eluting Stent Implantation For The Treatment Of Total Coronary Occlusions. Koen Teeuwen1, Ben Van den Branden2, Jacques Koolen3, Jose Henriques4, Jan Tijssen4, Hans Kelder1, René Van der Schaaf5, Paul Vermeersch6, Benno Rensing1, Maarten j. Suttorp1 1 Sint Antonius Hospital, Nieuwegein, Netherlands, 2Amphia Hospital, Breda, Netherlands, 3catharina hospital eindhoven netherlands, Eindhoven, The Netherlands, 4Academic Medical Center - University of Amsterdam, Amsterdam, Netherlands, 5Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands, 6 ZNA Middelheim, Antwerp, Belgium Background: We conducted a randomized comparison of Sirolimus-eluting stents (SES) with two Zotarlimus-eluting stents (ZES; Endeavor and Resolute) after successful recanalization of total coronary occlusions (TCO). At 9 months, SES were superior to Endeavor ZES and comparable to Resolute ZES with regard to angiographic late lumen loss. We do not know whether this superior angiographic outcome translates into improved clinical outcomes at two-year follow-up. Methods: We performed clinical follow-up after two years in the PRISON III trial comparing SES versus ZES (Endeavor or Resolute) in two study phases. In the first phase, 51 patients were randomized to receive SES and 46 Endeavor ZES. In the second phase, 103 and 104 patients were randomized to SES or Resolute ZES, respectively. Results: The table shows the occurrence of clinical events at two-year. The right panel demonstrates the SES versus the Endeavor ZES comparison and the left panel SES versus the Resolute ZES. There was a trend towards less target lesion revascularisation (TLR; 9.8% vs. 17.4%, p⫽0.43) and target vessel failure (TVF; 11.8% vs. 17.4%, p⫽0.62) with SES compared to Endeavor ZES. No differences in TLR and TVF were observed between SES and Resolute ZES (6.8% vs. 4.8%, p⫽0.75; 6.8% vs. 6.7%, p⫽0.80). There were only a few cases of cardiac death, myocardial infarctions and probable or definitive stent thrombosis.

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JACC Vol 60/17/Suppl B

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October 22–26, 2012

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TCT Abstracts/POSTER/Chronic Total Occlusions

www.jacc.tctabstracts2012.com

TUESDAY, OCTOBER 23, 8:00 AM–10:00 AM

Clinical events at two-year follow-up

SES

Endeavor

pvalue

SES

Resolute

pvalue

(nⴝ51)

(nⴝ46)

(nⴝ103)

(nⴝ104)

Target lesion revascularization, n (%)

5 (9.8)

8 (17.4)

0.43

7 (6.8)

5 (4.8)

0.75

Target vessel failure, n (%)†

6 (11.8)

8 (17.4)

0.62

7 (6.8)

7 (6.7)

0.73

Composite of cardiac death and MI, n (%)

1 (2.0)

2 (4.3)

0.60

0

2 (1.9)

0.49

Definite or probable stent thrombosis, n (%)ⴱ

1 (2.0)

2 (4.3)

0.60

0

1 (0.9)

1.00

Conclusions: A proportion of CTOs cannot be revascularised by conventional means and therapeutic enhancement of the collateral circulation may offer a novel approach. We have demonstrated increased tubule formation in primary human ECs in response to FG-2216. This novel proof of concept study represents a significant step towards the development of therapeutic angiogenesis. We are collecting mechanistic data to confirm the action of FG-2216 and will test its use as a stent-based therapy in models of CTO. TCT-442

ⴱAccording to the ARC criteria. †Composite of cardiac death, myocardial infarctions (MI) and target vessel revascularization.

Conclusions: Our study data indicate that the worse performance of Endeavor ZES relative to SES in terms of late lumen loss, might translate in more clinical events. In contrast, SES and Resolute ZES both show excellent angiographic outcome resulting in comparable low clinical event rates after two years in patients treated for total coronary occlusions. TCT-441 Enhanced Endothelial Tubule Formation in Response to Proly-Hydroxylase Inhibitor FG-2216: A Step Towards Therapeutic Angiogenesis in Chronic Total Occlusions Georgina Barnett1, Benjamin Wrigley2, Damien Kelly2, Emily Flashman3, Christopher Schofield3, Anthony Gershlick2 1 University of Leicester, Leicester, United Kingdom, 2University Hospitals of Leicester, Leicester, United Kingdom, 3University of Oxford, Oxford, United Kingdom

Renato Valenti1, Rossella Marcucci1, Angela Migliorini1, Anna Maria Gori1, Nazario Carrabba1, Betti Giusti1, Giampaolo Cerisano1, Guido Parodi1, Rita Paniccia1, Rosanna Abbate2, David Antoniucci3 1 Careggi Hospital, Florence, Italy, 2Careggi Hospital, Florence , Italy, 3Careggi Hospital, Florence, Italy Background: There is evidence that clopidogrel nonresponsivenss is a strong marker of poor outcome in patients with coronary artery disease treated invasively. No data exist about the impact of high residual platelet reactivity (HRPR) after 600 mg clopidogrel loading on long-term clinical outcome in patients undergoing drug-eluting stent (DES) implantation for chronic total occlusion (CTO). Methods: The Florence CTO-PCI registry include consecutive patients treated for at least 1 CTO by DES supported percutaneous coronary intervention (PCI). Patients had prospective platelet reactivity assessment by light transmittance aggregometry after a loading dose of 600 mg of clopidogrel and using adenosine 5’-diphosphate (ADP) as agonist. HRPR was defined as aggregation by 10 ␮mol/L ADP ⱖ 70. Clopidogrel therapy 75 mg daily was recommended for at least 1 year. The end point of the study was long-term cardiac mortality. Cardiac survival was assessed by Kaplan-Meier estimation and independent predictors of cardiac mortality were evaluated by forward stepwise Cox regression analysis. Results: From 2005 to 2010, 713 consecutive patients underwent CTO PCI and had “in vitro” platelet reactivity assessment. A successful PCI was achieved in 569 patients (80%). The incidence of HRPR after clopidogrel loading was 18%. There were no significant differences in baseline characteristics between patients with HRPR and patients with low residual platelet reactivity (LRPR). Successful CTO-PCI rates were similar between groups (76% vs. 81%). The 2-year cardiac survival rate was 98 ⫾ 1% in the LRPR group and 79 ⫾ 7% in the HRPR group (p⬍0.001). By multivariable analysis, HRPR resulted as a independent predictor of cardiac death (HR 3.0; p⫽0.007); the others variables related to cardiac death were age (HR 1.1; p⫽0.001), left ventricular ejection fraction ⬍ 0.40 (HR 6.8; p⫽0.001) and diabetes (HR 2.4; p⫽0.033). Conclusions: HRPR after clopidogrel loading is a strong prognostic marker of increased risk of cardiac death in patients undergoing PCI for CTO. TCT-443 Predictors of Reocclusion After Successful Drug-Eluting Stent Supported Percutaneus Coronary Intervention for Chronic Total Occlusion Renato Valenti1, Ruben Vergara1, Angela Migliorini1, Nazario Carrabba1, Guido Parodi1, Giampaolo Cerisano1, Piergiovanni Buonamici1, David Antoniucci1 1 Careggi Hospital, Florence, Italy Background: Large registries have shown a survival benefit in patients with successful chronic total occlusion (CTO)-PCI as compared to unsuccessful and/or unattempted CTO-PCI. Sustained vessel patency may be considered as a main variable related to long-term survival. Few data exist about the angiographic outcome of patients who performed CTO-PCI, due to lack or very low angiographic follow-up rate of CTO registries. The aim of this study was to assess the incidence of reocclusion and identifications of predictors of angiographic failure after successful CTO-PCI in the drug-eluting stent (DES) era. Methods: From the large prospective Florence CTO-PCI registry, since 2004 to 2010, 1005 patients underwent a PCI for CTO (⬎3 months). The protocol treatment includes routine 6- to 9-month angiographic FU. Clinical, angiographic, and procedural variables were included into the model of multivariable binary logistic regression analysis for the identification of the predictors of reocclusion. Results: From January 2004 to December 2010 1,005 patients underwent a PCI attempt for at least 1 CTO (⬎3 months). Out of these, 770 (77%) had a successful PCI. Baseline and procedural characteristics: mean age 68 ⫾ 11, male 84%, diabetes 24%, previous myocardial infarction 51%, LVEF⬍0.40 37%, 3-vessel disease 50%, everolimus-eluting stent (EES) 36%, stent lenght ⬎40 mm 54%, long subintimal tracking and very distal re-entry (STAR) 4%. STAR technique was used exclusively after failed intraluminal anterograde or retrograde attempt. The angiographic FU rate was 80% (578 patients). Reocclusion rate was 7.6%, while binary restenosis (⬎50%) or reocclusion rate was 21%. EES, was associated with a significant lower re-occlusion rate than other DES (2.4% vs. 9.9%; p⫽0.001). A successful STAR technique was associated with a 55% of rocclusion rate (p⬍0.001). At multivariable analysis STAR technique (OR 32; p⬍0.001) and EES (OR 0.19; p⫽0.002) were independently related to the risk of reocclusion. Conclusions: Successful EES supported CTO-PCI is associated with a very high patency rate (97.6%). Successful STAR technique is associated with a very low mid-term patency rate whatever the type of stent used.

JACC Vol 60/17/Suppl B

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October 22–26, 2012

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TCT Abstracts/POSTER/Chronic Total Occlusions

B127

PO STERS

Background: Enhancement of coronary antegrade collateral vessels represents a potentially novel therapeutic option for the treatment of chronic total occlusions (CTO). We have investigated two prolyl-hydroxylase inhibitors (PHI) for their ability to stimulate endothelial angiogenesis via upregulation of hypoxia inducible factor. We previously reported that di-methyl oxalylglycine (DMOG) increased collateral neovascularisation in a porcine CTO model. We now describe the actions of FG-2216, another PHI which unlike DMOG has been previously used in anaemic renal patients. Methods: Low passage (p3) human umbilical vein endothelial cells (HUVECs) were cultured on growth factor reduced Matrigel in the presence of FG-2216 at a range of doses (from 0 to 500␮M). Endothelial cell (EC) tubule formation was measured at 6 hours by image analysis of photomicrographs (image J). Results: Compared to control, ECs treated with FG-2216 demonstrated an enhanced tubule formation on Matrigel with the number of internal loops formed by branching tubules increasing with dose, up to 500␮M (20.56 (0␮M) versus 107.3 (500␮M), p⬍0.05) (Figure).

The Impact of High Residual Platelet Reactivity After Clopidogrel Loading on Cardiac Mortality in Patients Treated by Percutaneous Coronary Intervention for Chronic Total Occlusion