Predictors of Angiographic Outcomes Following In-Stent Restenosis Treatment With Paclitaxel-Eluting Balloons and Second-Generation Drug-Eluting Stents

Abstracts

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BACKGROUND:

In 2011, the FDA and Health Canada informed the public of post-marketing reports of myocardial infarction and stroke in users of varenicline, despite an absence of RCT data or biological rationale supporting increased risk. In December 2012, the FDA revised prescribing information based on the results of a meta-analysis of RCTs in the general population; although rare, cardiovascular (CV) events were numerically higher in the varenicline group. This difference was not statistically significant. Despite an FDA rapid assessment report in March 2013 indicating no difference in risk of CV events between varenicline and bupropion for smoking cessation, there remains concern about the CV safety of varenicline. METHODS: We examined the incidence of serious adverse events (SAEs) in the ongoing EVITA trial of patients motivated to quit smoking immediately post-ACS. Patients were randomized 1:1 to either varenicline or placebo for 12 weeks, and took at least one dose of study medication in-hospital. All SAEs underwent blinded adjudication. RESULTS: At the time of the blinded analysis, SAE data were available for 164 patients through 30 days following the 12week treatment period (approximately 16 weeks post-index ACS). Patients were predominantly male (74%) with a mean age of 56 years (SD¼9). Most were admitted with STEMI (58%) and underwent PCI during the index admission (82%). A total of 23 SAEs were experienced by 22 patients (11% of all patients) within 30 days of study medication discontinuation. This represents 8 patients (5%) with repeat ACS while taking the study medication; 4 patients with STEMI, including 2 early stent thromboses (one in a patient not compliant with ASA or clopidogrel), three patients with unstable angina, and 1 patient with NSTEMI. Four additional patients experienced CV events while taking the study medication, including ischemic cardiomyopathy, sick sinus syndrome, and a TIA. One patient had CHF onset 4 days after beginning the study medication, which led to his death 37 days later (18 days after study medication discontinuation). Median time to CV event from study medication initiation was 11 days (IQR 7,50). No events were considered related to the study medication by blinded adjudication. CONCLUSION: The incidence of CV events in this small, ongoing RCT appears to be consistent with expected CV risk in the post-ACS population. No signal to date is seen in this population, the most at-risk patients studied to date with varenicline. Table 1: Serious Adverse Events Within 30 days of study medication discontinuation n (%) Patients with any SAE*

22 (11.3)

Patients with any Cardiovascular Event

12 (7.3)

Cardiovascular Death

1 (0.6)

STEMI

4 (2.4)

NSTEMI

1 (0.6)

Unstable Angina

3 (1.8)

Other Cardiovascular ǂ

3 (1.8)

Patients with any Non-Cardiovascular Event^

11 (6.7)

*Breakdown categories do not sum to total patients with any SAE, as one patient experienced both a cardiovascular and a non-cardiovascular event. ǂ Ischemic cardiomyopathy, sick sinus syndrome , and a transient ischemic attack. ^Motor vehicle collision, melena, allergic reaction, hospitalization for bowel surgery, non -cardiac chest pain (2), acute exacerbation of COPD, exacerbation of rheumatoid arthritis, ruptured pseudoaneurysm, partial bowel obstruction, and peroneal embolus.

Canadian Cardiovascular Society (CCS) Poster CAD INTERVENTIONAL POSTER SESSION Saturday, October 19, 2013 498 PREDICTORS OF ANGIOGRAPHIC OUTCOMES FOLLOWING INSTENT RESTENOSIS TREATMENT WITH PACLITAXEL-ELUTING BALLOONS AND SECOND-GENERATION DRUG-ELUTING STENTS G Marquis Gravel, F Gobeil, N Noiseux, L Stevens, S Mansour Montréal, Québec BACKGROUND: Success of in-stent restenosis (ISR) treatment depends on angiographic lesion characteristics and comorbidities. The optimal treatment option for ISR between drug-eluting balloons (DEB) or drug-eluting stents (DES) is not well known. The objectives were to assess angiographic risk factors for adverse outcomes following ISR treatment, and to evaluate the use of DEB in this setting. METHODS: Multivariate binary logistic regression was performed to assess predictors of treatment success following ISR treatment in a cohort including 102 patients treated with paclitaxel-eluting balloons and 100 random patients treated with a second-generation DES between December 2009 and November 2012 in a Canadian tertiary center (mean follow-up: 169 months). The effect of using a DEB was adjusted for angiographic and clinical confounders. Mean age was 6511 years (p¼0.91). Indication for revascularisation was non-ST-elevation acute coronary syndrome in 145 cases (72%). Lesion localization was similar in both groups (p¼0.45): 4% left main, 33% LAD, 27% circumflex, and 37% RCA. ISR pattern was focal in 62% of patients in the DEB group, compared to 46% in the DES group (p¼0.02). RESULTS: Compared to diffuse, proliferative or occlusive lesions, a focal ISR was a protective factor against death (OR¼0.2 [95%CI: 0.1-0.7]; p¼0.01), and clinically-driven target-lesion revascularisation (TLR) (OR¼0.3 [95%CI: 0.10.9] p¼0.04) at follow-up, but not against MACE (death, non-fatal myocardial infarction [MI], and TLR) (p¼0.29), MI (p¼0.95), or 50% restenosis (p¼0.19). DEB/DES length was associated with MACE (OR¼1.0 [95%CI: 0.91.0]; p¼0.03), and death (OR¼0.9 [95%CI: 0.8-1.0]; p¼0.001), but not with TLR (p¼0.86), MI (p¼0.85), and 50% restenosis (p¼0.36). DEB/DES diameter, analyzed either as a continuous or as a dichotomous variable (3 mm versus <3 mm), was not associated with MACE, death, MI, TLR, and 50% restenosis (p>0.05 each). Presence of chronic kidney disease (CKD) was the only independent clinical or angiographic risk factor identified upon multivariate logistic regression for MACE (OR¼2.4 [95%CI: 1.05.3]; p¼0.04), and death (OR¼6.8 [95%CI: 2.1-21.3]; p¼0.001). MACE occurred in 25 patients (26%) in the DEB group, compared to 21 patients (24%) in the DES group (p¼0.80). Upon multivariate logistic regression adjusting for CKD, DEB/DES length, and focal ISR, DEB was not

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Canadian Journal of Cardiology Volume 29 2013

associated with MACE (OR¼0.8 [95%CI: 0.4-1.8]; p¼0.66) or death at follow-up (OR¼1.6 [95%CI: 0.5-5.9]; p¼0.45). CONCLUSION: Chronic kidney disease is an independent predictor of adverse outcomes following percutaneous treatment of ISR. The use of DEB appears safe, and as effective as DES for treatment of ISR when adjusted for confounders. Risk factors for MACE following percutaneous treatment of in-stent restenosis in all-comer patients Univariate

guidance was 1.1 ( SEM 0.03) versus 1.15 ( SEM 0.03) with US, p¼0.46. CONCLUSION: Use of US guidance to assist in TRA did not significantly reduce time to vascular access or the number of access attempts required. Our study does not support the routine use of US to assist in obtaining vascular access for TRA cases. The use of US to assist in obtaining TRA should therefore be reserved for selected cases only.

Multivariate

Odds ratio (95%CI)

p

Odds ratio (95%CI)

p

Age

1.0 (1.0-1.1)

0.05

1.0 (1.0-1.1)

0.38

Diabetes

2.3 (1.1-4.6)

0.02

2.0 (1.0-4.3)

0.06

CKD

3.1 (1.5-6.7)

0.03

2.4 (1.0-5.3)

0.04

Previous stroke

2.5 (1.0-6.5)

0.05

2.0 (0.7-5.6)

0.20

DEB/DES length (mm)

1.0 (0.9-1.0)

0.03

1.0 (0.9-1.0)

0.12

500 SHORTER DOOR TO BALLOON TIMES ARE EQUALLY IMPORTANT IN ELDERLY STEMI PATIENTS JG Abunassar, M Labinaz, DY So, A Dick, C Glover, M Froeschl, J Marquis, GA Wells, M Blondeau, MR Le May Ottawa, Ontario

499 ULTRASOUND GUIDANCE FOR VASCULAR ACCESS IN PATIENTS UNDERGOING CORONARY ANGIOGRAPHY VIA THE TRANSRADIAL APPROACH: A PROSPECTIVE CLINICAL STUDY A Camuglia, M Malak, S Preston, A Sharma, S Lavi London, Ontario BACKGROUND:

Transradial access (TRA) for invasive coronary assessment and percutaneous coronary intervention (PCI) has evolved as an alternative default strategy for vascular access to the femoral approach, and in many centres is used more frequently than femoral access. One of the barriers to more widespread adoption of TRA is achieving successful cannulation of the radial artery, both in a timely fashion, and with minimal needle passes so as to reduce the rate of arterial spasm. We sought to assess the value of using ultrasound (US) to improve these parameters. METHODS: We performed a prospective, single centre study of consecutive patients presenting for invasive coronary angiography (or PCI) via the transradial approach. The first phase of the study enrolled consecutive patients underwent TRA without the assistance of ultrasound (US) followed by consecutive patients who underwent TRA using US guidance. Primary outcome measures were time between commencing needle attempts for arterial access and sheath insertion, number of needle passes through the skin to achieve arterial access and number of artery punctures to secure access with wire and sheath. RESULTS: 200 consecutive patients were enrolled. 95 consecutive patients underwent TRA without US guidance followed by 105 patients with US assistance. There were no statistically significant differences in any of the primary outcome measures. Mean time between commencing needle attempts for arterial access to sheath insertion with no US guidance was 157 seconds ( SEM 11.13 seconds) versus 123 seconds ( SEM 10.14 seconds) with US, p¼0.16. Mean number of needle passes through the skin required with no US guidance was 3.26 ( SEM 0.34) versus 2.48 ( SEM 0.19) with US, p¼0.15. Mean number of arterial punctures with no US

BACKGROUND: Ideal reperfusion therapy in elderly patients remains controversial. We sought to compare the impact on 30-day mortality of shorter door-to-balloon time in elderly patients (age  75) presenting with ST-segment elevation myocardial infarction (STEMI) within the context of a regional primary percutaneous coronary intervention (PCI) program as compared to their younger cohorts. METHODS: We used the University of Ottawa Heart Institute database to identify patients with STEMI. We compared mortality at 30 days in patients  75 years of age who underwent primary PCI to those who were < 75 years of age and examined the relationship of door to balloon time on mortality in the two groups. RESULTS: Between July 2004 and May 2011, a total of 2,520 consecutive patients with confirmed STEMI were referred for primary PCI. Of these, 523 (20.8%) patients were 75 year old and 1997 (79.2%) patients were <75 year old. As compared to patients <75 years of age, mortality during the initial hospitalization was higher in the elderly patients, 12.0% vs. 2.8%; p<0.0001. Elderly patients also had higher rates of cardiogenic shock, 15.7 vs. 6.2; p<0.0001, stroke, 2.7% vs. 0.9%; p<0.0001 and TIMI major bleeding, 8.9% vs. 4.5%; p¼0.001. Mortality remained higher in the elderly at 30 days, 13.0% vs. 3.1%; p<0.0001. The continuous relationship between door-to-balloon time and 30-day mortality was examined and found not to be statistically different between young and older patients. By multivariate analysis, Killip class, OR¼8.02, 95%CI 2.33-27.61, p 75 OR ¼ 3.90, 95%CI 2.61-5.84, p 100 OR ¼ 1.96, 95%CI ¼ 1.30-2.96, p ¼ 0.001 and any major bleed OR ¼ 3.478, 95% CI ¼ 2.02-6.00, p <0.001, were all independent predictors for 30-day mortality. A second multivariate analysis did not identify age  75 as an independent predictor of major bleeding complications. CONCLUSION: Achieving shorter door-to-balloon times in elderly STEMI patients was associated with similar 30-day survival benefit as compared to younger patients. The increased absolute 30-day mortality in our elderly cohort seems to be attributable to an age-associated reduced