A Wholehearted Approach to Complex PCI

A passionate commitment to you and complex PCI

At Abbott, we're focusing all our energy on working with you to overcome the challenges of complex PCI. We're committed to bringing you the solutions you need to get the very best outcomes for your patients. It's all part of our wholehearted approach to complex PCI.

ACS

Image courtesy of Dr. Manish Parikh

Treating a patient with ACS means intervention at a critical time. You and your team rely on quickly making the right decisions — Abbott's role is to help you achieve the desired outcome.

Intermediate stenoses may be difficult to visually assess in ACS patients1

  • The AHA estimated that the incidence of ACS, including AMI and unstable angina, was approximately 625,000 cases in the US in 20102
  • FFR-guidance is recommended for non-culprit lesions in STEMI-ACS patients3
  • The COMPARE-ACUTE study demonstrated that complete revascularization guided by FFR is a superior strategy to treatment of only the infarct-related artery in STEMI patients4
  • FFR-guided complete revascularization of ACS patients reduces costs and the risk of events3-5
  • A cost assessment in the COMPARE-ACUTE trial showed an approximate 30% cost reduction in patients with complete revascularization by FFR guidance (Netherlands, Germany, Sweden, Poland, USA 27-28%)5

Abbott is committed to supporting you in doing the best for your patients

  • We conducted the COMPARE-ACUTE trial with 885 patients with STEMI and multivessel disease who had undergone primary percutaneous coronary intervention of an infarct-related coronary artery4
  • COMPARE-ACUTE randomized patients 1:2 to undergo complete revascularization of non-infarct-related coronary arteries guided by fractional flow reserve (FFR) (295 patients) or to undergo no revascularization of non-infarct-related coronary arteries (590 patients)4
  • Patients in the FFR-guided treatment arm of COMPARE-ACUTE had 13% lower MACCE rates, which resulted in a 65% risk reduction for MACCE at 1-year compared to patients undergoing angio-guided IRA-only treatment3-5

ACS = acute coronary syndrome; AHA = American Heart Association®; AMI = acute myocardial infarction; FFR = fractional flow reserve; STEMI = ST-elevation myocardial infarction; PCI = percutaneous coronary intervention; MACCE = major adverse cerebrovascular and cardiovascular events; IRA = infarct-related artery
1. Baptista SB, et al. Circ Cardiovasc Interv 2016;9:e003288. 2. Mozaffarian D, et al. Circulation 2015;131:1-295. 3. Fearon WF, et al. JACC 2016;68(11):1192-1194. 4. Smits PC, et al. NEJM 2017;376:1234-1244. 5. Omerovic E, et al. Presented at EuroPCR, Paris, France, 2017.

Bifurcation

Image courtesy of Dr. Manish Parikh

When treating bifurcations, lesion and plaque assessment is key to success. Abbott is committed to giving you tools that will inspire confidence and help you streamline these difficult procedures.

Compared with simple lesions, bifurcations have been associated with:

  • Lower procedural success rates1,2
  • Higher adverse event rates2
  • Longer procedures1,2
  • Worse angiographic and clinical outcomes1

An estimated 20% of percutaneous coronary interventions (PCIs) involve bifurcation lesions3

  • A physiologic evaluation of bifurcation disease can overcome the pitfalls of anatomical evaluations and address the uniqueness of side branch lesions4
  • The risk of side branch ostium restenosis can be reduced by precisely guiding wire re-crossing under OCT guidance5
  • OCT-guided bifurcation PCI also reduces strut malapposition5
  • OCT may be superior and easier to interpret in bifurcations than IVUS for the evaluation of the side branch ostium, stent positions, stent expansion, malapposition, wire positions, and in the detection of thrombus6-7
  • While QCA does not correlate with functional significance in jailed side branches, FFR can guide management of jailed side branches8 and can detect residual ischemia after side branch stenting5

Abbott is committed to supporting you in doing the best for your patients

  • The safety and efficacy of XIENCE in bifurcation lesion treatment has been established across many studies, over periods up to 4 years, involving almost 3,000 patients from 8 studies9-16

OCT = optical coherence tomography; PCI = percutaneous coronary intervention; IVUS = intravascular ultrasound; QCA = quantitative coronary angiography
1. Iakovou I, et al. Herz 2011;36(3):198-213. 2. Louvard Y, et al. Heart 2004;90:713-722. 3. Sawaya FJ, et al. JACC Card Interv 2016;9(18):1861-1878. 4. Park SH, et al. J Geriatr Cardiol 2012;9:278-284. 5. Alegría-Barrero E, et al. EuroIntervention 2012;8(2):205-213. 6. Lassen, et al. EuroIntervention 2018;13:1540-1553. 7. Wolfrum, et al. Exp Review of Cardiovasc Therapy 2017;15(9):705-713. 8. Koo BK, et al. Coronary Physiology in the Catheterization Laboratory 2013. 9. Stone G. TCT 2016. 10. Dzavic V, et al. Cath and Card Int 2013;82:E163-E172. 11. Hermiller JB, et al. Cath and Card Int 2016;88:62-70. 12. de la Torre Hernandez JM, et al. JACC Card Int 2010;3(9):911-919. 13. Murasato Y, et al. Cardiovasc Interv and Ther 2016;31(1):1-12. 14. Pan M, et al. Rev Esp Cardiol 2014;67(10):797-803. 15. Lam MK, et al. Am Heart J 2015;169(1):69-77. 16. Orvin K, et al. Cath and Card Int 2016;87:1092-1100.

Calcification

Image courtesy of Dr. Manish Parikh

Treating calcification requires both proficiency and patience. Abbott is committed to supporting you every step of the way.

Coronary artery calcification is very common and can impair stent delivery1-2

  • The prevalence of coronary artery calcification is age and sex dependent, occurring in ≥90% of men and ≥67% of women older than 70 years of age1,3-4
  • Coronary calcification results in impaired stent delivery, decreased stent expansion, increased malapposition and stent asymmetry, increased procedural complications, and increased rates of stent thrombosis and restenosis1-2

The presence and extent of calcification is underappreciated via angiography alone2

  • Ultrasound does not penetrate calcium; therefore, calcium thickness and volume cannot be determined by IVUS1
  • OCT can assess calcium thickness and measure calcium volume1,5
  • Several studies have shown DES are more effective than BMS in calcified lesions with less neointimal hyperplasia forming in calcified lesions after DES.1,6-11 Additionally, DES is associated with reduced angiographic late loss, restenosis and repeat revascularization1,7-10,12

Abbott is committed to supporting you in doing the best for your patients

  • We conducted the PROSPECT study in 697 patients who underwent three-vessel coronary angiography using gray-scale and radiofrequency intravascular ultrasonographic imaging after PCI13
  • In the PROSPECT study, patients with the highest dense calcium volumes were more likely to have high-risk atherosclerotic features and had the highest 3-year rates of MACE1,13-15
  • Our comprehensive family of guidewires provides tip redirective properties delivering crossability even in calcified lesions

IVUS = intravascular ultrasound; OCT = optical coherence tomography; DES = drug eluting stents; BMS = bare metal stents; PCI = percutaneous coronary intervention; MACE = major adverse cardiac events
1. Madhavan MV, et al. J Am Coll Cardiol 2014;63(17):1703-1714. 2. Kirtane A. CHIP 2017. 3. Wong ND, Kouwabunpat D, Vo AN, et al. Coronary calcium and atherosclerosis by ultrafast computed tomography in asymptomatic men and women: relation to age and risk factors. Am Heart J 1994;127:422-430. 4. Goel M, Wong ND, Eisenberg H, et al. Risk factor correlates of coronary calcium as evaluated by ultrafast computed tomography. Am J Cardiol 1992;70:977-980. 5. Kume T, Okura H, Kawamoto T, et al. Assessment of the coronary calcification by optical coherence tomography. EuroIntervention 2011;6:768-772. 6. Moussa I, Ellis SG, Jones M, et al. Impact of coronary culprit lesion calcium in patients undergoing paclitaxel-eluting stent implantation (a TAXUS-IV sub study). Am J Cardiol 2005;96:1242-1247. 7. Bangalore S, Vlachos HA, Selzer F, et al. Percutaneous coronary intervention of moderate to severe calcified coronary lesions: insights from the National Heart, Lung, and Blood Institute Dynamic Registry. Catheter Cardiovasc Interv 2011;77:22-28. 8. Seo A, Fujii T, Inoue T, et al. Initial and long-term outcomes of sirolimus-eluting stents for calcified lesions compared with bare-metal stents. Int Heart J 2007;48:137-147. 9. Khattab AA, Otto A, Hochadel M, et al. Drug-eluting stents versus bare metal stents following rotational atherectomy for heavily calcified coronary lesions: late angiographic and clinical follow-up results. J Interv Cardiol 2007;20:100-106. 10. Rathore S, Matsuo H, Terashima M, et al. Rotational atherectomy for fibro-calcific coronary artery disease in drug eluting stent era: procedural outcomes and angiographic follow-up results. Catheter Cardiovasc Interv 2010;75:919-927. 11. Schwartz BG, Mayeda GS, Economides C, et al. Rotational atherectomy in the drug-eluting stent era: a single-center experience. J Invasive Cardiol 2011;23:133-139. 12. Shimada Y, Kataoka T, Courtney BK, et al. Influence of plaque calcium on neointimal hyperplasia following bare metal and drug eluting stent implantation. Catheter Cardiovasc Interv 2006;67:866-869. 13. Xu Y, et al. Circulation. 2012;126:534-545. 14. Stone GW, Maehara A, Lansky AJ, et al. A prospective natural history study of coronary atherosclerosis. N Engl J Med 2011;364:226-235. 15. Shimizu T, Maehara A, Farah T, et al. Relationship between coronary artery calcification, high-risk “vulnerable plaque” characteristics, and future adverse events: the PROSPECT study. J Am Coll Cardiol 2012;59:E2102.

Left Main

Image courtesy of Dr. Manish Parikh

Left main interventions can be among the most difficult to treat which can put a lot of pressure on you and your team. Abbott is here to help you meet these challenges.

Untreated left main stenosis is associated with over 20% mortality at one year1

  • The left main coronary artery supplies at least two-thirds of the blood to the heart1

FFR can accurately assess left main and proximal LAD treatment needs2

  • ACC supports the use of FFR to assess the severity of left main lesions3
  • FFR use is safe in facilitating treatment in both simple and complex left main cases and can be used to assess the severity of ambiguous left main disease3,4
  • Routine use of FFR has the ability to increase the use of PCI for the treatment of left main disease by 19%5

Abbott is committed to supporting you in doing the best for your patients

  • We conducted the EXCEL trial with 1,905 patients with unprotected left main disease who have a SYNTAX score of 32 or lower and were randomized to CABG or PCI with XIENCE6
  • At 3 year follow up, these patients showed an 87% lower rate of definite stent thrombosis or symptomatic graft occlusion compared to CABG6
  • It is strongly recommended to have access to intravascular imaging modalities such as OCT during left main PCI, and utilize when procedural difficulties are encountered7
  • XIENCE Sierra is uniquely positioned to post-dilate up to 5.5 mm (maximum expansion for 3.5 mm and 4.0 mm stents) to treat large vessels

FFR = fractional flow reserve; LAD = left anterior descending artery; ACC = American College of Cardiology; PCI = percutaneous coronary intervention; CABG = coronary artery bypass graft; OCT = optical coherence tomography
1. Banning A. What we have learned about stenting the left main. TCT 2017. 2. Modi BN, et al. EuroIntervention 2017;13:820-827. 3. Patel MR, et al. JACC 2017;69(17):2212-2241. 4. Hamilos M, et al. Circulation 2009;120:1505-1512. 5. Ahn JM, et al. Am J Cardiol 2015;116:1163-1171. 6. Stone GW, et al. N Engl J Med 2016;375(23):2223-2235. 7. Lassen, et al. EuroIntervention 2018;13:1540-1553.

Educational Programs

Advanced Complex PCI
The advanced Complex PCI courses offer extended customized learning focused on therapeutic assessment and technical skill development in a Live Case Format. The course curriculum is tailored to address the specific objectives of the attendees in a small group format hosted in a clinical setting. Course attendees typically observe 3-5 complex procedures, which cover optimal device selection, clinical data and guidelines for the treatment of high-risk patients, managing challenging patient subsets (depressed LVEF, advanced HF), and overcoming challenging anatomy and technique optimization.

Contact your local Abbott representative to register for courses or for more information.

PCI = percutaneous coronary intervention; LVEF = left ventricular ejection fraction; HF = heart failure

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