stenting

In the wake of the ISCHEMIA trial results being published, and the media firestorm that ensued, I’ve run into some interesting scenarios, including STEMI patients saying they don’t want to be revascularized because they heard on the news that stents are useless (oh boy!). However, after a robust discussion with an intern, I decided to do a quick n dirty rundown of who does and does not need immediate revascularization, and which strategy to go with.

If there’s one thing you should know about the ISCHEMIA trial, it is that this study sought to answer the question of whether or not STABLE ischemic heart disease would benefit from an aggressive revascularization strategy vs a conservative strategy of goal-directed medical therapy. This had nothing to do with patients who had ACS. I will also add that with long-term followup, the results might change, nobody knows for certain. The reason I say this is because the PCI arm had a signal towards harm in the first 6 months after revascularization, but as they approached 4 years, the mortality curves started to separate in favor of the aggressive revascularization arm. As it stands, their conclusions were not in favor of an aggressive strategy over a conservative one. Interestingly, these results didn’t differ very much from the COURAGE trial, where they found no significant difference between optimal medical therapy vs PCI for stable ischemic heart disease. Differences to note include the fact that COURAGE did NOT use FFR, and did not have routine use of DES.

Keep in mind, patients with left main stenosis > 50% were excluded from both of these trials, as were those who had recent revascularization within the past 6 to 12 months (PCI or CABG). The reason I mention this is because some people thought these results contradicted the findings of the COMPLETE trials – but no, these trials looked at different sets of patients altogether!

A few big wins for the ISCHEMIA trial:

CT-angiography was shown to be very reliable
FFR-guided PCI is becoming more routinely accepted as the preferred method of PCI
Optimal medical therapy really helps…even if there turns out to be a mortality benefit in favor of early-PCI, the fact that it takes several years to emerge is a statement about how helpful these medications truly are.

With regards to stable ischemic heart disease, clear indications for revascularization include left main stenosis > 50%, proximal LAD with >50% stenosis, or multi-vessel disease with signs of impaired ventricular function. Typically, cardiologists will employ the SYNTAX score, which is a validated system used to grade the severity and complexity of lesions. Typically, SYNTAX scores < 23 are amenable to PCI and non-inferior to CABG. The typical scenario for PCI is when you have isolated disease in only 1 or 2 vessels, and this is amenable to stenting.

Once you have significant left main disease, especially in conjunction with 2-3 vessel disease, the SYNTAX score is > 32, and CABG is superior.

Until very recently, it was generally accepted that isolated left main disease could be treated by PCI or CABG. However, some controversy has erupted recently after the results of the EXCEL trial were published. Specifically, the EXCEL trial had a composite endpoint of stroke, MI, or death, and there was no statistically significant differences between the two groups. Surgeons will tell you that the higher rates of the composite endpoint were driven by excess all-cause mortality in the PCI arm, as compared to peri-procedural MI in the CABG arm…in other words, while the composite endpoints were similar in both groups, the individual endpoint of mortality was higher with PCI, whereas peri-procedural MI was higher with CABG. This can certainly be a bit contentious, especially if you wonder what the clinical significance of a troponin elevation is after CABG. Nonetheless, the trial was powered to detect differences in the COMPOSITE endpoint, not in the individual endpoint of mortality.

The STICH trial demonstrated a significant benefit (albeit 10 years out) in favor of revascularization (this study only looked at CABG) for patients with ischemic heart failure. The FREEDOM trial took it one step further and tried to compare DES to CABG for mutli-vessel CAD in diabetics. The findings were strongly in favor of CABG over PCI, and this has become the accepted paradigm.

When you’re not sure, if they have funky looking anatomy AND they’re diabetic, you can make a safe gamble and ask your attending if they think this patient is a CABG candidate. 9 times out of 10, you’ll look like a genius.

In Conclusion:Stable ischemic heart disease has some controversy surrounding the role of revascularization, but ALL patients should be on optimal medical therapy

Patients with significantly reduced EF, Left main, proximal LAD disease, all should warrant a closer look at whether or not they would benefit from revascularization

Always try to involve a multi-disciplinary team when thinking about revascularization, at the end of the day, we are in the business of do no harm, so a second set of eyes can be beneficial.

The views, opinions and positions expressed within this blog are those of the author(s) alone and do not represent those of the American Heart Association. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them. The Early Career Voice blog is not intended to provide medical advice or treatment. Only your healthcare provider can provide that. The American Heart Association recommends that you consult your healthcare provider regarding your personal health matters. If you think you are having a heart attack, stroke or another emergency, please call 911 immediately.

References:

https://www.ischemiatrial.org/

Boden, W. E., O’rourke, R. A., Teo, K. K., Hartigan, P. M., Maron, D. J., Kostuk, W. J., … & Chaitman, B. R. (2007). Title LM, Gau G, Blaustein AS, Booth DC, Bates ER, Spertus JA, Berman DS, Mancini GB, Weintraub WS; COURAGE Trial Research Group. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med, 356(15), 1503-16.

Campos, C. M., van Klaveren, D., Farooq, V., Simonton, C. A., Kappetein, A. P., Sabik III, J. F., … & Serruys, P. W. (2015). Long-term forecasting and comparison of mortality in the Evaluation of the Xience Everolimus Eluting Stent vs. Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial: prospective validation of the SYNTAX Score II. European heart journal, 36(20), 1231-1241.

Stone, G. W., Kappetein, A. P., Sabik, J. F., Pocock, S. J., Morice, M. C., Puskas, J., … & Banning, A. (2019). Five-year outcomes after PCI or CABG for left main coronary disease. New England Journal of Medicine, 381(19), 1820

Approximately 15-20% of all coronary interventions are bifurcations¹. Based on the overall Syntax Score, coronary artery bypass grafting is often recommended particularly in the setting of multi-vessel disease, diabetes and impaired left ventricular function. Once a decision to proceed with percutaneous revascularization is made, it is imperative that operators select the most appropriate revascularization strategy suited for an individual patient.

Briefly, the published data still recommends a provisional strategy as the default¹. Of course, a two-stent strategy is commonly employed for bail out. An up-front two stent strategy is reserved for the following:

This strategy is recommended for true Bifurcation Lesions with a Medina (111,011,101). This is of importance if the lesion is long and extends > 5-10 mm beyond the ostium of a sizeable side branch (> 2.5mm).
If the side branch is very large, poor myocardial reserve, and a high jeopardy score, the hemodynamic consequences may be significant warranting revascularization of the side branch.
Finally, if the angle to the side branch is acute rendering access too difficult, it is advisable to proceed with a two-stent strategy.

Over the course of the next couple of blogs, I will briefly review the randomized trials and steps of the different strategies. This month, my focus will be on DK-Crush.

DK Crush II was a randomized trial comparing DK-Crush to provisional stenting in symptomatic patients with a Medina 1,1,1 or 0,1,1 lesion. One-hundred and eight five were enrolled in each arm. The primary endpoint was major adverse cardiac events (MACE), namely cardiac death, MI and target vessel revascularization (TVR) at 5 years. It concluded that DK-Crush was associated with a lower 5-year MACE rate compared to provisional stenting.

Chen et al. Circ Cardiovasc Interv 2017;10:e 004497

DK Crush III was a randomized trial comparing DK-Crush to Culotte stenting in symptomatic patients with a distal Left Main lesion that is Medina 1,1,1 or 0,1,1. Approximately, 210 were enrolled in each arm. The primary endpoint was a composite of MACE and TVR at 3 years. It concluded that DK-Crush was associated with a lower 3-year MACE rate compared to Culotte stenting.

3-years outcome	DK crush	Culotte	p-value
Death %	1.4	2.9	0.34
MI %	3.4	8.2	0.037
TVR %	5.8	18.8	<0.001
Definite ST %	0	3.4	0.007

Chen et al. JACC. Cardiovasc. Interv 2015;8:1335-42

DK Crush V was a randomized trial comparing DK-Crush to a provisional strategy in symptomatic patients with a distal Left Main lesion that is Medina 1,1,1 or 0,1,1. It enrolled approximately 240 patients in each arm. The primary endpoint was target lesion failure defined as cardiac death, target vessel myocardial infarction or target lesion revascularization at 12 months. It concluded that DK-Crush was superior at 12 months.

Chen et al. J Am Coll Cardiol. 2017;70:2605-17

The steps of this technique can be summarized in the illustration (Image A). It is noteworthy, that critical steps in any bifurcation technique include intracoronary imaging and proximal optimization (POT). Imaging allows appropriate determination of size of the vessels in question, length of the disease and characterization of the lesion before the planned strategy. It, therefore, permits the operator to perform the necessary lesion preparation if calcified. Upon completion of the procedure, imaging allows appropriate evaluation of the stent expansion and apposition with additional post-dilatation if need be. Proximal optimization is a fundamental step irrespective of the technique adopted. It permits the operator to expand the main branch stent to facilitate the remainder of the steps, prevent the wire from entering behind the stent struts, prevent stent compression and ultimately permit appropriate stent apposition. This in itself facilitates future intervention and reduces stent thrombosis. Many have added an additional POT before the second kissing inflation to facilitate crossing into the SB. It is important that fluoroscopic imaging is sharp to allow appropriate positioning of the non-compliant balloon at the proximal stent edge and at the neo-carina. Several techniques including “Stent Boost” and “Clear Stent” specific to each vendor are readily available. Finally, given the multiple steps in bifurcation stenting, radiation safety is imperative for any and all techniques.

Image: Steps of DK Crush