Key Points

• The AMULET Left Atrial Appendage Occluder was shown to be noninferior to the Watchman device for patients with atrial fibrillation; results of the AMULET-IDE trial were presented at the European Society of Cardiology In August, 2021.
• Primary AMULET IDE results showed not only safety at 12 months and effectiveness at 18 months, but closure at 45 days, defined as peridevice leak of <5 mm.
• 12 month follow up with core-lab echocardiographic analysis of perivalvular leak, fewer patients with the AMULET device had moderate peridevice leak when compared to the Watchman device. Long term implications and consequences of peridevice leak are yet unknown.

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Key Points

• The SURTAVI trial randomized patients at intermediate risk for aortic valve replacement to receive either TAVR with and without PCI using a supra-annular self-expanding valve, to surgical AVR with and without CABG.
• This is the first reporting of the five-year follow up data for the original trial, assessing both clinical outcomes and echocardiographic measurements.
• At five years, there was no difference in all-cause mortality, disabling stroke, valve endocarditis, or valve thrombosis.

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Despite advances in therapy, the choice and duration of antiplatelet therapy following percutaneous coronary intervention (PCI) remains an area of active debate. While it has been postulated that long-term dual antiplatelet therapy (DAPT) are associated with reduced rates of thrombotic events, these benefits have been  offset by increased bleeding risk.

In the initial STOPDAPT-2 trial, which included patients with stable coronary artery disease (CAD) and with acute coronary syndrome (ACS) undergoing PCI, a strategy of 1 month of dual antiplatelet therapy (DAPT) followed by clopidogrel monotherapy was associated with significant reduction in the composite of cardiovascular and bleeding events when compared to standard-of-care 12 months of DAPT. While the net clinical benefit was observed in the overall population, the trial was not sufficiently powered to compare the effect of the 2 treatment strategies among ACS patients alone.

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Key Points:

• In the PRAGUE-17 study, patients with non-valvular atrial fibrillation were treated with either oral anticoagulants or left atrial appendage closure devices and followed over a median of 3.5 years of follow-up. The primary endpoint was a composite of stroke or TIA, systemic embolism, clinically relevant bleeding, CV death, or peri-procedural/device complication.
• Treatment with left atrial appendage closure was noninferior to NOAC treatment at long-term follow-up and was associated with significantly less non-procedural bleeding. Continue reading →

In patients with severe aortic stenosis (AS) undergoing transfemoral transcatheter aortic valve implantation (TAVI), periprocedural vascular complications are common and contribute significantly to the overall morbidity and mortality. These vascular complications are commonly related to the arterial access site of the TAVI procedure. As numerous plug-based and suture-based percutaneous vascular closure devices (VCDs) have been approved and available in the market, the real-world approach to vascular closure has been variable as these devices have been used interchangeably. Nonetheless, despite the abundance of these device closure techniques, randomized trials to compare techniques are lacking and remain an unmet need.

The CHOICE-CLOSURE trial (Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation) was an investigator-initiated, single-center, prospective, open-label randomized controlled trial that compared interventional access site closure using a plug-based strategy vs. suture-based strategy for during transfemoral TAVI. In the study, the investigators hypothesized that a relevant difference in the rate of peri-procedural complications of effectiveness of vascular closure would be present with either strategy vs. the other. Major exclusion criteria included, but were not limited to, vascular access site anatomy non-suitable for percutaneous vascular closure, prior history of vascular site complications, absence of computer tomographic data of the access site prior to the procedure, and known bleeding diathesis or significant unmanageable anemia.

Between June 2020 and July 2021, a total of 516 patients with severe AS undergoing transfemoral TAVI were randomly assigned in a 1 to 1 manner to have vascular access site closure using either a plug-based technique (MANTA, Teleflex Wayne PA) (n=258 patients) or a primary suture-based technique (ProGlide, Abbott Vascular, Abbott Park, IL) (n=258 patients). The primary outcome of the trial was the rate of in-hospital access-site or access-related vascular injury according to the Valve Academic Research Consortium-2 (VARC-2) definition through 7 days. Secondary outcomes included the rate of access-site or access-related vascular injury, as well as rate of VCD failure, and time to hemostasis.

The primary outcome occurred in 19.4% (50/258) of patients randomized to the plug-based technique, as compared with only 12.0% (31/258) in patients in the primary suture-based technique group (RR 1.61, 95% CI [1.07-2.44], p=0.029). There were no statistically significant differences in access-site or access related bleeding (11.6% vs. 7.4%, p=0.133) or device failure (4.7% vs. 5.4%, p=0.841). Time to hemostasis was significantly shorter with the plug-based technique (80 seconds vs. 240 seconds, p<0.001). Overall, the trial concluded that a pure plug-based vascular closure technique was associated with higher rates of access-site or access-related vascular complications, but shorter time to hemostasis, as compared with primary suture-based technique.

The results of the CHOICE-CLOSURE trial were presented by the principal investigator, Prof. Mohamed Abdel-Wahab, MD PhD (Leipzig Heart Center/University of Leipzig, Germany) on November 5^th, 2021 at 11:40 AM EDT as a late-breaking clinical trial at TCT 2021 in Orlando, FL and published simultaneously in Circulation.  The study was funded by Helios Kliniken GmbH; and Prof. Abdel-Wahab reported consulting fees/honoraria from Boston Scientific and Medtronic.

Key Points:

• In this pre-specified MASTER DAPT sub-study, patients with high bleeding risk and high ischemic risk (the latter of which was defined as those who have had a myocardial infarction within the last 12 months) who were treated with PCI with an Ultimaster stent were randomized to either standard care dual antiplatelet therapy (DAPT) or abbreviated DAPT starting after 30 days of DAPT post PCI. Standard DAPT was defined as an additional 2 or 5 month duration (with or without anticoagulation, respectively) followed by single antiplatelet therapy (SAPT) for up to 11 months following randomization. Abbreviated DAPT was defined as immediate DAPT discontinuation followed by SAPT for 11 months (or 5 months with anticoagulation).
• The three co-primary endpoints included the following at one year: a) net adverse clinical events (NACE), b) major adverse cardiac and cerebral events (MACCE), and c) major or clinically relevant non-major bleeding (MCB).
• Treatment with abbreviated DAPT was not significantly different from standard DAPT for NACE and MACCE in patients with high ischemic risk. Abbreviated DAPT resulted in lower major or nonmajor bleeding. There were no significant differences between the patients with high ischemic risk and those without.

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Key Points:

• • Patients with diabetes who undergo PCI are more likely to have target lesion failure and target vessel revascularization than their non-diabetic counterparts.
  • The Cre8 EVO stent is polymer-free with thin stent struts and elutes sirolimus via an amphiphilic carrier to promote drug delivery.
  • After diabetic participants were randomized in a 1:1 fashion the Cre8 EVO not only met noninferiority for target lesion failure, but suggested superiority for the same endpoint when compared to the Resolute Onyx stent.

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Key Points:

• Quantitative Flow Reserve (QFR) is a non-pressure wire method of assessing flow through the coronary arteries, using 3D reconstructions and computations from the angiogram.
• 3825 patients across several centers in China were randomized to receive PCI by standard angiography versus QFR guidance, in which stents were placed for vessels with QFR <0.8.
• At one year, MACCE was significantly lower in the QFR group compared to the standard angiography group (5.8 vs. 8.8%).
• Study authors suggest the use of QFR will increase over pressure-wire guided physiology due to its ease of use.

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The use of fractional flow reserve in the assessment of ischemia has increased over the past decade, as it has made its way into the guidelines for coronary revascularization. Some argue that it is still underutilized, and blame several factors for this: the need for a wire, which could introduce procedural complications; the added cost of the FFR wire and system; as well as added procedural time and the need for heparin. In a late breaking session at the 33^rd annual TCT conference, Dr. Bo Xu (Beijing, China) presented the findings of FAVOR III, a trial in which a novel physiologic assessment tool was used to guide PCI strategy in patients presenting to the cardiac catheterization lab.

Quantitative Flow Reserve (QFR) is an angiography-based physiologic measurement of coronary flow. Using high quality angiograms from two orthogonal views of each vessel, a three-dimensional reconstruction of the vessel is created. After inputting TIMI flow, a flow reserve measurement is calculated using the principles of fluid dynamics. Hyperemia and anticoagulation are not required for accurate measurements.

Investigators of FAVOR III China sought to answer whether standard use of QFR to guide PCI conferred any benefit over angiography alone, as did the current gold standard, FFR. In this multi-center sham-controlled, blinded randomized trial, participants undergoing coronary angiography for stable angina, unstable angina, and myocardial infarction were randomized to receive either QFR-guided PCI or standard angiography-guided PCI. After coronary angiography demonstrated at least one epicardial vessel of 2.5 mm reference diameter with 50-90% stenosis, participants were randomized in a 1:1 fashion. In the QFR arm, any qualifying lesion was assessed with QFR. If the QFR was >0.80, PCI was deferred, and if ≤0.80, PCI was performed. Participants and clinical assessors were blinded in the following fashion: participants were given headphones with music to wear during the length of the procedure; a 10 minute delay for QFR and sham calculation was implemented in both arms before the PCI; QFR results were not allowed into the medical record; and personnel involved in the PCI were precluded from participation in follow up.

At one year, 1905 participants in the QFR group and 1897 in the standard group were available for follow up. Participants were mostly men with a mean age of 63 years. Smoking, hyperlipidemia, and diabetes were present in a third of either arm, while hypertension was present in two thirds. 58% of either group underwent the procedure for unstable angina, and 25.8% of each group underwent angiography for stable angina. Multi-vessel disease was present in more than half of participants.

QFR Guidance Changed Strategy
The use of QFR did have an impact on whether PCI was undertaken. Of the vessels that were intended to be treated, 19.6% were deferred based on negative QFR values, compared to only 5.2% in the angiography group. 4.4% of vessels not initially intended to be treated were treated after receiving positive QFR values.

Results

At one year, MACE event rates were lower in the QFR-guided group compared to the angiography-guided group at 5.8% vs. 8.8% (HR 0.65 [95% CI 0.51 – 0.83], p = 0.004). The secondary outcome of MACE excluding peri-procedural MI

followed suit, with a decrease in event rates from 4.8% to 3.1 % (HR 0.64 [95% CI 0.46 – 0.89], p = 0.0073). There was no significant difference in the two groups when it came to other secondary endpoints, including periprocedural MI, target vessel revascularization and stent thrombosis.

In an interview with Dr. C. Michael Gibson, Dr. Bo Xu commented on the results, stating that he hopes to see a shift toward the use of QFR-guided PCI, as the technology is widely available in cardiac catheterization laboratories across China. “The benefit of a quick, 3 minute analysis, without the need for a wire or added procedural complications makes this strategy the most favorable method of hemodynamic assessment,” he stated before adding “It also ensures that patients are getting PCI for the right reasons”.  Some limitations of the study were its enrollment of lower risk patients as well as the lower rates of coronary imaging during PCI.  The study was simultaneously printed in Lancet.

Key Points:

• • All-comers with three vessel disease were randomized to undergo FFR-guided PCI or Coronary Artery Bypass Grafting in this multicenter, international randomized control trial.
  • FFR-guided PCI failed to meet noninferiority for the primary endpoint of MACCE (death, MI, stroke or repeat revascularization) at 1 year. There was no difference in the secondary endpoints, including those of procedural MI and stroke.
  • A subgroup analysis of patients with very low SYNTAX scores showed this to be the only group in which PCI is non-inferior to CABG.

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Key Points:

• • Prior observational and small randomized studies suggested that influenza vaccine may reduce future cardiovascular events in patients with known coronary artery disease.
  • The Influenza vaccination After Myocardial Infarction (IAMI) study is a double-blind, randomized controlled trial that tested whether influenza vaccination early after admission with myocardial infarction or high-risk coronary artery disease reduces cardiovascular events.
  • Late-breaking research presented in a Hot Line session today at ESC Congress 2021 showed that influenza vaccination reduces the risk of all-cause death, myocardial infarction, or stent thrombosis at 12 months in hospitalized patients with cardiovascular disease.
  • According to study authors, these findings suggest that influenza vaccination is underutilized in the cardiovascular disease population and should be considered as part of in-hospital treatment after myocardial infarction.

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Key Points:

• The STEP Study was a multicenter, randomized, controlled trial which was conducted in 42 clinical centers in China. Patients aged 60 – 80 years with hypertension were randomized to a systolic blood-pressure target of 110 to less than 130 mm Hg (intensive treatment) or a target of 130 to less than 150 mm Hg (standard treatment).
• The results of the trial mostly favored intensive treatment, including better outcomes with respect to rates of stroke, acute coronary syndrome, acute decompensated heart failure, coronary revascularization, atrial fibrillation and death from cardiovascular causes in the intensive as compared to the control group.
• The results for safety and renal outcomes did not differ significantly between the two groups, except for the incidence of hypotension, which was higher in the intensive-treatment group.
• The trial’s principal investigator, Dr. Jun Cai, wrote in an exclusive interview: “We suggested that in older patients treated for hypertension, the target of systolic blood pressure (SBP) should be below 130 mm H​g​ for better ​cardiovascular [outcomes]. The results of STEP could be generalized to and benefit more than 100 million persons in China, and we believe​ our result will provide important evidence for ​the development of future hypertension guidelines and bring ​progress in​ public health​ in the near future”.

The prevalence of arterial hypertension continues to rise worldwide, mainly due to arterial stiffening because of an aging global population. The impacts of chronic blood pressure elevation are enormous since hypertension is a major risk factor not only for cardiovascular morbidity and mortality but also for cognitive decline and autonomy loss later in life. The ideal targets for management of older adults with hypertension is increasingly discussed, and the STEP Study presented by Principal investigator Professor Jun Cai of the Chinese Academy of Medical Sciences, Beijing, China at today’s ESC Congress 2021 sought to provide additional evidence that would guide clinicians in optimal blood pressure management for elderly adults. Currently, optimal blood pressure targets are uncertain. During Dr. Cai’s presentation this morning he pointed out that several recent trials that focus on this topic have diverging findings regarding benefits of intensive blood pressure management as well as the risks. As a result, blood pressure target guidelines differ all over the world and by institution.

To clarify the optimal blood pressure target goals, Dr. Cai’s group launched the STEP trail – a prospective, multicenter, randomized, controlled trial which aimed to determine if intensive hypertension treatment (systolic blood-pressure [SBP] target, 110 to <130 mm Hg) would reduce cardiovascular risk to a greater extent than standard treatment (target, 130 to <150 mm Hg) in Chinese patients 60 to 80 years ​of age with hypertension over a planned 4-year period.

Beginning in January 2017, a total of 8,511 patients were enrolled in the study from 42 clinical sites in China. All participants had a SBP of 140–190 mmHg during three screening visits or were taking antihypertensive medication. Patients with prior stroke were excluded. After randomization, all patients were scheduled for follow up at 1, 2, and 3 months, and every 3 months thereafter until month 48 or until the end of study. Antihypertensive medications were provided to the patients. Office blood pressure monitoring was all conducted on a standardized, validated monitor, by a trained physician or nurse, measured three times with 1-minute intervals, and participants were required to rest for at least 5 minutes prior to measurement.

Though medication titrations were based off in-office blood pressure measurements, this trial was unique in that patients also received validated and automated home blood pressure monitors. The blood-pressure monitor was paired to the smartphone-based app with a Bluetooth function. The app was used to collect home blood-pressure readings obtained by the patient and then to upload the readings to a data-recording center. All the patients were required to obtain home blood- pressure readings at least 1 day per week during follow-up. Patients were not enrolled in the trial unless they could use the app or had a family member who could use it on their behalf. The details of the effects of the app-based management are not presented in the current study.

The primary outcome was a composite of stroke, acute coronary syndrome (which included acute myocardial infarction and hospitalization for unstable angina), acute decompensated heart failure, coronary revascularization, atrial fibrillation, or death from cardiovascular causes. Secondary outcomes included the components of the primary endpoint, death from any cause, major adverse cardiac events, and renal outcomes (a decrease in renal function or the development of end-stage renal disease).

The results of the study, published today in the New England Journal of Medicine, showed that baseline characteristics were evenly matched between the intensive and standard treatment groups, though importantly >75% of patients were aged 60-69 years in both groups. During the median follow up period of 3.34 years, the average decrease in SBP from baseline was 19.4 mmHg in the intensive treatment group and 10.1 mmHg in the standard treatment group. Average SBP reached 126.7 mmHg and 135.9 mmHg in the intensive and standard groups, respectively, with an average between-group difference of 9.2 mmHg. A total of 196 primary outcome events occurred in the standard treatment group (4.6%) compared to 147 events in the intensive treatment group (3.5%), with a relative risk reduction of 26% (hazard ratio with intensive treatment 0.74; 95% confidence interval [CI] 0.60–0.92). Dr. Cai wrote in an email interview, “Th​e results showed ​that t​he risk of adverse cardiovascular events was reduced by 26% with intensive treatment, and ​the results f​or safety (except for hypotension) and renal outcomes did not differ significantly between the two group​s.”​ The results for most of the secondary outcomes were also more favorable in the intensive-treatment group than in the standard-treatment group, including a 33% lower relative risk of  stroke (95%CI 0.47–0.97) and a 33% lower relative risk of acute coronary syndrome (95%CI 0.47– 0.94) in the intensive as compared to standard blood pressure control groups.

During the ESC Congress live release this morning, commentator Dr. Bryan Williams (University College London – London, United Kingdom of Great Britain and Northern Ireland) points out that the study population was relatively low risk, with very few patients with cardiovascular or renal disease and none with prior stroke because of exclusion criteria. He notes the impressive findings of the study included reduction in several important cardiovascular outcomes in the intensive group, which was extremely well tolerated as indicated by the few adverse events in this study arm. He makes the point, however, that older adults are a rather heterogenous group due to wide spectrums of comorbidities, frailty, and cognitive function among the elderly. He therefore remarked that this study indicates that clinicians may need to be more aggressive with blood pressure targets in certain groups, though the risk versus benefit of intensive blood pressure lowering may differ according to each patient.

Key points:

• The Amulet IDE is an open-label clinical trial that randomized 1,878 patients with non-valvular atrial fibrillation to receive either the novel Amulet device or the first-generation Watchman device, to compare the efficacy and safety of the two percutaneous left atrial appendage occlusion (LAAO) devices.

• The Amulet device was found to be superior to first-generation Watchman in effectively occluding the LAA (residual jet ≤5 mm at 45 days, 98.9% vs 96-8%, p=0.0025) and non-inferior with regard to procedure-related complications, major bleeding or all-cause death at 12 months (safety), and ischemic stroke or systemic embolism at 18 months (efficacy).

• Despite the difference in antithrombotic regimens used with the two devices (aspirin + warfarin for Watchman, versus aspirin + clopidogrel or aspirin + direct oral anticoagulant for Amulet), both the rates of bleeding and device-related thrombus were similar in the two arms.

• On August 14th, 2021, the Amulet percutaneous LAAO device received FDA approval.
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Key Points:

• The Salt Substitute and Stroke (SSaSS) study compared the effect of the consumption of a reduced sodium salt substitute to regular salt on stroke, cardiovascular events, and mortality.
• The trial, which was conducted in 600 villages in China, enrolled 35 participants from each village for a total of 20,995 participants.
• During almost 5 years of follow up, participants who consumed salt substitutes had significantly lower rates of all stroke, major adverse cardiac events, and total mortality. There was no evidence of harm with salt substitutes, and no significant increase in hyperkalemia.

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Key Points:

• ENVISAGE-TAVI AF is a large, multinational, randomized-control trial investigate the safety and efficacy of edoxaban versus warfarin for those with atrial fibrillation undergoing TAVI.
• Edoxaban was noninferior to warfarin in the primary efficacy endpoint, a composite of adverse clinical events.
• Edoxaban  had higher rates of major bleeding, driven mostly by gastrointestinal (GI) bleeds. In patients requiring dose adjustment, however, no increase in bleeding events was seen.

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Key Points:                                  

• Finerenone is a nonsteroidal mineralocorticoid antagonist that has been shown to decrease adverse cardiovascular outcomes in patients with advanced diabetic kidney disease (DKD).

• FIGARO-DKD is a randomized, placebo-controlled trial assessing the cardiovascular effects of finerenone on patients with mild to moderate DKD.

• Finerenone was associated with fewer cardiovascular events, including a 30% decrease in heart failure hospitalization, as well as less progression to advanced CKD.

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KEY POINTS:

• Implantable Cardioverter Defibrillators (ICDs) are indicated for post-myocardial infarction patients with severely reduced left ventricular systolic function, however, less is known about patients with moderately reduced LVEF.
• SMART-MI randomized post-myocardial infarction (MI) patients with moderate reduction in LVEF to receive an implantable cardiac monitor or continue with standard of care.
• In the Implantable Cardiac Monitor (ICM) group, arrhythmias were detected three times as often, and led to a higher number of therapies delivered to terminate such arrhythmias.

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Key Points:

• • Patients with chronic heart failure with preserved ejection fraction (HFpEF, defined here as EF>40%) with or without diabetes were treated with empagliflozin, a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, in addition to standard of care therapy. The control arm was treated with standard of care alone.
  • Treatment with empagliflozin led to a significant reduction in the primary endpoint (time to first event of adjudicated cardiovascular death or heart failure hospitalization [HHF]) as well as both secondary endpoints (first and recurrent HHF and slope of change of eGFR). There was no effect on all-cause mortality.
  • The benefit of empagliflozin was seen across all pre-specified subgroups, including patients with or without diabetes.

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The results of the VICTORIA trial were presented at the American College of Cardiology 2020 Meeting and simultaneously published in the New England Journal of Medicine. The trial demonstrated that vericiguat, an oral guanylate cyclase stimulator, decreased the occurrence of death from cardiovascular cause or hospitalization for heart failure in patients admitted with high-risk heart failure.

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The results of a pooled analysis of the ORION-10 and ORION-11 trials were recently presented at the American College of Cardiology 2020 Conference. The combined results published in the New England Journal of Medicine, demonstrated that inclisiran, a drug that inhibits hepatic synthesis of proprotein convertase subtilisin–kexin type 9, reduced low-density lipoprotein (LDL) cholesterol by 50% over 510 days.

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The results of the COMPLETE Optical Coherence Tomography Substudy were presented by Dr. Natalia Pinilla-Echeverri at the American Heart Association 2019 meeting. The substudy found that in patients with an ST-elevation myocardial infarction and multivessel coronary artery disease, half of the patients had a non-culprit lesion with vulnerable plaque morphology.

The COMPLETE trial previously demonstrated that routine angiography guided staged a percutaneous coronary intervention (PCI) of non-culprit lesions reduced the composite endpoint of cardiovascular death or myocardial infarction by 26%. However, whether the benefit of routine PCI of non-culprit lesions is, as a result, the non-culprit lesions having characteristics that were consistent with a vulnerable plaque is not known. Optical coherence tomography (OCT) is a form of intracoronary imaging that is able to identify vulnerable plaques. OCT is able to recognize thin cap fibroadenoma (TCFA), an indicator of a vulnerable plaque that is at risk of rupturing. The investigators wanted to identify the prevalence of TCFA in obstructive compared to non-obstructive non-culprit lesions.

In the COMPLETE trial, patients with a STEMI and multivessel disease who underwent successful PCI of the culprit lesion were randomized to either routine staged PCI of all suitable non-culprit lesions with the goal of complete revascularization regardless of whether there were clinical symptoms or evidence of ischemia or culprit-lesion revascularization only. Patients were deemed to have multivessel disease if they had angiographically significant non-culprit vessel disease of a vessel that was at least 2.5mm in diameter. A lesion was considered angiographically significant if it had at least 70% stenosis of the vessel diameter or 50-69% stenosis with a fractional flow reserve of less than 0.8. In this substudy, STEMI patients with stenosis of at least one non-culprit vessel with more than 70% stenosis that was suitable for OCT were identified. After randomization, multivessel OCT imaging was performed on vessels with non-culprit lesions that underwent PCI, additional vessels with or without target non-culprit lesions for PCI, and STEMI vessels with segments more than 50mm that were unstented.

A total of 93 patients and 425 lesions were included in this substudy. The baseline characteristics in the main study were similar to this imaging study. The average age was 61.3, 82.8% were male, 12.9% had diabetes, 64% had 1 residual diseased vessel and 36% had two or more residual diseased vessels. The non-culprit lesions were classified according to whether they had significant stenosis and whether they had a TCFA. Of the lesions with greater than 70% obstruction, 58 (38.7%) had a TCFA and 92 did not. Of the lesions with less than 70% obstruction, 74 (23.2%) had a TCFA and 201 did not. When assessing the prevalence of TCFAs per patient, the investigators found that half of the patients with TCFA had an obstructive non-culprit lesion that contained vulnerable plaque.

In an interview with Dr. Arzu Kalayci, Dr. Pinilla-Echeverri discussed the implications of the study. She said, “this is very important in the STEMI population because we believe the STEMI population has higher rates of future cardiovascular events. IT may all be related to the inflammatory response that is behind [this]. This is telling us that these patients had a definitely higher risk because they had vulnerable plaques far from the culprit segment. This is reassuring that acute coronary syndrome implies a diffuse pathophysiology with vulnerable plaque not only in the culprit segment but in places far away from the culprit lesion. These results support the findings in the COMPLETE trial.” However, this study does have its limitations. The substudy was observational and is affected by confounding and bias. The substudy was not powered to link clinical evens to morphology. Regardless, the findings of this study could potentially explain the benefit of routine PCI of obstructive non-culprit lesions in patients with STEMI and multivessel disease.

Click here to view the study slides.

Click here to listen to Dr. Kalayci and Dr. Pinilla-Echeverri.