Important Trial Results for Interventional Cardiology From ESC Congress and TCT 2018
By George W. Vetrovec, MD, MACC
Editorial Team Lead, Invasive Cardiovascular Angiography & Interventions collection on ACC.org
The following is a compilation of summaries written by expert colleagues reviewing and commenting on the major trials presented at the European Society of Cardiology Congress 2018 (ESC Congress 2018) and Transcatheter Cardiovascular Therapeutics 2018 (TCT 2018) that are relevant to the Invasive Cardiovascular Angiography and Intervention Clinical Topic Collection on ACC.org. Although many summaries exist online, our meeting trial summaries have consistently been popular because of the concise and thoughtful comments provided by our authors. This summary is no exception. My grateful appreciation to the authors for their quick turnaround and succinct comments.
As always, your comments are appreciated.
CULPRIT-SHOCK (Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock)
By George W. Vetrovec, MD, MACC
Editorial Team Lead, Invasive Cardiovascular Angiography & Interventions collection on ACC.org
To briefly review, the CULPRIT-SHOCK trial, initially presented at TCT 2017, demonstrated that in patients with angiographic multivessel coronary artery disease (CAD) presenting with an acute myocardial infarction (MI) and cardiogenic shock, a strategy of culprit-only percutaneous coronary intervention (PCI) revascularization improved patient outcomes (primary composite endpoint was all-cause mortality and need for renal replacement therapy) compared with primary multivessel PCI. The primary endpoint at 30 days occurred in 45.9% of culprit-only patients versus 55.4% of the multivessel PCI group (p = 0.01). The concept of the 1-year results was to affirm or refute the benefit of immediate, complete revascularization in the setting of cardiogenic shock aimed at improving the outcome in this highly lethal event without a significant change in outcome, even in the setting of contemporary management of acute MI.
The current report focuses on the consistency of these results over 1-year follow-up. A lower composite primary endpoint (mortality and need for renal replacement therapy) persisted for culprit-only PCI at 1 year compared with multivessel PCI: 52.0% versus 59.5% (p = 0.048). All-cause mortality risk at 1 year was 56.9% for multivessel PCI versus 50.0% for culprit-only PCI (p = 0.07). Thus the 30-day results were confirmed at 1 year.
A landmark analysis from 30 days to 1 year revealed a markedly lower rate of death for both groups with no difference between groups. Thus, the primary 1-year CULPRIT-SHOCK outcome was driven by a high 30-day incidence of death, but subsequent mortality (30 days to 1 year) was relatively low and not significantly different between groups. Late MI occurred in 6.7% of the culprit-only group compared with 5.3% in the multivessel PCI group. This suggests that there was not a late "catch-up" higher risk of MI in the culprit-only group.
Two additional findings in the 1-year results were of note. Perhaps expected, the incidence of revascularization was higher for the culprit-only group: 32.3% versus 9.4%, p < 0.001. More concerning is the fact that although the incidence was low, the 1-year rate of hospitalization for heart failure (HF) was higher in the culprit-only PCI group (5.2 vs. 1.2, p = 0.003), raising the question of whether, in appropriately selected patients, complete revascularization might improve late cardiac performance.
Some aspects of the study were not generally consistent with "usual" practice. Specifically, chronic total occlusions were performed as part of "complete revascularization" in the acute cardiogenic shock circumstance and operators doing multivessel PCI were not allowed to make clinical decisions about whether performing revascularization and/or the extensiveness revascularization should be individualized in patients with pre-existent renal dysfunction. It remains unknown how these factors may have influenced the study results.
Going forward, US guideline committees will need to decide how applicable these results are to the recommended PCI management of cardiogenic shock. The European guidelines have been modified to recommend culprit-only PCI in the acute MI with shock setting. However, there are increasing data addressing the strategy of immediate hemodynamic support with left ventricular unloading prior to PCI in shock aimed at reducing the extremely high mortality in cardiogenic shock. Mechanical circulatory support may be more effective than an isolated strategy of immediate complete revascularization as tested in the CULPRIT-SHOCK trial.
RESET (Randomized Evaluation of Sirolimus-Eluting Versus Everolimus-Eluting Stent Trial)
Multiple studies have compared the clinical outcomes of the current-generation everolimus-eluting stent (EES) with first-generation paclitaxel-eluting stent (PES) and have shown lower rates of target-vessel failure with a reduction in late lumen loss, restenosis, and stent thrombosis with EES. Patient outcomes in these trials (see SPIRIT [Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions] trials) were measured up to 5 years.1,2
RESET compared current-generation EES with first-generation SES, and clinical endpoints were measured at 1 and 7 years. The trial was performed on 3,197 Japanese patients randomly assigned to receive either the SES (Cypher [Cordis; Fremont, CA]) or the EES (Xience V [Abbott; Santa Clara, CA]). The study was carried out in mainly stable patients (82%) with a low SYNTAX score (median 10). Intravascular ultrasound (IVUS) was performed in 82% of patients. Multivessel disease was present in 47%, but single-vessel PCI was performed in 89%. The left anterior descending artery was the treated vessel in 43%, and the left main trunk was treated in only 2%. The mean number of lesions treated was 1.2, with a stent length of 31 mm. Although 40% had bifurcation lesions, a two-stent approach was used in only 1%. The PCI success rate was slightly higher in the EES arm (97.8% vs. 96.6%).3
At year one, the target lesion revascularization (TLR) rate was similar (4.3% vs 5.0%, EES vs. SES), as was target vessel revascularization (6.9% in both groups). Major adverse cardiac events (MACE) were low in both groups. All-cause mortality was 1.9% versus 2.5%, MI occurred in 3.0 versus 3.5%, and stent thrombosis was 0.32% versus 0.38% for the EES and SES arms, respectively.3 In a subgroup of patients assigned to undergo follow-up angiography at 8 months, late loss was similar: 0.06 mm versus 0.02 mm, respectively.3
The 7-year follow-up of the RESET cohort were presented at TCT 2018. For EES versus SES at 7 years:
- TLR was 10.2% versus 11.7%, p = 0.24
- Death was 16.8% versus 18.5%, p = 0.27
- Death or MI was 20.6% versus 23.6%, p = 0.06
- Definite stent thrombosis was 0.9% versus 1.0%, p = 0.82
- Target-vessel failure occurred in 13.3% for EES and 18.1% for SES, p = 0.001
The most striking aspect of this trial is the durable result that can be achieved with drug-eluting stent (DES) placement in stable patients with straightforward anatomy. Not surprisingly, the success rate was slightly higher in these non-complex patients with the more flexible, deliverable stent. This difference might have been more pronounced in patients with more complex anatomy. The clinical event rates were extremely low at long-term follow-up, with stent thrombosis rates of only 1%. This is reassuring given the concern raised in previous studies that showed a 0.6% annual rate of very late stent thrombosis with early-generation DES.4 Another interesting feature of the study was the high rate of IVUS use, which may have contributed to these excellent long-term clinical outcomes by optimizing stent placement.
MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX)
By Adhir Shroff, MD, MPH, FACC
University of IllinoisChicago
The MATRIX trial was a large clinical study that was presented at ESC Congress 2018 in Munich, Germany, on August 25, 2018, and published contemporaneously in Lancet.5 In this prospective, randomized trial, the investigators studied 3 separate questions using a sequential randomization process. As reported, 8,404 patients with acute coronary syndromes (ACS) (ST-segment elevation MI [STEMI] = 47.7% and non-ST-segment elevation MI [NSTEMI] = 52.3%) were randomized to radial or femoral access. After the diagnostic procedure, the remaining 7,213 patients who underwent PCI were randomized to a particular antithrombotic regimen (bivalirudin bolus and infusion [n = 1,811], bivalirudin bolus with prolonged infusion [n = 1,799], or unfractionated heparin [n = 3,603]). Use of glycoprotein inhibitors and choice of P2Y12 inhibitor were left to the operator's discretion. Clinical follow-up was at 30 days and 1 year. The co-primary outcomes for the access and antithrombin studies included MACE (composite of all-cause mortality, MI, or stroke up to 30 days) and net adverse clinical events (NACE) (major bleeding and MACE). For the treatment duration study, the primary endpoint was a composite of urgent target vessel revascularization, definite stent thrombosis, or NACE at 30 days.
For the ACCESS study, the radial access group demonstrated a non-significant trend toward reduced MACE (rate ratio [RR] 0.89 (95% confidence interval [CI], 0.80-1.00); p = 0.0526) and a significant reduction in NACE (RR 0.87 (95% CI, 0.780.97); p = 0.0128) compared with the femoral access group. There was similar all-cause mortality, lower cardiovascular mortality, and lower major bleeding among the radial access patients. For the ANTITHROMBIN study, there were similar rates of MACE and NACE among patients receiving bivalirudin or unfractionated heparin. Among the bivalirudin patients, the rate of stent thrombosis was increased (1.1% vs. 0.6%; RR 1.72, 1.02-2.91; p = 0.0401), and the rate of major bleeding was decreased (2.2% vs. 3.3%; RR 0.68, 0.51-0.91; p = 0.0083). Finally, for the PROLONGED BIVALIRUDIN INFUSION study, there was no difference in the primary endpoint.
This analysis confirms the investigators' observations at the 30-day endpoint.6 Radial access continues to lead to lower rates of access site and bleeding complications. These investigators observed lower rates of cardiovascular mortality, although the mechanism of this observation is not clear. The authors suggested that the operators and centers in this clinical trial may not be reflective of the typical operator or center. In order to qualify for this trial, an operator must have performed 75 transradial PCI in the year prior to enrollment. The operator must have also performed transfemoral interventions as a senior operator for at least 2 years. This may help to explain the discrepancy in the relatively low rates of vascular access complications in this trial compared with what is observed in registry studies.
The choice of antithrombin medications may have become clearer with the results of this study. Bivalirudin does not appear to lower ischemic risk alone or ischemic and safety combined endpoints. However, there does appear to be a lowering of bleeding events at 1 year in the bivalirudin group, supporting its use as a tool for bleeding avoidance. Finally, for those patients treated with bivalirudin infusion for PCI, there does not appear to be data to support prolonged duration of therapy.
Therefore, among experienced radial and femoral operators, this paper further solidifies the role of radial access as the default access site for patients with ACS. In the accompanying editorial, the author states "The long-term benefit for net adverse clinical events, driven by a reduction in major bleeding and cardiovascular mortality, ought to change practice so that radial access should be the default approach in invasively managed patients with acute coronary syndrome."7 In terms of antithrombotic therapy, clinicians can still choose between unfractionated heparin and bivalirudin for their anti-ischemic properties; however, bivalirudin does seem to be associated with less bleeding and may be considered as part of a multi-pronged approach to decrease bleeding.
FAST-FFR (FFRangio Accuracy Versus Standard FFR)
By Marc D. Feldman, MD, FACC
University of Texas Health Science Center at San Antonio
San Antonio, TX
Measuring coronary flow reserve has been shown to guide revascularization decisions, leading to improved patient outcomes. However, fractional flow reserve (FFR) measured invasively with a wire during hyperemia (FFRhyperemia) has not been widely adopted in the catheterization laboratory because it requires insertion of a pressure wire and making the measurement during maximal hyperemia to allow pressure to be equated with flow. Although instantaneous wave-free ratio when used can eliminate the need for hyperemia, the additional time of wire insertion remains a barrier. Although computed tomography (CT) angiography was felt to be a solution as a method to obtain FFR noninvasively, FFR-CT is limited by CT resolution, with calcification and arrhythmias also influencing image quality. Invasive angiography-derived FFR (FFRangio) solves many of these issues because angiography has much better resolution than CT in assessing coronary anatomy. Thus, it is logical to use three-dimensional quantitative coronary angiography obtained in the catheterization laboratory as a superior method to assess FFR.
Preliminary studies have found that FFRangio, when measured offsite by experienced operators, correlates well with FFRhyperemia. However, FFRangio has not been validated when performed onsite by local operators blinded to FFRhyperemia and compared with core laboratory-analyzed FFR values in a large, prospective, multicenter fashion. That was the basis for the performance of the FAST-FFR trial, presented at TCT 2018 and published in Circulation in September 2018.
A total of 301 patients was enrolled internationally in the FAST-FFR trial, with performance of FFRhyperemia and FFRangio onsite and at a core laboratory. Patients with reduced left ventricular ejection fraction, diffuse disease, left main, and chronic total occlusions were excluded. Angiography required the entire vessel to be visualized, with adequate contrast opacification, avoiding vessel overlap, and without panning the table or moving the image intensifier.
FFRangio was successfully measured in 99% of patients, and the mean and median FFR between FFRangio and FFRhyperemia differed by 0.01 at most. The per-vessel sensitivity and specificity were 94% (95% CI, 88-97%) and 91% (86-95%), respectively. The diagnostic accuracy of FFRangio was 92% overall and remained high when only considering FFR values between 0.75-0.85 (87%). However, the correlation coefficient was only r = 0.80; therefore, for any given patient, it was not usual for differences of 0.1 between FFRangio and FFRhyperemia when the plot is examined visually. When point-to-point agreement versus FFR was quantified using a Bland-Altman plot, those differences were improved (mean ± SD: 0.01±0.07) and therefore unlikely to change positive to negative FFR results using FFRangio.
What are next steps? Could FFRangio replace the use of FFRhyperemia measurements? Similar to the FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) trials and trials comparing FFRhyperemia to instantaneous wave-free ratio, success in predicting clinical outcomes is vital. Following this approach, FFRangio will need to be examined prospectively in predicting clinical outcomes and determining whether stents should or should not be utilized. Only with the prediction of clinical outcomes will FFRangio be broadly accepted by invasive cardiologists.
CorMicA (Coronary Microvascular Angina)
By Sheila Sahni, MD, FACC
Garden State Heart Center
The CorMicA trial was a randomized trial in which patients found to have non-obstructive CAD after a clinically indicated coronary angiogram underwent 1:1 randomization to either treatment after diagnosis of microvascular angina or vasospastic angina or standard of care. A definitive diagnosis allowed for tailored therapy in this intervention arm; microvascular angina was treated with beta-blockers, and vasospastic angina was treated with either nitrates or calcium-channel blockers. After 6-month follow-up, change in Seattle Angina Questionnaire (primary endpoint) was 11.7 units higher in the intervention arm compared with the standard therapy arm (95% CI, 5-18.4; p = 0.01). The authors should be commended for this study because it is the first to look at patient-centered outcomes in the treatment of microvascular or vasospastic angina.
The interventional diagnostic procedure required an average time of 60 minutes to complete vasospasm provocation with acetylcholine, coronary flow reserve testing, index of microcirculatory resistance measurement, and FFR assessment with adenosine. Thus, the universal uptake of this strategy will be limited to major academic centers that can afford the resources to complete this thorough assessment. The small sample size makes the study inherently underpowered to assess for MACE or significant procedure-related events. The study is a step in the right direction and definitely sheds light on the complexity that is "non-obstructive coronary chest pain" and how specific therapy tailored to a specific syndrome can improve symptoms. More clinical studies are necessary to help push this field forward and support the increased use of resources to complete a thorough assessment in a diagnostic cardiac catheterization laboratory.
By Mamoo Nakamura, MD, FACC
Cedars-Sinai Medical Center
Los Angeles, CA
This open-label randomized trial examined if 23 months monotherapy with ticagrelor after 1 month of therapy of aspirin plus ticagrelor (experimental group) is superior to conventional dual antiplatelet therapy (DAPT) for 12 months followed by 12 months of aspirin monotherapy (conventional group) to decrease all-cause death or Q wave MI in patients who received PCI with biolimus A9-eluting stent for treatment of stable CAD or ACS.
This was a well-designed and well-conducted study that showed a trend toward the reduction in primary endpoint in the experimental group. But the study ultimately failed to demonstrate definite superiority of the experimental group to the conventional group. The study result does not support a change in the current standard DAPT regimen and is unlikely to substantially impact current clinical practice of antiplatelet therapy post-PCI with DES.
One condition that needs attention is that at 24 months, adherence to assigned treatment was significantly lower in the experimental group than in the conventional group (77.6% vs. 93.1%, respectively) primarily due to shortness of breath, which is a well-known side effect of ticagrelor. This may potentially impact the evaluation of the true efficacy of ticagrelor for prevention of death or Q wave MI compared with aspirin therapy from 1- to 2-year follow-up period post index PCI procedure. With an emphasis on medical compliance, additional trials are necessary to examine the superiority of ticagrelor monotherapy to aspirin monotherapy on mid- to long-term benefit to prevent the death or Q wave MI in patients with significant CAD who receive 1 year of conventional DAPT post-PCI.
FUTURE (Functional Testing Underlying Revascularization)
By Arnold H. Seto, MD, FACC
Long Beach VA Medical Center
Long Beach, CA
At ESC Congress 2018, further analyses of the FUTURE trial were presented by Gilles Rioufol. This randomized trial of FFR guidance versus angiography for revascularization decision-making (either PCI or coronary artery bypass graft surgery) was conducted at 31 centers in France and had a planned enrollment of 1,728 patients. Preliminary results were initially presented in 2016, after the trial was halted after an interim analysis found a higher rate of all-cause mortality in the FFR arm. The present follow-up analysis confirmed a higher rate of 1-year mortality in the FFR group, with 17 versus 7 deaths (3.7% vs. 1.5%, p = 0.036). However, the overall primary endpoint of all-cause mortality, MI, stroke, or repeat revascularization was no different between the 2 groups (14.6% vs. 14.4%; hazard ratio 0.97; 95% CI, 0.69-1.36), and no difference was seen in the individual endpoints of cardiovascular death, stroke, or revascularization.
This trial was an outlier compared with nearly all prior trials of FFR guidance (FAME, FAME 2, and FAMOUS-NSTEMI [Fractional Flow Reserve Versus Angiographically Guided Management to Optimise Outcomes in Unstable Coronary Syndromes]) that have demonstrated reduced clinical events across a spectrum of stable angina and ACS. Given the relative lack of complications from the FFR procedure itself and the fact that the components that would have been expected to lead to death (cardiovascular death and MI) were not different, the best interpretation would be that the mortality difference was a statistical outlier, a play of chance. For low-incidence events such as mortality, the "fragility index" is a better measure than the traditional p-value of how robust the results are. For the FUTURE study, the index is only 1, indicating that a change of a single event would have made the results statistically non-significant. As a result, it would imprudent to overinterpret this study.
An exploratory analysis for the cause of the excess mortality found that although as a whole the randomization was balanced and successful, there were more patients with higher risk SYNTAX score >32 in the FFR group (17.4% FFR vs. 0% control, p = 0.02) and trend toward a higher rate of PCI in the FFR group (4.0% FFR vs. 1.9% control, p = 0.10). The combination of more high-risk patients with a low rate of coronary artery bypass grafting in this study is one potential explanation for the excess mortality seen.
ULTIMATE (A Multicenter, Prospective, Randomized Trial Comparing Intravascular Ultrasound-Guided Versus Angiography-Guided Implantation of Drug-Eluting Stent in All-Comers)
By Thosaphol Limpijankit, MD, FACC
Ramathibodi Hospital Mahidol University
ULTIMATE was a multicenter, prospective, randomized study to evaluate the benefits of IVUS-guided DES implantation compared with angiography-guided DES implantation in all-comer patients. IVUS-guided PCI was associated with a lower frequency of target vessel failure at 12 months compared with angiography-guided PCI. The greatest benefit seemed to be reducing target vessel revascularization; there was no effect on MI and cardiac death. Among those who met the criteria for optimal IVUS-guided PCI, there appeared to be enhanced benefit. The results of this study emphasize the rationale for the more routine use of IVUS to guide PCI; however, the cost-effectiveness of the procedure is a concern. To address this, additional trials studying cardiac events beyond 1-year follow-up are needed to test the long-term benefits of IVUS guidance. Moreover, the IVUS-defined criteria for optimal stent deployment should be uniform in the next study because the criteria have been different in each study. In terms of angiography-guided PCI, for the operators who have a good angiographic approach, this study result may not change their routine practice. The IVUS-guided PCI approach would be reserved for high-risk anatomy or complex lesions. Nevertheless, for patients to benefit from the routine use of IVUS-guided stent implantation, it is necessary to have good image acquisition, accurate interpretation, and correct decision-making.
ABSORB IV (A Bioresorbable Everolimus-Eluting Scaffold Versus a Metallic Everolimus-Eluting Stent IV)
By Dean J. Kereiakes, MD, FACC
The Lindner Research Center
The Christ Hospital Heart and Vascular Center
The ABSORB III randomized clinical trial comparing the Absorb (Abbott; Santa Clara, CA) bioresorbable vascular scaffold (BVS) with the metallic EES demonstrated non-inferiority for target lesion failure (TLF), composite occurrence of cardiac death, target vessel MI, and ischemia-driven TLR to 1 year. However, early trials included patients with vessels smaller than intended for BVS use and excluded patients with MI in whom BVS might be well-suited. Further, the scaffold implantation technique was neither optimized nor standardized. ABSORB IV is an active-controlled (BVS vs. EES), single-blind, multicenter, randomized trial that enrolled 2,604 patients with stable CAD or biomarker-positive ACS (STEMI excluded). Significant differences in study design and population from ABSORB III included the following:
- Inclusion of biomarker-positive patients
- Up to 3 target lesions in a maximum of 2 vessels
- 1:1 randomization strata
- Focus on optimized BVS deployment technique
ABSORB IV successfully optimized target vessel sizing and reduced the percentage of patients with baseline reference vessel diameter <2.25 mm by quantitative coronary angiography (which corresponds to a visual estimate reference vessel diameter of <2.5 mm and should have been an exclusion to enrollment) from 18-19% in ABSORB III to 2-3% in ABSORB IV. Following deployment, high-pressure post-dilatation was performed in 83% of BVS scaffolds. The primary endpoint (TLF by intention-to-treat at 30 days powered for non-inferiority) was met (5.0% BVS vs. 3.7% EES; Pni = 0.02), as was the key secondary endpoint of TLF (intention-to-treat) to 1 year (7.8% BVS vs. 6.4% EES; Pni < 0.001). The lower prevalence of very small vessels in ABSORB IV was associated with a reduction in device thrombosis rates compared with ABSORB III (Figure 1). Importantly, thrombosis rates were reduced for both devices, but the relative risk for device thrombosis (BVS vs. EES) remained the same or slightly higher. Despite better target vessel/lesion selection and improved technique, both 30-day and 1-year rates of MI, ischemia-driven TLR, and device thrombosis tended to be increased with BVS versus EES. These results are largely consistent with earlier ABSORB clinical trials and emphasize both limitations of the current technology and the need for further advancements in device technology and technique.
Figure 1: Device Thrombosis to 1 Year in ABSORB III and ABSORB IV
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