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Originally Published 1 March 2021
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Primary Results of the EVOLVE Short DAPT Study: Evaluation of 3-Month Dual Antiplatelet Therapy in High Bleeding Risk Patients Treated With a Bioabsorbable Polymer-Coated Everolimus-Eluting Stent

Ajay J. Kirtane, MD, SM https://orcid.org/0000-0003-0061-1058 [email protected], Robert Stoler, MD, Robert Feldman, MD, Franz-Josef Neumann, MD, PhD, Loukas Boutis, MD, Naeem Tahirkheli, MD, Ralph Toelg, MD, … Show All … , Islam Othman, MD, Bernardo Stein, MD, James W. Choi, MD, Stephan Windecker, MD https://orcid.org/0000-0003-2653-6762, Robert W. Yeh, MD, MSC https://orcid.org/0000-0002-0564-4468, Harold L. Dauerman, MD, Matthew J. Price, MD, Paul Underwood, MD, Dominic Allocco, MD, Ian Meredith, AM, MBBS, PhD, and Dean J. Kereiakes, MD https://orcid.org/0000-0003-1086-127XAuthor Info & Affiliations
Circulation: Cardiovascular Interventions
Volume 14, Number 3
https://doi.org/10.1161/CIRCINTERVENTIONS.120.010144
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VIEW EDITORIAL:Evolving Landscapes in Coronary Stents for Patients at High Bleeding Risk

Graphical Abstract

Abstract

Background:

Prolonged dual antiplatelet therapy (DAPT) after percutaneous coronary intervention is associated with increased bleeding, despite a reduced incidence of ischemic events. The SYNERGY everolimus-eluting stent is a thin-strut platinum-chromium stent that elutes everolimus from a thin abluminal layer of bioabsorbable polymer. These design elements may facilitate rapid endothelialization and enable shorter-duration DAPT.

Methods:

EVOLVE Short DAPT prospectively evaluated the safety of 3-month DAPT in high bleeding risk patients treated with the SYNERGY everolimus-eluting stent, enrolling 2009 patients at 110 global sites. Patients with acute myocardial infarction or complex lesions were excluded. After percutaneous coronary intervention, patients were required to take DAPT (aspirin+P2Y12 inhibitor) for 3 months, except those on chronic anticoagulation in whom aspirin was optional. Patients free of events (stroke, myocardial infarction, revascularization, and stent thrombosis) who discontinued P2Y12 inhibitor at 3 months, but continued aspirin, and had at least 1 year of follow-up or an end point event were included in the primary analysis. Two powered coprimary end points were (1) death/myocardial infarction compared with a historical control and (2) study stent-related definite/probable stent thrombosis compared to a performance goal.

Results:

The analysis population consisted of 1487 patients. The adjusted rate of death/myocardial infarction between 3 and 15 months was 5.6% among patients receiving 3-month DAPT versus 5.7% patients in the 12-month DAPT control (propensity adjusted difference=−0.12%; 97.5% upper bound=1.63% which was less than the prespecified margin of 2.52; Pnon-inferiority=0.0016). The rate of study stent-related stent thrombosis between 3-15 months was 0.2% in the 3-month DAPT group (97.5% upper bound=0.63%; P=0.0005 for comparison to 1% performance goal).

Conclusions:

Favorable rates of ischemic outcomes were observed among selected high bleeding risk patients undergoing percutaneous coronary intervention with the SYNERGY everolimus-eluting stent who tolerated 3 months of P2Y12 inhibitor and then discontinued it, supporting the safety of abbreviated DAPT with this stent platform.

Registration:

URL: https://www.clinicaltrials.gov; Unique identifier: NCT02605447.

What Is Known

•
Prolonged dual antiplatelet therapy (DAPT) after percutaneous coronary intervention increases the risk of bleeding, despite reduced rates of myocardial infarction and stent thrombosis.
•
The SYNERGY stent with an ultrathin abluminal everolimus-eluting bioabsorbable polymer coating was designed to reduce stent thrombosis and the associated need for extended DAPT. Recent data with SYNERGY has shown reduced incidence of ischemic events in selected patients.

What the Study Adds

•
EVOLVE Short DAPT studying the safety of abbreviated DAPT (3 months) in high bleeding risk patients met both coprimary end points: (1) death/myocardial infarction in the 3-month DAPT group implanted with the SYNERGY stent was noninferior to a 12-month DAPT historical control and (2) definite/probable stent thrombosis related to the SYNERGY stent in the 3-month DAPT group was lower than the prespecified performance goal.
•
Abbreviated DAPT is associated with favorable rates of ischemic events in selected high bleeding risk patients implanted with the SYNERGY stent.

Introduction

See Editorial by Capodanno
Percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) requires administration of dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor to prevent stent thrombosis (ST). Prolonged DAPT after PCI is associated with increased bleeding, despite a reduced incidence of ischemic events.1 Current international guidelines recommend at least 6 to 12 months of DAPT in patients undergoing PCI with DES, with potentially shorter durations of DAPT for patients at higher bleeding risk (HBR).2,3 Particularly because the risk of ST is highest soon after implantation of a DES, for patients with HBR, longer duration DAPT may be associated with greater risk than benefit.
Specific modifications to DES design may alleviate the ongoing risk of ST and the need for longer duration DAPT. The SYNERGY everolimus-eluting stent (S-EES; Boston Scientific Corporation, Marlborough, MA) is a thin-strut (81 µm) platinum-chromium metal alloy platform coated abluminally with an ultrathin (4 µm) bioabsorbable poly(DL-lactide-co-glycolide) polymer.4 Everolimus is eluted within 90 days and polymer degradation occurs within 4 months.5 These design elements may facilitate rapid endothelialization and enable shorter durations of DAPT.
Longer-term data in both pivotal trials and large-scale observational registries have demonstrated the safety of S-EES in patients treated with standard durations of DAPT.6–8 However, there are limited data in patients with HBR who may particularly benefit from earlier discontinuation of DAPT. The EVOLVE Short DAPT Study was designed to prospectively evaluate the safety of 3-month DAPT in selected patients with HBR (without myocardial infarction (MI)/complex lesions) undergoing PCI with S-EES.

Methods

Study Design

EVOLVE Short DAPT was a prospective, single-arm, multicenter, global, FDA approved IDE study that enrolled 2009 patients with HBR at 110 centers in the United States, Europe, Brazil, and Japan. The study design has been reported previously.9 Patients with HBR were enrolled if they met at least one of the following inclusion criteria: age ≥75 years and in the opinion of the investigator, the anticipated risk of bleeding associated with >3 months of DAPT outweighed the anticipated benefit; need for chronic/lifelong anticoagulation; history of major bleeding within 12 months of the index procedure (severe/life-threatening or moderate bleeding based on GUSTO classification)10; history of ischemic or hemorrhagic stroke; renal insufficiency (creatinine ≥2.0 mg/dL) or failure (dialysis dependent); and platelet count ≤100 000/μL. Patients with non–ST-segment–elevation MI or ST-segment–elevation MI, treatment of >3 lesions or >2 major epicardial vessels, ostial or saphenous vein graft lesions, in-stent restenosis, left main disease, or total occlusion were excluded.
All patients provided written informed consent either preprocedure or within 3 days of S-EES stent(s) implantation. This study was approved by the Institutional Review Board at each site before enrollment and conformed with all applicable local and federal regulations. The data for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Corporation Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).

Treatment and Clinical Follow-Up

A detailed description of the implantation procedure and antiplatelet therapy has been published.9 Patients were required to take DAPT (aspirin and oral P2Y12 inhibitor) for 3 months following PCI with S-EES, except those on chronic anticoagulation in whom aspirin was optional. Patients were considered eligible to discontinue the P2Y12 inhibitor at 3 months postprocedure if they were adherent to DAPT (defined as taking >80% or <120% of prescribed doses of DAPT without interruption for ≥14 consecutive days) and were free from stroke, MI, revascularization, or ST. All enrolled patients who received S-EES were followed through 15 months regardless of eligibility to discontinue the P2Y12 inhibitor; follow-up was performed with telephone or office visits querying outcomes as well as adherence to DAPT.

Study End Points

The 3-month DAPT group (analysis population) consisted of patients that discontinued the P2Y12 inhibitor at 3 months, continued aspirin, and were free of events (stroke, MI, revascularization, ST) between 0 and 3 months. Evaluable patients with at least 425 days of follow-up or end point events were included in the final analysis. Clinical follow-up was performed in-hospital, at 3, 6, 12, and 15 months postindex procedure by telephone interview or office visit.
The 2 powered coprimary end points of all cause death/MI and study stent-related definite/probable ST11 were evaluated between 3 and 15 months post–S-EES stent implantation. The secondary end point was the rate of bleeding between 3 and 15 months postindex procedure in patients not receiving chronic anticoagulation, using the Bleeding Academic Research Consortium (BARC)12 classification (types 2, 3, and 5). Additional end points included the rates of the following composite end points (and individual components): major adverse cardiac and cerebrovascular events (all death, MI, and stroke), major adverse cardiac events (cardiac death, MI, and target vessel revascularization), target vessel failure (cardiac death, target vessel-related MI, and target vessel revascularization). All end points were adjudicated by an independent clinical events committee. The data monitoring committee reviewed all safety events.

Statistical Methods

The study was powered to test noninferiority of 3-month DAPT in the EVOLVE Short DAPT population compared with a historical control treated with 12-month DAPT, with respect to the coprimary end point of death/MI between 3 and 15 months.9 The propensity-adjusted 12-month DAPT historical control was derived from EVOLVE Short DAPT-like patients with HBR treated with EES in the PE+ PAS (PROMUS Element Plus US Post Approval Study),13 the PE PROVE (PROMUS Element Everolimus-Eluting Coronary Stent System European Post-Approval Surveillance Study),14 and the limus stents cohort in the DAPT Study (Dual Antiplatelet Therapy Study).1 Assuming a death/MI rate between 3 and 15 months of 5.6% based on data from the PROMUS EES trials,1,13,14 an estimated 2000 patients would provide 85% power to demonstrate noninferiority with a margin of 2.52%, with a 1-sided test significance level of 2.5%, while accounting for propensity score model variability (10%), dropout (15%), and attrition (3%).
The study was also powered to assess the second coprimary end point of study stent-related definite/probable ST compared to a prespecified performance goal of 1%.9 Based on PE PROVE, PE+PAS, and the DAPT study,1,13,14 the expected rate of ST between 3 and 15 months in the 3-month DAPT group was 0.4%. Given a performance goal of 1.0% and 1-sided test significance level of 2.5%, a minimum of 2000 patients would provide 80% power for ST after adjusting for dropout (15%) and attrition (3%).
The secondary end point of BARC 2, 3, and 5 bleeding occurring between 3 and 15 months in patients not on chronic anticoagulation was compared for superiority against propensity-adjusted 12-month DAPT patients from the DAPT study using a 1-sided test significance level of 2.5%. The control group included only limus stent–treated EVOLVE Short DAPT–like patients at high risk for bleeding obtained from DAPT Study1 as bleeding events were not clinical events committee–adjudicated in the PE+PAS and PE PROVE studies. An expected bleeding rate of 4.0% with 12-month DAPT was derived from this group. Propensity scores were calculated using a logistic regression model. The covariates for propensity score models included baseline demographic, geographic, clinical, and procedural data that were available in both the test and control groups. To maximize the number of control patients for each test patient, patients in the test group were first matched 1:1 to patients in the control group using the nearest neighbor method. Using this same method, a second matching was carried out with the remaining control patients such that the difference in the propensity scores between test and remaining control patients was <0.1. In total, 1948 propensity-matched control patients were identified (1487 and 461 from the first and second steps, respectively) and 1487 test patients that were included in the end point analyses for ischemic events. For bleeding comparisons, patients on chronic anticoagulation were excluded, allowing for 1333 control and 1032 test patients. For both the coprimary end point of death/MI as well as the secondary end point of bleeding, a propensity model was refitted to perform propensity quintile-based adjustment.
Statistical analyses were performed using SAS version 9.3 or later (SAS Institute, Inc, Cary, NC). Continuous variables were expressed as mean±SD and discrete variables as percentage and count/sample. Normal approximation was used to calculate P values. The 97.5% upper confidence bound of the adjusted between-group differences was calculated by Z test or Fisher exact test. 95% CIs were evaluated using exact CI for proportions.

Results

EVOLVE Short DAPT enrolled 2009 patients at 110 global study sites between February 2016 and March 2018. Among the 1912 patients with 3-month clinical follow-up, 425 patients were ineligible to discontinue P2Y12 inhibitor at 3 months as depicted in Figure 1. A total of 1487 patients who were free from stroke, MI, revascularization, or ST at 3 months and adherent to protocol-specified antiplatelet therapy were included in the end point analyses.
Figure 1. EVOLVE Short DAPT enrollment and follow-up. BARC indicates Bleeding Academic Research Consortium; DAPT, dual antiplatelet therapy; and f/u, follow-up. *Withdrawn due to adverse event, lost to follow-up, investigator discretion, or other reasons; †patients free from stroke, myocardial infarction (MI), revascularization and stent thrombosis (ST) between 0 and 3 mo eligible to discontinue; ‡patients may have had multiple reasons for not being eligible.
Baseline clinical characteristics for the analysis population are shown in Table 1. The mean age in the 3-month DAPT group was 76 years, 34.0% were women, 36.4% had diabetes, 18.8% had prior MI, 23.0% had congestive heart failure, 13.5% had history of cerebrovascular accident, 9.3% had renal insufficiency, and 12.6% had a history of peripheral vascular disease. A history of atrial fibrillation was present in 31.2% of the population. The majority of patients presented with stable ischemic syndromes, with 26.2% presenting with unstable angina. Overall, 22.9% of patients met >1 HBR criteria, with a mean of 1.3 HBR criteria per patient. The categories of HBR in the 3- and 12-month DAPT groups are shown in Tables I and II in the Data Supplement, respectively. The most frequent categories were advanced age, need for anticoagulation, and history of stroke.
Table 1. Baseline Clinical Characteristics
 3-mo DAPT; N=1487Enrolled; N=2009
Patient characteristics
 Age, y ±SD75.7±8.575.6±8.6
 Female506 (34.0)697 (34.7)
 White1159 (77.9)1541 (76.7)
 BMI28.7±5.728.7±5.7
Medical history
 Smoking status
  Current smoker98 (6.6)138 (6.9)
  Previous smoker714 (48.0)948 (47.2)
 Diabetes542 (36.4)762 (37.9)
  Medically treated478 (32.1)669 (33.3)
  Insulin dependent189 (12.7)275 (13.7)
 Hyperlipidemia1182 (79.5)1594 (79.3)
 Hypertension1310 (88.1)1782 (88.7)
Cardiac history
 Myocardial infarction280 (18.8)377 (18.8)
 Congestive heart failure342 (23.0)479 (23.8)
 NYHA class III/IV123/342 (36.0)179/479 (37.4)
 Silent ischemia131 (8.8)182 (9.1)
 Previous PCI485 (32.6)678 (33.7)
 Previous CABG181 (12.2)255 (12.7)
 Atrial fibrillation464 (31.2)627 (31.2)
 History of cerebrovascular accidents (stroke)201 (13.5)274 (13.6)
 Renal insufficiency (creatinine ≥2.0 mg/dL)139 (9.3)208 (10.4)
 History of PVD188 (12.6)267 (13.3)
Angina status
 Stable angina720 (48.4)960 (47.8)
 Unstable angina390 (26.2)541 (26.9)
 Unknown53 (3.6%)81 (4.0)
Values are mean±SD or n (%). BMI indicates body mass index; CABG, coronary angiography bypass grafting; DAPT, dual antiplatelet therapy; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association; PCI, percutaneous coronary intervention; and PVD, peripheral vascular disease.
In the analysis population, the LAD was the most commonly treated artery, and preprocedure lesion length, reference vessel diameter, and visually estimated percent diameter stenosis were 17.2±9.5 mm, 3.0±0.5 mm, and 82.6%±9.8%, respectively. Of the 1865 target lesions, 47.3% were categorized as American College of Cardiology/American Heart Association type B2/C (Table 2).
Table 2. Procedural Characteristics
 3-mo DAPT; N=1487Enrolled; N=2009
No. of lesions18652544
Target vessel treated
 LAD850 (45.6)1143 (44.9)
 LCx452 (24.2)634 (24.9)
 RCA562 (30.1)765 (30.1)
Lesion length, mm17.2±9.517.4±9.8
 <10297 (16.0)405 (15.9)
 10–281354 (72.7)1830 (72.0)
 >28211 (11.3)305 (12.0)
RVD, mm3.0±0.52.9±0.5
 <2.2524 (1.3)35 (1.4)
 2.25–<2.5166 (8.9)234 (9.2)
 2.5–<2.75433 (23.3)596 (23.5)
 ≥2.751233 (66.4)1669 (65.9)
% diameter stenosis82.6±9.882.8±9.8
Pre-TIMI flow grade <3214 (11.6)298 (11.8)
Modified AHA/ACC B2/C881 (47.3)1204 (47.4)
Calcification, moderate/severe543 (29.1)773 (30.4)
Tortuosity, moderate/severe315 (16.9)423 (16.6)
Staged procedure16 (1.1)21 (1.0)
Lesions treated/patient1.2±0.51.3±0.5
 2 lesions322 (21.7)452 (22.5)
 3 lesions23 (1.5)35 (1.7)
SYNERGY stents implanted
 Per patient1.4±0.61.4±0.6
 Per lesion1.1±0.31.1±0.4
 SYNERGY stent length, mm/patient28.1±16.628.5±16.9
 Predilation performed1356 (72.7)1855 (72.9)
 Procedure time, min42.4±24.143.3±25.5
 Postdilation performed1159 (62.1)1586 (62.3)
 Post-TIMI flow grade <35 (0.3)5 (0.2)
 Percent diameter stenosis (%)0.7±2.90.7±3.1
Values are mean±SD or n (%). Site reported lesion characteristics; % diameter stenosis was visually estimated. ACC indicates American College of Cardiology; AHA, American Heart Association; DAPT, dual antiplatelet therapy; LAD, left anterior descending artery; LCx, left circumflex artery; RCA, right coronary artery; RVD, reference vessel diameter; and TIMI, Thrombolysis in Myocardial Infarction.

Clinical Outcomes

Overall outcomes occurring between 3 and 15 months in the 3- versus 12-month DAPT groups are shown in Table 3; additional prespecified outcomes in all enrolled patients with HBR at 15 months are shown in Table III in the Data Supplement. The frequencies of cardiac death (2.1%), MI (1.9%), ST (0.3%), and target vessel revascularization (2.6%) between 3 and 15 months were relatively low.
Table 3. Ischemic Outcomes Between 3 and 15 Months
 12-mo DAPT (N=1948 subjects)3-mo DAPT (N=1487 subjects)
MACCE (death/MI/stroke)85/1502 (5.7)101/1457 (6.9)
Death and MI79/1502 (5.3)84/1457 (5.8)
Cardiac death and MI62/1502 (4.1)52/1457 (3.6)
Death51/1502 (3.4)62/1457 (4.3)
 Cardiac death32/1502 (2.1)30/1457 (2.1)
 Noncardiac death17/1502 (1.1)27/1457 (1.9)
 Vascular death2/1502 (0.1)5/1457 (0.3)
MI32/1502 (2.1)27/1457 (1.9)
Stroke9/1502 (0.6)21/1457 (1.4)
 Ischemic7/1502 (0.5)17/1457 (1.2)
 Hemorrhagic2/1502 (0.1)4/1457 (0.3)
 Undetermined0/1502 (0.0)0/1457 (0.0)
ST (ARC definite/probable/possible)13/1502 (0.9)16/1457 (1.1)
 ST (definite/probable)4/1502 (0.3)4/1457 (0.3)
 ST (definite)1/1502 (0.1)4/1457 (0.3)
 ST (probable)3/1502 (0.2)0/1457 (0.0)
 ST (possible)9/1502 (0.6)12/1457 (0.8)
Values are n/N (%). All percentages are binary rate estimates between 3 and 15 mo. ARC indicates Academic Research Consortium; DAPT, dual antiplatelet therapy; MACCE, major adverse cardiac and cerebrovascular events; MI, myocardial Infarction; and ST, stent thrombosis.

Coprimary End Points

For the prespecified assessment of the coprimary death/MI end point from 3 to 15 months, 1487 patients in the 3-month analysis group were propensity-matched to 1948 control patients treated with 12-month DAPT. Unadjusted and propensity quintile-adjusted characteristics of the 2 groups are presented in Table IV in the Data Supplement. After adjustment, both groups were well balanced in baseline clinical, lesion, and procedural characteristics. The propensity quintile-adjusted incidence of death/MI between 3 and 15 months was 5.6% patients in the 3-month DAPT group and 5.7% patients in the 12-month DAPT control group (Figure 2). Noninferiority of 3-month DAPT compared with 12-month DAPT was demonstrated with an absolute difference of -0.12% and a one-sided 97.5% upper bound of 1.63%, which was less than the prespecified noninferiority margin of 2.52 (P=0.0016 for noninferiority).
Figure 2. Coprimary end points of death/myocardial infarction (MI) and study stent-related definite/probable stent thrombosis (ST) between 3 and 15 mo in the analysis population. A, Noninferiority of the SYNERGY everolimus-eluting stent (S-EES) 3-mo dual antiplatelet therapy (DAPT; blue) to 12-mo DAPT historical (red) for death/MI. On the right, the plot shows propensity score-adjusted difference in death/MI between 3-mo DAPT and 12-mo DAPT control (black circle) with the 1-sided 97.5% upper confidence bound (UCB*) indicated by the error bar. The P value for noninferiority testing is from a 1-sided Z test. B, ST in the S-EES 3-mo DAPT group was compared to a 1.0% performance goal. One-sided 97.5% UCB* is indicated by the error bar. P value was calculated using the exact test.
The second coprimary end point of study stent-related definite/probable ST between 3 and 15 months was 0.2% in the 3-month DAPT group with a one-sided 97.5% upper bound of 0.63%, which was lower than the prespecified performance goal of 1.0% (P=0.0005; Figure 2). Study stent-related definite ST occurred in 3 patients: 2 events occurred late (171 and 253 days postprocedure) and 1 occurred very late (473 days postprocedure). All 3 definite ST patients were on aspirin but not P2Y12 inhibitor at the time of the event. Although there were no definite ST-related deaths, 2 patients had non–Q-wave MI associated with the ST event. All patients with definite ST were successfully revascularized with repeat PCI.

Secondary End Point

Propensity matching for a prespecified analysis of the secondary end point of BARC 2, 3, or 5 bleeding between 3 and 15 months (restricted to the group of patients, not on oral anticoagulation) resulted in 1032 and 1333 patients in the 3-month and 12-month DAPT groups, respectively. Notably, there was incomplete adjudication of the timing of events in the control group, so all control group events that occurred without a known date of occurrence were conservatively attributed to occur between 0 and 3 months, therefore, censoring them from the 3- to 15-month comparison with the test group. Using this analytic methodology, the propensity quintile-adjusted BARC 2, 3, or 5 bleeding rates between 3 and 15 months was 6.26% in the 3-month group and 4.17% in the control group (Table V in the Supplemental Material; difference=2.10%; 97.5% upper confidence bound=4.29%; 1-sided P=0.98).

Discussion

The EVOLVE Short DAPT study prospectively evaluated the safety of DAPT discontinuation at 3 months in patients with HBR treated with S-EES. There are several notable findings from this study. First, although patients with MI and complex lesions were not enrolled, bleeding risk was significant, and key subgroups (eg, elderly patients, need for anticoagulation) were well-represented in the study sample. Second, the study met both ischemic coprimary end points, with favorable rates of death/MI and an overall 0.2% (95% CI, 0.0%–0.6%) rate of study stent-related definite/probable ST between 3-15 months (after discontinuation of the P2Y12 inhibitor). Third, although the rate of the secondary end point of bleeding was not lower among EVOLVE Short DAPT patients when compared with the historical control group treated with 12-month DAPT, difficulties in the timing of event ascertainment within the control group render it difficult to draw definitive conclusions from this analysis. Together, these data support the safety of S-EES with a 3-month duration of DAPT in selected patients with HBR.
Despite limited representation in pivotal approval trials of DES, a significant proportion of patients treated with current day PCI meet HBR criteria.15 Because the rate of ischemic events (most directly ST) is typically highest during the first 30 days after DES implantation, defining the obligatory duration of DAPT needed to mitigate ST risk is essential, especially for patients with HBR for whom longer duration DAPT carries an even greater risk. First-generation DES were initially studied with durations of DAPT as short as 3 to 6 months; however, following observations of late ST over a decade ago, regulatory bodies and societies extended the recommended DAPT duration to a minimum of 12 months. More recent data with newer-generation DES have revised these recommendations, with the most recent guideline updates from both the US and the European Union recommending shorter durations of DAPT, especially for patients with HBR.2,3
Innovations in DES technology have also facilitated the investigation of shorter durations of DAPT in patients with HBR. The LEADERS-FREE study, which evaluated a polymer-free DES, demonstrated superior safety and efficacy of the polymer-free DES compared to a bare-metal stent in patients with HBR treated with 1-month DAPT,16 and the ONYX ONE trial17 demonstrated similar outcomes of a durable polymer DES with 1-month DAPT to the polymer-free DES. Similarly, the SENIOR trial in elderly patients treated with the S-EES stent and a short DAPT duration (1-month for patients without acute coronary syndrome) demonstrated lower rates of major cardiac events compared with a bare-metal stent.18 EVOLVE Short DAPT was designed as a single-arm multicenter study, with prespecified and powered primary and secondary study end points. This design was chosen given the inherent challenges in finding an adequate comparator group in which to test shorter durations of DAPT in patients with HBR (eg, in the United States, bare-metal stent use is low and polymer-free DES are not available).
EVOLVE Short DAPT enrolled patients with HBR based upon observed event rates in prior studies.1,13,14 Of particular note was the high proportion of patients treated with concomitant anticoagulation and elderly patients within the study. Event rates for the analysis population were assessed between 3 and 15 months, and despite being a high-risk population, the overall rate of ischemic events was low. The most feared event that often drives DAPT-related clinical decision-making in the first few months after PCI is ST. In this context, the observation of only 3 study stent-related definite/probable ST events following P2Y12 inhibitor discontinuation is notable, both for the low absolute event rate as well as in its favorable comparison to the prespecified performance goal of 1.0%.
The propensity-adjusted comparisons of EVOLVE Short DAPT study patients to historical control groups demonstrated similar adjusted rates of death/MI between 3 and 15 months post-PCI and numerically but nonsignificantly higher adjusted rates of BARC 2, 3, and 5 bleeding. Due to the design of the DAPT study that served as the control group, there was potential for differential underreporting of outcomes. For example, the timing of some events occurring between the index procedure and 12-month follow-up in the control group was unknown and led to an analytic methodology that used a conservative worst-case scenario analysis where all of these events were assumed to occur between the index procedure and 3 months and were, therefore, censored in all comparisons with the test group. Although this likely resulted in bias against the test group (perhaps providing further reassurance of the ischemic safety of shorter-duration DAPT with S-EES with respect to the death/MI end point), it does also limit the overall interpretability of the comparative analyses. For example, it is clinically implausible that 3-month DAPT following PCI would result in a higher rate of bleeding when compared with a 12-month duration of DAPT.
In toto, these data represent prospectively gathered evidence to support shorter DAPT durations in selected patients treated with S-EES. Whether design characteristics of this specific stent platform such as the strut thickness and thin abluminal layer of bioabsorbable polymer with abbreviated elution kinetics in comparison to durable polymer DES allow for even shorter durations of mandatory DAPT is at present unknown. Data from the present study will help to better inform the care of both patients with HBR as well as patients who may develop a need or desire to curtail overall DAPT due to unforeseen circumstances or side-effects from antithrombotic therapies.

Limitations

As a randomized bare-metal stent comparator group would have been extremely challenging to enroll and there is no currently approved short-duration DES within the United States, a nonrandomized study design was chosen with analytic limitations as discussed above. As a result, this study design is subject to both measured and unmeasured confounding despite multivariable adjustment. For example, the control group included different stent types, and as such this could have led to differences in the adequacy of comparisons. In addition, lesion complexity was restricted, and the enrolled population only included patients without MI due to concerns regarding the risk of shorter DAPT duration in patients at highest ischemic risk. Of note, a prior observational analysis demonstrated a greater rate of acute ST with S-EES19; although this finding was not replicated within the present study using more selected inclusion criteria for enrollment, careful attention to implantation technique and stent optimization is additionally warranted for all patients with HBR to mitigate early ST risk.

Conclusions

Favorable rates of ischemic outcomes were observed among selected patients with HBR undergoing PCI with S-EES who stopped a P2Y12 inhibitor at 3 months. These data support the safety of abbreviated DAPT following S-EES implantation.

Acknowledgments

We thank Pooja Bhatt, PhD, and Songtao Jiang, MSc (both of Boston Scientific Corporation), for editorial assistance in manuscript preparation and statistical analysis, respectively.

Footnote

Nonstandard Abbreviations and Acronyms

BARC
Bleeding Academic Research Consortium
DAPT
dual antiplatelet therapy
HBR
high bleeding risk
MI
myocardial infarction
PCI
percutaneous coronary intervention
PE PROVE
PROMUS Element Everolimus-Eluting Coronary Stent System European Post-Approval Surveillance Study
PE+PAS
PROMUS Element Plus US Post Approval Study
S-EES
SYNERGY everolimus-eluting stent
ST
stent thrombosis

Supplemental Material

File (circinterventions_circcvint-2020-010144d_supp1.docx)

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Information & Authors

Information

Published In

Go to Circulation: Cardiovascular Interventions
Go to Circulation: Cardiovascular Interventions
Circulation: Cardiovascular Interventions
Volume 14 • Number 3 • March 2021
PubMed: 33641374

Copyright

© 2021 American Heart Association, Inc.

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History

Received: 18 September 2020
Accepted: 27 October 2020
Published online: 1 March 2021
Published in print: March 2021

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Keywords

  1. aspirin
  2. everolimus
  3. percutaneous coronary intervention
  4. stent
  5. thrombosis

Subjects

  1. Percutaneous Coronary Intervention
  2. Stent

Authors

Affiliations

Ajay J. Kirtane, MD, SM https://orcid.org/0000-0003-0061-1058 [email protected]
Columbia University Irving Medical Center/NewYork-Presbyterian Hospital and the Cardiovascular Research Foundation, New York (A.J.K.)
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Robert Stoler, MD
Baylor Scott & White Heart and Vascular Hospital, Dallas, TX (R.S., J.W.C.)
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Robert Feldman, MD
MediQuest Research at AdventHealth Ocala, FL (R.F.)
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Franz-Josef Neumann, MD, PhD
University of Freiburg, Universitats-Herzzentrum Freiburg, Bad Krozingen, Germany (F.-J.N.)
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Loukas Boutis, MD
North Shore University Hospital, Manhasset, NY (L.B.)
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Naeem Tahirkheli, MD
Oklahoma Heart Hospital, Oklahoma City (N.T.)
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Ralph Toelg, MD
Herzzentrum Segeberger Kliniken, Bad Segeberg, Germany (R.T.)
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Islam Othman, MD
Duke University Health System, Durham, NC (I.O.)
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Bernardo Stein, MD
Morton Plant Mease Healthcare System, Clearwater, FL (B.S.)
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James W. Choi, MD
Baylor Scott & White Heart and Vascular Hospital, Dallas, TX (R.S., J.W.C.)
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Stephan Windecker, MD https://orcid.org/0000-0003-2653-6762
Bern University Hospital, Inselspital, University of Bern, Switzerland (S.W.)
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Robert W. Yeh, MD, MSC https://orcid.org/0000-0002-0564-4468
Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y.)
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Harold L. Dauerman, MD
University of Vermont Medical Center, Burlington (H.L.D.)
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Matthew J. Price, MD
Scripps Clinic, La Jolla, CA (M.J.P.)
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Paul Underwood, MD
Boston Scientific Corporation, Marlborough, MA (P.U., D.A., I.M.)
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Dominic Allocco, MD
Boston Scientific Corporation, Marlborough, MA (P.U., D.A., I.M.)
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Ian Meredith, AM, MBBS, PhD
Boston Scientific Corporation, Marlborough, MA (P.U., D.A., I.M.)
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Dean J. Kereiakes, MD https://orcid.org/0000-0003-1086-127X
Lindner Center for Research and Education at Christ Hospital, Cincinnati, OH (D.J.K.).
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Notes

This manuscript was sent to Dominick J. Angiolillo, MD, PhD, Guest Editor, for review by expert referees, editorial decision, and final disposition.
The Data Supplement is available at Supplemental Material.
For Sources of Funding and Disclosures, see page 309.
Correspondence to: Ajay Kirtane, MD, SM, 161 Ft Washington Ave, 6th Floor (HIP 6-608), New York, NY 10032. Email [email protected]

Disclosures

Disclosures Dr Kirtane received institutional funding to Columbia University or Cardiovascular Research Foundation from Medtronic, Boston Scientific Corporation (BSC), Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical. Dr Stoler was on the scientific advisory board for BSC and received honoraria from Medtronic. Dr Feldman received research grants from BSC, Abbott Vascular, Medtronic, Svelte Medical Systems, and Surmodics, Inc. Dr Neumann received grants from BSC, Biotronik, Edwards Lifesciences, Medtronic, Bayer Healthcare, Abbott Vascular, Novartis, Pfizer, and GlaxoSmithKline. Dr Yeh served on the advisory board, received research grants and consulting fees from Abbott Vascular, AstraZeneca, BSC, and Medtronic. Dr Choi received speaker’s bureau fees from BSC. Dr Windecker received research and educational grants to the institution from Abbott, Amgen, Bayer, Bristol Myers Squibb (BMS), BSC, Biotronik, CSL Behring, Edwards Lifesciences, Medtronic, Polares, and Sinomed. Dr Toelg received speaker’s honoraria from Bayer, Biotronik, Novartis. Dr Stein received speaker’s bureau fees for Astra Zeneca and Amgen. Dr Windecker received research and educational grants from Abbott, Amgen, Boston Scientific, Biotronik, Bayer, BMS, CLS Behring, Edwards Lifesciences, Medtronic, Polares, and Sinomed. Dr Price received consulting, speaking, and proctoring fees from Boston Scientific; consulting and speaking fees from Medtronic, Abbott Vascular, AstraZeneca, and Chiesi USA; and research grant (to institution) from Daiichi Sankyo. Drs Underwood, Allocco, and I. Meredith are full-time employees with equity interest in BSC. Dr Kereiakes received consultant fees from BSC and Abbott Vascular. The other authors report no conflicts.

Sources of Funding

EVOLVE Short DAPT was funded by Boston Scientific Corporation.

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Primary Results of the EVOLVE Short DAPT Study
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