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Article: Impact of premature coronary artery disease on adverse event risk following

Pinxterhuis, Tineke H / Ploumen, Eline H / Zocca, Paolo / Doggen, Carine J M / Schotborgh, Carl E / Anthonio, Rutger L / Roguin, Ariel / Danse, Peter W / Benit, Edouard / Aminian, Adel / Hartmann, Marc / Linssen, Gerard C M / von Birgelen, Clemens

Frontiers in cardiovascular medicine

2023 Volume 10, Page(s) 1160201

Abstract: Objectives: We assessed differences in risk profile and 3-year outcome between patients undergoing percutaneous coronary intervention (PCI) for : Background: The prevalence of CAD increases with age, yet some individuals develop obstructive CAD at ... ...

Abstract	Objectives: We assessed differences in risk profile and 3-year outcome between patients undergoing percutaneous coronary intervention (PCI) for Background: The prevalence of CAD increases with age, yet some individuals develop obstructive CAD at younger age. Methods: Among participants in four randomized all-comers PCI trials, without previous coronary revascularization or myocardial infarction (MI), we compared patients with premature (men <50 years; women <55 years) and non-premature CAD. Various clinical endpoints were assessed, including multivariate analyses. Results: Of 6,171 patients, 887 (14.4%) suffered from premature CAD. These patients had fewer risk factors than patients with non-premature CAD, but were more often smokers (60.7% vs. 26.4%) and overweight (76.2% vs. 69.8%). In addition, premature CAD patients presented more often with ST-segment elevation MI and underwent less often treatment of multiple vessels, and calcified or bifurcated lesions. Furthermore, premature CAD patients had a lower all-cause mortality risk (adj.HR: 0.23, 95%-CI: 0.10-0.52; Conclusions: About one out of seven PCI patients was treated for premature CAD. These patients had less complex risk profiles than patients with non-premature CAD; yet, their risk of repeated revascularization and stent thrombosis was higher. As lifetime event risk of patients with premature CAD is known to be particularly high, further efforts should be made to improve modifiable risk factors such as smoking and overweight. Twente trials: (TWENTE I, clinicaltrials.gov:
Language	English
Publishing date	2023-09-07
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2781496-8
ISSN	2297-055X
ISSN	2297-055X
DOI	10.3389/fcvm.2023.1160201
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Article ; Online: First myocardial infarction in patients with premature coronary artery disease: insights into patient characteristics and outcome after treatment with contemporary stents.

Pinxterhuis, Tineke H / Ploumen, Eline H / Doggen, Carine J M / Hartmann, Marc / Schotborgh, Carl E / Anthonio, Rutger L / Roguin, Ariel / Danse, Peter W / Benit, Edouard / Aminian, Adel / Linssen, Gerard C M / von Birgelen, Clemens

European heart journal. Acute cardiovascular care

2023 Volume 12, Issue 11, Page(s) 774–781

Abstract: Aims: Patients with premature coronary artery disease (CAD) have a higher incidence of myocardial infarction (MI) than patients with non-premature CAD. The aim of the present study is to asess differences in clinical outcome after a first acute MI, ... ...

Abstract	Aims: Patients with premature coronary artery disease (CAD) have a higher incidence of myocardial infarction (MI) than patients with non-premature CAD. The aim of the present study is to asess differences in clinical outcome after a first acute MI, percutaneously treated with new-generation drug-eluting stents between patients with premature and non-premature CAD. Methods and results: We pooled and analysed the characteristics and clinical outcome of all patients with a first MI (and no previous coronary revascularization) at time of enrolment, in four large-scale drug-eluting stent trials. Coronary artery disease was classified premature in men aged <50 and women <55 years. Myocardial infarction patients with premature and non-premature CAD were compared. The main endpoint was major adverse cardiac events (MACE): all-cause mortality, any MI, emergent coronary artery bypass surgery, or clinically indicated target lesion revascularization. Of 3323 patients with a first MI, 582 (17.5%) had premature CAD. These patients had lower risk profiles and underwent less complex interventional procedures than patients with non-premature CAD. At 30-day follow-up, the rates of MACE [hazard ratio (HR): 0.22, 95% confidence interval (CI): 0.07-0.71; P = 0.005), MI (HR: 0.22, 95% CI: 0.05-0.89; P = 0.020), and target vessel failure (HR: 0.30, 95% CI: 0.11-0.82; P = 0.012) were lower in patients with premature CAD. At 1 year, premature CAD was independently associated with lower rates of MACE (adjusted HR: 0.50, 95% CI: 0.26-0.96; P = 0.037) and all-cause mortality (adjusted HR: 0.24, 95% CI: 0.06-0.98; P = 0.046). At 2 years, premature CAD was independently associated with lower mortality (adjusted HR: 0.16, 95% CI: 0.05-0.50; P = 0.002). Conclusions: First MI patients with premature CAD, treated with contemporary stents, showed lower rates of MACE and all-cause mortality than patients with non-premature CAD, which is most likely related to differences in cardiovascular risk profile. TWENTE trials: TWENTE I, clinicaltrials.gov: NCT01066650), DUTCH PEERS (TWENTE II, NCT01331707), BIO-RESORT (TWENTE III, NCT01674803), and BIONYX (TWENTE IV, NCT02508714).
MeSH term(s)	Female ; Humans ; Male ; Coronary Artery Disease/complications ; Coronary Artery Disease/surgery ; Drug-Eluting Stents/adverse effects ; Myocardial Infarction/epidemiology ; Myocardial Infarction/surgery ; Myocardial Infarction/drug therapy ; Percutaneous Coronary Intervention/methods ; Risk Factors ; Treatment Outcome ; Middle Aged
Language	English
Publishing date	2023-08-22
Publishing country	England
Document type	Journal Article
ZDB-ID	2663340-1
ISSN	2048-8734 ; 2048-8726
ISSN (online)	2048-8734
ISSN	2048-8726
DOI	10.1093/ehjacc/zuad098
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Article: Outcome of percutaneous coronary intervention using ultrathin-strut biodegradable polymer sirolimus-eluting versus thin-strut durable polymer zotarolimus-eluting stents in patients with comorbid peripheral arterial disease: a post-hoc analysis from two randomized trials.

Pinxterhuis, Tineke H / Ploumen, Eline H / Zocca, Paolo / Doggen, Carine J M / Schotborgh, Carl E / Anthonio, Rutger L / Roguin, Ariel / Danse, Peter W / Benit, Edouard / Aminian, Adel / van Houwelingen, K Gert / Linssen, Gerard C M / Geelkerken, Robert H / von Birgelen, Clemens

Cardiovascular diagnosis and therapy

2023 Volume 13, Issue 4, Page(s) 673–685

Abstract: Background: In patients with peripheral arterial disease (PADs), who underwent percutaneous coronary intervention (PCI), little is known about the potential impact of using different new-generation drug-eluting stents (DES) on outcome. In PCI all-comers, ...

Abstract	Background: In patients with peripheral arterial disease (PADs), who underwent percutaneous coronary intervention (PCI), little is known about the potential impact of using different new-generation drug-eluting stents (DES) on outcome. In PCI all-comers, the results of most between-stent comparisons-stratified by strut thickness-suggested some advantage of coronary stents with ultrathin-struts. The current post-hoc analysis aimed to assess outcomes of PCI with ultrathin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) Methods: We pooled 3-year patient-level data from two large-scale randomized all-comer trials to compare Orsiro ultrathin-strut BP-SES Results: Of 4,830 trial participants, 360 had PADs: 177 (49.2%) were treated with BP-SES and 183 (50.8%) with DP-ZES. Baseline characteristics were similar. For BP-SES, the 3-year TVF rate was 11.0% and for DP-ZES 17.9% [hazard ratio (HR): 0.59, 95% CI: 0.33-1.04; P=0.07]. For BP-SES, the TVR rate was lower than for DP-ZES (4.1% Conclusions: In PCI patients with PADs, the 3-year TVF incidence was numerically lower in the ultrathin-strut BP-SES Trial registration: BIO-RESORT trial:
Language	English
Publishing date	2023-07-24
Publishing country	China
Document type	Journal Article
ZDB-ID	2685043-6
ISSN	2223-3660 ; 2223-3652
ISSN (online)	2223-3660
ISSN	2223-3652
DOI	10.21037/cdt-22-584
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Article: Percutaneous coronary intervention in patients undergoing transcatheter aortic valve implantation: a systematic review and meta-analysis.

Aarts, Hugo M / van Hemert, Nicole D / Meijs, Timion A / van Nieuwkerk, Astrid C / Berg, Jurriën M Ten / Wykrzykowska, Joanna J / van Royen, Niels / Schotborgh, Carl E / Tonino, Pim A L / IJsselmuiden, Alexander / Vossenberg, Tessel N / van Houwelingen, Gert K / Slagboom, Ton / Voskuil, Michiel / Delewi, Ronak

Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation

2023 Volume 31, Issue 12, Page(s) 489–499

Abstract: Objective: The importance of revascularisation of significant coronary artery disease (CAD) in patients undergoing transcatheter aortic valve implantation (TAVI) is unclear. Despite the lack of randomised controlled trials comparing different ... ...

Abstract	Objective: The importance of revascularisation of significant coronary artery disease (CAD) in patients undergoing transcatheter aortic valve implantation (TAVI) is unclear. Despite the lack of randomised controlled trials comparing different revascularisation strategies, guidelines currently recommend percutaneous coronary intervention (PCI) in patients with significant proximal CAD undergoing TAVI. Methods: In this systematic review and meta-analysis, a systematic search was conducted to identify studies comparing TAVI with and without PCI in patients with significant CAD on pre-TAVI coronary angiography. Endpoints were all-cause mortality, cardiac death, stroke, myocardial infarction and major bleeding. Results: In total, 14 studies were included, involving 3838 patients, of whom 1806 (47%) underwent PCI before TAVI. All-cause mortality did not differ significantly between TAVI with and without preceding PCI at 30 days, 1 year and > 1 year. There were no significant differences in risk of cardiac death, stroke or myocardial infarction between the groups. However, TAVI performed with PCI resulted in a higher risk of major bleeding within 30 days after TAVI (odds ratio: 0.66; 95% confidence interval: 0.46-0.94). Conclusion: This systematic review and meta-analysis showed no significant differences in clinical outcomes between patients with concomitant significant CAD who were treated with TAVI with and without preceding PCI at both short- and long-term follow-up. However, there was a higher risk of major bleeding at 30 days in patients undergoing TAVI with preceding PCI. In the context of serious risk of bias in the included studies, results of randomised controlled trials are warranted.
Language	English
Publishing date	2023-11-01
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	2211468-3
ISSN	1876-6250 ; 1568-5888 ; 0929-7456
ISSN (online)	1876-6250
ISSN	1568-5888 ; 0929-7456
DOI	10.1007/s12471-023-01824-w
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Article ; Online: Outcome after percutaneous coronary intervention with contemporary stents in patients with concomitant peripheral arterial disease: A patient-level pooled analysis of four randomized trials.

Pinxterhuis, Tineke H / Ploumen, Eline H / Zocca, Paolo / Doggen, Carine J M / Schotborgh, Carl E / Anthonio, Rutger L / Roguin, Ariel / Danse, Peter W / Benit, Edouard / Aminian, Adel / Stoel, Martin G / Linssen, Gerard C M / Geelkerken, Robert H / von Birgelen, Clemens

Atherosclerosis

2022 Volume 355, Page(s) 52–59

Abstract: Background and aims: A considerable number of patients who undergo percutaneous coronary intervention (PCI) also have peripheral arterial disease (PAD) - a signal of more advanced atherosclerosis. After bare metal and early-generation drug-eluting ... ...

Abstract	Background and aims: A considerable number of patients who undergo percutaneous coronary intervention (PCI) also have peripheral arterial disease (PAD) - a signal of more advanced atherosclerosis. After bare metal and early-generation drug-eluting coronary stent implantation, PAD patients showed inferior outcome. As stents and medical treatment were further improved, we aimed to assess the impact of PAD on outcome of PCI with contemporary new-generation stents. Methods: We analyzed 3-year pooled patient-level data from 4 large-scale randomized new-generation stent trials to compare all-comer patients with and without (core lab-verified) history of symptomatic PAD, defined as obstructive lesions in peripheral locations including lower and upper extremities, carotid, vertebral, mesenteric and renal arteries. Main endpoint was target vessel failure: cardiac death, target vessel-related myocardial infarction, or clinically indicated target vessel revascularization. Results: Of all 9204 patients, 695 (7.6%) had a history of symptomatic PAD. They were older and had more often diabetes, renal failure, hypertension, hypercholesterolemia, and prior stroke. PAD was an independent risk factor for target vessel failure (adjusted-HR:1.42, 95%-CI:1.12-1.73, p = 0.001). Target vessel revascularization (adjusted-HR:1.37, 95%-CI:1.04-1.80, p = 0.026), death (adjusted-HR:1.52, 95%-CI:1.17-1.99, p = 0.002), and major adverse cardiovascular event risks (adjusted-HR:1.36, 95%-CI:1.13-1.64, p = 0.001) were also substantially higher. Conclusions: A history of symptomatic PAD still allows to simply identify patients with increased risk of unfavorable clinical outcome after PCI, including a higher risk of repeated coronary revascularization, despite using contemporary stents. In clinical practice, this knowledge about higher event risks of PAD patients is helpful both during Heart Team discussions and when informing patients about the procedural risk.
MeSH term(s)	Coronary Artery Disease/complications ; Coronary Artery Disease/surgery ; Drug-Eluting Stents ; Humans ; Percutaneous Coronary Intervention/adverse effects ; Peripheral Arterial Disease/complications ; Peripheral Arterial Disease/diagnosis ; Peripheral Arterial Disease/therapy ; Randomized Controlled Trials as Topic ; Risk Factors ; Stents ; Treatment Outcome
Language	English
Publishing date	2022-05-20
Publishing country	Ireland
Document type	Journal Article ; Randomized Controlled Trial
ZDB-ID	80061-2
ISSN	1879-1484 ; 0021-9150
ISSN (online)	1879-1484
ISSN	0021-9150
DOI	10.1016/j.atherosclerosis.2022.05.002
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Article ; Online: Impact of prediabetes and diabetes on 3-year outcome of patients treated with new-generation drug-eluting stents in two large-scale randomized clinical trials.

Ploumen, Eline H / Pinxterhuis, Tineke H / Zocca, Paolo / Roguin, Ariel / Anthonio, Rutger L / Schotborgh, Carl E / Benit, Edouard / Aminian, Adel / Danse, Peter W / Doggen, Carine J M / von Birgelen, Clemens / Kok, Marlies M

Cardiovascular diabetology

2021 Volume 20, Issue 1, Page(s) 217

Abstract: Background: Diabetes is associated with adverse outcomes after percutaneous coronary intervention with drug-eluting stents (DES), but for prediabetes this association has not been definitely established. Furthermore, in patients with prediabetes treated ...

Abstract	Background: Diabetes is associated with adverse outcomes after percutaneous coronary intervention with drug-eluting stents (DES), but for prediabetes this association has not been definitely established. Furthermore, in patients with prediabetes treated with contemporary stents, bleeding data are lacking. We assessed 3-year ischemic and bleeding outcomes following treatment with new-generation DES in patients with prediabetes and diabetes as compared to normoglycemia. Methods: For this post-hoc analysis, we pooled patient-level data of the BIO-RESORT and BIONYX stent trials which both stratified for diabetes at randomization. Both trials were multicenter studies performed in tertiary cardiac centers. Study participants were patients of whom glycemic state was known based on hemoglobin A1c, fasting plasma glucose, or medically treated diabetes. Three-year follow-up was available in 4212/4330 (97.3 %) patients. The main endpoint was target vessel failure, a composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization. Results: Baseline cardiovascular risk profiles were progressively abnormal in patients with normoglycemia, prediabetes, and diabetes. The main endpoint occurred in 54/489 patients with prediabetes (11.2 %) and 197/1488 with diabetes (13.7 %), as compared to 142/2,353 with normoglycemia (6.1 %) (HR: 1.89, 95 %-CI 1.38-2.58, p < 0.001, and HR: 2.30, 95 %-CI 1.85-2.86, p < 0.001, respectively). In patients with prediabetes, cardiac death and target vessel revascularization rates were significantly higher (HR: 2.81, 95 %-CI 1.49-5.30, p = 0.001, and HR: 1.92, 95 %-CI 1.29-2.87, p = 0.001), and in patients with diabetes all individual components of the main endpoint were significantly higher than in patients with normoglycemia (all p ≤ 0.001). Results were consistent after adjustment for confounders. Major bleeding rates were significantly higher in patients with prediabetes and diabetes, as compared to normoglycemia (3.9 % and 4.1 % vs. 2.3 %; HR:1.73, 95 %-CI 1.03-2.92, p = 0.040, and HR:1.78, 95 %-CI 1.23-2.57, p = 0.002). However, after adjustment for confounders, differences were no longer significant. Conclusions: Not only patients with diabetes but also patients with prediabetes represent a high-risk population. After treatment with new-generation DES, both patient groups had higher risks of ischemic and bleeding events. Differences in major bleeding were mainly attributable to dissimilarities in baseline characteristics. Routine assessment of glycemic state may help to identify patients with prediabetes for intensified management of cardiovascular risk factors. Trial registration: BIO-RESORT ClinicalTrials.gov: NCT01674803, registered 29-08-2012; BIONYX ClinicalTrials.gov: NCT02508714, registered 27-7-2015.
MeSH term(s)	Aged ; Blood Glucose/drug effects ; Blood Glucose/metabolism ; Coronary Artery Disease/diagnostic imaging ; Coronary Artery Disease/mortality ; Coronary Artery Disease/therapy ; Coronary Thrombosis/mortality ; Diabetes Mellitus/blood ; Diabetes Mellitus/drug therapy ; Diabetes Mellitus/mortality ; Drug-Eluting Stents ; Female ; Glycated Hemoglobin A/metabolism ; Hemorrhage/mortality ; Humans ; Hypoglycemic Agents/therapeutic use ; Male ; Middle Aged ; Percutaneous Coronary Intervention/adverse effects ; Percutaneous Coronary Intervention/instrumentation ; Percutaneous Coronary Intervention/mortality ; Prediabetic State/blood ; Prediabetic State/drug therapy ; Prediabetic State/mortality ; Prosthesis Design ; Randomized Controlled Trials as Topic ; Risk Assessment ; Risk Factors ; Time Factors ; Treatment Outcome
Chemical Substances	Blood Glucose ; Glycated Hemoglobin A ; Hypoglycemic Agents ; hemoglobin A1c protein, human
Language	English
Publishing date	2021-10-30
Publishing country	England
Document type	Journal Article
ZDB-ID	2093769-6
ISSN	1475-2840 ; 1475-2840
ISSN (online)	1475-2840
ISSN	1475-2840
DOI	10.1186/s12933-021-01405-4
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Article ; Online: First Report of 3-Year Clinical Outcome After Treatment With Novel Resolute Onyx Stents in the Randomized BIONYX Trial.

Ploumen, Eline H / Buiten, Rosaly A / Zocca, Paolo / Doggen, Carine Jm / Aminian, Adel / Schotborgh, Carl E / Jessurun, Gillian Aj / Roguin, Ariel / Danse, Peter W / Benit, Edouard / von Birgelen, Clemens

Circulation journal : official journal of the Japanese Circulation Society

2021 Volume 85, Issue 11, Page(s) 1983–1990

Abstract: Background: At 1 year, the international randomized BIONYX trial (ClinicalTrials.gov:NCT02508714) established non-inferiority regarding safety and efficacy of the novel Resolute Onyx zotarolimus-eluting stent (RO-ZES) vs. the Orsiro sirolimus-eluting ... ...

Abstract	Background: At 1 year, the international randomized BIONYX trial (ClinicalTrials.gov:NCT02508714) established non-inferiority regarding safety and efficacy of the novel Resolute Onyx zotarolimus-eluting stent (RO-ZES) vs. the Orsiro sirolimus-eluting stent (O-SES). Although the RO-ZES is used in daily practice, no clinical results have been published beyond 2 years.Methods and Results:We assessed 3-year clinical outcomes of 2,488 all-comers after percutaneous coronary intervention (PCI) with RO-ZES vs. O-SES. The main endpoint was target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction (MI), or target vessel revascularization. Time-to-endpoints was assessed by Kaplan-Meier methods and between-group comparisons by log-rank tests. Follow-up was available in 2,433/2,488 (97.8%) patients. There was no significant between-stent difference in TVF (RO-ZES 112/1,243 [9.2%] vs. O-SES 109/1,245 [8.9%], hazard ratio [HR]: 1.03, 95% confidence interval [CI] 0.79-1.34; P Conclusions: This first 3-year randomized assessment of the RO-ZES showed a favorable rate of TVF that matched the outcomes of patients treated with O-SES. We observed a lower rate of all-cause death in the RO-ZES group, but long-term clinical follow-up is of interest.
MeSH term(s)	Coronary Artery Disease ; Drug-Eluting Stents ; Humans ; Percutaneous Coronary Intervention/adverse effects ; Prosthesis Design ; Stents ; Treatment Outcome
Language	English
Publishing date	2021-07-13
Publishing country	Japan
Document type	Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2068090-9
ISSN	1347-4820 ; 1346-9843
ISSN (online)	1347-4820
ISSN	1346-9843
DOI	10.1253/circj.CJ-21-0292
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Article ; Online: Risk of bleeding after percutaneous coronary intervention and its impact on further adverse events in clinical trial participants with comorbid peripheral arterial disease.

Pinxterhuis, Tineke H / Ploumen, Eline H / Zocca, Paolo / Doggen, Carine J M / Schotborgh, Carl E / Anthonio, Rutger L / Roguin, Ariel / Danse, Peter W / Benit, Edouard / Aminian, Adel / Stoel, Martin G / Linssen, Gerard C M / Geelkerken, Robert H / von Birgelen, Clemens

International journal of cardiology

2022 Volume 374, Page(s) 27–32

Abstract: Background: Both patients with obstructive coronary artery disease (CAD) and patients with peripheral arterial disease (PADs) have an increased bleeding risk. Information is scarce on bleeding in CAD patients, treated with percutaneous coronary ... ...

Abstract	Background: Both patients with obstructive coronary artery disease (CAD) and patients with peripheral arterial disease (PADs) have an increased bleeding risk. Information is scarce on bleeding in CAD patients, treated with percutaneous coronary intervention (PCI), who have comorbid PADs. We assessed whether PCI patients with PADs have a higher bleeding risk than PCI patients without PADs. Furthermore, in PCI patients with PADs we evaluated the extent by which bleeding increased the risk of further adverse events. Methods: Three-year pooled patient-level data of two randomized PCI trials (BIO-RESORT, BIONYX) with drug-eluting stents were analyzed to assess mortality and the composite endpoint major adverse cardiac events (MACE: all-cause mortality, any myocardial infarction, emergent coronary artery bypass surgery, or target lesion revascularization). Results: Among 5989 all-comer patients, followed for 3 years, bleeding occurred in 7.7% (34/440) with comorbid PADs and 5.0% (279/5549) without PADs (HR: 1.59, 95%CI: 1.11-2.23, p = 0.010). Of all PADs patients, those with a bleeding had significantly higher rates of all-cause mortality (HR: 4.70, 95%CI: 2.37-9.33, p < 0.001) and MACE (HR: 2.39, 95%CI: 1.23-4.31, p = 0.003). Furthermore, PADs patients with a bleeding were older (74.4 ± 6.9 vs. 67.4 ± 9.5, p < 0.001). After correction for age and other potential confounders, bleeding remained independently associated with all-cause mortality (adj.HR: 2.97, 95%CI: 1.37-6.43, p = 0.006) while the relation of bleeding with MACE became borderline non-significant (adj.HR: 1.85, 95%CI: 0.97-3.55, p = 0.06). Conclusion: PCI patients with PADs had a higher bleeding risk than PCI patients without PADs. In PADs patients, bleeding was associated with all-cause mortality, even after adjustment for potential confounders.
MeSH term(s)	Humans ; Percutaneous Coronary Intervention/adverse effects ; Risk Factors ; Coronary Artery Disease/diagnosis ; Coronary Artery Disease/epidemiology ; Coronary Artery Disease/surgery ; Myocardial Infarction ; Hemorrhage/diagnosis ; Hemorrhage/epidemiology ; Peripheral Arterial Disease/diagnosis ; Peripheral Arterial Disease/epidemiology ; Peripheral Arterial Disease/surgery ; Treatment Outcome
Language	English
Publishing date	2022-12-07
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	779519-1
ISSN	1874-1754 ; 0167-5273
ISSN (online)	1874-1754
ISSN	0167-5273
DOI	10.1016/j.ijcard.2022.12.009
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Article ; Online: Timing of Complete Multivessel Revascularization in Patients Presenting With Non-ST-Segment Elevation Acute Coronary Syndrome.

Elscot, Jacob J / Kakar, Hala / Scarparo, Paola / den Dekker, Wijnand K / Bennett, Johan / Schotborgh, Carl E / van der Schaaf, René / Sabaté, Manel / Moreno, Raúl / Ameloot, Koen / van Bommel, Rutger J / Forlani, Daniele / Van Reet, Bert / Esposito, Giovanni / Dirksen, Maurits T / Ruifrok, Willem P T / Everaert, Bert R C / Van Mieghem, Carlos / Pinar, Eduardo /

Alfonso, Fernando / Cummins, Paul / Lenzen, Mattie / Brugaletta, Salvatore / Daemen, Joost / Boersma, Eric / Van Mieghem, Nicolas M / Diletti, Roberto

JACC. Cardiovascular interventions

2024 Volume 17, Issue 6, Page(s) 771–782

Abstract: Background: Complete revascularization of the culprit and all significant nonculprit lesions in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and multivessel disease (MVD) reduces major adverse cardiac events, but optimal ... ...

Abstract	Background: Complete revascularization of the culprit and all significant nonculprit lesions in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and multivessel disease (MVD) reduces major adverse cardiac events, but optimal timing of revascularization remains unclear. Objectives: This study aims to compare immediate complete revascularization (ICR) and staged complete revascularization (SCR) in patients presenting with NSTE-ACS and MVD. Methods: This prespecified substudy of the BIOVASC (Percutaneous Complete Revascularization Strategies Using Sirolimus Eluting Biodegradable Polymer Coated Stents in Patients Presenting With Acute Coronary Syndrome and Multivessel Disease) trial included patients with NSTE-ACS and MVD. Risk differences of the primary composite outcome of all-cause mortality, myocardial infarction (MI), unplanned ischemia-driven revascularization (UIDR), or cerebrovascular events and its individual components were compared between ICR and SCR at 1 year. Results: The BIOVASC trial enrolled 1,525 patients; 917 patients presented with NSTE-ACS, of whom 459 were allocated to ICR and 458 to SCR. Incidences of the primary composite outcome were similar in the 2 groups (7.9% vs 10.1%; risk difference 2.2%; 95% CI: -1.5 to 6.0; P = 0.15). ICR was associated with a significant reduction of MIs (2.0% vs 5.3%; risk difference 3.3%; 95% CI: 0.9 to 5.7; P = 0.006), which was maintained after exclusion of procedure-related MIs occurring during the index or staged procedure (2.0% vs 4.4%; risk difference 2.4%; 95% CI: 0.1 to 4.7; P = 0.032). UIDRs were also reduced in the ICR group (4.2% vs 7.8%; risk difference 3.5%; 95% CI: 0.4 to 6.6; P = 0.018). Conclusions: ICR is safe in patients with NSTE-ACS and MVD and was associated with a reduction in MIs and UIDRs at 1 year.
MeSH term(s)	Humans ; Acute Coronary Syndrome/diagnostic imaging ; Acute Coronary Syndrome/therapy ; Acute Coronary Syndrome/complications ; Coronary Artery Disease/diagnostic imaging ; Coronary Artery Disease/therapy ; Coronary Artery Disease/complications ; Myocardial Infarction/complications ; Percutaneous Coronary Intervention/adverse effects ; Percutaneous Coronary Intervention/methods ; ST Elevation Myocardial Infarction/complications ; Stents ; Treatment Outcome
Language	English
Publishing date	2024-03-27
Publishing country	United States
Document type	Clinical Trial ; Journal Article
ZDB-ID	2452157-7
ISSN	1876-7605 ; 1936-8798
ISSN (online)	1876-7605
ISSN	1936-8798
DOI	10.1016/j.jcin.2024.01.278
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Article ; Online: Immediate versus staged complete revascularisation in patients presenting with acute coronary syndrome and multivessel coronary disease (BIOVASC): a prospective, open-label, non-inferiority, randomised trial.

Lancet (London, England)

2023 Volume 401, Issue 10383, Page(s) 1172–1182

Abstract: Background: In patients with acute coronary syndrome and multivessel coronary disease, complete revascularisation by percutaneous coronary intervention (PCI) is associated with improved clinical outcomes. We aimed to investigate whether PCI for non- ... ...

Abstract	Background: In patients with acute coronary syndrome and multivessel coronary disease, complete revascularisation by percutaneous coronary intervention (PCI) is associated with improved clinical outcomes. We aimed to investigate whether PCI for non-culprit lesions should be attempted during the index procedure or staged. Methods: This prospective, open-label, non-inferiority, randomised trial was done at 29 hospitals across Belgium, Italy, the Netherlands, and Spain. We included patients aged 18-85 years presenting with ST-segment elevation myocardial infarction or non-ST-segment elevation acute coronary syndrome and multivessel (ie, two or more coronary arteries with a diameter of 2·5 mm or more and ≥70% stenosis based on visual estimation or positive coronary physiology testing) coronary artery disease with a clearly identifiable culprit lesion. A web-based randomisation module was used to randomly assign patients (1:1), with a random block size of four to eight, stratified by study centre, to undergo immediate complete revascularisation (PCI of the culprit lesion first, followed by other non-culprit lesions deemed to be clinically significant by the operator during the index procedure) or staged complete revascularisation (PCI of only the culprit lesion during the index procedure and PCI of all non-culprit lesions deemed to be clinically significant by the operator within 6 weeks after the index procedure). The primary outcome was the composite of all-cause mortality, myocardial infarction, any unplanned ischaemia-driven revascularisation, or cerebrovascular events at 1 year after the index procedure. Secondary outcomes included all-cause mortality, myocardial infarction, and unplanned ischaemia-driven revascularisation at 1 year after the index procedure. Primary and secondary outcomes were assessed in all randomly assigned patients by intention to treat. Non-inferiority of immediate to staged complete revascularisation was considered to be met if the upper boundary of the 95% CI of the hazard ratio (HR) for the primary outcome did not exceed 1·39. This trial is registered with ClinicalTrials.gov, NCT03621501. Findings: Between June 26, 2018, and Oct 21, 2021, 764 patients (median age 65·7 years [IQR 57·2-72·9] and 598 [78·3%] males) were randomly assigned to the immediate complete revascularisation group and 761 patients (median age 65·3 years [58·6-72·9] and 589 [77·4%] males) were randomly assigned to the staged complete revascularisation group, and were included in the intention-to-treat population. The primary outcome at 1 year occurred in 57 (7·6%) of 764 patients in the immediate complete revascularisation group and in 71 (9·4%) of 761 patients in the staged complete revascularisation group (HR 0·78, 95% CI 0·55-1·11, p Interpretation: In patients presenting with acute coronary syndrome and multivessel disease, immediate complete revascularisation was non-inferior to staged complete revascularisation for the primary composite outcome and was associated with a reduction in myocardial infarction and unplanned ischaemia-driven revascularisation. Funding: Erasmus University Medical Center and Biotronik.
MeSH term(s)	Male ; Humans ; Aged ; Female ; Coronary Artery Disease ; Acute Coronary Syndrome/surgery ; Acute Coronary Syndrome/etiology ; Percutaneous Coronary Intervention/methods ; Prospective Studies ; Myocardial Infarction/etiology ; Treatment Outcome
Language	English
Publishing date	2023-03-05
Publishing country	England
Document type	Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	3306-6
ISSN	1474-547X ; 0023-7507 ; 0140-6736
ISSN (online)	1474-547X
ISSN	0023-7507 ; 0140-6736
DOI	10.1016/S0140-6736(23)00351-3
Database	MEDical Literature Analysis and Retrieval System OnLINE

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