A Systematic Review and Meta-Analysis Including 354 Patients from 13 Studies of Intravascular Lithotripsy for the Treatment of Underexpanded Coronary Stents
2023; Elsevier BV; Volume: 205; Linguagem: Inglês
10.1016/j.amjcard.2023.07.144
ISSN1879-1913
AutoresRodolfo Caminiti, Giampaolo Vetta, Antonio Parlavecchio, Alfonso Ielasi, Michele Magnocavallo, Domenico G. Della Rocca, Enrico Cerrato, Scipione Carerj, Gianluca Di Bella, Antonio Micari, Giampiero Vizzari,
Tópico(s)Cerebrovascular and Carotid Artery Diseases
ResumoCalcified coronary plaque (CCP) represents a challenging scenario for interventional cardiologists. Stent underexpansion (SU), often associated with CCP, can predispose to stent thrombosis and in-stent restenosis. To date, SU with heavily CCP can be addressed using very high–/high-pressure noncompliant balloons, off-label rotational atherectomy/orbital atherectomy, excimer laser atherectomy, and intravascular lithotripsy (IVL). In this meta-analysis, we investigated the success rate of IVL for the treatment of SU because of CCP. Studies and case-based experiences reporting on the use of IVL strategy for treatment of SU were included. The primary end point was IVL strategy success, defined as the adequate expansion of the underexpanded stent. A metanalysis was performed for the main focuses to calculate the proportions of procedural success rates with corresponding 95% confidence intervals (CIs). Random-effects models weighted by inverse variance were used because of clinical heterogeneity. This meta-analysis included 13 studies with 354 patients. The mean age was 71.3 years (95% CI 64.9 to 73.1), and 77% (95% CI 71.2% to 82.4%) were male. The mean follow-up time was 2.6 months (95% CI 1 to 15.3). Strategy success was seen in 88.7% (95% CI 82.3 to 95.1) of patients. The mean minimal stent area was reported in 6 studies, the pre-IVL value was 3.4 mm2Choi SY Witzenbichler B Maehara A Lansky AJ Guagliumi G Brodie B Kellett Jr, MA Dressler O Parise H Mehran R Dangas GD Mintz GS Stone GW. Intravascular ultrasound findings of early stent thrombosis after primary percutaneous intervention in acute myocardial infarction: a Harmonizing Outcomes with revascularization and Stents in acute myocardial infarction (HORIZONS-AMI) substudy.Circ Cardiovasc Interv. 2011; 4: 239-247Crossref PubMed Scopus (175) Google Scholar (95% CI 3 to 3.8), and the post-IVL value was 6.9 mm2Choi SY Witzenbichler B Maehara A Lansky AJ Guagliumi G Brodie B Kellett Jr, MA Dressler O Parise H Mehran R Dangas GD Mintz GS Stone GW. Intravascular ultrasound findings of early stent thrombosis after primary percutaneous intervention in acute myocardial infarction: a Harmonizing Outcomes with revascularization and Stents in acute myocardial infarction (HORIZONS-AMI) substudy.Circ Cardiovasc Interv. 2011; 4: 239-247Crossref PubMed Scopus (175) Google Scholar (95% CI 6.5 to 7.4). The mean diameter stenosis (percentage) was reported in 7 studies, the pre-IVL value was 69.4% (95% CI 60.7 to 78.2), and the post-IVL value was 14.6% (95% CI 11.1 to 18). The rate of intraprocedural complications was 1.6% (95% CI 0.3 to 2.9). In conclusion, the "stent-through" IVL plaque modification technique is a safe tool to treat SU caused by CCP, with a high success rate and a very low incidence of complications. Calcified coronary plaque (CCP) represents a challenging scenario for interventional cardiologists. Stent underexpansion (SU), often associated with CCP, can predispose to stent thrombosis and in-stent restenosis. To date, SU with heavily CCP can be addressed using very high–/high-pressure noncompliant balloons, off-label rotational atherectomy/orbital atherectomy, excimer laser atherectomy, and intravascular lithotripsy (IVL). In this meta-analysis, we investigated the success rate of IVL for the treatment of SU because of CCP. Studies and case-based experiences reporting on the use of IVL strategy for treatment of SU were included. The primary end point was IVL strategy success, defined as the adequate expansion of the underexpanded stent. A metanalysis was performed for the main focuses to calculate the proportions of procedural success rates with corresponding 95% confidence intervals (CIs). Random-effects models weighted by inverse variance were used because of clinical heterogeneity. This meta-analysis included 13 studies with 354 patients. The mean age was 71.3 years (95% CI 64.9 to 73.1), and 77% (95% CI 71.2% to 82.4%) were male. The mean follow-up time was 2.6 months (95% CI 1 to 15.3). Strategy success was seen in 88.7% (95% CI 82.3 to 95.1) of patients. The mean minimal stent area was reported in 6 studies, the pre-IVL value was 3.4 mm2Choi SY Witzenbichler B Maehara A Lansky AJ Guagliumi G Brodie B Kellett Jr, MA Dressler O Parise H Mehran R Dangas GD Mintz GS Stone GW. Intravascular ultrasound findings of early stent thrombosis after primary percutaneous intervention in acute myocardial infarction: a Harmonizing Outcomes with revascularization and Stents in acute myocardial infarction (HORIZONS-AMI) substudy.Circ Cardiovasc Interv. 2011; 4: 239-247Crossref PubMed Scopus (175) Google Scholar (95% CI 3 to 3.8), and the post-IVL value was 6.9 mm2Choi SY Witzenbichler B Maehara A Lansky AJ Guagliumi G Brodie B Kellett Jr, MA Dressler O Parise H Mehran R Dangas GD Mintz GS Stone GW. Intravascular ultrasound findings of early stent thrombosis after primary percutaneous intervention in acute myocardial infarction: a Harmonizing Outcomes with revascularization and Stents in acute myocardial infarction (HORIZONS-AMI) substudy.Circ Cardiovasc Interv. 2011; 4: 239-247Crossref PubMed Scopus (175) Google Scholar (95% CI 6.5 to 7.4). The mean diameter stenosis (percentage) was reported in 7 studies, the pre-IVL value was 69.4% (95% CI 60.7 to 78.2), and the post-IVL value was 14.6% (95% CI 11.1 to 18). The rate of intraprocedural complications was 1.6% (95% CI 0.3 to 2.9). In conclusion, the "stent-through" IVL plaque modification technique is a safe tool to treat SU caused by CCP, with a high success rate and a very low incidence of complications. Calcified coronary plaque (CCP) can complicate lesion preparation and optimal stent delivery or expansion, with consequent suboptimal results.1Kawaguchi R Tsurugaya H Hoshizaki H Toyama T Oshima S Taniguchi K. Impact of lesion calcification on clinical and angiographic outcome after sirolimus-eluting stent implantation in real-world patients.Cardiovasc Revasc Med. 2008; 9: 2-8Crossref PubMed Scopus (95) Google Scholar Moreover, in most cases, CCP treatment leads to an increased risk of complications such as vessel perforation.1Kawaguchi R Tsurugaya H Hoshizaki H Toyama T Oshima S Taniguchi K. Impact of lesion calcification on clinical and angiographic outcome after sirolimus-eluting stent implantation in real-world patients.Cardiovasc Revasc Med. 2008; 9: 2-8Crossref PubMed Scopus (95) Google Scholar Stent underexpansion (SU), secondary to inadequate lesion preparation, represents a common risk factor for stent thrombosis and in-stent restenosis (ISR).2Choi SY Witzenbichler B Maehara A Lansky AJ Guagliumi G Brodie B Kellett Jr, MA Dressler O Parise H Mehran R Dangas GD Mintz GS Stone GW. Intravascular ultrasound findings of early stent thrombosis after primary percutaneous intervention in acute myocardial infarction: a Harmonizing Outcomes with revascularization and Stents in acute myocardial infarction (HORIZONS-AMI) substudy.Circ Cardiovasc Interv. 2011; 4: 239-247Crossref PubMed Scopus (175) Google Scholar,3Yin D Mintz G Song L Chen Z Lee T Kirtane A Parikh M Moses J Fall K Jeremias A Ali Z Shlofmitz R Maehara A CollaboratorsIn-stent restenosis characteristics and repeat stenting underexpansion: insights from optical coherence tomography.EuroIntervention. 2020; 16: e335-e343Crossref PubMed Scopus (0) Google Scholar The management of SU related to CCP remains one of the most challenging settings for interventional cardiologists, and no expert consensus is currently available. Traditionally, the treatment of SU can be performed with noncompliant, high-/very high–pressure balloons, leading to a high risk of procedural failure and a high complication rate.4Wańha W Januszek R Kołodziejczak M Kuźma Ł Tajstra M Figatowski T Smolarek-Nicpoń M Gruz-Kwapisz M Tomasiewicz B Bartuś J Łoś A Jagielak D Roleder T Włodarczak A Kulczycki J Kowalewski M Hudziak D Stachowiak P Gorący J Sierakowska K Reczuch K Jaguszewski M Dobrzycki S Smolka G Bartuś S Ochała A Gąsior M Wojakowski W. Procedural and 1-year outcomes following large vessel coronary artery perforation treated by covered stents implantation: multicentre CRACK registry.PLoS One. 2021; 16e0249698Crossref Scopus (10) Google Scholar The off-label use of common "debulking" techniques, such as rotational atherectomy (RA)/orbital atherectomy (OA) and excimer laser atherectomy (ELCA), in this setting has been found to be effective with variable success rates and a high risk of procedural complications.5Ferri LA Jabbour RJ Giannini F Benincasa S Ancona M Regazzoli D Mangieri A Montorfano M Colombo A Latib A. Safety and efficacy of rotational atherectomy for the treatment of undilatable underexpanded stents implanted in calcific lesions.Catheter Cardiovasc Interv. 2017; 90: E19-E24Crossref PubMed Scopus (43) Google Scholar, 6Édes IF Ruzsa Z Szabó G Lux Á Gellér L Molnár L Nowotta F Hajas Á Szilveszter B Becker D Merkely B. Rotational atherectomy of undilatable coronary stents: stentablation, a clinical perspective and recommendation.EuroIntervention. 2016; 12: e632-e635Crossref PubMed Scopus (25) Google Scholar, 7Neupane S Basir M Tan C Sultan A Tabaku M Alqarqaz M Khandelwal A Gupta A Don C Alaswad K. Feasibility and safety of orbital atherectomy for the treatment of in-stent restenosis secondary to stent under-expansion.Catheter Cardiovasc Interv. 2021; 97: 2-7Crossref PubMed Scopus (19) Google Scholar, 8Whiteside HL Nagabandi A Kapoor D. Safety and efficacy of stentablation with rotational atherectomy for the management of underexpanded and undilatable coronary stents.Cardiovasc Revasc Med. 2019; 20: 985-989Crossref PubMed Scopus (18) Google Scholar, 9Latib A Takagi K Chizzola G Tobis J Ambrosini V Niccoli G Sardella G DiSalvo ME Armigliato P Valgimigli M Tarsia G Gabrielli G Lazar L Maffeo D Colombo A. Excimer laser LEsion modification to expand non-dilatable sTents: the ELLEMENT registry.Cardiovasc Revasc Med. 2014; 15: 8-12Crossref PubMed Scopus (117) Google Scholar The Shockwave System (Shockwave Medical Inc., Santa Clara, California) is a coronary lithotripsy tool composed of a semicompliant balloon, requiring inflation at a low pressure (around 4 atmospheres), and some emitters located inside the balloon (2 for coronary and 4 to 5 for peripheral); once activated, the emitters generate bubbles in the contrast-saline solution, causing the expansion and collapse of the fluid and releasing a circumferential sonic pressure wave (around 50 atmospheres) inside the vessel, resulting in deep and superficial calcium cracking.10Forero MNT Daemen J. The coronary intravascular lithotripsy system.Interv Cardiol. 2019; 14: 174-181Crossref PubMed Scopus (38) Google Scholar Coronary "lithoplasty" proved to be safe in the treatment of de novo lesions, with a low complication rate, a high procedural success, and wide availability.11Brinton TJ Ali ZA Hill JM Meredith IT Maehara A Illindala U Lansky A Götberg M Van Mieghem NM Whitbourn R Fajadet J Di Mario C. Feasibility of shockwave coronary intravascular lithotripsy for the treatment of calcified coronary stenoses.Circulation. 2019; 139: 834-836Crossref PubMed Scopus (212) Google Scholar, 12Ali ZA Nef H Escaned J Werner N Banning AP Hill JM De Bruyne B Montorfano M Lefevre T Stone GW Crowley A Matsumura M Maehara A Lansky AJ Fajadet J Di Mario C. Safety and effectiveness of coronary intravascular lithotripsy for treatment of severely calcified coronary stenoses: the disrupt CAD II study.Circ Cardiovasc Interv. 2019; 12e008434Crossref Scopus (209) Google Scholar, 13Hill JM Kereiakes DJ Shlofmitz RA Klein AJ Riley RF Price MJ Herrmann HC Bachinsky W Waksman R Stone GW Disrupt CAD III InvestigatorsIntravascular lithotripsy for treatment of severely calcified coronary artery disease.J Am Coll Cardiol. 2020; 76: 2635-2646Crossref PubMed Scopus (186) Google Scholar IVL was only approved for use in de novo setting; however, recent data from large registries and case series confirmed its potential role as an attractive approach for SU caused by CCP, with encouraging results.14Ielasi A Moscarella E Testa L Gioffrè G Morabito G Cortese B Colangelo S Tomai F Arioli F Maioli M Leoncini M Tumminello G Benedetto S Lucchina PG Pennesi M Ugo F Viganò E Bollati M Missiroli B Gaspardone A Calabrò P Bedogni F Tespili M IntravaScular lithotripsy for the management of UndILatable coronary StEnt: the SMILE registry.Cardiovasc Revasc Med. 2020; 21: 1555-1559Crossref PubMed Scopus (33) Google Scholar This meta-analysis aimed to evaluate the procedural success, complication rate, and major adverse cardiovascular events (MACEs) of the IVL treatment of SU because of CCP. A systematic search in Excerpta Medica Database (EMBASE), PubMed/MEDLINE, Cochrane, Ovid, and Scopus was performed from inception until November 30, 2022. The reference lists of bibliographies of identified articles were also reviewed. This search was conducted using the terms (coronary stent underexpansion) AND (lithotripsy) OR (lithoplasty). Our search was limited to English studies published in peer reviewed journals. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement for reporting systematic reviews and meta-analyses was used to define the methods for this study.15Liberati A Altman DG Tetzlaff J Mulrow C Gøtzsche PC Ioannidis JPA Clarke M Devereaux PJ Kleijnen J Moher D. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration.PLoS Med. 2009; 6e1000100Crossref Scopus (11154) Google Scholar The studies had to fulfill the following criteria to be included in the meta-analysis: (1) including patients with SU treated with IVL and (2) reporting the procedural success rate and/or procedural complications rate and/or MACE rate. A total of 2 authors (R.C. and G.V.) selected the studies and extracted the data independently. Data were extracted using standardized protocol and reporting forms. A total of 2 reviewers (R.C. and G.V.) independently evaluated the quality items, and disagreements were resolved by consensus. The quality assessment of all included studies was done using the Newcastle–Ottawa quality assessment scale for cohort studies, which was accommodated to the studies included in this metanalysis for assessing the risk for bias.16DerSimonian R Laird N. Meta-analysis in clinical trials.Control Clin Trials. 1986; 7: 177-188Abstract Full Text PDF PubMed Scopus (30707) Google Scholar The primary end point was IVL procedural success, defined as a residual angiographic stenosis <30% or <20%, according to the included study assessed by quantitative coronary analysis and/or intravascular imaging (intravascular ultrasound and/or optical coherence tomography). The safety study end points were (1) procedural complications (device failure, vessel perforation, dissection D-F, slow/no-reflow phenomenon, and periprocedural myocardial infarction [MI]) and (2) MACEs, defined as the composite of cardiac death, MI, and target vessel revascularization during follow-up. Descriptive statistics are presented as means and SDs for continuous variables or several cases (n) and percentages (%) for dichotomous and categorical variables. A metanalysis was performed for the main focuses to calculate the proportions of procedural success, procedural complications, and MACE rates, with corresponding 95% confidence intervals (CIs). Random-effects models weighted by inverse variance were used because of clinical heterogeneity. Sensitivity analyses were performed to assess the contribution of each study to the pooled estimate of the primary end point. Meta-regression analyses were performed for baseline and periprocedural features to assess the effect on procedural success using the Meta-regress command of STATA. Publication bias was assessed by graphical inspection of the funnel plots and the Egger test. Statistical significance was defined as a 2-tailed p <0.05. Statistical analysis was performed using the metadata function of STATA version 16 (StataCorp LLC, College Station, Texas). We screened 273 articles, of which 75 full-text articles were retrieved and reviewed for possible inclusion. Ultimately, 13 studies fulfilled the inclusion criteria and were included in the meta-analysis (Figure 1). Our meta-analysis included 13 studies14Ielasi A Moscarella E Testa L Gioffrè G Morabito G Cortese B Colangelo S Tomai F Arioli F Maioli M Leoncini M Tumminello G Benedetto S Lucchina PG Pennesi M Ugo F Viganò E Bollati M Missiroli B Gaspardone A Calabrò P Bedogni F Tespili M IntravaScular lithotripsy for the management of UndILatable coronary StEnt: the SMILE registry.Cardiovasc Revasc Med. 2020; 21: 1555-1559Crossref PubMed Scopus (33) Google Scholar,17Yeoh J Cottens D Cosgrove C Mallek K Strange J Anderson R Wilson S Hanratty C Walsh S McEntegart M Hill J Spratt JC. Management of stent underexpansion using intravascular lithotripsy-Defining the utility of a novel device.Catheter Cardiovasc Interv. 2021; 97: 22-29Crossref PubMed Scopus (26) Google Scholar, 18Aksoy A Salazar C Becher MU Tiyerili V Weber M Jansen F Sedaghat A Zimmer S Leick J Grube E Gonzalo N Sinning JM Escaned J Nickenig G Werner N Intravascular lithotripsy in calcified coronary lesions: a prospective, observational, multicenter registry.Circ Cardiovasc Interv. 2019; 12e008154Crossref PubMed Scopus (64) Google Scholar, 19Yaginuma K Werner GS. Resolving chronic stent under-expansion in calcified lesions by intravascular lithoplasty.J Cardiol Cases. 2020; 23: 136-139Abstract Full Text Full Text PDF PubMed Scopus (1) Google Scholar, 20Aziz A Bhatia G Pitt M Choudhury A Hailan A Upadhyaya S Lee L Testa L Casenghi M Ielasi A Cortese B Rides H Basavarajaiah S Intravascular lithotripsy in calcified-coronary lesions: a real-world observational, European multicenter study.Catheter Cardiovasc Interv. 2021; 98: 225-235Crossref PubMed Scopus (17) Google Scholar, 21Tassone EJ Tripolino C Morabito G Grillo P Missiroli B. Shockwave coronary lithoplasty for the treatment of under-expanded stent.J Cardiol Cardiovasc Sci. 2020; 4: 1-5Crossref Google Scholar, 22Mousa MAA Bingen BO Amri IA Digiacomo S Karalis I Jukema JW Montero-Cabezas JM. Bail-out intravascular lithotripsy for the treatment of acutely underexpanded stents in heavily calcified coronary lesions: a case series.Cardiovasc Revasc Med. 2022; 40: 189-194Crossref PubMed Scopus (5) Google Scholar, 23Brunner FJ Becher PM Waldeyer C Zengin-Sahm E Schnabel RB Clemmensen P Westermann D Blankenberg S Seiffert M. Intravascular lithotripsy for the treatment of calcium-mediated coronary in-stent restenoses.J Invasive Cardiol. 2021; 33: E25-E31PubMed Google Scholar, 24Tovar Forero MT Sardella G Salvi N Cortese B di Palma G Werner N Aksoy A Escaned J Salazar C Gonzalo N Ugo F Cavallino C Sheth T Kardys I Van Mieghem NM Daemen J Coronary lithotripsy for the treatment of underexpanded stents; the international multicentre CRUNCH registry.EuroIntervention. 2022; 18: 574-581Crossref PubMed Scopus (25) Google Scholar, 25Mastrangelo A Monizzi G Galli S Grancini L Ferrari C Olivares P Chiesa M Calligaris G Fabbiocchi F Montorsi P Bartorelli AL. Intravascular lithotripsy in calcified coronary lesions: A single-center experience in "real-world" patients.Front Cardiovasc Med. 2022; 9829117Crossref Scopus (2) Google Scholar, 26Wańha W Tomaniak M Wańczura P Bil J Januszek R Wolny R Opolski MP Kuźma Ł Janas A Figatowski T Gąsior P Milewski M Roleder-Dylewska M Lewicki Ł Kulczycki J Włodarczak A Tomasiewicz B Iwańczyk S Sacha J Koltowski Ł Dziarmaga M Jaguszewski M Kralisz P Olajossy B Sobieszek G Dyrbuś K Łebek M Smolka G Reczuch K Gil RJ Dobrzycki S Kwiatkowski P Rogala M Gąsior M Ochała A Kochman J Witkowski A Lesiak M D'Ascenzo F Bartuś S Wojakowski W Intravascular lithotripsy for the treatment of stent underexpansion: the multicenter IVL-DRAGON registry.J Clin Med. 2022; 11: 1779Crossref PubMed Scopus (16) Google Scholar, 27El Jattari H Holvoet W De Roeck F Cottens D Ungureanu C Bennett J McCutcheon K Ghafari C Carlier S Zivelonghi C Segers VFM Dens J. Intracoronary lithotripsy in calcified coronary lesions: A multicenter observational study.J Invasive Cardiol. 2022; 34: E24-E31PubMed Google Scholar with 354 patients; the study by Mastrangelo et al25Mastrangelo A Monizzi G Galli S Grancini L Ferrari C Olivares P Chiesa M Calligaris G Fabbiocchi F Montorsi P Bartorelli AL. Intravascular lithotripsy in calcified coronary lesions: A single-center experience in "real-world" patients.Front Cardiovasc Med. 2022; 9829117Crossref Scopus (2) Google Scholar was divided in 2 separate subanalyses because of different groups. Table 1 lists the included studies characteristics. The definitions of procedural success and safety for each of the included studies are shown in Table 2. The mean age was 71.3 years (95% CI 64.9 to 73.1), and 77% (95% CI 71.2 to 82.4%) were male, as listed in Table 3. A large proportion of patients had hypertension (90.1%, 95% CI 83.6% to 95.3%) and dyslipidemia (80.3%, 95% CI 73.6% to 86.4%), previous MI was found in over half of the population (56.4%, 95% CI 43.6% to 68.9%), and diabetes mellitus was found in 45.9% (95% CI 39.4% to 52.6%). The indication for coronary angiography was acute coronary syndrome in 45% (unstable angina 13.9% [95% CI 7.8% to 17.6%], non–ST-segment elevation MI 25.8% [95% CI 18.6% to 30.4%], ST-segment elevation MI 5.3% [95% CI 1.2% to 7.7%]), and chronic coronary syndrome in 55% (95% CI 46.1% to 63.7%).Table 1Baseline characteristics of included studiesA. Ielasi et al.M. A.A. Mousa et al.J. Yeoh et al.A. Aksoy et al.M. N. Tovar Forero et al.F. J. Brunner et al.A. Mastrangelo et al.*In-stent restenosis subgroup of A. Mastrangelo et al, study.A. Mastrangelo et al.†Bailout subgroup of A. Mastrangelo et al, study. IVUS = intravascular ultrasound; LAD = left anterior descending; LCX = left circumflex; LM = left main; MI = myocardial infarction; OCT = optical coherence tomography; RCA = right coronary artery.W. Wanha et al.K. Yaginuma et al.H. El Jattari et al.A. Aziz et al.H. Sinclair et al.E. J. Tassone et al.Year20202021201920192022202120222022202220202022202020202020Patient3451316706221162740461210Lesions3951316646231162740461210Follow-up time112.8±6.51114.5±1.58.9±3.113.4±8.41N/AN/AN/AN/A1Age69.6±169.2±9.670.2±8.175.9±8.673.1±9.275.3±8.372.5±7.273.6±8.769±7.169.9±8.1N/AN/AN/A65.8±7.2Sex n (%) male26 (76.4)4 (80)10 (76)11 (68.8)53 (75.7)6 (100%)18 (81.8)9 (81.8)41 (66.1)6 (85)N/AN/AN/A9 (90)Hypertension n (%)29 (85.2)4 (80)8 (61)16 (100)62 (88.6)6 (100%)18 (81.8)7 (63.6)58 (93.5)N/AN/AN/AN/A10 (100)Diabetes Mellitus n (%)18 (52.9)3 (60)6 (46)5 (31.3)37 (52.9)2 (33.3%)7 (31.8)2 (18.2)28 (45.2)N/AN/AN/AN/A7 (70)Dyslipidemia n (%)28 (82.3)2 (40)9 (69)10 (62.5)50 (71.4)4 (66.7%)17 (77.3)8 (72.7)58 (93.5)N/AN/AN/AN/A10 (100)Prior MI n (%)14 (41.1)1 (20)014 (87.5)38 (54.3)3 (50.0%)21 (95.5)5 (54.5)43 (69.4)N/AN/AN/AN/A8 (80)Clinical PresentationStable Angina19 (55.9)07 (53)8 (40)33 (47.1)4 (67)15 (68.2)11 (100)30 (48.4)N/AN/AN/AN/AN/AUnstable Angina5 (14.7)03 (18.8)12 (17.1)2 (33)1 (31.8)010 (16.1)N/AN/AN/AN/AN/ANSTEMI09 (26.5)3 (70%)6 (46)3 (18.8)18 (25.7)04 (18.2)020 (32.3)N/AN/AN/AN/AN/ASTEMI1 (2.9)1 (30%)1 (6.3)7 (10)02 (9.1)02 (3.2)N/AN/AN/AN/AN/AVessel n (%)LM4 (10.1)004 (23.6)11 (15.7)01 (4.4)1 (9.1)6 (9.7)0N/AN/AN/A0LAD19 (48.6%)3 (60%)9 (69)6 (35.3)36 (51.4)2 (33)12 (52.2)6 (54.6)16 (25.8)0N/AN/AN/A8 (80)RCA6 (15.3)1 (20%)4 (30)5 (29.4)19 (27.1)4 (67)8 (34.8)2 (18.2)31 (50.0)5 (71)N/AN/AN/A1 (10)LCX3 (7.6)1 (20%)02 (11.8)9 (12.9)02 (8.7)2 (18.2)9 (14.5)2 (29)N/AN/AN/A1 (10)IVUS n (%)19 (48.7)006 (35.3)N/A1 (16)6 (26.1)3 (27.3)14 (22.6)6 (85)N/AN/A010 (100)OCT n (%)9 (23.1)013 (100)5 (29.4)N/A2 (33)5 (21.7)015 (24.2)0N/AN/A5 (62.5)N/A In-stent restenosis subgroup of A. Mastrangelo et al, study.† Bailout subgroup of A. Mastrangelo et al, study.IVUS = intravascular ultrasound; LAD = left anterior descending; LCX = left circumflex; LM = left main; MI = myocardial infarction; OCT = optical coherence tomography; RCA = right coronary artery. Open table in a new tab Table 2Primary endpoints, safety endpoints, and MACE definition of included studiesPrimary endpoint (procedural success)Safety endpoint and/or MACE definitionA. Ielasi et al.The primary endpoint of the study was successful IVL dilatation defined as IVL balloon delivery and application at the target site followed by an increase (after NC balloon expansion failure) of at least 1 mm2 in minimal stent cross-sectional area (MSA) on intracoronary imaging or an increase of at least 20% in minimal stent diameter (MSD) by quantitative coronary analysis (QCA)Periprocedural cardiac death, target-vessel myocardial infarction (MI), target lesion revascularization (TLR) and stent thrombosis (ST) occurring during the hospitalization.M. A.A. Mousa et al. (CS)Angiographic success was defined as a final residual stenosis <30%.N/AJ. Yeoh et al. (CS)N/ASafety parameters including coronary perforation, no reflow and ventricular arrhythmias, and in-hospital and 30-day major adverse cardiac and cerebrovascular events (MACCE) were recorded.MACCE was defined as a composite of acute coronary syndrome, cerebrovascular events, need for repeat revascularization, and death.A. Aksoy et al.Primary end point was strategy success (stent expansion with <20% in-stent residual stenosis).Safety outcome was procedural complication, defined as coronary dissection, slow or no reflow, new coronary thrombus formation during PCI, abrupt vessel closure and device failure (inability to place the balloon, malfunction, or burst). In-hospital major adverse cardiovascular event (MACE) defined as proposed by American Heart Association and the Academic Research Consortium-2 in fourth universal definition for myocardial infarction associated with PCI.M. N. Tovar Forero et al.The primary efficacy endpoint was device success, a composite of technical success (successful lesion crossing + successful delivery of intended number of IVL pulses + successful retrieval of the device) and residual %DS <50% as assessed by offline QCA analysis.Secondary endpoints included procedural success (defined as device success in the absence of MACE until discharge) and technical success.The primary safety endpoint was in-hospital major adverse cardiac events (MACE), defined as a composite of cardiac death, non-fatal myocardial infarction and any repeat revascularization.F. J. Brunner et al.Angiographic success was defined as residual lumen stenosis <20% and Thrombolysis in Myocardial Infarction 3 flow.N/AA. Mastrangelo et al.*The primary effectiveness endpoint was angiographic success, defined as the composite of successful IVL balloon delivery to the target lesions, adequate stent expansion, residual stenosis 80.The secondary endpoint was freedom from device-oriented composite endpoint (DOCE) (defined as a composite of cardiac death, target lesion revascularization (TLR), target lesion revascularization, (TLR), and target vessel myocardial infarction (MI)) at 30 days.K. Yaginuma et al. (CS)N/AN/AH. El Jattari et al.The primary endpoint was final procedural success. Optimal final procedural success was defined as angiographic ≤30% residual stenosis, no coronary artery dissection or perforation, and Thrombolysis in Myocardial Infarction (TIMI) 3 flow.Secondary endpoints included IVL therapy effect, angiographic result post stenting, and MACE. Optimal IVL therapy effect was defined as no IVL balloon waist visual on fluoroscopy, no coronary artery dissection or perforation, and TIMI 3 flow.A. Aziz et al.Angiographic success was defined as the ability to complete the procedure with complete expansion of balloon and/or stent (with residual stenosis <30%) with TIMI 3 flow.The measured endpoints during this follow-up were: death from any cause, cardiac death; target vessel myocardial infarction (TVMI); target lesion revascularisation (TLR); TVR; stent thrombosis (definite and probable); and major adverse cardiac event (MACE).The MACE rate was defined as combination of cardiac death, TVMI and TLR.H. Sinclair et al.Technical success was defined as successful delivery and deployment of the IVL balloon catheter. Procedural success was defined as residual angiographic stenosis <30%.Angiographic complications were defined as dissection, slow flow, perforation, abrupt closure, or no reflow in the treated artery.The outcomes collected were death, myocardial infarction, or repeat target vessel revascularization.E. J. Tassone et al. (CS)N/AN/ACS = case series; MACCEs = major adverse cardiac and cerebrovascular events; MSA = minimal stent area; MSD = minimal stent diameter; QCA = quantitative coronary analysis; ST = stent thrombosis; TIMI = thrombolysis in myocardial infarction; TLR = target lesion revascularization. Open table in a new tab Table 3Baseline characteristics pooled analysis of included studiesPooled Analysis (95% C.I.)*Values are percentage or median. IVUS = intravascular ultrasound; LAD = left anterior descending; LCX = left circumflex; LM = left main; NC = noncompliant; OCT = optical coher
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