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UMarta Francesca Brancati, 1 Francesco Burzotta, 2 Carlo Trani, 2 Ornella Leonzi, 1 Claudio Cuccia, 1 Filippo Crea2 1 UMnyango Wezifo Zenhliziyo, Isibhedlela iPoliambulanza Foundation, eBrescia, 2 UMnyango Wezifo Zenhliziyo, iCatholic University of the Sacred Heart of Rome, e-Italy Isifinyezo: Ama-Drug-Eluting Stents (DES) anciphisa ukulinganiselwa kwama-stents ensimbi angenalutho (BMS) ngemva kokungenelela kwenhliziyo okuhamba nge-percutaneous. Kodwa-ke, nakuba ukwethulwa kwe-DES yesizukulwane sesibili kubonakala sengathi kuye kwanciphisa lesi simo uma kuqhathaniswa ne-DES yesizukulwane sokuqala, ukukhathazeka okukhulu kusasele mayelana nezinkinga ezingaba khona kamuva zokufakelwa kwe-stent, njenge-stent thrombosis (ST) kanye nokususwa kwe-stent. I-Stenosis (ISR). I-ST iyisenzakalo esingaba yinhlekelele esincishiswe kakhulu ngokusebenzisa i-stenting ethuthukisiwe, imiklamo emisha ye-stent, kanye nokwelashwa okubili kwe-antiplatelet. Indlela eqondile echaza ukwenzeka kwayo iyaphenywa, futhi empeleni, kunezici eziningi ezibangela lokho. I-ISR ku-BMS ngaphambili yayibhekwa njengesimo esizinzile esinezinga eliphezulu lokuqala le-hyperplasia ye-intimal (ezinyangeni eziyi-6) kulandelwa isikhathi sokubuyela emuva esingaphezu konyaka owodwa. Ngokuphambene nalokho, kokubili izifundo zezokwelapha neze-histological ze-DESS zibonise ubufakazi bokukhula okuqhubekayo kwe-neointimal ngesikhathi sokulandelwa kwesikhathi eside, into eyaziwa ngokuthi isenzakalo "sokubamba sekwephuzile". Umbono wokuthi i-ISR iyisimo sezokwelapha esingenabungozi usanda kuphikiswa ubufakazi bokuthi iziguli ezine-ISR zingase zibe ne-acute coronary syndromes. Ukuthwebula izithombe ngaphakathi kwe-coronary kuyindlela ehlaselayo engakwazi ukuhlonza ama-plaque e-atherosclerotic ane-stent kanye nezici zokuphulukiswa kwemithambo yegazi ngemuva kwe-stent; Ivame ukusetshenziselwa ukuqedela i-angiography ye-coronary yokuxilonga nokuqhuba izinqubo zokungenelela. I-Intracoronary optical coherence tomography okwamanje ibhekwa njengendlela yokuthwebula esezingeni eliphezulu kakhulu. Uma iqhathaniswa ne-ultrasound yangaphakathi kwemithambo yegazi, inikeza isisombululo esingcono (okungenani izikhathi ezingaphezu kweziyi-10), okuvumela ukucaciswa okuningiliziwe kwesakhiwo sodonga lwemithambo yegazi. "Izifundo zokuthwebula izithombe ze-In vivo" ezihambisana nokutholakele kwe-histological zisikisela ukuthi ukuvuvukala okungapheli kanye/noma ukungasebenzi kahle kwe-endothelial kungabangela i-neo-atherosclerosis yesigaba sokugcina ngaphakathi kwe-BMS kanye ne-DES. Ngakho-ke, i-neo-atherosclerosis isibe yisisulu esiyinhloko ekubangeleni ukwehluleka kwe-stent kwakamuva. Amagama angukhiye: i-coronary stent, i-stent thrombosis, i-restenosis, i-neoatherosclerosis
Ukungenelela kwe-Percutaneous coronary (PCI) ngokufakelwa kwe-stent kuyindlela esetshenziswa kakhulu ekwelapheni isifo semithambo ye-coronary esinezimpawu, futhi le ndlela iyaqhubeka nokukhula.1 Nakuba ama-stent e-drug-eluting (DES) enciphisa ukulinganiselwa kwama-stents angenalutho (ama-BMS), izinkinga ezifika sekwephuzile njenge-stent thrombosis (ST) kanye ne-in-stent restenosis (ISR) zingase zenzeke ngokufakelwa kwe-stent. , kusalokhu kunezinkinga ezinkulu.2-5
Uma i-ST iyisenzakalo esingaba yinhlekelele, ukuqashelwa kokuthi i-ISR iyisifo esingenabungozi kuye kwaphikiswa muva nje ubufakazi be-acute coronary syndrome (ACS) ezigulini ze-ISR.4
Namuhla, i-intracoronary optical coherence tomography (OCT)6-9 ibhekwa njengendlela yokuthwebula izithombe yesimanje, enikeza isisombululo esingcono kune-intravascular ultrasound (IVUS).”Izifundo zokuthwebula izithombe ze-In vivo,10-12 ezihambisana nokutholakele kwe-histological, zibonisa indlela “entsha” yokusabela kwemithambo yegazi ngemva kokufakelwa kwe-stent, kanye ne-“neoatherosclerosis” entsha ngaphakathi kwe-BMS kanye ne-DES.
Ngo-1964, uCharles Theodore Dotter noMelvin P Judkins bachaza i-angioplasty yokuqala. Ngo-1978, u-Andreas Gruntzig wenza i-angioplasty yokuqala yebhaluni (i-angioplasty yebhaluni endala ecacile); kwakuyindlela yokwelapha eguquguqukayo kodwa yayinezinkinga zokuvalwa kwemithambo yegazi okubukhali kanye ne-restenosis.13 Lokhu kwaholela ekutholakaleni kwama-stents enhliziyo: UPuel noSigwart bafaka i-stent yokuqala yenhliziyo ngo-1986, banikeza i-stent yokuvimbela ukuvalwa kwemithambo yegazi okubukhali kanye nokuhoxiswa kwe-systolic sekwephuzile.14 Nakuba la ma-stents okuqala avimbela ukuvalwa kwemithambo yegazi ngokuzumayo, abangela umonakalo omkhulu we-endothelial kanye nokuvuvukala. Kamuva, izivivinyo ezimbili ezibalulekile, i-Belgian-Dutch Stent Trial 15 kanye ne-Stent Restenosis Study 16, zakhuthaza ukuphepha kwe-stenting nge-dual antiplatelet therapy (DAPT) kanye/noma amasu okufaka afanele.17,18 Ngemva kwalezi zivivinyo, kwaba nokwanda okukhulu kwenani lama-PCI enziwa.
Kodwa-ke, inkinga ye-iatrogenic in-stent neointimal hyperplasia ngemuva kokubekwa kwe-BMS yatholakala ngokushesha, okwaholela ku-ISR ku-20%–30% wezilonda ezelashwe. Ngo-2001, i-DES yethulwa19 ukunciphisa isidingo sokuphumula nokungenelela kabusha. Ama-DES andise ukuzethemba kodokotela benhliziyo, okuvumela inani elikhulayo lezilonda eziyinkimbinkimbi ukuthi zelashwe ezazicatshangwa ukuthi zixazululwa ngaphambilini ngokuxhunyelelwa kwemithambo ye-coronary bypass. Ngo-2005, ama-80%–90% awo wonke ama-PCI ayehambisana ne-DES.
Konke kunezinkinga zako, futhi kusukela ngo-2005, ukukhathazeka ngokuphepha kwe-DES "yesizukulwane sokuqala" kuye kwanda, futhi ama-stents esizukulwane esisha afana nama-20,21 athuthukiswe futhi aqalwa.22 Kusukela ngaleso sikhathi, imizamo yokuthuthukisa ukusebenza kwe-stent ikhule ngokushesha, futhi ubuchwepheshe obusha, obumangalisayo buqhubeke nokutholakala futhi bulethwa emakethe ngokushesha.
I-BMS iyipayipi lensimbi elincane eline-mesh. Ngemva kokuhlangenwe nakho kokuqala nge-“Wall” mount, i-Gianturco-Roubin mount kanye ne-Palmaz-Schatz mount, ama-BMS amaningi ahlukene manje aseyatholakala.
Imiklamo emithathu ehlukene ingenzeka: ikhoyili, i-tubular mesh kanye ne-slots tube. Imiklamo yekhoyili inezintambo zensimbi noma imichilo eyakhiwe yaba yisimo sekhoyili esiyindilinga; imiklamo ye-tubular mesh inezintambo ezihlanganiswe ndawonye zibe yi-mesh ukuze zenze i-tube; imiklamo ye-tube ene-slots iqukethe amashubhu ensimbi anqunywe nge-laser. Lawa madivayisi ayahlukahluka ngokwakheka (insimbi engagqwali, i-nichrome, i-cobalt chrome), ukwakheka kwesakhiwo (amaphethini ahlukene e-strut nobubanzi, ububanzi nobude, amandla e-radial, i-radiopacity) kanye nezinhlelo zokulethwa (ezizikhulisayo noma ezinwebekayo ngebhaluni).
Ngokuvamile, i-BMS entsha iqukethe i-cobalt-chromium alloy, okuholela ezintanjeni ezincane ezinokuhamba okuthuthukisiwe, okugcina amandla okusebenza.
Ziqukethe ipulatifomu ye-stent yensimbi (ngokuvamile insimbi engagqwali) futhi embozwe nge-polymer engenazo izindlela zokwelapha ezilwa nokwanda kanye/noma ezilwa nokuvuvukala.
I-Sirolimus (eyaziwa nangokuthi i-rapamycin) ekuqaleni yaklanywa njenge-ejenti yokulwa ne-fungus. Indlela yayo yokusebenza ivela ekuvimbeleni ukuqhubeka komjikelezo weseli ngokuvimbela ukuguquka kusuka esigabeni se-G1 kuya esigabeni se-S nokuvimbela ukwakheka kwe-neointima. Ngo-2001, isipiliyoni "sokuqala kumuntu" nge-SES sabonisa imiphumela ethembisayo, okwaholela ekuthuthukisweni kwe-stent ye-Cypher.23 Izilingo ezinkulu zibonise ukusebenza kwayo ekuvimbeleni i-ISR.24
I-Paclitaxel yavunywa ekuqaleni komdlavuza wesibeletho, kodwa izakhiwo zayo ezinamandla ze-cytostatic - umuthi uzinzisa ama-microtubules ngesikhathi se-mitosis, uholela ekumisweni komjikelezo weseli futhi uvimbele ukwakheka kwe-neointimal - okwenza kube yinhlanganisela ye-Taxus Express PES. Izivivinyo ze-TAXUS V kanye ne-VI zibonise ukusebenza kahle kwesikhathi eside kwe-PES esifweni semithambo yenhliziyo esiyingozi kakhulu nesiyinkimbinkimbi.25,26 I-TAXUS Liberté eyalandela yayineplatifomu yensimbi engagqwali ukuze kube lula ukulethwa.
Ubufakazi obuphelele obuvela ekubuyekezweni okuhlelekile okubili kanye nokuhlaziywa kwe-meta kusikisela ukuthi i-SES inenzuzo kune-PES ngenxa yamazinga aphansi e-ISR kanye ne-target vessel revascularization (TVR), kanye nokuthambekela kokwanda kwe-acute myocardial infarction (AMI) eqenjini le-PES. 27,28
Amadivayisi esizukulwane sesibili anobukhulu obunciphile be-strut, ukuguquguquka/ukulethwa okuthuthukisiwe, amaphrofayili e-polymer biocompatibility/drug elution athuthukisiwe, kanye ne-re-endothelialization kinetics enhle kakhulu. Emikhubeni yanamuhla, ayimiklamo ye-DES ethuthuke kakhulu kanye nama-coronary stents amakhulu afakwe emhlabeni jikelele.
I-Taxus Elements iyintuthuko eyengeziwe ene-polymer ehlukile eyenzelwe ukwandisa ukukhishwa kwangaphambi kwesikhathi kanye nesistimu entsha ye-platinum-chromium strut enikeza ama-strut amancane kanye ne-radiopacity ethuthukisiwe. Isivivinyo se-PERSEUS 29 siphawule imiphumela efanayo phakathi kwe-Element ne-Taxus Express kuze kube yizinyanga ezingu-12. Kodwa-ke, izivivinyo zokuqhathanisa izakhi ze-yew nezinye i-DES zesizukulwane sesibili azikho.
I-zotarolimus-eluting stent (ZES) Endeavor isekelwe epulatifomu eqinile ye-cobalt-chromium stent enokuguquguquka okuphezulu kanye nosayizi omncane we-stent strut. I-Zotarolimus iyi-analog ye-sirolimus enemiphumela efanayo yokucindezela amasosha omzimba kodwa ithuthukisa i-lipophilicity ukuthuthukisa indawo yodonga lwemithambo yegazi. I-ZES isebenzisa i-polymer coating entsha ye-phosphorylcholine eyenzelwe ukwandisa ukuhambisana kwezinto eziphilayo nokunciphisa ukuvuvukala. Imithi eminingi ayitholakali ngesikhathi sokuqala sokulimala, kulandelwa ukulungiswa kwemithambo yegazi. Ngemuva kwesilingo sokuqala se-ENDEAVOR, isilingo esilandelayo se-ENDEAVOR III saqhathanisa i-ZES ne-SES, ebonise ukulahleka okukhulu kwe-lumen sekwephuzile kanye ne-ISR kodwa kunezehlakalo ezimbalwa ezimbi zenhliziyo (MACE) kune-SES.30 Isilingo se-ENDEAVOR IV, esiqhathanisa i-ZES ne-PES, siphinde sathola ukwanda okuphezulu kwe-ISR, kodwa ukwanda okuphansi kwe-AMI, okubonakala sengathi kuvela ku-ST ethuthukile kakhulu eqenjini le-ZES.31 Kodwa-ke, isilingo se-PROTECT sehlulekile ukukhombisa umehluko emazingeni e-ST phakathi kwe-Endeavor ne-Cypher stents.32
I-Endeavor Resolute inguqulo ethuthukisiwe ye-stent ye-Endeavor ene-polymer entsha enezingqimba ezintathu. I-Resolute Integrity entsha (ngezinye izikhathi ebizwa ngokuthi i-DES yesizukulwane sesithathu) isekelwe epulatifomu entsha enamakhono aphezulu okulethwa (ipulatifomu ye-Integrity BMS), kanye ne-polymer entsha, ehambisana kakhulu ne-bio enezingqimba ezintathu, ingacindezela impendulo yokuqala yokuvuvukala futhi isuse iningi lomuthi ezinsukwini ezingama-60 ezizayo. Ukuhlolwa okuqhathanisa i-Resolute ne-Xience V (i-stent ye-everolimus-eluting [EES]) kubonise ukungabi ngaphansi kohlelo lwe-Resolute maqondana nokufa kanye nokwehluleka kwesilonda esiqondiwe.33,34
I-Everolimus, okususelwa ku-sirolimus, futhi iyisithiyo somjikelezo weseli esisetshenziswa ekuthuthukisweni kwe-Xience (ipulatifomu ye-Multi-link Vision BMS)/Promus (ipulatifomu ye-Platinum Chromium) EES. Isivivinyo se-SPIRIT 35-37 sibonise ukusebenza okuthuthukisiwe kanye nokwehla kwe-MACE nge-Xience V uma kuqhathaniswa ne-PES, kuyilapho isivivinyo se-EXCELLENT sibonise ukuthi i-EES yayingeyona ephansi kune-SES ekucindezeleni ukulahlekelwa sekwephuzile ezinyangeni ezingu-9 kanye nemicimbi yezokwelapha ezinyangeni ezingu-12.38 Okokugcina, i-stent ye-Xience ibonise izinzuzo ngaphezu kwe-BMS esimweni se-ST-segment elevation myocardial infarction (MI).39
Ama-EPC ayiqembu lamaseli ajikelezayo ahilelekile ekulungisweni kwe-vascular homeostasis kanye nokulungiswa kwe-endothelial. Ukuthuthukiswa kwama-EPC endaweni yokulimala kwemithambo yegazi kuzokhuthaza ukuvuselelwa kabusha kwe-endothelialization kusenesikhathi, okungenzeka kunciphise ingozi yomzamo wokuqala we-ST.EPC biology emkhakheni wokuklama i-stent yi-CD34 antibody-coated Genous stent, ekwazi ukubopha ama-EPC ajikelezayo ngokusebenzisa izimpawu zayo ze-hematopoietic ukuthuthukisa ukuvuselelwa kabusha kwe-endothelialization. Nakuba izifundo zokuqala zazikhuthaza, ubufakazi bamuva bukhomba amazinga aphezulu e-TVR.40
Uma sibheka imiphumela engaba yingozi yokuphulukiswa okubambezelekile okubangelwa yi-polymer, okuhlotshaniswa nengozi ye-ST, ama-polymer angakwazi ukumuncwa yi-bio anikeza izinzuzo ze-DES, egwema ukukhathazeka kwesikhathi eside mayelana nokuphikelela kwe-polymer. Kuze kube manje, izinhlelo ezahlukene ezingakwazi ukumuncwa yi-bio ziye zavunyelwa (isb. i-Nobori ne-Biomatrix, i-biolimus eluting stent, i-Synergy, i-EES, i-Ultimaster, i-SES), kodwa izincwadi ezisekela imiphumela yazo yesikhathi eside zilinganiselwe.41
Izinto ezimuncwa yizinto eziphilayo zinenzuzo yethiyori yokuhlinzeka ngokusekelwa kwemishini ekuqaleni lapho kucatshangelwa ukuhlehla kwe-elastic nokunciphisa izingozi zesikhathi eside ezihlobene nezinsimbi zensimbi ezikhona. Ubuchwepheshe obusha buholele ekuthuthukisweni kwama-polymer asekelwe ku-lactic acid (i-poly-l-lactic acid [PLLA]), kodwa izinhlelo eziningi ze-stent ziyathuthukiswa, yize ukuthola ibhalansi efanele phakathi kokususa izidakamizwa kanye ne-degradation kinetics kuseyinselele. Isivivinyo se-ABSORB sibonise ukuphepha nokusebenza kahle kwama-stents e-PLLA e-everolimus-eluting.43 Ukubuyekezwa kwe-Absorb stent yesizukulwane sesibili kwaba ngcono kuneyangaphambilini ngokulandelwa okuhle kweminyaka emi-2.44 Isivivinyo se-ABSORB II esiqhubekayo, isivivinyo sokuqala esingahleliwe esiqhathanisa i-Absorb stent ne-Xience Prime stent, kufanele sinikeze idatha eyengeziwe, futhi imiphumela yokuqala etholakalayo iyathembisa.45 Kodwa-ke, indawo efanele, indlela efanele yokufaka, kanye nephrofayili yokuphepha yezilonda zenhliziyo kudingeka kucaciswe kangcono.
I-Thrombosis kokubili ku-BMS kanye ne-DES inemiphumela emibi yezokwelapha. Ebhukwini leziguli ezithola i-DES implantation, ama-24% amacala e-ST abangela ukufa, ama-60% avela ku-MI engabulali, kanye nama-7% avela ku-angina engazinzile. I-PCI ezimweni eziphuthumayo ze-ST ivame ukuba yimbi kakhulu, kanti ukuphinda kuvele kuma-12% amacala.48
I-ST ethuthukisiwe ingaba nemiphumela emibi yezokwelapha. Esifundweni se-BASKET-LATE, ezinyangeni eziyi-6 kuya kweziyi-18 ngemuva kokufakwa kwe-stent, amazinga okufa kwenhliziyo kanye ne-MI engabulali ayephezulu eqenjini le-DES kunaseqenjini le-BMS (4.9% kanye no-1.3%, ngokulandelana).20 Ukuhlaziywa kwe-meta-analysis kwezivivinyo eziyisishiyagalolunye, lapho iziguli ezingu-5,261 zahlelwa ngokungahleliwe ku-SES, PES, noma i-BMS, kubike ukuthi eminyakeni emi-4 yokulandelela, i-SES (0.6% vs 0%, p=0.025) kanye ne-PES (0.7%) ) zandise izehlakalo ze-ST ephuzile kakhulu uma kuqhathaniswa ne-BMS ngo-0.2%, p=0.028).49 Ngokuphambene nalokho, ekuhlaziyeni kwe-meta okuhlanganisa iziguli ezingu-5,108, ezingu-21 ukwanda okuhlobene nokufa noma i-MI kwabikwa nge-SES uma kuqhathaniswa ne-BMS (p=0.03), kanti i-PES yayihlotshaniswa nokwanda okungabalulekile okungu-15% (Ukulandelela izinyanga eziyi-9 kuya kwezingu-3). iminyaka).
Amarejista amaningi, izivivinyo ezingahleliwe, kanye nokuhlaziywa kwe-meta kuphenye ingozi ehlobene ye-ST ngemuva kokufakelwa kwe-BMS kanye ne-DES futhi kubike imiphumela engqubuzanayo. Ebhukwini leziguli ezingu-6,906 ezithola i-BMS noma i-DES, bekungekho mehluko emiphumeleni yezokwelapha noma amazinga e-ST ngesikhathi sokulandelela konyaka owodwa.48 Kwenye irejista yeziguli ezingu-8,146, ingozi ye-ST eqhubekayo eningi itholakale ingu-0.6%/ngonyaka uma kuqhathaniswa ne-BMS.49 Ukuhlaziywa kwe-meta kokuhlolwa okuqhathanisa i-SES noma i-PES ne-BMS kubonise ingozi eyengeziwe yokufa kanye ne-MI ne-DES yesizukulwane sokuqala uma kuqhathaniswa ne-BMS, engu-21 kanye nokunye ukuhlaziywa kwe-meta kweziguli ezingu-4,545 okungahleliwe ku-SES noma Bekungekho mehluko ekwehlekeni kwe-ST phakathi kwe-PES ne-BMS eminyakeni engu-4 yokulandelela.50 Ezinye izifundo zangempela zibonise ingozi eyengeziwe ye-ST ne-MI ethuthukile ezigulini ezithola i-DES yesizukulwane sokuqala ngemuva kokuyekiswa kwe-DAPT.51
Ngenxa yobufakazi obuphikisanayo, ukuhlaziywa okuningana okuhlanganisiwe kanye nokuhlaziywa kwe-meta ndawonye kunqume ukuthi i-DES ne-BMS yesizukulwane sokuqala azihlukanga kakhulu engcupheni yokufa noma i-MI, kodwa i-SES ne-PES zazinengozi enkulu ye-ST ethuthukile kakhulu uma kuqhathaniswa ne-BMS. Ukuze kubuyekezwe ubufakazi obutholakalayo, i-US Food and Drug Administration (FDA) iqoke iphaneli lochwepheshe53 elakhipha isitatimende esivuma ukuthi i-DES yesizukulwane sokuqala yayisebenza kahle ezimpawini ezikwilebula nokuthi ingozi ye-ST ethuthukile kakhulu yayincane kodwa incane. Ukwanda okukhulu. Ngenxa yalokho, i-FDA kanye nenhlangano batusa ukwelula isikhathi se-DAPT sibe unyaka owodwa, yize kunedatha encane yokusekela lesi simangalo.
Njengoba kushiwo ngaphambili, i-DES yesizukulwane sesibili enezici zokuklama ezithuthukisiwe iye yathuthukiswa. Ama-CoCr-EES adlule ezifundweni zezokwelapha ezibanzi kakhulu. Ekuhlaziyweni kwe-meta okwenziwe nguBaber et al, 54 kufaka phakathi iziguli ezingu-17,101, i-CoCr-EES yehlise kakhulu i-ST eqinisekile/engenzeka kanye ne-MI uma kuqhathaniswa ne-PES, SES, kanye ne-ZES ngemva kwezinyanga ezingu-21. Okokugcina, uPalmeri et al ukhombisile ekuhlaziyweni kwe-meta kweziguli ezingu-16,775 ukuthi i-CoCr-EES yayine-ST eqinisekile ephansi kakhulu ekuqaleni, ngasekupheleni, yonyaka ongu-1 nowe-2 uma kuqhathaniswa nezinye i-DES ezihlanganisiwe.55 Izifundo zangempela zibonise ukwehla kwengozi ye-ST nge-CoCr-EES uma kuqhathaniswa ne-DES yesizukulwane sokuqala.56
I-Re-ZES iqhathaniswe ne-CoCr-EES ezivivinyweni ze-RESOLUTE-AC kanye ne-TWENTE.33,57 Akukho mehluko obalulekile ekwehlekeni kokufa, i-myocardial infarction, noma i-ST eqondile phakathi kwama-stents amabili.
Ekuhlaziyweni kwenethiwekhi kweziguli ezingu-50,844 okuhlanganisa nama-RCT angu-49, i-58CoCr-EES yayihlotshaniswa nokusabalala okuphansi kakhulu kwe-ST eqondile kune-BMS, umphumela awuzange ubonwe kwamanye ama-DES; ukwehla akuzange kube nje kuphela ekuqaleni kwe-Signific kanye nasezinsukwini ezingu-30 (isilinganiso samathuba [OR] 0.21, isikhawu sokuzethemba esingu-95% [CI] 0.11-0.42) kanye nangonyaka o-1 (OR 0.27, 95% CI 0.08-0.74) kanye neminyaka emi-2 (OR 0.35, 95% CI 0.17–0.69). Uma kuqhathaniswa ne-PES, SES, kanye ne-ZES, i-CoCr-EES yayihlotshaniswa nokusabalala okuphansi kwe-ST ngonyaka o-1.
I-ST yasekuqaleni ihlobene nezici ezahlukene. Ukwakheka kwe-plaque okuyisisekelo kanye nomthwalo we-thrombus kubonakala kuthonya imiphumela ngemuva kwe-PCI; 59 Ukungena okujulile kwe-strut ngenxa yokuwa kwe-necrotic core (NC), ukudabuka kwe-medial kubude be-stent, ukuhlukaniswa kwesibili okunemingcele eseleyo, noma ukunciphisa okukhulu kwemingcele Ukufakwa kwe-stenting okuhle, ukufakwa okungaphelele, kanye nokwanda okungaphelele60 Uhlelo lokwelapha ngemithi ye-antiplatelet aluthinti kakhulu ukusabalala kwe-ST yasekuqaleni: ukusabalala kwe-ST ebukhali kanye ne-subacute ngesikhathi se-DAPT esivivinyweni esingahleliwe esiqhathanisa i-BMS ne-DES Amanani ayefana (<1%).61 Ngakho-ke, i-ST yasekuqaleni ibonakala ihlobene kakhulu nezilonda zokwelapha eziyisisekelo kanye nezici zokuhlinzwa.
Namuhla, ukugxila okukhethekile ku-ST sekwephuzile/sekwephuzile kakhulu. Uma izici zenqubo kanye nezobuchwepheshe zibonakala zidlala indima enkulu ekuthuthukisweni kwe-ST ebukhali neyi-subacute, indlela yokusebenza kwezehlakalo ze-thrombotic ezibambezelekile ibonakala iyinkimbinkimbi kakhulu. Kuye kwaphakanyiswa ukuthi izici ezithile zesiguli zingaba yizici eziyingozi ze-ST ethuthukile nethuthuke kakhulu: isifo sikashukela, i-ACS ngesikhathi sokuhlinzwa kokuqala, ukwehluleka kwezinso, ukuguga, ingxenye yokukhipha encishisiwe, izehlakalo ezinkulu ezimbi zenhliziyo zingakapheli izinsuku ezingama-30 zokuhlinzwa kokuqala. Kwi-BMS kanye ne-DES, izinguquko zenqubo, njengosayizi omncane wemithambo yegazi, ukuhlukana kwemithambo yegazi, isifo se-polyvascular, i-calcification, ukuvaleka okuphelele, ama-stents amade, kubonakala sengathi kuhlotshaniswa nengozi ye-ST.62,63 Impendulo enganele ekwelashweni kwe-antiplatelet iyisici esikhulu sengozi ye-DES thrombosis ethuthukile 51. Lokhu kusabela kungase kube ngenxa yokunganamatheli kwesiguli, ukuphuza umthamo ongaphansi, ukusebenzisana kwezidakamizwa, izifo ezihambisanayo ezithinta impendulo yemithi, ama-polymorphisms ezakhi zofuzo ezingeni le-receptor (ikakhulukazi ukumelana ne-clopidogrel), kanye nokwenyuka kwezinye izindlela zokusebenzisa ama-platelet. I-In-stent neoatherosclerosis ibhekwa njengendlela ebalulekile yesikhathi esidlule ukwehluleka kwe-stent, okuhlanganisa ne-ST64 yamuva (isigaba esithi “In-stent neoatherosclerosis”). I-endothelium engashintshiwe ihlukanisa udonga lwemithambo yegazi olune-thrombosed kanye ne-stent struts ekugelezeni kwegazi futhi ikhiphe izinto ezilwa nokuvuvukala kwegazi kanye ne-vasodilator. I-DES iveza udonga lwemithambo yegazi emithini yokulwa nokwanda kwegazi kanye neplatifomu yokususa izidakamizwa enemiphumela ehlukile ekwelapheni nasekusebenzeni kwe-endothelial, enengozi ye-thrombosis yamuva.65 Izifundo ze-pathological ziphakamisa ukuthi ama-polymer aqinile e-DES yesizukulwane sokuqala angase abe nomthelela ekuvuvukeni okungapheli, ukufakwa kwe-fibrin okungapheli, ukuphulukiswa okungekuhle kwe-endothelial, kanye nengozi eyengeziwe ye-thrombosis.3 Ukuzwela kwe-DES kwamuva kubonakala kungenye indlela eholela ku-ST. UVirmani et al66 babike okutholakele ngemuva kokufa ngemuva kwe-ST okubonisa ukwanda kwe-aneurysm engxenyeni ye-stent ngokusabela kwe-hypersensitivity yendawo okwakhiwa ama-T lymphocytes nama-eosinophils; lokhu okutholakele kungabonisa ithonya lama-polymer angenakunyakaziswa.67 Ukungasebenzi kahle kwe-stent kungase kubangelwe ukwanda kwe-stent okungaphansi kokufanele noma kwenzeke ezinyangeni ngemuva kwe-PCI.Nakuba ukungasebenzi kahle kwenqubo kuyisici esiyingozi se-ST ebukhali neyi-subacute, ukubaluleka kwezokwelapha kokungasebenzi kahle kwe-stent okutholiwe kungancika ekuguqulweni kabusha kwemithambo yegazi okunamandla noma ekuphulukisweni okulibazisekile okubangelwa izidakamizwa, kodwa ukubaluleka kwayo kwezokwelapha kuyaphikiswana.68
Imiphumela yokuvikela ye-DES yesizukulwane sesibili ingafaka phakathi i-endothelialization esheshayo nengaguquki, kanye nomehluko ku-stent alloy kanye nesakhiwo, ukujiya kwe-strut, izakhiwo ze-polymer, kanye nohlobo lwesidakamizwa esilwa nokwanda, umthamo, kanye ne-kinetics.
Uma kuqhathaniswa ne-CoCr-EES, ama-struts amancane (81 µm) e-cobalt-chromium stent, ama-fluoropolymer alwa nokuphazamiseka kwegazi, i-polymer ephansi, kanye nomthwalo wemithi kungabangela ukwanda kwe-ST. Izifundo zokuhlola zibonise ukuthi i-thrombosis kanye nokufakwa kwama-platelet kwama-stents ambozwe yi-fluoropolymer kuphansi kakhulu kunalawo ama-stents angenalutho.69 Ukuthi ezinye i-DES zesizukulwane sesibili zinezakhiwo ezifanayo yini kufanele kufundwe kabanzi.
Ama-stents e-coronary athuthukisa izinga lempumelelo yokuhlinzwa kokungenelela kwe-coronary uma kuqhathaniswa ne-percutaneous transluminal coronary angioplasty yendabuko (i-PTCA), enezinkinga zomshini (ukuvaleka kwemithambo yegazi, ukuhlukaniswa kwemithambo yegazi, njll.) kanye namazinga aphezulu okuphumula (kufika ku-40%–50% wamacala). Ngasekupheleni kweminyaka yama-1990, cishe ama-PCI angama-70% ayesenziwe ngokufakelwa kwe-BMS.70
Kodwa-ke, naphezu kwentuthuko kwezobuchwepheshe, amasu, kanye nokwelashwa kwezokwelapha, ingozi ye-restenosis ngemva kokufakelwa kwe-BMS icishe ibe ngu-20%, kanti >40% emaqenjini amancane athile.71 Sekukonke, izifundo zezokwelapha zibonise ukuthi i-restenosis ngemva kokufakelwa kwe-BMS, efana naleyo ebonwa nge-PTCA evamile, ifinyelela esicongweni ezinyangeni ezingu-3-6 futhi iphela ngemva konyaka owodwa.72
I-DES inciphisa kakhulu ukwanda kwe-ISR,73 yize lokhu kuncipha kuncike ku-angiography kanye nesimo sezokwelapha. I-polymer coating ku-DES ikhipha ama-anti-inflammatory kanye nama-anti-proliferative agents, ivimbela ukwakheka kwe-neointima, futhi ilibazise inqubo yokulungisa imithambo yegazi izinyanga kuya eminyakeni.74 Ukukhula okuqhubekayo kwe-neointima ngesikhathi sokulandelela isikhathi eside ngemva kokufakelwa kwe-DES, into eyaziwa ngokuthi "ukubanjwa kwe-late catch-up", yabonwa ezifundweni zezokwelapha neze-histological.75
Ukulimala kwemithambo yegazi ngesikhathi se-PCI kudala inqubo eyinkimbinkimbi yokuvuvukala nokulungiswa esikhathini esifushane (amasonto kuya ezinyangeni), okuholela ekukhuleni kwezicubu zomzimba kanye nokumbozwa kwezicubu zomzimba. Ngokusho kokubonwa kwe-histopathological, i-neointimal hyperplasia (i-BMS ne-DES) ngemva kokufakelwa kwe-stent yayakhiwe kakhulu ngamaseli emisipha ebushelelezi e-proliferative ku-proteoglycan-rich extracellular matrix.70
Ngakho-ke, i-neointimal hyperplasia imelela inqubo yokulungisa ehilela ukuqina kwezicubu kanye nezici zokuvuvukala kanye namaseli abangela ukwanda kwamaseli emisipha ebushelelezi kanye nokwakheka kwe-extracellular matrix. Ngokushesha ngemva kwe-PCI, ama-platelet kanye ne-fibrin kufakwa odongeni lwemithambo yegazi bese kuqoqa ama-leukocyte ngochungechunge lwama-molecule okunamathela kwamaseli. Ama-leukocyte ajikelezayo anamathela kuma-platelet anamathelayo ngokusebenzisana phakathi kwe-leukocyte integrin Mac-1 (CD11b/CD18) kanye ne-platelet glycoprotein Ibα 53 noma i-fibrinogen eboshwe kwi-platelet glycoprotein IIb/IIIa.76,77
Ngokusho kwedatha evelayo, amaseli okuzala avela kumongo ahilelekile ezindleleni zokuphendula kwemithambo yegazi kanye nezinqubo zokulungisa. Ukuhlanganiswa kwama-EPC kusuka kumongo kuya egazini elingaphandle kukhuthaza ukuvuselelwa kwe-endothelial kanye nokuvuselelwa kwemithambo yegazi ngemva kokubeletha. Kubonakala sengathi amaseli okuzala abushelelezi emisipha yamathambo (i-SMPC) aya endaweni yokulimala kwemithambo yegazi, okuholela ekwandeni kwemithambo yegazi.78 Ngaphambilini, amaseli ane-CD34 ayebhekwa njengeqembu eliqinile lama-EPC; izifundo ezengeziwe zikhombisile ukuthi i-antigen ye-CD34 surface empeleni iyawabona amaseli okuqala e-bone marrow angahlukaniswanga anekhono lokuhlukanisa abe ama-EPC nama-SMPC. Ukuguqulwa kwamaseli ane-CD34-positive kuya ku-EPC noma ku-SMPC kuncike endaweni yasendaweni; izimo ze-ischemic zibangela ukwahlukana kuya ku-phenotype ye-EPC ukukhuthaza ukuvuselelwa kabusha kwe-endothelialization, kuyilapho izimo zokuvuvukala zibangela ukwahlukana kuya ku-phenotype ye-SMPC ukukhuthaza ukwanda kwemithambo yegazi.79
Isifo sikashukela sandisa ingozi ye-ISR ngo-30%–50% ngemva kokufakelwa kwe-BMS,80 kanye nokwanda kwe-restenosis ezigulini ezinesifo sikashukela uma kuqhathaniswa neziguli ezingesona isifo sikashukela nakho kwaqhubeka enkathini ye-DES. Izindlela ezisekela lokhu kuqaphela cishe ziyizinto eziningi, ezihilela izinto ezisebenza emzimbeni (isb., ukuguquguquka kwempendulo yokuvuvukala) kanye nezinto ezithinta umzimba (isb., imithambo yegazi emincane, izilonda ezinde, isifo esisabalalayo, njll.) ezikhulisa ngokuzimela Ingozi ye-ISR.70
Ububanzi bomkhumbi kanye nobude besilonda kuthinte ngokuzimela ukwanda kwe-ISR, kanti ububanzi obuncane/izilonda ezinde zandisa kakhulu amazinga okuphumula uma kuqhathaniswa nobubanzi obukhulu/izilonda ezimfushane.71
Amapulatifomu e-stent esizukulwane sokuqala abonise ama-strut amakhulu kanye namazinga aphezulu e-ISR uma kuqhathaniswa namapulatifomu e-stent esizukulwane sesibili ane-strut encane.
Ngaphezu kwalokho, ukwenzeka kwe-restenosis kwakuhlobene nobude be-stent, kanti ubude be-stent bungaphezulu kuka-35 mm cishe buphindwe kabili kunalabo abangaphansi kuka-20 mm. Ububanzi be-lumen yokugcina ye-stent encane nabo badlale indima ebalulekile: ububanzi be-lumen encane yokugcina babikezela ingozi ekhulayo kakhulu ye-restenosis.81,82
Ngokwesiko, i-intimal hyperplasia ngemva kokufakelwa kwe-BMS ibhekwa njengezinzile, kanye nenani eliphakeme ekuqaleni phakathi kwezinyanga eziyi-6 nonyaka owodwa, kulandelwe isikhathi sokuthula sekwephuzile. Inani eliphakeme ekuqaleni kokukhula kwe-intimal labikwa ngaphambilini, kulandelwe i-intimal regression kanye nokwandiswa kwe-lumen eminyakeni eminingana ngemva kokufakelwa kwe-stent;71 ukuvuthwa kwamaseli emisipha ebushelelezi kanye noshintsho ku-extracellular matrix kuye kwaphakanyiswa njengezindlela ezingenzeka zokubuyela emuva kwe-neointimal sekwephuzile.83 Kodwa-ke, izifundo ezinokulandelwa kwesikhathi eside zibonise impendulo ye-triphasic ngemva kokubekwa kwe-BMS, kanye ne-restenosis yasekuqaleni, i-intermediate regression, kanye ne-late lumen restenosis.84
Esikhathini se-DES, ukukhula kwe-neointimal sekwephuzile kwaqala kwabonakala ngemuva kokufakelwa kwe-SES noma i-PES kumamodeli ezilwane.85 Izifundo eziningana ze-IVUS zibonise ukuncishiswa kokuqala kokukhula kwe-intimal kulandelwa ukubanjwa sekwephuzile ngokuhamba kwesikhathi ngemuva kokufakelwa kwe-SES noma i-PES, mhlawumbe ngenxa yenqubo yokuvuvukala eqhubekayo.86
Naphezu "kokuzinza" okuvame ukubhekwa njenge-ISR, cishe ingxenye eyodwa kwezintathu yeziguli ze-BMS ISR ziba ne-ACS.4
Kukhona ubufakazi obandayo bokuthi ukuvuvukala okungapheli kanye/noma ukungasebenzi kahle kwe-endothelial kubangela i-neoatherosclerosis ethuthukisiwe ngaphakathi kwe-BMS kanye ne-DES (ikakhulukazi i-DES yesizukulwane sokuqala), okungaba yindlela ebalulekile ye-ISR ethuthukisiwe noma i-ST ethuthukisiwe. Inoue et al. 87 babike okutholakele kwe-histological okuvela kumasampula okuhlolwa kwesidumbu ngemuva kokufakwa kwama-stents e-coronary e-Palmaz-Schatz, okuphakamisa ukuthi ukuvuvukala kwe-peri-stent kungasheshisa izinguquko ezintsha ze-atherosclerotic ezingasebenzi kahle ngaphakathi kwe-stent. Ezinye izifundo10 zibonise ukuthi izicubu ze-restenotic ngaphakathi kwe-BMS, eminyakeni engaphezu kwemi-5, zakhiwe yi-atherosclerosis esanda kuvela, enokuvuvukala kwe-peri-stent noma engenakho; Amasampula avela emacaleni e-ACS abonisa ama-plaque avamile asengozini emithanjeni yenhliziyo yomdabu I-Histological morphology ye-block enama-macrophage ane-foamy kanye namakristalu e-cholesterol. Ngaphezu kwalokho, lapho kuqhathaniswa i-BMS ne-DES, kwaphawulwa umehluko omkhulu ngesikhathi sokuthuthukiswa kwe-atherosclerosis entsha.11,12 Izinguquko zokuqala ze-atherosclerotic ekungeneni kwe-foamy macrophage zaqala ezinyangeni ezi-4 ngemuva kokufakelwa kwe-SES, kanti izinguquko ezifanayo ezilonda ze-BMS zenzeka eminyakeni emi-2 kamuva futhi zahlala ziyinto engavamile kwaze kwaba yiminyaka emi-4. Ngaphezu kwalokho, i-DES stenting yezilonda ezingazinzile njenge-thin-cap fibroatherosclerosis (TCFA) noma i-intimal rupture inesikhathi esifushane sokuthuthukiswa uma kuqhathaniswa ne-BMS. Ngakho-ke, i-neoatherosclerosis ibonakala ivame kakhulu futhi yenzeka ekuqaleni kwe-DES yesizukulwane sokuqala kune-BMS, mhlawumbe ngenxa ye-pathogenesis ehlukile.
Umthelela we-DES noma i-DES yesizukulwane sesibili ekuthuthukisweni usazofundwa; yize okunye okubonwe kakade kwe-DESS yesizukulwane sesibili kuphakamisa ukuvuvukala okuncane, ukwanda kwe-neoatherosclerosis kufana nokwesizukulwane sokuqala, kodwa ucwaningo olwengeziwe lusadingeka.