Abstracts
OBJECTIVE: To perform a comparative analysis of in-hospital results obtained from AMI patients who underwent rescue or primary PTCA. METHODS: From the Brazilian Interventional National Registry (CENIC), we selected all consecutive patients who underwent a percutaneous coronary intervention for myocardial infarction (< 24 hours), between 1997 and 2000, analyzing those undergoing a rescue (n=840) or a primary (n=8,531) procedure, and comparing their in-hospital results. RESULTS: Rescue patients were significantly younger males with anterior wall infarctions, associated with left ventricular dysfunction, but had less multivessel disease, compared with those treated with primary intervention. Coronary stents were implanted in at similar rates (56.9% vs. 54.9%; P=0.283). Procedural success were lower for rescue cases (88.1% vs. 91.2%; P<0.001), with higher mortality (7.4% vs. 5.6%; P=0.034), compared with the primary intervention group; target vessel revascularization (< 0.5%), emergency bypass surgery (< 0.3%) and reinfarction (< 2.6%) rates were similar for both strategies. Multivariate analysis identified the rescue procedure as a predictor of in-hospital death [OR(CI=95%) = 1.60 (1.17-2.19); P=0.003]. CONCLUSION: Patients who underwent a rescue coronary intervention had higher in-hospital death rates compared with those who underwent a primary coronary intervention.
angioplasty; myocardial infarction; reperfusion; thrombolysis; stent; platelet inhibitors
OBJETIVO: Análise comparativa dos resultados hospitalares em pacientes infartados reperfundidos por meio de uma intervenção coronariana percutânea de resgate ou primária. MÉTODOS: Selecionados pacientes consecutivos, submetidos a uma intervenção percutânea no infarto do miocárdio (< 24h), entre 1997 e 2000, incluídos no registro nacional multicêntrico CENIC, comparando os resultados hospitalares, entre aqueles submetidos ao procedimento de resgate (n=840) ou primário (n=8.531). RESULTADOS: Os pacientes que realizaram intervenção de resgate eram significativamente mais jovens, com infarto anterior, associado à presença de disfunção ventricular, porém com menor porcentual de doença coronariana multiarterial, comparados aos primários. As taxas de implante de stents foram similares (56,9% vs. 54,9%; p=0,283), mas o sucesso do procedimento foi menor nos casos de resgate (88,1% vs. 91,2%; p<0,001), cursando com maior mortalidade (7,4% vs. 5,6%; p=0,034), comparado à intervenção primária; nova revascularização (< 0,5%), cirurgia de emergência (< 0,3%) e reinfarto (< 2,6%) foram similares. A análise multivariada identificou o procedimento de resgate como preditor de mortalidade ao final da fase hospitalar [RC (IC=95%) = 1,60 (1,17-2,19); p=0,003]. CONCLUSÃO: Neste registro nacional, a intervenção de resgate apresentou uma maior mortalidade hospitalar, comparada ao procedimento primário.
angioplastia; infarto do miocárdio; reperfusão; trombólise; stent; antiplaquetários
ORIGINAL ARTICLE
A comparison of rescue and primary percutaneous coronary interventions for acute myocardial infarction. A multicenter registry report of 9,371 patients
Luiz Alberto Mattos, Amanda G.M.R. Sousa; Ibraim M.F. Pinto; Expedito R. Silva; José Klauber Carneiro; J. Eduardo Sousa; José Armando Mangione; Paulo Caramori; Valter Lima; Ronaldo L. Bueno
Instituto Dante Pazzanese de Cardiologia e Sociedade Brasileira de Hemodinâmica e Cardiologia Intervencionista, São Paulo, SP, Brasil - in the name off all investigators CENIC/SBHCI. São Paulo, SP - Brazil
Correspondence Correspondence to Luiz Alberto Mattos Av. Jandira, 550/121 Cep - 04080-003 São Paulo, SP, Brasil E-mail: pivmattos@uol.com.br
ABSTRACT
OBJECTIVE: To perform a comparative analysis of in-hospital results obtained from AMI patients who underwent rescue or primary PTCA.
METHODS: From the Brazilian Interventional National Registry (CENIC), we selected all consecutive patients who underwent a percutaneous coronary intervention for myocardial infarction (< 24 hours), between 1997 and 2000, analyzing those undergoing a rescue (n=840) or a primary (n=8,531) procedure, and comparing their in-hospital results.
RESULTS: Rescue patients were significantly younger males with anterior wall infarctions, associated with left ventricular dysfunction, but had less multivessel disease, compared with those treated with primary intervention. Coronary stents were implanted in at similar rates (56.9% vs. 54.9%; P=0.283). Procedural success were lower for rescue cases (88.1% vs. 91.2%; P<0.001), with higher mortality (7.4% vs. 5.6%; P=0.034), compared with the primary intervention group; target vessel revascularization (< 0.5%), emergency bypass surgery (< 0.3%) and reinfarction (< 2.6%) rates were similar for both strategies. Multivariate analysis identified the rescue procedure as a predictor of in-hospital death [OR(CI=95%) = 1.60 (1.17-2.19); P=0.003].
CONCLUSION: Patients who underwent a rescue coronary intervention had higher in-hospital death rates compared with those who underwent a primary coronary intervention.
Key words: angioplasty, myocardial infarction, reperfusion, thrombolysis, stent, platelet inhibitors
Fibrinolytic therapy and primary percutaneous transluminal coronary angioplasty are effective methods used to promote myocardial reperfusion in acute myocardial infarction (AMI) 1. However, the re-establishment of normal epicardial flow (TIMI grade 3) is not achieved in a significant number of patients who undergo fibrinolytic treatment 2,3. The strategy of a rescue percutaneous coronary intervention (PCI) early after failure of fibrinolytic treatment has a logical indication; however, the clinical impact and the selection of the precise strategy is still controversial and still has inferior results when compared with the results of a primary procedure 4-8. Therefore, primary PCI, when available, is considered the gold standard for coronary reperfusion 9.
The objective of this study was to perform a comparative analysis of in-hospital results obtained from AMI patients who underwent rescue or primary PTCA, consecutively included in a national registry of interventional cardiology (CENIC - Central Nacional de Intervenções Cardiovasculares).
Methods
The CENIC registry was created in 1991 and sponsored by the Brazilian Society of Interventional Cardiology (SBHCI). The procedures were established in a spontaneous fashion. The consistency of the results have been analyzed in former publications10-13. The PCI procedures started being gathered in a central nationwide database in 1992; the new coronary percutaneous device technology was incorporated in 1996. From January 1997 until December 2000, the CENIC databank received consecutive information on 68,236 patients who underwent PCI, either with balloon or coronary stent implantation, performed by 215 invasive cardiologist members of SBHCI, in 185 different hospitals, encompassing all 5 different geographic regions in Brazil. The PCI procedure report was sent to the CENIC coordinating center in Sao Paulo, by conventional or electronic mail, on a prespecified and equal database sheet. This file contains the clinical and angiographic baseline plus the procedural results, as well as the occurrence of major in-hospital adverse cardiac events. Additional information may be obtained at the SBHCI Web site (www.sbhci.org.br).
We analyzed files that indicated that a primary or a rescue PCI had been performed in the first 24 hours after AMI onset. Only complete files were analyzed. All the information obtained from the files was displayed. Data with consistent and frequent flaws were discarded. The diagnosis of AMI was performed in each center. During this period, 9,371 (13.7% of the total) patients fulfilled these criteria, and their data were then analyzed in a comparative fashion: 840 (1.2%) underwent a rescue and 8,531 (12.5%) a primary PCI.
In the rescue group, patients were previously treated with streptokinase, alteplase, or with a combination. Patients underwent rescue PCI according to the discretion of the clinician, during the first 24 hours of the acute event. We analyzed only patients with a culprit AMI vessel clearly identified and with a visual estimation of a lesion < 90%. All primary PCI patients were analyzed (patients who did not receive previous fibrinolytics).
In more than 90% of the patients, aspirin were administered plus ticlopidine or clopidogrel, in the event of a coronary stent implantation. Abciximab was administered at the operator's discretion, and was the only IIb/IIIa blocker recorded in the registry. We classified the AMI location as being anterior or nonanterior related to the culprit AMI vessel presentation, either the left anterior descending or a surgical graft. The left ventricular ejection fraction and the diameter of stenosis of the vessels were analyzed with a qualitative method (visual), performed in each center without interference from the CENIC center.
The PCI success was defined as a final stenosis diameter less than 50% with TIMI flow grade 2 or 3 14, and major adverse events were considered until hospital discharge: reinfarction as recurrent chest pain associated with any secondary increase in the creatinine kinase, new target vessel-revascularization (TVR) as the performance of a new PCI of the culprit vessel or coronary bypass surgery in patients with recurrent ischemic symptoms, emergency surgical revascularization as the need for the patient to undergo a coronary bypass revascularization within the first 24 hours after the index procedure, and all-cause deaths were considered.
The statistical analysis was done with SPSS 10.0 statistical software. All continuous variables were expressed as mean ± SD. Univariate analysis included the chi-square test for evaluating dichotomous variables and the Student t test for continuous variables. Cox progressive regression analysis was performed to identify the independent influence of each baseline variable in the in-hospital death rate. P values < 0.05 were considered significant.
Results
Streptokinase was the fibrinolytic agent more frequently administered before rescue PCI was performed [n=733 (87.3%)], followed by alteplase [n=61 (7.3%)]. In 46 (5.4%) patients, the fibrinolytic strategy was combination of these. Rescue PCI procedures were performed in younger patients, more frequently men, with significantly more infarctions located in the anterior wall, when compared with those who underwent a primary procedure, without previous fibrinolytic therapy (tab. I). The angiographic variables demonstrated that by the time of the rescue procedure, significantly more patients had a severe reduction in ejection fraction, but with fewer diagnoses of multivessel coronary heart disease (tab. I). A higher incidence of visible thrombi (>70%) was noted for both PCI strategies, with the treatment of a native coronary artery in the vast majority of the cases (>90%), represented by complete occlusion (TIMI 0-1) of the culprit vessel (>90%), in either forms of PCI in AMI. Overall, abciximab usage was below 15%, but even lower in the rescue PCI group compared with its use in primary procedures (4.6% vs. 15.2%, P<0.001). At least half of the patients received a coronary stent implant, in similar rates either for rescue or primary intervention (56.9% vs. 54.9%, P=0.283) (tab. II).
The achievement of procedural success was significantly higher in patients who had not received previous fibrinolytic therapy (91.2% vs. 88.1%, P=0.003). The final diameter of stenosis was significantly lower in patients who underwent primary versus rescue PCI (13.2±12% vs. 15.9±14%, P<0.001) (tab. II).
The need for emergency bypass surgery or a new and urgent TVR were uncommon events, for both PCI strategies (<0.5%). Reinfarctions were observed in less than 3% of the patients, similarly for rescue or primary PCI (2.3% vs. 2.6%, P=0.552). In-hospital death rates were significantly higher for patients who underwent rescue PCI, after the failure of previous fibrinolytic therapy (7.4% vs. 5.6%, P=0.034). The association of PCI failure and in-hospital mortality indicated similar casualties for both groups [23 (23.0%) vs. 173 (23.1%); P=0.977]. Hospital discharge was effective at the end of the first week either for rescue or primary PCI (7.36±3.0 vs. 7.26±3.2 days, p=0.360) (tab. III).
Multivariate analysis identified independent predictors for in-hospital mortality. Patients who underwent a rescue procedure had a higher chance of suffering a fatal event until hospital discharge [OR (95%CI) = 1.60 (1.17-2.19); P=0.003]. Other demographic variables were also identified, most of them already known as independent predictors of a worse procedural and clinical outcome (tab. IV).
Discussion
Rescue PCI remains an uncommon procedure in this recent national registry analysis, when compared with primary coronary intervention in myocardial infarction 15,16.
Patients who underwent a PCI after fibrinolytic failure were identified as more likely to be young, with an anterior myocardial infarction, and with more extensive left ventricular dysfunction, when compared with patients admitted for primary PCI. Otherwise, primary patients were older and with a more frequent diagnosis of multivessel coronary heart disease. More than 90% of the AMI patients had a totally occluded vessel. We observed a balance between the adversity of the baseline variable distribution between both groups, regarding the ones considered more prone to the occurrence of death. Probably they reflected the bias of the indication of each procedure, for example, the anterior MI location for rescue patients and older age for those undergoing a primary procedure.
Abciximab was not used very often and even less in rescue procedures compared with its use in primary PCI. The predominance of streptokinase as the fibrinolytic of first choice might have warranted its use related to the fear of the occurrence of major bleeding events. Despite coronary stent implantation in more than half of the patients, like primary procedures, the success was significantly lower for rescue patients.
In-hospital major adverse events occurred at similar rates but with the exception of mortality. In-hospital death was nearly 25% higher in rescue patients. The relationship between procedural failure and death was not demonstrated because both mechanical strategies had similar rates, up to 20%. After multivariate analysis, rescue PCI was identified as an independent predictor for higher hospital mortality.
The analysis of primary PCI results resembles other results already published, either regarding procedural success (>90%) or in-hospital deaths (<6%) 17-19. However, these results were not transferred for patients who underwent rescue PCI. Randomized trials that studied the performance of PCI after fibrinolytic treatment (PRAGUE 1 and 2 8,20) corroborate these findings, with a significant trend toward higher death rates in these patients. These trials may be a good comparison with the Brazilian registry because the fibrinolytic regimen was the same (streptokinase). A word of caution should be mentioned, regarding the inclusion criteria of the PRAGUE 1 and 2 trials in which the analysis was focused on transferring patients to PCI centers and not only on those with failure of lytic treatment 21.
Former consecutive series and randomized trials reported the results obtained after rescue PCI, using in the vast majority of patients, only the balloon. These series also showed higher death rates when rescue was compared with primary PCI 4-6,22-26. In the RESCUE I-II study, the death rates were greater than 5% and close to 10% 7. The higher reocclusion rates (20-30%) might be responsible for that, a reflection of the balloon PCI era. Coronary stent implantation had strongly reduced the in-hospital rates of recurrent ischemia and as a consequence, vessel reocclusion 27.
One Dutch registry is the exception. This study 24 also compared rescue and primary PCI with similar in-hospital mortality rates (4.7% vs. 6.6%, P=0.37) in a scenario of a lower rate of stent usage (<40%). The authors speculated that lower time to treatment delay might have helped them (<3 hours). Our results were different, and one of the multiple explanations might be the interaction of the baseline variables, some not reported in the CENIC registry.
How can we explain the higher death rate after a rescue PCI? These patients had a worse prognosis related to a more extensive and thicker atherosclerotic plaque, associated with extensive myocardial damage, especially to microvascular circulation 28,29. Former analysis of randomized data emphasizes the importance of the protection of the distal coronary circulation, measured by the tissue myocardial perfusion grade (TMPG). In the TIMI 10B trial 30, patients who achieved a higher TMPG score (grade 2 or 3) had a lower mortality rate in the 2-year follow-up after a rescue PCI, compared with those with lower (0 or 1) TMPG scores (9.1% vs. 4.8%, P=0.038) 31,32.
Is it possible to optimize rescue PCI results? There is a strong trend toward the more liberal use of potent antiplatelet agents (IIb/IIIa inhibitors) in these high-risk AMI patients, justified by their capacity to protect the microvascular coronary circulation. Their use is still not frequent, but most often is related to the administration of the nonfibrin- specific agents, like streptokinase. A recent metaanalysis of 12 trials that included AMI patients who underwent treatment with the last generation of fibrin-specific agents, demonstrated a more liberal and concomitant use of IIb/IIIa inhibitors 3. In 3,418 rescue procedures, 1,032 patients had a trend toward a reduced 30-day death rate [4.6% vs. 6.6%; OR (CI=95%)=0.71 (0.49-1.01)], without significantly increasing the cerebral vascular bleeding rate [0.4% vs. 0.9%; OR (CI=95%) 1.64 (0.19-1.90)], compared with those who did not receive IIb/IIIa agents. However, the total sum of moderate or severe bleeding rates was higher in these patients [10.2% vs. 8.1%; OR=(CI=95%)= 1.64(1.24-2.16)]. The prescription of these agents (IIb/IIIa inhibitors) to patients who are undergoing rescue PCI is expanding, as is the association of new percutaneous devices that enhance distal microcirculation protection like thrombi extractors or distal vessel filters 27,33-35. Ongoing trials will clarify and stratify the use of these new pharmacological and mechanical strategies for those patients undergoing rescue PCI.
The CENIC registry promoted the possibility of analyzing a large cohort of patients in a short period, reflecting the real and daily practice of PCI in Brazil. Former analyses were performed and the results published, already proving the consistency of these data 10-13. However, the registry has its own pitfalls. Many other clinical, angiographic, and procedural variables were not collected, such as the Killip class, AMI vessel TIMI flow, and the occurrence of other major adverse events like bleeding with their consequences. Other important variables were registered but frequently had flaws, like time to treatment delay and the size and number of percutaneous devices used. Also, it has already been mentioned that this is a spontaneous registry that might not reflect all the nationwide PCI procedures, and finally, the judgment of the PCI results was performed at each center and not by an independent center. We hope to optimize and correct these limitations in the near future.
We concluded from this comparative analysis between 2 different strategies of PCI performance in AMI patients that rescue PCI had less procedural success with higher in-hospital death rates. Rescue PCI was identified as an independent predictor of a higher death rate. Future research should be focused on improving the results in this subgroup of patients who still exhibit worse results when compared with those treated with the gold standard, primary PCI.
Acknowledgment
The following 215 Brazilian interventional cardiologists contributed to this registry in the following period, 1997 to 2000, data originating from 185 different invasive cardiology centers: Adnam Salmam, Adriano Caixeta, Alberto Najjar, Alberto Sottomayor, Alcides Zago, Aldegio Caldeira, Aldo Duarte, Alexandre Abizaid, Alexandre Azmuz, Alexandre Varela, Álvaro Moura, André Labrunie, André Pessanha, Angelo de Paola, Ângelo Tedeschi, Anselmo Salgado, Antenor Queiroga, Antenor Portela, Antenório Aiolfi, Antônio Carlos Silva, Antônio Forte, Antônio Ferreira, Antônio Esteves Filho, Antônio Godinho, Antônio Souza, Antônio Secches, Antônio Botelho Silva, Antônio Azevedo, Antônio Muniz, Antônio Vianna, Ari Mandil, Arthur Barreto, Augusto Lima, Caio Pessoa, Carlos Zapata, Carlos Gottschall, Carlos Areas, Carlos Cardoso, Carmine Scianni, Charles Vieira, Clacir Staudt, Cláudia Alves, Celso Takimura, Celmo Souza, Clemente Greguolo, Costantino Costantini, Deborah Nercolini, Décio Salvadori, Edgar Victor, Edson Bocchi, Edson Peixoto, Ederval Key, Edmur Araújo, Eduardo Nogueira, Eduardo Costa, Eduardo Nicolelo, Elias Ayres Neto, Enio Gueiros, Esmeralci Ferreira, Euler Mesquita, Eulógio Martinez, Evandro Osterne, Expedito Ribeiro, Fábio Brito, Fausto Feres, Fernando Santana, Fernando DeVito, Flávio Barbosa, Flávio Leboute, Francisco Cardoso, Francisco Cruz, Francisco Falcão, Francisco Stella, Frederico Silva, Galo Maldonado, Gilberto Nunes, Gilvan Dourado, Gustavo Alvarez, Gustavo Ramalho, Haroldo Glavan, Heitor Carvalho, Hélio Castello Jr, Hélio Figueira, Helman Martins, Itamar Oliveira, Ivan Lessa, James Glesser, Jamil Saad, João Batista Loures, João Batista Guimarães, João Batista Oliveira, João Otávio de Freitas, João Roberto Carvalho, Jocelino Soares, Jorge Guimarães, Jorge Camargo Neto, Jorge Buchler, José Alfredo Sejópoles, José Domingos Almeida, José Klauber Carneiro, José Albino Souza, José Antônio Jatene, José Antonio Marin Neto, José Armando Mangione, José Augusto de Souza, José Augusto Araújo, José Gomes Filho, José Barreto, José Breno de Souza Filho, José Carlos Mello, José Carlos Brito, José Eduardo Sousa, José Henrique Mota, José Luiz Attab, José Marconi Souza, José Maiello, José Maria Bastos, José Maria Gomes, José Ribeiro de Souza, José Silvério Guimarães, José Tadeu Mourão, José Nogueira Paes, José Walter Nogueira, Júlio Cesar Andrea, Júlio Teixeira, Klermann Lopes, La Hore Rodrigues, Lázaro Garcia, Lélio Silva, Leônidas Alvarenga Henriques, Leslie Aloan, Luciano Abreu, Luciano Façanha, Ludmilla Oliveira, Luis Campos, Luis Maria Yordi, Luiz Lessa, Luiz Alberto Mattos, Luiz Alberto Maneschy, Luiz Antônio Gubolino, Luiz Bastos, Luiz Finzi, Luiz Lavalle, Luiz São Thiago, Luiz Fernando Morrone, Luiz Kajita, Marcelo Cantarelli, Marcelo Queiroga, Márcio Truffa, Márcio Silva, Marco Perin, Marcos Flávio Ribeiro, Marcos Marino, Marcos Gama, Mário Salles, Maurício Barbosa, Miguel Ratti, Milton Soares Neto, Milton Ferreira Filho, Moisés Lima, Murilo Furukawa, Nahaniel Rodrigues, Newton Stradler, Nílton Machado, Nílton Oliveira, Nílson Ramos, Norberto Duda, Norival Romão, Noriaki Takeshita, Paulo Jorge, Paulo Almeida, Paulo de Andrade, Paulo Caramori, Paulo Galvão, Paulo Sérgio de Oliveira, Paulo Soares, Pedro Abílio Rezek, Pedro Horta, Pedro Beltrão, Pedro de Andrade, Pedro Pascoli, Pierre Labrunie, Rafael Przytyk, Raimundo de Melo, Raul Mora, Ricardo Barbosa, Ricardo Cavalcanti, Rinaldo Carneiro, Roberto César, Roberto Freire, Roberto Otsubo, Roberto Botelho, Rodolfo Alencar, Rodolfo Staico, Rogério Guimarães, Ronaldo Bueno, Ronaldo Villela, Ronei Matos, Salvador Cristovão, Samuel Silva, Sérgio Berti, Sérgio Leandro, Sérgio Prata, Siguemituzo Arie, Valter Lima, Vasco Miller, Vicente Mota, Virgílio Mares, Walkimar Veloso, Wilson Coelho, Wilson Oliveira, Wilson Pimentel e Wilson Vieira.
References
Received: 6/11/03
Accepted: 11/24/03
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Publication Dates
-
Publication in this collection
08 June 2004 -
Date of issue
May 2004
History
-
Accepted
24 Nov 2003 -
Received
11 June 2003