Epilogue
Gerry Coghlan
Introduction
When interventional cardiology was born 28 years ago few could have foreseen its rapid growth and current dominant position in cardiology. In the late 1980s when percutaneous coronary intervention (PCI) had already become a significant player in the world of revascularization, “gut feeling” rather than knowledge underpinned the approach to hardware selection and adjunctive pharmacotherapy. The transformation of interventional cardiology from “eminence-based” to the most evidence-based speciality in medicine in just over 15 years has been truly remarkable.
This collection of classic papers document this change, showing how ideas tested in vitro and in vivo, coupled with registry-based observations, helped formulate specific questions, which were refined by small scale studies and culminated in practice-changing randomized trials.
These articles focus on studies that led to step changes in our understanding of coronary artery disease and the vascular and thrombotic responses to intervention, and our daily practice in revascularization. These articles allow those with little knowledge of interventional cardiology, to understand the place of PCI in 2005, while for those in the field it summarizes neatly that which one needs to know about the history of PCI to date.
The first two chapters take the reader through the pivotal articles which led to our current understanding of the nature of atherosclerosis, the factors which cause progression, regression and clinical events, followed by the nature and limitations of imaging techniques which have con- tributed to this understanding. The next two chapters deal with studies that established the superiority of PCI in acute myocardial infarction and high risk acute coronary syndromes during a period of rapid evolution of medical therapies for the same conditions. Chapter 5 shows how registry studies identified high risk subgroups for PCI providing the kind of detailed real-life pop- ulation analysis that is often missing from controlled randomized studies. Some of these risk fac- tors have been overcome with advances in technology (female sex and type B lesions) and some remain significant challenges (chronic occlusions and left main stem lesions). Chapters 6 and 7 deal with technological advances, illustrating how many exciting techniques were shown not to improve outcomes (directional and rotational atherectomy, eximer laser and cutting balloons) and have thus become niche products, while others such as stents have become part of routine practice. The pace of progress in our understanding of the haemostatic systems and how to safely manipulate them is particularly gratifying and perfectly illustrated by the articles in chapter 8. In chapter 9, the potential of a world without cardiac surgery is considered; it is clear from the articles presented that coronary artery bypass grafting (CABG) though in retreat, is not yet dead.
To close I would simply like to add a few articles which did not in themselves change the world, but which foreshadowed greater works. These are in essence the articles that set the scene for further investigation down a line that ultimately changed practice. The authors, with the exception of Essed et al. (Title 4) who simply made a fortuitous observation, are the vision- aries who saw well beyond the limitations of current practice, they are in essence the pioneers without whom PCI would not have evolved as it has.
The percutaneous dilatation of chronic coronary stenoses – experiments and morphology
Author
Grüntzig A, Schneider HJ
Reference
Schweiz Med Wochenschr 1977; 107(44): 1588
Abstract
Since 1971, percutaneous transluminal angioplasty of peripheral arteries has been performed in 225 patients. There was an overall patency rate of 70–80% after 2 years. Our technique was then adapted and modified to perform coronary dilatation. This was performed successfully in 8 dogs in which selective coronary artery stenosis was induced by silk ligature and secondary inflammatory changes. The technique was then applied to the coronary lesions in postmortal humans and tested in the operating room during A–C bypass to evaluate vessel patency, peripheral debris, etc.
Summary
This study describes the process of adapting peripheral angioplasty for use in human coronar- ies. Proof of concept in carefully designed animal studies followed by work in humans in controlled circumstances opened the way for Grüntzig’s definitive work that was published 2 years later.
Citation Count 21
Related References
One could simply list all work published on coronary angioplasty. A Medline search yields over 16,000 articles, while PubMed search yields nearly 25,000.
Key message
Non-operative revascularization of human coronaries is possible.
Why it’s important
This is the article that led to the development of coronary angioplasty as we know it today.
Strengths
Careful and logical exploration of the feasibility and safety of the technique.
Weaknesses
No procedures performed in pigs. Unlike dogs, pigs lack collaterals, this would have provided greater insight into the likely tolerance of brief periods of ischaemia required for percutaneous coronary angioplasty.
Relevance
This article reports the first successful work in coronary angioplasty, the methodology demon- strated the essential safety of the technique in controlled circumstances. As a forerunner of their 1979 article on PCI in patients, it set the framework and neutralized many of the potential wor- ries which might have been expressed, and thus set the scene for the very rapid adoption of the technique that followed.
Treatment of unstable angina pectoris with percutaneous transluminal coronary angioplasty (PTCA)
Author
Meyer J, Schmitz H, Erbel R, Kiesslich T, Bocker-Josephs B, Krebs W, Braun PC, Bardos P, Minale C, Messmer BJ, Effert S
Reference
Cathet Cardiovasc Diagn 1981; 7(4): 361–371
Abstract
Percutaneous transluminal coronary angioplasty (PTCA) was performed in 40 patients (34 male, 6 female; 51.0 8.5 years) with the typical clinical picture of unstable angina. All had a short history of pain (2.9 2.0 months), angina at rest, transient ST and/or T-wave changes during this period, and little or no enzyme elevations. The patients had a total of 41 stenoses (39 sin- gle, one double; one main-stem, 26 left anterior descending, 14 right coronary artery). The degree of the stenoses was 95.5 4.9% (area method) and 81.8 10.7% (diameter method).
PTCA was successfully performed in 26 cases (63%), reducing the stenoses to 61.5 12.4%
(area method) and 39.1 10.0% (diameter method). One patient (2.5%) received an immedi- ate bypass operation because of an acute vessel occlusion. Eleven of the 14 not successfully treated patients received an aortocoronary bypass within the next three to 35 days. All still had symptoms of unstable angina. Three patients refused operation. Their treatment consisted of nitroglycerin, beta-blockers and nifedipine. Seventeen of the 26 successfully treated patients were restudied after 4.9 1.7 months. The degree of stenosis had risen to 69.2 17.4% (area method). While the stenoses in 12 patients were equal or less than before PTCA, stenosis recurred in five cases. Two patients were successfully retreated. PTCA can be performed with a good early success rate and a low complication rate in patients with unstable angina. Relief of pain and improvement of blood supply to the jeopardized myocardium can be provided imme- diately and with a limited amount of expense. The method can therefore be regarded as first- stage treatment in such patients.
Summary
This is the first article to detail the successful application of coronary angioplasty in a high-risk population. Two-thirds of patients responded to intervention alone, leaving only one-third need- ing operation. Follow-up angiography suggested that restenosis was not uncommon.
Citation Count 40
Related References
1. Faxon DP, Detre KM, McCabe CH, Fisher L, Holmes DR, Cowley MJ, Bourassa MG, Van Raden M, Ryan TJ. Role of percutaneous transluminal coronary angioplasty in the treatment of unstable angina. Report from the National Heart, Lung, and Blood Institute Percutaneous
Transluminal Coronary Angioplasty and Coronary Artery Surgery Study Registries. Am J Cardiol 1984; 53(12): 131C–135C.
2. Strauss WE, Fortin T, Hartigan P, Folland ED, Parisi AF. A comparison of quality of life scores in patients with angina pectoris after angioplasty compared with after medical therapy.
Outcomes of a randomized clinical trial. Veterans Affairs Study of Angioplasty Compared to Medical Therapy Investigators. Circulation 1995; 92(7): 1710–1719.
3. Morrison DA, Sacks J, Grover F, Hammermeister KE. Effectiveness of percutaneous translu- minal coronary angioplasty for patients with medically refractory rest angina pectoris and high risk of adverse outcomes with coronary artery bypass grafting. Am J Cardiol 1995; 75(4):
237–240.
4. Morrison DA, Bies RD, Sacks J. Coronary angioplasty for elderly patients with “high risk”
unstable angina: short-term outcomes and long-term survival. J Am Coll Cardiol 1997; 29(2):
339–344.
Key message
PTCA can be performed safely and successfully in most patients with unstable angina, leading to relief of ischaemia.
Why it’s important
Patients with unstable angina spent weeks to months in hospital, and had a significant likeli- hood of progressing to myocardial infarction. Conservative practitioners treated this population with bed rest and drug therapies, regarding operative intervention as risky and unproven in this subpopulation. The advent of a less “traumatic” interventional approach, rapidly converted many of these physicians, though absolute proof of the superiority of an interventional approach was still many years away.
Strengths
Though PCI had only been practiced for 2 years at the time of publication, this article describes a relatively large homogenous population. In many countries the management of this population was backward. Meyer and colleagues were describing a potentially efficient method of address- ing the needs of this population which captured the imagination of cardiologists throughout the world.
Weaknesses
This was a registry, there was no control population, and thus no evidence that any of the estab- lished techniques (medical or surgical) were inferior to this new technique.
Relevance
One of the most successful applications of PCI has been in managing acute coronary syn- dromes. The management of such patients has been revolutionized in the past two decades.
This article represents an early application of the technique to this difficult population, yet despite many trials it would be nearly two decades before unequivocal evidence for the superi- ority of PCI over medical management of this population was established.
Percutaneous transluminal coronary angioplasty with and without thrombolytic therapy for treatment of acute
myocardial infarction
Author
Hartzler GO, Rutherford BD, McConahay DR, Johnson WL Jr, McCallister BD, Gura GM Jr, Conn RC, Crockett JE
Reference
Am Heart J 1983; 106(5 Pt 1): 965–973
Abstract
Successful percutaneous transluminal coronary angioplasty (PTCA) was performed during evolving acute myocardial infarction (AMI) in 41 patients. Catheterization was performed within 1 hour of presentation, from 1 to 12 hours (mean 3.3) following symptom onset. In 17 of 29 patients with a totally occluded coronary artery, successful thrombolytic therapy was followed by PTCA of a residual high-grade atheromatous stenosis. Successful PTCA without prior thrombolytic therapy was employed in 11 of 12 subtotal coronary stenoses producing acute infarction syndromes and in two patients having critical coronary stenoses not immediately responsible for AMI. Three patients experienced early in-hospital reocclusion with reinfarction.
One death occurred in a patient presenting with cardiogenic shock. All remaining patients had prompt pain relief, subsequent stable clinical courses, and no clinical or late angiographic evi- dence of coronary reocclusion. Dramatic improvement of regional and global left ventricular function was evident in 22 of 27 patients undergoing late left ventricular angiography. At follow- up, 94% of patients remained free of angina although three required repeat dilatation of recur- rent stenoses. We concluded that PTCA may be performed with or without thrombolytic therapy in selected patients with AMI and may reduce the likelihood of late reocclusion follow- ing successful thrombolytic therapy.
Summary
This study describes the acute catheterization of patients presenting with acute myocardial infarction, followed by intracoronary thrombolysis and subsequent angioplasty for occlusions, and angioplasty alone for those with residual flow. Early improvement of left ventricular function was documented in most patients.
Citation Count 244
Related References
1. Lee G, Amsterdam EA, Low R, Joye JA, Kimchi A, DeMaria AN, Mason DT. Efficacy of per- cutaneous transluminal coronary recanalization utilizing streptokinase thrombolysis in patients with acute myocardial infarction. Am Heart J 1981; 102(6 Pt 2): 1159–1167.
2. Pepine CJ, Prida X, Hill JA, Feldman RL, Conti CR. Percutaneous transluminal coronary angioplasty in acute myocardial infarction. Am Heart J 1984; 107(4): 820–822.
3. Grbic M, Sigwart U, Goy JJ, Maendly R, Essinger A, Perret C, Nicod P, Sadeghi H.
Mechanical recanalization and dilatation of coronary arteries in the acute stage of myocardial infarction. Schweiz Med Wochenschr 1985; 115(45): 1583–1586.
4. Zijlstra F, de Boer MJ, Hoorntje JC, Reiffers S, Reiber JH, Suryapranata H. A comparison of immediate coronary angioplasty with intravenous streptokinase in acute myocardial infarction.
New Engl J Med 1993; 328(10): 680–684.
5. Zijlstra F, de Boer MJ, Ottervanger JP, Liem AL, Hoorntje JC, Suryapranata H. Primary coro- nary angioplasty versus intravenous streptokinase in acute myocardial infarction: differences in outcome during a mean follow-up of 18 months. Coron Artery Dis 1994; 5(8): 707–712.
6. Liem AL, Zijlstra F. Favorable long-term results of primary percutaneous transluminal coro- nary angioplasty in acute myocardial infarction compared to intravenous streptokinase treat- ment; a randomized study. Ned Tijdschr Geneeskd 1995; 139(49): 2564–2567.
7. Zeymer U, Uebis R, Vogt A, Glunz HG, Vohringer HF, Harmjanz D, Neuhaus KL, ALKK-Study Group. Randomized comparison of percutaneous transluminal coronary angioplasty and med- ical therapy in stable survivors of acute myocardial infarction with single vessel disease: a study of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausarzte. Circulation 2003;
108(11): 1324–1328.
Key message
Thrombolysis is not essential when establishing reperfusion in patients with acute myocardial infarction.
Why it’s important
Although the final step of mechanical disobliteration of occlusive thrombus was not taken in this study, it showed for the first time that thrombotic lesions responded to mechanical therapy in the absence of adjunctive thrombolytic therapy.
Strengths
At the time of this study not even systemic thrombolysis had been established as a proven ther- apy. The open artery hypothesis was accepted by most, but it was believed that thrombus required thrombolytic therapy. This article shows that in the presence of thrombus equivalent results can be obtained with or without thrombolysis. Importantly the study shows that left ventricular function improves if one successfully opens the artery.
Weaknesses
The essential step of comparing mechanical recanalization with and without adjuvant throm- bolytic therapy in a single population was not taken.
Relevance
Primary PCI for myocardial infarction is now recognized as the treatment of choice for ST ele- vation MI. At the time the work reported here was performed, the concept was truly ground- breaking, while thrombolysis was used as adjunctive therapy in patients with complete occlusions, the direction of thinking is clear. Direct angioplasty for myocardial infarction was being reported within a year of this publication.
Transluminal coronary angioplasty and early restenosis.
Fibrocellular occlusion after wall laceration
Author
Essed CE, Van den Brand M, Becker AE
Reference
Br Heart J 1983; 49(4): 393–396
Abstract
Transluminal coronary angioplasty was performed in a 51 year old man with a localised narrow- ing of the proximal segment of the left anterior descending coronary artery. Initial inflations with a small size balloon catheter were unsuccessful. A second attempt, during the same procedure, using a larger calibre catheter relieved the obstruction but produced a dissection. Angina pec- toris reappeared approximately three months later. Another attempt to relieve the obstruction by angioplasty, five months after the initial procedure, induced ST segment elevation before angio- plasty, followed by ventricular fibrillation and death. The necropsy showed a split in the pre- existent sclerotic plaque and a dissecting aneurysm of the media. A proliferation of fibrocellular tissue filled the false channel and almost totally occluded the pre-existent arterial lumen. The observation suggests that wall laceration with exposure of smooth muscle cells to blood may have initiated the excessive fibrocellular tissue response. This event may be the underlying pathogenetic mechanism for the occurrence of early restenosis after transluminal coronary angioplasty.
Summary
Post mortem evaluation of a restenotic plaque showed that fibrocellular proliferation, rather than recoil, thrombus or atherosclerosis was responsible for luminal occlusion.
Citation Count 263
Related References
1. Schwartz RS, Huber KC, Murphy JG, Edwards WD, Camrud AR, Vlietstra RE, Holmes DR.
Restenosis and the proportional neointimal response to coronary artery injury: results in a porcine model. J Am Coll Cardiol 1992; 19(2): 267–274.
2. MacLeod DC, Strauss BH, de Jong M, Escaned J, Umans VA, van Suylen RJ, Verkerk A, de Feyter PJ, Serruys PW. Proliferation and extracellular matrix synthesis of smooth muscle cells cultured from human coronary atherosclerotic and restenotic lesions. J Am Coll Cardiol 1994; 23(1): 59–65.
3. Orford JL, Selwyn AP, Ganz P, Popma JJ, Rogers C. The comparative pathobiology of atherosclerosis and restenosis. Am J Cardiol 2000; 86(4B): 6H–11H.
4. Chorny M, Fishbein I, Golomb G. Drug delivery systems for the treatment of restenosis. Crit Rev Ther Drug Carrier Syst 2000; 17(3): 249–284.
5. Waksman R, Cheneau E, Ajani AE, White RL, Pinnow E, Torguson R, Deible R, Satler LF, Pichard AD, Kent KM, Teirstein PS, Lindsay J. Intracoronary radiation therapy improves the clin- ical and angiographic outcomes of diffuse in-stent restenotic lesions: results of the Washington Radiation for In-Stent Restenosis Trial for Long Lesions (Long WRIST) Studies. Circulation 2003; 107(13): 1744–1749.
6. Farb A, Burke AP, Kolodgie FD, Virmani R. Pathological mechanisms of fatal late coronary stent thrombosis in humans. Circulation 2003; 108(14): 1701–1706.
7. Indolfi C, Pavia M, Angelillo IF. Drug-eluting stents versus bare metal stents in percutaneous coronary interventions (a meta-analysis). Am J Cardiol 2005; 95(10): 1146–1152.
Key message
Intimal proliferation in response to arterial wall injury may explain early restenosis.
Strengths
The anatomical and histopathological detail.
Weaknesses
This is a case report. Larger series followed, but reliance on post-mortem data always raised the possibility that the restenosis seen in the population who died, might be different from gen- eral restenosis. Only with the advent of atherectomy was this issue finally decided.
Relevance
While merely a case report, this article managed to identify the true nature of coronary resteno- sis for the first time. Throughout the 1980s and early 1990s a much greater understanding of the process was developed, but yet many of the treatments tried showed scant regard for the essential pathobiological nature of balloon/stent injury and the fibrocellular response which fol- lowed. Only with the advent of antimitotic drug eluting stents has any real impact on this process been made.
Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty
Author
Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L
Reference
New Engl J Med 1987; 316(12): 701–706
Abstract
Occlusion and restenosis are the most common reasons that transluminal balloon angioplasty may fail to provide long-term benefit. An intravascular mechanical support was therefore developed with the aim of preventing restenosis and sudden closure of diseased arteries after angioplasty. The endoprosthesis consists of a self-expandable stainless-steel mesh that can be implanted nonsurgi- cally in the coronary or peripheral arteries. Experiments in animals showed complete intimal cover- age within weeks and no late thrombosis during a follow-up period of up to one year. We performed 10 implantations in 6 patients for iliac or femoral arterial disease; 24 coronary-artery stents were implanted in 19 patients who presented with coronary-artery restenoses (n 17) or abrupt closure (n 4) after transluminal angioplasty or deterioration of coronary-bypass grafts (n 3). We observed three complications in the group with coronary disease. One thrombotic occlusion of a stent resulted in asymptomatic closure, a second acute thrombosis was managed successfully with thrombolysis, and one patient died after bypass surgery for a suspected but unfound occlusion.
Follow-up in the patients has continued for nine months without evidence of any further restenoses within the stented segments. Our preliminary experience suggests that this vascular endoprosthe- sis may offer a useful way to prevent occlusion and restenosis after transluminal angioplasty. Long- term follow-up will be required to validate the early success of this procedure.
Summary
Endovascular stainless-steel stents were tested in animal models, and implanted in human peripheral and coronary arteries. Coronary patients included those with restenosis after plain old balloon angioplasty (POBA), a group known for high rates of recurrent restenosis and those with abrupt occlusion, for whom there was at this time no effective intravascular solution. This report consists of evidence of deployability and a low rate of early stent thrombosis.
Citation Count 827
Related References
All 8887 studies of coronary stenting published since.
Key message
Stents can be placed in human coronary arteries percutaneously without substantial risks of acute occlusion, and with some evidence to suggest that restenosis is ameliorated.
Why it’s important
Sigwart and colleagues addressed two of the fundamental problems of coronary angioplasty, dissection and recoil, and applied a logical solution.
Strengths
The structure of the study is logical, moving from animal studies to peripheral arterial studies and finally to high-risk coronary lesions. Follow up is excellent, with repeat angiography at a time when restenosis is likely to have occurred.
Weaknesses
This is only a pilot study. No evidence of the superiority of stenting over conventional manage- ment is presented, and the problems of early stent occlusion are clear, but cannot be evaluated in such a small population.
Relevance
Stenting is now regarded as an essential component of PCI. Yet when Sigwart and colleagues performed this work, it was by no means clear that placing and leaving a lump of metal in a coronary artery was sensible or safe. By this time many adjunctive techniques were being explored, most have since disappeared or become niche products. Of all the ideas generated only stenting has truly stood the test of time.
The future
So what is the future of PCI? This brief trip through history shows that the future lies in identify- ing the important clinical problems of PCI and using the imagination and creativity of interven- tionists harnessed with the expertise of our colleagues in basic science, imaging and technology, to help solve the remaining issues and the as yet, unknown, problems that may emerge. We will need to be as inventive, bold and brave as our predecessors if we are to make another quantum leap in our ability to make further progress in helping our patients.
Unsolved problems include bifurcation lesions, chronic occlusions, restenosis in the drug- eluting stent era, and the absence of long term outcome comparisons of current practices and strategies versus CABG, both in terms of mortality and cost per quality adjusted life-years.
None of the bifurcation stents currently being tested seem user-friendly enough to have a great future, but this may simply be a matter of time. Guidewires capable of forcing their way through fibrous tissue have been developed, and can now provide directional control, but as yet, no system allowing completely safe luminal tracking, has been developed. Whether multi- slice computerized tomography (MSCT), intracoronary ultrasound and systems which can detect the change in electrical parameters between media and intima, will become part of routine PCI is unclear.
Healthcare organizations and others who fund cardiovascular care will want evidence that PCI and adjunctive therapies and pre and post PCI investigations, are necessary and cost effec- tive. So, we may have the technology, the skills, the enthusiasm and the capacity to provide an increasing PCI service for all presentations and types of coronary heart disease, but not the sanction of those who have to pay for these effective but costly treatments.
Whether increasingly effective primary and secondary prevention will reduce the need for PCI is also not known, but it is likely that these therapies will merely delay, rather than remove the need for PCI. Our patients will be older with co-morbidity and the procedure will be more
medical and surgical specialities. Indeed, as a result of our enthusiasm, efforts and capability to offer myocardial revascularization and effective secondary prevention to our patients, we are largely responsible for increasing the average age of the patients operated on by our surgical colleagues.
Comparisons of drug eluting stenting for multivessel disease versus CABG are underway.
Few doubt that this will show equivalence, but will this be cost effective? Advances in medical therapy may also change the character and presentation of coronary heart disease.
The greatest challenge for the interventionalist, is not the lesions that we treat, it is those that we leave. We rely on antiplatelet drugs, statins and angiotensin-converting enzyme (ACE) inhibitors to pacify these lesions. As our therapies improve, will there is any need for the inter- ventionalist in the future? I think we are safe from extinction for the next 20 years, but after that all bets are off.
angioplasty
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