PCI versus medical treatment

PCI has been compared with medical treatment in patients with CAD in several randomised clinical trials (table 8.4). In the ACME trial13 involving patients with symptomatic single vessel CAD, the group allocated to PTCA had earlier and more complete relief of angina and better exercise performance during follow up. However, patients undergoing PTCA had an increased risk of undergoing emergency CABG because of procedural complications, although there were no differences with respect to death and infarction. Similar findings were reported in the RITA-2 trial14 comparing PTCA with medical treatment in symptomatic patients with single and double

Figure 8.7. (A) Risk ratio and 95% confidence intervals for death or MI after CABG or PTCA for multivessel CAD at one, three, and five years in six randomised trials. (B) Risk ratio and 95% confidence intervals for reintervention after an initial strategy of CABG or PTCA for multivessel CAD at one year of follow up in six randomised trials. Reproduced with permission from Meier B. Balloon angioplasty. In: Topol EJ, ed. Comprehensive cardiovascular medicine. Philadelphia: Lippincott-Raven, 1998:2251-84.

Figure 8.7. (A) Risk ratio and 95% confidence intervals for death or MI after CABG or PTCA for multivessel CAD at one, three, and five years in six randomised trials. (B) Risk ratio and 95% confidence intervals for reintervention after an initial strategy of CABG or PTCA for multivessel CAD at one year of follow up in six randomised trials. Reproduced with permission from Meier B. Balloon angioplasty. In: Topol EJ, ed. Comprehensive cardiovascular medicine. Philadelphia: Lippincott-Raven, 1998:2251-84.

vessel disease. Patients undergoing PTCA featured greater relief of angina and better exercise performance at an increased risk of death and MI (6% PTCA group v 3% medically treated group, p = 0.02), largely because of enzyme elevations at the time of the procedure.

In the recently reported AVERT trial a strategy of aggressive lipid lowering treatment with atorvastatin was compared with PCI in minimally symptomatic (Canadian Cardiovascular Society class I—II), mostly single vessel CAD patients.w79 There was a non-significant trend towards a reduction in the composite end point of death, MI, revascularisation, and worsening angina in patients allocated to atorvastatin (13% atorvastatin group v 21% PCI group, p = ns), but the differences in favour of atorv-astatin treatment were exclusively limited to a decreased revascularisation and rehospitalisation rate. As in previous trials patients undergoing PCI in AVERT had significantly improved symptoms compared with medically treated patients, and one wonders why the interventionally treated patients had adequate cholesterol control withheld despite established evidence of their beneficial effect in secondary prevention. All the above studies comparing PCI with medical treatment do not reflect current practice of interventional cardiology with widespread utilisation of coronary stents and glycoprotein IIb/IIIa inhibitors, which contributed significantly to a decrease in major adverse cardiac events and target vessel revascularisation. In summary, PTCA effectively relieves symptoms and improves exercise performance at the cost of a small incidence of MI and a need for reinterventions because of restenosis in patients with single vessel CAD.

PCI versus bypass surgery PTCA has been compared with left internal mammary artery (LIMA) grafting in 134 patients with isolated proximal left anterior descending artery (LAD) stenosis in the randomised Lausanne study (table 8.5).w80 At five years of follow up there were no differences between patients allocated to PTCA and LIMA grafting with respect to death, Q wave MI, functional status, and antianginal drug treatment. However, patients allocated to PTCA had more frequent non-Q wave infarction related to abrupt closure or unstable angina related to restenosis, and required addi-

tional revascularisation procedures more often compared with surgically revascularised patients. The same investigators initiated a randomised trial in 123 patients with isolated proximal LAD stenosis comparing coronary stenting with LIMA grafting. There were no differences in the incidence of in-hospital death and MI, with low rates in both groups. During follow up the combined end point of death and MI was equal; however, 21% of stented patients required additional revascularisation compared with no patients in the surgical group.

Several randomised trials compared PTCA with CABG in patients with multivessel CAD.15 16 w81-85 The results of these trials have been remarkably consistent (fig 8.7) and revealed that an initial strategy of PTCA and CABG in selected patients with multivessel CAD results in: (1) similar survival and freedom from MI 1-7 years after the procedure; (2) a better relief of angina in CABG patients at least during the first year after the intervention; (3) an increased need for further coronary interventions in patients allocated to PTCA mostly during the first year after the intervention; and (4) similar long term costs during a follow up period of 5-8 years. An important issue raised in the BARI trial56 was that the subgroup of treated diabetic patients had significantly better survival rates with CABG (66% PTCA v 81% CABG, p = 0.003).

The advent of coronary stents has significantly reduced the need for target lesion revas-cularisation and therefore trials have been initiated comparing stent supported PTCA with CABG in patients with multivessel CAD (ARTS, SOS, ERACI-II). The one year follow up results of ARTS have recently been reported (P Serruys, European Society of Cardiology, Barcelona, 1999) and revealed: (1) a similar incidence of death, MI and stroke; (2) an increased need for additional revascularisation procedures in patients initially treated by coronary stenting, and (3) a cost saving of 4278 Euros during the initial hospitalisation and of 2965 Euros at one year follow up in favour of coronary stenting. The most important finding of ARTS is the reduction by more than half in the need for additional revascularisation procedures in patients undergoing coronary stenting (17%) as compared with the previous PTCA/ CABG trials featuring revascularisation rates of 30-40% at one year follow up, confirming the hypothesis that stents improve long term outcome (table 8.5). An even further improvement of PCI can be predicted by the addition of glycoprotein IIb/IIIa inhibitors to coronary stenting as indicated by the complementary benefit of abciximab and coronary stenting in the EPISTENT trial12 (table 8.1). Compared with coronary stenting alone, the addition of abciximab resulted in improved survival at one year follow up (2.4% stent alone v 1.0% stent plus abciximab, p = 0.04) and an 18% reduction in target vessel revascularisation (10.6% stent alone v 8.7% stent plus abciximab, p = 0.2), which became significant in diabetic patients (16.6% stent alone v 8.1% stent plus abciximab, p = 0.02).

In summary, since there are no major differences in prognosis between the two treatment modalities, in non-diabetic patients with multi-vessel disease and maintained left ventricular function amenable to both PCI and CABG, the choice of revascularisation method rests on weighing the more invasive nature of CABG against the increased need of additional revas-cularisation after PCI.

1. Gruntzig AR, Senning A, Siegenthaler WE.

Nonoperative dilatation of coronary-artery stenosis. Percutaneous transluminal coronary angioplasty. N Engl J Med 1979;301:61-8.

• Original paper by Andreas Gruntzig introducing balloon angioplasty into clinical practice.

2. Bittl JA. Advances in coronary angioplasty. N Engl J Med 1996;335:1290-302

• Recent comprehensive review about percutaneous coronary interventions, adjunctive pharmacologic treatment and comparison with medical and surgical treatment in patients with coronary artery disease.

Trial acronyms

ACME: Angioplasty Compared with Medicine ARTS: Arterial Revascularisation Therapy Study AVERT: Atorvastatin Versus Revascularization Treatment Investigators

BARI: Bypass Angioplasty Revascularization Investigation BENESTENT: Belgium-Netherlands Stent Study BOAT: Balloon versus Optimal Atherectomy Trial CAPTURE: Chimeric 7E3 Anti-Platelet in Unstable Angina

Refractory to Standard Treatment Trial CAVEAT: Coronary Angioplasty Versus Excisional Atherectomy Trial

CLASSICS: CLopidogrel plus Aspirin Stent International Cooperative Study

DEBATE: Doppler Endpoints Balloon Angioplasty Trial Europe EPIC: Evaluation of IIb/IIIa platelet receptor antagonist 7E3 in Preventing Ischemic Complications trial EPILOG: Evaluation of PTCA to Improve Long-term Outcome by c7E3 GP IIb/IIIa receptor blockade trial EPISTENT: Evaluation of Platelet GP IIb/IIIa Inhibitor for Stenting

ERBAC: Excimer laser, Rotational atherectomy, and Balloon

Angioplasty Comparison Study FANTASTIC: Full Anticoagulation Versus Ticlopidine plus Aspirin

After Stent Implantation Trial GUSTO: Global Use of Strategies To Open Occluded Coronary Arteries

HELVETICA: Hirudin in a European Trial Versus Heparin in the

Prevention of Restenosis After PTCA IMPACT: Integrilin to Manage Platelet Aggregation to Combat

Thrombosis Trial ISAR: Intracoronary Stenting and Antithrombotic Regimen Trial MATTIS: Multicenter Aspirin and Ticlopidine After Intracoronary Stenting Trial

OCBAS: Optimal Coronary Balloon Angioplasty with Provisional

Stenting versus Stent Trial RAPPORT: Reo Pro and Primary PTCA Organisation and

Randomized Trial REDUCE: Reduction of Restenosis After PTCA, Early Administration of Reviparin in a Double-blind, Unfractionated Heparin and Placebo Controlled Evaluation RESTORE: Randomised Efficacy Study of Tirofiban for Outcomes and Restenosis Trial RITA: Randomised Intervention Treatment of Angina Trial SOS: Stent Or Surgery trial STARS: Stent Anticoagulation Regimen Study STRESS: Stent Restenosis Study website extra

Additional references appear on the Heart website


3. Narins CR, Holmes DR Jr, Topol EJ. A call for provisional stenting: the balloon is back! Circulation 1998;97:1298-305.

• Excellent summary of the state of contemporary percutaneous coronary interventions and description of the concept of provisional stenting.

4. Goy JJ, Eeckhout E. Intracoronary stenting. Lancet 1998;351:1943-9.

• Recent review of the coronary artery stents with focus on established evidence from clinical trials.

5. Serruys PW, De Jaegere P, Kiemeneij F, et al. A

comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. N Engl J Med 1994;331:489-95.

6. Fischman DL, Leon MB, Baim DS, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. N Engl J Med 1994;331:496-501.

7. Kimura T, Yokoi H, Nakagawa Y, et al. Three-year follow-up after implantation of metallic coronary-artery stents. N Engl J Med 1996;334:561-6.

8. Reifart N, Vandormael M, Krajcar M, et al. Randomized comparison of angioplasty of complex coronary lesions at a single center. Excimer laser, rotational atherectomy, and balloon angioplasty comparison (ERBAC) study. Circulation 1997;96:91-8.

9. Leon MB, Baim DS, Popma JJ, et al. A clinical trial comparing three antithrombotic-drug regimens after coronary-artery stenting. Stent anticoagulation restenosis study investigators. N Engl J Med 1998;339:1665-71.

10. EPILOG Investigators. Platelet glycoprotein Ilb/IIIa receptor blockade and low-dose heparin during percutaneous coronary revascularization. The EPILOG investigators. N Engl J Med 1997;336:1689-96.

11. Topol EJ, Serruys PW. Frontiers in interventional cardiology. Circulation 1998;98:1802-20

• Review article dealing with PCI and special emphasis on coronary artery stents, adjunctive pharmacologic therapy and future perspectives.

12. Lincoff AM, Califf RM, Moliterno DJ, et al.

Complementary clinical benefits of coronary-artery stenting and blockade of platelet glycoprotein IIb/IIIa receptors. Evaluation of platelet IIb/IIIa inhibition in stenting investigators. N Engl J Med 1999;341:319-27.

13. Parisi AF, Folland ED, Hartigan P. A comparison of angioplasty with medical therapy in the treatment of single-vessel coronary artery disease. N EnglJMed 1992;326:10-16.

14. RITA-2 Trial Participants. Coronary angioplasty versus medical therapy for angina: the second randomised intervention treatment of angina (RITA-2) trial. RITA-2 trial participants. Lancet 1997;350:461-8.

15. Pocock SJ, Henderson RA, Rickards AF, et al.

Meta-analysis of randomised trials comparing coronary angioplasty with bypass surgery. Lancet 1995;346:1184-9.

16. BARI Investigators. Comparison of coronary bypass surgery with angioplasty in patients with multivessel disease. The bypass angioplasty revascularization investigation (BARI) investigators. N Engl J Med 1996;335:217-25.


0 0

Post a comment