Читать книгу Practical Cardiovascular Medicine - Elias B. Hanna - Страница 206

General PCI indications and pitfalls- Consider the following three settings:

 PCI is a first-line consideration for one- or two-vessel CAD, along with severe angina.

 PCI is an alternative to CABG in three-vessel CAD, or two-vessel CAD involving the proximal LAD, with an angiographic SYNTAX score ≤22 and no diabetes.

 In three-vessel CAD, or complex two-vessel disease involving the LAD (especially proximal LAD), with either diabetes or SYNTAX score >22, CABG significantly improves survival in comparison with PCI (SYNTAX and FREEDOM trials).

PCI is flawed by a risk of restenosis of 20% with BMS, which is reduced to <10% with DES. At the 5-year follow-up of PCI populations without extensive CAD, 20-25% of patients had recurrent events, mainly recurrent symptoms with a need for revascularization. Approximately 50% of these events occur in the target vessel, mainly the target stented lesion, while 50% occur in remote vessels (non-culprit disease progression).^67,71 Those events would be more common in patients with diffuse and complex CAD, who not only have a higher risk of restenosis but also a higher risk of progression of non-target lesions/vessels, as PCI only addresses the focal disease.

PCI vs medical therapy-The COURAGE trial evaluated patients with stable, rather mild angina, normal EF, and a good functional status (mean stress test exercise time = 7 min).⁷² It included a large population of patients with multivessel CAD (~70%, including 30% three-vessel CAD) and patients with proximal LAD disease (~35%). Initial PCI did not improve death or MI outcomes as compared to initial medical therapy ± delayed PCI (PCI was eventually performed in 31% of patients in the medical therapy arm). COURAGE results, however, do not dismiss the value of PCI in highly symptomatic patients with frequent anginal episodes (i.e., daily), those with severely limiting angina, or those with persistent angina despite medical therapy, patients in whom PCI has strong effects on quality of life and functional status, according to the COURAGE quality-of-life substudy.⁷³

Similar results were replicated in the BARI 2D trial.⁷⁴ In diabetic patients with mild angina, initial revascularization did not reduce death or MI in comparison to initial medical therapy, although 40% of patients eventually crossed over from medical therapy to revascularization over 5 years. More specifically, in patients with one- or two-vessel CAD, initial revascularization with PCI did not reduce death or MI in comparison with medical therapy (PCI stratum). In patients with extensive CAD randomized to initial CABG vs. medical therapy (CABG stratum), initial CABG reduced MI (14.6% vs. 7.4% at 5 years) but not death in comparison with medical therapy.

The FAME 2 trial randomized patients who mainly had one- or two-vessel CAD (65% proximal/mid-LAD) to FFR-guided PCI vs. medical therapy. FAME-2 trial differs from the COURAGE trial mainly in the use of FFR guidance. PCI strikingly reduced the risk of urgent revascularization at 8 months and 5 years (6% vs 21%), as well as all future revascularizations (13% vs 51%), more so in lesions with FFR≤0.65.⁶⁶ Yet PCI failed to show any mortality or MI reduction even at 5 years.²⁸ While PCI significantly reduced the risk of late spontaneous MI, which occurred in 10% of medically managed patients vs. 6.5% of PCI patients at 5 years, it was associated with a risk of periprocedural MI (2%) and stent thrombosis (1%) which, beside non-target lesion progression, negated the overall MI benefit. Moreover, late STEMI was not reduced by PCI and was similarly low in both arms (1.6% at 5 years). It was speculated that long-term mortality rates might diverge in favor of PCI, as spontaneous MI has a larger impact on long-term mortality than periprocedural MI,⁷⁵ but this was not seen at 5 years (not even a trend).

The ISCHEMIA trial selected stable patients with moderate or severe ischemia on stress testing (≥10% of the LV). Those patients were subjected to coronary CTA to confirm CAD diagnosis (≥50% in a major epicardial vessel) and to rule out left main disease; ~5% of screened patients had left main disease and were excluded. Patients with CAD were randomized to medical therapy vs. cardiac catheterization followed by revascularization; patients in the medical therapy arm only received CTA at baseline, not cardiac catheterization.¹⁸ Unlike COURAGE and BARI 2D, this trial randomized patients before any catheterization was done. In a way, this study did not just question the value of revascularization, but also the value of invasive coronary angiography after a severely abnormal stress test. At baseline, in both groups, 45% of patients had 3-vessel CAD on CTA, 31% had 2-vessel CAD, 47% had proximal LAD disease, and 42% had diabetes. In the invasive arm, only 13% did not have significant CAD on catheterization, and thus most patients underwent revascularization, of whom 76% received PCI and 24% received CABG. At 4 years of follow-up, invasive strategy and revascularization did not affect mortality (~6.5% in both arms), MI, or the combined endpoint of MI/mortality (11.7% for invasive vs 13.9% for conservative). Invasive strategy increased MI by ~2% in the first 6 months (large periprocedural MI) and reduced it by 4% between 6 months and 5 years (spontaneous MI), with a nearly neutral overall effect. This lack of benefit was consistent across all subgroups, including 3-vessel CAD, proximal LAD, and diabetic subgroups; and was not affected by ischemia or anatomic severity.⁶³ Of note, only EF>35% was included, and EF was mostly normal (median 60%). The biggest pitfall is that >95% of patients had CCS 0-II angina and most patients had infrequent angina, monthly or less.